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                     HOUSE OF REPRESENTATIVES  
                                                        
_______________________________________________________________________

                                     

 
                         21ST CENTURY CURES ACT

                               ----------                              

                              R E P O R T

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                         [TO ACCOMPANY H.R. 6]

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


  July 7, 2015.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed
              


                         
114th Congress  }                                        { Rept. 114-190
                        HOUSE OF REPRESENTATIVES
 1st Session    }                                        {  Part 1

======================================================================




                         21ST CENTURY CURES ACT

                                _______
                                

  July 7, 2015.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

                                _______
                                

  Mr. Upton, from the Committee on Energy and Commerce, submitted the 
                               following

                              R E P O R T

                         [To accompany H.R. 6]

      [Including cost estimate of the Congressional Budget Office]

    The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 6) to accelerate the discovery, development, and 
delivery of 21st century cures, and for other purposes, having 
considered the same, report favorably thereon with an amendment 
and recommend that the bill as amended do pass.

                                CONTENTS

                                                                   Page
Purpose and Summary..............................................    85
Background and Need for Legislation..............................    85
Hearings.........................................................    85
Committee Consideration..........................................    88
Committee Votes..................................................    88
Committee Oversight Findings.....................................    90
Statement of General Performance Goals and Objectives............    90
New Budget Authority, Entitlement Authority, and Tax Expenditures    90
Earmark, Limited Tax Benefits, and Limited Tariff Benefits.......    90
Committee Cost Estimate..........................................    90
Congressional Budget Office Estimate.............................    90
Federal Mandates Statement.......................................   104
Duplication of Federal Programs..................................   104
Disclosure of Directed Rule Makings..............................   105
Advisory Committee Statement.....................................   105
Applicability to Legislative Branch..............................   105
Section-by-Section Analysis of the Legislation...................   105
Changes in Existing Law Made by the Bill, as Reported............   129

    The amendment is as follows:
  Strike all after the enacting clause and insert the 
following:

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

  (a) Short Title.--This Act may be cited as the ``21st Century Cures 
Act''.
  (b) Table of Contents.--The table of contents for this Act is as 
follows:

Sec. 1. Short title; table of contents.

                           TITLE I--DISCOVERY

           Subtitle A--National Institutes of Health Funding

Sec. 1001. National Institutes of Health reauthorization.
Sec. 1002. NIH Innovation Fund.

 Subtitle B--National Institutes of Health Planning and Administration

Sec. 1021. NIH research strategic plan.
Sec. 1022. Increasing accountability at the National Institutes of 
Health.
Sec. 1023. Reducing administrative burdens of researchers.
Sec. 1024. Exemption for the National Institutes of Health from the 
Paperwork Reduction Act requirements.
Sec. 1025. NIH travel.
Sec. 1026. Other transactions authority.
Sec. 1027. NCATS phase IIB restriction.
Sec. 1028. High-risk, high-reward research.
Sec. 1029. Sense of Congress on increased inclusion of underrepresented 
communities in clinical trials.

            Subtitle C--Supporting Young Emerging Scientists

Sec. 1041. Improvement of loan repayment programs of the National 
Institutes of Health.
Sec. 1042. Report.

                   Subtitle D--Capstone Grant Program

Sec. 1061. Capstone award.

     Subtitle E--Promoting Pediatric Research Through the National 
                          Institutes of Health

Sec. 1081. National pediatric research network.
Sec. 1082. Global pediatric clinical study network sense of Congress.
Sec. 1083. Appropriate age groupings in clinical research.

 Subtitle F--Advancement of the National Institutes of Health Research 
                            and Data Access

Sec. 1101. Sharing of data generated through NIH-funded research.
Sec. 1102. Standardization of data in Clinical Trial Registry Data Bank 
on eligibility for clinical trials.

            Subtitle G--Facilitating Collaborative Research

Sec. 1121. Clinical trial data system.
Sec. 1122. National neurological diseases surveillance system.
Sec. 1123. Data on natural history of diseases.
Sec. 1124. Accessing, sharing, and using health data for research 
purposes.

               Subtitle H--Council for 21st Century Cures

Sec. 1141. Council for 21st Century Cures.

                         TITLE II--DEVELOPMENT

              Subtitle A--Patient-Focused Drug Development

Sec. 2001. Development and use of patient experience data to enhance 
structured risk-benefit assessment framework.

      Subtitle B--Qualification and Use of Drug Development Tools

Sec. 2021. Qualification of drug development tools.
Sec. 2022. Accelerated approval development plan.

           Subtitle C--FDA Advancement of Precision Medicine

Sec. 2041. Precision medicine guidance and other programs of Food and 
Drug Administration.

        Subtitle D--Modern Trial Design and Evidence Development

Sec. 2061. Broader application of Bayesian statistics and adaptive 
trial designs.
Sec. 2062. Utilizing evidence from clinical experience.
Sec. 2063. Streamlined data review program.

                 Subtitle E--Expediting Patient Access

Sec. 2081. Sense of Congress.
Sec. 2082. Expanded access policy.
Sec. 2083. Finalizing draft guidance on expanded access.

    Subtitle F--Facilitating Responsible Manufacturer Communications

Sec. 2101. Facilitating dissemination of health care economic 
information.
Sec. 2102. Facilitating responsible communication of scientific and 
medical developments.

                Subtitle G--Antibiotic Drug Development

Sec. 2121. Approval of certain drugs for use in a limited population of 
patients.
Sec. 2122. Susceptibility test interpretive criteria for 
microorganisms.
Sec. 2123. Encouraging the development and use of new antimicrobial 
drugs.

         Subtitle H--Vaccine Access, Certainty, and Innovation

Sec. 2141. Timely review of vaccines by the Advisory Committee on 
Immunization Practices.
Sec. 2142. Review of processes and consistency of ACIP recommendations.
Sec. 2143. Meetings between CDC and vaccine developers.

   Subtitle I--Orphan Product Extensions Now; Incentives for Certain 
                    Products for Limited Populations

Sec. 2151. Extension of exclusivity periods for a drug approved for a 
new indication for a rare disease or condition.
Sec. 2152. Reauthorization of rare pediatric disease priority review 
voucher incentive program.

       Subtitle J--Domestic Manufacturing and Export Efficiencies

Sec. 2161. Grants for studying the process of continuous drug 
manufacturing.
Sec. 2162. Re-exportation among members of the European Economic Area.

           Subtitle K--Enhancing Combination Products Review

Sec. 2181. Enhancing combination products review.

          Subtitle L--Priority Review for Breakthrough Devices

Sec. 2201. Priority review for breakthrough devices.

       Subtitle M--Medical Device Regulatory Process Improvements

Sec. 2221. Third-party quality system assessment.
Sec. 2222. Valid scientific evidence.
Sec. 2223. Training and oversight in least burdensome appropriate means 
concept.
Sec. 2224. Recognition of standards.
Sec. 2225. Easing regulatory burden with respect to certain class I and 
class II devices.
Sec. 2226. Advisory committee process.
Sec. 2227. Humanitarian device exemption application.
Sec. 2228. CLIA waiver study design guidance for in vitro diagnostics.

Subtitle N--Sensible Oversight for Technology Which Advances Regulatory 
                               Efficiency

Sec. 2241. Health software.
Sec. 2242. Applicability and inapplicability of regulation.
Sec. 2243. Exclusion from definition of device.

                Subtitle O--Streamlining Clinical Trials

Sec. 2261. Protection of human subjects in research; applicability of 
rules.
Sec. 2262. Use of non-local institutional review boards for review of 
investigational device exemptions and human device exemptions.
Sec. 2263. Alteration or waiver of informed consent for clinical 
investigations.

     Subtitle P--Improving Scientific Expertise and Outreach at FDA

Sec. 2281. Silvio O. Conte Senior Biomedical Research Service.
Sec. 2282. Enabling FDA scientific engagement.
Sec. 2283. Reagan-Udall Foundation for the Food and Drug 
Administration.
Sec. 2284. Collection of certain voluntary information exempted from 
Paperwork Reduction Act.
Sec. 2285. Hiring authority for scientific, technical, and professional 
personnel.

       Subtitle Q--Exempting From Sequestration Certain User Fees

Sec. 2301. Exempting from sequestration certain user fees of Food and 
Drug Administration.

                          TITLE III--DELIVERY

                      Subtitle A--Interoperability

Sec. 3001. Ensuring interoperability of health information technology.

                         Subtitle B--Telehealth

Sec. 3021. Telehealth services under the Medicare program.

  Subtitle C--Encouraging Continuing Medical Education for Physicians

Sec. 3041. Exempting from manufacturer transparency reporting certain 
transfers used for educational purposes.

              Subtitle D--Disposable Medical Technologies

Sec. 3061. Treatment of certain items and devices.

              Subtitle E--Local Coverage Decision Reforms

Sec. 3081. Improvements in the Medicare local coverage determination 
(LCD) process.

      Subtitle F--Medicare Pharmaceutical and Technology Ombudsman

Sec. 3101. Medicare pharmaceutical and technology ombudsman.

        Subtitle G--Medicare Site-of-Service Price Transparency

Sec. 3121. Medicare site-of-Service price transparency.

  Subtitle H--Medicare Part D Patient Safety and Drug Abuse Prevention

Sec. 3141. Programs to prevent prescription drug abuse under Medicare 
parts C and D.

             TITLE IV--MEDICAID, MEDICARE, AND OTHER REFORMS

               Subtitle A--Medicaid and Medicare Reforms

Sec. 4001. Limiting Federal Medicaid reimbursement to States for 
durable medical equipment (DME) to Medicare payment rates.
Sec. 4002. Medicare payment incentive for the transition from 
traditional x-ray imaging to digital radiography and other Medicare 
imaging payment provision.
Sec. 4003. Implementation of Office of Inspector General recommendation 
to delay certain Medicare prescription drug plan prepayments.

                   Subtitle B--Cures Innovation Fund

Sec. 4041. Cures Innovation Fund.

                       Subtitle C--Other Reforms

Sec. 4061. SPR drawdown.

                       Subtitle D--Miscellaneous

Sec. 4081. Lyme disease and other tick-borne diseases.

                           TITLE I--DISCOVERY

           Subtitle A--National Institutes of Health Funding

SEC. 1001. NATIONAL INSTITUTES OF HEALTH REAUTHORIZATION.

  Section 402A(a)(1) of the Public Health Service Act (42 U.S.C. 
282a(a)(1)) is amended--
          (1) in subparagraph (B), by striking at the end ``and'';
          (2) in subparagraph (C), by striking at the end the period 
        and inserting a semicolon; and
          (3) by adding at the end the following new subparagraphs:
                  ``(D) $31,811,000,000 for fiscal year 2016;
                  ``(E) $33,331,000,000 for fiscal year 2017; and
                  ``(F) $34,851,000,000 for fiscal year 2018.''.

SEC. 1002. NIH INNOVATION FUND.

  (a) Use of Innovation Fund.--Section 402(b) of the Public Health 
Service Act (42 U.S.C. 282(b)) is amended--
          (1) in paragraph (23), by striking at the end ``and'';
          (2) in paragraph (24), by striking at the end the period and 
        inserting ``; and''; and
          (3) by inserting after paragraph (24), the following new 
        paragraph:
          ``(25) shall, with respect to funds appropriated under 
        section 402A(e) to the NIH Innovation Fund, allocate such funds 
        to the national research institutes and national centers for 
        conducting and supporting innovation fund initiatives 
        identified under paragraph (3) of such section.''.
  (b) Establishment of Innovation Fund.--Section 402A of the Public 
Health Service Act (42 U.S.C. 282a)is amended--
          (1) by redesignating subsection (e) as subsection (f); and
          (2) by inserting after subsection (d) the following new 
        subsection:
  ``(e) NIH Innovation Fund.--
          ``(1) Establishment.--For the purpose of allocations under 
        section 402(b)(25), there is established a fund to be known as 
        the NIH Innovation Fund. The Director of NIH shall, with 
        respect to funds appropriated to the NIH Innovation Fund, 
        allocate such funds to support biomedical research through the 
        funding of basic, translational, and clinical research.
          ``(2) Amounts made available to fund.--
                  ``(A) In general.--Subject to subparagraph (B), there 
                is authorized to be appropriated, and appropriated, to 
                the NIH Innovation Fund out of any funds in the 
                Treasury not otherwise appropriated, $2,000,000,000 for 
                each of fiscal years 2016 through 2020. The amounts 
                appropriated to the Fund by the preceding sentence 
                shall be in addition to any amounts otherwise made 
                available to the National Institutes of Health.
                  ``(B) Availability subject to appropriations.--
                Amounts in the Fund shall not be available except to 
                the extent and in such amounts as are provided in 
                advance in appropriation Acts.
                  ``(C) Allocation of amounts.--Of the amounts made 
                available from the NIH Innovation Fund for allocations 
                under section 402(b)(25) for a fiscal year--
                          ``(i) not less than $500,000,000 shall be for 
                        the Accelerating Advancement Program under 
                        paragraph (5);
                          ``(ii) not less than 35 percent of such 
                        amounts remaining after subtracting the 
                        allocation for the Accelerating Advancement 
                        Program shall be for early stage investigators 
                        (as defined in paragraph (7));
                          ``(iii) not less than 20 percent of such 
                        amounts remaining after subtracting the 
                        allocation for the Accelerating Advancement 
                        Program shall be for high-risk, high-reward 
                        research under section 409K; and
                          ``(iv) not more than 10 percent of such 
                        amounts (without subtracting the allocation for 
                        the Accelerating Advancement Program) shall be 
                        for intramural research.
                  ``(D) Inapplicability of certain provisions.--Amounts 
                in the NIH Innovation Fund shall not be subject to--
                          ``(i) any transfer authority of the Secretary 
                        or the Director of NIH under section 241, 
                        subsection (c), subsection (d), or any other 
                        provision of law (other than section 402(b)(25) 
                        and this subsection); or
                          ``(ii) the Nonrecurring expenses fund under 
                        section 223 of division G of the Consolidated 
                        Appropriations Act, 2008 (42 U.S.C. 3514a).
          ``(3) Authorized uses.--Amounts in the NIH Innovation Fund 
        established under paragraph (1) may be used only to conduct or 
        support innovative biomedical research through the following:
                  ``(A) Research in which--
                          ``(i) a principal investigator has a specific 
                        project or specific objectives; and
                          ``(ii) funding is tied to pursuit of such 
                        project or objectives.
                  ``(B) Research in which--
                          ``(i) a principal investigator has shown 
                        promise in biomedical research; and
                          ``(ii) funding is not tied to a specific 
                        project or specific objectives.
                  ``(C) Research to be carried out by an early stage 
                investigator (as defined in paragraph (7)).
                  ``(D) Research to be carried out by a small business 
                concern (as defined in section 3 of the Small Business 
                Act).
                  ``(E) The Accelerating Advancement Program under 
                paragraph (5).
                  ``(F) Development and implementation of the strategic 
                plan under paragraph (6).
          ``(4) Coordination.--In funding programs and activities 
        through the NIH Innovation Fund, the Secretary, acting through 
        the Director of NIH, shall--
                  ``(A) ensure coordination among the national research 
                institutes, the national centers, and other 
                departments, agencies, and offices of the Federal 
                Government; and
                  ``(B) minimize unnecessary duplication.
          ``(5) Accelerating advancement program.--The Director of NIH 
        shall establish a program, to be known as the Accelerating 
        Advancement Program, under which--
                  ``(A) the Director of NIH partners with national 
                research institutes and national centers to accomplish 
                important biomedical research objectives; and
                  ``(B) for every $1 made available by the Director of 
                NIH to a national research institute or national center 
                for a research project, the institute or center makes 
                $1 available for such project from funds that are not 
                derived from the NIH Innovation Fund.
          ``(6) Strategic plan.--
                  ``(A) In general.--The Director of NIH shall ensure 
                that scientifically based strategic planning is 
                implemented in support of research priorities, 
                including through development, use, and updating of a 
                research strategic plan that--
                          ``(i) is designed to increase the efficient 
                        and effective focus of biomedical research in a 
                        manner that leverages the best scientific 
                        opportunities through a deliberative planning 
                        process;
                          ``(ii) identifies areas, to be known as 
                        strategic focus areas, in which the resources 
                        of the NIH Innovation Fund can contribute to 
                        the goals of expanding knowledge to address, 
                        and find more effective treatments for, unmet 
                        medical needs in the United States, including 
                        the areas of--
                                  ``(I) biomarkers;
                                  ``(II) precision medicine;
                                  ``(III) infectious diseases, 
                                including pathogens listed as a 
                                qualifying pathogen under section 
                                505E(f) of the Federal Food, Drug, and 
                                Cosmetic Act or listed or designated as 
                                a tropical disease under section 524 of 
                                such Act; and
                                  ``(IV) antibiotics;
                          ``(iii) includes objectives for each such 
                        strategic focus area; and
                          ``(iv) ensures that basic research remains a 
                        priority.
                  ``(B) Updates and reviews.--The Director shall review 
                and, as appropriate, update the research strategic plan 
                under subparagraph (A) not less than every 18 months.
          ``(7) Definition.--In this subsection, the term `early stage 
        investigator' means an investigator who--
                  ``(A) will be the principal investigator or the 
                program director of the proposed research;
                  ``(B) has never been awarded, or has been awarded 
                only once, a substantial, competing grant by the 
                National Institutes of Health for independent research; 
                and
                  ``(C) is within 10 years of having completed--
                          ``(i) the investigator's terminal degree; or
                          ``(ii) a medical residency (or the 
                        equivalent).''.
  (c) Supplement, Not Supplant; Prohibition Against Transfer.--Funds 
appropriated pursuant to section 402A(e) of the Public Health Service 
Act, as inserted by subsection (b)--
          (1) shall be used to supplement, not supplant, the funds 
        otherwise allocated by the National Institutes of Health for 
        biomedical research; and
          (2) notwithstanding any transfer authority in any 
        appropriation Act, shall not be used for any purpose other than 
        allocating funds for conducting and supporting innovation fund 
        initiatives as described in section 402(b)(25) of the Public 
        Health Service Act, as added by subsection (a).

 Subtitle B--National Institutes of Health Planning and Administration

SEC. 1021. NIH RESEARCH STRATEGIC PLAN.

  Section 402 of the Public Health Service Act (42 U.S.C. 282) is 
amended--
          (1) in subsection (b), by amending paragraph (5) to read as 
        follows:
          ``(5) shall ensure that scientifically based strategic 
        planning is implemented in support of research priorities as 
        determined by the agencies of the National Institutes of 
        Health, including through development, use, and updating of the 
        research strategic plan under subsection (m);''; and
          (2) by adding at the end the following:
  ``(m) Research Strategic Plan.--
          ``(1) Five-year plans for biomedical research strategy.--
                  ``(A) In general.--For each successive five-year 
                period beginning with the period of fiscal years 2016 
                through 2020, the Director of NIH, in consultation with 
                the entities described in subparagraph (B), shall 
                develop and maintain a biomedical research strategic 
                plan that--
                          ``(i) is designed to increase the efficient 
                        and effective focus of biomedical research in a 
                        manner that leverages the best scientific 
                        opportunities through a deliberative planning 
                        process;
                          ``(ii) identifies areas, to be known as 
                        strategic focus areas, in which the resources 
                        of the National Institutes of Health can best 
                        contribute to the goal of expanding knowledge 
                        on human health in the United States through 
                        biomedical research; and
                          ``(iii) includes objectives for each such 
                        strategic focus area.
                  ``(B) Entities described.--The entities described in 
                this subparagraph are the directors of the national 
                research institutes and national centers, researchers, 
                patient advocacy groups, and industry leaders.
          ``(2) Use of plan.--The Director of NIH and the directors of 
        the national research institutes and national centers shall use 
        the strategic plan--
                  ``(A) to identify research opportunities; and
                  ``(B) to develop individual strategic plans for the 
                research activities of each of the national research 
                institutes and national centers that--
                          ``(i) have a common template; and
                          ``(ii) identify strategic focus areas in 
                        which the resources of the national research 
                        institutes and national centers can best 
                        contribute to the goal of expanding knowledge 
                        on human health in the United States through 
                        biomedical research.
          ``(3) Contents of plans.--
                  ``(A) Strategic focus areas.--The strategic focus 
                areas identified pursuant to paragraph (1)(A)(ii) 
                shall--
                          ``(i) be identified in a manner that--
                                  ``(I) considers the return on 
                                investment to the United States public 
                                through the investments of the National 
                                Institutes of Health in biomedical 
                                research; and
                                  ``(II) contributes to expanding 
                                knowledge to improve the United States 
                                public's health through biomedical 
                                research; and
                          ``(ii) include overarching and trans-National 
                        Institutes of Health strategic focus areas, to 
                        be known as Mission Priority Focus Areas, which 
                        best serve the goals of preventing or 
                        eliminating the burden of a disease or 
                        condition and scientifically merit enhanced and 
                        focused research over the next 5 years.
                  ``(B) Rare and pediatric diseases and conditions.--In 
                developing and maintaining a strategic plan under this 
                subsection, the Director of NIH shall ensure that rare 
                and pediatric diseases and conditions remain a 
                priority.
                  ``(C) Workforce.--In developing and maintaining a 
                strategic plan under this subsection, the Director of 
                NIH shall ensure that maintaining the biomedical 
                workforce of the future, including the participation by 
                scientists from groups traditionally underrepresented 
                in the scientific workforce, remains a priority.
          ``(4) Initial plan.--Not later than 270 days after the date 
        of enactment of this subsection, the Director of NIH and the 
        directors of the national research institutes and national 
        centers shall--
                  ``(A) complete the initial strategic plan required by 
                paragraphs (1) and (2); and
                  ``(B) make such initial strategic plan publicly 
                available on the website of the National Institutes of 
                Health.
          ``(5) Review; updates.--
                  ``(A) Progress reviews.--Not less than annually, the 
                Director of NIH, in consultation with the directors of 
                the national research institutes and national centers, 
                shall conduct progress reviews for each strategic focus 
                area identified under paragraph (1)(A)(ii).
                  ``(B) Updates.--Not later than the end of the 5-year 
                period covered by the initial strategic plan under this 
                subsection, and every 5 years thereafter, the Director 
                of NIH, in consultation with the directors of the 
                national research institutes and national centers, 
                stakeholders in the scientific field, advocates, and 
                the public at large, shall--
                          ``(i) conduct a review of the plan, including 
                        each strategic focus area identified under 
                        paragraph (2)(B); and
                          ``(ii) update such plan in accordance with 
                        this section.''.

SEC. 1022. INCREASING ACCOUNTABILITY AT THE NATIONAL INSTITUTES OF 
                    HEALTH.

  (a) Appointment and Terms of Directors of National Research 
Institutes and National Centers.--Subsection (a) of section 405 of the 
Public Health Service Act (42 U.S.C. 284) is amended to read as 
follows: ``(a) Appointment; Terms.--
          ``(1) Appointment.--The Director of the National Cancer 
        Institute shall be appointed by the President and the directors 
        of the other national research institutes, as well as the 
        directors of the national centers, shall be appointed by the 
        Director of NIH. The directors of the national research 
        institutes, as well as national centers, shall report directly 
        to the Director of NIH.
          ``(2) Terms.--
                  ``(A) In general.--The term of office of a director 
                of a national research institute or national center 
                shall be 5 years.
                  ``(B) Removal.--The director of a national research 
                institute or national center may be removed from office 
                by the Director of NIH prior to the expiration of such 
                director's 5-year term.
                  ``(C) Reappointment.--At the end of the term of a 
                director of a national research institute or national 
                center, the director may be reappointed. There is no 
                limit on the number of terms a director may serve.
                  ``(D) Vacancies.--If the office of a director of a 
                national research institute or national center becomes 
                vacant before the end of such director's term, the 
                director appointed to fill the vacancy shall be 
                appointed for a 5-year term starting on the date of 
                such appointment.
                  ``(E) Transitional provision.--Each director of a 
                national research institute or national center serving 
                on the date of enactment of the 21st Century Cures Act 
                is deemed to be appointed for a 5-year term under this 
                subsection starting on such date of enactment.''.
  (b) Compensation to Consultants or Individual Scientists.--Section 
202 of the Departments of Labor, Health and Human Services, and 
Education, and Related Agencies Appropriations Act, 1993 (Public Law 
102-394; 42 U.S.C. 238f note) is amended by striking ``portable 
structures;'' and all that follows and inserting ``portable 
structures.''.
  (c) Review of Certain Awards by Directors.--Section 405(b) of the 
Public Health Service Act (42 U.S.C. 284(b)) is amended by adding at 
the end the following:
  ``(3) Before an award is made by a national research institute or by 
a national center for a grant for a research program or project 
(commonly referred to as an `R-series grant'), other than an award 
constituting a noncompeting renewal of such grant, or a noncompeting 
administrative supplement to such grant, the director of such national 
research institute or national center--
          ``(A) shall review and approve the award; and
          ``(B) shall take into consideration--
                  ``(i) the mission of the national research institute 
                or national center and the scientific priorities 
                identified in the strategic plan under section 402(m); 
                and
                  ``(ii) whether other agencies are funding programs or 
                projects to accomplish the same goal.''.
  (d) IOM Study on Duplication in Federal Biomedical Research.--The 
Secretary of Health and Human Services shall enter into an arrangement 
with the Institute of Medicine of the National Academies (or, if the 
Institute declines, another appropriate entity) under which the 
Institute (or other appropriate entity) not later than 2 years after 
the date of enactment of this Act will--
          (1) complete a study on the extent to which biomedical 
        research conducted or supported by Federal agencies is 
        duplicative; and
          (2) submit a report to the Congress on the results of such 
        study, including recommendations on how to prevent such 
        duplication.

SEC. 1023. REDUCING ADMINISTRATIVE BURDENS OF RESEARCHERS.

  (a) Plan Preparation and Implementation of Measures To Reduce 
Administrative Burdens.--The Director of the National Institutes of 
Health shall prepare a plan, including time frames, and implement 
measures to reduce the administrative burdens of researchers funded by 
the National Institutes of Health, taking into account the 
recommendations, evaluations, and plans researched by the following 
entities:
          (1) The Scientific Management Review Board.
          (2) The National Academy of Sciences.
          (3) The 2007 and 2012 Faculty Burden Survey conducted by The 
        Federal Demonstration Partnership.
          (4) Relevant recommendations from the Research Business 
        Models Working Group.
  (b) Report.--Not later than two years after the date of enactment of 
this Act, the Director of the National Institutes of Health shall 
submit to Congress a report on the extent to which the Director has 
implemented measures pursuant to subsection (a).

SEC. 1024. EXEMPTION FOR THE NATIONAL INSTITUTES OF HEALTH FROM THE 
                    PAPERWORK REDUCTION ACT REQUIREMENTS.

  Section 3518(c)(1) of title 44, United States Code, is amended--
          (1) in subparagraph (C), by striking ``; or'' and inserting a 
        semicolon;
          (2) in subparagraph (D), by striking the period at the end 
        and inserting ``; or''; and
          (3) by inserting at the end the following new subparagraph:
          ``(E) during the conduct of research by the National 
        Institutes of Health.''.

SEC. 1025. NIH TRAVEL.

  It is the sense of Congress that participation in or sponsorship of 
scientific conferences and meetings is essential to the mission of the 
National Institutes of Health.

SEC. 1026. OTHER TRANSACTIONS AUTHORITY.

  Section 480 of the Public Health Service Act (42 U.S.C. 287a) is 
amended--
          (1) in subsection (b), by striking ``the appropriation of 
        funds as described in subsection (g)'' and inserting ``the 
        availability of funds as described in subsection (f)'';
          (2) in subsection (e)(3), by amending subparagraph (C) to 
        read as follows:
                  ``(C) Other transactions authority.--The Director of 
                the Center shall have other transactions authority in 
                entering into transactions to fund projects in 
                accordance with the terms and conditions of this 
                section.'';
          (3) by striking subsection (f); and
          (4) by redesignating subsection (g) as subsection (f).

SEC. 1027. NCATS PHASE IIB RESTRICTION.

  Section 479 of the Public Health Service Act (42 U.S.C. 287) is 
amended--
          (1) prior to making the amendments under paragraph (2), by 
        striking ``IIB'' each place it appears and inserting ``III''; 
        and
          (2) by striking ``IIA'' each place it appears and inserting 
        ``IIB''.

SEC. 1028. HIGH-RISK, HIGH-REWARD RESEARCH.

  Part B of title IV of the Public Health Service Act (42 U.S.C. 284 et 
seq.) is amended by adding at the end the following:

``SEC. 409K. HIGH-RISK, HIGH-REWARD RESEARCH PROGRAM.

  ``The director of each national research institute shall, as 
appropriate--
          ``(1) establish programs to conduct or support research 
        projects that pursue innovative approaches to major 
        contemporary challenges in biomedical research that involve 
        inherent high risk, but have the potential to lead to 
        breakthroughs; and
          ``(2) set aside a specific percentage of funding, to be 
        determined by the Director of NIH for each national research 
        institute, for such projects.''.

SEC. 1029. SENSE OF CONGRESS ON INCREASED INCLUSION OF UNDERREPRESENTED 
                    COMMUNITIES IN CLINICAL TRIALS.

  It is the sense of Congress that the National Institute on Minority 
Health and Health Disparities (NIMHD) should include within its 
strategic plan ways to increase representation of underrepresented 
communities in clinical trials.

            Subtitle C--Supporting Young Emerging Scientists

SEC. 1041. IMPROVEMENT OF LOAN REPAYMENT PROGRAMS OF THE NATIONAL 
                    INSTITUTES OF HEALTH.

  (a) In General.--Part G of title IV of the Public Health Service (42 
U.S.C. 288 et seq.) is amended--
          (1) by redesignating the second section 487F (42 U.S.C. 288-
        6; relating to pediatric research loan repayment program) as 
        section 487G; and
          (2) by inserting after section 487G, as so redesignated, the 
        following:

``SEC. 487H. LOAN REPAYMENT PROGRAM.

  ``(a) In General.--The Secretary shall establish a program, based on 
workforce and scientific needs, of entering into contracts with 
qualified health professionals under which such health professionals 
agree to engage in research in consideration of the Federal Government 
agreeing to pay, for each year of engaging in such research, not more 
than $50,000 of the principal and interest of the educational loans of 
such health professionals.
  ``(b) Adjustment for Inflation.--Beginning with respect to fiscal 
year 2017, the Secretary may increase the maximum amount specified in 
subsection (a) by an amount that is determined by the Secretary, on an 
annual basis, to reflect inflation.
  ``(c) Limitation.--The Secretary may not enter into a contract with a 
health professional pursuant to subsection (a) unless such professional 
has a substantial amount of educational loans relative to income.
  ``(d) Applicability of Certain Provisions Regarding Obligated 
Service.--Except to the extent inconsistent with this section, the 
provisions of sections 338B, 338C, and 338E shall apply to the program 
established under this section to the same extent and in the same 
manner as such provisions apply to the National Health Service Corps 
Loan Repayment Program established under section 338B.
  ``(e) Availability of Appropriations.--Amounts appropriated for a 
fiscal year for contracts under subsection (a) are authorized to remain 
available until the expiration of the second fiscal year beginning 
after the fiscal year for which the amounts were appropriated.''.
  (b) Update of Other Loan Repayment Programs.--
          (1) Section 464z-5(a) of the Public Health Service Act (42 
        U.S.C.285t-2(a)) is amended--
                  (A) by striking ``$35,000'' and inserting 
                ``$50,000''; and
                  (B) by adding at the end the following new sentence: 
                ``Subsection (b) of section 487H shall apply with 
                respect to the maximum amount specified in this 
                subsection in the same manner as it applies to the 
                maximum amount specified in subsection (a) of such 
                section.''.
          (2) Section 487A(a) of such Act (42 U.S.C. 288-1(a)) is 
        amended--
                  (A) by striking ``$35,000'' and inserting 
                ``$50,000''; and
                  (B) by adding at the end the following new sentence: 
                ``Subsection (b) of section 487H shall apply with 
                respect to the maximum amount specified in this 
                subsection in the same manner as it applies to the 
                maximum amount specified in subsection (a) of such 
                section.''.
          (3) Section 487B(a) of such Act (42 U.S.C. 288-2(a)) is 
        amended--
                  (A) by striking ``$35,000'' and inserting 
                ``$50,000''; and
                  (B) by adding at the end the following new sentence: 
                ``Subsection (b) of section 487H shall apply with 
                respect to the maximum amount specified in this 
                subsection in the same manner as it applies to the 
                maximum amount specified in such subsection (a) of such 
                section.''.
          (4) Section 487C(a)(1) of such Act (42 U.S.C. 288-3(a)(1)) is 
        amended--
                  (A) by striking ``$35,000'' and inserting 
                ``$50,000''; and
                  (B) by adding at the end the following new sentence: 
                ``Subsection (b) of section 487H shall apply with 
                respect to the maximum amount specified in this 
                paragraph in the same manner as it applies to the 
                maximum amount specified in such subsection (a) of such 
                section.''.
          (5) Section 487E(a)(1) of such Act (42 U.S.C. 288-5(a)(1)) is 
        amended--
                  (A) by striking ``$35,000'' and inserting 
                ``$50,000''; and
                  (B) by adding at the end the following new sentence: 
                ``Subsection (b) of section 487H shall apply with 
                respect to the maximum amount specified in this 
                paragraph in the same manner as it applies to the 
                maximum amount specified in such subsection (a) of such 
                section.''.
          (6) Section 487F(a) of such Act (42 U.S.C. 288-5a(a)), as 
        added by section 205 of Public Law 106-505, is amended--
                  (A) by striking ``$35,000'' and inserting 
                ``$50,000''; and
                  (B) by adding at the end the following new sentence: 
                ``Subsection (b) of section 487H shall apply with 
                respect to the maximum amount specified in this 
                subsection in the same manner as it applies to the 
                maximum amount specified in such subsection (a) of such 
                section.''.
          (7) Section 487G of such Act (42 U.S.C. 288-6, as 
        redesignated by section 1041(a)(1)), is further amended--
                  (A) in subsection (a)(1), by striking ``$35,000'' and 
                inserting ``$50,000''; and
                  (B) in subsection (b), by adding at the end the 
                following new sentence: ``Subsection (b) of section 
                487H shall apply with respect to the maximum amount 
                specified in subsection (a)(1) in the same manner as it 
                applies to the maximum amount specified in such 
                subsection (a) of such section.''.

SEC. 1042. REPORT.

  Not later than 18 months after the date of the enactment of this Act, 
the Director of the National Institutes of Health shall submit to 
Congress a report on efforts of the National Institutes of Health to 
attract, retain, and develop emerging scientists.

                   Subtitle D--Capstone Grant Program

SEC. 1061. CAPSTONE AWARD.

  Part G of title IV of the Public Health Service Act (42 U.S.C. 288 et 
seq.) is amended by adding at the end the following:

``SEC. 490. CAPSTONE AWARD.

  ``(a) In General.--The Secretary may make awards (each of which, 
hereafter in this section, referred to as a `Capstone Award') to 
support outstanding scientists who have been funded by the National 
Institutes of Health.
  ``(b) Purpose.--Capstone Awards shall be made to facilitate the 
successful transition or conclusion of research programs, or for other 
purposes, as determined by the Director of NIH, in consultation with 
the directors of the national research institutes and national centers.
  ``(c) Duration and Amount.--The duration and amount of each Capstone 
Award shall be determined by the Director of NIH in consultation with 
the directors of the national research institutes and national centers.
  ``(d) Limitation.--Individuals who have received a Capstone Award 
shall not be eligible to have principle investigator status on 
subsequent awards from the National Institutes of Health.''.

     Subtitle E--Promoting Pediatric Research Through the National 
                          Institutes of Health

SEC. 1081. NATIONAL PEDIATRIC RESEARCH NETWORK.

  Section 409D(d) of the Public Health Service Act (42 U.S.C. 284h(d)) 
is amended--
          (1) in paragraph (1)--
                  (A) by striking ``in consultation with the Director 
                of the Eunice Kennedy Shriver National Institute of 
                Child Health and Human Development and in collaboration 
                with other appropriate national research institutes and 
                national centers that carry out activities involving 
                pediatric research'' and inserting ``in collaboration 
                with the national research institutes and national 
                centers that carry out activities involving pediatric 
                research'';
                  (B) by striking subparagraph (B);
                  (C) by striking ``may be comprised of, as 
                appropriate'' and all that follows through ``the 
                pediatric research consortia'' and inserting ``may be 
                comprised of, as appropriate, the pediatric research 
                consortia''; and
                  (D) by striking ``; or'' at the end and inserting a 
                period; and
          (2) in paragraph (1), paragraph (2)(A), the first sentence of 
        paragraph (2)(E), and paragraph (4), by striking ``may'' each 
        place it appears and inserting ``shall''.

SEC. 1082. GLOBAL PEDIATRIC CLINICAL STUDY NETWORK SENSE OF CONGRESS.

  It is the sense of Congress that--
          (1) the National Institutes of Health should encourage a 
        global pediatric clinical study network through the allocation 
        of grants, contracts, or cooperative agreements to supplement 
        the salaries of new and early investigators who participate in 
        the global pediatric clinical study network;
          (2) National Institutes of Health grants, contracts, or 
        cooperative agreements should be awarded, solely for the 
        purpose of supplementing the salaries of new and early 
        investigators, to entities that participate in the global 
        pediatric clinical study network;
          (3) the Food and Drug Administration should engage the 
        European Medicines Agency and other foreign regulatory entities 
        during the formation of the global pediatric clinical study 
        network to encourage their participation; and
          (4) once a global pediatric clinical study network is 
        established and becomes operational, the Food and Drug 
        Administration should continue to engage the European Medicines 
        Agency and other foreign regulatory entities to encourage and 
        facilitate their participation in the network with the goal of 
        enhancing the global reach of the network.

SEC. 1083. APPROPRIATE AGE GROUPINGS IN CLINICAL RESEARCH.

  (a) Input From Experts.--Not later than 180 days after the date of 
enactment of this Act, the Director of the National Institutes of 
Health shall convene a workshop of experts on pediatrics and experts on 
geriatrics to provide input on--
          (1) appropriate age groupings to be included in research 
        studies involving human subjects; and
          (2) acceptable scientific justifications for excluding 
        participants from a range of age groups from human subjects 
        research studies.
  (b) Guidelines.--Not later than 180 days after the conclusion of the 
workshop under subsection (a), the Director of the National Institutes 
of Health shall publish guidelines--
          (1) addressing the consideration of age as an inclusion 
        variable in research involving human subjects; and
          (2) identifying criteria for justifications for any age-
        related exclusions in such research.
  (c) Public Availability of Findings and Conclusions.--The Director of 
the National Institutes of Health shall--
          (1) make the findings and conclusions resulting from the 
        workshop under subsection (a) available to the public on the 
        website of the National Institutes of Health; and
          (2) not less than biennially, disclose to the public on such 
        website the number of children included in research that is 
        conducted or supported by the National Institutes of Health, 
        disaggregated by developmentally appropriate age group, race, 
        and gender.

 Subtitle F--Advancement of the National Institutes of Health Research 
                            and Data Access

SEC. 1101. SHARING OF DATA GENERATED THROUGH NIH-FUNDED RESEARCH.

  Section 402 of the Public Health Service Act (42 U.S.C. 282) (as 
amended by section 1021(2)) is further amended by adding at the end the 
following:
  ``(n) Sharing of Data Generated Through NIH-funded Research.--
          ``(1) Authority.--Subject to paragraph (2), the Director of 
        NIH may require recipients of the award of an NIH grant or 
        other financial support, provided that the research is fully 
        funded through such grant or other support, to share scientific 
        data generated from research conducted through such support for 
        research purposes.
          ``(2) Limitation.--The Director of NIH shall not require the 
        sharing of data that is inconsistent with applicable law and 
        policy protecting--
                  ``(A) privacy and confidentiality;
                  ``(B) proprietary interests;
                  ``(C) business confidential information;
                  ``(D) intellectual property rights; and
                  ``(E) other relevant rights.''.

SEC. 1102. STANDARDIZATION OF DATA IN CLINICAL TRIAL REGISTRY DATA BANK 
                    ON ELIGIBILITY FOR CLINICAL TRIALS.

  (a) Standardization.--
          (1) In general.--Section 402(j) of the Public Health Service 
        Act (42 U.S.C. 282(j)) is amended--
                  (A) by redesignating paragraph (7) as paragraph (8); 
                and
                  (B) by inserting after paragraph (6) the following:
          ``(7) Standardization.--The Director of NIH shall--
                  ``(A) ensure that the registry and results data bank 
                is easily used by the public;
                  ``(B) ensure that entries in the registry and results 
                data bank are easily compared;
                  ``(C) ensure that information required to be 
                submitted to the registry and results data bank, 
                including recruitment information under paragraph 
                (2)(A)(ii)(II), is submitted by persons and posted by 
                the Director of NIH in a standardized format and 
                includes at least--
                          ``(i) the disease or indication being 
                        studied;
                          ``(ii) inclusion criteria such as age, 
                        gender, diagnosis or diagnoses, laboratory 
                        values, or imaging results; and
                          ``(iii) exclusion criteria such as specific 
                        diagnosis or diagnoses, laboratory values, or 
                        prohibited medications; and
                  ``(D) to the extent possible, in carrying out this 
                paragraph, make use of standard health care 
                terminologies, such as the International Classification 
                of Diseases or the Current Procedural Terminology, that 
                facilitate electronic matching to data in electronic 
                health records or other relevant health information 
                technologies.''.
          (2) Conforming amendment.--Clause (iv) of section 
        402(j)(2)(B) of the Public Health Service Act (42 U.S.C. 
        282(j)(2)(B)) is hereby stricken.
  (b) Consultation.--Not later than 90 days after the date of enactment 
of this Act, the Secretary of Health and Human Services shall consult 
with stakeholders (including patients, researchers, physicians, 
industry representatives, health information technology providers, the 
Food and Drug Administration, and standard setting organizations such 
as CDISC that have experience working with Federal agencies to 
standardize health data submissions) to receive advice on enhancements 
to the clinical trial registry data bank under section 402(j) of the 
Public Health Service Act (42 U.S.C. 282(j)) (including enhancements to 
usability, functionality, and search capability) that are necessary to 
implement paragraph (7) of section 402(j) of such Act, as added by 
subsection (a).
  (c) Applicability.--Not later than 18 months after the date of 
enactment of this Act, the Secretary of Health and Human Services shall 
begin implementation of paragraph (7) of section 402(j) of the Public 
Health Service Act, as added by subsection (a).

            Subtitle G--Facilitating Collaborative Research

SEC. 1121. CLINICAL TRIAL DATA SYSTEM.

  (a) Establishment.--The Secretary, acting through the Commissioner of 
Food and Drugs and the Director of the National Institutes of Health, 
shall enter into a cooperative agreement, contract, or grant for a 
period of 7 years, to be known as the Clinical Trial Data System 
Agreement, with one or more eligible entities to implement a pilot 
program with respect to all clinical trial data obtained from qualified 
clinical trials for purposes of registered users conducting further 
research on such data.
  (b) Application.--Eligible entities seeking to enter into a 
cooperative agreement, contract, or grant with the Secretary under this 
section shall submit to the Secretary an application in such time and 
manner, and containing such information, as the Secretary may require 
in accordance with this section. The Secretary shall not enter into a 
cooperative agreement, contract, or grant under this section with an 
eligible entity unless such entity submits an application including the 
following:
          (1) A certification that the eligible entity is not currently 
        and does not plan to be involved in sponsoring, operating, or 
        participating in a clinical trial nor collaborating with 
        another entity for the purposes of sponsoring, operating, or 
        participating in a clinical trial.
          (2) Information demonstrating that the eligible entity can 
        compile clinical trial data in standardized formats using 
        terminologies and standards that have been developed by 
        recognized standards developing organizations with input from 
        diverse stakeholder groups, and information demonstrating that 
        the eligible entity can de-identify clinical trial data 
        consistent with the requirements of section 164.514 of title 
        45, Code of Federal Regulations (or successor regulations).
          (3) A description of the system the eligible entity will use 
        to store and maintain such data, and information demonstrating 
        that this system will comply with applicable standards and 
        requirements for ensuring the security of the clinical trial 
        data.
          (4) A certification that the eligible entity will allow only 
        registered users to access and use de-identified clinical trial 
        data, gathered from qualified clinical trials, and that the 
        eligible entity will allow each registered user to access and 
        use such data only after such registered user agrees in writing 
        to the terms described in (e)(4)(B), and such other carefully 
        controlled contractual terms as may be defined by the 
        Secretary.
          (5) Evidence demonstrating the ability of the eligible entity 
        to ensure that registered users disseminate the results of the 
        research conducted in accordance with this section to 
        interested parties to serve as a guide to future medical 
        product development or scientific research.
          (6) The plan of the eligible entity for securing funding for 
        the activities it would conduct under the clinical trial data 
        system agreement from governmental sources and private 
        foundations, entities, and individuals.
          (7) Evidence demonstrating a proven track record of--
                  (A) being a neutral third party in working with 
                medical product manufacturers, academic institutions, 
                and the Food and Drug Administration; and
                  (B) having the ability to protect confidential data.
          (8) An agreement that the eligible entity will work with the 
        Comptroller General of the United States for purposes of the 
        study and report under subsection (d).
  (c) Extension, Expansion, Termination.--The Secretary, acting through 
the Commissioner of Food and Drugs and the Director of the National 
Institutes of Health, upon the expiration of the 7-year period referred 
to in subsection (a), may extend (including permanently), expand, or 
terminate the pilot program established under such subsection, in whole 
or in part.
  (d) Study and Report.--
          (1) In general.--The Comptroller General of the United States 
        shall conduct a study and issue a report to the Congress and 
        the Secretary with respect to the pilot program established 
        under subsection (a), not later than 6 years after the date on 
        which the pilot program is established under subsection (a).
          (2) Study.--The study under paragraph (1) shall--
                  (A) review the effectiveness of the pilot program 
                established under subsection (a); and
                  (B) be designed to formulate recommendations on 
                improvements to the program.
          (3) Report.--The report under paragraph (1) shall contain at 
        least the following information:
                  (A) The new discoveries, research inquiries, or 
                clinical trials that have resulted from accessing 
                clinical trial data under the pilot program established 
                under subsection (a).
                  (B) The number of times scientists have accessed such 
                data, disaggregated by research area and clinical trial 
                phase.
                  (C) An analysis of whether the program has helped to 
                reduce adverse events in clinical trials.
                  (D) An analysis of whether scientists have raised any 
                concerns about the burden of having to share data with 
                the system established under the program and a 
                description, if any, of such burden.
                  (E) An analysis of privacy and data integrity 
                practices used in the program.
  (e) Definitions.--In this section:
          (1) The term ``eligible entity'' means an entity that has 
        experienced personnel with clinical and other technical 
        expertise in the biomedical sciences and biomedical ethics and 
        that is--
                  (A) an institution of higher education (as such term 
                is defined in section 1001 of the Higher Education Act 
                of 1965 (20 U.S.C. 1001)) or a consortium of such 
                institutions; or
                  (B) an organization described in section 501(c)(3) of 
                title 26 of the Internal Revenue Code of 1986 and 
                exempt from tax under section 501(a) of such title.
          (2) The term ``medical product'' means a drug (as defined in 
        section 201(g) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 331(g))), a device (as defined in section 201(h) of such 
        Act (21 U.S.C. 331(h)), a biological product (as defined in 
        section 351 of the Public Health Service Act (42 U.S.C. 262)), 
        or any combination thereof.
          (3) The term ``qualified clinical trial'' means a clinical 
        trial sponsored solely by an agency of the Department of Health 
        and Human Services with respect to a medical product--
                  (A) that--
                          (i) was approved or cleared under section 
                        505, 510(k), or 515, or has an exemption for 
                        investigational use in effect under section 505 
                        or 520(m), of the Federal Food, Drug, and 
                        Cosmetic Act (42 U.S.C. 301 et seq.); or
                          (ii) was licensed under section 351 of the 
                        Public Health Service Act (42 U.S.C. 262) or 
                        has an exemption for investigational use in 
                        effect under such section 351; or
                  (B) that is an investigational product for which the 
                original development was discontinued and with respect 
                to which--
                          (i) no additional work to support approval, 
                        licensure, or clearance of such medical product 
                        is being or is planned to be undertaken by the 
                        sponsor of the original development program, 
                        its successors, assigns, or collaborators; and
                          (ii) the sponsor of the original 
                        investigational development program has 
                        provided its consent to the Secretary for 
                        inclusion of data regarding such product in the 
                        system established under this section.
          (4) The term ``registered user'' means a scientific or 
        medical researcher who has--
                  (A) a legitimate biomedical research purpose for 
                accessing information from the clinical trials data 
                system and has appropriate qualifications to conduct 
                such research; and
                  (B) agreed in writing not to transfer to any other 
                person that is not a registered user de-identified 
                clinical trial data from qualified clinical trials 
                accessed through an eligible entity, use such data for 
                reasons not specified in the research proposal, or seek 
                to re-identify qualified clinical trial participants.
          (5) The term ``Secretary'' means the Secretary of Health and 
        Human Services.

SEC. 1122. NATIONAL NEUROLOGICAL DISEASES SURVEILLANCE SYSTEM.

  Part P of title III of the Public Health Service Act (42 U.S.C. 280g 
et seq.) is amended by adding at the end the following:

``SEC. 399V-6 SURVEILLANCE OF NEUROLOGICAL DISEASES.

  ``(a) In General.--The Secretary, acting through the Director of the 
Centers for Disease Control and Prevention and in coordination with 
other agencies as determined appropriate by the Secretary, shall--
          ``(1) enhance and expand infrastructure and activities to 
        track the epidemiology of neurological diseases, including 
        multiple sclerosis and Parkinson's disease; and
          ``(2) incorporate information obtained through such 
        activities into a statistically sound, scientifically credible, 
        integrated surveillance system, to be known as the National 
        Neurological Diseases Surveillance System.
  ``(b) Research.--The Secretary shall ensure that the National 
Neurological Diseases Surveillance System is designed in a manner that 
facilitates further research on neurological diseases.
  ``(c) Content.--In carrying out subsection (a), the Secretary--
          ``(1) shall provide for the collection and storage of 
        information on the incidence and prevalence of neurological 
        diseases in the United States;
          ``(2) to the extent practicable, shall provide for the 
        collection and storage of other available information on 
        neurological diseases, such as information concerning--
                  ``(A) demographics and other information associated 
                or possibly associated with neurological diseases, such 
                as age, race, ethnicity, sex, geographic location, and 
                family history;
                  ``(B) risk factors associated or possibly associated 
                with neurological diseases, including genetic and 
                environmental risk factors; and
                  ``(C) diagnosis and progression markers;
          ``(3) may provide for the collection and storage of 
        information relevant to analysis on neurological diseases, such 
        as information concerning--
                  ``(A) the epidemiology of the diseases;
                  ``(B) the natural history of the diseases;
                  ``(C) the prevention of the diseases;
                  ``(D) the detection, management, and treatment 
                approaches for the diseases; and
                  ``(E) the development of outcomes measures; and
          ``(4) may address issues identified during the consultation 
        process under subsection (d).
  ``(d) Consultation.--In carrying out this section, the Secretary 
shall consult with individuals with appropriate expertise, including--
          ``(1) epidemiologists with experience in disease surveillance 
        or registries;
          ``(2) representatives of national voluntary health 
        associations that--
                  ``(A) focus on neurological diseases, including 
                multiple sclerosis and Parkinson's disease; and
                  ``(B) have demonstrated experience in research, care, 
                or patient services;
          ``(3) health information technology experts or other 
        information management specialists;
          ``(4) clinicians with expertise in neurological diseases; and
          ``(5) research scientists with experience conducting 
        translational research or utilizing surveillance systems for 
        scientific research purposes.
  ``(e) Grants.--The Secretary may award grants to, or enter into 
contracts or cooperative agreements with, public or private nonprofit 
entities to carry out activities under this section.
  ``(f) Coordination With Other Federal, State, and Local Agencies.--
Subject to subsection (h), the Secretary shall make information and 
analysis in the National Neurological Diseases Surveillance System 
available, as appropriate--
          ``(1) to Federal departments and agencies, such as the 
        National Institutes of Health, the Food and Drug 
        Administration, the Centers for Medicare & Medicaid Services, 
        the Agency for Healthcare Research and Quality, the Department 
        of Veterans Affairs, and the Department of Defense; and
          ``(2) to State and local agencies.
  ``(g) Public Access.--Subject to subsection (h), the Secretary shall 
make information and analysis in the National Neurological Diseases 
Surveillance System available, as appropriate, to the public, including 
researchers.
  ``(h) Privacy.--The Secretary shall ensure that privacy and security 
protections applicable to the National Neurological Diseases 
Surveillance System are at least as stringent as the privacy and 
security protections under HIPAA privacy and security law (as defined 
in section 3009(a)(2)).
  ``(i) Report.--Not later than 4 years after the date of the enactment 
of this section, the Secretary shall submit a report to the Congress 
concerning the implementation of this section. Such report shall 
include information on--
          ``(1) the development and maintenance of the National 
        Neurological Diseases Surveillance System;
          ``(2) the type of information collected and stored in the 
        System;
          ``(3) the use and availability of such information, including 
        guidelines for such use; and
          ``(4) the use and coordination of databases that collect or 
        maintain information on neurological diseases.
  ``(j) Definition.--In this section, the term `national voluntary 
health association' means a national nonprofit organization with 
chapters, other affiliated organizations, or networks in States 
throughout the United States.
  ``(k) Authorization of Appropriations.--To carry out this section, 
there is authorized to be appropriated $5,000,000 for each of fiscal 
years 2016 through 2020.''.

SEC. 1123. DATA ON NATURAL HISTORY OF DISEASES.

  (a) Sense of Congress.--It is the sense of the Congress that studies 
on the natural history of diseases can help to facilitate and expedite 
the development of medical products for such diseases.
  (b) Authority.--Part A of title II of the Public Health Service Act 
(42 U.S.C. 202 et seq.) is amended by adding at the end the following:

``SEC. 229A. DATA ON NATURAL HISTORY OF DISEASES.

  ``(a) In General.--The Secretary may, for the purposes described in 
subsection (b)--
          ``(1) participate in public-private partnerships engaged in 
        one or more activities specified in subsection (c); and
          ``(2) award grants to patient advocacy groups or other 
        organizations determined appropriate by the Secretary.
  ``(b) Purposes Described.--The purposes described in this subsection 
are to establish or facilitate the collection, maintenance, analysis, 
and interpretation of data regarding the natural history of diseases, 
with a particular focus on rare diseases.
  ``(c) Activities of Public-Private Partnerships.--The activities of 
public-private partnerships in which the Secretary may participate for 
purposes of this section include--
          ``(1) cooperating with other entities that sponsor or 
        maintain disease registries, including disease registries and 
        disease registry platforms for rare diseases;
          ``(2) developing or enhancing a secure information technology 
        system that--
                  ``(A) has the capacity to support data needs across a 
                wide range of disease studies;
                  ``(B) is easily modified as knowledge is gained 
                during such studies; and
                  ``(C) is capable of handling increasing amounts of 
                data as more studies are carried out; and
          ``(3) providing advice to clinical researchers, patient 
        advocacy groups, and other entities with respect to--
                  ``(A) the design and conduct of disease studies;
                  ``(B) the modification of any such ongoing studies; 
                and
                  ``(C) addressing associated patient privacy issues.
  ``(d) Availability of Data on Natural History of Diseases.--Data 
relating to the natural history of diseases obtained, aggregated, or 
otherwise maintained by a public-private partnership in which the 
Secretary participates under subsection (a) shall be made available, 
consistent with otherwise applicable Federal and State privacy laws, to 
the public (including patient advocacy groups, researchers, and drug 
developers) to help to facilitate and expedite medical product 
development programs.
  ``(e) Confidentiality.--Notwithstanding subsection (d), nothing in 
this section authorizes the disclosure of any information that is a 
trade secret or commercial or financial information that is privileged 
or confidential and subject to section 552(b)(4) of title 5, United 
States Code, or section 1905 of title 18, United States Code.
  ``(f) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section $5,000,000 for each of fiscal 
years 2016 through 2020.''.

SEC. 1124. ACCESSING, SHARING, AND USING HEALTH DATA FOR RESEARCH 
                    PURPOSES.

  (a) In General.--(1) The HITECH Act (title XIII of division A of 
Public Law 111-5) is amended by adding at the end of subtitle D of such 
Act (42 U.S.C. 17921 et seq.) the following:

   ``PART 4--ACCESSING, SHARING, AND USING HEALTH DATA FOR RESEARCH 
                                PURPOSES

``SEC. 13441. REFERENCES.

  ``In this part:
          ``(1) The rule.--References to `the Rule' refer to part 160 
        or part 164, as appropriate, of title 45, Code of Federal 
        Regulations (or any successor regulation).
          ``(2) Part 164.--References to a specified section of `part 
        164', refer to such specified section of part 164 of title 45, 
        Code of Federal Regulations (or any successor section).

``SEC. 13442. DEFINING HEALTH DATA RESEARCH AS PART OF HEALTH CARE 
                    OPERATIONS.

  ``(a) In General.--Subject to subsection (b), the Secretary shall 
revise or clarify the Rule to allow the use and disclosure of protected 
health information by a covered entity for research purposes, including 
studies whose purpose is to obtain generalizable knowledge, to be 
treated as the use and disclosure of such information for health care 
operations described in subparagraph (1) of the definition of health 
care operations in section 164.501 of part 164.
  ``(b) Modifications to Rules for Disclosures for Health Care 
Operations.--In applying section 164.506 of part 164 to the disclosure 
of protected health information described in subsection (a)--
          ``(1) the Secretary shall revise or clarify the Rule so that 
        the disclosure may be made by the covered entity to only--
                  ``(A) another covered entity for health care 
                operations (as defined in section 164.501 of part 164);
                  ``(B) a business associate that has entered into a 
                contract under section 164.504(e) of part 164 with a 
                disclosing covered entity to perform health care 
                operations; or
                  ``(C) a business associate that has entered into a 
                contract under section 164.504(e) of part 164 for the 
                purpose of data aggregation (as defined in section 
                164.501 of part 164); and
          ``(2) the Secretary shall further revise or clarify the Rule 
        so that the limitation specified by section 164.506(c)(4) of 
        part 164 does not apply to disclosures that are described by 
        subsection (a).
  ``(c) Rule of Construction.--This section shall not be construed as 
prohibiting or restricting a use or disclosure of protected health 
information for research purposes that is otherwise permitted under 
part 164.

``SEC. 13443. TREATING DISCLOSURES OF PROTECTED HEALTH INFORMATION FOR 
                    RESEARCH SIMILARLY TO DISCLOSURES OF SUCH 
                    INFORMATION FOR PUBLIC HEALTH PURPOSES.

  ``(a) Remuneration.--The Secretary shall revise or clarify the Rule 
so that disclosures of protected health information for research 
purposes are not subject to the limitation on remuneration described in 
section 164.502(a)(5)(ii)(B)(2)(ii) of part 164.
  ``(b) Permitted Uses and Disclosures.--The Secretary shall revise or 
clarify the Rule so that research activities, including comparative 
research activities, related to the quality, safety, or effectiveness 
of a product or activity that is regulated by the Food and Drug 
Administration are included as public health activities for purposes of 
which a covered entity may disclose protected health information to a 
person described in section 164.512(b)(1)(iii) of part 164.

``SEC. 13444. PERMITTING REMOTE ACCESS TO PROTECTED HEALTH INFORMATION 
                    BY RESEARCHERS.

  ``The Secretary shall revise or clarify the Rule so that subparagraph 
(B) of section 164.512(i)(1)(ii) of part 164 (prohibiting the removal 
of protected health information by a researcher) shall not prohibit 
remote access to health information by a researcher so long as--
          ``(1) appropriate security and privacy safeguards are 
        maintained by the covered entity and the researcher; and
          ``(2) the protected health information is not copied or 
        otherwise retained by the researcher.

``SEC. 13445. ALLOWING ONE-TIME AUTHORIZATION OF USE AND DISCLOSURE OF 
                    PROTECTED HEALTH INFORMATION FOR RESEARCH PURPOSES.

  ``(a) In General.--The Secretary shall revise or clarify the Rule to 
specify that an authorization for the use or disclosure of protected 
health information, with respect to an individual, for future research 
purposes shall be deemed to contain a sufficient description of the 
purpose of the use or disclosure if the authorization--
          ``(1) sufficiently describes the purposes such that it would 
        be reasonable for the individual to expect that the protected 
        health information could be used or disclosed for such future 
        research;
          ``(2) either--
                  ``(A) states that the authorization will expire on a 
                particular date or on the occurrence of a particular 
                event; or
                  ``(B) states that the authorization will remain valid 
                unless and until it is revoked by the individual; and
          ``(3) provides instruction to the individual on how to revoke 
        such authorization at any time.
  ``(b) Revocation of Authorization.--The Secretary shall revise or 
clarify the Rule to specify that, if an individual revokes an 
authorization for future research purposes such as is described by 
subsection (a), the covered entity may not make any further uses or 
disclosures based on that authorization, except, as provided in 
paragraph (b)(5) of section 164.508 of part 164, to the extent that the 
covered entity has taken action in reliance on the authorization.''.
  (2) The table of sections in section 13001(b) of such Act is amended 
by adding at the end of the items relating to subtitle D the following 
new items:

   ``Part 4--Accessing, Sharing, and Using Health Data for Research 
                                Purposes

``Sec. 13441. References.
``Sec. 13442. Defining health data research as part of health care 
operations.
``Sec. 13443. Treating disclosures of protected health information for 
research similarly to disclosures of such information for public health 
purposes.
``Sec. 13444. Permitting remote access to protected health information 
by researchers.
``Sec. 13445. Allowing one-time authorization of use and disclosure of 
protected health information for research purposes.''.

  (b) Revision of Regulations.--Not later than 12 months after the date 
of the enactment of this Act, the Secretary of Health and Human 
Services shall revise and clarify the provisions of title 45, Code of 
Federal Regulations, for consistency with part 4 of subtitle D of the 
HITECH Act, as added by subsection (a).

               Subtitle H--Council for 21st Century Cures

SEC. 1141. COUNCIL FOR 21ST CENTURY CURES.

  Title II of the Public Health Service Act (42 U.S.C. 202 et seq.) is 
amended by adding at the end the following:

                ``PART E--COUNCIL FOR 21ST CENTURY CURES

``SEC. 281. ESTABLISHMENT.

  ``A nonprofit corporation to be known as the Council for 21st Century 
Cures (referred to in this part as the `Council') shall be established 
in accordance with this section. The Council shall be a public-private 
partnership headed by an Executive Director (referred to in this part 
as the `Executive Director'), appointed by the members of the Board of 
Directors. The Council shall not be an agency or instrumentality of the 
United States Government.

``SEC. 281A. PURPOSE.

  ``The purpose of the Council is to accelerate the discovery, 
development, and delivery in the United States of innovative cures, 
treatments, and preventive measures for patients.

``SEC. 281B. DUTIES.

  ``For the purpose described in section 281A, the Council shall--
          ``(1) foster collaboration and coordination among the 
        entities that comprise the Council, including academia, 
        government agencies, industry, health care payors and 
        providers, patient advocates, and others engaged in the cycle 
        of discovery, development, and delivery of life-saving and 
        health-enhancing innovative interventions;
          ``(2) undertake communication and dissemination activities;
          ``(3) publish information on the activities funded under 
        section 281D;
          ``(4) establish a strategic agenda for accelerating the 
        discovery, development, and delivery in the United States of 
        innovative cures, treatments, and preventive measures for 
        patients;
          ``(5) identify gaps and opportunities within and across the 
        discovery, development, and delivery cycle;
          ``(6) develop and propose recommendations based on the gaps 
        and opportunities so identified;
          ``(7) facilitate the interoperability of the components of 
        the discovery, development, and delivery cycle;
          ``(8) propose recommendations that will facilitate 
        precompetitive collaboration;
          ``(9) identify opportunities to work with, but not duplicate 
        the efforts of, nonprofit organizations and other public-
        private partnerships; and
          ``(10) identify opportunities for collaboration with 
        organizations operating outside of the United States, such as 
        the Innovative Medicines Initiative of the European Union.

``SEC. 281C. ORGANIZATION; ADMINISTRATION.

  ``(a) Board of Directors.--
          ``(1) Establishment.--
                  ``(A) In general.--The Council shall have a Board of 
                Directors (in this part referred to as the `Board of 
                Directors'), which shall be composed of the ex officio 
                members under subparagraph (B) and the appointed 
                members under subparagraph (C). All members of the 
                Board shall be voting members.
                  ``(B) Ex officio members.--The ex officio members of 
                the Board shall be the following individuals or their 
                designees:
                          ``(i) The Director of the National Institutes 
                        of Health.
                          ``(ii) The Commissioner of Food and Drugs.
                          ``(iii) The Administrator of the Centers for 
                        Medicare & Medicaid Services.
                          ``(iv) The heads of five other Federal 
                        agencies deemed by the Secretary to be engaged 
                        in biomedical research and development.
                  ``(C) Appointed members.--The appointed members of 
                the Board shall consist of 17 individuals, of whom--
                          ``(i) 8 shall be appointed by the Comptroller 
                        General of the United States from a list of 
                        nominations submitted by leading trade 
                        associations--
                                  ``(I) 4 of whom shall be 
                                representatives of the 
                                biopharmaceutical industry;
                                  ``(II) 2 of whom shall be 
                                representatives of the medical device 
                                industry; and
                                  ``(III) 2 of whom shall be 
                                representatives of the information and 
                                digital technology industry; and
                          ``(ii) 9 shall be appointed by the 
                        Comptroller General of the United States, after 
                        soliciting nominations--
                                  ``(I) 2 of whom shall be 
                                representatives of academic 
                                researchers;
                                  ``(II) 3 of whom shall be 
                                representatives of patients;
                                  ``(III) 2 of whom shall be 
                                representatives of health care 
                                providers; and
                                  ``(IV) 2 of whom shall be 
                                representatives of health care plans 
                                and insurers.
                  ``(D) Chair.--The Chair of the Board shall be 
                selected by the members of the Board by majority vote 
                from among the members of the Board.
          ``(2) Terms and vacancies.--
                  ``(A) In general.--The term of office of each member 
                of the Board appointed under paragraph (1)(C) shall be 
                5 years.
                  ``(B) Vacancy.--Any vacancy in the membership of the 
                Board--
                          ``(i) shall not affect the power of the 
                        remaining members to execute the duties of the 
                        Board; and
                          ``(ii) shall be filled by appointment by the 
                        appointed members described in paragraph (1)(C) 
                        by majority vote.
                  ``(C) Partial term.--If a member of the Board does 
                not serve the full term applicable under subparagraph 
                (A), the individual appointed under subparagraph (B) to 
                fill the resulting vacancy shall be appointed for the 
                remainder of the term of the predecessor of the 
                individual.
          ``(3) Responsibilities.--Not later than 90 days after the 
        date on which the Council is incorporated and its Board of 
        Directors is fully constituted, the Board of Directors shall 
        establish bylaws and policies for the Council that--
                  ``(A) are published in the Federal Register and 
                available for public comment;
                  ``(B) establish policies for the selection and, as 
                applicable, appointment of--
                          ``(i) the officers, employees, agents, and 
                        contractors of the Council; and
                          ``(ii) the members of any committees of the 
                        Council;
                  ``(C) establish policies, including ethical 
                standards, for the conduct of programs and other 
                activities under section 281D; and
                  ``(D) establish specific duties of the Executive 
                Director.
          ``(4) Meetings.--
                  ``(A) In general.--The Board of Directors shall--
                          ``(i) meet on a quarterly basis; and
                          ``(ii) submit to Congress, and make publicly 
                        available, the minutes of such meetings.
                  ``(B) Agenda.--The Board of Directors shall, not 
                later than 3 months after the incorporation of the 
                Council--
                          ``(i) issue an agenda (in this part referred 
                        to as the `agenda') outlining how the Council 
                        will achieve the purpose described in section 
                        281A; and
                          ``(ii) annually thereafter, in consultation 
                        with the Executive Director, review and update 
                        such agenda.
  ``(b) Appointment and Incorporation.--Not later than 6 months after 
the date of enactment of the 21st Century Cures Act--
          ``(1) the Comptroller General of the United States shall 
        appoint the appointed members of the Board of Directors under 
        subsection (a)(1)(C); and
          ``(2) the ex officio members of the Board of Directors under 
        subsection (a)(1)(B) shall serve as incorporators and shall 
        take whatever actions are necessary to incorporate the Council.
  ``(c) Nonprofit Status.--In carrying out this part, the Board of 
Directors shall establish such policies and bylaws, and the Executive 
Director shall carry out such activities, as may be necessary to ensure 
that the Council maintains status as an organization that--
          ``(1) is described in subsection (c)(3) of section 501 of the 
        Internal Revenue Code of 1986; and
          ``(2) is, under subsection (a) of such section, exempt from 
        taxation.
  ``(d) Executive Director.--The Executive Director shall--
          ``(1) be the chief executive officer of the Council; and
          ``(2) subject to the oversight of the Board of Directors, be 
        responsible for the day-to-day management of the Council.

``SEC. 281D. OPERATIONAL ACTIVITIES AND ASSISTANCE.

  ``(a) In General.--The Council shall establish a sufficient 
operational infrastructure to fulfill the duties specified in section 
281B.
  ``(b) Private Sector Matching Funds.--The Council may accept 
financial or in-kind support from participating entities or private 
foundations or organizations when such support is deemed appropriate.

``SEC. 281E. TERMINATION; REPORT.

  ``(a) In General.--The Council shall terminate on September 30, 2023.
  ``(b) Report.--Not later than one year after the date on which the 
Council is established and each year thereafter, the Executive Director 
shall submit to the appropriate congressional committees a report on 
the performance of the Council. In preparing such report, the Council 
shall consult with a nongovernmental consultant with appropriate 
expertise.

``SEC. 281F. FUNDING.

  ``For the each of fiscal years 2016 through 2023, there is authorized 
to be appropriated $10,000,000 to the Council for purposes of carrying 
out the duties of the Council under this part.''.

                         TITLE II--DEVELOPMENT

              Subtitle A--Patient-Focused Drug Development

SEC. 2001. DEVELOPMENT AND USE OF PATIENT EXPERIENCE DATA TO ENHANCE 
                    STRUCTURED RISK-BENEFIT ASSESSMENT FRAMEWORK.

  (a) In General.--Section 505 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355) is amended--
          (1) in subsection (d), by striking ``The Secretary shall 
        implement'' and all that follows through ``premarket approval 
        of a drug.''; and
          (2) by adding at the end the following new subsections:
  ``(x) Structured Risk-Benefit Assessment Framework.--
          ``(1) In general.--The Secretary shall implement a structured 
        risk-benefit assessment framework in the new drug approval 
        process--
                  ``(A) to facilitate the balanced consideration of 
                benefits and risks; and
                  ``(B) to develop and implement a consistent and 
                systematic approach to the discussion of, regulatory 
                decisionmaking with respect to, and the communication 
                of, the benefits and risks of new drugs.
          ``(2) Rule of construction.--Nothing in paragraph (1) shall 
        alter the criteria for evaluating an application for premarket 
        approval of a drug.
  ``(y) Development and Use of Patient Experience Data To Enhance 
Structured Risk-Benefit Assessment Framework.--
          ``(1) In general.--Not later than two years after the date of 
        the enactment of this subsection, the Secretary shall establish 
        and implement processes under which--
                  ``(A) an entity seeking to develop patient experience 
                data may submit to the Secretary--
                          ``(i) initial research concepts for feedback 
                        from the Secretary; and
                          ``(ii) with respect to patient experience 
                        data collected by the entity, draft guidance 
                        documents, completed data, and summaries and 
                        analyses of such data;
                  ``(B) the Secretary may request such an entity to 
                submit such documents, data, and summaries and 
                analyses; and
                  ``(C) patient experience data may be developed and 
                used to enhance the structured risk-benefit assessment 
                framework under subsection (x).
          ``(2) Patient experience data.--In this subsection, the term 
        `patient experience data' means data collected by patients, 
        parents, caregivers, patient advocacy organizations, disease 
        research foundations, medical researchers, research sponsors, 
        or other parties determined appropriate by the Secretary that 
        is intended to facilitate or enhance the Secretary's risk-
        benefit assessments, including information about the impact of 
        a disease or a therapy on patients' lives.''.
  (b) Guidance.--
          (1) In general.--The Secretary of Health and Human Services 
        shall publish guidance on the implementation of subsection (y) 
        of section 505 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 355), as added by subsection (a). Such guidance shall 
        include--
                  (A) with respect to draft guidance documents, data, 
                or summaries and analyses submitted to the Secretary 
                under paragraph (1)(A) of such subsection, guidance--
                          (i) specifying the timelines for the review 
                        of such documents, data, or summaries and 
                        analyses by the Secretary; and
                          (ii) on how the Secretary will use such 
                        documents, data, or summaries and analyses to 
                        update any guidance documents published under 
                        this subsection or publish new guidance;
                  (B) with respect to the collection and analysis of 
                patient experience data (as defined in paragraph (2) of 
                such subsection (y)), guidance on--
                          (i) methodological considerations for the 
                        collection of patient experience data, which 
                        may include structured approaches to gathering 
                        information on--
                                  (I) the experience of a patient 
                                living with a particular disease;
                                  (II) the burden of living with or 
                                managing the disease;
                                  (III) the impact of the disease on 
                                daily life and long-term functioning; 
                                and
                                  (IV) the effect of current 
                                therapeutic options on different 
                                aspects of the disease; and
                          (ii) the establishment and maintenance of 
                        registries designed to increase understanding 
                        of the natural history of a disease;
                  (C) methodological approaches that may be used to 
                assess patients' beliefs with respect to the benefits 
                and risks in the management of the patient's disease; 
                and
                  (D) methodologies, standards, and potential 
                experimental designs for patient-reported outcomes.
          (2) Timing.--Not later than 3 years after the date of the 
        enactment of this Act, the Secretary of Health and Human 
        Services shall issue draft guidance on the implementation of 
        subsection (y) of section 505 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 355), as added by subsection (a). The 
        Secretary shall issue final guidance on the implementation of 
        such subsection not later than one year after the date on which 
        the comment period for the draft guidance closes.
          (3) Workshops.--
                  (A) In general.--Not later than 6 months after the 
                date of the enactment of this Act and once every 6 
                months during the following 12-month period, the 
                Secretary of Health and Human Services shall convene a 
                workshop to obtain input regarding methodologies for 
                developing the guidance under paragraph (1), including 
                the collection of patient experience data.
                  (B) Attendees.--A workshop convened under this 
                paragraph shall include--
                          (i) patients;
                          (ii) representatives from patient advocacy 
                        organizations, biopharmaceutical companies, and 
                        disease research foundations;
                          (iii) representatives of the reviewing 
                        divisions of the Food and Drug Administration; 
                        and
                          (iv) methodological experts with significant 
                        expertise in patient experience data.
          (4) Public meeting.--Not later than 90 days after the date on 
        which the draft guidance is published under this subsection, 
        the Secretary of Health and Human Services shall convene a 
        public meeting to solicit input on the guidance.

      Subtitle B--Qualification and Use of Drug Development Tools

SEC. 2021. QUALIFICATION OF DRUG DEVELOPMENT TOOLS.

  (a) Findings.--Congress finds the following:
          (1) Development of new drugs has become increasingly 
        challenging and resource intensive.
          (2) Development of drug development tools can benefit the 
        availability of new medical therapies by helping to translate 
        scientific discoveries into clinical applications.
          (3) Biomedical research consortia (as defined in section 
        507(f) of the Federal Food, Drug, and Cosmetic Act, as added by 
        subsection (c)) can play a valuable role in helping to develop 
        and qualify drug development tools.
  (b) Sense of Congress.--It is the sense of Congress that--
          (1) Congress should promote and facilitate a collaborative 
        effort among the biomedical research consortia described in 
        subsection (a)(3)--
                  (A) to develop, through a transparent public process, 
                data standards and scientific approaches to data 
                collection accepted by the medical and clinical 
                research community for purposes of qualifying drug 
                development tools;
                  (B) to coordinate efforts toward developing and 
                qualifying drug development tools in key therapeutic 
                areas; and
                  (C) to encourage the development of accessible 
                databases for collecting relevant drug development tool 
                data for such purposes; and
          (2) an entity seeking to qualify a drug development tool 
        should be encouraged, in addition to consultation with the 
        Secretary, to consult with biomedical research consortia and 
        other individuals and entities with expert knowledge and 
        insights that may assist the requestor and benefit the process 
        for such qualification.
  (c) Qualification of Drug Development Tools.--Chapter V of the 
Federal Food, Drug, and Cosmetic Act is amended by inserting after 
section 506F the following new section:

``SEC. 507. QUALIFICATION OF DRUG DEVELOPMENT TOOLS.

  ``(a) Process for Qualification.--
          ``(1) In general.--The Secretary shall establish a process 
        for the qualification of drug development tools for a proposed 
        context of use under which--
                  ``(A)(i) a requestor initiates such process by 
                submitting a letter of intent to the Secretary; and
                  ``(ii) the Secretary shall accept or decline to 
                accept such letter of intent;
                  ``(B)(i) if the Secretary accepts the letter of 
                intent, a requestor shall submit a qualification plan 
                to the Secretary; and
                  ``(ii) the Secretary shall accept or decline to 
                accept the qualification plan; and
                  ``(C)(i) if the Secretary accepts the qualification 
                plan, the requestor submits to the Secretary a full 
                qualification package;
                  ``(ii) the Secretary shall determine whether to 
                accept such qualification package for review; and
                  ``(iii) if the Secretary accepts such qualification 
                package for review, the Secretary shall conduct such 
                review in accordance with this section.
          ``(2) Acceptance and review of submissions.--
                  ``(A) In general.--The succeeding provisions of this 
                paragraph shall apply with respect to the treatment of 
                a letter of intent, a qualification plan, or a full 
                qualification package submitted under paragraph (1) 
                (referred to in this paragraph as `qualification 
                submissions').
                  ``(B) Acceptance factors; nonacceptance.--The 
                Secretary shall determine whether to accept a 
                qualification submission based on factors which may 
                include the scientific merit of the submission and the 
                available resources of the Food and Drug Administration 
                to review the qualification submission. A determination 
                not to accept a submission under paragraph (1) shall 
                not be construed as a final determination by the 
                Secretary under this section regarding the 
                qualification of a drug development tool for its 
                proposed context of use.
                  ``(C) Prioritization of qualification review.--The 
                Secretary may prioritize the review of a full 
                qualification package submitted under paragraph (1) 
                with respect to a drug development tool, based on 
                factors determined appropriate by the Secretary, 
                including--
                          ``(i) as applicable, the severity, rarity, or 
                        prevalence of the disease or condition targeted 
                        by the drug development tool and the 
                        availability or lack of alternative treatments 
                        for such disease or condition; and
                          ``(ii) the identification, by the Secretary 
                        or by biomedical research consortia and other 
                        expert stakeholders, of such a drug development 
                        tool and its proposed context of use as a 
                        public health priority.
                  ``(D) Engagement of external experts.--The Secretary 
                may, for purposes of the review of qualification 
                submissions, through the use of cooperative agreements, 
                grants, or other appropriate mechanisms, consult with 
                biomedical research consortia and may consider the 
                recommendations of such consortia with respect to the 
                review of any qualification plan submitted under 
                paragraph (1) or the review of any full qualification 
                package under paragraph (3).
          ``(3) Review of full qualification package.--The Secretary 
        shall--
                  ``(A) conduct a comprehensive review of a full 
                qualification package accepted under paragraph (1)(C); 
                and
                  ``(B) determine whether the drug development tool at 
                issue is qualified for its proposed context of use.
          ``(4) Qualification.--The Secretary shall determine whether a 
        drug development tool is qualified for a proposed context of 
        use based on the scientific merit of a full qualification 
        package reviewed under paragraph (3).
  ``(b) Effect of Qualification.--
          ``(1) In general.--A drug development tool determined to be 
        qualified under subsection (a)(4) for a proposed context of use 
        specified by the requestor may be used by any person in such 
        context of use for the purposes described in paragraph (2).
          ``(2) Use of a drug development tool.--Subject to paragraph 
        (3), a drug development tool qualified under this section may 
        be used for--
                  ``(A) supporting or obtaining approval or licensure 
                (as applicable) of a drug or biological product 
                (including in accordance with section 506(c)) under 
                section 505 of this Act or section 351 of the Public 
                Health Service Act; or
                  ``(B) supporting the investigational use of a drug or 
                biological product under section 505(i) of this Act or 
                section 351(a)(3) of the Public Health Service Act.
          ``(3) Rescission or modification.--
                  ``(A) In general.--The Secretary may rescind or 
                modify a determination under this section to qualify a 
                drug development tool if the Secretary determines that 
                the drug development tool is not appropriate for the 
                proposed context of use specified by the requestor. 
                Such a determination may be based on new information 
                that calls into question the basis for such 
                qualification.
                  ``(B) Meeting for review.--If the Secretary rescinds 
                or modifies under subparagraph (A) a determination to 
                qualify a drug development tool, the requestor involved 
                shall be granted a request for a meeting with the 
                Secretary to discuss the basis of the Secretary's 
                decision to rescind or modify the determination before 
                the effective date of the rescission or modification.
  ``(c) Transparency.--
          ``(1) In general.--Subject to paragraph (3), the Secretary 
        shall make publicly available, and update on at least a 
        biannual basis, on the Internet website of the Food and Drug 
        Administration the following:
                  ``(A) Information with respect to each qualification 
                submission under the qualification process under 
                subsection (a), including--
                          ``(i) the stage of the review process 
                        applicable to the submission;
                          ``(ii) the date of the most recent change in 
                        stage status;
                          ``(iii) whether the external scientific 
                        experts were utilized in the development of a 
                        qualification plan or the review of a full 
                        qualification package; and
                          ``(iv) submissions from requestors under the 
                        qualification process under subsection (a), 
                        including any data and evidence contained in 
                        such submissions, and any updates to such 
                        submissions.
                  ``(B) The Secretary's formal written determinations 
                in response to such qualification submissions.
                  ``(C) Any rescissions or modifications under 
                subsection (b)(3) of a determination to qualify a drug 
                development tool.
                  ``(D) Summary reviews that document conclusions and 
                recommendations for determinations to qualify drug 
                development tools under subsection (a).
                  ``(E) A comprehensive list of--
                          ``(i) all drug development tools qualified 
                        under subsection (a); and
                          ``(ii) all surrogate endpoints which were the 
                        basis of approval or licensure (as applicable) 
                        of a drug or biological product (including in 
                        accordance with section 506(c)) under section 
                        505 of this Act or section 351 of the Public 
                        Health Service Act.
          ``(2) Relation to trade secrets act.--Information made 
        publicly available by the Secretary under paragraph (1) shall 
        be considered a disclosure authorized by law for purposes of 
        section 1905 of title 18, United States Code.
          ``(3) Applicability.--Nothing in this section shall be 
        construed as authorizing the Secretary to disclose any 
        information contained in an application submitted under section 
        505 of this Act or section 351 of the Public Health Service Act 
        that is confidential commercial or trade secret information 
        subject to section 552(b)(4) of title 5, United States Code, or 
        section 1905 of title 18, United States Code.
  ``(d) Rule of Construction.--Nothing in this section shall be 
construed--
          ``(1) to alter the standards of evidence under subsection (c) 
        or (d) of section 505, including the substantial evidence 
        standard in such subsection (d), or under section 351 of the 
        Public Health Service Act (as applicable); or
          ``(2) to limit the authority of the Secretary to approve or 
        license products under this Act or the Public Health Service 
        Act, as applicable (as in effect before the date of the 
        enactment of the 21st Century Cures Act).
  ``(e) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section, $10,000,000 for each of fiscal 
years 2016 through 2020.
  ``(f) Definitions.--In this section:
          ``(1) Biomarker.--(A) The term `biomarker' means a 
        characteristic (such as a physiologic, pathologic, or anatomic 
        characteristic or measurement) that is objectively measured and 
        evaluated as an indicator of normal biologic processes, 
        pathologic processes, or biological responses to a therapeutic 
        intervention; and
          ``(B) such term includes a surrogate endpoint.
          ``(2) Biomedical research consortia.--The term `biomedical 
        research consortia' means collaborative groups that may take 
        the form of public-private partnerships and may include 
        government agencies, institutions of higher education (as 
        defined in section 101(a) of the Higher Education Act of 1965, 
        patient advocacy groups, industry representatives, clinical and 
        scientific experts, and other relevant entities and 
        individuals.
          ``(3) Clinical outcome assessment.--(A) The term `clinical 
        outcome assessment' means a measurement of a patient's 
        symptoms, overall mental state, or the effects of a disease or 
        condition on how the patient functions; and
          ``(B) such term includes a patient-reported outcome.
          ``(4) Context of use.--The term `context of use' means, with 
        respect to a drug development tool, a statement that describes 
        the circumstances under which the drug development tool is to 
        be used in drug development and regulatory review.
          ``(5) Drug development tool.--The term `drug development 
        tool' includes--
                  ``(A) a biomarker;
                  ``(B) a clinical outcome assessment; and
                  ``(C) any other method, material, or measure that the 
                Secretary determines aids drug development and 
                regulatory review for purposes of this section.
          ``(6) Patient-reported outcome.--The term `patient-reported 
        outcome' means a measurement based on a report from a patient 
        regarding the status of the patient's health condition without 
        amendment or interpretation of the patient's report by a 
        clinician or any other person.
          ``(7) Qualification.--The terms `qualification' and 
        `qualified' mean a determination by the Secretary that a drug 
        development tool and its proposed context of use can be relied 
        upon to have a specific interpretation and application in drug 
        development and regulatory review under this Act.
          ``(8) Requestor.--The term `requestor' means an entity or 
        entities, including a drug sponsor or a biomedical research 
        consortia, seeking to qualify a drug development tool for a 
        proposed context of use under this section.
          ``(9) Surrogate endpoint.--The term `surrogate endpoint' 
        means a marker, such as a laboratory measurement, radiographic 
        image, physical sign, or other measure, that is not itself a 
        direct measurement of clinical benefit, and--
                  ``(A) is known to predict clinical benefit and could 
                be used to support traditional approval of a drug or 
                biological product; or
                  ``(B) is reasonably likely to predict clinical 
                benefit and could be used to support the accelerated 
                approval of a drug or biological product in accordance 
                with section 506(c).''.
  (d) Guidance.--
          (1) In general.--The Secretary of Health and Human Services 
        shall, in consultation with biomedical research consortia (as 
        defined in subsection (f) of section 507 the Federal Food, 
        Drug, and Cosmetic Act (as added by subsection (c))) and other 
        interested parties through a collaborative public process, 
        issue guidance to implement such section 507 that--
                  (A) provides a conceptual framework describing 
                appropriate standards and scientific approaches to 
                support the development of biomarkers delineated under 
                the taxonomy established under paragraph (3);
                  (B) makes recommendations for demonstrating that a 
                surrogate endpoint is reasonably likely to predict 
                clinical benefit for the purpose of supporting the 
                accelerated approval of a drug under section 506(c) of 
                the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
                356(c));
                  (C) with respect to the qualification process under 
                such section 507--
                          (i) describes the requirements that entities 
                        seeking to qualify a drug development tool 
                        under such section shall observe when engaging 
                        in such process;
                          (ii) outlines reasonable timeframes for the 
                        Secretary's review of letters, qualification 
                        plans, or full qualification packages submitted 
                        under such process; and
                          (iii) establishes a process by which such 
                        entities or the Secretary may consult with 
                        biomedical research consortia and other 
                        individuals and entities with expert knowledge 
                        and insights that may assist the Secretary in 
                        the review of qualification plans and full 
                        qualification submissions under such section; 
                        and
                  (D) includes such other information as the Secretary 
                determines appropriate.
          (2) Timing.--Not later than 24 months after the date of the 
        enactment of this Act, the Secretary of Health and Human 
        Services shall issue draft guidance under paragraph (1) on the 
        implementation of section 507 of the Federal Food, Drug, and 
        Cosmetic Act (as added by subsection (c)). The Secretary shall 
        issue final guidance on the implementation of such section not 
        later than 6 months after the date on which the comment period 
        for the draft guidance closes.
          (3) Taxonomy.--
                  (A) In general.--For purposes of informing guidance 
                under this subsection, the Secretary of Health and 
                Human Services shall, in consultation with biomedical 
                research consortia and other interested parties through 
                a collaborative public process, establish a taxonomy 
                for the classification of biomarkers (and related 
                scientific concepts) for use in drug development.
                  (B) Public availability.--Not later than 12 months 
                after the date of the enactment of this Act, the 
                Secretary of Health and Human Services shall make such 
                taxonomy publicly available in draft form for public 
                comment. The Secretary shall finalize the taxonomy not 
                later than 12 months after the close of the public 
                comment period.
  (e) Meeting and Report.--
          (1) Meeting.--Not later than 12 months after the date of the 
        enactment of this Act, the Secretary of Health and Human 
        Services shall convene a public meeting to describe and solicit 
        public input regarding the qualification process under section 
        507 of the Federal Food, Drug, and Cosmetic Act, as added by 
        subsection (c).
          (2) Report.--Not later than 5 years after the date of the 
        enactment of this Act, the Secretary shall make publicly 
        available on the Internet website of the Food and Drug 
        Administration a report. Such report shall include, with 
        respect to the qualification process under section 507 of the 
        Federal Food, Drug, and Cosmetic Act, as added by subsection 
        (c), information on--
                  (A) the number of requests submitted, as a letter of 
                intent, for qualification of a drug development tool 
                (as defined in subsection (f) of such section);
                  (B) the number of such requests accepted and 
                determined to be eligible for submission of a 
                qualification plan or full qualification package (as 
                such terms are defined in such subsection), 
                respectively;
                  (C) the number of such requests for which external 
                scientific experts were utilized in the development of 
                a qualification plan or review of a full qualification 
                package; and
                  (D) the number of qualification plans and full 
                qualification packages, respectively, submitted to the 
                Secretary; and
          (3) the drug development tools qualified through such 
        qualification process, specified by type of tool, such as a 
        biomarker or clinical outcome assessment (as such terms are 
        defined in subsection (f) of such section 507).

SEC. 2022. ACCELERATED APPROVAL DEVELOPMENT PLAN.

  (a) In General.--Section 506 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 356) is amended by adding the following subsection:
  ``(g) Accelerated Approval Development Plan.--
          ``(1) In general.--In the case of a drug that the Secretary 
        determines may be eligible for accelerated approval in 
        accordance with subsection (c), the sponsor of such drug may 
        request, at any time after the submission of an application for 
        the investigation of the drug under section 505(i) of this Act 
        or section 351(a)(3) of the Public Health Service Act, that the 
        Secretary agree to an accelerated approval development plan 
        described in paragraph (2).
          ``(2) Plan described.--A plan described in this paragraph, 
        with respect to a drug described in paragraph (1), is an 
        accelerated approval development plan, which shall include 
        agreement on--
                  ``(A) the surrogate endpoint to be assessed under 
                such plan;
                  ``(B) the design of the study that will utilize the 
                surrogate endpoint; and
                  ``(C) the magnitude of the effect of the drug on the 
                surrogate endpoint that is the subject of the agreement 
                that would be sufficient to form the primary basis of a 
                claim that the drug is effective.
          ``(3) Modification; termination.--The Secretary may require 
        the sponsor of a drug that is the subject of an accelerated 
        approval development plan to modify or terminate the plan if 
        additional data or information indicates that--
                  ``(A) the plan as originally agreed upon is no longer 
                sufficient to demonstrate the safety and effectiveness 
                of the drug involved; or
                  ``(B) the drug is no longer eligible for accelerated 
                approval under subsection (c).
          ``(4) Sponsor consultation.--If the Secretary requires the 
        modification or termination of an accelerated approval 
        development plan under paragraph (3), the sponsor shall be 
        granted a request for a meeting to discuss the basis of the 
        Secretary's decision before the effective date of the 
        modification or termination.
          ``(5) Definition.--In this section, the term `accelerated 
        approval development plan' means a development plan agreed upon 
        by the Secretary and the sponsor submitting the plan that 
        contains study parameters for the use of a surrogate endpoint 
        that--
                  ``(A) is reasonably likely to predict clinical 
                benefit; and
                  ``(B) is intended to be the basis of the accelerated 
                approval of a drug in accordance with subsection 
                (c).''.
  (b) Technical Amendments.--Section 506 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 356) is amended--
          (1) by striking ``(f) Awareness Efforts'' and inserting ``(e) 
        Awareness Efforts''; and
          (2) by striking ``(e) Construction'' and inserting ``(f) 
        Construction''.

           Subtitle C--FDA Advancement of Precision Medicine

SEC. 2041. PRECISION MEDICINE GUIDANCE AND OTHER PROGRAMS OF FOOD AND 
                    DRUG ADMINISTRATION.

  Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 
et seq.) is amended by adding at the end the following:

                   ``Subchapter J--Precision Medicine

``SEC. 591. GENERAL AGENCY GUIDANCE ON PRECISION MEDICINE.

  ``(a) In General.--The Secretary shall issue and periodically update 
guidance to assist sponsors in the development of a precision drug or 
biological product. Such guidance shall--
          ``(1) define the term `precision drug or biological product'; 
        and
          ``(2) address the topics described in subsection (b).
  ``(b) Certain Issues.--The topics to be addressed by guidance under 
subsection (a) are--
          ``(1) the evidence needed to support the use of biomarkers 
        (as defined in section 507(e)) that identify subsets of 
        patients as likely responders to therapies in order to 
        streamline the conduct of clinical trials;
          ``(2) recommendations for the design of studies to 
        demonstrate the validity of a biomarker as a predictor of drug 
        or biological product response;
          ``(3) the manner and extent to which a benefit-risk 
        assessment may be affected when clinical trials are limited to 
        patient population subsets that are identified using 
        biomarkers;
          ``(4) the development of companion diagnostics in the context 
        of a drug development program; and
          ``(5) considerations for developing biomarkers that inform 
        prescribing decisions for a drug or biological product, and 
        when information regarding a biomarker may be included in the 
        approved prescription labeling for a precision drug or 
        biological product.
  ``(c) Date Certain for Initial Guidance.--The Secretary shall issue 
guidance under subsection (a) not later than 18 months after the date 
of the enactment of the 21st Century Cures Act.

``SEC. 592. PRECISION MEDICINE REGARDING ORPHAN-DRUG AND EXPEDITED-
                    APPROVAL PROGRAMS.

  ``(a) In General.--In the case of a precision drug or biological 
product that is the subject of an application submitted under section 
505(b)(1), or section 351(a) of the Public Health Service Act, for the 
treatment of a serious or life-threatening disease or condition and has 
been designated under section 526 as a drug for a rare disease or 
condition, the Secretary may--
          ``(1) consistent with applicable standards for approval, rely 
        upon data or information previously submitted by the sponsor of 
        the precision drug or biological product, or another sponsor, 
        provided that the sponsor of the precision drug or biological 
        product has obtained a contractual right of reference to such 
        other sponsor's data and information, in an application 
        approved under section 505(c) or licensed under section 351(a) 
        of the Public Health Service Act, as applicable--
                  ``(A) for a different drug or biological product; or
                  ``(B) for a different indication for such precision 
                drug or biological product,
        in order to expedite clinical development for a precision drug 
        or biological product that is using the same or similar 
        approach as that used to support approval of the prior approved 
        application or license, as appropriate; and
          ``(2) as appropriate, consider the application for approval 
        of such precision drug or biological product to be eligible for 
        expedited review and approval programs described in section 
        506, including accelerated approval in accordance with 
        subsection (c) of such section.
  ``(b) Rule of Construction.--Nothing in this section shall be 
construed to--
          ``(1) limit the authority of the Secretary to approve 
        products pursuant to this Act and the Public Health Service Act 
        as authorized prior to the date of enactment of this section; 
        or
          ``(2) confer any new rights, beyond those authorized under 
        this Act prior to enactment of this section, with respect to a 
        sponsor's ability to reference information contained in another 
        application submitted under section 505(b)(1) of this Act or 
        section 351(a) of the Public Health Service Act.''.

        Subtitle D--Modern Trial Design and Evidence Development

SEC. 2061. BROADER APPLICATION OF BAYESIAN STATISTICS AND ADAPTIVE 
                    TRIAL DESIGNS.

  (a) Proposals for Use of Innovative Statistical Methods in Clinical 
Protocols for Drugs and Biological Products.--For purposes of assisting 
sponsors in incorporating adaptive trial design and Bayesian methods 
into proposed clinical protocols and applications for new drugs under 
section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) 
and biological products under section 351 of the Public Health Service 
Act (42 U.S.C. 262), the Secretary shall conduct a public meeting and 
issue guidance in accordance with subsection (b).
  (b) Guidance Addressing Use of Adaptive Trial Designs and Bayesian 
Methods.--
          (1) In general.--The Secretary of Health and Human Services, 
        acting through the Commissioner of Food and Drugs (in this 
        subsection referred to as the ``Secretary''), shall--
                  (A) update and finalize the draft guidance addressing 
                the use of adaptive trial design for drugs and 
                biological products; and
                  (B) issue draft guidance on the use of Bayesian 
                methods in the development and regulatory review and 
                approval or licensure of drugs and biological products.
          (2) Contents.--The guidances under paragraph (1) shall 
        address--
                  (A) the use of adaptive trial designs and Bayesian 
                methods in clinical trials, including clinical trials 
                proposed or submitted to help to satisfy the 
                substantial evidence standard under section 505(d) of 
                the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
                355(d));
                  (B) how sponsors may obtain feedback from the 
                Secretary on technical issues related to modeling and 
                simulations prior to--
                          (i) completion of such modeling or 
                        simulations; or
                          (ii) the submission of resulting information 
                        to the Secretary;
                  (C) the types of quantitative and qualitative 
                information that should be submitted for review; and
                  (D) recommended analysis methodologies.
          (3) Public meeting.--Prior to updating or developing the 
        guidances required by paragraph (1), the Secretary shall 
        consult with stakeholders, including representatives of 
        regulated industry, academia, patient advocacy organizations, 
        and disease research foundations, through a public meeting to 
        be held not later than 1 year after the date of enactment of 
        this Act.
          (4) Schedule.--The Secretary shall publish--
                  (A) the final guidance required by paragraph (1)(A) 
                not later than 18 months after the date of the public 
                meeting required by paragraph (3); and
                  (B) the guidance required by paragraph (1)(B) not 
                later than 48 months after the date of the public 
                meeting required by paragraph (3).

SEC. 2062. UTILIZING EVIDENCE FROM CLINICAL EXPERIENCE.

  Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by 
inserting after section 505E of such Act (21 U.S.C. 355f) the 
following:

``SEC. 505F. UTILIZING EVIDENCE FROM CLINICAL EXPERIENCE.

  ``(a) In General.--The Secretary shall establish a program to 
evaluate the potential use of evidence from clinical experience--
          ``(1) to help to support the approval of a new indication for 
        a drug approved under section 505(b); and
          ``(2) to help to support or satisfy postapproval study 
        requirements.
  ``(b) Evidence From Clinical Experience Defined.--In this section, 
the term `evidence from clinical experience' means data regarding the 
usage, or the potential benefits or risks, of a drug derived from 
sources other than randomized clinical trials, including from 
observational studies, registries, and therapeutic use.
  ``(c) Program Framework.--
          ``(1) In general.--Not later than 18 months after the date of 
        enactment of this section, the Secretary shall establish a 
        draft framework for implementation of the program under this 
        section.
          ``(2) Contents of framework.--The framework shall include 
        information describing--
                  ``(A) the current sources of data developed through 
                clinical experience, including ongoing safety 
                surveillance, registry, claims, and patient-centered 
                outcomes research activities;
                  ``(B) the gaps in current data collection activities;
                  ``(C) the current standards and methodologies for 
                collection and analysis of data generated through 
                clinical experience; and
                  ``(D) the priority areas, remaining challenges, and 
                potential pilot opportunities that the program 
                established under this section will address.
          ``(3) Consultation.--
                  ``(A) In general.--In developing the program 
                framework under this subsection, the Secretary shall 
                consult with regulated industry, academia, medical 
                professional organizations, representatives of patient 
                advocacy organizations, disease research foundations, 
                and other interested parties.
                  ``(B) Process.--The consultation under subparagraph 
                (A) may be carried out through approaches such as--
                          ``(i) a public-private partnership with the 
                        entities described in such subparagraph in 
                        which the Secretary may participate; or
                          ``(ii) a contract, grant, or other 
                        arrangement, as determined appropriate by the 
                        Secretary with such a partnership or an 
                        independent research organization.
  ``(d) Program Implementation.--The Secretary shall, not later than 24 
months after the date of enactment of this section and in accordance 
with the framework established under subsection (c), implement the 
program to evaluate the potential use of evidence from clinical 
experience.
  ``(e) Guidance for Industry.--The Secretary shall--
          ``(1) utilize the program established under subsection (a), 
        its activities, and any subsequent pilots or written reports, 
        to inform a guidance for industry on--
                  ``(A) the circumstances under which sponsors of drugs 
                and the Secretary may rely on evidence from clinical 
                experience for the purposes described in subsection 
                (a)(1) or (a)(2); and
                  ``(B) the appropriate standards and methodologies for 
                collection and analysis of evidence from clinical 
                experience submitted for such purposes;
          ``(2) not later than 36 months after the date of enactment of 
        this section, issue draft guidance for industry as described in 
        paragraph (1); and
          ``(3) not later than 48 months after the date of enactment of 
        this section, after providing an opportunity for public comment 
        on the draft guidance, issue final guidance.
  ``(f) Rule of Construction.--
          ``(1) Subject to paragraph (2), nothing in this section 
        prohibits the Secretary from using evidence from clinical 
        experience for purposes not specified in this section, provided 
        the Secretary determines that sufficient basis exists for any 
        such nonspecified use.
          ``(2) This section shall not be construed to alter--
                  ``(A) the standards of evidence under--
                          ``(i) subsection (c) or (d) of section 505, 
                        including the substantial evidence standard in 
                        such subsection (d); or
                          ``(ii) section 351(a) of the Public Health 
                        Service Act; or
                  ``(B) the Secretary's authority to require 
                postapproval studies or clinical trials, or the 
                standards of evidence under which studies or trials are 
                evaluated.

``SEC. 505G. COLLECTING EVIDENCE FROM CLINICAL EXPERIENCE THROUGH 
                    TARGETED EXTENSIONS OF THE SENTINEL SYSTEM.

  ``(a) In General.--The Secretary shall, in parallel to implementing 
the program established under section 505F and in order to build 
capacity for utilizing the evidence from clinical experience described 
in that section, identify and execute pilot demonstrations to extend 
existing use of the Sentinel System surveillance infrastructure 
authorized under section 505(k).
  ``(b) Pilot Demonstrations.--
          ``(1) In general.--The Secretary--
                  ``(A) shall design and implement pilot demonstrations 
                to utilize data captured through the Sentinel System 
                surveillance infrastructure authorized under section 
                505(k) for purposes of, as appropriate--
                          ``(i) generating evidence from clinical 
                        experience to improve characterization or 
                        assessment of risks or benefits of a drug 
                        approved under section 505(c);
                          ``(ii) protecting the public health; or
                          ``(iii) advancing patient-centered care; and
                  ``(B) may make strategic linkages with sources of 
                complementary public health data and infrastructure the 
                Secretary determines appropriate and necessary.
          ``(2) Consultation.--In developing the pilot demonstrations 
        under this subsection, the Secretary shall--
                  ``(A) consult with regulated industry, academia, 
                medical professional organizations, representatives of 
                patient advocacy organizations, disease research 
                foundations, and other interested parties through a 
                public process; and
                  ``(B) develop a framework to promote appropriate 
                transparency and dialogue about research conducted 
                under these pilot demonstrations, including by--
                          ``(i) providing adequate notice to a sponsor 
                        of a drug approved under section 505 or section 
                        351 of the Public Health Service Act of the 
                        Secretary's intent to conduct analyses of such 
                        sponsor's drug or drugs under these pilot 
                        demonstrations;
                          ``(ii) providing adequate notice of the 
                        findings related to analyses described in 
                        clause (i) and an opportunity for the sponsor 
                        of such drug or drugs to comment on such 
                        findings; and
                          ``(iii) ensuring the protection from public 
                        disclosure of any information that is a trade 
                        secret or confidential information subject to 
                        section 552(b)(4) of title 5, United States 
                        Code, or section 1905 of title 18, United 
                        States Code.
          ``(3) Public health exemption.--The Secretary may--
                  ``(A) deem such pilot demonstrations public health 
                activities, permitting the use and disclosure of 
                protected health information as described in section 
                164.512(b)(1)(iii) of title 45, Code of Federal 
                Regulations (or any successor regulation) and exempted 
                as a public health activity as described in section 
                46.101(b)(5) of title 46, Code of Federal Regulations 
                (or any successor regulation); and
                  ``(B) deem safety surveillance performed at the 
                request of the Food and Drug Administration or under 
                such jurisdiction by a sponsor with responsibility for 
                a drug approved under this section or section 351 of 
                the Public Health Services Act using the Sentinel 
                System surveillance infrastructure authorized under 
                section 505(k), including use of analytic tools and 
                querying capabilities developed to implement the active 
                postmarket surveillance system described in this 
                section, public health activities as described in 
                section 164.512(b)(1)(iii) of title 45, Code of Federal 
                Regulations (or any successor regulation) and exempted 
                as a public health activity as described in section 
                46.101(b)(5) of title 46, Code of Federal Regulations 
                (or any successor regulation).
  ``(c) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section $3,000,000 for each of fiscal 
years 2016 through 2020.''.

SEC. 2063. STREAMLINED DATA REVIEW PROGRAM.

  (a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic 
Act, as amended by section 2062, is further amended by inserting after 
section 505G of such Act the following:

``SEC. 505H. STREAMLINED DATA REVIEW PROGRAM.

  ``(a) In General.--The Secretary shall establish a streamlined data 
review program under which a holder of an approved application 
submitted under section 505(b)(1) or under section 351(a) of the Public 
Health Service Act may, to support the approval or licensure (as 
applicable) of the use of the drug that is the subject of such approved 
application for a new qualified indication, submit qualified data 
summaries.
  ``(b) Eligibility.--In carrying out the streamlined data review 
program under subsection (a), the Secretary may authorize the holder of 
the approved application to include one or more qualified data 
summaries described in subsection (a) in a supplemental application 
if--
          ``(1) the drug has been approved under section 505(c) of this 
        Act or licensed under section 351(a) of the Public Health 
        Service Act for one or more indications, and such approval or 
        licensure remains in effect;
          ``(2) the supplemental application is for approval or 
        licensure (as applicable) under such section 505(c) or 351(a) 
        of the use of the drug for a new qualified indication under 
        such section 505(c) or 351(a);
          ``(3) there is an existing database acceptable to the 
        Secretary regarding the safety of the drug developed for one or 
        more indications of the drug approved under such section 505(c) 
        or licensed under such section 351(a);
          ``(4) the supplemental application incorporates or 
        supplements the data submitted in the application for approval 
        or licensure referred to in paragraph (1); and
          ``(5) the full data sets used to develop the qualified data 
        summaries are submitted, unless the Secretary determines that 
        the full data sets are not required.
  ``(c) Public Availability of Information on Program.--The Secretary 
shall post on the public website of the Food and Drug Administration 
and update annually--
          ``(1) the number of applications reviewed under the 
        streamlined data review program;
          ``(2) the average time for completion of review under the 
        streamlined data review program versus other review of 
        applications for new indications; and
          ``(3) the number of applications reviewed under the 
        streamlined data review program for which the Food and Drug 
        Administration made use of full data sets in addition to the 
        qualified data summary.
  ``(d) Definitions.--In this section:
          ``(1) The term `qualified indication' means--
                  ``(A) an indication for the treatment of cancer, as 
                determined appropriate by the Secretary; or
                  ``(B) such other types of indications as the 
                Secretary determines to be subject to the streamlined 
                data review program under this section.
          ``(2) The term `qualified data summary' means a summary of 
        clinical data intended to demonstrate safety and effectiveness 
        with respect to a qualified indication for use of a drug.''.
  (b) Sense of Congress.--It is the sense of Congress that the 
streamlined data review program under section 505H of the Federal Food, 
Drug, and Cosmetic Act, as added by subsection (a), should enable the 
Food and Drug Administration to make approval decisions for certain 
supplemental applications based on qualified data summaries (as defined 
in such section 505H).
  (c) Guidance; Regulations.--The Commissioner of Food and Drugs--
          (1) shall--
                  (A) issue final guidance for implementation of the 
                streamlined data review program established under 
                section 505H of the Federal Food, Drug, and Cosmetic 
                Act, as added by subsection (a), not later than 24 
                months after the date of enactment of this Act; and
                  (B) include in such guidance the process for 
                expanding the types of indications to be subject to the 
                streamlined data review program, as authorized by 
                section 505H(c)(1)(B) of such Act; and
          (2) in addition to issuing guidance under paragraph (1), may 
        issue such regulations as may be necessary for implementation 
        of the program.

                 Subtitle E--Expediting Patient Access

SEC. 2081. SENSE OF CONGRESS.

  It is the sense of Congress that the Food and Drug Administration 
should continue to expedite the approval of drugs designated as 
breakthrough therapies pursuant to section 506(a) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 356(a)) by approving drugs so 
designated as early as possible in the clinical development process, 
regardless of the phase of development, provided that the Secretary of 
Health and Human Services determines that an application for such a 
drug meets the standards of evidence of safety and effectiveness under 
section 505 of such Act (21 U.S.C. 355), including the substantial 
evidence standard under subsection (d) of such section or under section 
351(a) of the Public Health Service Act (42 U.S.C. 262(a)).

SEC. 2082. EXPANDED ACCESS POLICY.

  Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by 
inserting after section 561 (21 U.S.C. 360bbb) the following:

``SEC. 561A. EXPANDED ACCESS POLICY REQUIRED FOR INVESTIGATIONAL DRUGS.

  ``(a) In General.--The manufacturer or distributor of one or more 
investigational drugs for the diagnosis, monitoring, or treatment of 
one or more serious diseases or conditions shall make publicly 
available the policy of the manufacturer or distributor on evaluating 
and responding to requests submitted under section 561(b) for provision 
of such a drug. A manufacturer or distributor may satisfy the 
requirement of the preceding sentence by posting such policy as 
generally applicable to all of such manufacturer's or distributor's 
investigational drugs.
  ``(b) Content of Policy.--A policy described in subsection (a) shall 
include making publicly available--
          ``(1) contact information for the manufacturer or distributor 
        to facilitate communication about requests described in 
        subsection (a);
          ``(2) procedures for making such requests;
          ``(3) the general criteria the manufacturer or distributor 
        will consider or use to approve such requests; and
          ``(4) the length of time the manufacturer or distributor 
        anticipates will be necessary to acknowledge receipt of such 
        requests.
  ``(c) No Guarantee of Access.--The posting of policies by 
manufacturers and distributors under subsection (a) shall not serve as 
a guarantee of access to any specific investigational drug by any 
individual patient.
  ``(d) Revised Policy.--A manufacturer or distributor that has made a 
policy publicly available as required by this section may revise the 
policy at any time.
  ``(e) Application.--This section shall apply to a manufacturer or 
distributor with respect to an investigational drug beginning on the 
later of--
          ``(1) the date that is 60 days after the date of enactment of 
        the 21st Century Cures Act; or
          ``(2) the first initiation of a phase 2 or phase 3 study (as 
        such terms are defined in section 312.21(b) and (c) of title 
        21, Code of Federal Regulations (or any successor regulations)) 
        with respect to such investigational new drug.''.

SEC. 2083. FINALIZING DRAFT GUIDANCE ON EXPANDED ACCESS.

  (a) In General.--Not later than 12 months after the date of enactment 
of this Act, the Secretary of Health and Human Services shall finalize 
the draft guidance entitled ``Expanded Access to Investigational Drugs 
for Treatment Use--Qs & As'' and dated May 2013.
  (b) Contents.--The final guidance referred to in subsection (a) shall 
clearly define how the Secretary of Health and Human Services 
interprets and uses adverse drug event data reported by investigators 
in the case of data reported from use under a request submitted under 
section 561(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360bbb(b)).

    Subtitle F--Facilitating Responsible Manufacturer Communications

SEC. 2101. FACILITATING DISSEMINATION OF HEALTH CARE ECONOMIC 
                    INFORMATION.

  Section 502(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
352(a)) is amended--
          (1) by striking ``(a) If its'' and inserting ``(a)(1) If 
        its'';
          (2) by striking ``a formulary committee, or other similar 
        entity, in the course of the committee or the entity carrying 
        out its responsibilities for the selection of drugs for managed 
        care or other similar organizations'' and inserting ``a payor, 
        formulary committee, or other similar entity with knowledge and 
        expertise in the area of health care economic analysis, 
        carrying out its responsibilities for the selection of drugs 
        for coverage or reimbursement'';
          (3) by striking ``directly relates'' and inserting 
        ``relates'';
          (4) by striking ``and is based on competent and reliable 
        scientific evidence. The requirements set forth in section 
        505(a) or in section 351(a) of the Public Health Service Act 
        shall not apply to health care economic information provided to 
        such a committee or entity in accordance with this paragraph'' 
        and inserting ``, is based on competent and reliable scientific 
        evidence, and includes, where applicable, a conspicuous and 
        prominent statement describing any material differences between 
        the health care economic information and the labeling approved 
        for the drug under section 505 or under section 351 of the 
        Public Health Service Act. The requirements set forth in 
        section 505(a) or in subsections (a) and (k) of section 351 of 
        the Public Health Service Act shall not apply to health care 
        economic information provided to such a payor, committee, or 
        entity in accordance with this paragraph''; and
          (5) by striking ``In this paragraph, the term'' and all that 
        follows and inserting the following:
  ``(2)(A) For purposes of this paragraph, the term `health care 
economic information' means any analysis (including the clinical data, 
inputs, clinical or other assumptions, methods, results, and other 
components underlying or comprising the analysis) that identifies, 
measures, or describes the economic consequences, which may be based on 
the separate or aggregated clinical consequences of the represented 
health outcomes, of the use of a drug. Such analysis may be comparative 
to the use of another drug, to another health care intervention, or to 
no intervention.
  ``(B) Such term does not include any analysis that relates only to an 
indication that is not approved under section 505 or under section 351 
of the Public Health Service Act for such drug.''.

SEC. 2102. FACILITATING RESPONSIBLE COMMUNICATION OF SCIENTIFIC AND 
                    MEDICAL DEVELOPMENTS.

  (a) Guidance.--Not later than 18 months after the date of enactment 
of this Act, the Secretary of Health and Human Services shall issue 
draft guidance on facilitating the responsible dissemination of 
truthful and nonmisleading scientific and medical information not 
included in the approved labeling of drugs and devices.
  (b) Definition.--In this section, the terms ``drug'' and ``device'' 
have the meaning given to such terms in section 201 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321).

                Subtitle G--Antibiotic Drug Development

SEC. 2121. APPROVAL OF CERTAIN DRUGS FOR USE IN A LIMITED POPULATION OF 
                    PATIENTS.

  (a) Purpose.--The purpose of this section is to help to expedite the 
development and availability of treatments for serious or life-
threatening bacterial or fungal infections in patients with unmet 
needs, while maintaining safety and effectiveness standards for such 
treatments, taking into account the severity of the infection and the 
availability or lack of alternative treatments.
  (b) Approval of Certain Antibacterial and Antifungal Drugs.--Section 
505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), as 
amended by section 2001, is further amended by adding at the end the 
following new subsection:
  ``(z) Approval of Certain Antibacterial and Antifungal Drugs for Use 
in a Limited Population of Patients.--
          ``(1) Process.--At the request of the sponsor of an 
        antibacterial or antifungal drug that is intended to treat a 
        serious or life-threatening infection, the Secretary--
                  ``(A) may execute a written agreement with the 
                sponsor on the process for developing data to support 
                an application for approval of such drug, for use in a 
                limited population of patients in accordance with this 
                subsection;
                  ``(B) shall proceed in accordance with this 
                subsection only if a written agreement is reached under 
                subparagraph (A);
                  ``(C) shall provide the sponsor with an opportunity 
                to request meetings under paragraph (2);
                  ``(D) if a written agreement is reached under 
                subparagraph (A), may approve the drug under this 
                subsection for such use--
                          ``(i) in a limited population of patients for 
                        which there is an unmet medical need;
                          ``(ii) based on a streamlined development 
                        program; and
                          ``(iii) only if the standards for approval 
                        under subsections (c) and (d) of this section 
                        or licensure under section 351 of the Public 
                        Health Service Act, as applicable, are met; and
                  ``(E) in approving a drug in accordance with this 
                subsection, subject to subparagraph (D)(iii), may rely 
                upon--
                          ``(i) traditional endpoints, alternate 
                        endpoints, or a combination of traditional and 
                        alternate endpoints, and, as appropriate, data 
                        sets of a limited size; and
                          ``(ii)(I) additional data, including 
                        preclinical, pharmacologic, or pathophysiologic 
                        evidence;
                          ``(II) nonclinical susceptibility and 
                        pharmacokinetic data;
                          ``(III) data from phase 2 clinical trials; 
                        and
                          ``(IV) such other confirmatory evidence as 
                        the Secretary determines appropriate to approve 
                        the drug.
          ``(2) Formal meetings.--
                  ``(A) In general.--To help to expedite and facilitate 
                the development and review of a drug for which a 
                sponsor intends to request approval in accordance with 
                this subsection, the Secretary may, at the request of 
                the sponsor, conduct meetings that provide early 
                consultation, timely advice, and sufficient 
                opportunities to develop an agreement described in 
                paragraph (1)(A) and help the sponsor design and 
                conduct a drug development program as efficiently as 
                possible, including the following types of meetings:
                          ``(i) An early consultation meeting.
                          ``(ii) An assessment meeting.
                          ``(iii) A postapproval meeting.
                  ``(B) No altering of goals.--Nothing in this 
                paragraph shall be construed to alter agreed upon goals 
                and procedures identified in the letters described in 
                section 101(b) of the Prescription Drug User Fee 
                Amendments of 2012.
                  ``(C) Breakthrough therapies.--In the case of a drug 
                designated as a breakthrough therapy under section 
                506(a), the sponsor of such drug may elect to utilize 
                meetings provided under such section with respect to 
                such drug in lieu of meetings described in subparagraph 
                (A).
          ``(3) Labeling requirement.--The labeling of an antibacterial 
        or antifungal drug approved in accordance with this subsection 
        shall contain the statement `Limited Population' in a prominent 
        manner and adjacent to, and not more prominent than, the brand 
        name of the product. The prescribing information for such 
        antibacterial or antifungal drug required by section 201.57 of 
        title 21, Code of Federal Regulations (or any successor 
        regulation) shall also include the following statement: `This 
        drug is indicated for use in a limited and specific population 
        of patients.'.
          ``(4) Promotional materials.--The provisions of section 
        506(c)(2)(B) shall apply with respect to approval in accordance 
        with this subsection to the same extent and in the same manner 
        as such provisions apply with respect to accelerated approval 
        in accordance with section 506(c)(1).
          ``(5) Termination of requirements or conditions.--If a drug 
        is approved in accordance with this subsection for an 
        indication in a limited population of patients and is 
        subsequently approved or licensed under this section or section 
        351 of the Public Health Service Act, other than in accordance 
        with this subsection, for--
                  ``(A) the same indication and the same conditions of 
                use, the Secretary shall remove any labeling 
                requirements or postmarketing conditions that were made 
                applicable to the drug under this subsection; or
                  ``(B) a different indication or condition of use, the 
                Secretary shall not apply the labeling requirements and 
                postmarketing conditions that were made applicable to 
                the drug under this subsection to the subsequent 
                approval of the drug for such different indication or 
                condition of use.
          ``(6) Relation to other provisions.--Nothing in this 
        subsection shall be construed to prohibit the approval of a 
        drug for use in a limited population of patients in accordance 
        with this subsection, in combination with--
                  ``(A) an agreement on the design and size of a 
                clinical trial pursuant to subparagraphs (B) and (C) of 
                subsection (b)(5);
                  ``(B) designation and treatment of the drug as a 
                breakthrough therapy under section 506(a);
                  ``(C) designation and treatment of the drug as a fast 
                track product under section 506(b); or
                  ``(D) accelerated approval of the drug in accordance 
                with section 506(c).
          ``(7) Rule of construction.--Nothing in this subsection shall 
        be construed--
                  ``(A) to alter the standards of evidence under 
                subsection (c) or (d) (including the substantial 
                evidence standard in subsection (d));
                  ``(B) to waive or otherwise preclude the application 
                of requirements under subsection (o);
                  ``(C) to otherwise, in any way, limit the authority 
                of the Secretary to approve products pursuant to this 
                Act and the Public Health Service Act as authorized 
                prior to the date of enactment of this subsection; or
                  ``(D) to restrict in any manner, the prescribing of 
                antibiotics or other products by health care providers, 
                or to otherwise limit or restrict the practice of 
                health care.
          ``(8) Effective immediately.--The Secretary shall have the 
        authorities vested in the Secretary by this subsection 
        beginning on the date of enactment of this subsection, 
        irrespective of when and whether the Secretary promulgates 
        final regulations or guidance.
          ``(9) Definitions.--In this subsection:
                  ``(A) Early consultation meeting.--The term `early 
                consultation meeting' means a pre-investigational new 
                drug meeting or an end-of-phase-1 meeting that--
                          ``(i) is conducted to review and reach a 
                        written agreement--
                                  ``(I) on the scope of the streamlined 
                                development plan for a drug for which a 
                                sponsor intends to request approval in 
                                accordance with this subsection; and
                                  ``(II) which, as appropriate, may 
                                include agreement on the design and 
                                size of necessary preclinical and 
                                clinical studies early in the 
                                development process, including clinical 
                                trials whose data are intended to form 
                                the primary basis for an effectiveness 
                                claim; and
                          ``(ii) provides an opportunity to discuss 
                        expectations of the Secretary regarding studies 
                        or other information that the Secretary deems 
                        appropriate for purposes of applying paragraph 
                        (5), relating to the termination of labeling 
                        requirements or postmarketing conditions.
                  ``(B) Assessment meeting.--The term `assessment 
                meeting' means an end-of-phase 2 meeting, pre-new drug 
                application meeting, or pre-biologics license 
                application meeting conducted to resolve questions and 
                issues raised during the course of clinical 
                investigations, and details addressed in the written 
                agreement regarding postapproval commitments or 
                expansion of approved uses.
                  ``(C) Postapproval meeting.--The term `postapproval 
                meeting' means a meeting following initial approval or 
                licensure of the drug for use in a limited population, 
                to discuss any issues identified by the Secretary or 
                the sponsor regarding postapproval commitments or 
                expansion of approved uses.''.
  (c) Guidance.--Not later than 18 months after the date of enactment 
of this Act, the Secretary of Health and Human Services, acting through 
the Commissioner of Food and Drugs, shall issue draft guidance 
describing criteria, process, and other general considerations for 
demonstrating the safety and effectiveness of antibacterial and 
antifungal drugs to be approved for use in a limited population in 
accordance with section 505(z) of the Federal Food, Drug, and Cosmetic 
Act, as added by subsection (b).
  (d) Conforming Amendments.--
          (1) Licensure of certain biological products.--Section 351(j) 
        of the Public Health Service Act (42 U.S.C. 262(j)) is 
        amended--
                  (A) by striking ``(j)'' and inserting ``(j)(1)'';
                  (B) by inserting ``505(z),'' after ``505(p),''; and
                  (C) by adding at the end the following new paragraph:
  ``(2) In applying section 505(z) of the Federal Food, Drug, and 
Cosmetic Act to the licensure of biological products under this 
section--
          ``(A) references to an antibacterial or antifungal drug that 
        is intended to treat a serious or life-threatening infection 
        shall be construed to refer to a biological product intended to 
        treat a serious or life-threatening bacterial or fungal 
        infection; and
          ``(B) references to approval of a drug under section 505(c) 
        of such Act shall be construed to refer to a licensure of a 
        biological product under subsection (a) of this section.''.
          (2) Misbranding.--Section 502 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 352) is amended by adding at the end 
        the following new subsection:
  ``(dd) If it is a drug approved in accordance with section 505(z) and 
its labeling does not meet the requirements under paragraph (3) of such 
subsection, subject to paragraph (5) of such subsection.''.
  (e) Evaluation.--
          (1) Assessment.--Not later than 48 months after the date of 
        enactment of this Act, the Secretary of Health and Human 
        Services shall publish for public comment an assessment of the 
        program established under section 505(z) of the Federal Food, 
        Drug, and Cosmetic Act, as added by subsection (b). Such 
        assessment shall determine if the limited-use pathway 
        established under such section 505(z) has improved or is likely 
        to improve patient access to novel antibacterial or antifungal 
        treatments and assess how the pathway could be expanded to 
        cover products for serious or life-threatening diseases or 
        conditions beyond bacterial and fungal infections.
          (2) Meeting.--Not later than 90 days after the date of the 
        publication of such assessment, the Secretary, acting through 
        the Commissioner of Food and Drugs, shall hold a public meeting 
        to discuss the findings of the assessment, during which public 
        stakeholders may present their views on the success of the 
        program established under section 505(z) of the Federal Food, 
        Drug, and Cosmetic Act, as added by subsection (b), and the 
        appropriateness of expanding such program.
  (f) Expansion of Program.--If the Secretary of Health and Human 
Services determines, based on the assessment under subsection (e)(1), 
evaluation of the assessment, and any other relevant information, that 
the public health would benefit from expansion of the limited-use 
pathway established under section 505(z) of the Federal Food, Drug, and 
Cosmetic Act (as added by subsection (b)) beyond the drugs approved in 
accordance with such section, the Secretary may expand such limited-use 
pathway in accordance with such a determination. The approval of any 
drugs under any such expansion shall be subject to the considerations 
and requirements described in such section 505(z) for purposes of 
expansion to other serious or life-threatening diseases or conditions.
  (g) Monitoring.--The Public Health Service Act is amended by 
inserting after section 317T (42 U.S.C. 247b-22) the following:

``SEC. 317U. MONITORING ANTIBACTERIAL AND ANTIFUNGAL DRUG USE AND 
                    RESISTANCE.

  ``(a) Monitoring.--The Secretary shall use an appropriate monitoring 
system to monitor--
          ``(1) the use of antibacterial and antifungal drugs, 
        including those receiving approval or licensure for a limited 
        population pursuant to section 505(z) of the Federal Food, 
        Drug, and Cosmetic Act; and
          ``(2) changes in bacterial and fungal resistance to drugs.
  ``(b) Public Availability of Data.--The Secretary shall make 
summaries of the data derived from monitoring under this section 
publicly available for the purposes of--
          ``(1) improving the monitoring of important trends in 
        antibacterial and antifungal resistance; and
          ``(2) ensuring appropriate stewardship of antibacterial and 
        antifungal drugs, including those receiving approval or 
        licensure for a limited population pursuant to section 505(z) 
        of the Federal Food, Drug, and Cosmetic Act.''.

SEC. 2122. SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA FOR 
                    MICROORGANISMS.

  (a) In General.--Section 511 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360a) is amended to read as follows:

``SEC. 511. IDENTIFYING AND UPDATING SUSCEPTIBILITY TEST INTERPRETIVE 
                    CRITERIA FOR MICROORGANISMS.

  ``(a) Purpose; Identification of Criteria.--
          ``(1) Purpose.--The purpose of this section is to provide the 
        Secretary with an expedited, flexible method for--
                  ``(A) clearance or premarket approval of 
                antimicrobial susceptibility testing devices utilizing 
                updated, recognized susceptibility test interpretive 
                criteria to characterize the in vitro susceptibility of 
                particular bacteria, fungi, or other microorganisms to 
                antimicrobial drugs; and
                  ``(B) providing public notice of the availability of 
                recognized interpretive criteria to meet premarket 
                submission requirements or other requirements under 
                this Act for antimicrobial susceptibility testing 
                devices.
          ``(2) In general.--The Secretary shall identify appropriate 
        susceptibility test interpretive criteria with respect to 
        antimicrobial drugs--
                  ``(A) if such criteria are available on the date of 
                approval of the drug under section 505 of this Act or 
                licensure of the drug under section 351 of the Public 
                Health Service Act (as applicable), upon such approval 
                or licensure; or
                  ``(B) if such criteria are unavailable on such date, 
                on the date on which such criteria are available for 
                such drug.
          ``(3) Bases for initial identification.--The Secretary shall 
        identify appropriate susceptibility test interpretive criteria 
        under paragraph (2), based on the Secretary's review of, to the 
        extent available and relevant--
                  ``(A) preclinical and clinical data, including 
                pharmacokinetic, pharmacodynamic, and epidemiological 
                data;
                  ``(B) Bayesian and pharmacometric statistical 
                methodologies; and
                  ``(C) such other evidence and information as the 
                Secretary considers appropriate.
  ``(b) Susceptibility Test Interpretive Criteria Website.--
          ``(1) In general.--Not later than 1 year after the date of 
        the enactment of the 21st Century Cures Act, the Secretary 
        shall establish, and maintain thereafter, on the website of the 
        Food and Drug Administration, a dedicated website that contains 
        a list of any appropriate new or updated susceptibility test 
        interpretive criteria standards in accordance with paragraph 
        (2) (referred to in this section as the `Interpretive Criteria 
        Website').
          ``(2) Listing of susceptibility test interpretive criteria 
        standards.--
                  ``(A) In general.--The list described in paragraph 
                (1) shall consist of any new or updated susceptibility 
                test interpretive criteria standards that are--
                          ``(i) established by a nationally or 
                        internationally recognized standard development 
                        organization that--
                                  ``(I) establishes and maintains 
                                procedures to address potential 
                                conflicts of interest and ensure 
                                transparent decisionmaking;
                                  ``(II) holds open meetings to ensure 
                                that there is an opportunity for public 
                                input by interested parties, and 
                                establishes and maintains processes to 
                                ensure that such input is considered in 
                                decisionmaking; and
                                  ``(III) permits its standards to be 
                                made publicly available, through the 
                                National Library of Medicine or another 
                                similar source acceptable to the 
                                Secretary; and
                          ``(ii) recognized in whole, or in part, by 
                        the Secretary under subsection (c).
                  ``(B) Other list.--The Interpretive Criteria Website 
                shall, in addition to the list described in 
                subparagraph (A), include a list of interpretive 
                criteria, if any, that the Secretary has determined to 
                be appropriate with respect to legally marketed 
                antimicrobial drugs, where--
                          ``(i) the Secretary does not recognize, in 
                        whole or in part, an interpretive criteria 
                        standard described under subparagraph (A) 
                        otherwise applicable to such a drug;
                          ``(ii) the Secretary withdraws under 
                        subsection (c)(1)(B) recognition of a standard, 
                        in whole or in part, otherwise applicable to 
                        such a drug;
                          ``(iii) the Secretary approves an application 
                        under section 505 of this Act or section 351 of 
                        the Public Health Service Act, as applicable, 
                        with respect to marketing of such a drug for 
                        which there are no relevant interpretive 
                        criteria included in a standard recognized by 
                        the Secretary under subsection (c); or
                          ``(iv) because the characteristics of such a 
                        drug differ from other drugs with the same 
                        active ingredient, the interpretive criteria 
                        with respect to such drug--
                                  ``(I) differ from otherwise 
                                applicable interpretive criteria 
                                included in a standard listed under 
                                subparagraph (A) or interpretive 
                                criteria otherwise listed under this 
                                subparagraph; and
                                  ``(II) are determined by the 
                                Secretary to be appropriate for the 
                                drug.
                  ``(C) Required statements of limitations of 
                information.--The Interpretive Criteria Website shall 
                include the following:
                          ``(i) A statement that--
                                  ``(I) the website provides 
                                information about the susceptibility of 
                                bacteria, fungi, or other 
                                microorganisms to a certain drug (or 
                                drugs); and
                                  ``(II) the safety and efficacy of the 
                                drug in treating clinical infections 
                                due to such bacteria, fungi, or other 
                                microorganisms may not have been 
                                established in adequate and well-
                                controlled clinical trials and the 
                                clinical significance of such 
                                susceptibility information in such 
                                trials is unknown.
                          ``(ii) A statement that directs health care 
                        practitioners to consult the approved product 
                        labeling for specific drugs to determine the 
                        uses for which the Food and Drug Administration 
                        has approved the product.
                          ``(iii) Any other statement that the 
                        Secretary determines appropriate to adequately 
                        convey the limitations of the data supporting 
                        susceptibility test interpretive criteria 
                        standard listed on the website.
          ``(3) Notice.--Not later than the date on which the 
        Interpretive Criteria Website is established, the Secretary 
        shall publish a notice of that establishment in the Federal 
        Register.
          ``(4) Inapplicability of misbranding provision.--The 
        inclusion in the approved labeling of an antimicrobial drug of 
        a reference or hyperlink to the Interpretive Criteria Website, 
        in and of itself, shall not cause the drug to be misbranded in 
        violation of section 502, or the regulations promulgated 
        thereunder.
          ``(5) Trade secrets and confidential information.--Nothing in 
        this section shall be construed as authorizing the Secretary to 
        disclose any information that is a trade secret or confidential 
        information subject to section 552(b)(4) of title 5, United 
        States Code.
  ``(c) Recognition of Susceptibility Test Interpretive Criteria From 
Standard Development Organizations.--
          ``(1) In general.--Beginning on the date of the establishment 
        of the Interpretive Criteria Website, and at least every 6 
        months thereafter, the Secretary shall--
                  ``(A) evaluate any appropriate new or updated 
                susceptibility test interpretive criteria standards 
                established by a nationally or internationally 
                recognized standard development organization described 
                in subsection (b)(2)(A)(i); and
                  ``(B) publish on the public website of the Food and 
                Drug Administration a notice--
                          ``(i) withdrawing recognition of any 
                        different susceptibility test interpretive 
                        criteria standard, in whole or in part;
                          ``(ii) recognizing the new or updated 
                        standards;
                          ``(iii) recognizing one or more parts of the 
                        new or updated interpretive criteria specified 
                        in such a standard and declining to recognize 
                        the remainder of such standard; and
                          ``(iv) making any necessary updates to the 
                        lists under subsection (b)(2).
          ``(2) Bases for updating interpretive criteria standards.--In 
        evaluating new or updated susceptibility test interpretive 
        criteria standards under paragraph (1)(A), the Secretary may 
        consider--
                  ``(A) the Secretary's determination that such a 
                standard is not applicable to a particular drug because 
                the characteristics of the drug differ from other drugs 
                with the same active ingredient;
                  ``(B) information provided by interested third 
                parties, including public comment on the annual 
                compilation of notices published under paragraph (3);
                  ``(C) any bases used to identify susceptibility test 
                interpretive criteria under subsection (a)(2); and
                  ``(D) such other information or factors as the 
                Secretary determines appropriate.
          ``(3) Annual compilation of notices.--Each year, the 
        Secretary shall compile the notices published under paragraph 
        (1)(B) and publish such compilation in the Federal Register and 
        provide for public comment. If the Secretary receives comments, 
        the Secretary will review such comments and, if the Secretary 
        determines appropriate, update pursuant to this subsection 
        susceptibility test interpretive criteria standards--
                  ``(A) recognized by the Secretary under this 
                subsection; or
                  ``(B) otherwise listed on the Interpretive Criteria 
                Website under subsection (b)(2).
          ``(4) Relation to section 514(c).--Any susceptibility test 
        interpretive standard recognized under this subsection or any 
        criteria otherwise listed under subsection (b)(2)(B) shall be 
        deemed to be recognized as a standard by the Secretary under 
        section 514(c)(1).
          ``(5) Voluntary use of interpretive criteria.--Nothing in 
        this section prohibits a person from seeking approval or 
        clearance of a drug or device, or changes to the drug or the 
        device, on the basis of susceptibility test interpretive 
        criteria standards which differ from those recognized pursuant 
        to paragraph (1).
  ``(d) Antimicrobial Drug Labeling.--
          ``(1) Drugs marketed prior to establishment of interpretive 
        criteria website.--With respect to an antimicrobial drug 
        lawfully introduced or delivered for introduction into 
        interstate commerce for commercial distribution before the 
        establishment of the Interpretive Criteria Website, a holder of 
        an approved application under section 505 of this Act or 
        section 351 of the Public Health Service Act, as applicable, 
        for each such drug--
                  ``(A) not later than 1 year after establishment of 
                the Interpretive Criteria Website, shall submit to the 
                Secretary a supplemental application for purposes of 
                changing the drug's labeling to substitute a reference 
                or hyperlink to such Website for any susceptibility 
                test interpretive criteria and related information; and
                  ``(B) may begin distribution of the drug involved 
                upon receipt by the Secretary of the supplemental 
                application for such change.
          ``(2) Drugs marketed subsequent to establishment of 
        interpretive criteria website.--With respect to antimicrobial 
        drugs lawfully introduced or delivered for introduction into 
        interstate commerce for commercial distribution on or after the 
        date of the establishment of the Interpretive Criteria Website, 
        the labeling for such a drug shall include, in lieu of 
        susceptibility test interpretive criteria and related 
        information, a reference to such Website.
  ``(e) Special Condition for Marketing of Antimicrobial Susceptibility 
Testing Devices.--
          ``(1) In general.--Notwithstanding sections 501, 502, 510, 
        513, and 515, if the conditions specified in paragraph (2) are 
        met (in addition to other applicable provisions under this 
        chapter) with respect to an antimicrobial susceptibility 
        testing device described in subsection (f)(1), the Secretary 
        may authorize the marketing of such device for a use described 
        in such subsection.
          ``(2) Conditions applicable to antimicrobial susceptibility 
        testing devices.--The conditions specified in this paragraph 
        are the following:
                  ``(A) The device is used to make a determination of 
                susceptibility using susceptibility test interpretive 
                criteria that are--
                          ``(i) included in a standard recognized by 
                        the Secretary under subsection (c); or
                          ``(ii) otherwise listed on the Interpretive 
                        Criteria Website under subsection (b)(2).
                  ``(B) The labeling of such device prominently and 
                conspicuously--
                          ``(i)  includes a statement that--
                                  ``(I) the device provides information 
                                about the susceptibility of bacteria 
                                and fungi to certain drugs; and
                                  ``(II) the safety and efficacy of 
                                such drugs in treating clinical 
                                infections due to such bacteria or 
                                fungi may not have been established in 
                                adequate and well-controlled clinical 
                                trials and the clinical significance of 
                                such susceptibility information in 
                                those instances is unknown;
                          ``(ii) includes a statement directing health 
                        care practitioners to consult the approved 
                        labeling for drugs tested using such a device, 
                        to determine the uses for which the Food and 
                        Drug Administration has approved such drugs; 
                        and
                          ``(iii) includes any other statement the 
                        Secretary determines appropriate to adequately 
                        convey the limitations of the data supporting 
                        the interpretive criteria described in 
                        subparagraph (A).
  ``(f) Definitions.--In this section:
          ``(1) The term `antimicrobial susceptibility testing device' 
        means a device that utilizes susceptibility test interpretive 
        criteria to determine and report the in vitro susceptibility of 
        certain microorganisms to a drug (or drugs).
          ``(2) The term `qualified infectious disease product' means a 
        qualified infectious disease product designated under section 
        505E(d).
          ``(3) The term `susceptibility test interpretive criteria' 
        means--
                  ``(A) one or more specific numerical values which 
                characterize the susceptibility of bacteria or other 
                microorganisms to the drug tested; and
                  ``(B) related categorizations of such susceptibility, 
                including categorization of the drug as susceptible, 
                intermediate, resistant, or such other term as the 
                Secretary determines appropriate.
          ``(4)(A) The term `antimicrobial drug' means, subject to 
        subparagraph (B), a systemic antibacterial or antifungal drug 
        that--
                  ``(i) is intended for human use in the treatment of a 
                disease or condition caused by a bacterium or fungus;
                  ``(ii) may include a qualified infectious disease 
                product designated under section 505E(d); and
                  ``(iii) is subject to section 503(b)(1).
          ``(B) If provided by the Secretary through regulations, such 
        term may include--
                  ``(i) drugs other than systemic antibacterial and 
                antifungal drugs; and
                  ``(ii) biological products (as such term is defined 
                in section 351 of the Public Health Service Act) to the 
                extent such products exhibit antimicrobial activity. 
  ``(g) Rule of Construction.--Nothing in this section shall be 
construed--
          ``(1) to alter the standards of evidence--
                  ``(A) under subsection (c) or (d) of section 505, 
                including the substantial evidence standard in section 
                505(d), or under section 351 of the Public Health 
                Service Act (as applicable); or
                  ``(B) with respect to marketing authorization for 
                devices, under section 510, 513, or 515;
          ``(2) to apply with respect to any drug, device, or 
        biological product, in any context other than--
                  ``(A) an antimicrobial drug; or
                  ``(B) an antimicrobial susceptibility testing device 
                that uses susceptibility test interpretive criteria to 
                characterize and report the in vitro susceptibility of 
                certain bacteria, fungi, or other microorganisms to 
                antimicrobial drugs in accordance with this section; or
          ``(3) unless specifically stated, to have any effect on 
        authorities provided under other sections of this Act, 
        including any regulations issued under such sections.''.
  (b) Conforming Amendments.--
          (1) Repeal of related authority.--Section 1111 of the Food 
        and Drug Administration Amendments Act of 2007 (42 U.S.C. 247d-
        5a; relating to identification of clinically susceptible 
        concentrations of antimicrobials) is repealed.
          (2) Clerical amendment.--The table of contents in section 2 
        of the Food and Drug Administration Amendments Act of 2007 is 
        amended by striking the item relating to section 1111.
          (3) Misbranding.--Section 502 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 352), as amended by section 2121, is 
        further amended by adding at the end the following:
  ``(ee) If it is an antimicrobial drug and its labeling fails to 
conform with the requirements under section 511(d).''.
          (4) Recognition of interpretive criteria as device 
        standard.--Section 514(c)(1)(A) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 360d(c)(1)(A)) is amended by inserting 
        after ``the Secretary shall, by publication in the Federal 
        Register'' the following: ``(or, with respect to susceptibility 
        test interpretive criteria or standards recognized or otherwise 
        listed under section 511, by posting on the Interpretive 
        Criteria Website in accordance with such section)''.
  (c) Report to Congress.--Not later than two years after the date of 
enactment of this Act, the Secretary of Health and Human Services shall 
submit to the Committee on Energy and Commerce of the House of 
Representatives and the Committee on Health, Education, Labor and 
Pensions of the Senate a report on the progress made in implementing 
section 511 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360a), as amended by this section.
  (d) Requests for Updates to Interpretive Criteria Website.--Chapter 
35 of title 44, United States Code, shall not apply to the collection 
of information from interested parties regarding the updating of lists 
under paragraph (2) of subsection (b) section 511 of the Federal Food, 
Drug, and Cosmetic Act (as amended by subsection (a)) and posted on the 
Interpretive Criteria Website established under paragraph (1) of such 
subsection (b).
  (e) No Effect on Health Care Practice.--Nothing in this subtitle 
(including the amendments made by this subtitle) shall be construed to 
restrict, in any manner, the prescribing or administering of 
antibiotics or other products by health care practitioners, or to limit 
the practice of health care.

SEC. 2123. ENCOURAGING THE DEVELOPMENT AND USE OF NEW ANTIMICROBIAL 
                    DRUGS.

  (a) Additional Payment for New Antimicrobial Drugs Under Medicare.--
          (1) In general.--Section 1886(d)(5) of the Social Security 
        Act (42 U.S.C. 1395ww(d)(5)) is amended by adding at the end 
        the following new subparagraph:
  ``(M)(i) As part of the annual rulemaking under this subsection for 
payment for subsection (d) hospitals for each fiscal year beginning 
with fiscal year 2018, the Secretary shall--
          ``(I) include publication of a list of the new antimicrobial 
        drugs for such fiscal year; and
          ``(II) with respect to discharges by eligible hospitals that 
        involve a drug so published, provide for an additional payment 
        to be made under this subsection in accordance with the 
        provisions of this subparagraph.
  ``(ii) Additional payments may not be made for a drug under this 
subparagraph--
          ``(I) other than during the 5-fiscal-year period beginning 
        with the fiscal year for which the drug is first included in 
        the publication described in clause (i)(I); and
          ``(II) with respect to which payment has ever been made 
        pursuant to subparagraph (K).
  ``(iii) For purposes of this subparagraph, the term `new 
antimicrobial drug' means a product that is approved for use, or a 
product for which an indication is first approved for use, by the Food 
and Drug Administration on or after December 1, 2014, and that the Food 
and Drug Administration determines--
          ``(I) either--
                  ``(aa) is intended to treat an infection caused by, 
                or likely to be caused by, a qualifying pathogen (as 
                defined under section 505E(f) of the Federal Food, 
                Drug, and Cosmetic Act); or
                  ``(bb) meets the definition of a qualified infectious 
                disease product under section 505E(g) of the Federal 
                Food, Drug, and Cosmetic Act; and
          ``(II) is intended to treat an infection--
                  ``(aa) for which there is an unmet medical need; and
                  ``(bb) which is associated with high rates of 
                mortality or significant patient morbidity, as 
                determined in consultation with the Director of the 
                Centers for Disease Control and Prevention and the 
                infectious disease professional community.
Such determination may be revoked only upon a finding that the request 
for such determination contained an untrue statement of material fact.
  ``(iv) For purposes of this subparagraph, the term `eligible 
hospital' means a subsection (d) hospital that participates in the 
National Healthcare Safety Network of the Centers for Disease Control 
and Prevention (or, to the extent a similar surveillance system 
reporting program that includes reporting about antimicrobial drugs is 
determined by the Secretary to be available to such hospitals, such 
similar surveillance system as the Secretary may specify).
  ``(v)(I) Subject to the succeeding provisions of this clause, the 
additional payment under this subparagraph, with respect to a drug, 
shall be in the amount provided for such drug under section 1847A.
  ``(II) The Secretary shall, as part of the rulemaking referred to in 
clause (i) for each fiscal year, estimate--
          ``(aa) the total amount of the additional payments that will 
        be made under this subsection pursuant to this subparagraph for 
        discharges in such fiscal year without regard to the 
        application of subclause (III); and
          ``(bb) the total program payments to be made under this 
        subsection for all discharges in such fiscal year.
  ``(III) If the estimated total amount described in subclause (II)(aa) 
for a fiscal year exceeds the applicable percentage of the estimated 
total program payments described in subclause (II)(bb) for such fiscal 
year, the Secretary shall reduce in a pro rata manner the amount of 
each additional payment under this subsection pursuant to this 
subparagraph for such fiscal year in order to ensure that the total 
amount of the additional payments under this subsection pursuant to 
this subparagraph for such fiscal year do not exceed the applicable 
percentage of the estimated total program payments described in 
subclause (II)(bb) for such fiscal year.
  ``(IV) For purposes of subclause (III), the term `applicable 
percentage' means 0.03 percent.''.
          (2) Conforming amendments.--
                  (A) No duplicative ntap payments.--Section 
                1886(d)(5)(K)(vi) of the Social Security Act (42 U.S.C. 
                1395ww(d)(5)(K)(vi)) is amended by inserting ``if 
                additional payment has never been made under this 
                subsection pursuant to subparagraph (M) with respect to 
                the service or technology'' after ``if the service or 
                technology''.
                  (B) Access to price information.--Section 
                1927(b)(3)(A)(iii) of the Social Security Act (42 
                U.S.C. 1396r-8(b)(3)(A)(iii)) is amended--
                          (i) in subclause (II), by inserting ``or 
                        under section 1886(d) pursuant to paragraph 
                        (5)(M) of such section,'' after ``1847A,''; and
                          (ii) in the matter following subclause (III), 
                        by inserting ``or section 1886(d)(5)(M)'' after 
                        ``1881(b)(13)(A)(ii)''.
  (b) Study and Report on Removing Barriers to Development of New 
Antimicrobial Drugs.--
          (1) Study.--The Comptroller General of the United States 
        shall, in consultation with the Director of the National 
        Institutes of Health, the Commissioner of Food and Drugs, and 
        the Director of the Centers for Disease Control and Prevention, 
        conduct a study to--
                  (A) identify and examine the barriers that prevent 
                the development of new antimicrobial drugs, as defined 
                in section 1886(d)(5)(M)(iii) of the Social Security 
                Act (42 U.S.C. 1395ww(d)(5)(M)(iii)), as added by 
                subsection (a)(1); and
                  (B) develop recommendations for actions to be taken 
                in order to overcome any barriers identified under 
                subparagraph (A).
          (2) Report.--Not later than 1 year after the date of the 
        enactment of this Act, the Comptroller General shall submit to 
        Congress a report on the study conducted under paragraph (1).

         Subtitle H--Vaccine Access, Certainty, and Innovation

SEC. 2141. TIMELY REVIEW OF VACCINES BY THE ADVISORY COMMITTEE ON 
                    IMMUNIZATION PRACTICES.

  Section 2102(a) of the Public Health Service Act (42 U.S.C. 300aa-
2(a)) is amended by adding at the end the following:
          ``(10) Advisory committee on immunization practices.--
                  ``(A) Standard periods of time for making 
                recommendations.--Upon the licensure of any vaccine or 
                any new indication for a vaccine, the Director of the 
                Program shall direct the Advisory Committee on 
                Immunization Practices, at its next regularly scheduled 
                meeting, to consider the use of the vaccine.
                  ``(B) Expedited review pursuant to request by sponsor 
                or manufacturer.--If the Advisory Committee does not 
                make recommendations with respect to the use of a 
                vaccine at the Advisory Committee's first regularly 
                scheduled meeting after the licensure of the vaccine or 
                any new indication for the vaccine, the Advisory 
                Committee, at the request of the sponsor of the 
                vaccine, shall make such recommendations on an 
                expedited basis.
                  ``(C) Expedited review for breakthrough therapies and 
                for use during public health emergencies.--If a vaccine 
                is designated as a breakthrough therapy under section 
                506 of the Federal Food, Drug, and Cosmetic Act and is 
                licensed under section 351 of this Act, the Advisory 
                Committee shall make recommendations with respect to 
                the use of the vaccine on an expedited basis.
                  ``(D) Definition.--In this paragraph, the terms 
                `Advisory Committee on Immunization Practices' and 
                `Advisory Committee' mean the advisory committee on 
                immunization practices established by the Secretary 
                pursuant to section 222, acting through the Director of 
                the Centers for Disease Control and Prevention.''.

SEC. 2142. REVIEW OF PROCESSES AND CONSISTENCY OF ACIP RECOMMENDATIONS.

  (a) Review.--The Director of the Centers for Disease Control and 
Prevention shall conduct a review of the process used by the Advisory 
Committee on Immunization Practices to evaluate consistency in 
formulating and issuing recommendations pertaining to vaccines.
  (b) Considerations.--The review under subsection (a) shall include 
assessment of--
          (1) the criteria used to evaluate new and existing vaccines;
          (2) the Grading of Recommendations, Assessment, Development, 
        and Evaluation (GRADE) approach to the review and analysis of 
        scientific and economic data, including the scientific basis 
        for such approach; and
          (3) the extent to which the processes used by the working 
        groups of the Advisory Committee on Immunization Practices are 
        consistent among groups.
  (c) Stakeholders.--In carrying out the review under subsection (a), 
the Director of the Centers for Disease Control and Prevention shall 
solicit input from vaccine stakeholders.
  (d) Report.--Not later than 18 months after the date of enactment of 
this Act, the Director of the Centers for Disease Control and 
Prevention shall submit to the appropriate committees of the Congress 
and make publicly available a report on the results of the review under 
subsection (a), including recommendations on improving the consistency 
of the process described in such subsection.
  (e) Definition.--In this section, the term ``Advisory Committee on 
Immunization Practices'' means the advisory committee on immunization 
practices established by the Secretary of Health and Human Services 
pursuant to section 222 of the Public Health Service Act (42 U.S.C. 
217a), acting through the Director of the Centers for Disease Control 
and Prevention.

SEC. 2143. MEETINGS BETWEEN CDC AND VACCINE DEVELOPERS.

  Section 310 of the Public Health Service Act (42 U.S.C. 242o) is 
amended by adding at the end the following:
  ``(c)(1) In this subsection, the term `vaccine developer' means a 
nongovernmental entity engaged in--
          ``(A)(i) the development of a vaccine with the intent to 
        pursue licensing of the vaccine by the Food and Drug 
        Administration; or
          ``(ii) the production of a vaccine licensed by the Food and 
        Drug Administration; and
          ``(B) vaccine research.
  ``(2)(A) Upon the submission of a written request for a meeting by a 
vaccine developer, that includes a justification for the meeting, the 
Secretary, acting through the Director of the Centers for Disease 
Control and Prevention, shall convene a meeting of representatives of 
the vaccine developer and experts from the Centers for Disease Control 
and Prevention in immunization programs, epidemiology, and other 
relevant areas at which the Director (or the Director's designee), for 
the purpose of informing the vaccine developer's understanding of 
public health needs and priorities, shall provide the perspectives of 
the Centers for Disease Control and Prevention and other relevant 
Federal agencies regarding--
          ``(i) public health needs, epidemiology, and implementation 
        considerations with regard to a vaccine developer's potential 
        vaccine profile; and
          ``(ii) potential implications of such perspectives for the 
        vaccine developer's vaccine research and development planning.
  ``(B) In addition to the representatives specified in subparagraph 
(A), the Secretary may, with the agreement of the vaccine developer 
requesting a meeting under such subparagraph, include in such meeting 
representatives of--
          ``(i) the Food and Drug Administration; and
          ``(ii) the National Vaccine Program.
  ``(C) The Secretary shall convene a meeting requested under 
subparagraph (A) not later than 120 days after receipt of the request 
for the meeting.
  ``(3)(A) Upon the submission of a written request by a vaccine 
developer, the Secretary, acting through the Director of the Centers 
for Disease Control and Prevention, shall provide to the vaccine 
developer any age-based or other demographically assessed disease 
epidemiological analyses or data that--
          ``(i) are specified in the request;
          ``(ii) have been published;
          ``(iii) have been performed by or are in the possession of 
        the Centers;
          ``(iv) are not a trade secret or commercial or financial 
        information that is privileged or confidential and subject to 
        section 552(b)(4) of title 5, United States Code, or section 
        1905 of title 18, United States Code; and
          ``(v) do not contain individually identifiable information.
  ``(B) The Secretary shall provide analyses requested by a vaccine 
manufacturer under subparagraph (A) not later than 120 calendar days 
after receipt of the request for the analyses.
  ``(4) The Secretary shall promptly notify a vaccine developer if--
          ``(A) the Secretary becomes aware of any change to 
        information that was--
                  ``(i) shared by the Secretary with the vaccine 
                developer during a meeting under paragraph (2); or
                  ``(ii) provided by the Secretary to the vaccine 
                developer in one or more analyses under paragraph (3); 
                and
          ``(B) the change to such information may have implications 
        for the vaccine developer's vaccine research and 
        development.''.

   Subtitle I--Orphan Product Extensions Now; Incentives for Certain 
                    Products for Limited Populations

SEC. 2151. EXTENSION OF EXCLUSIVITY PERIODS FOR A DRUG APPROVED FOR A 
                    NEW INDICATION FOR A RARE DISEASE OR CONDITION.

  (a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic 
Act, as amended by sections 2062 and 2063, is further amended by 
inserting after section 505H of such Act the following:

``SEC. 505I. EXTENSION OF EXCLUSIVITY PERIODS FOR A DRUG APPROVED FOR A 
                    NEW INDICATION FOR A RARE DISEASE OR CONDITION.

  ``(a) Designation.--
          ``(1) In general.--The Secretary shall designate a drug as a 
        drug approved for a new indication to prevent, diagnose, or 
        treat a rare disease or condition for purposes of granting the 
        extensions under subsection (b) if--
                  ``(A) prior to approval of an application or 
                supplemental application for the new indication, the 
                drug was approved or licensed for marketing under 
                section 505(c) of this Act or section 351(a) of the 
                Public Health Service Act, but was not so approved or 
                licensed for the new indication;
                  ``(B)(i) the sponsor of the approved or licensed drug 
                files an application or a supplemental application for 
                approval of the new indication for use of the drug to 
                prevent, diagnose, or treat the rare disease or 
                condition; and
                  ``(ii) the Secretary approves the application or 
                supplemental application; and
                  ``(C) the application or supplemental application for 
                the new indication contains the consent of the 
                applicant to notice being given by the Secretary under 
                paragraph (4) respecting the designation of the drug.
          ``(2) Revocation of designation.--
                  ``(A) In general.--Except as provided in subparagraph 
                (B), a designation under paragraph (1) shall not be 
                revoked for any reason.
                  ``(B) Exception.--The Secretary may revoke a 
                designation of a drug under paragraph (1) if the 
                Secretary finds that the application or supplemental 
                application resulting in such designation contained an 
                untrue statement of material fact.
          ``(3) Notification prior to discontinuance of production for 
        solely commercial reasons.--A designation of a drug under 
        paragraph (1) shall be subject to the condition that the 
        sponsor of the drug will notify the Secretary of any 
        discontinuance of the production of the drug for solely 
        commercial reasons at least one year before such 
        discontinuance.
          ``(4) Notice to public.--Notice respecting the designation of 
        a drug under paragraph (1) shall be made available to the 
        public.
  ``(b) Extension.--If the Secretary designates a drug as a drug 
approved for a new indication for a rare disease or condition, as 
described in subsection (a)(1)--
          ``(1)(A) the 4-, 5-, and 7\1/2\-year periods described in 
        subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of section 505, the 
        3-year periods described in clauses (iii) and (iv) of 
        subsection (c)(3)(E) and clauses (iii) and (iv) of subsection 
        (j)(5)(F) of section 505, and the 7-year period described in 
        section 527, as applicable, shall be extended by 6 months; or
          ``(B) the 4- and 12-year periods described in subparagraphs 
        (A) and (B) of section 351(k)(7) of the Public Health Service 
        Act and the 7-year period described in section 527, as 
        applicable, shall be extended by 6 months; and
          ``(2)(A) if the drug is the subject of a listed patent for 
        which a certification has been submitted under subsection 
        (b)(2)(A)(ii) or (j)(2)(A)(vii)(II) of section 505 or a listed 
        patent for which a certification has been submitted under 
        subsections (b)(2)(A)(iii) or (j)(2)(A)(vii)(III) of section 
        505, the period during which an application may not be approved 
        under section 505(c)(3) or section 505(j)(5)(B) shall be 
        extended by a period of 6 months after the date the patent 
        expires (including any patent extensions); or
          ``(B) if the drug is the subject of a listed patent for which 
        a certification has been submitted under subsection 
        (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505, and in the 
        patent infringement litigation resulting from the certification 
        the court determines that the patent is valid and would be 
        infringed, the period during which an application may not be 
        approved under section 505(c)(3) or section 505(j)(5)(B) shall 
        be extended by a period of 6 months after the date the patent 
        expires (including any patent extensions).
  ``(c) Relation to Pediatric and Qualified Infectious Disease Product 
Exclusivity.--Any extension under subsection (b) of a period shall be 
in addition to any extension of the periods under sections 505A and 
505E of this Act and section 351(m) of the Public Health Service Act, 
as applicable, with respect to the drug.
  ``(d) Limitations.--The extension described in subsection (b) shall 
not apply if the drug designated under subsection (a)(1) has previously 
received an extension by operation of subsection (b).
  ``(e) Definition.--In this section, the term `rare disease or 
condition' has the meaning given to such term in section 526(a)(2).''.
  (b) Application.--Section 505G of the Federal Food, Drug, and 
Cosmetic Act, as added by subsection (a), applies only with respect to 
a drug for which an application or supplemental application described 
in subsection (a)(1)(B)(i) of such section 505G is first approved under 
section 505(c) of such Act (21 U.S.C. 355(c)) or section 351(a) of the 
Public Health Service Act (42 U.S.C. 262(a)) on or after the date of 
the enactment of this Act.
  (c) Conforming Amendments.--
          (1) Relation to pediatric exclusivity for drugs.--Section 
        505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        355a) is amended--
                  (A) in subsection (b), by adding at the end the 
                following:
          ``(3) Relation to exclusivity for a drug approved for a new 
        indication for a rare disease or condition.--Notwithstanding 
        the references in paragraph (1) to the lengths of the 
        exclusivity periods after application of pediatric exclusivity, 
        the 6-month extensions described in paragraph (1) shall be in 
        addition to any extensions under section 505G.''; and
                  (B) in subsection (c), by adding at the end the 
                following:
          ``(3) Relation to exclusivity for a drug approved for a new 
        indication for a rare disease or condition.--Notwithstanding 
        the references in paragraph (1) to the lengths of the 
        exclusivity periods after application of pediatric exclusivity, 
        the 6-month extensions described in paragraph (1) shall be in 
        addition to any extensions under section 505G.''.
          (2) Relation to exclusivity for new qualified infectious 
        disease products that are drugs.--Subsection (b) of section 
        505E of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        355f) is amended--
                  (A) by amending the subsection heading to read as 
                follows: ``Relation to Pediatric Exclusivity and 
                Exclusivity for a Drug Approved for a New Indication 
                for a Rare Disease or Condition.--''; and
                  (B) by striking ``any extension of the period under 
                section 505A'' and inserting ``any extension of the 
                periods under sections 505A and 505G, as applicable,''.
          (3) Relation to pediatric exclusivity for biological 
        products.--Section 351(m) of the Public Health Service Act (42 
        U.S.C. 262(m)) is amended by adding at the end the following:
          ``(5) Relation to exclusivity for a biological product 
        approved for a new indication for a rare disease or 
        condition.--Notwithstanding the references in paragraphs 
        (2)(A), (2)(B), (3)(A), and (3)(B) to the lengths of the 
        exclusivity periods after application of pediatric exclusivity, 
        the 6-month extensions described in such paragraphs shall be in 
        addition to any extensions under section 505G.''.

SEC. 2152. REAUTHORIZATION OF RARE PEDIATRIC DISEASE PRIORITY REVIEW 
                    VOUCHER INCENTIVE PROGRAM.

  (a) In General.--Section 529 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360ff) is amended--
          (1) in subsection (a)--
                  (A) in paragraph (3), by amending subparagraph (A) to 
                read as follows:
                  ``(A) The disease is a serious or life-threatening 
                disease in which the serious or life-threatening 
                manifestations primarily affect individuals aged from 
                birth to 18 years, including age groups often called 
                neonates, infants, children, and adolescents.''; and
                  (B) in paragraph (4)--
                          (i) in subparagraph (E), by striking ``and'' 
                        at the end;
                          (ii) in subparagraph (F), by striking the 
                        period at the end and inserting ``; and''; and
                          (iii) by adding at the end the following:
                  ``(G) is for a drug or biological product for which a 
                priority review voucher has not been issued under 
                section 524 (relating to tropical disease products).''; 
                and
          (2) in subsection (b), by striking paragraph (5) and 
        inserting the following:
          ``(5) Termination of authority.--The Secretary may not award 
        any priority review vouchers under paragraph (1) after December 
        31, 2018.''.
  (b) GAO Study and Report.--
          (1) Study.--The Comptroller General of the United States 
        shall conduct a study on the effectiveness of awarding priority 
        review vouchers under section 529 of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 360ff) in providing incentives for 
        the development of drugs that treat or prevent rare pediatric 
        diseases (as defined in subsection (a)(3) of such section) that 
        would not otherwise have been developed. In conducting such 
        study, the Comptroller General shall examine the following:
                  (A) The indications for which each drug for which a 
                priority review voucher was awarded under such section 
                529 was approved under section 505 of such Act (21 
                U.S.C. 355) or section 351 of the Public Health Service 
                Act (42 U.S.C. 262).
                  (B) Whether the priority review voucher impacted a 
                sponsor's decision to invest in developing a drug to 
                treat or prevent a rare pediatric disease.
                  (C) An analysis of the drugs that utilized such 
                priority review vouchers, which shall include--
                          (i) the indications for which such drugs were 
                        approved under section 505 of the Federal Food, 
                        Drug, and Cosmetic Act (21 U.S.C. 355) or 
                        section 351 of the Public Health Service Act 
                        (42 U.S.C. 262);
                          (ii) whether unmet medical needs were 
                        addressed through the approval of such drugs, 
                        including, for each such drug--
                                  (I) if an alternative therapy was 
                                previously available to treat the 
                                indication; and
                                  (II) the benefit or advantage the 
                                drug provided over another available 
                                therapy;
                          (iii) the number of patients potentially 
                        treated by such drugs;
                          (iv) the value of the priority review voucher 
                        if transferred; and
                          (v) the length of time between the date on 
                        which a priority review voucher was awarded and 
                        the date on which it was used.
                  (D) With respect to the priority review voucher 
                program under section 529 of the Federal Food, Drug, 
                and Cosmetic Act (21 U.S.C. 360ff)--
                          (i) the resources used by, and burden placed 
                        on, the Food and Drug Administration in 
                        implementing such program, including the effect 
                        of such program on the Food and Drug 
                        Administration's review of drugs for which a 
                        priority review voucher was not awarded or 
                        used;
                          (ii) the impact of the program on the public 
                        health as a result of the expedited review of 
                        applications for drugs that treat or prevent 
                        non-serious indications that are generally used 
                        by the broader public; and
                          (iii) alternative approaches to improving 
                        such program so that the program is 
                        appropriately targeted toward providing 
                        incentives for the development of clinically 
                        important drugs that--
                                  (I) prevent or treat rare pediatric 
                                diseases; and
                                  (II) would likely not otherwise have 
                                been developed to prevent or treat such 
                                diseases.
          (2) Report.--Not later than December 31, 2017, the 
        Comptroller General of the United States shall submit to the 
        Committee on Energy and Commerce of the House of 
        Representatives and the Committee on Health, Education, Labor 
        and Pensions of the Senate a report containing the results of 
        the study of conducted under paragraph (1).

       Subtitle J--Domestic Manufacturing and Export Efficiencies

SEC. 2161. GRANTS FOR STUDYING THE PROCESS OF CONTINUOUS DRUG 
                    MANUFACTURING.

  (a) In General.--The Commissioner of Food and Drugs may award grants 
to institutions of higher education and nonprofit organizations for the 
purpose of studying and recommending improvements to the process of 
continuous manufacturing of drugs and biological products and similar 
innovative monitoring and control techniques.
  (b) Definitions.--In this section:
          (1) The term ``drug'' has the meaning given to such term in 
        section 201 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 321).
          (2) The term ``biological product'' has the meaning given to 
        such term in section 351(i) of the Public Health Service Act 
        (42 U.S.C. 262(i)).
          (3) The term ``institution of higher education'' has the 
        meaning given to such term in section 101 of the Higher 
        Education Act of 1965 (20 U.S.C. 1001).
  (c) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section $5,000,000 for each of fiscal 
years 2016 through 2020.

SEC. 2162. RE-EXPORTATION AMONG MEMBERS OF THE EUROPEAN ECONOMIC AREA.

  Section 1003 of the Controlled Substances Import and Export Act (21 
U.S.C. 953) is amended--
          (1) in subsection (f)--
                  (A) in paragraph (5)--
                          (i) by striking ``(5)'' and inserting 
                        ``(5)(A)'';
                          (ii) by inserting ``, except that the 
                        controlled substance may be exported from the 
                        second country to another country that is a 
                        member of the European Economic Area'' before 
                        the period at the end; and
                          (iii) by adding at the end the following:
          ``(B) Subsequent to any re-exportation described in 
        subparagraph (A), a controlled substance may continue to be 
        exported from any country that is a member of the European 
        Economic Area to any other such country, provided that--
                  ``(i) the conditions applicable with respect to the 
                first country under paragraphs (1), (2), (3), (4), (6), 
                and (7) are met by each subsequent country from which 
                the controlled substance is exported pursuant to this 
                paragraph; and
                  ``(ii) the conditions applicable with respect to the 
                second country under such paragraphs are met by each 
                subsequent country to which the controlled substance is 
                exported pursuant to this paragraph.''; and
                  (B) in paragraph (6)--
                          (i) by striking ``(6)'' and inserting 
                        ``(6)(A)''; and
                          (ii) by adding at the end the following:
          ``(B) In the case of re-exportation among members of the 
        European Economic Area, within 30 days after each re-
        exportation, the person who exported the controlled substance 
        from the United States delivers to the Attorney General--
                  ``(i) documentation certifying that such re-
                exportation has occurred; and
                  ``(ii) information concerning the consignee, country, 
                and product.''; and
          (2) by adding at the end the following:
  ``(g) Limitation.--The Attorney General shall not promulgate nor 
enforce any regulation, subregulatory guidance, or enforcement policy 
which impedes re-exportation among European Economic Area countries (as 
provided in subsection (f)(5)), including by promulgating or enforcing 
any requirement that--
          ``(1) re-exportation from the first country to the second 
        country or re-exportation from the second country to another 
        country (as such terms are used in subsection (f)) occur within 
        a specified period of time; or
          ``(2) information concerning the consignee, country, and 
        product be provided prior to exportation of the controlled 
        substance from the United States or prior to each re-
        exportation among members of the European Economic Area.''.

           Subtitle K--Enhancing Combination Products Review

SEC. 2181. ENHANCING COMBINATION PRODUCTS REVIEW.

  Section 503(g)(4)(C) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 353(g)(4)(C)) is amended by adding at the end the following new 
clause:
  ``(iii) Not later than 18 months after the date of the enactment of 
the 21st Century Cures Act, the Secretary shall issue final guidance 
that describes the responsibilities of each agency center regarding its 
review of combination products. The Secretary shall, after soliciting 
public comment, review and update the guidance periodically.''.

          Subtitle L--Priority Review for Breakthrough Devices

SEC. 2201. PRIORITY REVIEW FOR BREAKTHROUGH DEVICES.

  (a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic 
Act is amended--
          (1) in section 515(d)--
                  (A) by striking paragraph (5); and
                  (B) by redesignating paragraph (6) as paragraph (5); 
                and
          (2) by inserting after section 515A (21 U.S.C. 360e-1) the 
        following:

``SEC. 515B. PRIORITY REVIEW FOR BREAKTHROUGH DEVICES.

  ``(a) In General.--In order to provide for more effective treatment 
or diagnosis of life-threatening or irreversibly debilitating human 
diseases or conditions, the Secretary shall establish a program to 
provide priority review for devices--
          ``(1) representing breakthrough technologies;
          ``(2) for which no approved alternatives exist;
          ``(3) offering significant advantages over existing approved 
        or cleared alternatives, including the potential to, compared 
        to existing approved or cleared alternatives, reduce or 
        eliminate the need for hospitalization, improve patient quality 
        of life, facilitate patients' ability to manage their own care 
        (such as through self-directed personal assistance), or 
        establish long-term clinical efficiencies; or
          ``(4) the availability of which is in the best interest of 
        patients.
  ``(b) Request for Designation.--A sponsor of a device may request 
that the Secretary designate the device for priority review under this 
section. Any such request for designation may be made at any time prior 
to the submission of an application under section 515(c), a petition 
for classification under section 513(f)(2), or a notification under 
section 510(k).
  ``(c) Designation Process.--
          ``(1) In general.--Not later than 60 calendar days after the 
        receipt of a request under subsection (b), the Secretary shall 
        determine whether the device that is the subject of the request 
        meets the criteria described in subsection (a). If the 
        Secretary determines that the device meets the criteria, the 
        Secretary shall designate the device for priority review.
          ``(2) Review.--Review of a request under subsection (b) shall 
        be undertaken by a team that is composed of experienced staff 
        and managers of the Food and Drug Administration and is chaired 
        by a senior manager. 
          ``(3) Designation determination.--A determination approving 
        or denying a request under subsection (b) shall be considered a 
        significant decision under section 517A and the Secretary shall 
        provide a written, substantive summary of the basis for the 
        determination in accordance with section 517A(a).
          ``(4) Reconsideration.--
                  ``(A) Request for reconsideration.--Any person whose 
                request under subsection (b) is denied may, within 30 
                days of the denial, request reconsideration of the 
                denial in accordance with section 517A(b)--
                          ``(i) based upon the submission of documents 
                        by such person; or
                          ``(ii) based upon such documents and a 
                        meeting or teleconference.
                  ``(B) Response.--Reconsideration of a designation 
                determination under this paragraph shall be conducted 
                in accordance with section 517A(b).
          ``(5) Withdrawal.--If the Secretary approves a priority 
        review designation for a device under this section, the 
        Secretary may not withdraw the designation based on the fact 
        that the criteria specified in subsection (a) are no longer met 
        because of the subsequent clearance or approval of another 
        device that was designated under--
                  ``(A) this section; or
                  ``(B) section 515(d)(5) (as in effect immediately 
                prior to the enactment of the 21st Century Cures Act).
  ``(d) Priority Review.--
          ``(1) Actions.--For purposes of expediting the development 
        and review of devices designated under subsection (c), the 
        Secretary shall--
                  ``(A) assign a team of staff, including a team leader 
                with appropriate subject matter expertise and 
                experience, for each device for which a request is 
                submitted under subsection (b);
                  ``(B) provide for oversight of the team by senior 
                agency personnel to facilitate the efficient 
                development of the device and the efficient review of 
                any submission described in subsection (b) for the 
                device;
                  ``(C) adopt an efficient process for timely dispute 
                resolution;
                  ``(D) provide for interactive communication with the 
                sponsor of the device during the review process;
                  ``(E) expedite the Secretary's review of 
                manufacturing and quality systems compliance, as 
                applicable;
                  ``(F) disclose to the sponsor in advance the topics 
                of any consultation concerning the sponsor's device 
                that the Secretary intends to undertake with external 
                experts or an advisory committee and provide the 
                sponsor an opportunity to recommend such external 
                experts;
                  ``(G) for applications submitted under section 
                515(c), provide for advisory committee input, as the 
                Secretary determines appropriate (including in response 
                to the request of the sponsor); and
                  ``(H) assign staff to be available within a 
                reasonable time to address questions posed by 
                institutional review committees concerning the 
                conditions and clinical testing requirements applicable 
                to the investigational use of the device pursuant to an 
                exemption under section 520(g).
          ``(2) Additional actions.--In addition to the actions 
        described in paragraph (1), for purposes of expediting the 
        development and review of devices designated under subsection 
        (c), the Secretary, in collaboration with the device sponsor, 
        may, as appropriate--
                  ``(A) coordinate with the sponsor regarding early 
                agreement on a data development plan;
                  ``(B) take steps to ensure that the design of 
                clinical trials is as efficient as practicable, such as 
                through adoption of shorter or smaller clinical trials, 
                application of surrogate endpoints, and use of adaptive 
                trial designs and Bayesian statistics, to the extent 
                scientifically appropriate;
                  ``(C) facilitate, to the extent scientifically 
                appropriate, expedited and efficient development and 
                review of the device through utilization of timely 
                postmarket data collection, with regard to applications 
                for approval under section 515(c); and
                  ``(D) agree to clinical protocols that the Secretary 
                will consider binding on the Secretary and the sponsor, 
                subject to--
                          ``(i) changes agreed to by the sponsor and 
                        the Secretary;
                          ``(ii) changes that the Secretary determines 
                        are required to prevent an unreasonable risk to 
                        the public health; or
                          ``(iii) the identification of a substantial 
                        scientific issue determined by the Secretary to 
                        be essential to the safety or effectiveness of 
                        the device involved.
  ``(e) Priority Review Guidance.--
          ``(1) Content.--The Secretary shall issue guidance on the 
        implementation of this section. Such guidance shall include the 
        following:
                  ``(A) The process for a person to seek a priority 
                review designation.
                  ``(B) A template for requests under subsection (b).
                  ``(C) The criteria the Secretary will use in 
                evaluating a request for priority review.
                  ``(D) The standards the Secretary will use in 
                assigning a team of staff, including team leaders, to 
                review devices designated for priority review, 
                including any training required for such personnel on 
                effective and efficient review.
          ``(2) Process.--Prior to finalizing the guidance under 
        paragraph (1), the Secretary shall propose such guidance for 
        public comment.
  ``(f) Construction.--
          ``(1) Purpose.--This section is intended to encourage the 
        Secretary and provide the Secretary sufficient authorities to 
        apply efficient and flexible approaches to expedite the 
        development of, and prioritize the agency's review of, devices 
        that represent breakthrough technologies.
          ``(2) Construction.--Nothing in this section shall be 
        construed to alter the criteria and standards for evaluating an 
        application pursuant to section 515(c), a report and request 
        for classification under section 513(f)(2), or a report under 
        section 510(k), including the recognition of valid scientific 
        evidence as described in section 513(a)(3)(B), and 
        consideration of the least burdensome means of evaluating 
        device effectiveness or demonstrating substantial equivalence 
        between devices with differing technological characteristics, 
        as applicable. Nothing in this section alters the authority of 
        the Secretary to act on an application pursuant to section 
        515(d) before completion of an establishment inspection, as the 
        Secretary deems appropriate.''.
  (b) Conforming Amendment Related to Designation Determinations.--
Section 517A(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360g-1(a)(1)) is amended by inserting ``a request for 
designation under section 515B,'' after ``an application under section 
515,''.

       Subtitle M--Medical Device Regulatory Process Improvements

SEC. 2221. THIRD-PARTY QUALITY SYSTEM ASSESSMENT.

  (a) Establishment of Third-Party Quality System Assessment Program.--
Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by 
inserting after section 524A (21 U.S.C. 360n-1) the following new 
section:

``SEC. 524B. THIRD-PARTY QUALITY SYSTEM ASSESSMENT.

  ``(a) Accreditation and Assessment.--
          ``(1) In general; certification of device quality system.--
        The Secretary shall, in accordance with this section, establish 
        a third-party quality system assessment program--
                  ``(A) to accredit persons to assess whether a 
                requestor's quality system, including its design 
                controls, can reasonably assure the safety and 
                effectiveness of in-scope devices subject to device-
                related changes;
                  ``(B) under which accredited persons shall (as 
                applicable) certify that a requestor's quality system 
                meets the criteria included in the guidance issued 
                under paragraph (5) with respect to the in-scope 
                devices at issue; and
                  ``(C) under which the Secretary shall rely on such 
                certifications for purposes of determining the safety 
                and effectiveness (or as applicable, substantial 
                equivalence) of in-scope devices subject to the device-
                related changes involved, in lieu of compliance with 
                the following submission requirements:
                          ``(i) A premarket notification.
                          ``(ii) A thirty-day notice.
                          ``(iii) A Special PMA supplement.
          ``(2) Definitions.--For purposes of this section-
                  ``(A) the term `device-related changes' means changes 
                made by a requestor with respect to in-scope devices, 
                which are--
                          ``(i) changes to a device found to be 
                        substantially equivalent under sections 513(i) 
                        and 510(k) to a predicate device, that--
                                  ``(I) would otherwise be subject to a 
                                premarket notification; and
                                  ``(II) do not alter--
                                          ``(aa) the intended use of 
                                        the changed device; or
                                          ``(bb) the fundamental 
                                        scientific technology of such 
                                        device;
                          ``(ii) manufacturing changes subject to a 30-
                        day notice;
                          ``(iii) changes that qualify for a Special 
                        PMA Supplement; and
                          ``(iv) such other changes relating to the 
                        devices or the device manufacturing process as 
                        the Secretary determines appropriate;
                  ``(B) the term `in-scope device' means a device 
                within the scope of devices agreed to by the requestor 
                and the accredited person for purposes of a request for 
                certification under this section;
                  ``(C) the term `premarket notification' means a 
                premarket notification under section 510(k);
                  ``(D) the term `quality system' means the methods 
                used in, and the facilities and controls used for, the 
                design, manufacture, packaging, labeling, storage, 
                installation, and servicing of devices, as described in 
                section 520(f);
                  ``(E) the term `requestor' means a device 
                manufacturer that is seeking certification under this 
                section of a quality system used by such manufacturer;
                  ``(F) the term `Special PMA' means a Special PMA 
                supplement under section 814.39(d) of title 21, Code of 
                Federal Regulations (or any successor regulations); and
                  ``(G) the term `thirty-day notice' means a notice 
                described in section 515(d)(6).
          ``(3) Accreditation process; accreditation renewal.--Except 
        as inconsistent with this section, the process and 
        qualifications for accreditation of persons and renewal of such 
        accreditation under section 704(g) shall apply with respect to 
        accreditation of persons and renewal of such accreditation 
        under this section.
          ``(4) Use of accredited parties to conduct assessments.--
                  ``(A) Initiation of assessment services.--
                          ``(i) Date assessments authorized.--Beginning 
                        after the date on which the final guidance is 
                        issued under paragraph (5), an accredited 
                        person may conduct an assessment under this 
                        section.
                          ``(ii) Initiation of assessments.--Use of one 
                        or more accredited persons to assess a 
                        requestor's quality system under this section 
                        with respect to in-scope devices shall be at 
                        the initiation of the person who registers and 
                        lists the devices at issue under section 510.
                  ``(B) Compensation.--Compensation for such accredited 
                persons shall--
                          ``(i) be determined by agreement between the 
                        accredited person and the person who engages 
                        the services of the accredited person; and
                          ``(ii) be paid by the person who engages such 
                        services.
                  ``(C) Accredited person selection.--Each person who 
                chooses to use an accredited person to assess a 
                requestor's quality system, as described in this 
                section, shall select the accredited person from a list 
                of such persons published by the Secretary in 
                accordance with section 704(g)(4).
          ``(5) Guidance; criteria for certification.--
                  ``(A) In general.--The criteria for certification of 
                a quality system under this section shall be as 
                specified by the Secretary in guidance issued under 
                this paragraph.
                  ``(B) Contents; certification criteria.--The guidance 
                under this paragraph shall include specification of--
                          ``(i) evaluative criteria to be used by an 
                        accredited person to assess and, as applicable, 
                        certify a requestor's quality system under this 
                        section with respect to in-scope devices; and
                          ``(ii) criteria for accredited persons to 
                        apply for a waiver of, and exemptions from, the 
                        certification criteria under clause (i).
                  ``(C) Timeframe for issuing guidance.--The Secretary 
                shall issue under this paragraph--
                          ``(i) draft guidance not later than 12 months 
                        after the enactment of the 21st Century Cures 
                        Act; and
                          ``(ii) final guidance not later than 12 
                        months after issuance of the draft guidance 
                        under clause (i).
  ``(b) Use of Third-Party Assessment.--
          ``(1) Assessment summary; certification.--
                  ``(A) Submission of assessment to secretary.--An 
                accredited person who assesses a requestor's quality 
                system under subsection (a) shall submit to the 
                Secretary a summary of the assessment--
                          ``(i) within 30 days of the assessment; and
                          ``(ii) which shall include (as applicable)--
                                  ``(I) the accredited person's 
                                certification that the requestor has 
                                satisfied the criteria specified in the 
                                guidance issued under subsection (a)(5) 
                                for quality system certification with 
                                respect to the in-scope devices at 
                                issue; and
                                  ``(II) any waivers or exemptions from 
                                such criteria applied by the accredited 
                                person.
                  ``(B) Treatment of assessments.--Subject to action by 
                the Secretary under subparagraph (C), with respect to 
                assessments which include a certification under this 
                section--
                          ``(i) the Secretary's review of the 
                        assessment summary shall be deemed complete on 
                        the day that is 30 days after the date on which 
                        the Secretary receives the summary under 
                        subparagraph (A); and
                          ``(ii) the assessment summary and 
                        certification of the quality system of a 
                        requestor shall be deemed accepted by the 
                        Secretary on such 30th day.
                  ``(C) Actions by secretary.--
                          ``(i) In general.--Within 30 days of 
                        receiving an assessment summary and 
                        certification under subparagraph (A), the 
                        Secretary may, by written notice to the 
                        accredited person submitting such assessment 
                        certification, deem any such certification to 
                        be provisional beyond such 30-day period, 
                        suspended pending further review by the 
                        Secretary, or otherwise qualified or cancelled, 
                        based on the Secretary's determination that (as 
                        applicable)--
                                  ``(I) additional information is 
                                needed to support such certification;
                                  ``(II) such assessment or 
                                certification is unwarranted; or
                                  ``(III) such action with regard to 
                                the certification is otherwise 
                                justified according to such factors and 
                                criteria as the Secretary finds 
                                appropriate.
                          ``(ii) Acceptance of certification.--If 
                        following action by the Secretary under clause 
                        (i) with respect to a certification, the 
                        Secretary determines that such certification is 
                        acceptable, the Secretary shall issue written 
                        notice to the applicable accredited person 
                        indicating such acceptance.
          ``(2) Notifications to secretary by certified requestors or 
        accredited persons for program evaluation purposes.--
                  ``(A) Annual summary report for device-related 
                changes otherwise subject to premarket notification.--A 
                requestor whose quality system is certified under this 
                section that effectuates device-related changes with 
                respect to in-scope devices, without prior submission 
                of a premarket notification, shall ensure that an 
                annual summary report is submitted to the Secretary by 
                the accredited person which--
                          ``(i) describes the changes made to the in-
                        scope device; and
                          ``(ii) indicates the effective dates of such 
                        changes.
                  ``(B) Periodic notification for manufacturing changes 
                otherwise subject to thirty-day notice.--A requestor 
                whose quality system is certified under this section 
                that effectuates device-related changes with respect to 
                in-scope devices, without prior submission of a thirty-
                day notice, shall provide notification to the Secretary 
                of such changes in the requestor's next periodic report 
                under section 814.84(b) of title 21, Code of Federal 
                Regulations (or any successor regulation). Such 
                notification shall--
                          ``(i) describe the changes made; and
                          ``(ii) indicate the effective dates of such 
                        changes.
                  ``(C) Periodic notification for device-related 
                changes otherwise subject to special pma supplement.--A 
                requestor whose quality system is certified under this 
                section that effectuates device-related changes with 
                respect to in-scope devices, without prior submission 
                of a Special PMA Supplement, shall provide notification 
                to the Secretary of such changes in the requestor's 
                next periodic report under section 814.84(b) of title 
                21, Code of Federal Regulations (or any successor 
                regulation). Such notification shall--
                          ``(i) describe the changes made, including a 
                        full explanation of the basis for the changes; 
                        and
                          ``(ii) indicate the effective dates of such 
                        changes.
                  ``(D) Use of notifications for program evaluation 
                purposes.--Information submitted to the Secretary under 
                subparagraphs (A) through (C) shall be used by the 
                Secretary for purposes of the program evaluation under 
                subsection (d).
  ``(c) Duration and Effect of Certification.--A certification under 
this section--
          ``(1) shall remain in effect for a period of 2 years from the 
        date such certification is accepted by the Secretary, subject 
        to paragraph (6);
          ``(2) may be renewed through the process described in 
        subsection (a)(3);
          ``(3) shall continue to apply with respect to device-related 
        changes made during such 2-year period, provided the 
        certification remains in effect, irrespective of whether such 
        certification is renewed after such 2-year period;
          ``(4) shall have no effect on the need to comply with 
        applicable submission requirements specified in subsection 
        (a)(1)(C) with respect to any change pertaining to in-scope 
        devices which is not a device-related change under subsection 
        (a)(2);
          ``(5) shall have no effect on the authority of the Secretary 
        to conduct an inspection or otherwise determine whether the 
        requestor has complied with the applicable requirements of this 
        Act; and
          ``(6) may be revoked by the Secretary upon a determination 
        that the requestor's quality system no longer meets the 
        certification criteria specified in the guidance issued under 
        subsection (a)(5) with respect to the in-scope devices at 
        issue.
  ``(d) Notice of Revocation.--The Secretary shall provide written 
notification to the requestor of a revocation pursuant to subsection 
(c)(6) not later than 10 business days after the determination 
described in such subsection. Upon receipt of the written notification, 
the requestor shall satisfy the applicable submission requirements 
specified in subsection (a)(1)(C) for any device-related changes 
effectuated after the date of such determination. After such 
revocation, such requestor is eligible to seek re-certification under 
this section of its quality system.
  ``(e) Program Evaluation; Sunset.--
          ``(1) Program evaluation and report.--
                  ``(A) Evaluation.--The Secretary shall complete an 
                evaluation of the third-party quality system assessment 
                program under this section no later than January 31, 
                2021, based on--
                          ``(i) analysis of information from a 
                        representative group of device manufacturers 
                        obtained from notifications provided by 
                        certified requestors or accredited persons 
                        under subsection (b)(2); and
                          ``(ii) such other available information and 
                        data as the Secretary determines appropriate.
                  ``(B) Report.--No later than 1 year after completing 
                the evaluation under subparagraph (A), the Secretary 
                shall issue a report of the evaluation's findings on 
                the website of the Food and Drug Administration, which 
                shall include the Secretary's recommendations with 
                respect to continuation and as applicable expansion of 
                the program under this section to encompass--
                          ``(i) device submissions beyond those 
                        identified in subsection (a)(1)(C); and
                          ``(ii) device changes beyond those described 
                        in subsection (a)(2)(A).
          ``(2) Sunset.--This section shall cease to be effective 
        October 1, 2022.
  ``(f) Rule of Construction.--Nothing in this section shall be 
construed to limit the authority of the Secretary to request and review 
the complete assessment of a certified requestor under this section on 
a for-cause basis.''.
  (b) Conforming Amendments.--
          (1) Requirements for premarket approval supplements.--Section 
        515(d)(5)(A)(i) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 360e(d)(5)(A)(i)), as redesignated by section 2201, is 
        further amended by inserting ``, subject to section 524B'' 
        after ``that affects safety or effectiveness''.
          (2) Requirements for thirty-day notice.--Section 
        515(d)(5)(A)(ii) of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 360e(d)(5)(A)(ii)), as redesignated by section 2201, 
        is further amended by inserting ``, subject to section 524B'' 
        after ``the date on which the Secretary receives the notice''.
          (3) Requirements for premarket notification; technical 
        correction to reference to section 510(k).--Section 510(l) of 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(l)) is 
        amended by striking ``of this subsection under subsection (m)'' 
        and inserting ``of subsection (k) under subsection (m) or 
        section 524B''.
          (4) Misbranded devices.--Section 502(t) of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 352(t)) is amended by 
        inserting ``or 524B'' after ``section 519''.

SEC. 2222. VALID SCIENTIFIC EVIDENCE.

  Section 513(a)(3)(B) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360c(a)(3)(B)) is amended--
          (1) by redesignating clauses (i) and (ii) as subclauses (I) 
        and (II), respectively;
          (2) by striking ``(B) If the Secretary'' and inserting 
        ``(B)(i) If the Secretary''; and
          (3) by adding at the end the following:
  ``(ii) For purposes of clause (i), valid scientific evidence may 
include--
          ``(I) evidence described in well-documented case histories, 
        including registry data, that are collected and monitored under 
        an acceptable protocol;
          ``(II) studies published in peer-reviewed journals; and
          ``(III) data collected in countries other than the United 
        States so long as such data otherwise meet the criteria 
        specified in this subparagraph.
  ``(iii) In the case of a study published in a peer-reviewed journal 
that is offered as valid scientific evidence for purposes of clause 
(i), the Secretary may request data underlying the study if--
          ``(I) the Secretary, in making such request, complies with 
        the requirement of subparagraph (D)(ii) to consider the least 
        burdensome appropriate means of evaluating device effectiveness 
        or subsection (i)(1)(D) to consider the least burdensome means 
        of determining substantial equivalence, as applicable;
          ``(II) the Secretary furnishes a written rationale for so 
        requesting the underlying data together with such request; and
          ``(III) if the requested underlying data for such a study are 
        unavailable, the Secretary shall consider such study to be part 
        of the totality of the evidence with respect to the device, as 
        the Secretary determines appropriate.''.

SEC. 2223. TRAINING AND OVERSIGHT IN LEAST BURDENSOME APPROPRIATE MEANS 
                    CONCEPT.

  (a) In General.--Section 513 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360c) is amended by adding at the end the following:
  ``(j) Training and Oversight in Least Burdensome Appropriate Means 
Concept.--
          ``(1) Training.--Each employee of the Food and Drug 
        Administration who is involved in the review of premarket 
        submissions under section 515 or section 510(k), including 
        supervisors, shall receive training regarding the meaning and 
        implementation of the least burdensome appropriate means 
        concept in the context of the use of that term in subsections 
        (a)(3)(D) and (i)(1)(D) of this section and in section 
        515(c)(5).
          ``(2) Guidance documents.--
                  ``(A) Draft updated guidance.--Not later than 12 
                months after the date of enactment of the 21st Century 
                Cures Act, the Secretary shall issue a draft guidance 
                document updating the October 4, 2002, guidance 
                document entitled `The Least Burdensome Provision of 
                the FDA Modernization Act of 1997: Concept and 
                Principles; Final Guidance for FDA and Industry'.
                  ``(B) Meeting of stakeholders.--In developing such 
                draft guidance document, the Secretary shall convene a 
                meeting of stakeholders to ensure a full record to 
                support the publication of such document.
          ``(3) Ombudsman audit.--Not later than 18 months after the 
        date of issuance of final version of the draft guidance under 
        paragraph (2), the ombudsman for the organizational unit of the 
        Food and Drug Administration responsible for the premarket 
        review of devices shall--
                  ``(A) conduct, or have conducted, an audit of the 
                training described in paragraph (1); and
                  ``(B) include in such audit interviews with a 
                representative sample of persons from industry 
                regarding their experience in the device premarket 
                review process.''.
  (b) Additional Information Regarding Premarket Applications.--
Subsection (c) of section 515 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360e) is amended by adding at the end the following:
  ``(5)(A) Whenever the Secretary requests additional information from 
an applicant regarding an application under paragraph (1), the 
Secretary shall consider the least burdensome appropriate means 
necessary to demonstrate device safety and effectiveness, and request 
information accordingly.
  ``(B) For purposes of subparagraph (A), the term `necessary' means 
the minimum required information that would support a determination by 
the Secretary that an application provides a reasonable assurance of 
the safety and effectiveness of the device.
  ``(C) Nothing in this paragraph alters the standards for premarket 
approval of a device.''.

SEC. 2224. RECOGNITION OF STANDARDS.

  Section 514(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360d(c)) is amended--
          (1) in paragraph (1), by inserting after subparagraph (B) the 
        following new subparagraphs:
  ``(C)(i) Any person may submit a request for recognition under 
subparagraph (A) of all or part of an appropriate standard established 
by a nationally or internationally recognized standard organization.
  ``(ii) Not later than 60 days after the Secretary receives such a 
request, the Secretary shall--
          ``(I) make a determination to recognize all, part, or none of 
        the standard that is the subject of the request; and
          ``(II) issue to the person who submitted such request a 
        response in writing that states the Secretary's rationale for 
        that determination, including the scientific, technical, 
        regulatory, or other basis for such determination.
  ``(iii) The Secretary shall make a response issued under clause 
(ii)(II) publicly available, in such manner as the Secretary determines 
appropriate.
  ``(iv) The Secretary shall take such actions as may be necessary to 
implement all or part of a standard recognized under clause (i)(I), in 
accordance with subparagraph (A). 
  ``(D) The Secretary shall make publicly available, in such manner as 
the Secretary determines appropriate, the rationale for recognition 
under subparagraph (A) of part of a standard, including the scientific, 
technical, regulatory, or other basis for such recognition.''; and
          (2) by adding at the end the following new paragraphs:
          ``(4) Training on use of standards.--The Secretary shall 
        provide to all employees of the Food and Drug Administration 
        who review premarket submissions for devices periodic training 
        on the concept and use of recognized standards for purposes of 
        meeting a premarket submission requirement or other applicable 
        requirement under this Act, including standards relevant to an 
        employee's area of device review.
          ``(5) Guidance.--
                  ``(A) Draft guidance.--The Secretary shall publish 
                guidance identifying the principles for recognizing 
                standards under this section. In publishing such 
                guidance, the Secretary shall consider--
                          ``(i) the experience with, and reliance on, a 
                        standard by other Federal regulatory 
                        authorities and the device industry; and
                          ``(ii) whether recognition of a standard will 
                        promote harmonization among regulatory 
                        authorities in the regulation of devices.
                  ``(B) Timing.--The Secretary shall publish--
                          ``(i) draft guidance under subparagraph (A) 
                        not later than 12 months after the date of the 
                        enactment of the 21st Century Cures Act; and
                          ``(ii) final guidance not later than 12 
                        months after the close of the public comment 
                        period for the draft guidance under clause 
                        (i).''.

SEC. 2225. EASING REGULATORY BURDEN WITH RESPECT TO CERTAIN CLASS I AND 
                    CLASS II DEVICES.

  (a) Class I Devices.--Section 510(l) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360(l)) is amended--
          (1) by striking ``A report under subsection (k)'' and 
        inserting ``(1) A report under subsection (k)''; and
          (2) by adding at the end the following new paragraph:
  ``(2) Not later than 120 days after the date of the enactment of the 
21st Century Cures Act, the Secretary shall identify, through 
publication in the Federal Register, any type of class I device that 
the Secretary determines no longer requires a report under subsection 
(k) to provide reasonable assurance of safety and effectiveness. Upon 
such publication--
          ``(A) each type of class I device so identified shall be 
        exempt from the requirement for a report under subsection (k); 
        and
          ``(B) the classification regulation applicable to each such 
        type of device shall be deemed amended to incorporate such 
        exemption.''.
  (b) Class II Devices.--Section 510(m) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360(m)) is amended--
          (1) by striking paragraph (1) and inserting the following new 
        paragraph: ``(1) The Secretary shall--
          ``(A) not later than 60 days after the date of the enactment 
        of the 21st Century Cures Act--
                  ``(i) publish in the Federal Register a notice that 
                contains a list of each type of class II device that 
                the Secretary determines no longer requires a report 
                under subsection (k) to provide reasonable assurance of 
                safety and effectiveness; and
                  ``(ii) provide for a period of not less than 60 days 
                for public comment beginning on the date of the 
                publication of such notice; and
          ``(B) not later than 180 days after the date of the enactment 
        of 21st Century Cures Act, publish in the Federal Register a 
        list representing the Secretary's final determination with 
        respect to the devices included in the list published under 
        subparagraph (A).'';
          (2) in paragraph (2)--
                  (A) by striking ``1 day after the date of the 
                publication of a list under this subsection,'' and 
                inserting ``1 day after the date of publication of the 
                final list under paragraph (1)(B),''; and
                  (B) by striking ``30-day period'' and inserting ``60-
                day period''; and
          (3) by adding at the end the following new paragraph:
  ``(3) Upon the publication of the final list under paragraph (1)(B)--
          ``(A) each type of class II device so listed shall be exempt 
        from the requirement for a report under subsection (k); and
          ``(B) the classification regulation applicable to each such 
        type of device shall be deemed amended to incorporate such 
        exemption.''.

SEC. 2226. ADVISORY COMMITTEE PROCESS.

  (a) Classification Panels.--Paragraph (5) of section 513(b) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(b)) is amended--
          (1) by striking ``(5)'' and inserting ``(5)(A)''; and
          (2) by adding at the end the following:
  ``(B) When a device is specifically the subject of review by a 
classification panel, the Secretary shall--
          ``(i) ensure that adequate expertise is represented on the 
        classification panel to assess--
                  ``(I) the disease or condition which the device is 
                intended to cure, treat, mitigate, prevent, or 
                diagnose; and
                  ``(II) the technology of the device; and
          ``(ii) as part of the process to ensure adequate expertise 
        under clause (i), give due consideration to the recommendations 
        of the person whose premarket submission is subject to panel 
        review on the expertise needed among the voting members of the 
        panel.
  ``(C) For review by a classification panel of a premarket submission 
for a device, the Secretary shall--
          ``(i) provide an opportunity for the person whose premarket 
        submission is subject to panel review to provide 
        recommendations on the expertise needed among the voting 
        members of the panel; and
          ``(ii) give due consideration to such recommendations and 
        ensure that adequate expertise is represented on advisory 
        panels to assess--
                  ``(I) the disease or condition for which the device 
                is intended to cure, treat, mitigate, prevent, or 
                diagnose; and
                  ``(II) the technology of the device.
  ``(D) For purposes of subparagraph (B)(ii), the term `adequate 
expertise' means, with respect to the membership of the classification 
panel reviewing a premarket submission, that such membership includes--
          ``(i) two or more voting members, with a specialty or other 
        expertise clinically relevant to the device under review; and
          ``(ii) at least one voting member who is knowledgeable about 
        the technology of the device.''.
  (b) Panel Review Process.--Section 513(b)(6) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360c(b)(6)) is amended--
          (1) in subparagraph (A)(iii), by inserting before the period 
        at the end ``, including by designating a representative who 
        will be provided a time during the panel meeting to address the 
        panel individually (or accompanied by experts selected by such 
        representative) for the purpose of correcting misstatements of 
        fact or providing clarifying information, subject to the 
        discretion of the panel chairperson''; and
          (2) by striking subparagraph (B) and inserting the following 
        new subparagraph:
  ``(B)(i) Any meeting of a classification panel for a device that is 
specifically the subject of review shall--
          ``(I) provide adequate time for initial presentations by the 
        person whose device is specifically the subject of a 
        classification panel review and by the Secretary; and
          ``(II) encourage free and open participation by all 
        interested persons.
  ``(ii) Following the initial presentations described in clause (i), 
the panel may--
          ``(I) pose questions to a designated representative described 
        in subparagraph (A)(iii); and
          ``(II) consider the responses to such questions in the 
        panel's review of the device that is specifically the subject 
        of review by the panel.''.

SEC. 2227. HUMANITARIAN DEVICE EXEMPTION APPLICATION.

  (a) In General.--Section 520(m) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360j) is amended--
          (1) in paragraph (1) by striking ``fewer than 4,000'' and 
        inserting ``not more than 8,000'';
          (2) in paragraph (2)(A) by striking ``fewer than 4,000'' and 
        inserting ``not more than 8,000''; and
          (3) in paragraph (6)(A)(ii), by striking ``4,000'' and 
        inserting ``8,000''
  (b) Guidance Document on Probable Benefit.--Not later than 18 months 
after the date of enactment of this Act, the Secretary of Health and 
Human Services, acting through the Commissioner of Food and Drugs, 
shall publish a draft guidance document that defines the criteria for 
establishing ``probable benefit'' as that term is used in section 
520(m)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360j(m)(2)(C)).

SEC. 2228. CLIA WAIVER STUDY DESIGN GUIDANCE FOR IN VITRO DIAGNOSTICS.

  (a) Draft Revised Guidance.--Not later than 12 months after the date 
of the enactment of this Act, the Secretary of Health and Human 
Services shall publish a draft guidance that--
          (1) revises ``Section V. Demonstrating Insignificant Risk of 
        an Erroneous Result--`Accuracy''' of the guidance entitled 
        ``Recommendations for Clinical Laboratory Improvement 
        Amendments of 1988 (CLIA) Waiver Applications for Manufacturers 
        of In Vitro Diagnostic Devices'' and dated January 30, 2008; 
        and
          (2) includes guidance on the appropriate use of comparable 
        performance between a waived user and a moderately complex 
        laboratory user to demonstrate accuracy.
  (b) Final Revised Guidance.--The Secretary of Health and Human 
Services shall finalize the draft guidance published under subsection 
(a) not later than 12 months after the comment period for such draft 
guidance closes.

Subtitle N--Sensible Oversight for Technology Which Advances Regulatory 
                               Efficiency

SEC. 2241. HEALTH SOFTWARE.

  Section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
321) is amended by adding at the end the following:
  ``(ss)(1) The term `health software' means software that does not, 
through use of an in vitro diagnostic device or signal acquisition 
system, acquire, process, or analyze an image or physiological signal, 
is not an accessory, is not an integral part of a device necessary to 
support the use of the device, is not used in the manufacture and 
transfusion of blood and blood components to assist in the prevention 
of disease in humans, and--
          ``(A) is intended for use for administrative or operational 
        support or the processing and maintenance of financial records;
          ``(B) is intended for use in clinical, laboratory, or 
        administrative workflow and related recordkeeping;
          ``(C)(i) is intended for use solely in the transfer, 
        aggregation, conversion (in accordance with a present 
        specification), storage, management, retrieval, or transmission 
        of data or information;
          ``(ii) utilizes a connectivity software platform, electronic 
        or electrical hardware, or a physical communications 
        infrastructure; and
          ``(iii) is not intended for use--
                  ``(I) in active patient monitoring; or
                  ``(II) in controlling or altering the functions or 
                parameters of a device that is connected to such 
                software;
          ``(D) is intended for use to organize and present information 
        for health or wellness education or for use in maintaining a 
        healthy lifestyle, including medication adherence and health 
        management tools;
          ``(E) is intended for use to analyze information to provide 
        general health information that does not include patient-
        specific recommended options to consider in the prevention, 
        diagnosis, treatment, cure, or mitigation of a particular 
        disease or condition; or
          ``(F) is intended for use to analyze information to provide 
        patient-specific recommended options to consider in the 
        prevention, diagnosis, treatment, cure, or mitigation of a 
        particular disease or condition.
  ``(2) The term `accessory' means a product that--
          ``(A) is intended for use with one or more parent devices;
          ``(B) is intended to support, supplement, or augment the 
        performance of one or more parent devices; and
          ``(C) shall be classified by the Secretary--
                  ``(i) according to its intended use; and
                  ``(ii) independently of any classification of any 
                parent device with which it is used.''.

SEC. 2242. APPLICABILITY AND INAPPLICABILITY OF REGULATION.

  Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 351 et seq.), as amended by section 2221(a), is further 
amended by adding at the end the following:

``SEC. 524C. HEALTH SOFTWARE.

  ``(a) Inapplicability of Regulation to Health Software.--Except as 
provided in subsection (b), health software shall not be subject to 
regulation under this Act.
  ``(b) Exception.--
          ``(1) In general.--Subsection (a) shall not apply with 
        respect to a software product--
                  ``(A) of a type described in subparagraph (F) of 
                section 201(ss)(1); and
                  ``(B) that the Secretary determines poses a 
                significant risk to patient safety.
          ``(2) Considerations.--In making a determination under 
        subparagraph (B) of paragraph (1) with respect to a product to 
        which such paragraph applies, the Secretary shall consider the 
        following:
                  ``(A) The likelihood and severity of patient harm if 
                the product were to not perform as intended.
                  ``(B) The extent to which the product is intended to 
                support the clinical judgment of a medical 
                professional.
                  ``(C) Whether there is a reasonable opportunity for a 
                medical professional to review the basis of the 
                information or treatment recommendation provided by the 
                product.
                  ``(D) The intended user and user environment, such as 
                whether a medical professional will use a software 
                product of a type described in subparagraph (F) of 
                section 201(ss)(1).
  ``(c) Delegation.--The Secretary shall delegate primary jurisdiction 
for regulating a software product determined under subsection (b) to be 
subject to regulation under this Act to the center at the Food and Drug 
Administration charged with regulating devices. 
  ``(d) Regulation of Software.--
          ``(1) In general.--The Secretary shall review existing 
        regulations and guidance regarding the regulation of software 
        under this Act. The Secretary may implement a new framework for 
        the regulation of software and shall, as appropriate, modify 
        such regulations and guidance or issue new regulations or 
        guidance.
          ``(2) Issuance by order.--Notwithstanding subchapter II of 
        chapter 5 of title 5, United States Code, the Secretary may 
        modify or issue regulations for the regulation of software 
        under this Act by administrative order published in the Federal 
        Register following the publication of a proposed order.
          ``(3) Areas under review.--The review of existing regulations 
        and guidance under paragraph (1) may include review of the 
        following areas:
                  ``(A) Classification of software.
                  ``(B) Standards for development of software.
                  ``(C) Standards for validation and verification of 
                software.
                  ``(D) Review of software.
                  ``(E) Modifications to software.
                  ``(F) Manufacturing of software.
                  ``(G) Quality systems for software.
                  ``(H) Labeling requirements for software.
                  ``(I) Postmarketing requirements for reporting of 
                adverse events.
          ``(4) Process for issuing proposed regulations, 
        administrative order, and guidance.--Not later than 18 months 
        after the date of enactment of this section, the Secretary 
        shall consult with external stakeholders (including patients, 
        industry, health care providers, academia, and government) to 
        gather input before issuing regulations, an administrative 
        order, and guidance under this subsection.
  ``(e) Rule of Construction.--Nothing in this section shall be 
construed as providing the Secretary with the authority to regulate 
under this Act any health software product of the type described in 
subparagraph (F) of section 201(ss)(1) unless and until the Secretary 
has made a determination described in subsection (b)(1)(B) with respect 
to such product.''.

SEC. 2243. EXCLUSION FROM DEFINITION OF DEVICE.

  Section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
321) is amended--
          (1) in subparagraph (2), by striking ``or'' after ``or other 
        animals,'';
          (2) in subparagraph (3), by striking ``and'' and inserting 
        ``or''; and
          (3) by inserting after subparagraph (3) the following:
          ``(4) not health software (other than software determined to 
        be a risk to patient safety under section 524B(b)), and''.

                Subtitle O--Streamlining Clinical Trials

SEC. 2261. PROTECTION OF HUMAN SUBJECTS IN RESEARCH; APPLICABILITY OF 
                    RULES.

  (a) In General.--In order to simplify and facilitate compliance by 
researchers with applicable regulations for the protection of human 
subjects in research, the Secretary of Health and Human Services shall, 
to the extent possible and consistent with other statutory provisions, 
harmonize differences between the HHS Human Subject Regulations and the 
FDA Human Subject Regulations in accordance with subsection (b).
  (b) Avoiding Regulatory Duplication and Unnecessary Delays.--
          (1) In general.--The Secretary shall--
                  (A) make such modifications to the provisions of the 
                HHS Human Subject Regulations, the FDA Human Subject 
                Regulations, and the vulnerable-populations rules as 
                may be necessary--
                          (i) to reduce regulatory duplication and 
                        unnecessary delays;
                          (ii) to modernize such provisions in the 
                        context of multisite and cooperative research 
                        projects; and
                          (iii) to incorporate local considerations, 
                        community values, and mechanisms to protect 
                        vulnerable populations; and
                  (B) ensure that human subject research that is 
                subject to the HHS Human Subject Regulations or to the 
                FDA Human Subject Regulations may--
                          (i) use joint or shared review;
                          (ii) rely upon the review of--
                                  (I) an independent institutional 
                                review board; or
                                  (II) an institutional review board of 
                                an entity other than the sponsor of the 
                                research; or
                          (iii) use similar arrangements to avoid 
                        duplication of effort.
          (2) Regulations and guidance.--Not later than 36 months after 
        the date of enactment of this Act, the Secretary, acting 
        through the relevant agencies and offices of the Department of 
        Health and Human Services, including the Office for Human 
        Research Protections and relevant agencies and offices of the 
        Food and Drug Administration, shall issue such regulations and 
        guidance and take such other actions as may be necessary to 
        implement this section and help to facilitate the broader use 
        of single, central, or lead institutional review boards. Such 
        regulations and guidance shall clarify the requirements and 
        policies relating to the following:
                  (A) Arrangements to avoid duplication described in 
                paragraph (1)(A)(i), including--
                          (i) delineating the roles of institutional 
                        review boards in multisite or cooperative, 
                        multisite studies where one or more local 
                        institutional review boards are relied upon, or 
                        similar arrangements are used;
                          (ii) the risks and benefits to human 
                        subjects;
                          (iii) standardizing the informed consent and 
                        other processes and legal documents; and
                          (iv) incorporating community values through 
                        the use of local institutional review boards 
                        while continuing to use central or lead 
                        institutional review boards.
                  (B) Concerns about regulatory and legal liability 
                contributing to decisions by the sponsors of research 
                to rely on local institutional review boards for 
                multisite research.
          (3) Consultation.--In issuing regulations or guidance under 
        paragraph (2), the Secretary shall consult with stakeholders 
        (including researchers, academic organizations, hospitals, 
        institutional research boards, pharmaceutical, biotechnology 
        and medical device developers, clinical research organizations, 
        patient groups, and others).
  (c) Timing.--The Secretary shall complete the harmonization described 
in subsection (a) not later than 36 months after the date of enactment 
of this Act.
  (d) Progress Report.--Not later than 24 months after the date of 
enactment of this Act, the Secretary shall submit to Congress a report 
on the progress made toward completing such harmonization.
  (e) Draft NIH Policy.--Not later than 12 months after the date of 
enactment of this Act, the Secretary, acting through the Director of 
the National Institutes of Health, shall finalize the draft policy 
entitled ``Draft NIH Policy on Use of a Single Institutional Review 
Board for Multi-Site Research''.
  (f) Definitions.--
          (1) Human subject regulations.--In this section:
                  (A) FDA human subject regulations.--The term ``FDA 
                Human Subject Regulations'' means the provisions of 
                parts 50, 56, 312, and 812 of title 21, Code of Federal 
                Regulations (or any successor regulations).
                  (B) HHS human subject regulations.--The term ``HHS 
                Human Subject Regulations'' means the provisions of 
                subpart A of part 46 of title 45, Code of Federal 
                Regulations (or any successor regulations).
                  (C) Vulnerable-populations rules.--The term 
                ``vulnerable-populations rules''--
                          (i) subject to clause (ii), means the 
                        provisions of subparts B through D of such part 
                        46 (or any successor regulations); or
                          (ii) as applicable to research that is 
                        subject to the FDA Human Subject Regulations, 
                        means the provisions applicable to vulnerable 
                        populations under part 56 of such title 21 (or 
                        any successor regulations) and subpart D of 
                        part 50 of such title 21 (or any successor 
                        regulations).
          (2) Other definitions.--In this section:
                  (A) Institutional review board.--The term 
                ``institutional review board'' has the meaning that 
                applies to the term ``institutional review board'' 
                under the HHS Human Subject Regulations.
                  (B) Lead institutional review board.--The term ``lead 
                institutional review board'' means an institutional 
                review board that otherwise meets the requirements of 
                the HHS Human Subject Regulations and enters into a 
                written agreement with an institution, another 
                institutional review board, a sponsor, or a principal 
                investigator to approve and oversee human subject 
                research that is conducted at multiple locations. 
                References to an institutional review board include an 
                institutional review board that serves a single 
                institution as well as a lead institutional review 
                board.

SEC. 2262. USE OF NON-LOCAL INSTITUTIONAL REVIEW BOARDS FOR REVIEW OF 
                    INVESTIGATIONAL DEVICE EXEMPTIONS AND HUMAN DEVICE 
                    EXEMPTIONS.

  (a) In General.--Section 520 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360(j)) is amended--
          (1) in subsection (g)(3)--
                  (A) by striking ``local'' each place it appears; and
                  (B) in subparagraph (A)(i), by striking ``which has 
                been''; and
          (2) in subsection (m)(4)--
                  (A) by striking ``local'' each place it appears; and
                  (B) by striking subparagraph (A) and inserting the 
                following new subparagraph:
          ``(A) in facilities in which clinical testing of devices is 
        supervised by an institutional review committee established in 
        accordance with the regulations of the Secretary, and''.
  (b) Regulations.--Not later than 12 months after the date of the 
enactment of this Act, the Secretary of Health and Human Services shall 
revise or issue such regulations or guidance as may be necessary to 
carry out the amendments made by subsection (a).

SEC. 2263. ALTERATION OR WAIVER OF INFORMED CONSENT FOR CLINICAL 
                    INVESTIGATIONS.

  (a) Devices.--Section 520(g)(3) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360j(g)(3)) is amended--
          (1) in subparagraph (D), by striking ``except where subject 
        to such conditions as the Secretary may prescribe, the 
        investigator'' and inserting the following: ``except where, 
        subject to such conditions as the Secretary may prescribe--
                  ``(i) the proposed clinical testing poses no more 
                than minimal risk to the human subject and includes 
                appropriate safeguards to protect the rights, safety, 
                and welfare of the human subject; or
                  ``(ii) the investigator''; and
          (2) in the matter following subparagraph (D), by striking 
        ``subparagraph (D)'' and inserting ``subparagraph (D)(ii)''.
  (b) Drugs.--Section 505(i)(4) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355(i)(4)) is amended by striking ``except where it is 
not feasible or it is contrary to the best interests of such human 
beings'' and inserting ``except where it is not feasible, it is 
contrary to the best interests of such human beings, or the proposed 
clinical testing poses no more than minimal risk to such human beings 
and includes appropriate safeguards as prescribed to protect the 
rights, safety, and welfare of such human beings''.

     Subtitle P--Improving Scientific Expertise and Outreach at FDA

SEC. 2281. SILVIO O. CONTE SENIOR BIOMEDICAL RESEARCH SERVICE.

  (a) Hiring and Retention Authority.--Section 228 of the Public Health 
Service Act (42 U.S.C. 237) is amended--
          (1) in the section heading, by inserting ``and biomedical 
        product assessment'' after ``research'';
          (2) in subsection (a)(1), by striking ``Silvio O. Conte 
        Senior Biomedical Research Service, not to exceed 500 members'' 
        and inserting ``Silvio O. Conte Senior Biomedical Research and 
        Biomedical Product Assessment Service (in this section referred 
        to as the `Service'), the purpose of which is to recruit and 
        retain competitive and qualified scientific and technical 
        experts outstanding in the field of biomedical research, 
        clinical research evaluation, and biomedical product 
        assessment'';
          (3) by amending subsection (a)(2) to read as follows:
  ``(2) The authority established in paragraph (1) may not be construed 
to require the Secretary to reduce the number of employees serving 
under any other employment system in order to offset the number of 
members serving in the Service.'';
          (4) in subsection (b)--
                  (A) in the matter preceding paragraph (1), by 
                striking ``or clinical research evaluation'' and 
                inserting ``, clinical research evaluation or 
                biomedical product assessment''; and
                  (B) in paragraph (1), by inserting ``or a master's 
                level degree in engineering, bioinformatics, or a 
                related or emerging field,'' after the comma;
          (5) in subsection (d)(2), by striking ``and shall not exceed 
        the rate payable for level I of the Executive Schedule unless 
        approved by the President under section 5377(d)(2) of title 5, 
        United States Code'' and inserting ``and shall not exceed the 
        rate payable for the President'';
          (6) by striking subsection (e); and
          (7) by redesignating subsections (f) and (g) as subsections 
        (e) and (f), respectively.
  (b) Report.--Not later than 3 years after the date of the enactment 
of this Act, the Secretary of Health and Human Services shall submit, 
and publish on the website of the Department of Health and Human 
Services a report on the implementation of the amendments made by 
subsection (a), including whether the amendments have improved the 
ability of the Food and Drug Administration to hire and retain 
qualified experts to fulfill obligations specified under user fee 
agreements.

SEC. 2282. ENABLING FDA SCIENTIFIC ENGAGEMENT.

  It is the sense of Congress that the participation in, or sponsorship 
of, scientific conferences and meetings is essential to the mission of 
the Food and Drug Administration.

SEC. 2283. REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG 
                    ADMINISTRATION.

  (a) Board of Directors.--
          (1) Composition and size.--Section 770(d)(1)(C) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379dd(d)(1)(C)) 
        is amended--
                  (A) by redesignating clause (ii) as clause (iii);
                  (B) by inserting after clause (i) the following:
                          ``(ii) Additional members.--The Board, 
                        through amendments to the bylaws of the 
                        Foundation, may provide that the number of 
                        voting members of the Board shall be a number 
                        (to be specified in such amendment) greater 
                        than 14. Any Board positions that are 
                        established by any such amendment shall be 
                        appointed (by majority vote) by the individuals 
                        who, as of the date of such amendment, are 
                        voting members of the Board and persons so 
                        appointed may represent any of the categories 
                        specified in subclauses (I) through (V) of 
                        clause (i), so long as no more than 30 percent 
                        of the total voting members of the Board 
                        (including members whose positions are 
                        established by such amendment) are 
                        representatives of the general pharmaceutical, 
                        device, food, cosmetic, and biotechnology 
                        industries.''; and
                  (C) in clause (iii)(I), as redesignated by 
                subparagraph (A), by striking ``The ex officio members 
                shall ensure'' and inserting ``The ex officio members, 
                acting pursuant to clause (i), and the Board, acting 
                pursuant to clause (ii), shall ensure''.
          (2) Federal employees allowed to serve on board.--Clause 
        (iii)(II) of section 770(d)(1)(C) of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 379dd(d)(1)(C)), as redesignated by 
        paragraph (1)(A), is amended by adding at the end the 
        following: ``For purposes of this section, the term `employee 
        of the Federal Government' does not include a `special 
        Government employee', as that term is defined in section 202(a) 
        of title 18, United States Code.''.
          (3) Staggered terms.--Subparagraph (A) of section 770(d)(3) 
        of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        379dd(d)(3)) is amended to read as follows:
                  ``(A) Term.--The term of office of each member of the 
                Board appointed under paragraph (1)(C)(i), and the term 
                of office of any member of the Board whose position is 
                established pursuant to paragraph (1)(C)(ii), shall be 
                4 years, except that--
                          ``(i) the terms of offices for the members of 
                        the Board initially appointed under paragraph 
                        (1)(C)(i) shall expire on a staggered basis as 
                        determined by the ex officio members; and
                          ``(ii) the terms of office for the persons 
                        initially appointed to positions established 
                        pursuant to paragraph (1)(C)(ii) may be made to 
                        expire on a staggered basis, as determined by 
                        the individuals who, as of the date of the 
                        amendment establishing such positions, are 
                        members of the Board.''.
  (b) Executive Director Compensation.--Section 770(g)(2) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379dd(g)(2)) is amended 
by striking ``but shall not be greater than the compensation of the 
Commissioner''.
  (c) Separation of Funds.--Section 770(m) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379dd(m)) is amended by striking ``are held 
in separate accounts from funds received from entities under subsection 
(i)'' and inserting ``are managed as individual programmatic funds 
under subsection (i), according to best accounting practices''.

SEC. 2284. COLLECTION OF CERTAIN VOLUNTARY INFORMATION EXEMPTED FROM 
                    PAPERWORK REDUCTION ACT.

   Chapter VII of the Federal Food, Drug, and Cosmetic Act is amended 
by inserting after section 708 of such Act (21 U.S.C. 379) the 
following:

``SEC. 708A. COLLECTION OF CERTAIN VOLUNTARY INFORMATION EXEMPTED FROM 
                    PAPERWORK REDUCTION ACT.

  ``Chapter 35 of title 44, United States Code, shall not apply to the 
collection from patients, industry, academia, and other stakeholders, 
of voluntary information such as through voluntary surveys or 
questionnaires, initiated by the Secretary.''.

SEC. 2285. HIRING AUTHORITY FOR SCIENTIFIC, TECHNICAL, AND PROFESSIONAL 
                    PERSONNEL.

  (a) In General.--The Federal Food, Drug, and Cosmetic Act is amended 
by inserting after section 714 (21 U.S.C. 379d-3) the following:

``SEC. 714A. ADDITIONAL HIRING AUTHORITY.

  ``(a) In General.--The Secretary may, without regard to the 
provisions of title 5, United States Code, governing appointments in 
the competitive service, appoint qualified candidates to scientific, 
technical, or professional positions within the following centers of 
the Food and Drug Administration:
          ``(1) The Center for Drug Evaluation and Research.
          ``(2) The Center for Biologics Evaluation and Research.
          ``(3) The Center for Devices and Radiological Health.
Such positions shall be within the competitive service.
  ``(b) Compensation.--
          ``(1) In general.--Notwithstanding any other provision of 
        law, including any requirement with respect to General Schedule 
        pay rates under subchapter III of chapter 53 of title 5, United 
        States Code, and consistent with the requirements of paragraph 
        (2), the Secretary may determine and fix--
                  ``(A) the annual rate of pay of any individual 
                appointed under subsection (a); and
                  ``(B) for purposes of retaining qualified employees, 
                the annual rate of pay for any highly qualified 
                scientific, technical, or professional personnel 
                appointed to a position at any of the centers listed 
                under subsection (a) before the date of enactment of 
                this section.
          ``(2) Limitation.--The annual rate of pay established 
        pursuant to paragraph (1) may not exceed the annual rate of pay 
        of the President.
  ``(c) Sunset.--The authority to appoint employees under this section 
shall terminate on September 30, 2022.
  ``(d) Report.--
          ``(1) In general.--Not later than September 30, 2021, the 
        Secretary shall submit a report to Congress that examines the 
        extent to which the authority to appoint and retain personnel 
        under this section enhanced the Food and Drug Administration's 
        ability to meet the agency's critical need for highly qualified 
        individuals for scientific, technical, or professional 
        positions.
          ``(2) Recommendations.--The report under paragraph (1) shall 
        include the recommendations of the Secretary on--
                  ``(A) whether the authority to appoint personnel 
                under this section should be reauthorized; and
                  ``(B) other personnel authorities that would help the 
                Food and Drug Administration to better recruit and 
                retain highly qualified individuals for scientific, 
                technical, or professional positions in the agency's 
                medical product centers.''.
  (b) Rule of Construction.--The authority provided by section 714A of 
the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)) 
shall not be construed to affect the authority provided under section 
714 of such Act.

       Subtitle Q--Exempting From Sequestration Certain User Fees

SEC. 2301. EXEMPTING FROM SEQUESTRATION CERTAIN USER FEES OF FOOD AND 
                    DRUG ADMINISTRATION.

  The Balanced Budget and Emergency Deficit Control Act of 1985 is 
amended--
          (1) in section 255(g)(1)(A) (2 U.S.C. 905(g)(1)(A)), by 
        inserting after the item relating to ``Financial Agent 
        Services'' the following new item:
                   ``Food and Drug Administration, Salaries and 
                Expenses, but only the portion of appropriations under 
                such account corresponding to fees collected under 
                sections 736, 738, 740, 741, 744B, and 744H of the 
                Federal Food, Drug, and Cosmetic Act (75-9911-0-1-
                554).''; and
          (2) in section 256(h) (2 U.S.C. 906(h)), by adding at the end 
        the following new paragraph:
          ``(5) Notwithstanding any other provision of law, this 
        subsection shall not apply with respect to the portion of 
        administrative expenses incurred by the Food and Drug 
        Administration that are funded through fees collected under 
        sections 736, 738, 740, 741, 744B, and 744H of the Federal 
        Food, Drug, and Cosmetic Act.''.

                          TITLE III--DELIVERY

                      Subtitle A--Interoperability

SEC. 3001. ENSURING INTEROPERABILITY OF HEALTH INFORMATION TECHNOLOGY.

  (a) Interoperability Standards.--
          (1) In general.--Subtitle A of title XXX of the Public Health 
        Service Act (42 U.S.C. 300jj-11 et seq.) is amended by adding 
        at the end the following new section:

``SEC. 3010. ENSURING INTEROPERABILITY OF HEALTH INFORMATION 
                    TECHNOLOGY.

  ``(a) Interoperability.--In order for health information technology 
to be considered interoperable, such technology must satisfy the 
following criteria:
          ``(1) Secure transfer.--The technology allows the secure 
        transfer of the entirety of a patient's data from any and all 
        health information technology for authorized use under 
        applicable law.
          ``(2) Complete access to health data.--The technology allows 
        access to the entirety of a patient's available data for 
        authorized use under applicable law without special effort, as 
        defined by recommendations for interoperability standards 
        adopted under section 3004, by the requestor of such data 
        unless such data is not disclosable under applicable law.
          ``(3) No information blocking.--The technology is not 
        configured, set up, or implemented to engage in information 
        blocking, as defined in section 3010A(f).
  ``(b) Categories for Interoperability Standards.--The categories 
described in this subsection, with respect to standards for determining 
if health information technology is interoperable, consistent with the 
criteria described in subsection (a), include the following categories 
of standards:
          ``(1) Standards with respect to vocabulary and terminology.
          ``(2) Standards with respect to content and structure.
          ``(3) Standards with respect to transport of information.
          ``(4) Security standards.
          ``(5) Service standards.''.
          (2) Guidance.--Not later than January 1, 2017, the Secretary 
        of Health and Human Services, through the National Coordinator 
        of the Office of the National Coordinator for Health 
        Information Technology, shall issue guidance with respect to 
        the implementation of section 3010 of the Public Health Service 
        Act, as added by paragraph (1), including with respect to 
        defining and providing examples of authorized use of health 
        information technology, as described in such section.
  (b) Improvements to Recommendation Process.--
          (1) HIT policy committee to incorporate policies for updates 
        to interoperability standards.--Section 3002 of the Public 
        Health Service Act (42 U.S.C. 300jj-12) is amended--
                  (A) in subsection (a)--
                          (i) by striking ``National Coordinator'' and 
                        inserting ``Secretary, in consultation with the 
                        National Coordinator,''; and
                          (ii) by adding at the end the following new 
                        sentence: ``The HIT Policy Committee is 
                        authorized only to provide policy and priority 
                        recommendations to the Secretary and not 
                        authorized to otherwise affect the development 
                        or modification of any standard, implementation 
                        specification, or certification criterion under 
                        this title.''; and
                  (B) in subsection (b)(2)--
                          (i) in subparagraph (A), in the first 
                        sentence--
                                  (I) by striking ``The HIT Policy 
                                Committee'' and inserting ``Subject to 
                                subparagraph (D), the HIT Policy 
                                Committee''; and
                                  (II) by inserting ``(including the 
                                areas in which modifications and 
                                additions to interoperability standards 
                                under section 3010 are needed for the 
                                electronic exchange and use of health 
                                information for purposes of adoption of 
                                such modifications and additions under 
                                section 3004)'' after ``section 3004''.
                          (ii) by adding at the end the following new 
                        subparagraph:
                  ``(D) Special rule related to interoperability.--Any 
                recommendation made by the HIT Policy Committee on or 
                after the date of the enactment of this subparagraph 
                with respect to interoperability of health information 
                technology shall be consistent with the criteria 
                described in subsection (a) of section 3010.''.
          (2) Sunset of hit standards committee.--Section 3003 of the 
        Public Health Service Act (42 U.S.C. 300jj-13) is amended by 
        adding at the end the following new subsection:
  ``(f) Termination.--The HIT Standards Committee shall terminate on 
the date that is 90 days after the date of the enactment of this 
subsection.''.
          (3) Standards development organizations.--Title XXX of the 
        Public Health Service Act is amended by inserting after section 
        3003 the following new section:

``SEC. 3003A. RECOMMENDATIONS FOR STANDARDS THROUGH CONTRACTS WITH 
                    STANDARDS DEVELOPMENT ORGANIZATIONS.

  ``(a) Contracts.--
          ``(1) In general.--For purposes of activities conducted under 
        this title, the Secretary shall enter into contracts with 
        health care standards development organizations accredited by 
        the American National Standards Institute to carry out the 
        duties described in subsection (b), as applicable.
          ``(2) Timing for first contract.--As soon as practicable 
        after the date of the enactment of this section, the Secretary 
        shall enter into the first contract under paragraph (1).
          ``(3) Period of contract.--Each contract under paragraph (1) 
        shall be for a period determined necessary by the Secretary, in 
        consultation with the National Coordinator, to carry out the 
        applicable duties described in subsection (b).
          ``(4) Appropriate organizations.--The Secretary shall ensure 
        the most appropriate organizations described in paragraph (1) 
        are selected for each contract under such paragraph.
          ``(5) Allowance for variations.--Standards developed pursuant 
        to a contract under this subsection, and the methods to test 
        such standards, shall allow for variations on such standards as 
        long as such variations are consistent with the standards so 
        developed under this section.
  ``(b) Duties.--
          ``(1) Initial contract.--Under the initial contract under 
        subsection (a)(1), the standards development organizations--
                  ``(A) shall provide to the Secretary, in consultation 
                with the National Coordinator, for adoption under 
                section 3004, recommendations, in accordance with 
                section 3010, for interoperability standards, and 
                methods to test such standards, consistent with the 
                criteria described in subsection (a) of such section 
                and with respect to the categories described in 
                subsection (b)(1) of such section; and
                  ``(B) may provide to the Secretary recommendations 
                described in paragraph (2).
          ``(2) Subsequent contracts.--Under each subsequent contract, 
        the organizations shall provide to the Secretary, in 
        consultation with the National Coordinator, for adoption under 
        section 3004 recommendations for any standards (including 
        interoperability standards and methods to test such standards), 
        implementation specifications, and certification criteria (and 
        modifications, including additions, to such standards, 
        specifications, and criteria), which are in accordance with the 
        policies and priorities developed by the Secretary, in 
        consultation with the National Coordinator.
          ``(3) Multiple methods to test interoperability standards.--
        For the purposes of developing methods to test interoperability 
        standards for adoption under section 3004, the Secretary shall 
        ensure that contracts under this section allow for multiple 
        methods to test such standards to account for variations in the 
        adoption of such standards that do not conflict with section 
        3010(a).
  ``(c) Modifications and Subsequent Contracts.--
          ``(1) In general.--The Secretary, in consultation with the 
        National Coordinator, shall periodically conduct hearings to 
        evaluate and review the standards, implementation 
        specifications, and certification criteria adopted under 
        section 3004 for purposes of determining if modifications, 
        including any additions, are needed with respect to such 
        standards, specifications, and criteria.
          ``(2) Contract trigger.--Based on the needs for standards, 
        implementation specifications, and certification criteria (and 
        modifications, including additions, to such standards, 
        specifications, and criteria) under this title, as determined 
        by the Secretary, in consultation with the National 
        Coordinator, the Secretary shall, as needed, enter into 
        contracts under subsection (a) in addition to the initial 
        contract.
  ``(d) Authorization of Appropriations.--There is authorized to be 
appropriated $10,000,000 for contracts under subsection (a), to remain 
available until expended.''.
          (4) Modifications to role of onchit.--Section 3001(c)(1)(A) 
        of the Public Health Service Act (42 U.S.C. 300jj-11(c)(1)(A)) 
        is amended by inserting ``for recommendations made before the 
        date of the enactment of the 21st Century Cures Act,'' before 
        ``review and determine''.
  (c) Adoption.--Section 3004 of the Public Health Service Act (42 
U.S.C. 300jj-14) is amended--
          (1) in subsection (a)--
                  (A) in paragraph (1), by inserting after ``section 
                3001(c)'' the following: ``(or, subject to subsection 
                (c), in the case of a standard, specification, or 
                criterion recommended on or after the date of the 
                enactment of the 21st Century Cures Act, after the date 
                of submission of the recommendation to the Secretary 
                under section 3003A)''; and
                  (B) in paragraph (2)(B), by striking ``and the HIT 
                Standards Committee'';
          (2) in subsection (b), by adding at the end the following new 
        paragraph:
          ``(4) Limitation.--The Secretary may not adopt any standards, 
        implementation specifications, or certification criteria under 
        this subsection or subsection (a) that are inconsistent with or 
        duplicative of an interoperability standard adopted under this 
        section, in accordance with subsections (c) and (d). In the 
        case of a standard, specification, or criterion that has been 
        adopted under this section and is inconsistent or duplicative 
        of such an interoperability standard that is subsequently 
        adopted under this section, such interoperability standard 
        shall supercede such other standard, specification, or 
        criterion and such other standard, specification, or criterion 
        shall no longer be considered adopted under this section 
        beginning on the date that such interoperability standard 
        becomes effective.''; and
          (3) by adding at the end the following new subsections:
  ``(c) Adoption of Initial Interoperability Standards.--
Notwithstanding the previous subsections of this section, the following 
shall apply in the case of the initial set of interoperability 
standards recommended under section 3003A:
          ``(1) Review of standards.--Not later than 90 days after the 
        date of receipt of recommendations for such interoperability 
        standards, the Secretary, in consultation with the National 
        Coordinator and representatives of other relevant Federal 
        agencies, shall jointly review such standards and shall 
        determine whether or not to propose adoption of such standards.
          ``(2) Determination to adopt.--If the Secretary determines--
                  ``(A) to propose adoption of such standards, the 
                Secretary shall, by regulation under section 553 of 
                title 5, United States Code, determine whether or not 
                to adopt such standards; or
                  ``(B) not to propose adoption of such standards, the 
                Secretary shall notify the applicable standards 
                development organizations with a contract under section 
                3003A in writing of such determination and the reasons 
                for not proposing the adoption of the recommendation 
                for such standards.
          ``(3) Publication.--The Secretary shall provide for 
        publication in the Federal Register of all determinations made 
        by the Secretary under paragraph (1).
          ``(4) Application.--Any standard adopted under this 
        subsection shall be effective 12 months after the date of 
        publication of the determination to adopt such standard.
  ``(d) Rules for Adoption.--In the case of a standard (including 
interoperability standard), implementation specification, or 
certification criteria adopted under this section on or after the date 
of the enactment of the 21st Century Cures Act, the following shall 
apply:
          ``(1) In general.--Except as provided in paragraph (2), any 
        such standard (including interoperability standard), 
        implementation specification, or certification criterion shall 
        be a standard, specification, or criterion that has been 
        recommended by the standards development organizations with 
        which the Secretary has entered into a contract under section 
        3003A.
          ``(2) Special rule if no standard, specification, or 
        criterion recommended.--If no standard is recommended under 
        paragraph (1)--
                  ``(A) in the case of interoperability standards, 
                relating to a category described in section 3010(b)--
                          ``(i) paragraph (1) shall not apply; and
                          ``(ii) paragraph (4) shall apply; or
                  ``(B) in the case of any other standard, 
                implementation specification, or certification 
                criteria, relating to a policy or priority to carry out 
                this title, as determined by the Secretary, in 
                consultation with the National Coordinator--
                          ``(i) paragraph (1) shall not apply; and
                          ``(ii) paragraph (4) shall apply.
          ``(3) Effective date.--Any standard, implementation 
        specification, or certification criterion adopted under this 
        section shall be effective 12 months after the date of 
        publication of the final rule to adopt such standard, 
        implementation specification, or certification criterion.
          ``(4) Assistance to the secretary.--In complying with the 
        requirements of this subsection, the Secretary shall rely on 
        the recommendations of the National Committee on Vital and 
        Health Statistics established under section 306(k), and shall 
        consult with appropriate Federal and State agencies and private 
        organizations. The Secretary shall publish in the Federal 
        Register any recommendation of the National Committee on Vital 
        and Health Statistics regarding the adoption of a standard, 
        implementation specification, or certification criterion under 
        this section. Any standard, implementation specification, or 
        certification criterion adopted pursuant to this paragraph 
        shall be promulgated in accordance with the rulemaking 
        procedures of subchapter III of chapter 5 of title 5, United 
        States Code.''.
  (d) Reports and Notifications.--Section 3010 of the Public Health 
Service Act, as added by subsection (a), is amended by adding at the 
end the following new subsection:
  ``(c) Dissemination of Information.--
          ``(1) Initial summary report.--Not later than July 1, 2017, 
        the Secretary, after consultation with relevant stakeholders, 
        shall submit to Congress and provide for publication in the 
        Federal Register and the posting on the Internet website of the 
        Office of the National Coordinator for Health Information 
        Technology of a report on the following:
                  ``(A) The initial set of interoperability standards 
                adopted under section 3004(c).
                  ``(B) The strategies for achieving widespread 
                interoperability.
                  ``(C) An overview of the extent to which electronic 
                health records and health information technology 
                offered as of such date satisfy such initial set.
                  ``(D) Any barriers that are preventing widespread 
                interoperability.
                  ``(E) The plan and milestones, including specific 
                steps, to achieve widespread interoperability.
          ``(2) Followup determination and report on widespread 
        interoperability.--Not later than December 31, 2019, the 
        Secretary shall provide for publication in the Federal Register 
        and the posting on the Internet website of the Office of the 
        National Coordinator for Health Information Technology of the 
        following:
                  ``(A) A determination by the Secretary whether the 
                goal of widespread interoperability has been achieved.
                  ``(B) A list identifying the vendors of, or other 
                entities offering, qualified electronic health records, 
                which categorizes such entities, with respect to such 
                records, as in compliance or not in compliance with the 
                certification criteria described in section 
                3001(c)(5)(B)(ii) and with the requirements under 
                clause (i) of section 3001(c)(5)(C) (including with the 
                terms of the attestation and other requirements under 
                such clause).
                  ``(C) Actions that may be taken by entities 
                identified under subparagraph (B) as not being in 
                compliance with such criteria and requirements in order 
                for such entities to become in compliance with such 
                criteria and requirements.
                  ``(D) Penalties described in section 3010A(d) to 
                which entities, with respect to such qualified 
                electronic health records, beginning January 1, 2019, 
                are subject if such technology and entities are not in 
                compliance with the certification criteria described in 
                section 3001(c)(5)(B)(ii) and with the requirements 
                under clause (i) of section 3001(c)(5)(C), 
                respectively.
          ``(3) Ongoing publication of recommendations.--The Secretary 
        shall provide for publication in the Federal Register and the 
        posting on the Internet website of the Office of the National 
        Coordinator for Health Information Technology of all 
        recommendations made under this section.''.
  (e) Certification and Other Enforcement Provisions.--
          (1) Certification of qualified electronic health records.--
                  (A) In general.--Section 3007(b) of the Public Health 
                Service Act (42 U.S.C. 300jj-17(b)) is amended by 
                striking ``under section 3001(c)(3) to be in compliance 
                with'' and all that follows through the period at the 
                end and inserting ``under section 3001(c)(3)--
          ``(1) for certifications made before January 1, 2018, to be 
        in compliance with applicable standards adopted under 
        subsections (a) and (b) of section 3004; and
          ``(2) for certifications made on or after January 1, 2018, to 
        be in compliance with applicable standards adopted under 
        subsections (a) and (b) of section 3004 and to be interoperable 
        in accordance with section 3010, including by being in 
        compliance with interoperability standards adopted under 
        section 3004.''.
                  (B) Requirements of secretary.--Section 3001(c)(5) of 
                the Public Health Service Act (42 U.S.C. 300jj-
                11(c)(5)) is amended--
                          (i) by amending subparagraph (B) of such 
                        section to read as follows:
                  ``(B) Certification criteria described.--In this 
                title, the term `certification criteria' means, with 
                respect to qualified electronic health records--
                          ``(i) for certifications made before January 
                        1, 2018, criteria to establish that the records 
                        meet standards and implementation 
                        specifications adopted under subsections (a) 
                        and (b) of section 3004 for qualified 
                        electronic health records; and
                          ``(ii) for certifications made on or after 
                        January 1, 2018, criteria described in clause 
                        (i) and criteria to establish that the records 
                        are interoperable, in accordance with section 
                        3010, including by being in compliance with 
                        interoperability standards adopted under 
                        section 3004.''; and
                          (ii) by adding at the end the following new 
                        subparagraph:
                  ``(C) Enforcement; decertifications.--
                          ``(i) Requirements.--Under any program kept 
                        or recognized under subparagraph (A), the 
                        Secretary shall ensure that any vendor of or 
                        other entity offering qualified electronic 
                        health records seeking a certification of such 
                        records under such program on or after January 
                        1, 2018, shall, as a condition of certification 
                        (and maintenance of certification) of such a 
                        record under such program--
                                  ``(I) provide to the Secretary an 
                                attestation--
                                          ``(aa) that the entity, 
                                        unless for a legitimate purpose 
                                        specified by the Secretary, has 
                                        not taken any action, including 
                                        through any financial, 
                                        administrative, or 
                                        technological barrier, which 
                                        the entity knows or should know 
                                        (as defined in section 
                                        1128A(i)(7) of the Social 
                                        Security Act), is to limit or 
                                        restrict the exchange of 
                                        information or to prevent or 
                                        disincentivize widespread 
                                        interoperability between any 
                                        providers using such records or 
                                        other health information 
                                        technology in connection with 
                                        such record;
                                          ``(bb) on the pricing 
                                        information described in clause 
                                        (v) for purposes of the portal 
                                        created under paragraph (9); 
                                        that such information will be 
                                        available on a public Web site 
                                        of such entity and in marketing 
                                        materials, communications 
                                        statements, and other 
                                        assertions of such entity 
                                        related to such record; and 
                                        that the entity will 
                                        voluntarily provide such 
                                        information to customers prior 
                                        to providing any qualified 
                                        electronic health records or 
                                        related product or service 
                                        (including subsequent updates, 
                                        add-ons, or additional products 
                                        or services to be provided 
                                        during the course of an on-
                                        going contract), prospective 
                                        customers (such as persons who 
                                        request or receive a quotation, 
                                        estimate, or other similar 
                                        marketing or promotional 
                                        material), and other persons 
                                        who request such information;
                                          ``(cc) that the software with 
                                        respect to such records have 
                                        published application 
                                        programming interfaces for 
                                        medical records data, search 
                                        and indexing, semantic 
                                        harmonization and vocabulary 
                                        translation, and user interface 
                                        applications;
                                          ``(dd) that the entity has 
                                        successfully tested the use of 
                                        the record in the type of 
                                        setting in which it would be 
                                        marketed;
                                          ``(ee) the entity has in 
                                        place implementation guidelines 
                                        for such record that support 
                                        interoperability, consistent 
                                        with section 3010; and
                                          ``(ff) that the entity has in 
                                        place data sharing programs or 
                                        capabilities based on common 
                                        data elements through 
                                        application programming 
                                        interfaces without the 
                                        requirement for vendor-specific 
                                        interfaces;
                                  ``(II) publish application 
                                programming interfaces and associated 
                                documentation, with respect to such 
                                records, for medical records data, 
                                search and indexing, semantic 
                                harmonization and vocabulary 
                                translation, and user interface 
                                applications; and
                                  ``(III) demonstrate to the 
                                satisfaction of the Secretary that data 
                                from such records are able to be 
                                exchanged through the use of 
                                application programming interfaces and 
                                used in a manner that allows for 
                                exchange and everyday use, as 
                                authorized under applicable law, of 
                                such records.
                          ``(ii) Decertification.--Under any program 
                        kept or recognized under subparagraph (A), the 
                        Secretary shall ensure that beginning January 
                        1, 2019, any qualified electronic health 
                        records that do not satisfy the certification 
                        criteria described in section 3001(c)(5)(B)(ii) 
                        or with respect to which the vendor or other 
                        entity described in clause (i) does not satisfy 
                        the requirements under such clause (or is 
                        determined to be in violation of the terms of 
                        the attestation or other requirements under 
                        such clause) shall no longer be considered as 
                        certified under such program.
                          ``(iii) Annual publication.--For 2019 and 
                        each subsequent year, the Secretary shall post 
                        on the public Internet website of the 
                        Department of Health and Human Services a list 
                        of any vendors of or other entities offering 
                        qualified electronic health records with 
                        respect to which certification has been 
                        withdrawn under clause (ii) during such year.
                          ``(iv) Periodic review.--The Secretary shall 
                        periodically review and confirm that vendors of 
                        and other entities offering qualified 
                        electronic health records have publicly 
                        published application programming interfaces 
                        and associated documentation as required by 
                        clause (i)(II) for purposes of certification 
                        and maintaining certification under any program 
                        kept or recognized under subparagraph (A).
                          ``(v) Pricing information.--For purposes of 
                        clause (i)(I)(bb), the pricing information 
                        described in this clause, with respect to a 
                        vendor of or other entity offering a qualified 
                        electronic health record, is the following:
                                  ``(I) Additional types of costs or 
                                fees (whether fixed, recurring, 
                                transaction based, or otherwise) 
                                imposed by the entity (or any third-
                                party from whom the entity purchases, 
                                licenses, or obtains any technology, 
                                products, or services in connection 
                                with the qualified electronic health 
                                record) to purchase, license, 
                                implement, maintain, upgrade, use, or 
                                otherwise enable and support the use of 
                                capabilities to which such record is to 
                                be certified under this section; or in 
                                connection with any data generated in 
                                the course of using any capability to 
                                which the record is to be so certified.
                                  ``(II) Limitations, whether by 
                                contract or otherwise, on the use of 
                                any capability to which the record is 
                                to be certified under this section for 
                                any purpose within the scope of the 
                                record's certification; or in 
                                connection with any data generated in 
                                the course of using any capability to 
                                which the record is to be certified 
                                under this section.
                                  ``(III) Limitations, including 
                                technical or practical limitations of 
                                technology or its capabilities, that 
                                could prevent or impair the successful 
                                implementation, configuration, 
                                customization, maintenance, support, or 
                                use of any capabilities to which the 
                                record is to be certified under this 
                                section; or that could prevent or limit 
                                the use, exchange, or portability of 
                                any data generated in the course of 
                                using any capability to which the 
                                record is to be so certified.''.
          (2) Additional enforcement provisions under the public health 
        service act.--Subtitle A of title XXX of the Public Health 
        Service Act (42 U.S.C. 300jj-11 et seq.), as amended by 
        subsections (a)(1) and (d), is further amended by adding at the 
        end the following new section:

``SEC. 3010A. ENFORCEMENT MECHANISMS.

  ``(a) Inspector General Authority.--The Inspector General of the 
Department of Health and Human Services shall have the authority to 
investigate claims of--
          ``(1) vendors of, or other entities offering, qualified 
        electronic health records--
                  ``(A) being in violation of an attestation made under 
                section 3001(c)(5)(C)(i)(I), with respect to the use of 
                such records by a health care provider under a 
                specified meaningful use incentive program; and
                  ``(B) having engaged in information blocking (as 
                defined in subsection (f)), unless for a legitimate 
                purpose specified by the Secretary, with respect to the 
                use of such records by a health care provider under 
                such a program;
          ``(2) health care providers, with respect to the use of such 
        records under a specified meaningful use incentive program, 
        having, unless for a legitimate purpose specified by the 
        Secretary, engaged in information blocking (as so defined);
          ``(3) health information system providers described in 
        subsection (b) having engaged in information blocking (as so 
        defined), unless for a legitimate purpose specified by the 
        Secretary, with respect to the use of such records under a 
        specified meaningful use incentive program; and
          ``(4) vendors of, or other entities offering, health 
        information technology (other than technology described in 
        paragraph (1)), health care providers, with respect to the use 
        of such technology, and health information system providers, 
        with respect to such technology, unless for a legitimate 
        purpose specified by the Secretary, having engaged in 
        information blocking (as so defined).
  ``(b) Health Information System Providers.--The Inspector General of 
the Department of Health and Human Services shall, in coordination with 
the Federal Trade Commission, ensure that health information system 
providers (such as operators of health information exchanges and other 
systems that facilitate the exchange of information) investigate claims 
of information blocking, with respect to the use of such records under 
a specified meaningful use incentive program.
  ``(c) Information Sharing Provisions.--
          ``(1) In general.--The National Coordinator may serve as a 
        technical consultant to the Inspector General of the Department 
        of Health and Human Services and the Federal Trade Commission 
        for purposes of carrying out this section. As such technical 
        consultant, the National Coordinator may, notwithstanding any 
        other provision of law, share information related to claims or 
        investigations under subsection (a) or (b) with the Federal 
        Trade Commission for purposes of such investigations.
          ``(2) Protection from disclosure of information.--Any 
        information shared by the National Coordinator under paragraph 
        (1) shall not be subject to the provisions of section 552 of 
        title 5, United States Code (commonly referred to as the 
        Freedom of Information Act). Any information acquired pursuant 
        to paragraph (1) shall be held in confidence and shall not be 
        disclosed to any person except as may be necessary to carry out 
        the purposes of subsection (a).
          ``(3) Non-application of paperwork reduction act.--Chapter 35 
        of title 44, United States Code (commonly referred to as the 
        Paperwork Reduction Act of 1995) shall not apply to the 
        National Coordinator or to the Office of the National 
        Coordinator for Health Information Technology with respect to 
        the collection of complaints relating to claims described in 
        subsection (a).
  ``(d) Penalty.--Any person or entity determined to have committed an 
act described in paragraph (1), (2), or (3) of subsection (a), in 
connection with a specified meaningful use incentive program, shall be 
subject to a civil monetary penalty of not more than $10,000 for each 
such act. The provisions of section 1128A (other than subsections (a) 
and (b)) shall apply to a civil money penalty applied under this 
subsection in the same manner as they apply to a civil money penalty or 
proceeding under section 1128A(a).
  ``(e) Specified Meaningful Use Incentive Program.--For purposes of 
this section, the term `specified meaningful use incentive program' 
includes the following:
          ``(1) The incentive payments under subsection (o) of section 
        1848 of the Social Security Act (42 U.S.C. 1395w-4) and 
        adjustments under subsection (a)(7) of such section.
          ``(2) The incentive payments under subsection (n) of section 
        1848 of such Act (42 U.S.C. 1395ww) and adjustments under 
        subsection (b)(3)(B) of such section.
          ``(3) The incentive payments and adjustments made under 
        subsections (l) and (m) of section 1853 of such Act (42 U.S.C. 
        1395w-23).
          ``(4) The incentive payment under paragraph (3) of section 
        1814(l) of such Act (42 U.S.C. 1395f(l)) and adjustment under 
        paragraph (4) of such section.
          ``(5) The shared savings program under section 1899 of such 
        Act (42 U.S.C. 1395jjj).
          ``(6) The payments to Medicaid providers described in section 
        1903(t) of such Act (42 U.S.C. 1396b(t)).
  ``(f) Information Blocking.--
          ``(1) In general.--For purposes of this section and section 
        3010, the term `information blocking' means, with respect to 
        the use of qualified electronic health records or other health 
        information technology under a specified meaningful use 
        incentive program, business, technical, and organizational 
        practices, including practices described in paragraph (2), 
        that--
                  ``(A) prevent or materially discourage the exchange 
                of electronic health information;
                  ``(B) the actor knows or should know (as defined in 
                section 1128A(i)(7) of the Social Security Act) are 
                likely to interfere with the exchange or use of 
                electronic health information; and
                  ``(C) do not serve to protect patient safety, 
                maintain the privacy and security of individuals' 
                health information or promote competition and consumer 
                welfare.
          ``(2) Practices described.--For purposes of paragraph (1), 
        the practices described in this paragraph are the following:
                  ``(A) Contract terms, policies, or other business or 
                organizational practices that restrict individuals' 
                access to their electronic health information or 
                restrict the exchange or use of that information for 
                treatment and other permitted purposes.
                  ``(B) Charging prices or fees (such as for data 
                exchange, portability, and interfaces) that make 
                exchanging and using electronic health information cost 
                prohibitive.
                  ``(C) Developing or implementing health information 
                technology in nonstandard ways that are likely to 
                substantially increase the costs, complexity, or burden 
                of sharing electronic health information, especially in 
                cases in which relevant interoperability standards or 
                methods to measure interoperability have been adopted 
                by the Secretary.
                  ``(D) Developing or implementing health information 
                technology in ways that are likely to lock in users or 
                electronic health information, such as not allowing for 
                the full export of data; lead to fraud, waste, or 
                abuse; or impede innovations and advancements in health 
                information exchange and health information technology-
                enabled care delivery.
  ``(g) Treatment of Vendors With Respect to Patient Safety 
Organizations.--In applying part C of title IX--
          ``(1) vendors shall be treated as a provider (as defined in 
        section 921) for purposes of reporting requirements under such 
        part, to the extent that such reports are related to 
        attestation requirements under section 3001(c)(5)(C)(i)(I);
          ``(2) claims of information blocking described in subsection 
        (a) shall be treated as a patient safety activity under such 
        part for purposes of reporting requirements under such part; 
        and
          ``(3) health care providers that are not members of patient 
        safety organizations shall be treated in the same manner as 
        health care providers that are such members for purposes of 
        such reporting requirements with respect to claims of 
        information blocking described in subsection (a).''.
          (3) ONCHIT.--
                  (A) Portal.--Section 3001(c) of the Public Health 
                Service Act (42 U.S.C. 300jj-11(c)) is amended by 
                adding at the end the following new paragraph:
          ``(9) Portal.--Not later than January 1, 2019, the National 
        Coordinator shall create a portal to make the information 
        described in paragraph (5)(C)(I)(i)(bb) available to the public 
        in a manner that allows for comparison of price information 
        among health information technology products and that aids in 
        making informed decisions for purchasing such a product.''.
                  (B) Information blocking.--Not later than 12 months 
                after the date of the enactment of this Act, the 
                National Coordinator of the Office of the National 
                Coordinator of Health Information Technology shall, 
                through rulemaking, implement the provisions of this 
                section, and amendments made by this section, relating 
                to information blocking.
                  (C) HIPAA.--Not later than January 1, 2017, the 
                National Coordinator shall publish guidance to clarify 
                the relationship of the HIPAA privacy and security law, 
                as defined in section 3009(a)(2) of the Public Health 
                Service Act (42 U.S.C. 300jj-19(a)(2)) as such 
                provisions relate to information blocking (as defined 
                in section 3010A(f) of such Act, as added by paragraph 
                (2)), including examples of how such provisions may 
                result in information blocking.
          (4) Demonstration required for meaningful ehr use incentives 
        under medicare.--
                  (A) Incentives for professionals.--
                          (i) In general.--Section 1848(o)(2)(C) of the 
                        Social Security Act (42 U.S.C. 1395w-
                        4(o)(2)(C)) is amended by adding at the end the 
                        following new clause:
                          ``(iii) Interoperability.--With respect to 
                        EHR reporting periods for payment years 
                        beginning with 2018, the means described in 
                        clause (i) specified by the Secretary shall 
                        include a demonstration, through means such as 
                        an attestation, that the professional has not 
                        taken any action described in subsection (a)(2) 
                        of section 3010A of the Public Health Service 
                        Act, with respect to the use of any certified 
                        EHR technology.''.
                          (ii) Hardship exemption in case of 
                        decertified ehr.--Subparagraph (B) of section 
                        1848(a)(7) of the Social Security Act (42 
                        U.S.C. 1395w-4(a)(7)) is amended to read as 
                        follows:
                  ``(B) Significant hardship exception.--
                          ``(i) In general.--The Secretary may, on a 
                        case-by-case basis, exempt an eligible 
                        professional from the application of the 
                        payment adjustment under subparagraph (A) if 
                        the Secretary determines, subject to annual 
                        renewal, that compliance with the requirement 
                        for being a meaningful EHR user would result in 
                        a significant hardship, such as in the case of 
                        an eligible professional who practices in a 
                        rural area without sufficient Internet access.
                          ``(ii) Decertification.--
                                  ``(I) In general.--The Secretary may, 
                                on a case-by-case basis, exempt an 
                                eligible professional from the 
                                application of the payment adjustment 
                                under subparagraph (A) if the Secretary 
                                determines that such professional was 
                                determined to not be a meaningful EHR 
                                user because the qualified electronic 
                                health record used by such professional 
                                was decertified under section 
                                3001(c)(5)(C) of the Public Health 
                                Service Act. An exemption under the 
                                previous sentence may be applied to an 
                                eligible professional only, subject to 
                                subclause (II), during the first 
                                payment year with respect to the first 
                                EHR reporting period to which such 
                                decertification applies.
                                  ``(II) Duration.--
                                          ``(aa) In general.--In no 
                                        case shall an exemption by 
                                        reason of this clause be for a 
                                        period of less than 12 months.
                                          ``(bb) Extension.--An 
                                        exemption under this clause may 
                                        be extended for a period of an 
                                        additional 12 months subject to 
                                        the limitation described in 
                                        clause (ii).
                          ``(iii) Limitation.--Subject to clause 
                        (ii)(II)(aa), in no case may an eligible 
                        professional be granted an exemption under this 
                        subparagraph for more than 5 years.''.
                  (B) Incentives for hospitals.--
                          (i) In general.--Section 1886(o)(1) of the 
                        Social Security Act (42 U.S.C. 1395ww(o)(1)) is 
                        amended--
                                  (I) in subparagraph (A), by inserting 
                                before the period at the end the 
                                following: ``and, for performance 
                                periods for fiscal year 2018 or a 
                                subsequent fiscal year, that provide a 
                                demonstration described in subparagraph 
                                (D) to the Secretary''; and
                                  (II) by adding at the end the 
                                following new subparagraph:
                  ``(D) Demonstration described.--The demonstration 
                described in this subparagraph is a demonstration, 
                through means such as an attestation, that the hospital 
                has not taken any action described in subsection (a)(2) 
                of section 3010A of the Public Health Service Act, with 
                respect to the use of any certified EHR technology.''.
                          (ii) Hardship exemption in case of 
                        decertified ehr.--Subclause (II) of section 
                        1886(b)(3)(B)(ix) of the Social Security Act 
                        (42 U.S.C. 1395ww(b)(3)(B)(ix)) is amended to 
                        read as follows:
  ``(II)(aa) The Secretary may, on a case-by-case basis, exempt a 
subsection (d) hospital from the application of subclause (I) with 
respect to a fiscal year if the Secretary determines, subject to annual 
renewal, that requiring such hospital to be a meaningful EHR user 
during such fiscal year would result in a significant hardship, such as 
in the case of a hospital in a rural area without sufficient Internet 
access.
  ``(bb) The Secretary may, on a case-by-case basis, exempt a 
subsection (d) hospital from the application of subclause (I) with 
respect to a fiscal year if the Secretary determines, subject to annual 
renewal, that such hospital was determined to not be a meaningful EHR 
user because the qualified electronic health record used by such 
hospital was decertified under section 3001(c)(5)(C) of the Public 
Health Service Act. An exemption under the previous sentence may be 
applied to a subsection (d) hospital only, subject to items (cc) and 
(dd), during the first payment year with respect to the first EHR 
reporting period to which such decertification applies.
  ``(cc) In no case shall an exemption by reason of item (bb) be for a 
period of less than 12 months.
  ``(dd) An exemption under item (bb) may be extended for a period of 
an additional 12 months subject to the limitation described in item 
(ee).
  ``(ee) Subject to item (cc), in no case may a hospital be granted an 
exemption under this subclause for more than 5 years.''.
                  (C) Demonstration required for meaningful ehr use 
                incentives under medicaid.--Section 1903(t)(2) of the 
                Social Security Act (42 U.S.C. 1396b(t)(2)) is amended 
                by adding at the end the following: ``An eligible 
                professional shall not qualify as a Medicaid provider 
                under this subsection, with respect to a year beginning 
                with 2018, unless such provider demonstrates to the 
                Secretary, through means such as an attestation, that 
                the provider has not taken any action described in 
                subsection (a)(2) of section 3010A of the Public Health 
                Service Act with respect to which the provider knows or 
                should know (as defined in section 1128A(i)(7) of the 
                Social Security Act) about, with respect to the use of 
                any certified EHR technology.''.
  (f) Definitions.--
          (1) Certified ehr technology.--Paragraph (1) of section 3000 
        of the Public Health Service Act (42 U.S.C. 300jj) is amended 
        to read as follows:
          ``(1) Certified ehr technology.--The term `certified EHR 
        technology' means a qualified electronic health record that is 
        certified pursuant to section 3001(c)(5) as meeting the 
        certification criteria defined in subparagraph (B) of such 
        section that are applicable to the type of record involved (as 
        determined by the Secretary, such as an ambulatory electronic 
        health record for office-based physicians or an inpatient 
        hospital electronic health record for hospitals) including, 
        beginning January 1, 2018, with respect to which the vendor or 
        other entity offering such technology is in compliance with the 
        requirements under section 3001(c)(5)(C)(i).''.
          (2) Widespread interoperability.--Section 3000 of the Public 
        Health Service Act (42 U.S.C. 300jj) is amended by adding at 
        the end the following new paragraph:
          ``(15) Widespread interoperability.--The term `widespread 
        interoperability' means that, on a nationwide basis--
                  ``(A) health information technology is interoperable, 
                in accordance with section 3010; and
                  ``(B) such technology is employed by meaningful EHR 
                users under the specified meaningful use incentive 
                programs (as defined in section 3010A(e)) and by other 
                clinicians and health care providers.''.
  (g) Conforming Amendments.--
          (1) Voluntary use of standards.--Section 3006 of the Public 
        Health Service Act (42 U.S.C. 300jj-16) is amended--
                  (A) in subsection (a)(1), by inserting ``, including 
                an interoperability standard adopted under such 
                section'' after ``section 3004''.
                  (B) in subsection (b), by inserting ``, including the 
                interoperability standards adopted under such section'' 
                after ``section 3004''.
          (2) HIPAA privacy and security law definition correction.--
        Section 3009(a)(2)(A) of the Public Health Service Act (42 
        U.S.C. 300jj-19(a)(2)(A)) is amended by striking ``title IV'' 
        and inserting ``title XIII''.
          (3) Coordination of federal activities.--Section 13111 of the 
        HITECH Act is amended--
                  (A) in subsection (a), by inserting before the period 
                at the end the following: ``(and, beginning on January 
                1, 2018, that are also interoperable under section 3010 
                of such Act, including by being in compliance with 
                interoperability standards adopted under section 3004 
                of such Act)''; and
                  (B) in subsection (b), by inserting ``(and, beginning 
                on January 1, 2018, including an interoperability 
                standard adopted under section 3004 of such Act)'' 
                before ``the President''.
          (4) Application to private entities.--Section 13112 of the 
        HITECH Act is amended by inserting before the period at the end 
        the following: ``(and, beginning on January 1, 2018, that are 
        also interoperable under section 3010 of such Act, including by 
        being in compliance with interoperability standards adopted 
        under section 3004 of such Act)''.
          (5) Coordination with recommendations for achieving 
        widespread ehr interoperability.--Section 106 of the Medicare 
        Access and CHIP Reauthorization Act of 2015 (Public Law 114-10) 
        is amended by striking subsection (b).''.
  (h) Patient Empowerment.--It is the sense of Congress that--
          (1) patients have the right to the entirety of the health 
        information of such patients, including such information 
        contained in an electronic health record of such patients;
          (2) such right extends to both structured and unstructured 
        data; and
          (3) to further facilitate patient ownership over health 
        information of such patient--
                  (A) health care providers should not have the ability 
                to deny a patient's request for access to the entirety 
                of such health information of such patient; and
                  (B) health care providers do not need the consent of 
                their patients to share personal health information of 
                such patients with other covered entities, in 
                compliance with the HIPAA privacy regulations 
                promulgated pursuant to section 264(c) of the Health 
                Insurance Portability and Accountability Act of 1996 
                for the purposes of supporting patient care, except in 
                situations where consent is specifically required under 
                such regulations, such as in cases related to the 
                psychiatric records of the patient.

                         Subtitle B--Telehealth

SEC. 3021. TELEHEALTH SERVICES UNDER THE MEDICARE PROGRAM.

  (a) Provision of Information by Centers for Medicare & Medicaid 
Services.--Not later than 1 year after the date of the enactment of 
this Act, the Administrator of the Centers for Medicare & Medicaid 
Services shall provide to the committees of jurisdiction of the House 
of Representatives and the Senate information on the following:
          (1) The populations of Medicare beneficiaries, such as those 
        who are dually eligible for the Medicare program under title 
        XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) and 
        the Medicaid program under title XIX of such Act (42 U.S.C. 
        1396 et seq.) and those with chronic conditions, whose care may 
        be improved most in terms of quality and efficiency by the 
        expansion, in a manner that meets or exceeds the existing in-
        person standard of care under the Medicare program under title 
        XVIII of such Act, of telehealth services under section 
        1834(m)(4) of such Act (42 U.S.C. 1395m(m)(4)).
          (2) Activities by the Center for Medicare and Medicaid 
        Innovation which examine the use of telehealth services in 
        models, projects, or initiatives funded through section 1115A 
        of the Social Security Act (42 U.S.C. 1315a).
          (3) The types of high volume procedures codes or diagnoses 
        under such title XVIII which might be suitable to the 
        furnishing of services via telehealth.
          (4) Barriers that might prevent the expansion of telehealth 
        services under section 1834(m)(4) of the Social Security Act 
        (42 U.S.C. 1395m(m)(4)) beyond such services that are in effect 
        as of the date of the enactment of this Act.
  (b) Provision of Information by MedPAC.--Not later than 1 year after 
the date of the enactment of this Act, the Medicare Payment Advisory 
Commission established under section 1805 of the Social Security Act 
(42 U.S.C. 1395b-6) shall, using data from the Medicare Advantage 
program under part C of title XVIII of such Act (42 U.S.C. 1395w-21 et 
seq.), provide information to the committees of jurisdiction of the 
House of Representatives and the Senate that identifies--
          (1) services--
                  (A) for which payment could not be made, as of the 
                date of the enactment of this Act, under the fee-for-
                service program under parts A and B of such title by 
                reason of any limitation imposed under section 1834(m) 
                of such Act (42 U.S.C. 1395m(m)); and
                  (B) that are services that are recommended by the 
                Commission to be included as telehealth services for 
                which payment may be made under the fee-for-service 
                program under parts A and B of such title; and
          (2) barriers to furnishing telehealth services for which 
        payment may be made under such title XVIII and solutions to 
        address such barriers.
  (c) Sense of Congress.--It is the sense of Congress that--
          (1) States should collaborate, through the use of State 
        health board compacts or other mechanisms, to create common 
        licensure requirements services in order to facilitate 
        multistate practices and allow for health care providers to 
        provide such services across State lines;
          (2) health care providers should be appropriately licensed in 
        the physical location where the patient is receiving services;
          (3) eligible originating sites should be expanded beyond 
        those originating sites described in section 1834(m)(4)(C) of 
        the Social Security Act (42 U.S.C. 1395m(m)(4)(C)); and
          (4) any expansion of telehealth services under the Medicare 
        program should--
                  (A) recognize that telemedicine is the delivery of 
                safe, effective, quality health care services, by a 
                health care provider, using technology as the mode of 
                care delivery;
                  (B) meet or exceed the conditions of coverage and 
                payment with respect to the Medicare program under 
                title XVIII unless specifically address in subsequent 
                statute, of such Act if the service were furnished in 
                person, including standards of care; and
                  (C) involve clinically appropriate means to furnish 
                such services.

  Subtitle C--Encouraging Continuing Medical Education for Physicians

SEC. 3041. EXEMPTING FROM MANUFACTURER TRANSPARENCY REPORTING CERTAIN 
                    TRANSFERS USED FOR EDUCATIONAL PURPOSES.

  (a) In General.--Section 1128G(e)(10)(B) of the Social Security Act 
(42 U.S.C. 1320a-7h(e)(10)(B)) is amended--
          (1) in clause (iii), by inserting ``, including peer-reviewed 
        journals, journal reprints, journal supplements, medical 
        conference reports, and medical textbooks'' after ``patient 
        use''; and
          (2) by adding at the end the following new clause:
                          ``(xiii) In the case of a covered recipient 
                        who is a physician, an indirect payment or 
                        transfer of value to the covered recipient--
                                  ``(I) for speaking at, or preparing 
                                educational materials for, an 
                                educational event for physicians or 
                                other health care professionals that 
                                does not commercially promote a covered 
                                drug, device, biological, or medical 
                                supply; or
                                  ``(II) that serves the sole purpose 
                                of providing the covered recipient with 
                                medical education, such as by providing 
                                the covered recipient with the tuition 
                                required to attend an educational event 
                                or with materials provided to 
                                physicians at an educational event.''.
  (b) Effective Date.--The amendments made by this section shall apply 
with respect to transfers of value made on or after the date of the 
enactment of this Act.

              Subtitle D--Disposable Medical Technologies

SEC. 3061. TREATMENT OF CERTAIN ITEMS AND DEVICES.

  (a) In General.--Section 1834 of the Social Security Act (42 U.S.C. 
1395m) is amended by adding at the end the following new subsection:
  ``(r) Payment for Certain Disposable Devices.--
          ``(1) In general.--The Secretary shall make separate payment 
        in the amount established under paragraph (3) to a home health 
        agency for a device described in paragraph (2) when furnished 
        to an individual who receives home health services for which 
        payment is made under section 1895(b).
          ``(2) Device described.--For purposes of paragraph (1), a 
        device described in this paragraph is a disposable device for 
        which, as of January 1, 2015, there is--
                  ``(A) a Level I Healthcare Common Procedure Coding 
                System (HCPCS) code for which the description for a 
                professional service includes the furnishing of such 
                device; and
                  ``(B) a separate Level I HCPCS code for a 
                professional service that uses durable medical 
                equipment instead of such device.
          ``(3) Payment amount.--The Secretary shall establish the 
        separate payment amount for such a device such that such amount 
        does not exceed the payment that would be made for the HCPCS 
        code described in paragraph (2)(A) under section 1833(t) 
        (relating to payment for covered OPD services).''.
  (b) Conforming Amendment.--Section 1861(m)(5) of the Social Security 
Act (42 U.S.C. 1395x(m)(5)) is amended by inserting ``and devices 
described in section 1834(r)(2)'' after ``durable medical equipment''.
  (c) Effective Date.--The amendments made by this section shall apply 
to devices furnished on or after January 1, 2017.

              Subtitle E--Local Coverage Decision Reforms

SEC. 3081. IMPROVEMENTS IN THE MEDICARE LOCAL COVERAGE DETERMINATION 
                    (LCD) PROCESS.

  (a) In General.--Section 1862(l)(5) of the Social Security Act (42 
U.S.C. 1395y(l)(5)) is amended by adding at the end the following new 
subparagraph:
                  ``(D) Local coverage determinations.--The Secretary 
                shall require each medicare administrative contractor 
                that develops a local coverage determination to make 
                available on the website of such contractor and in the 
                coverage database on the Medicare website, at least 45 
                days before the effective date of such determination, 
                the following information:
                          ``(i) Such determination in its entirety.
                          ``(ii) Where and when the proposed 
                        determination was first made public.
                          ``(iii) Hyperlinks to the proposed 
                        determination and a response to comments 
                        submitted to the contractor with respect to 
                        such proposed determination.
                          ``(iv) A summary of evidence that was 
                        considered by the contractor during the 
                        development of such determination and a list of 
                        the sources of such evidence.
                          ``(v) An explanation of the rationale that 
                        supports such determination.''.
  (b) Effective Date.--The amendment made by subsection (a) shall apply 
with respect to local coverage determinations that are proposed or 
revised on or after the date that is 180 days after the date of the 
enactment of this Act.

      Subtitle F--Medicare Pharmaceutical and Technology Ombudsman

SEC. 3101. MEDICARE PHARMACEUTICAL AND TECHNOLOGY OMBUDSMAN.

  Section 1808(c) of the Social Security Act (42 U.S.C. 1395b-9(c)) is 
amended by adding at the end the following new paragraph:
          ``(4) Pharmaceutical and technology ombudsman.--Not later 
        than 12 months after the date of the enactment of this 
        paragraph, the Secretary shall provide for a pharmaceutical and 
        technology ombudsman within the Centers for Medicare & Medicaid 
        Services who shall receive and respond to complaints, 
        grievances, and requests that--
                  ``(A) are from entities that manufacture 
                pharmaceutical, biotechnology, medical device, or 
                diagnostic products that are covered or for which 
                coverage is being sought under this title; and
                  ``(B) are with respect to coverage, coding, or 
                payment under this title for such products.''.

        Subtitle G--Medicare Site-of-Service Price Transparency

SEC. 3121. MEDICARE SITE-OF-SERVICE PRICE TRANSPARENCY.

  Section 1834 of the Social Security Act (42 U.S.C. 1395m), as amended 
by section 3061, is further amended by adding at the end the following 
new subsection:
  ``(s) Site-of-Service Price Transparency.--
          ``(1) In general.--In order to facilitate price transparency 
        with respect to items and services for which payment may be 
        made either to a hospital outpatient department or to an 
        ambulatory surgical center under this title, the Secretary 
        shall, for 2017 and each year thereafter, make available to the 
        public via a searchable website, with respect to an appropriate 
        number of such items and services--
                  ``(A) the estimated payment amount for the item or 
                service under the outpatient department fee schedule 
                under subsection (t) of section 1833 and the ambulatory 
                surgical center payment system under subsection (i) of 
                such section; and
                  ``(B) the estimated amount of beneficiary liability 
                applicable to the item or service.
          ``(2) Calculation of estimated beneficiary liability.--For 
        purposes of paragraph (1)(B), the estimated amount of 
        beneficiary liability, with respect to an item or service, is 
        the amount for such item or service for which an individual who 
        does not have coverage under a medicare supplemental policy 
        certified under section 1882 or any other supplemental 
        insurance coverage is responsible.
          ``(3) Implementation.--In carrying out this subsection, the 
        Secretary--
                  ``(A) shall include in the notice described in 
                section 1804(a) a notification of the availability of 
                the estimated amounts made available under paragraph 
                (1); and
                  ``(B) may utilize mechanisms in existence on the date 
                of the enactment of this subsection, such as the 
                portion of the website of the Centers for Medicare & 
                Medicaid Services on which information comparing 
                physician performance is posted (commonly referred to 
                as the Physician Compare website), to make available 
                such estimated amounts under such paragraph.
          ``(4) Funding.--For purposes of implementing this subsection, 
        the Secretary shall provide for the transfer, from the 
        Supplemental Medical Insurance Trust Fund under section 1841 to 
        the Centers for Medicare & Medicaid Services Program Management 
        Account, of $6,000,000 for fiscal year 2015, to remain 
        available until expended.''.

  Subtitle H--Medicare Part D Patient Safety and Drug Abuse Prevention

SEC. 3141. PROGRAMS TO PREVENT PRESCRIPTION DRUG ABUSE UNDER MEDICARE 
                    PARTS C AND D.

  (a) Drug Management Program for At-Risk Beneficiaries.--
          (1) In general.--Section 1860D-4(c) of the Social Security 
        Act (42 U.S.C. 1395w-10(c)) is amended by adding at the end the 
        following:
          ``(5) Drug management program for at-risk beneficiaries.--
                  ``(A) Authority to establish.--A PDP sponsor may 
                establish a drug management program for at-risk 
                beneficiaries under which, subject to subparagraph (B), 
                the PDP sponsor may, in the case of an at-risk 
                beneficiary for prescription drug abuse who is an 
                enrollee in a prescription drug plan of such PDP 
                sponsor, limit such beneficiary's access to coverage 
                for frequently abused drugs under such plan to 
                frequently abused drugs that are prescribed for such 
                beneficiary by one or more prescribers selected under 
                subparagraph (D), and dispensed for such beneficiary by 
                one or more pharmacies selected under such 
                subparagraph.
                  ``(B) Requirement for notices.--
                          ``(i) In general.--A PDP sponsor may not 
                        limit the access of an at-risk beneficiary for 
                        prescription drug abuse to coverage for 
                        frequently abused drugs under a prescription 
                        drug plan until such sponsor--
                                  ``(I) provides to the beneficiary an 
                                initial notice described in clause (ii) 
                                and a second notice described in clause 
                                (iii); and
                                  ``(II) verifies with the providers of 
                                the beneficiary that the beneficiary is 
                                an at-risk beneficiary for prescription 
                                drug abuse.
                          ``(ii) Initial notice.--An initial notice 
                        described in this clause is a notice that 
                        provides to the beneficiary--
                                  ``(I) notice that the PDP sponsor has 
                                identified the beneficiary as 
                                potentially being an at-risk 
                                beneficiary for prescription drug 
                                abuse;
                                  ``(II) information describing all 
                                State and Federal public health 
                                resources that are designed to address 
                                prescription drug abuse to which the 
                                beneficiary has access, including 
                                mental health services and other 
                                counseling services;
                                  ``(III) notice of, and information 
                                about, the right of the beneficiary to 
                                appeal such identification under 
                                subsection (h) and the option of an 
                                automatic escalation to external 
                                review;
                                  ``(IV) a request for the beneficiary 
                                to submit to the PDP sponsor 
                                preferences for which prescribers and 
                                pharmacies the beneficiary would prefer 
                                the PDP sponsor to select under 
                                subparagraph (D) in the case that the 
                                beneficiary is identified as an at-risk 
                                beneficiary for prescription drug abuse 
                                as described in clause (iii)(I);
                                  ``(V) an explanation of the meaning 
                                and consequences of the identification 
                                of the beneficiary as potentially being 
                                an at-risk beneficiary for prescription 
                                drug abuse, including an explanation of 
                                the drug management program established 
                                by the PDP sponsor pursuant to 
                                subparagraph (A);
                                  ``(VI) clear instructions that 
                                explain how the beneficiary can contact 
                                the PDP sponsor in order to submit to 
                                the PDP sponsor the preferences 
                                described in subclause (IV) and any 
                                other communications relating to the 
                                drug management program for at-risk 
                                beneficiaries established by the PDP 
                                sponsor; and
                                  ``(VII) contact information for other 
                                organizations that can provide the 
                                beneficiary with assistance regarding 
                                such drug management program (similar 
                                to the information provided by the 
                                Secretary in other standardized notices 
                                provided to part D eligible individuals 
                                enrolled in prescription drug plans 
                                under this part).
                          ``(iii) Second notice.--A second notice 
                        described in this clause is a notice that 
                        provides to the beneficiary notice--
                                  ``(I) that the PDP sponsor has 
                                identified the beneficiary as an at-
                                risk beneficiary for prescription drug 
                                abuse;
                                  ``(II) that such beneficiary is 
                                subject to the requirements of the drug 
                                management program for at-risk 
                                beneficiaries established by such PDP 
                                sponsor for such plan;
                                  ``(III) of the prescriber (or 
                                prescribers) and pharmacy (or 
                                pharmacies) selected for such 
                                individual under subparagraph (D);
                                  ``(IV) of, and information about, the 
                                beneficiary's right to appeal such 
                                identification under subsection (h) and 
                                the option of an automatic escalation 
                                to external review;
                                  ``(V) that the beneficiary can, in 
                                the case that the beneficiary has not 
                                previously submitted to the PDP sponsor 
                                preferences for which prescribers and 
                                pharmacies the beneficiary would prefer 
                                the PDP sponsor select under 
                                subparagraph (D), submit such 
                                preferences to the PDP sponsor; and
                                  ``(VI) that includes clear 
                                instructions that explain how the 
                                beneficiary can contact the PDP 
                                sponsor.
                          ``(iv) Timing of notices.--
                                  ``(I) In general.--Subject to 
                                subclause (II), a second notice 
                                described in clause (iii) shall be 
                                provided to the beneficiary on a date 
                                that is not less than 60 days after an 
                                initial notice described in clause (ii) 
                                is provided to the beneficiary.
                                  ``(II) Exception.--In the case that 
                                the PDP sponsor, in conjunction with 
                                the Secretary, determines that concerns 
                                identified through rulemaking by the 
                                Secretary regarding the health or 
                                safety of the beneficiary or regarding 
                                significant drug diversion activities 
                                require the PDP sponsor to provide a 
                                second notice described in clause (iii) 
                                to the beneficiary on a date that is 
                                earlier than the date described in 
                                subclause (I), the PDP sponsor may 
                                provide such second notice on such 
                                earlier date.
                  ``(C) At-risk beneficiary for prescription drug 
                abuse.--
                          ``(i) In general.--For purposes of this 
                        paragraph, the term `at-risk beneficiary for 
                        prescription drug abuse' means a part D 
                        eligible individual who is not an exempted 
                        individual described in clause (ii) and--
                                  ``(I) who is identified through the 
                                use of clinical guidelines developed by 
                                the Secretary in consultation with PDP 
                                sponsors and other stakeholders 
                                described in section 3141(f)(2)(A) of 
                                the 21st Century Cures Act; or
                                  ``(II) with respect to whom the PDP 
                                sponsor of a prescription drug plan, 
                                upon enrolling such individual in such 
                                plan, received notice from the 
                                Secretary that such individual was 
                                identified under this paragraph to be 
                                an at-risk beneficiary for prescription 
                                drug abuse under the prescription drug 
                                plan in which such individual was most 
                                recently previously enrolled and such 
                                identification has not been terminated 
                                under subparagraph (F).
                          ``(ii) Exempted individual described.--An 
                        exempted individual described in this clause is 
                        an individual who--
                                  ``(I) receives hospice care under 
                                this title;
                                  ``(II) is a resident of a long-term 
                                care facility, of an intermediate care 
                                facility for the mentally retarded, or 
                                of another facility for which 
                                frequently abused drugs are dispensed 
                                for residents through a contract with a 
                                single pharmacy; or
                                  ``(III) the Secretary elects to treat 
                                as an exempted individual for purposes 
                                of clause (i).
                  ``(D) Selection of prescribers and pharmacies.--
                          ``(i) In general.--With respect to each at-
                        risk beneficiary for prescription drug abuse 
                        enrolled in a prescription drug plan offered by 
                        such sponsor, a PDP sponsor shall, based on the 
                        preferences submitted to the PDP sponsor by the 
                        beneficiary pursuant to clauses (ii)(IV) and 
                        (iii)(V) of subparagraph (B), select--
                                  ``(I) one or more individuals who are 
                                authorized to prescribe frequently 
                                abused drugs (referred to in this 
                                paragraph as `prescribers') who may 
                                write prescriptions for such drugs for 
                                such beneficiary; and
                                  ``(II) one or more pharmacies that 
                                may dispense such drugs to such 
                                beneficiary.
                          ``(ii) Reasonable access.--In making the 
                        selections under this subparagraph--
                                  ``(I) a PDP sponsor shall ensure that 
                                the beneficiary continues to have 
                                reasonable access to frequently abused 
                                drugs (as defined in subparagraph (G)), 
                                taking into account geographic 
                                location, beneficiary preference, 
                                impact on costsharing, and reasonable 
                                travel time; and
                                  ``(II) a PDP sponsor shall ensure 
                                such access (including access to 
                                prescribers and pharmacies with respect 
                                to frequently abused drugs) in the case 
                                of individuals with multiple residences 
                                and in the case of natural disasters 
                                and similar emergency situations.
                          ``(iii) Beneficiary preferences.--
                                  ``(I) In general.--If an at-risk 
                                beneficiary for prescription drug abuse 
                                submits preferences for which in-
                                network prescribers and pharmacies the 
                                beneficiary would prefer the PDP 
                                sponsor select in response to a notice 
                                under subparagraph (B), the PDP sponsor 
                                shall--
                                          ``(aa) review such 
                                        preferences;
                                          ``(bb) select or change the 
                                        selection of prescribers and 
                                        pharmacies for the beneficiary 
                                        based on such preferences; and
                                          ``(cc) inform the beneficiary 
                                        of such selection or change of 
                                        selection.
                                  ``(II) Exception.--In the case that 
                                the PDP sponsor determines that a 
                                change to the selection of prescriber 
                                or pharmacy under item (bb) by the PDP 
                                sponsor is contributing or would 
                                contribute to prescription drug abuse 
                                or drug diversion by the beneficiary, 
                                the PDP sponsor may change the 
                                selection of prescriber or pharmacy for 
                                the beneficiary without regard to the 
                                preferences of the beneficiary 
                                described in subclause (I).
                          ``(iv) Confirmation.--Before selecting a 
                        prescriber (or prescribers) or pharmacy (or 
                        pharmacies) under this subparagraph, a PDP 
                        sponsor must request and receive confirmation 
                        from such a prescriber or pharmacy 
                        acknowledging and accepting that the 
                        beneficiary involved is in the drug management 
                        program for at-risk beneficiaries.
                  ``(E) Terminations and appeals.--The identification 
                of an individual as an at-risk beneficiary for 
                prescription drug abuse under this paragraph, a 
                coverage determination made under a drug management 
                program for at-risk beneficiaries, and the selection of 
                prescriber or pharmacy under subparagraph (D) with 
                respect to such individual shall be subject to 
                reconsideration and appeal under subsection (h) and the 
                option of an automatic escalation to external review to 
                the extent provided by the Secretary.
                  ``(F) Termination of identification.--
                          ``(i) In general.--The Secretary shall 
                        develop standards for the termination of 
                        identification of an individual as an at-risk 
                        beneficiary for prescription drug abuse under 
                        this paragraph. Under such standards such 
                        identification shall terminate as of the 
                        earlier of--
                                  ``(I) the date the individual 
                                demonstrates that the individual is no 
                                longer likely, in the absence of the 
                                restrictions under this paragraph, to 
                                be an at-risk beneficiary for 
                                prescription drug abuse described in 
                                subparagraph (C)(i); and
                                  ``(II) the end of such maximum period 
                                of identification as the Secretary may 
                                specify.
                          ``(ii) Rule of construction.--Nothing in 
                        clause (i) shall be construed as preventing a 
                        plan from identifying an individual as an at-
                        risk beneficiary for prescription drug abuse 
                        under subparagraph (C)(i) after such 
                        termination on the basis of additional 
                        information on drug use occurring after the 
                        date of notice of such termination.
                  ``(G) Frequently abused drug.--For purposes of this 
                subsection, the term `frequently abused drug' means a 
                drug that is a controlled substance that the Secretary 
                determines to be frequently abused or diverted.
                  ``(H) Data disclosure.--In the case of an at-risk 
                beneficiary for prescription drug abuse whose access to 
                coverage for frequently abused drugs under a 
                prescription drug plan has been limited by a PDP 
                sponsor under this paragraph, such PDP sponsor shall 
                disclose data, including any necessary individually 
                identifiable health information, in a form and manner 
                specified by the Secretary, about the decision to 
                impose such limitations and the limitations imposed by 
                the sponsor under this part.
                  ``(I) Education.--The Secretary shall provide 
                education to enrollees in prescription drug plans of 
                PDP sponsors and providers regarding the drug 
                management program for at-risk beneficiaries described 
                in this paragraph, including education--
                          ``(i) provided by medicare administrative 
                        contractors through the improper payment 
                        outreach and education program described in 
                        section 1874A(h); and
                          ``(ii) through current education efforts 
                        (such as State health insurance assistance 
                        programs described in subsection (a)(1)(A) of 
                        section 119 of the Medicare Improvements for 
                        Patients and Providers Act of 2008 (42 U.S.C. 
                        1395b-3 note)) and materials directed toward 
                        such enrollees.
                  ``(J) Application under ma-pd plans.--Pursuant to 
                section 1860D--21(c)(1), the provisions of this 
                paragraph apply under part D to MA organizations 
                offering MA-PD plans to MA eligible individuals in the 
                same manner as such provisions apply under this part to 
                a PDP sponsor offering a prescription drug plan to a 
                part D eligible individual.''.
          (2) Information for consumers.--Section 1860D-4(a)(1)(B) of 
        the Social Security Act (42 U.S.C. 1395w-104(a)(1)(B)) is 
        amended by adding at the end the following:
                          ``(v) The drug management program for at-risk 
                        beneficiaries under subsection (c)(5).''.
  (b) Utilization Management Programs.--Section 1860D-4(c) of the 
Social Security Act (42 U.S.C. 1395w-104(c)), as amended by subsection 
(a)(1), is further amended--
          (1) in paragraph (1), by inserting after subparagraph (D) the 
        following new subparagraph:
                  ``(E) A utilization management tool to prevent drug 
                abuse (as described in paragraph (6)(A)).''; and
          (2) by adding at the end the following new paragraph:
          ``(6) Utilization management tool to prevent drug abuse.--
                  ``(A) In general.--A tool described in this paragraph 
                is any of the following:
                          ``(i) A utilization tool designed to prevent 
                        the abuse of frequently abused drugs by 
                        individuals and to prevent the diversion of 
                        such drugs at pharmacies.
                          ``(ii) Retrospective utilization review to 
                        identify--
                                  ``(I) individuals that receive 
                                frequently abused drugs at a frequency 
                                or in amounts that are not clinically 
                                appropriate; and
                                  ``(II) providers of services or 
                                suppliers that may facilitate the abuse 
                                or diversion of frequently abused drugs 
                                by beneficiaries.
                          ``(iii) Consultation with the contractor 
                        described in subparagraph (B) to verify if an 
                        individual enrolling in a prescription drug 
                        plan offered by a PDP sponsor has been 
                        previously identified by another PDP sponsor as 
                        an individual described in clause (ii)(I).
                  ``(B) Reporting.--A PDP sponsor offering a 
                prescription drug plan (and an MA organization offering 
                an MA-PD plan) in a State shall submit to the Secretary 
                and the Medicare drug integrity contractor with which 
                the Secretary has entered into a contract under section 
                1893 with respect to such State a report, on a monthly 
                basis, containing information on--
                          ``(i) any provider of services or supplier 
                        described in subparagraph (A)(ii)(II) that is 
                        identified by such plan sponsor (or 
                        organization) during the 30-day period before 
                        such report is submitted; and
                          ``(ii) the name and prescription records of 
                        individuals described in paragraph (5)(C).''.
  (c) Expanding Activities of Medicare Drug Integrity Contractors 
(MEDICs).--
          (1) In general.--Section 1893 of the Social Security Act (42 
        U.S.C. 1395ddd) is amended by adding at the end the following 
        new subsection:
  ``(j) Expanding Activities of Medicare Drug Integrity Contractors 
(MEDICs).--
          ``(1) Access to information.--Under contracts entered into 
        under this section with Medicare drug integrity contractors 
        (including any successor entity to a Medicare drug integrity 
        contractor), the Secretary shall authorize such contractors to 
        directly accept prescription and necessary medical records from 
        entities such as pharmacies, prescription drug plans, MA-PD 
        plans, and physicians with respect to an individual in order 
        for such contractors to provide information relevant to the 
        determination of whether such individual is an at-risk 
        beneficiary for prescription drug abuse, as defined in section 
        1860D-4(c)(5)(C).
          ``(2) Requirement for acknowledgment of referrals.--If a PDP 
        sponsor or MA organization refers information to a contractor 
        described in paragraph (1) in order for such contractor to 
        assist in the determination described in such paragraph, the 
        contractor shall--
                  ``(A) acknowledge to the sponsor or organization 
                receipt of the referral; and
                  ``(B) in the case that any PDP sponsor or MA 
                organization contacts the contractor requesting to know 
                the determination by the contractor of whether or not 
                an individual has been determined to be an individual 
                described such paragraph, shall inform such sponsor or 
                organization of such determination on a date that is 
                not later than 15 days after the date on which the 
                sponsor or organization contacts the contractor.
          ``(3) Making data available to other entities.--
                  ``(A) In general.--For purposes of carrying out this 
                subsection, subject to subparagraph (B), the Secretary 
                shall authorize MEDICs to respond to requests for 
                information from PDP sponsors and MA organizations, 
                State prescription drug monitoring programs, and other 
                entities delegated by such sponsors or organizations 
                using available programs and systems in the effort to 
                prevent fraud, waste, and abuse.
                  ``(B) HIPAA compliant information only.--Information 
                may only be disclosed by a MEDIC under subparagraph (A) 
                if the disclosure of such information is permitted 
                under the Federal regulations (concerning the privacy 
                of individually identifiable health information) 
                promulgated under section 264(c) of the Health 
                Insurance Portability and Accountability Act of 1996 
                (42 U.S.C. 1320d-2 note).''.
          (2) OIG study and report on effectiveness of medics.--
                  (A) Study.--The Inspector General of the Department 
                of Health and Human Services shall conduct a study on 
                the effectiveness of Medicare drug integrity 
                contractors with which the Secretary of Health and 
                Human Services has entered into a contract under 
                section 1893 of the Social Security Act (42 U.S.C. 
                1395ddd) in identifying, combating, and preventing 
                fraud under the Medicare program, including under the 
                authority provided under section 1893(j) of the Social 
                Security Act, added by paragraph (1).
                  (B) Report.--Not later than 1 year after the date of 
                the enactment of this Act, the Inspector General shall 
                submit to Congress a report on the study conducted 
                under subparagraph (A). Such report shall include such 
                recommendations for improvements in the effectiveness 
                of such contractors as the Inspector General determines 
                appropriate.
  (d) Treatment of Certain Complaints for Purposes of Quality or 
Performance Assessment.--Section 1860D-42 of the Social Security Act 
(42 U.S.C. 1395w-152) is amended by adding at the end the following new 
subsection:
  ``(d) Treatment of Certain Complaints for Purposes of Quality or 
Performance Assessment.--In conducting a quality or performance 
assessment of a PDP sponsor, the Secretary shall develop or utilize 
existing screening methods for reviewing and considering complaints 
that are received from enrollees in a prescription drug plan offered by 
such PDP sponsor and that are complaints regarding the lack of access 
by the individual to prescription drugs due to a drug management 
program for at-risk beneficiaries.''.
  (e) Sense of Congress Regarding Use of Technology Tools To Combat 
Fraud.--It is the sense of Congress that MA organizations and PDP 
sponsors should consider using e-prescribing and other health 
information technology tools to support combating fraud under MA-PD 
plans and prescription drug plans under parts C and D of the Medicare 
program.
  (f) Effective Date.--
          (1) In general.--The amendments made by this section shall 
        apply to prescription drug plans (and MA-PD plans) for plan 
        years beginning more than 1 year after the date of the 
        enactment of this Act.
          (2) Stakeholder meetings prior to effective date.--
                  (A) In general.--Not later than January 1, 2016, the 
                Secretary of Health and Human Services shall convene 
                stakeholders, including individuals entitled to 
                benefits under part A of title XVIII of the Social 
                Security Act or enrolled under part B of such title of 
                such Act, advocacy groups representing such 
                individuals, physicians, pharmacists, and other 
                clinicians, retail pharmacies, plan sponsors, entities 
                delegated by plan sponsors, and biopharmaceutical 
                manufacturers for input regarding the topics described 
                in subparagraph (B).
                  (B) Topics described.--The topics described in this 
                subparagraph are the topics of--
                          (i) the impact on cost-sharing and ensuring 
                        accessibility to prescription drugs for 
                        enrollees in prescription drug plans of PDP 
                        sponsors, and enrollees in MA-PD plans, who are 
                        at-risk beneficiaries for prescription drug 
                        abuse (as defined in subparagraph (C) of 
                        paragraph (5) of section 1860D-4(c) of the 
                        Social Security Act (42 U.S.C. 1395w-104(c)));
                          (ii) the use of an expedited appeals process 
                        under which such an enrollee may appeal an 
                        identification of such enrollee as an at-risk 
                        beneficiary for prescription drug abuse under 
                        such paragraph (similar to the processes 
                        established under the Medicare Advantage 
                        program under part C of title XVIII of the 
                        Social Security Act that allow an automatic 
                        escalation to external review of claims 
                        submitted under such part);
                          (iii) the types of enrollees that should be 
                        treated as exempted individuals, as described 
                        in subparagraph (C)(ii) of such paragraph;
                          (iv) the manner in which terms and 
                        definitions in such paragraph should be 
                        applied, such as the use of clinical 
                        appropriateness in determining whether an 
                        enrollee is an at-risk beneficiary for 
                        prescription drug abuse as defined in 
                        subparagraph (C) of such paragraph;
                          (v) the information to be included in the 
                        notices described in subparagraph (B) of such 
                        paragraph and the standardization of such 
                        notices; and
                          (vi) with respect to a PDP sponsor (or 
                        Medicare Advantage organization) that 
                        establishes a drug management program for at-
                        risk beneficiaries under such paragraph, the 
                        responsibilities of such PDP sponsor (or 
                        organization) with respect to the 
                        implementation of such program.
  (g) Rulemaking.--The Secretary of Health and Human Services shall 
promulgate regulations based on the input gathered pursuant to 
subsection (f)(2)(A).

            TITLE IV--MEDICAID, MEDICARE, AND OTHER REFORMS

               Subtitle A--Medicaid and Medicare Reforms

SEC. 4001. LIMITING FEDERAL MEDICAID REIMBURSEMENT TO STATES FOR 
                    DURABLE MEDICAL EQUIPMENT (DME) TO MEDICARE PAYMENT 
                    RATES.

  (a) Medicaid Reimbursement.--
          (1) In general.--Section 1903(i) of the Social Security Act 
        (42 U.S.C. 1396b(i)) is amended--
                  (A) in paragraph (25), by striking ``or'' at the end;
                  (B) in paragraph (26), by striking the period at the 
                end and inserting ``; or''; and
                  (C) by inserting after paragraph (26) the following 
                new paragraph:
          ``(27) with respect to any amounts expended by the State on 
        the basis of a fee schedule for items described in section 
        1861(n), as determined in the aggregate with respect to each 
        class of such items as defined by the Secretary, in excess of 
        the aggregate amount, if any, that would be paid for such items 
        within such class on a fee-for-service basis under the program 
        under part B of title XVIII, including, as applicable, under a 
        competitive acquisition program under section 1847 in an area 
        of the State.''.
          (2) Effective date.--The amendments made by this subsection 
        shall be effective with respect to payments for items furnished 
        on or after January 1, 2020.
  (b) Medicare Ombudsman.--Section 1808(c) of the Social Security Act 
(42 U.S.C. 1395b(c)), as amended by section 3101, is further amended by 
adding at the end the following new paragraph:
          ``(5) Monitoring dme reimbursement under medicaid.--The 
        ombudsmen under each of paragraphs (1) and (4) shall evaluate 
        the impact of the competitive acquisition program under section 
        1847, including as applied under section 1903(i)(27), on 
        beneficiary health status and health outcomes.''.

SEC. 4002. MEDICARE PAYMENT INCENTIVE FOR THE TRANSITION FROM 
                    TRADITIONAL X-RAY IMAGING TO DIGITAL RADIOGRAPHY 
                    AND OTHER MEDICARE IMAGING PAYMENT PROVISION.

  (a) Physician Fee Schedule.--
          (1) Payment incentive for transition.--
                  (A) In general.--Section 1848(b) of the Social 
                Security Act (42 U.S.C. 1395w-4(b)) is amended by 
                adding at the end the following new paragraph:
          ``(9) Special rule to incentivize transition from traditional 
        x-ray imaging to digital radiography.--
                  ``(A) Limitation on payment for film x-ray imaging 
                services.--In the case of imaging services that are X 
                rays taken using film and that are furnished during 
                2017 or a subsequent year, the payment amount for the 
                technical component (including the technical component 
                portion of a global fee) of such services that would 
                otherwise be determined under this section (without 
                application of this paragraph and before application of 
                any other adjustment under this section) for such year 
                shall be reduced by 20 percent.
                  ``(B) Phased-in limitation on payment for computed 
                radiography imaging services.--In the case of imaging 
                services that are X rays taken using computed 
                radiography technology--
                          ``(i) in the case of such services furnished 
                        during 2018, 2019, 2020, 2021, or 2022 the 
                        payment amount for the technical component 
                        (including the technical component portion of a 
                        global fee) of such services that would 
                        otherwise be determined under this section 
                        (without application of this paragraph and 
                        before application of any other adjustment 
                        under this section) for such year shall be 
                        reduced by 7 percent; and
                          ``(ii) in the case of such services furnished 
                        during 2023 or a subsequent year, the payment 
                        amount for the technical component (including 
                        the technical component portion of a global 
                        fee) of such services that would otherwise be 
                        determined under this section (without 
                        application of this paragraph and before 
                        application of any other adjustment under this 
                        section) for such year shall be reduced by 10 
                        percent.
                  ``(C) Computed radiography technology defined.--For 
                purposes of this paragraph, the term `computed 
                radiography technology' means cassette-based imaging 
                which utilizes an imaging plate to create the image 
                involved.
                  ``(D) Implementation.--In order to implement this 
                paragraph, the Secretary shall adopt appropriate 
                mechanisms which may include use of modifiers.''.
                  (B) Exemption from budget neutrality.--Section 
                1848(c)(2)(B)(v) of the Social Security Act (42 U.S.C. 
                1395w-4(c)(2)(B)(v)) is amended by adding at the end 
                the following new subclause:
                                  ``(X) Reduced expenditures 
                                attributable to incentives to 
                                transition to digital radiography.--
                                Effective for fee schedules established 
                                beginning with 2017, reduced 
                                expenditures attributable to 
                                subparagraph (A) of subsection (b)(9) 
                                and effective for fee schedules 
                                established beginning with 2018, 
                                reduced expenditures attributable to 
                                subparagraph (B) of such subsection.''.
          (2) Elimination of application of multiple procedure payment 
        reduction.--Section 1848(b)(4) of the Social Security Act (42 
        U.S.C. 1395w-4(b)(4)) is amended by adding at the end the 
        following new subparagraph:
                  ``(E) Elimination of application of multiple 
                procedure payment reduction.--
                          ``(i) In general.--Not later than January 1, 
                        2016, the Secretary shall not apply a multiple 
                        procedure payment reduction policy to the 
                        professional component of imaging services 
                        furnished in any subsequent year that is prior 
                        to a year in which the Secretary conducts and 
                        publishes, as part of the Medicare Physician 
                        Fee Schedule Proposed Rule for a year, the 
                        empirical analysis described in clause (ii).
                          ``(ii) Empirical analysis described.--The 
                        empirical analysis described in this clause is 
                        an analysis of the Resource-Based Relative 
                        Value Scale (commonly known as the `RBRVS') 
                        Data Manager information that is used to 
                        determine what, if any, efficiencies exist 
                        within the professional component of imaging 
                        services when two or more studies are performed 
                        on the same patient on the same day. Such 
                        empirical analysis shall include--
                                  ``(I) work sheets and other 
                                information detailing which physician 
                                work activities performed given the 
                                typical vignettes were assigned 
                                reduction percentages of 0, 25, 50, 75 
                                and 100 percent;
                                  ``(II) a discussion of the clinical 
                                aspects that informed the assignment of 
                                the reduction percentages described in 
                                subclause (I);
                                  ``(III) an explanation of how the 
                                percentage reductions for pre-, intra-, 
                                and post-service work were determined 
                                and calculated; and
                                  ``(IV) a demonstration that the 
                                Centers for Medicare & Medicaid 
                                Services has consulted with practicing 
                                radiologists to gain knowledge of how 
                                radiologists interpret studies of 
                                multiple body parts on the same 
                                individual on the same day.''.
  (b) Payment Incentive for Transition Under Hospital Outpatient 
Prospective Payment System.--Section 1833(t)(16) of the Social Security 
Act (42 U.S.C. 1395(t)(16)) is amended by adding at the end the 
following new subparagraph:
                  ``(F) Payment incentive for the transition from 
                traditional x-ray imaging to digital radiography.--
                Notwithstanding the previous provisions of this 
                subsection:
                          ``(i) Limitation on payment for film x-ray 
                        imaging services.--In the case of imaging 
                        services that are X rays taken using film and 
                        that are furnished during 2017 or a subsequent 
                        year, the payment amount for the technical 
                        component (including the technical component 
                        portion of a global fee) of such services that 
                        would otherwise be determined under this 
                        section (without application of this paragraph 
                        and before application of any other adjustment 
                        under this subsection) for such year shall be 
                        reduced by 20 percent.
                          ``(ii) Phased-in limitation on payment for 
                        computed radiography imaging services.--In the 
                        case of imaging services that are X rays taken 
                        using computed radiography technology (as 
                        defined in section 1848(b)(9)(C))--
                                  ``(I) in the case of such services 
                                furnished during 2018, 2019, 2020, 
                                2021, or 2022 the payment amount for 
                                the technical component (including the 
                                technical component portion of a global 
                                fee) of such services that would 
                                otherwise be determined under this 
                                section (without application of this 
                                paragraph and before application of any 
                                other adjustment under this subsection) 
                                for such year shall be reduced by 7 
                                percent; and
                                  ``(II) in the case of such services 
                                furnished during 2023 or a subsequent 
                                year, the payment amount for the 
                                technical component (including the 
                                technical component portion of a global 
                                fee) of such services that would 
                                otherwise be determined under this 
                                section (without application of this 
                                paragraph and before application of any 
                                other adjustment under this subsection) 
                                for such year shall be reduced by 10 
                                percent.
                          ``(iii) Application without regard to budget 
                        neutrality.--The reductions made under this 
                        paragraph--
                                  ``(I) shall not be considered an 
                                adjustment under paragraph (2)(E); and
                                  ``(II) shall not be implemented in a 
                                budget neutral manner.''.

SEC. 4003. IMPLEMENTATION OF OFFICE OF INSPECTOR GENERAL RECOMMENDATION 
                    TO DELAY CERTAIN MEDICARE PRESCRIPTION DRUG PLAN 
                    PREPAYMENTS.

  Section 1860D-15(d) of the Social Security Act (42 U.S.C. 1395w-
115(d)) is amended by adding at the end the following:
          ``(5) Timing of payments.--With respect to monthly 
        reinsurance payment amounts under this section to a PDP sponsor 
        for months in a year (beginning with 2020), such payment 
        amounts for a month shall be made on the first business day 
        occurring on or after the following date for that month:
                  ``(A) For the month of January, January 2nd.
                  ``(B) For the month of February, February 5th.
                  ``(C) For the month of March, March 10th.
                  ``(D) For the month of April, April 15th.
                  ``(E) For the month of May, May 20th.
                  ``(F) For the month of June, June 25th.
                  ``(G) For the month of July and each succeeding month 
                (other than December) in a year, the first day of the 
                next month.
                  ``(H) For the month of December, December 24th.''.

                   Subtitle B--Cures Innovation Fund

SEC. 4041. CURES INNOVATION FUND.

  (a) Establishment.--There is hereby established in the Treasury of 
the United States a fund to be known as the Cures Innovation Fund (in 
this section referred to as the ``Fund'').
  (b) Appropriations.--There is hereby appropriated to the Fund, out of 
any funds in the Treasury not otherwise appropriated, $110,000,000 for 
each of fiscal years 2016 through 2020.
  (c) Expenditures.--Amounts in the Fund shall be available, as 
provided by appropriation Acts, for making expenditures for carrying 
out the following:
          (1) Section 229A of the Public Health Service Act, as added 
        by section 1123 (relating to data on natural history of 
        diseases).
          (2) Part E of title II of the Public Health Service Act, as 
        added by section 1141 (relating to Council for 21st Century 
        Cures).
          (3) Section 2001 and the amendments made by such section 
        (relating to development and use of patient experience data to 
        enhance structured risk-benefit assessment framework).
          (4) Section 2021 and the amendments made by such section 
        (relating to qualification of drug development tools).
          (5) Section 2062 and the amendments made by such section 
        (relating to utilizing evidence from clinical experience).
          (6) Section 2161 (relating to grants for studying the process 
        of continuous drug manufacturing).
  (d) Supplement, Not Supplant; Prohibition Against Transfer.--Funds 
appropriated by subsection (b)--
          (1) shall be used to supplement, not supplant, amounts 
        otherwise made available to the National Institutes of Health 
        and the Food and Drug Administration; and
          (2) notwithstanding any transfer authority in any 
        appropriation Act, shall not be used for any purpose other than 
        the expenditures listed in subsection (c).

                       Subtitle C--Other Reforms

SEC. 4061. SPR DRAWDOWN.

  (a) Drawdown and Sale.--Notwithstanding section 161 of the Energy 
Policy and Conservation Act (42 U.S.C. 6241), the Secretary of Energy 
shall draw down and sell 8,000,000 barrels of crude oil from the 
Strategic Petroleum Reserve during each of the fiscal years 2018 
through 2025, except as provided in subsection (b). Amounts received 
for a sale under this subsection shall be deposited in the general fund 
of the Treasury during the fiscal year in which the sale occurs.
  (b) Emergency Protection.--The Secretary shall not draw down and sell 
crude oil under this section in amounts that would result in a 
Strategic Petroleum Reserve that contains an inventory of petroleum 
products representing less than 90 days of emergency reserves, based on 
the average daily level of net imports of crude oil and petroleum 
products in the previous calendar year.
  (c) Proceeds.--Proceeds from a sale under this section shall be 
deposited into the general fund of the Treasury of the United States.

                       Subtitle D--Miscellaneous

SEC. 4081. LYME DISEASE AND OTHER TICK-BORNE DISEASES.

  (a) In General.--Title III of the Public Health Service Act (42 
U.S.C. 241 et seq.) is amended by adding at the end the following new 
part:

          ``PART W--LYME DISEASE AND OTHER TICK-BORNE DISEASES

``SEC. 399OO. RESEARCH.

  ``(a) In General.--The Secretary shall conduct or support 
epidemiological, basic, translational, and clinical research regarding 
Lyme disease and other tick-borne diseases.
  ``(b) Biennial Reports.--The Secretary shall ensure that each 
biennial report under section 403 includes information on actions 
undertaken by the National Institutes of Health to carry out subsection 
(a) with respect to Lyme disease and other tick-borne diseases, 
including an assessment of the progress made in improving the outcomes 
of Lyme disease and such other tick-borne diseases.

``SEC. 399OO-1. WORKING GROUP.

  ``(a) Establishment.--The Secretary shall establish a permanent 
working group, to be known as the Interagency Lyme and Tick-Borne 
Disease Working Group (in this section and section 399OO-2 referred to 
as the `Working Group'), to review all efforts within the Department of 
Health and Human Services concerning Lyme disease and other tick-borne 
diseases to ensure interagency coordination, minimize overlap, and 
examine research priorities.
  ``(b) Responsibilities.--The Working Group shall--
          ``(1) not later than 24 months after the date of enactment of 
        this part, and every 24 months thereafter, develop or update a 
        summary of--
                  ``(A) ongoing Lyme disease and other tick-borne 
                disease research related to causes, prevention, 
                treatment, surveillance, diagnosis, diagnostics, 
                duration of illness, intervention, and access to 
                services and supports for individuals with Lyme disease 
                or other tick-borne diseases;
                  ``(B) advances made pursuant to such research;
                  ``(C) the engagement of the Department of Health and 
                Human Services with persons that participate at the 
                public meetings required by paragraph (5); and
                  ``(D) the comments received by the Working Group at 
                such public meetings and the Secretary's response to 
                such comments;
          ``(2) ensure that a broad spectrum of scientific viewpoints 
        is represented in each such summary;
          ``(3) monitor Federal activities with respect to Lyme disease 
        and other tick-borne diseases;
          ``(4) make recommendations to the Secretary regarding any 
        appropriate changes to such activities; and
          ``(5) ensure public input by holding annual public meetings 
        that address scientific advances, research questions, 
        surveillance activities, and emerging strains in species of 
        pathogenic organisms.
  ``(c) Membership.--
          ``(1) In general.--The Working Group shall be composed of a 
        total of 14 members as follows:
                  ``(A) Federal members.--Seven Federal members, 
                consisting of one or more representatives of each of--
                          ``(i) the Office of the Assistant Secretary 
                        for Health;
                          ``(ii) the Food and Drug Administration;
                          ``(iii) the Centers for Disease Control and 
                        Prevention;
                          ``(iv) the National Institutes of Health; and
                          ``(v) such other agencies and offices of the 
                        Department of Health and Human Services as the 
                        Secretary determines appropriate.
                  ``(B) Non-federal public members.--Seven non-Federal 
                public members, consisting of representatives of the 
                following categories:
                          ``(i) Physicians and other medical providers 
                        with experience in diagnosing and treating Lyme 
                        disease and other tick-borne diseases.
                          ``(ii) Scientists or researchers with 
                        expertise.
                          ``(iii) Patients and their family members.
                          ``(iv) Nonprofit organizations that advocate 
                        for patients with respect to Lyme disease and 
                        other tick-borne diseases.
                          ``(v) Other individuals whose expertise is 
                        determined by the Secretary to be beneficial to 
                        the functioning of the Working Group.
          ``(2) Appointment.--The members of the Working Group shall be 
        appointed by the Secretary, except that of the non-Federal 
        public members under paragraph (1)(B)--
                  ``(A) one shall be appointed by the Speaker of the 
                House of Representatives; and
                  ``(B) one shall be appointed by the majority leader 
                of the Senate.
          ``(3) Diversity of scientific perspectives.--In making 
        appointments under paragraph (2), the Secretary, the Speaker of 
        the House of Representatives, and the majority leader of the 
        Senate shall ensure that the non-Federal public members of the 
        Working Group represent a diversity of scientific perspectives.
          ``(4) Terms.--The non-Federal public members of the Working 
        Group shall each be appointed to serve a 4-year term and may be 
        reappointed at the end of such term.
  ``(d) Meetings.--The Working Group shall meet as often as necessary, 
as determined by the Secretary, but not less than twice each year.
  ``(e) Applicability of FACA.--The Working Group shall be treated as 
an advisory committee subject to the Federal Advisory Committee Act.
  ``(f) Reporting.--Not later than 24 months after the date of 
enactment of this part, and every 24 months thereafter, the Working 
Group--
          ``(1) shall submit a report on its activities, including an 
        up-to-date summary under subsection (b)(1) and any 
        recommendations under subsection (b)(4), to the Secretary, the 
        Committee on Energy and Commerce of the House of 
        Representatives, and the Committee on Health, Education, Labor 
        and Pensions of the Senate;
          ``(2) shall make each such report publicly available on the 
        website of the Department of Health and Human Services; and
          ``(3) shall allow any member of the Working Group to include 
        in any such report minority views.

``SEC. 399OO-2. STRATEGIC PLAN.

  ``Not later than 3 years after the date of enactment of this section, 
and every 5 years thereafter, the Secretary shall submit to the 
Congress a strategic plan, informed by the most recent summary under 
section 399OO-1(b)(1), for the conduct and support of Lyme disease and 
tick-borne disease research, including--
          ``(1) proposed budgetary requirements;
          ``(2) a plan for improving outcomes of Lyme disease and other 
        tick-borne diseases, including progress related to chronic or 
        persistent symptoms and chronic or persistent infection and co-
        infections;
          ``(3) a plan for improving diagnosis, treatment, and 
        prevention;
          ``(4) appropriate benchmarks to measure progress on achieving 
        the improvements described in paragraphs (2) and (3); and
          ``(5) a plan to disseminate each summary under section 399OO-
        1(b)(1) and other relevant information developed by the Working 
        Group to the public, including health care providers, public 
        health departments, and other relevant medical groups.''.
  (b) No Additional Authorization of Appropriations.--No additional 
funds are authorized to be appropriated for the purpose of carrying out 
this section and the amendment made by this section, and this section 
and such amendment shall be carried out using amounts otherwise 
available for such purpose.

                          Purpose and Summary

    For decades, our nation's commitment to the discovery, 
development, and delivery of new treatments and cures has made 
the United States the biomedical innovation capital of the 
world, bringing life-saving and life-improving drugs and 
devices to patients. It is clear that the discovery, 
development, and delivery process is a cycle. Information 
captured and analyzed at the ``end'' of the process--the 
delivery phase--can be used for new discovery and development 
of better treatments. The purpose of this legislation is to 
foster this cycle to help bring more cures and treatments to 
patients and strengthen the innovation ecosystem in the United 
States.

                  Background and Need for Legislation

    For over a year, the Energy and Commerce Committee has 
engaged in a public conversation with patients, innovators, 
providers, regulators, and researchers about how to move 
advances in science and medicine into new therapies. The fight 
to treat and cure disease is an urgent, nonpartisan, national 
priority. With 10,000 known diseases, 7,000 of which are rare, 
and treatments for only 500 of them, it is clear that there is 
much work to do. Disease management costs billions of dollars, 
and its personal costs are much higher, causing pain and 
heartbreak during the battle and with each loss of life. The 
United States has been at the forefront of medical innovation, 
developing many promising treatments and cures. Nonetheless, 
improvement in the battle with disease and furthering the 
nation's leadership position in health care innovation is 
possible.
    The yearlong 21st Century Cures listening session explored 
the complete cycle of cures--from the discovery of clues in 
basic science, to the development of new treatments, to the 
delivery of those cures, and back again to further discovery.
    As explained in the section by section below, this 
legislation contains a number of policies to accelerate the 
cycle and help find cures and treatments for the thousands of 
diseases, particularly rare and serious disease.

                                Hearings

    The Subcommittee on Health held a hearing entitled ``The 
President's Council of Advisors on Science and Technology 
(PCAST) Report on Drug Innovation'' on May 20, 2014. The 
Subcommittee received testimony from:
           Gary Neil, M.D., Global Head of Research and 
        Development, Medgenics;
           Sara Radcliffe, Executive Vice President of 
        Health Section, Biotechnology Industry Organization;
           Frank J. Sasinowski, Director, Hyman, Phelps 
        & McNamara, PC;
           Jeff Allen, Executive Director, Friends of 
        Cancer Research; and
           Sean Tunis, M.D., Founder and Chief 
        Executive Officer, Center for Medical Technology 
        Policy.
    The Subcommittee on Health held a hearing entitled 
``Examining the Role of Incentives in Advancing Treatments and 
Cures for Patients'' on June 11, 2014. The Subcommittee 
received testimony from:
           Kenneth Davis, President and CEO, Mt. Sinai 
        Health System;
           Marc Boutin, Executive Vice President and 
        Chief Operating Officer, National Health Council;
           Alexis Borisy, Partner, Third Rock Ventures;
           Mike Carusi, General Partner, Advanced 
        Technology Ventures;
           Fred Ledley, Professor, Natural & Applied 
        Sciences and Management Director, Center for 
        Integration of Science and Industry, Bentley 
        University;
           C. Scott Hemphill, Professor of Law, 
        Columbia Law School; and
           Steven Miller, Senior Vice President and 
        Chief Medical Officer, Express Scripts Holding Company.
    The Subcommittee on Health held a hearing entitled 
``Modernizing Clinical Trials'' on July 9, 2014. The 
Subcommittee received testimony from:
           Roy S. Herbst, M.D., Ph.D., Chief of Medical 
        Oncology, Yale Cancer Center;
           Sundeep Khosla, M.D., Director, Center for 
        Clinical and Translational Science, Mayo Clinic;
           Jay P. Siegel, M.D., Chief Biotechnology 
        Office and Head, Scientific Strategy and Policy, 
        Johnson & Johnson;
           William V. Murray, President and CEO, 
        Medical Device Innovation Consortium;
           Robert J. Meyer, M.D., Director, Virginia 
        Center for Translational and Regulatory Sciences, 
        University of Virginia School of Medicine;
           Paula Brown Stafford, M.P.H., President, 
        Clinical Development, Quintiles; and
           Aaron S. Kesselheim, M.D., J.D., M.P.H, 
        Assistant Professor of Medicine at Harvard Medical 
        School.
    The Subcommittee on Health held a hearing entitled 
``Incorporating the Patient Perspective'' on July 11, 2014. The 
Subcommittee received testimony from:
           Janet Woodcock, M.D, Director, Center for 
        Drug Evaluation and Research, Food and Drug 
        Administration;
           Richard F. Pops, Chairman and CEO, Alkermes;
           Robert J. Beall, Ph.D., President and CEO, 
        Cystic Fibrosis Foundation;
           Pat Furlong, Founding President and CEO, 
        Parent Project Muscular Dystrophy;
           Leonard Lichtenfeld, M.D., Deputy Chief 
        Medical Officer, American Cancer Society; and
           Marshall Summar, M.D., Director, Scientific 
        Advisory Committee, National Organization for Rare 
        Disorders.
    The Subcommittee on Health held a hearing entitled 
``Technology for 21st Century Cures'' on July 17, 2014. The 
Subcommittee received testimony from:
           Robert Jarrin, Senior Director, Government 
        Affairs, Qualcomm Incorporated;
           Paul Misener, Vice President, Global Public 
        Policy, Amazon;
           Jonathan Niloff, Chief Medical Officer and 
        Vice President, McKesson Connected Care and Analytics, 
        McKesson Corporation;
           Dan Riskin, Founder, Health Fidelity; and
           Dave Vockell, Chief Executive Officer, 
        LyfeChannel.
    The Subcommittee on Health held a hearing entitled 
``Examining Barriers to Ongoing Evidence Development and 
Communication'' on July 22, 2014. The Subcommittee received 
testimony from:
           Mary Grealy, President, Healthcare 
        Leadership Council;
           Michael A. Mussallem, Chairman and CEO, 
        Edwards Lifesciences;
           Gregory Schimizzi, M.D., Cofounder, Carolina 
        Arthritis Associates, on behalf of the Alliance for 
        Specialty Medicine;
           Josh Rising, M.D., M.P.H., Director, Medical 
        Devices, The Pew Charitable Trusts; and
           Louis Jacques, Senior Vice President and 
        Chief Clinical Officer, ADVI.
    The Subcommittee on Health held a hearing entitled 
``Examining the Regulation of Laboratory Developed Tests'' on 
September 9, 2014. The Subcommittee received testimony from:
           Jeffrey Shuren, M.D., J.D., Director, Center 
        for Devices and Radiological Health, Food and Drug 
        Administration;
           Christopher Newton-Cheh, M.D., Assistant 
        Professor of Medicine, Harvard Medical School, 
        Massachusetts General Hospital;
           Andrew Fish, Executive Director, AdvaMed 
        Diagnostics;
           Alan Mertz, President, American Clinical 
        Laboratory Association;
           Charles Sawyers, M.D., Immediate-Past 
        President, American Association for Cancer Research; 
        and
           Kathleen Wilsey, Ph.D., Co-Founder, 
        Coalition for 21st Century Medicine.
    The Subcommittee on Health held a hearing entitled 
``Examining Ways to Combat Antibiotic Resistance and Foster New 
Drug Development'' on September 19, 2014. The Subcommittee 
received testimony from:
           Janet Woodcock, M.D., Director, Center for 
        Drug Evaluation and Research, U.S. Food and Drug 
        Administration;
           Kenneth J. Hillan, Chief Executive Officer, 
        Achaogen, Inc.;
           Barbara E. Murray, President, Infectious 
        Diseases Society of America;
           Kevin Outterson, Professor of Law, Boston 
        University School of Law;
           Adrian Thomas, Vice President, Global Market 
        Access and Public Health, Janssen Global Services, LLC;
           Allan Coukell, Director, Medical Programs, 
        Pew Health Group, The Pew Charitable Trusts; and
           John H. Powers, Assistant Clinical Professor 
        of Medicine, George Washington University School of 
        Medicine.
    The Subcommittee on Health held a hearing to review H.R. 6, 
21st Century Cures Act, on April 30, 2015. The Subcommittee 
received testimony from:
           Kathy Hudson, Deputy Director for Science, 
        Outreach, and Policy, National Institutes of Health;
           Janet Woodcock, M.D., Director of the Center 
        for Drug Evaluation and Research, Center for Drug 
        Evaluation and Research, U.S. Food and Drug 
        Administration; and
           Jeff Shuren, M.D., J.D., Director of the 
        Center for Devices and Radiological Health, Center for 
        Devices and Radiological Health, U.S. Food and Drug 
        Administration.

                        Committee Consideration

    On May 14, 2015, the Subcommittee on Health met in open 
markup session and forwarded H.R. 6 to the full Committee, as 
amended, by a voice vote. On May 19, 2015, the full Committee 
on Energy and Commerce met in open markup session and ordered 
H.R. 6 reported to the House, as amended, by a recorded vote of 
51 yeas and 0 nays.

                            Committee Votes

    Clause 3(b) of rule XIII of the Rules of the House of 
Representatives requires the Committee to list the recorded 
votes on the motion to report legislation and amendments 
thereto. A motion by Mr. Upton to order H.R. 6 reported to the 
House, with amendment, was agreed to by a recorded vote of 51 
ayes and 0 nays. The following reflects the recorded votes 
taken during the Committee consideration:


                      Committee Oversight Findings

    Pursuant to clause 3(c)(1) of rule XIII of the Rules of the 
House of Representatives, the Committee the Committee held 
hearings and made findings that are reflected in this report.

         Statement of General Performance Goals and Objectives

    The goal of this legislation is to help accelerate the 
discovery, development, and delivery of promising new 
treatments and cures for patients and strengthen the innovation 
ecosystem in the United States.

   New Budget Authority, Entitlement Authority, and Tax Expenditures

    In compliance with clause 3(c)(2) of rule XIII of the Rules 
of the House of Representatives, the Committee finds that H.R. 
6, would result in no new or increased budget authority, 
entitlement authority, or tax expenditures or revenues.

       Earmark, Limited Tax Benefits, and Limited Tariff Benefits

    In compliance with clause 9(e), 9(f), and 9(g) of rule XXI 
of the Rules of the House of Representatives, the Committee 
finds that H.R. 6 contains no earmarks, limited tax benefits, 
or limited tariff benefits.

                        Committee Cost Estimate

    The Committee adopts as its own the cost estimate prepared 
by the Director of the Congressional Budget Office pursuant to 
section 402 of the Congressional Budget Act of 1974.

                  Congressional Budget Office Estimate

    Pursuant to clause 3(c)(3) of rule XIII of the Rules of the 
House of Representatives, the following is the cost estimate 
provided by the Congressional Budget Office pursuant to section 
402 of the Congressional Budget Act of 1974:

                                     U.S. Congress,
                               Congressional Budget Office,
                                     Washington, DC, June 23, 2015.
Hon. Fred Upton,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
prepared the enclosed cost estimate for H.R. 6, the 21st 
Century Cures Act.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contacts are Tom Bradley 
and Chad Chirico.
            Sincerely,
                                              Keith Hall, Director.
    Enclosure.

H.R. 6--21st Century Cures Act

    Summary: H.R. 6 would authorize appropriations for the 
National Institutes of Health (NIH), the Food and Drug 
Administration (FDA), and other agencies within the Department 
of Health and Human Services (HHS) for programs aimed at 
promoting the discovery and development of drugs and other 
technologies that prevent, diagnose, and treat disease or to 
support activities authorized by the legislation. The bill also 
would make related changes to those agencies' programs.
    In addition, H.R. 6 contains provisions that would:
           Grant additional periods of exclusivity for 
        certain brand-name drugs approved for a new indication 
        that treats a rare disease or condition;
           Require Medicare to make an additional 
        payment to hospitals when Medicare beneficiaries use 
        certain antimicrobial drugs during the course of their 
        hospital stay;
           Direct the sale of 8 million barrels of oil 
        from the Strategic Petroleum Reserve (SPR) in each of 
        the fiscal years 2018 through 2025;
           Delay monthly reinsurance payments to stand-
        alone prescription drug plans in Medicare Part D by 
        shifting payments between certain fiscal years; and
           Limit federal Medicaid reimbursement to 
        states for durable medical equipment (DME).
    CBO estimates that implementing the legislation would cost 
$106.4 billion over the 2016-2020 period, assuming the 
appropriation of the authorized and necessary amounts.
    CBO estimates that enacting H.R. 6 would reduce direct 
spending, on net, by $11.9 billion over the 2016-2025 period. 
(Of that amount, CBO estimates that off-budget costs for the 
U.S. Postal Service would total $6 million over the 2016-2025 
period.) Pay-as-you-go procedures apply because enacting the 
legislation would affect direct spending. Enacting H.R. 6 would 
not affect revenues.
    H.R. 6 contains no intergovernmental mandates as defined in 
the Unfunded Mandates Reform Act (UMRA). However, because the 
bill would delay entry into the market of some generic drugs 
and limit Medicaid payments to states for DME, the bill could 
increase state Medicaid costs by $2.6 billion over the 2016-
2025 period, CBO estimates. States have flexibility in that 
program to adjust their financial and programmatic 
responsibilities, so those costs would not result from an 
intergovernmental mandate.
    The bill would impose private-sector mandates, as defined 
in UMRA, on drug manufacturers. CBO estimates that the 
aggregate cost of the mandates would fall below the annual 
threshold established in UMRA ($154 million in 2015, adjusted 
annually for inflation) in each of the first five years that 
the mandates are in effect.
    Estimated cost to the Federal Government: The estimated 
budgetary effects of H.R. 6 are shown in Table 1. The effects 
of the legislation fall primarily within budget functions 270 
(energy), 550 (health) and 570 (Medicare).
    Basis of estimate: For this estimate, CBO assumes that H.R. 
6 will be enacted near the start of fiscal year 2016 and that 
authorized amounts will be appropriated each year. Outlay 
estimates are based on historical spending patterns for 
affected programs.

                                      TABLE 1. BUDGETARY EFFECTS OF H.R. 6
----------------------------------------------------------------------------------------------------------------
                                                        By fiscal year, in millions of dollars--
                                       -------------------------------------------------------------------------
                                          2016      2017      2018      2019      2020    2016-2020   2016-2025
----------------------------------------------------------------------------------------------------------------
                                  CHANGES IN SPENDING SUBJECT TO APPROPRIATION
 
Department of Health and Human
 Services
    National Institutes of Health
        Authorization Level...........    33,811    35,331    36,851     2,000     2,000    109,993         n.a.
        Estimated Outlays.............     8,576    27,473    33,679    26,687     8,625    105,040         n.a.
    Food and Drug Administrationa
        Estimated Authorization Level.       194       223       240       256       257      1,171         n.a.
        Estimated Outlays.............        59       127       178       234       274        872         n.a.
    Centers for Disease Control and
     Prevention
        Estimated Authorization Level.        17         6         6         6         6         41         n.a.
        Estimated Outlays.............         6        10         7         6         6         35         n.a.
Other HHS Programsb
        Estimated Authorization Level.       112       104       106       109       111        543         n.a.
        Estimated Outlays.............        35        82        97       104       109        427         n.a.
Other Departments and Agencies
        Estimated Authorization Level.         1         *         4         6         9         21         n.a.
        Estimated Outlays.............         1         *         4         6         9         21         n.a.
    Subtotal
        Estimated Authorization Level.    34,135    35,665    37,207     2,378     2,384    111,768         n.a.
        Estimated Outlays.............     8,677    27,692    33,964    27,037     9,024    106,395         n.a.
 
                                           CHANGES IN DIRECT SPENDINGc
 
Estimated Budget Authority............         1       -12      -571      -532    -4,005     -5,119      -11,888
Estimated Outlays.....................         1       -12      -571      -532    -4,005     -5,119      -11,888
----------------------------------------------------------------------------------------------------------------
Notes: * = less than $500,000; n.a. = not applicable; HHS = Health and Human Services.
Numbers may not add up to totals because of rounding.
aAmounts include authorizations of appropriations of $110 million for each of fiscal years 2016 through 2020
  from the Cures Innovation Fund established in title IV of the bill. Estimated outlays from the Cures
  Innovation Fund are also reported here, assuming appropriation action consistent with the bill.
bH.R. 6 would provide authorizations of appropriations of $10 million for each of fiscal years 2016 through 2023
  for the Council for 21st Century Cures.
cIn addition, CBO estimates that enacting H.R. 6 would increase off-budget costs for the U.S. Postal Service by
  $6 million over the 2016-2025 period.

    Spending subject to appropriation: H.R. 6 would authorize 
funding and modify programs within HHS that support medical 
research, oversee the development and marketing approval for 
drugs, and monitor the use of drugs in the United States. The 
legislation also would change the regulatory framework 
surrounding medical devices and oversight of technology by FDA. 
As shown in Table 2, CBO estimates that implementing H.R. 6 
would cost $106.4 billion over the 2016-2020 period, assuming 
appropriation of the authorized and estimated amounts. Of that 
amount, $105.5 billion would be spent from amounts specifically 
authorized by H.R. 6. CBO estimated other authorizations based 
on information from NIH, FDA, Centers for Disease Control and 
Prevention (CDC), and other government agencies.
    Assuming appropriation action consistent with the bill, CBO 
estimates that over the 2016-2020 period:
           Provisions implemented by NIH would cost 
        $105.0 billion;
           Provisions administered by FDA would cost 
        $872 million;
           Provisions administered by CDC would cost 
        $35 million;
           Provisions affecting discretionary spending 
        by other HHS programs would cost $427 million; and
           Provisions affecting discretionary spending 
        by other Departments and agencies would cost $21 
        million.

                          TABLE 2. ESTIMATED AUTHORIZATIONS OF APPROPRIATIONS IN H.R. 6
----------------------------------------------------------------------------------------------------------------
                                                               By fiscal year, in millions of dollars--
                                                     -----------------------------------------------------------
                                                                                                          2016-
                                                        2016      2017      2018      2019      2020      2020
----------------------------------------------------------------------------------------------------------------
                                  CHANGES IN SPENDING SUBJECT TO APPROPRIATIONa
Title 1--Discovery
    NIH Reauthorization
        Authorization Level.........................    31,811    33,331    34,851         0         0    99,993
        Estimated Outlays...........................     8,190    25,750    31,781    24,735     6,645    97,100
    NIH Innovation Fund
        Authorization Level.........................     2,000     2,000     2,000     2,000     2,000    10,000
        Estimated Outlays...........................       386     1,723     1,897     1,952     1,980     7,939
    Other Provisionsb
        Estimated Authorization Level...............        21        22        22        21        21       107
        Estimated Outlays...........................         7        17        19        20        21        84
        Subtotal, Title I
            Estimated Authorization Level...........    33,832    35,353    36,873     2,021     2,021   110,100
            Estimated Outlays.......................     8,583    27,490    33,698    26,707     8,646   105,124
Title ll--Development
    Development and Approval of Prescription Drugs
     and Biologics
        Estimated Authorization Level...............        51        55        66        69        73       315
        Estimated Outlays...........................        22        45        62        69        73       270
    Development and Regulation of Medical Devices
     and Technology
        Estimated Authorizations Level..............        44        58        65        82        82       331
        Estimated Outlays...........................        31        51        61        75        80       299
        Subtotal, Title II
            Estimated Authorization Level...........        95       113       131       151       155       646
            Estimated Outlays.......................        52        96       123       145       153       569
Title III--Delivery
    Health Information Technology and Other
     Provisions
        Estimated Authorization Level...............        12         2         2         2         2        19
        Estimated Outlays...........................         6         4         3         3         2        18
Title IV--Medicaid, Medicare, and Other Reforms
    Cures Innovation Fundc
        Authorization Level.........................       110       110       110       110       110       550
        Estimated Outlays...........................        11        36        58        94       129       327
    SPR Drawdown
        Estimated Authorization Level...............         0         0         2         2         2         6
        Estimated Outlays...........................         0         0         2         2         2         6
    Lyme Disease and Other Tick-borne Diseases
        Estimated Authorization Level...............        86        87        90        92        94       448
        Estimated Outlays...........................        25        67        81        87        92       351
        Subtotal, Title IV
            Estimated Authorization Level...........       193       197       202       204       206     1,004
            Estimated Outlays.......................        36       102       141       182       223       684
        Total
            Estimated Authorization Level...........    34,135    35,665    37,207     2,378     2,384   111,768
            Estimated Outlays.......................     8,677    27,692    33,964    27,037     9,024   106,395
----------------------------------------------------------------------------------------------------------------
Notes: NIH = National Institutes of Health; SPR = Strategic Petroleum Reserve.
Numbers may not add up to totals because of rounding.
aEstimated outlays for specified authorizations of appropriations in H.R. 6 are shown for the title in which the
  authorization of appropriation is identified in the bill, assuming appropriation action is consistent with the
  bill.
bIncludes authorizations of appropriations of $10 million for each of fiscal years 2016 through 2023 for the
  Council for 21st Century Cures.
cReflects estimated outlays from the Cures Innovation Fund, including any amounts disbursed by the Fund for
  activities that also are associated with separate authorizations identified in titles I and II of the bill.

    Title I--Discovery. Title I would reauthorize NIH, make 
several programmatic changes to the agency's research and loan 
repayment programs, and authorize other initiatives aimed at 
promoting medical research. CBO estimates that implementing 
title I would cost $105.1 billion over the 2016-2020 period, 
assuming the availability of appropriated funds.
    NIH Reauthorization. Section 1001 would authorize the 
appropriation of almost $100 billion over the next three years 
for NIH. The authority for research programs at NIH that are 
subject to future appropriations expired at the end of fiscal 
year 2009. Since then, however, the Congress has appropriated 
an average of about $30 billion annually to continue operating 
those programs across all areas of research at NIH. CBO 
estimates that reauthorizing NIH would cost $97.1 billion over 
the 2016-2020 period.
    NIH Innovation Fund. Section 1002 would direct the 
Secretary of HHS to establish an ``NIH Innovation Fund'' in the 
U.S. Treasury to support biomedical research. The bill would 
authorize the appropriation of $2 billion from that fund for 
each of fiscal years 2016 through 2020. CBO estimates that 
spending from the NIH Innovation Fund would total $7.9 billion 
over the 2016-2020 period.
    Other Provisions. Other provisions of title I would aim to 
promote medical research and accelerate the availability of new 
therapies. CBO estimates that implementing those provisions of 
title I would cost $84 million over the 2016-2020 period. That 
amount includes:
           $45 million for the Council for 21st Century 
        Cures, a public-private partnership intended to help 
        accelerate the discovery, development, and delivery of 
        treatments for patients in the United States. (The bill 
        would authorize the appropriation of $10 million for 
        each of fiscal years 2016 through 2023 for such 
        activities.);\1\
---------------------------------------------------------------------------
    \1\The legislation also would authorize the appropriation of 
additional funds for such purposes from the Cures Innovation Fund 
established in title IV of the bill. See discussion of spending by the 
Cures Innovation Fund later in the cost estimate.
---------------------------------------------------------------------------
           $21 million for CDC to develop a 
        surveillance system for neurological diseases. (The 
        bill would authorize the appropriation of $5 million 
        for each of fiscal years 2016 through 2020 for such 
        activities.)
           $12 million for the Secretary of HHS to 
        participate in public-private partnerships and award 
        grants to facilitate the collection, analysis, and 
        availability of data on diseases. (The bill would 
        authorize the appropriation of $5 million for each of 
        fiscal years 2016 through 2020 for such 
        activities.);\1\ and
           $6 million for FDA to establish a pilot 
        program to create a research sharing system (in 
        coordination with NIH) that would give third parties 
        direct access to data generated from clinical trials 
        funded exclusively by the federal government and to 
        assist NIH with standardizing certain information in 
        the registry data bank involving eligibility for 
        clinical trials.
    Title II--Development. Title II of H.R. 6 would modify 
FDA's approach to regulating prescription drugs, biologicals, 
medical devices, and health-related technology. It also would 
make changes to certain surveillance activities by the CDC 
relating to antimicrobials and to CDC's vaccine-related 
activities. CBO's estimates reflect the expected number of 
personnel and investment in information technology required to 
implement the bill based on information provided by the 
affected agency. (Provisions in title II primarily affect 
regulatory activities by FDA.) We estimate that implementing 
Title II would cost $569 million over the 2016-2020 period, 
assuming the appropriation of the necessary amounts. As 
discussed below, Title II would affect two regulatory areas: 1) 
prescription drugs and biologics and 2) medical devices and 
health-related technology.
    Development and Approval of Prescription Drugs and 
Biologics. Title II of H.R. 6 contains several provisions that 
would modify FDA's regulatory framework for overseeing the 
development and approval process of drugs and biologics. The 
title also would establish a grant program for institutions of 
higher education and nonprofit organizations to study 
improvements in the process of continuous manufacturing and 
other production-related techniques. Finally, this title would 
make changes to CDC's administrative procedures involving 
antibiotics and vaccines. Taken together, CBO estimates that 
implementing provisions relating to drugs and biologics in 
title II would cost $270 million over the 2016-2020 period. 
That amount includes:
           $33 million to establish a process to 
        qualify or validate certain drug development tools, 
        such as biomarkers, for use in certain applications. 
        That funding would also allow FDA to enter into 
        cooperative agreements and to award grants to assist 
        the agency with the review of such qualification 
        submissions. (The bill would authorize the 
        appropriation of $10 million for each of fiscal years 
        2016 through 2020 for such activities.);\1\
           $33 million to identify and publish a list 
        of interpretive criteria for tests that characterize 
        the susceptibility of particular bacteria, fungi, or 
        other microorganisms to drugs;
           $31 million to facilitate approval for 
        certain antibacterial and antifungal drugs used by a 
        limited population of patients;
           $25 million to issue and update guidance to 
        industry, including documents that would assist 
        sponsors in the development of precision drugs and 
        biologics, provide guidelines on responsible 
        communication of certain types of information, and 
        clarify agency procedures regarding its review of 
        combination drug products;
           $21 million to administer a new grant 
        program to study continuous drug manufacturing and 
        production-related technologies. (The bill would 
        authorize the appropriation of $5 million each of 
        fiscal years 2016 through 2020 for that program.);\1\
           $21 million to implement a program that 
        would aim to provide incentives to drug companies to 
        develop new indications for drugs and biologics that 
        target rare diseases and conditions and to extend the 
        voucher program for rare pediatric diseases through 
        December 31, 2018;
           $20 million to develop a regulatory 
        structure that would allow the use of new protocols for 
        statistical modeling and trial designs to support 
        marketing applications for drug and biological 
        products;
           $18 million to devise a plan with sponsors 
        of drug and biological products eligible for 
        accelerated approval to agree on certain details of the 
        design of clinical studies in a manner that would 
        expedite approval of such products;
           $14 million, which reflects the costs for a 
        range of federal programs generated by a provision that 
        would extend exclusivities for certain brand-name 
        drugs. (See discussion of the effect of that provision 
        on mandatory costs for federal health programs below.);
           $14 million to establish a ``streamlined 
        data review program'' that would allow sponsors to 
        submit qualified summaries of clinical data to support 
        the approval or licensure of new indications under 
        certain circumstances;
           $14 million to conduct pilot demonstrations 
        that would expand the use of FDA's existing 
        surveillance program (that allows the agency to query 
        electronic data systems and proactively evaluate safety 
        issues with medical products) to also capture 
        additional evidence of clinical experiences associated 
        with marketed drug products. (The bill would authorize 
        the appropriation of $3 million for each of fiscal 
        years 2016 through 2020 for such activities.);\1\
           $13 million for CDC to monitor and track 
        usage of antibiotic and antifungal drugs; and
           $14 million for miscellaneous provisions of 
        title II that would affect discretionary spending by 
        various federal agencies, primarily FDA, CDC, and the 
        Government Accountability Office.
    Development and Regulation of Medical Devices and 
Technology. Title II of the bill also contains provisions that 
would modify the regulatory framework surrounding medical 
devices and oversight of technology by FDA. Assuming 
appropriation of the necessary amounts, CBO estimates that 
implementing those provisions would cost $299 million over the 
2016-2020 period, primarily for FDA's personnel-related 
expenses. That amount includes:
           $158 million to establish a program to 
        provide expedited review for certain devices that 
        represent breakthrough technologies where no approved 
        alternatives exist and that technology offers 
        significant advantages over existing alternatives;
           $68 million to establish a new accreditation 
        program for third parties to expedite the approval 
        process for certain devices, review and recognize 
        national and international standards, and develop and 
        update several guidances and regulations;
           $68 million to implement a new framework for 
        the regulation of medical software based on a new 
        definition of health software, and exempting such 
        software from most regulation; and
           $4 million for FDA's Center for Devices and 
        Radiological Health to issue final guidance regarding 
        its review of combination products within 18 months 
        after the date of enactment of H.R. 6, and to update 
        that guidance regularly.
    Title III--Delivery. CBO estimates that implementing title 
III would cost $18 million over the 2016-2020 period, assuming 
appropriation of the necessary funds. That amount reflects:
           $10 million for contracts with organizations 
        that develop standards to make recommendations for new 
        interoperability standards for electronic health 
        records. (The bill would authorize the appropriation of 
        $10 million in 2016 for such activities.);
           $5 million for the Office of the National 
        Coordinator of Health Information Technology to 
        administer the adoption of those interoperability 
        standards and to publish reports on interoperability;
           $2 million for the Centers for Medicare and 
        Medicaid Services (CMS) and the Medicare Payment 
        Advisory Commission to provide information to the 
        Congress on the use and limitations of telehealth 
        services; and
           $1 million for the Secretary of HHS to 
        establish a Medicare pharmaceutical and technology 
        ombudsman within CMS.
    Title III also contains provisions that would affect direct 
spending. Those provisions are discussed in the direct spending 
section below.
    Title IV--Medicaid, Medicare, and Other Reforms. H.R. 6 
would create a fund to pay for new initiatives and 
administrative costs associated with regulatory requirements 
established by the bill. It would also direct the Department of 
Energy (DOE) to sell 64 million barrels of oil from the SPR, 
and would expand research activities on Lyme disease and other 
tick-borne diseases. CBO estimates that implementing the 
provisions in title IV would cost $684 million over the 2016-
2020 period, assuming appropriation of the necessary funds. 
(Title IV also contains provisions that would affect direct 
spending.)
    Cures Innovation Fund. Section 4041 would direct the 
Secretary of HHS to establish a ``Cures Innovation Fund'' in 
the U.S. Treasury. The legislation would authorize the 
appropriation of $110 million a year from the fund for fiscal 
years 2016 through 2020. Such authorizations would be in 
addition to any amounts made available from other 
authorizations of appropriations identified specifically in 
titles I and II for the following activities:
           Participating in public-private partnerships 
        and awarding grants that foster the collection, 
        analysis, and availability of data on the natural 
        history of disease;
           Supporting initiatives of the Council for 
        21st Century Cures;
           Creating a regulatory framework at FDA that 
        incorporates information about patients' experiences 
        with a specific condition or disease, including the 
        risks and benefits of new drug treatments;
           Establishing a process to qualify or 
        validate certain drug development tools, such as 
        biomarkers, for use in certain applications and 
        allowing FDA to enter into cooperative agreements and 
        to award grants to assist the agency with reviewing 
        such qualification submissions;
           Establishing a regulatory framework at FDA 
        to allow information from clinical experiences to 
        support the approval or licensure of a new indication 
        for a drug or biologic, or to fulfill requirements for 
        post-approval study; and
           Administering a new FDA grant program that 
        promotes the study of continuous drug manufacturing and 
        other production-related technologies.
    CBO estimates that spending from the Cures Innovation Fund 
would total $327 million over the 2016-2020 period, assuming 
appropriation of the authorized amounts.
    SPR Drawdown. The bill would direct the DOE to sell 64 
million barrels of oil from the SPR, subject to certain 
conditions. Based on information from DOE, CBO estimates that 
the transaction costs associated with selling oil from the SPR 
would average about 21 cents per barrel. Thus, assuming the 
appropriation of the necessary amounts, CBO estimates that 
implementing the sales would cost $6 million over the 2016-2020 
period. That estimate includes the incremental cost of power, 
storage, labor, and various other logistical expenses. 
According to DOE, selling a total of 64 million barrels from 
the SPR--which would reduce the current inventory by roughly 9 
percent--would not require any decommissioning activities or 
expenses. (See discussion of the effect of the provision on 
mandatory costs in the direct spending section of the cost 
estimate.)
    Lyme Disease and Other Tick-borne Diseases. Section 4081 
would amend the Public Health Service Act to require the 
Secretary of HHS to conduct or support research on Lyme disease 
and other tick-borne diseases. Currently, several federal 
agencies fund research on tick-borne diseases including NIH and 
CDC. The bill also would require the Secretary to establish a 
permanent interagency working group on Lyme disease and other 
tick-borne diseases and to periodically submit to the Congress 
a strategic plan for conducting and supporting research in that 
area. Based on a 2011 study by the Institute of Medicine that 
reported the average annual funding level for Lyme disease and 
other tick-borne diseases totaled almost $90 million, CBO 
estimates that implementing section 4081 would cost $351 
million over the 2016-2020 period.
    Direct spending: Several provisions in H.R. 6 would affect 
direct spending. Taken together, CBO estimates that enacting 
H.R. 6 would reduce on-budget direct spending, on net, by about 
$11.9 billion over the 2016-2025 period (see Table 3); off-
budget costs for the U.S. Postal Service would increase by $6 
million over the same period.

                                           TABLE 3. ESTIMATED CHANGES IN ON-BUDGET MANDATORY COSTS FOR H.R. 6
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                          By fiscal year, in millions of dollars--
                                   ---------------------------------------------------------------------------------------------------------------------
                                      2016     2017     2018     2019     2020      2021      2022      2023      2024      2025    2016-2020  2016-2025
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                          CHANGES IN ON-BUDGET DIRECT SPENDINGa
 
Title II--Development
  Encouraging the Development and         0        0       49       60        63        66        71        72        73        81        172        535
   Use of New Antimicrobial Drugs.
    Extension of Exclusivity              0        0       14       47        84       114       142       147       149       172        145        869
     Periods for Certain Drugs
     Approved for a New Indication
     for a Rare Disease or
     Condition....................
        Subtotal, Title II........        0        0       63      107       147       180       213       219       222       253        317      1,404
Title III--Delivery
    Treatment of Certain Items and        0       -4       -8      -11       -15       -17       -23       -27       -30       -37        -38       -172
     Devices......................
    Medicare Site-of-service Price        1        5        0        0         0         0         0         0         0         0          6          6
     Transparency.................
    Programs to Prevent                   0       -8      -10      -11       -12       -13       -15       -15       -15       -16        -41       -115
     Prescription Drug Abuse under
     Medicare Parts C and D.......
        Subtotal, Title III.......        1       -7      -18      -22       -27       -30       -38       -42       -45       -53        -73       -281
Title IV--Medicaid, Medicare, and
 Other Reforms
    Limiting Federal Medicaid             0        0        0        0      -274      -391      -417      -444      -473      -504       -274     -2,503
     Reimbursement to States for
     DME..........................
    Medicare Payment for X-rays           0       -5      -16      -17       -17       -18       -19       -18       -17       -18        -55       -145
     and Other Imaging Services...
    Delay Certain Payments to             0        0        0        0    -3,184      -301    -4,139      -708     3,786      -417     -3,184     -4,963
     Medicare Prescription Drug
     Plans........................
    SPR Drawdown..................        0        0     -600     -600      -650      -650      -700      -700      -750      -750     -1,850     -5,400
        Subtotal, Title IV........        0       -5     -616     -617    -4,125    -1,360    -5,275    -1,870     2,546    -1,689     -5,363    -13,011
        Total, Changes in On-           -11      -12     -571     -532    -4,005    -1,210    -5,100    -1,693     2,723    -1,489     -5,119     11,888
         budget Direct Spendingb..
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notes: DME = durable medical equipment; SPR = Strategic Petroleum Reserve.
Numbers may not add up to totals because of rounding.
a Budget authority equals outlays for all direct spending provisions. Medicare provisions include interactions with Medicare Advantage payments, the
  effect on Medicare Part A and Part B premiums, and TRICARE.
b CBO estimates that enacting H.R. 6 also would increase off-budget costs for the U.S. Postal Service by $6 million over the 2016-2025 period.

    Title II--Development. Title II of the bill would require 
Medicare to make additional payments to hospitals for using 
qualifying antimicrobial drugs. It also would extend 
exclusivity periods for certain drugs approved for a new 
indication that pertains to treating a rare disease or 
condition. CBO estimates that implementing such provisions 
would increase on-budget direct spending for mandatory health 
programs by $1.4 billion over the 2016-2025 period.\2\
---------------------------------------------------------------------------
    \2\Extending exclusivity periods for certain drugs would affect 
off-budget spending by the U.S. Postal Service (USPS) for health 
insurance premiums for its workers and retirees who are covered under 
the Federal Employees Health Benefits program. CBO estimates that the 
bill would increase USPS costs (which are classified as off-budget) by 
$6 million over the 2016-2025 period.
---------------------------------------------------------------------------
    Encouraging the Development and Use of New Antimicrobial 
Drugs. The bill would require Medicare to make an additional 
payment to hospitals when Medicare beneficiaries use certain 
new antimicrobial drugs during the course of their hospital 
stay. To qualify for the additional payment, a drug would have 
to meet certain criteria, including: the drug must be approved 
to treat certain infections for which existing antibiotics are 
not sufficient and the drug must receive approval for use or 
for a new indication on or after December 1, 2014. A qualifying 
drug would be eligible for the additional payment for a period 
of five years. Each year, the Secretary would establish payment 
rates for eligible drugs based on payment rates under Part B of 
Medicare, subject to the pro rata reduction, if any, that the 
Secretary estimates is needed to limit total payments for such 
drugs to 0.03 percent of expected Medicare spending for 
hospital inpatient services. Based on information about drugs 
currently in the development pipeline that would be likely to 
satisfy the specified criteria and data from the CDC on rates 
of antibiotic-resistant infection, CBO estimates that enacting 
that provision would increase direct spending by about $535 
million over the 2016-2025 period.
    Extension of Exclusivity Periods for Certain Drugs Approved 
for a New Indication for a Rare Disease or Condition. Section 
2151 of the bill would authorize the FDA to extend exclusivity 
periods for certain brand-name drugs already on the market by 
six months if, after enactment of the bill, the drug is 
approved for a new indication that pertains to treating a rare 
disease or condition. Such extensions could delay the timing of 
market entry by lower-priced generic drugs or biosimilars. In 
addition, the provision would add six months of exclusivity to 
the patents of select drugs; such provision only would apply to 
certain designated drugs previously approved under the Federal 
Food, Drug, and Cosmetic Act (FDCA) and not to biologics 
previously licensed under the Public Health Service Act.
    In order to be eligible for the six month exclusivity 
period, a drug manufacturer would have to demonstrate safety 
and efficacy for treatment of a rare disease or condition for 
which the drug had not been previously approved. CBO expects 
that approval for the new indication would hinge on 
successfully completing new clinical trials. While many 
manufacturers could benefit over the next 10 years from such an 
extension of exclusivity, CBO expects that only certain drugs 
that meet all of the following criteria likely would receive 
one. First, a drug must have the potential to treat a rare 
disease or condition for which it was not originally approved. 
Second, the expected value of returns from undertaking the 
additional research to obtain approval for the new indication 
must offset the costs. And finally, sufficient time must be 
available for the manufacturer to conduct the necessary trials, 
prepare a marketing application, undergo regulatory review, and 
obtain approval before facing generic competition.
    CBO estimates that about 15 percent of the share of brand-
name sales for drugs previously approved under the FDCA that 
are expected to first experience generic competition before 
2025 would have such competition delayed by 6 months under this 
provision. By delaying the timing of market entry of lower 
priced generics or biosimilars, CBO expects the provision would 
increase the drug-related costs of federal health programs 
(both mandatory and discretionary programs) that pay for 
prescription drugs and biological products. CBO estimates that 
the provision would increase on-budget spending on prescription 
drugs by mandatory health programs by $869 million over the 
2016-2025 period. Beyond 2025, the potential for the 
legislation to delay the entry of generic drugs or biosimilars 
is greater and the federal budgetary effect would increase in 
later years.
    Title III--Delivery. Title III of the bill also contains 
provisions that would affect direct spending for Medicare. CBO 
estimates that enacting those provisions would reduce direct 
spending, on net, by $281 million over the 2016-2025 period.
    Treatment of Certain Items and Devices. Under current law, 
Medicare beneficiaries may receive negative pressure wound 
therapy (NPWT), which uses a vacuum pump and special dressings 
to promote wound healing. NPWTs are available using either a 
durable pump or a disposable pump that can be used at home. If 
a home health agency (HHA) furnishes a beneficiary with NPWT 
using a durable form of the device, Medicare makes a payment to 
the HHA for the visit and to a DME supplier for the NPWT. If 
the HHA uses a disposable NPWT, Medicare does not make an 
additional payment and the HHA absorbs the cost of the NPWT. 
H.R. 6 would establish a new add-on payment to HHAs when they 
furnish disposable NPWT; that payment would be lower than the 
payment for durable NPWT. CBO estimates that there would be 
some switching from durable NPWT to disposable NPWT and thus 
this provision would save about $172 million over the 2016-2025 
period.
    Medicare Site-of-service Price Transparency. H.R. 6 would 
require CMS to create a new database and website that would 
enable beneficiaries to compare the estimated Medicare payment 
and cost-sharing amounts for items and services provided in 
hospital outpatient departments and ambulatory surgical 
centers. The bill would appropriate $6 million for this purpose 
and CBO estimates that all of the funding would be spent by the 
end of fiscal year 2017.
    Programs to Prevent Prescription Drug Abuse under Medicare 
Parts C and D. The bill would permit private drug plans that 
administer the Medicare Part D prescription drug benefit to 
establish a program to limit the number of physicians and 
pharmacies allowed to prescribe and dispense certain drugs to 
enrollees identified as being at high risk for prescription 
drug abuse. Under H.R. 6, plans that implement such a program 
would use clinical guidelines established by the Secretary of 
HHS to target certain beneficiaries who use controlled 
substances the Secretary determines are frequently abused or 
diverted. For example, restrictions might be placed on 
beneficiaries suspected of abusing or reselling certain 
controlled substances, but not placed on beneficiaries with 
cancer or other conditions for which those drugs are considered 
appropriate. Based on information from HHS and other 
stakeholders, CBO estimates that enacting that provision would 
reduce direct spending by $115 million over the 2016-2025 
period.
    Title IV--Medicaid, Medicare, and Other Reforms. Title IV 
of the bill contains provisions that would reduce direct 
spending. CBO estimates that enacting those provisions would 
reduce direct spending by $13.0 billion over the 2016-2025 
period.
    Limiting Federal Medicaid Reimbursement to States for DME. 
Under current law, states have broad flexibility to set 
coverage and payment policies in their Medicaid programs. 
Generally, the federal government reimburses states for a 
portion of the amount they spend on Medicaid. Section 4001 
would limit the amount of spending by states to purchase DME 
that is eligible for federal reimbursement to the amount that 
would be paid by the Medicare program. Twelve states have 
adopted similar policies as of 2014. CBO estimates that 
enacting DME payment limits in the remaining states beginning 
January 2020 would reduce direct spending for Medicaid by 
approximately $2.5 billion over the 2016-2025 period.
    Medicare Payments for X-rays and Other Imaging Services. 
The legislation would reduce Medicare's payment rates under the 
physician fee schedule for x-ray and other imaging services 
that do not use digital imaging technology, beginning in 2017. 
Payment rates for imaging services that use film would be 
reduced by 20 percent. The reduction for imaging services that 
use computed radiography would be 7 percent in 2018 through 
2022, then 10 percent in 2023 and subsequent years. Based on a 
review of Medicare claims, CBO estimates that about 1 percent 
of current spending for imaging services paid under the 
physician fee schedule would be subject to the reductions in 
2017. CBO expects that implementation of the payment reductions 
would spur adoption of digital technology, and that less than 
0.2 percent of spending would be subject to those reductions by 
2025. This provision would reduce direct spending about $145 
million over the 2016-2025 period, CBO estimates.
    Delay Certain Payments to Medicare Prescription Drug Plans. 
Under current law, most Medicare payments to Part D plans 
(including capitated payments and reinsurance payments for 
beneficiaries whose spending exceeds the threshold for the 
catastrophic portion of the prescription drug benefit) are made 
on either the first day of the month or the last day of the 
preceding month (when the first day is a weekend or holiday). 
Beginning in calendar year 2020, the legislation would delay 
monthly reinsurance payments to stand-alone prescription drug 
plans in Medicare Part D. Starting with a payment shift from 
2020 to 2021, the provision would shift spending between fiscal 
years and would shift an estimated $5.0 billion from fiscal 
year 2025 to fiscal year 2026.\3\
---------------------------------------------------------------------------
    \3\For example, $3.2 billion would be shifted from fiscal year 2020 
to 2021, thereby reducing direct spending in 2020 by that amount. For 
2021, that $3.2 billion would be shifted into 2021, but $3.5 billion 
would be shifted into 2022. As a result, the net change in spending in 
2021 would amount to $0.3 billion. By 2025, $4.5 billion would be 
shifted in (from 2024) and almost $5.0 billion would be shifted out (to 
2026); the net effect in 2025 would amount to 0.4 billion.
---------------------------------------------------------------------------
    SPR Drawdown. Section 4061 would direct the DOE to sell 8 
million barrels of oil from the SPR in each of the fiscal years 
2018 through 2025, subject to certain conditions. Under this 
bill, the proceeds from such sales would be deposited in the 
general fund of the Treasury by the end of each fiscal year and 
could not be spent to purchase oil for the reserve. CBO 
estimates that enacting that provision would increase 
offsetting receipts (which are certain collections that are 
treated as reductions in direct spending) by $5.4 billion over 
the 2016-2025 period.
    The estimated receipts reflect CBO's March 2015 projection 
of oil prices, adjusted for the technical characteristics of 
the oil being sold from the SPR (those adjusted prices range 
from about $75 to $96 per barrel over the sales period). Based 
on information from the Energy Information Administration, CBO 
estimates that the volume of crude oil in the SPR after these 
sales would exceed an amount equivalent to a 90-day supply of 
net imports crude oil and petroleum products, as required by 
the bill.
    Pay-As-You-Go considerations: The Statutory Pay-As-You-Go 
Act of 2010 establishes budget-reporting and enforcement 
procedures for legislation affecting direct spending or 
revenues. The net changes in outlays that are subject to those 
pay-as-you-go procedures are shown in the table below. Only on-
budget changes to outlays are subject to pay-as-you-go rules. 
Enacting H.R. 6 would not affect revenues.

           CBO ESTIMATE OF PAY-AS-YOU-GO EFFECTS FOR H.R. 6, AS ORDERED REPORTED BY THE HOUSE COMMITTEE ON ENERGY AND COMMERCE ON MAY 21, 2015
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                         By fiscal year, in millions of dollars--
                                ------------------------------------------------------------------------------------------------------------------------
                                  2015   2016    2017     2018     2019     2020      2021      2022      2023     2024     2025    2015-2020  2015-2025
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                          NET DECREASE IN THE ON-BUDGET DEFICIT
 
Total Changes..................      0      1      -12     -571     -532    -4,005    -1,210    -5,100    -1,693   2,723    -1,489     -5,119    -11,888
Less:
Adjustment for Timing Shifta...      0      0        0        0        0         0         0         0         0       0    -4,963          0     -4,963
Statutory Pay-As-You-Go Impact.      0      1      -12     -571     -532    -4,005    -1,210    -5,100    -1,693   2,723     3,474     -5,119     -6,925
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: Congressional Budget Office.
aSection 4 of the Statutory Pay-As-You-Go Act of 2010 provides for adjustments related to certain shifts in the timing of spending or revenues. The
  provision in H.R. 6 that would delay certain payments to Medicare prescription drug plans would create such a timing shift. That provision would shift
  payments in each year beginning with 2020. The adjustment for timing shifts under pay-as-you-go procedures is only applied to the spending that is
  shifted from 2025 to 2026.

    Increase in long term direct spending: None.
    Estimated impact on state, local, and tribal governments: 
H.R. 6 contains no intergovernmental mandates as defined in 
UMRA. The bill would delay entry into the market of some 
generic drugs resulting in an increase of state Medicaid 
spending for prescription drugs of $50 million over the 2016-
2025 period. In addition, the bill would limit the amount that 
is eligible for federal matching payments to states for DME in 
Medicaid to the amount that Medicare would pay. That limitation 
could increase state Medicaid costs by about $2.5 billion over 
the 2016-2025 period. However, because states have flexibility 
in Medicaid to adjust their financial and programmatic 
responsibilities, including the ability to reduce the amounts 
they would pay vendors for DME, those costs would not result 
from an intergovernmental mandate.
    Estimated impact to the private sector: H.R. 6 would impose 
private-sector mandates, as defined in UMRA, on drug 
manufacturers. CBO estimates that the aggregate cost of the 
mandates would fall below the annual threshold established in 
UMRA ($154 million in 2015, adjusted annually for inflation) in 
each of the first five years that the mandates are in effect.
    The bill would impose a mandate on manufacturers of generic 
drugs and biosimilars by extending by six months the periods of 
marketing exclusivity for products that receive a new 
indication for the treatment of a rare disease. Granting drugs 
additional marketing exclusivity would delay the entry of 
lower-priced versions of products in those markets. The cost of 
the mandate for manufacturers of generic products and 
biosimilars would be the annual net loss of income resulting 
from the delay, which could be significant depending on the 
drugs granted an extension. However, based on information about 
the sales of drugs that could be affected in the first five 
years that the mandate is in effect, CBO estimates that the 
cost of the mandate would amount to about $50 million or less 
in each of those years.
    The bill would impose two additional mandates, and CBO 
estimates that the cost of each of those mandates would be 
small. The bill would require manufacturers of investigational 
drugs to make public their policy for reviewing and responding 
to requests for access to those drugs under compassionate use 
policies. The bill would allow manufacturers to comply with the 
mandate by posting a general policy applicable to all its 
investigational drugs. The bill also would require 
manufacturers of antimicrobial drugs to submit an application 
to FDA for changes to the product's label sooner than they 
would need to under current law. The bill would require that 
labels for all antimicrobial drugs include a reference to an 
FDA website which would contain the updated criteria for 
determining the effectiveness of such drugs. The mandate would 
result in savings to the affected manufacturers in later years 
because they would not need to change a product's label each 
time those criteria are updated.
    Estimate prepared by: Federal Costs: National Institutes of 
Health--Ellen Werble; Food and Drug Administration--Julia 
Christensen, Anna Cook, and Ellen Werble; Centers for Disease 
Control and Prevention--Rebecca Yip; Health Information 
Technology--Zoe Williams; Medicaid--Daniel Hoople; Medicare--
Lori Housman, Kevin McNellis, Jamease Miles, Andrea Noda, Lara 
Robillard, and Rebecca Yip; Strategic Petroleum Reserve--Kathy 
Gramp. Impact on State, Local, and Tribal Governments: J'nell 
Blanco Suchy. Impact on the Private Sector: Amy Petz.
    Estimate approved by: Holly Harvey, Deputy Assistant 
Director for Budget Analysis.

                       Federal Mandates Statement

    The Committee adopts as its own the estimate of Federal 
mandates prepared by the Director of the Congressional Budget 
Office pursuant to section 423 of the Unfunded Mandates Reform 
Act.

                    Duplication of Federal Programs

    No provision of H.R. 6 establishes or reauthorizes a 
program of the Federal Government known to be duplicative of 
another Federal program, a program that was included in any 
report from the Government Accountability Office to Congress 
pursuant to section 21 of Public Law 111-139, or a program 
related to a program identified in the most recent Catalog of 
Federal Domestic Assistance.

                  Disclosure of Directed Rule Makings

    The Committee estimates that enacting H.R. 6 specifically 
directs to be completed 3 rule makings within the meaning of 5 
U.S.C. 551.

                      Advisory Committee Statement

    No advisory committees within the meaning of section 5(b) 
of the Federal Advisory Committee Act were created by this 
legislation.

                  Applicability to Legislative Branch

    The Committee finds that the legislation does not relate to 
the terms and conditions of employment or access to public 
services or accommodations within the meaning of section 
102(b)(3) of the Congressional Accountability Act.

             Section-by-Section Analysis of the Legislation


                           TITLE I--DISCOVERY

Section 1001. National Institutes of Health reauthorization

    Section 1001 would reauthorize the National Institutes of 
Health (NIH) for three years: Fiscal Year (FY) 2016, 
$31,811,000,000; FY 2017, $33,331,000,000; and FY 2018, 
$34,851,000,000. The NIH authorization expired at the end of FY 
2009.

Section 1002. NIH Innovation Fund

    This section would establish an innovation fund at NIH for 
five years, FY 2016 through FY 2020, to support biomedical 
research through the funding of basic, translation, and 
clinical research. The Innovation Fund is meant to spur 
scientific innovation and discovery by providing an additional, 
supplementary funding stream to NIH. These funds will go toward 
high-risk high reward research and research performed by early 
stage investigators, among other initiatives. This section 
establishes an Accelerating Advancement Program at NIH that 
would allow for dollar for dollar matching from the Office of 
the Director for institutes and centers seeking funding from 
the Innovation Fund.
    NIH also is encouraged to support research into effective 
treatments for areas of unmet medical needs. These areas 
include, but are not limited to, biomarkers, precision 
medicine, infectious diseases, and antibiotics. The infectious 
diseases studied should include the pathogens listed as 
qualifying pathogens by the FDA: Acinetobacter species, 
Aspergillus species, Burkholderia cepacia complex, 
Campylobacter species, Candida species, Clostridium difficile, 
Enterobacteriaceae, Enterococcus species, Mycobacterium 
tuberculosis complex, Neisseria gonorrhoeae, Neisseria 
meningitidis, Non-tuberculous mycobacteria species, Pseudomonas 
species, Staphylococcus aureus, Streptococcus agalactiae, 
Streptococcus pneumoniae, Streptococcus pyogenes, Vibrio 
cholera, Coccidioides species, Crytococcus species, and 
Helicobacter pylori. These also should include those pathogens 
listed by FDA in the future.
    The Committee also recognizes that several tropical 
diseases have been identified in the United States over the 
last decade, including West Nile virus, Chagas disease, 
cysticerosis, and toxocariasis. While NIH currently supports 
tropical medicine research centers located in endemic areas 
outside the U.S., similar support is necessary in parts of the 
U.S. that are emerging as highly endemic as well, such as the 
Gulf Coast and Southwest regions. Considering the urgent need 
for diagnostics and vaccines, the Committee expects NIH to 
consider tropical diseases endemic to the U.S. to be ``unmet 
medical needs in the United States'' for purposes of 
identifying strategic focus areas for the Innovation Fund, in 
addition to the tropical diseases listed as eligible for the 
priority review voucher program established in the Food and 
Drug Administration Amendments Act of 2007.

Section 1021. NIH research strategic plan

    Section 1021 directs NIH to create a scientifically based 
five-year strategic plan to support research priorities 
determined by NIH. The plan would be used by the Director of 
NIH to identify research opportunities and strategic focus 
areas in which the resources of the national research 
institutes and national centers can best contribute to the goal 
of expanding knowledge of human health in the U.S. The plan 
also would contain overarching and trans-NIH Mission Priority 
Focus Areas that have the goal of preventing or eliminating the 
burden of a disease or condition. NIH would have to update the 
plan every five years. The strategic plan also would ensure 
that NIH prioritizes maintaining the biomedical workforce of 
the future.
    Currently, individual institutes and centers compile their 
own strategic plans. NIH as a whole does not have an 
overarching strategic plan to inform decisions on where to 
focus research efforts. At this time, no plan shows how inter-
institute research is occurring or coordinated. With increased 
funding, taxpayers should understand the overarching vision of 
NIH and the priorities it is setting.

Section 1022. Increasing accountability at the National Institutes of 
        Health

    This section would provide the Director of NIH with 
increased authority and address duplication in Federal 
biomedical research. Under this section, the Director of NIH 
would have the authority to appoint directors of the national 
research institutes, excluding the Director of the National 
Cancer Institute, as well as the directors of the national 
centers for five-year terms. There would be no limit on the 
number of terms a director may serve. If the office of a 
director of a national research institute or national center is 
vacant before the end of a five-year term, the Director of NIH 
could appoint a new director for a five year term starting at 
the date of appointment. Currently, the Director of NIH makes 
recommendations to the Secretary of Health and Human Services 
(HHS), and the Secretary makes the final decision on the 
appointment of the directors.
    Section 1022 also would increase accountability by 
including a review of all ``R-series'' grants by directors of 
the national research institutes or national centers. Directors 
would have to consider the NIH strategic plan when awarding 
these grants and whether other agencies are funding programs or 
projects to accomplish the same goal.
    This section would instruct the Institute of Medicine (IOM) 
to conduct a report on duplication in Federal biomedical 
research.
    This section, in conjunction with the strategic plan, is 
intended to increase accountability and ownership of decision-
making and prioritization at NIH.

Section 1023. Reducing administrative burdens of researchers

    This section would help reduce the administrative burden on 
researchers funded by NIH by implementing findings from various 
sources. The Scientific Management Review Board, the National 
Academy of Sciences, and the 2007 and 2012 Faculty Burden 
Surveys conducted by the Federal Demonstration Partnership have 
examined this issue extensively. Administrative burden takes 
time away from researchers focusing on their scientific 
pursuits.

Section 1024. Exemption for the National Institutes of Health from the 
        Paper Work Reduction Act requirements

    This section would exempt the NIH from the Paperwork 
Reduction Act (PRA) requirements surrounding proposed 
information collection. Currently, two rounds of public comment 
and Office of Management and Budget (OMB) approval are required 
for each proposed information collection. The complete review 
and approval process takes between six and nine months. The PRA 
was designed to maximize the utility of information collected 
by the Federal government. However, this review is burdensome 
on NIH investigators and delays important research efforts.

Section 1025. NIH travel

    This section would set forth a sense of Congress to 
reiterate the importance of scientific conferences and meetings 
to the mission of NIH.

Section 1026. Other transactions authority

    This section would provide the National Center for 
Advancing Translational Science (NCATS) at NIH with more 
flexibility on the use of Other Transaction Authority (OTA) so 
that it can operate like the Defense Advanced Research Projects 
Agency (DARPA).

Section 1027. NCATS phase IIB restriction

    This section would remove a restriction NCATS' conduct of, 
or grants for, phase II and III clinical trials.

Section 1028. High-risk, high-reward research

    This section would support research that pursues innovative 
approaches to major challenges in biomedical research that 
involve inherent high risk, but has the potential to lead to 
breakthroughs.
    Robert Lefkowitz, the 2012 Nobel Prize winner for Chemistry 
said:

          There's a current problem in biomedical research. The 
        emphasis is on doing things which are not risky. To 
        have a grant proposal funded, you have to propose 
        something and then present what is called preliminary 
        data, which is basically evidence that you've already 
        done what you're proposing to do. If there's any risk 
        involved, then your proposal won't be funded. So the 
        entire system tends to encourage not particularly 
        creative research, relatively descriptive and 
        incremental changes which are incremental advances 
        which you are certain to make but not change things 
        very much.

    According to the most recent budget congressional 
justification, NIH states:

          Since the High-Risk High-Reward program tests new 
        ways of supporting innovation, NIH commissioned a 
        rigorous external evaluation of the most mature of 
        these initiatives, the Pioneer Awards. Comparison of 
        research from Pioneer Awards, R01s (NIH's most common 
        project-based grant mechanism), and research funded by 
        the Howard Hughes Medical Institute (HHMI) showed that 
        the Pioneer program has been successful in attracting 
        and supporting research that is more innovative and has 
        greater impact than R01s, and it is comparable to HHMI-
        supported research.

    The language would build on actions already occurring at 
NIH and require each institute, as appropriate, to fund high 
risk, high impact science. The NIH Director would establish the 
percentage of funding an individual institute will be required 
to spend in this area. Institute Directors in collaboration 
with the NIH Director would establish programs to accomplish 
this goal. This language does not state what funding mechanism 
must be used to accomplish this goal. While NIH's Pioneer and 
Innovator Awards would be logical types of programs, this 
section would provide NIH with flexibility to accomplish the 
goal. The NIH Director would be given the authority to 
establish the percentage of funding because not all Institute 
Directors have embraced funding this type of research.

Section 1029. Sense of Congress on increased inclusion of 
        underrepresented communities in clinical trials

    Over the past twenty-five years, there have been national 
efforts in the U.S. to increase the representation of 
minorities in clinical trials. Although current participation 
rates do not fully represent the overall population of 
minorities in the U.S., some progress has been made. This 
section would set forth a sense of Congress to reiterate the 
importance of increasing the representation of underrepresented 
communities in clinical trials. This would help ensure that 
adequate information is available to assess the safety and 
effectiveness of drugs in all populations.

Section 1041. Improvement of loan repayment programs of National 
        Institutes of Health

    The NIH loan repayment programs help attract and retain 
early career health professionals by assisting in their 
repayment of debt associated with medical education and 
training. NIH wants to encourage outstanding health 
professionals to pursue careers in biomedical, behavioral, 
social and clinical research. Since 1998, the NIH Loan 
Repayment Programs have encouraged promising researchers and 
scientists to pursue research careers by repaying up to $35,000 
of their qualified student loan debt each year if they commit 
at least two years to conducting qualified research.
    Participation in the NIH Loan Repayment Programs has had a 
major impact on the careers of thousands of research 
scientists. Participants in the NIH Loan Repayment Programs 
stay in research longer, apply for and receive more research 
grants, and become independent investigators more frequently 
than their colleagues who do not receive loan repayment program 
funding.
    This section would increase the loan repayment cap from 
$35,000 to $50,000 for the loan repayment programs administered 
at NIH.

Section 1042. Report

    The bulk of the money received by NIH goes to researchers 
who are esteemed in their fields--but there are concerns that 
this may limit funding for early or mid-career scientists who 
may have innovative and potentially transformational ideas. A 
study for the National Bureau of Economic Research from 2005 
examined the age at which over 2,000 Nobel Prize winners and 
other notable scientists in the 20th century came up with the 
idea that led to their breakthrough. Most were between thirty-
five and thirty-nine. Yet the median age of first-time 
recipients of R01 grants, the most common and sought-after form 
of NIH funding, is forty-two, while the median age of all 
recipients is fifty-two. More people over sixty-five are funded 
with research grants than those under age thirty-five.
    The most innovative thinking frequently comes from younger 
scientists. NIH is aware of the disparity; NIH Director Francis 
S. Collins has spoken out about not investing in young 
scientists and taken steps to target younger researchers. As a 
result, the average age of first-time grant recipients has 
stopped rising, but the problem still exists, and NIH can do 
more.
    The language in this section would require NIH to submit a 
report to Congress within eighteen months of enactment on the 
actions taken by NIH to attract, retain, and develop emerging 
scientists.

Section 1061. Capstone Award

    The reasons for the age increase of NIH grantees are 
diverse and complicated. There are not enough faculty positions 
for the number of graduates with PhDs. When mandatory 
retirement at age 65 was removed from academia, the number of 
scientists remaining on the faculty after age sixty-five and 
even after age seventy dramatically increased. Since so few 
openings in academia become available, individuals often pursue 
multiple postdoctoral fellowships. This increases the age at 
which they start applying for R01 or R01-equivalent grants 
higher and higher. The current structure actually encourages 
individuals to get multiple postdoctoral fellowships. Another 
reason academic institutions encourage multiple postdoctoral 
fellowships is because postdoctoral fellows cost academic 
centers and labs less.
    The language would create a new ``Capstone Award'' at NIH. 
The award could be used to facilitate the transition or 
conclusion of research programs for senior investigators. This 
award would allow researchers a new funding mechanism should 
senior researchers choose to transition their research to 
pursue other opportunities. Once a researcher receives a 
capstone award, he or she may not receive another grant from 
NIH. The Howard Hughes Medical Institute created a similar 
program, which has seen significant success.

Section 1081. National Pediatric Research Network

    The National Pediatric Research Network Act of 2013 passed 
as part of the PREEMIE Reauthorization Act and became law on 
November 27, 2013.
    The bill amended the Public Health Service Act to authorize 
the Director of NIH to establish a National Pediatric Research 
Network.
    It authorized the Director of NIH, in part, to make awards 
for not more than twenty pediatric research consortia, 
disseminate scientific findings, and meet requirements 
prescribed by the Director.
    This provision would amend the law to require NIH to 
establish new pediatric research consortia, and clarify that 
the Office of the Director can work with any other research 
institutes or centers to implement the National Pediatric 
Research Network Act.

Section 1082. Global pediatric clinical study network sense of Congress

    Clinical trials are one of the most challenging, resource 
intensive, and time consuming components of medical product 
development. Clinical trials for pediatric products prove even 
more challenging due to limited populations and a limited 
infrastructure. According to the discussion paper, Developing a 
Clinical Trials Infrastructure, by Paul Eisenberg, Amgen, Inc.; 
Petra Kaufmann, National Institute of Neurological Disorders 
and Stroke; Ellen Sigal, Friends of Cancer Research; and Janet 
Woodcock, U.S. Food and Drug Administration, ``clinical trials 
in the United States have become too expensive, difficult to 
enroll, inefficient to implement, and ineffective to support 
the development of new medical products using modern 
evidentiary standards.'' The cost and time associated with 
clinical trials are symptoms of dysfunction within the clinical 
trial system and infrastructure. Establishing a pediatric 
clinical study network would create a mechanism to facilitate 
clinical trials for pediatrics in a more efficient and cost 
effective way.
    This sense of Congress encourages NIH and FDA to work with 
external stakeholders to build on the success of the Enro-EMA 
pediatric network to establish a larger and stronger 
infrastructure to facilitate more pediatric research in order 
to increase the number of medical products for pediatric 
populations.

Section 1083. Appropriate age groupings in clinical research

    This section would ensure appropriate age groups are 
included in research studies involving human subjects.

Section 1101. Sharing of data generated through NIH-funded research

    There is an increasing expectation from the scientific 
community and the public that data generated with Federal 
funds, particularly scientific data, should be shared to 
enhance transparency in Federal research spending, improve the 
return on investment in research, and help enhance the quality 
of research. In particular, the President has directed Federal 
agencies to ensure that peer-
reviewed publications and digital scientific data resulting 
from Federally funded scientific research are accessible to the 
public, the scientific community, and industry.
    NIH has long-standing policies that expect data to be 
shared, such as the 2003 Data Sharing Policy and the 2014 
Genomic Data Sharing Policy, as well as specific program 
policies in place at NIH Institutes and Centers. The NIH 
Director has explicit statutory authority (section 217 of the 
HHS Omnibus Appropriations Act of 2009) to require NIH-funded 
investigators to make their final, peer-reviewed manuscripts 
publicly available through submission to PubMed Central.
    NIH promotes data sharing among awardees in a number of 
ways. For example, consistent with the Final NIH Statement on 
Sharing Research Data (Data Sharing Policy) issued in 2003, NIH 
generally expects applicants to address data sharing in their 
applications. Through the applicants' submission of data 
sharing plans, which are incorporated into the terms and 
conditions of grant awards, sharing consistent with those plans 
becomes a requirement.
    This section would make explicit in statute that the 
Director has the authority to require researchers to share data 
that results from NIH funded research.

Section 1102. Standardization of data in clinical trial registry data 
        bank on eligibility for clinical trials

    This section would enhance patient searches for ongoing 
trials by requiring NIH to standardize certain patient 
inclusion and exclusion information across all trials housed in 
ClinicalTrials.gov.
    The Committee recognizes the important role 
ClinicalTrials.gov can and does play in helping to facilitate 
patient matching with ongoing clinical trials. While the 
current database does afford opportunities for patients and 
providers to identify such trials, the process is cumbersome 
and can be difficult to navigate.
    During hearings that preceded the legislative process of 
21st Century Cures, various patient advocates and other 
stakeholders noted that increased standardization of data 
elements across the various trials would help ease the time and 
effort required to search the database. Such standardization 
would serve as a foundation upon which health information 
technology developers might develop applications that 
facilitate searches from a physician's office through platforms 
such as electronic health records. Such innovation would help 
support patients in search of treatment who have run out of 
FDA-approved treatment options.
    The Committee agrees that increased standardization would 
be of immense benefit to those seeking to search 
ClinicalTrials.gov, but recognizes that too much 
standardization could result in valuable data being excluded.

Section 1121. Clinical trial data system

    This section would create a pilot third-party scientific 
research sharing system for trials solely funded by the 
agencies of HHS in order to allow the use and analysis of de-
identified data beyond each individual research project.
    Currently, the U.S. is the world leader in medical and 
scientific research. The Committee commends NIH for its 
leadership and as supports increased funding through the 21st 
Century Cures legislation. However, the Committee recognizes 
that the data generated from such research can play a role in 
the development of future cures well beyond the conclusion of 
the specific project being funded.
    The NIH has taken steps to increase access to participant-
level data from clinical trials. For example, a National 
Institute of Allergy and Infectious Diseases program provided 
de-identified participant level information from a network of 
clinical trials studying autoimmune disorders. Additionally, 
the National Institute of Mental Health is establishing a 
common informatics platform for exchanging data from clinical 
trials of novel interventions for the treatment of mental 
illness. The creation of the clinical trial data system would 
build upon those efforts.
    The creation of a database designed to store data 
originating from HHS funded research projects for use and 
analysis beyond the initial research project holds much promise 
for the future research. Consider the implications of granting 
researchers access to de-identified, patient-specific clinical 
trial data in order to identify ways to improve subsequent 
trials and reduce the potential for bad outcomes, such as 
adverse events or even death. Or, consider the potential that 
research projects in one area could help inform successful 
solutions in others. The Committee is also cognizant of the 
paramount importance of protecting patient privacy and 
confidential commercial information and is confident that these 
benefits can be obtained while simultaneously protecting these 
important concerns.
    The Committee finds that the creation of a clinical trial 
database for the purposes of sharing HHS funded data with 
researchers to support the development of new cures for 
patients in need allows the Federal government to maximize the 
benefit of such data and support our global authority in the 
area of new medical product development.

Section 1122. National neurological diseases surveillance system

    Currently, there is limited infrastructure to advance data 
collection regarding neurological diseases. This lack of data 
has hindered research and understanding of neurological 
diseases and new disease targets.
    Section 1122 would require the Centers for Disease Control 
and Prevention (CDC) to set up a surveillance system for 
neurological diseases like Parkinson's and MS. Other diseases 
could include Alzheimer's disease among others. The 
neurological disease surveillance system would enhance and 
expand the infrastructure and activities to track the 
epidemiology of neurological diseases. This system will help 
foster the collection of information on neurological diseases, 
such as demographics, risk factors, diagnosis, progression 
markers, and other relevant information.
    This provision would authorize $5 million for FY 2016 to FY 
2020 for the activities authorized in section 1122. Recognizing 
the scope of this program will be governed by the availability 
of resources, the CDC should include multiple sclerosis and 
Parkinson's disease, and others as practicable.

Section 1123. Data on natural history of diseases

    Section 1123 would add section 229A to Part A of title II 
of the Public Health Service Act, authorizing the Secretary to 
participate in public-private partnerships and award grants to 
patient advocacy organizations or other organizations to 
establish or facilitate the collection, maintenance, analysis, 
and interpretation of data regarding the natural history of 
diseases, with a particular focus on rare diseases. Such data 
would be made publicly available to help facilitate and 
expedite medical product development programs.

Section 1124. Accessing, sharing, and using health data for research 
        purposes

    Section 1124 would make several clarifications and 
revisions to the regulations implementing the Health Insurance 
Portability and Accountability Act (HIPAA).
    First, it would permit, but not require, covered entities 
to use protected health information for research purposes by 
including research within the definition of health care 
operations. The Committee intends for the covered entity to be 
able to elect for an activity meeting the requirements of this 
section to constitute health care operations, for the purposes 
of compliance with HIPAA, even if it constitutes research under 
other applicable law. The Committee also intends that this bill 
creates no changes with respect to the handling of information 
protected under the Uniform Trade Secrets Act or other 
commercial or financial information that is privileged or 
confidential.
    Further, section 1124 would permit covered entities to 
provide access to data for research purposes in the same 
controlled ways as they currently do for public health 
activities. In addition, it would permit remote access to 
protected health information maintained by a covered entity or 
by a business associate and/or cloud provider on behalf of a 
covered entity. However, a researcher authorized to access such 
information may not copy or otherwise retain the protected 
health information after the approved activities are concluded. 
The covered entity and the researcher must maintain appropriate 
privacy and security safeguards.
    Finally, section 1124 would clarify the permissibility of 
authorization for future research use and disclosure of an 
individual's protected health information under controlled 
conditions

Section 1141. Council for 21st Century Cures

    This section would establish a public-private partnership 
in the U.S. to accelerate the discovery, development, and 
delivery of innovative cures, treatments, and preventive 
measures for patients. This public-private partnership would 
bring together regulators, academia, patients, providers and 
others to review and recommend improvements to help accelerate 
cures and treatments.

                         TITLE II--DEVELOPMENT

Section 2001. Development and use of patient experience data to enhance 
        structured risk-benefit framework

    Section 2001 would amend section 505 of the Federal Food, 
Drug and Cosmetic Act (FFDCA), requiring the Secretary, in the 
context of the new drug review process, to implement a 
structured framework to facilitate the incorporation of patient 
experiences in the consideration of a drug's benefits and 
risks. Within two years of the date of enactment of this bill, 
the Secretary would be required to establish processes under 
which an entity seeking to develop patient experience data, 
such as data relating to the impact of a disease or a therapy 
on patients' lives could submit research concepts, proposed 
guidance documents, completed data, and summaries and analyses 
of such data, among other things. Further, within three years 
of enactment and after convening workshops to obtain input, the 
Secretary would be required to publish draft guidance on, among 
other things, methodological considerations and approaches for 
the collection of patient experience data, including patient-
reported outcomes. Final guidance would be published after a 
public meeting is convened and not later than one year after 
the comment period for the draft guidance closes.

Section 2021. Qualification of drug development tools

    The Committee believes that collaboratively improving the 
development and qualification of drug development tools, 
including biomarkers, is critical and that biomedical research 
consortia and other outside entities can play an important role 
throughout the process.
    Section 2021 would add section 507 to the FFDCA, codifying 
a structured framework for the submission, review, and 
qualification of biomarkers and other drug development tools 
for specific contexts of use that, if qualified, can be relied 
on by any person for such purposes. The Secretary may consult 
with outside experts and consider their recommendations 
throughout the review of a qualification package submitted 
under this framework.
    In addition, section 2021 would require the Secretary to 
make public information related to each submission, all drug 
development tools qualified, and all surrogate endpoints that 
were the basis of approval or licensure of a drug or biological 
product, while maintaining the protections currently in place 
for confidential commercial or trade secret information 
contained in an application submitted outside this 
legislation's public qualification process and under section 
505 of the FFDCA or section 351 of the Public Health Service 
Act.
    The Secretary, in consultation with biomedical research 
consortia and other interested parties, through a collaborative 
public process, is required under section 2021 to issue draft 
guidance on the implementation of section 507 no later than two 
years after enactment. The development of this guidance is to 
be informed by the Secretary's publication of a taxonomy for 
the classification of biomarkers, which is required to be 
published in draft form no later than one year after enactment.

Section 2022. Accelerated approval development plan

    Section 2022 would amend section 506 of the FFDCA to enable 
the sponsor of a drug that the Secretary determines may be 
eligible for accelerated approval (i.e., a drug that the 
Secretary determines could meet all of the statutory and 
regulatory criteria for approval pursuant section 506(c)) to 
request voluntarily that the Secretary agree to an accelerated 
approval development plan, including the surrogate endpoint to 
be assessed; the design of the study that will utilize the 
surrogate endpoint; and the magnitude of the effect of the 
surrogate endpoint that would be sufficient to form the primary 
basis of a claim that the drug is effective. The Secretary may 
require the sponsor to modify or terminate such plan if 
additional data or information indicates the plan as originally 
agreed upon is no longer sufficient to demonstrate the safety 
and effectiveness of the drug, or the drug is no longer 
eligible for accelerated approval under section 506(c). Prior 
to the effective date of the modification or termination, the 
sponsor shall be granted a meeting to discuss the Secretary's 
basis for the modification or termination.

Section 2041. Precision medicine guidance and other programs of Food 
        and Drug Administration

    Section 2041 would require the Secretary to issue and 
periodically update guidance defining the term ``precision drug 
or biological product'' and assisting sponsors in their 
development. Further, section 2041 would add section 592 to the 
FFDCA authorizing the Secretary, in the case of a drug or 
biological product for the treatment of a serious or life-
threatening disease or condition designated under section 526 
as a drug for a rare disease or condition, to rely upon data or 
information previously submitted by the sponsor for a different 
drug or biological product that incorporates or utilizes the 
same or similar underlying approach. This provision does not 
permit FDA or any applicant to rely upon data or information of 
another sponsor unless the applicant has provided the agency 
with an effective contractual right of reference permitting 
such reliance.

Section 2061. Broader application of Bayesian statistics and adaptive 
        trial designs

    Section 2061 would require FDA to hold a public meeting and 
issue guidance documents that would assist sponsors in 
incorporating adaptive designs and Bayesian statistical 
modeling into their proposed clinical protocols and 
applications for new drugs and biological products.

Section 2062. Utilizing evidence from clinical experience

    Section 2062 would amend the FFDCA by adding section 505F, 
which would require the Secretary to establish a program to 
evaluate the potential use of evidence from clinical experience 
to help support the approval of a new indication for a drug 
approved under section 505(b) and to help support or satisfy 
post-approval study requirements. Such program shall be 
implemented no later than two years after enactment. In 
parallel, FDA would identify and execute pilot demonstrations 
to extend existing use of the Sentinel System to, among other 
things, support these efforts. The Committee does not intend 
for anything in this section to be construed as prohibiting the 
Secretary from using evidence from clinical experience for 
purposes not specified in this section or in any way altering 
the standards of evidence required by the FFDCA or the PHS Act, 
or the Secretary's authority to require post-approval studies 
or clinical trials. Furthermore, the Committee believes that 
FDA's current safety surveillance activities using Sentinel are 
exempt under existing law, and that no inference should be 
drawn that the activities set forth in the provision, or 
similar activities, are not exempt under existing law.

Section 2063. Streamlined data review program

    Section 2063 would amend the FFDCA by adding section 505H, 
which would require the Secretary to establish a program 
authorizing the holder of an approved application to submit a 
summary of clinical data intended to support the approval or 
licensure of the drug for a new indication for the treatment of 
cancer or other types of indications as determined appropriate 
by the Secretary. The Committee believes that this program 
should enable FDA to make approval decisions for certain 
supplemental applications based on such qualified data 
summaries. In implementing the program, the Secretary is 
required to post on the FDA website and update annually the 
number of applications reviewed under the program, the average 
time for completion of reviews, and the number of applications 
for which FDA made use of full data sets in addition to the 
qualified data summary. Further, FDA is required to issue final 
guidance on implementing the program within two years of 
enactment, including the process for expanding the types of 
indications to be considered.

Section 2081. Sense of Congress

    Section 2081 reaffirms the Committee's belief that FDA 
should continue to expedite the approval of drugs designated as 
breakthrough therapies as early as possible in the clinical 
development process, provided that the Secretary determines 
that an application for a drug meets the required evidentiary 
standards of safety and effectiveness under the FFDCA.

Section 2082. Expanded access policy

Section 2083. Finalizing draft guidance on expanded access

    Expanded access programs provide a pathway for patients to 
gain access to investigational new drugs that have not been 
approved by the FDA. However, some patients encounter 
challenges navigating that. There are also scientific 
challenges regarding how adverse events experienced by patients 
should be used during FDA's review of a drug for safety and 
efficacy.
    Section 2082 would require certain manufacturers or 
distributors of an investigational drug to make publicly 
available, such as through a manufacturer's or distributor's 
web site, basic information on their expanded access policy. 
Such policy may apply generally to all of such manufacturer's 
or distributor's investigational drugs. The provision would not 
require such companies to offer a drug through an expanded 
access program or serve as a right to an expanded access 
program.
    Section 2083 would require the FDA to expedite guidance 
providing clarity to sponsors seeking drug approval regarding 
the consideration during the drug review process of adverse 
events experienced by patients receiving a drug through an 
expanded access program.

Section 2101. Facilitating dissemination of health care economic 
        information

    Section 2101 would amend section 502(a) of the FFDCA to 
clarify the scope of health care economic information drug 
manufacturers can permissibly disseminate to payors, formulary 
committees, or other similar entities.

Section 2102. Facilitating responsible communication of scientific and 
        medical developments

    Section 2102 would require the Secretary to issue draft 
guidance, no later than eighteen months from the date of 
enactment, to clarify how drug and device manufacturers can 
permissibly disseminate truthful and non-misleading scientific 
and medical information about a drug or device that is not 
included in the approved labeling for the product.

Section 2121. Approval of certain drugs for use in a limited population 
        of patients

Section 2122. Susceptibility test interpretive criteria for 
        microorganisms

Section 2123. Encouraging the development and use of antimicrobial 
        drugs

    This section would build off of the progress Congress made 
with the passage of the GAIN Act as a part of the Food and Drug 
Safety and Innovation Act (FDASIA) in 2012 by facilitating the 
development of new antibacterial or antifungal drugs through a 
new FDA approval pathway and creating economic incentives for 
new drug development.
    The Committee believes that antibiotic resistance remains a 
real and material public threat to the U.S. The unique nature 
of resistance means that every antimicrobial drug currently on 
the market is susceptible to drug resistance. The development 
of new and important treatments for patients with unmet medical 
needs therefore needs to continue if we are to stay ahead of 
the pace of antimicrobial resistance. The Committee thinks such 
development can benefit from regulatory improvements and 
increased Federal investments. Furthermore, the Committee 
recognizes that the prudent and appropriate use of 
antimicrobial drugs can help to prevent the development of 
resistance and maintain the effectiveness of these drugs.
    The Committee supports a limited population approval 
pathway that would allow the FDA, in partnership with 
developers, to develop a regulatory process that takes into 
account the nature of the product and the population of 
patients it is intended to treat as a means of reducing the 
time and investment needed to approve such drugs.
    In order for such a pathway to function appropriately, 
choosing such an approach over the traditional development 
pathway must be voluntary for both the sponsor and Agency. In 
addition, pursuit of approval for a limited population of 
patients under this pathway, with its commensurate 
requirements, should only begin upon completion of a formal 
written agreement between the sponsor and FDA.
    Products approved under this pathway are intended for use 
in limited populations of patients with infections for which 
there are few or no satisfactory treatment options available, 
most likely infections caused by multi-drug resistant 
organisms. The new tools that will be available to the Agency 
include labeling requirements that stipulate that the words 
``Limited Population'' be placed in a prominent manner and 
adjacent to the brand name on the product labeling. This 
branding element will assist in alerting the healthcare 
community about the additional uncertainty and risk associated 
with these products as a result of their streamlined 
development program. It also will assist FDA, CDC, and 
professional groups by educating healthcare providers that the 
risk-benefit profile for these drugs is different than for 
antimicrobial products approved under a traditional pathway and 
that these products should be used judiciously and only for 
patients with serious or life-threatening infections where 
other suitable, alternative therapies are not available.
    Section 2122 provides a streamlined mechanism for the 
incorporation of updated susceptibility interpretive criteria 
(`breakpoints') in antimicrobial susceptibility testing (AST) 
devices, and in their labeling. It does this by establishing an 
efficient and transparent process for FDA recognition of 
susceptibility test interpretive criteria, while maintaining 
FDA's rigorous review standards. AST devices use breakpoints to 
identify whether a pathogen is susceptible (likely to respond), 
intermediate, or resistant (not likely to respond) to the 
tested antimicrobial drugs. These breakpoints change over time 
because of the evolving nature of antimicrobial resistance. 
Given the urgent public health crisis caused by antimicrobial 
resistance, and the need to support the prudent and appropriate 
use of antimicrobial drugs, the Committee believes that AST 
devices must provide information based on up-to-date 
breakpoints for the wide range of pathogens seen in clinical 
practice, while directing healthcare providers to the labeling 
of antimicrobial drugs for information about their approved 
uses.
    The Committee also has put forward a new economic incentive 
through Medicare-payment policy for antimicrobial drugs 
developed to treat highly-resistant infections. In combination, 
the Committee intends that such efforts support the development 
of new and lifesaving antibiotic treatments.

Section 2141. Timely review of vaccines by the Advisory Committee on 
        Immunization Practices

    In addition to the challenging development environment for 
vaccines, vaccine manufacturers have an additional step in the 
development process; the Advisory Committee on Immunization 
Practices (ACIP) Recommendation process, which takes place 
following FDA licensure. ACIP working groups ``carefully review 
data available on the vaccine in order to make recommendations 
to ACIP'' and the 15 voting members of ACIP vote on their 
working groups recommendations before forwarding them to the 
CDC's Director for approval.\1\
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downloads/vacsafe-acip-color-office.pdf.
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    The Committee believes the working groups should have 
enough time to review the data and information to make an 
informed recommendation to ACIP, and that ACIP vote on such 
recommendations in a timely way to ensure patient access to 
these lifesaving vaccines. Under this section, ACIP would have 
to provide a decision or update the working groups' status at 
each scheduled meeting so manufacturers will be able to plan 
for vaccine distribution. If the Advisory Committee does not 
make recommendations regarding a vaccine at the first regularly 
scheduled meeting after licensure, the sponsor can request that 
the Advisory Committee make such recommendations on an 
expedited basis.

Section 2142. Review of processes and consistency of ACIP 
        recommendations

    This section would require the Director of the CDC to 
conduct a review of the process used by ACIP in order to 
evaluate ACIP's consistency in formulating and issuing 
recommendations pertaining to vaccines. Following such review, 
the CDC Director shall publish a report on the results of the 
review, including recommendations on improving the consistency 
of process.

Section 2143. Meetings between CDC and vaccine developers

    Currently, there is no formalized process for stakeholders 
to meet with CDC to understand the process for developing 
vaccines. This section would create and formalize processes for 
the making of vaccination scheduling recommendations by ACIP, 
for CDC review of ACIP recommendations, and for meetings 
between CDC and vaccine developers. These meetings will provide 
companies investing in vaccines more certainty and 
understanding when establishing investment and development 
plans.

Section 2151. Extension of exclusivity periods for a drug approved for 
        a new indication for a rare disease or condition

    Despite the success of the Orphan Drug Act in bringing 
drugs to market to patients facing diseases with smaller 
patient populations, most of the thirty million patients 
suffering from 7,000 rare diseases still have no treatment 
options. Ninety-five percent of rare diseases have no FDA-
approved treatment.
    Section 2151 would incentivize the repurposing of major 
market drugs for rare diseases--advancing safe and effective 
treatments and cures to patients facing these rare diseases. 
The provision would provide a one-time, six month extension of 
certain exclusivity periods and patent protection for an 
already-approved drug if the drug's sponsor obtains approval of 
a new indication for the drug for a rare disease or condition.

Section 2152. Reauthorization of rare pediatric disease priority review 
        voucher incentive program

    This section would reauthorize the rare pediatric disease 
priority review voucher (PRV) program through December 31, 
2018. The rare pediatric disease PRV program was established in 
FDASIA in order to encourage companies to invest in rare 
pediatric diseases. There are many challenges associated with 
pediatric drug development and even greater hurdles for rare 
pediatric diseases with small patient populations. The ability 
to sell such priority review vouchers was intended to provide 
an incentive to foster drug development for rare pediatric 
diseases.
    This section also would broaden the definition of a rare 
pediatric disease to ensure that pediatric oncology drugs and 
treatments for sickle cell disease are eligible for 
designation. The original legislation intended for these 
products to be included; but FDA found that it could not 
interpret the statutory language to include them. The draft 
guidance that FDA released on November 17, 2014, entitled 
``Rare Pediatric Disease Priority Review Vouchers,'' 
interpreted the definition of rare pediatric disease to mean 
greater than 50 percent of the affected population with the 
rare disease in the U.S. is aged 0 through 18 years. While many 
drugs have qualified for this program under this 
interpretation, including some drugs for pediatric cancers, 
this section broadens the definition to include more drugs for 
pediatric rare diseases, including drugs for a broader range of 
pediatric cancers and sickle cell disease.
    Finally, this provision requires the U.S. Government 
Accounting Office to complete a report evaluating the 
effectiveness of the program for encouraging drug development 
for rare pediatric diseases.

Section 2161. Grants for studying the process of continuous drug 
        manufacturing

    This section would allow FDA to award grants to higher 
education and non-profit organizations to study and recommend 
improvements to the process of continuous manufacturing (and 
other similar innovative monitoring and control techniques) of 
drugs and biologics.
    The Committee believes that continuous manufacturing 
advancements will make drug development less expensive and 
manufacturing more flexible, and improve the quality of drugs.

Section 2162. Re-exportation among members of the European Economic 
        Area

    Under current law, U.S. companies and manufacturers are 
limited in their ability to re-export controlled substances 
products within the European Economic Area. Section 2162 would 
allow U.S. pharmaceutical companies to re-export controlled 
substances similar to foreign pharmaceutical manufacturers, 
providing a level-playing field regarding controlled substances 
exports.

Section 2181. Enhancing combination products review

    Combination products are often at the cutting edge of 
innovation as they combine drugs, devices, and/or biological 
products. Section 2181 requires FDA to issue a final guidance 
document describing the role of all agency centers when 
reviewing a combination product

Section 2201. Priority review for breakthrough devices

    Section 2201 would add section 515B to the FFDCA, which 
would require the Secretary to establish a program to provide 
priority review for qualifying medical devices.
    Under this section, a sponsor would be able to request 
designation at any time prior to the submission of an 
application under section 515(c), a petition for classification 
under section 513(f)(2), or a notification under section 
510(k). No later than sixty days after the receipt of such a 
request, the Secretary shall determine whether the device 
qualifies based on criteria set forth in this section. For 
purposes of expediting the development and review of qualifying 
devices, this section would require the Secretary to take a 
number of actions, including the assignment of senior agency 
personnel to oversee the process.
    The Committee believes that this section is intended to 
encourage the Secretary and provide the Secretary with 
sufficient authorities to apply efficient and flexible 
approaches to expedite the development of, and prioritize the 
agency's review of, devices that represent breakthrough 
technologies.

Section 2221. Third-party quality system assessment

    Section 2221 would amend the FFDCA by adding section 524B. 
Section 524B would require the Secretary to establish a third-
party quality system assessment program to accredit persons to 
assess whether a requestor's quality system, including its 
design controls, can reasonably assure the safety and 
effectiveness of certain devices. This section would allow 
companies to make specified changes to devices or device 
manufacturing processes without prior FDA approval or clearance 
if their quality system has been assessed by an accredited 
person and deemed certified by the Secretary as being capable 
of evaluating such specified changes and ensuring the safety 
and effectiveness of the devices subject to such changes.
    A certification deemed accepted by the Secretary under 
proposed section 524B may be revoked upon a determination that 
the requestor's quality system no longer meets the 
certification criteria specified in the final guidance with 
respect to in-scope devices. As a result, any device-related 
changes made to an in-scope device subsequent to such a 
determination are subject to the applicable submission 
requirements. Any device that incorporates device-related 
changes implemented subsequent to the determination would be 
considered unapproved or uncleared, and thus may not serve as a 
legally marketed predicate until the Secretary has approved or 
cleared the changed device for marketing.

Section 2222. Valid scientific evidence

    Section 2222 would amend section 513(a)(3)(B) of the FFDCA 
to clarify that the Secretary, in the context of reviewing 
device submissions, may rely on registry data, studies 
published in peer-reviewed journals, and data collected in 
countries other than the U.S.

Section 2223. Training and oversight in least-burdensome appropriate 
        means concept

    Section 2223 would amend section 513 of the FFDCA and 
require that each FDA employee involved in the review of 
premarket device submissions under section 515 or section 
510(k) receive training on the ``least burdensome'' concept, 
which has been in statute since 1997. Further, FDA would be 
required to update its guidance and have an audit by the FDA 
ombudsman conducted on such training.

Section 2224. Recognition of standards

    Section 2224 would amend section 514(c) of the FFDCA to 
establish a process by which any person can request that the 
Secretary recognize all or part of an appropriate standard 
relating to devices that has been established by a nationally 
or internationally recognized standard setting organization. 
This section would require the Secretary, within sixty days of 
receiving such a request, to make a determination and issue a 
response in writing that explains the Secretary's rationale for 
such determination, including the scientific, technical, 
regulatory, or other basis, and to make such response publicly 
available as the Secretary determines appropriate. Further, 
section 2224 would require the Secretary to provide training on 
the use of such standards in device reviews and to issue 
guidance identifying principles for recognizing standards.

Section 2225. Easing regulatory burden with respect to certain Class I 
        and Class II devices

    Section 2225 would amend section 510(l) and (m) of the 
FFDCA to provide a process for the Secretary to identify, 
through publication in the Federal Register, certain types of 
class I and II devices the Secretary determines no longer 
require reports under section 510(k) to provide reasonable 
assurance of safety and effectiveness.

Section 2226. Advisory committee process

    Section 2226 would amend section 513(b) of the FFDCA to 
enable the more active participation of the person whose device 
is specifically the subject of the panel review. It would 
provide the sponsor the opportunity to make recommendations on 
the expertise needed among voting members of the panel and 
codify the Secretary's existing practice for giving due 
consideration to such recommendations. Further, the Secretary 
would be required to provide adequate time for initial 
presentations by the person whose device is specifically the 
subject of the classification panel review. The provisions in 
section 2226 apply only to panel meetings where a specific 
device is the subject, not panel meetings where an entire 
device type is the subject.
    For purposes of 513(b)(5)(B) and 513(b)(6)(A) and (B), as 
amended by section 2226, a device that is specifically the 
subject of review of a classification panel means a device that 
is the subject a premarket approval application, premarket 
notification (510(k)), de novo classification request, 
humanitarian device exemption application, or investigational 
device exemption application, or such other type of premarket 
submission as the Secretary in its sole discretion may specify, 
and which was referred to the panel for review.

Section 2227. Humanitarian device exemption application

    Section 2227 would amend section 520(m) of the FFDCA to 
provide the Secretary with the authority to apply the 
humanitarian device exemption to diseases and conditions that 
affect up to 8,000 individuals in the U.S.

Section 2228. CLIA waiver study design guidance for in vitro 
        diagnostics

    Section 2228 would require the Secretary to publish draft 
guidance within one year of enactment on the appropriate use of 
comparable performance between a waived user and a moderately 
complex laboratory user to demonstrate accuracy under the 
Clinical Laboratory Improvement Amendments of 1988 (CLIA). The 
Secretary would be required to finalize such guidance no later 
than one year after the comment period closes.

Section 2241. Health software

Section 2242. Applicability and inapplicability of regulation

Section 2243. Exclusion from definition of device

    Technological innovation around health software and 
wireless platforms such as smartphones hold great promise for 
the health care system. However, there are concerns related to 
the current regulatory approach for health technologies. 
Sections 2241, 2242, and 2243 would support further development 
in this field by updating the regulatory laws around software 
and creating clarity for developers and reviewers alike.
    The Committee believes that regulatory discretion is an 
important tool for FDA to keep up with the pace of innovation.
    The Committee believes that the ability to bring certainty 
and clarity to developers of software products will encourage 
further innovation in the health care sector. Software and 
hardware products are unique platforms and distinct enough from 
each other to warrant review of the ways in which software is 
approved by FDA to ensure such innovation in this sector 
continues long into the future.
    Further, the Committee believes that software-provided 
health-related information, in and of itself, is not a threat 
to the health and welfare of the public. As such, it should not 
on its own warrant FDA regulation. Save for those products 
designed to replace the judgment of a clinician, the Committee 
believes that the Federal government should take a cautious 
approach to regulation. The Committee believes that the clarity 
for developers that these provisions provide will support 
continued health information technology development in the 
health care sector for decades to come.

Section 2261. Protection of human subjects in research; applicability 
        of rules

    Section 2261 would require the Secretary to harmonize 
differences between the HHS Human Subject Regulations and the 
FDA Human Subject Regulations to simplify and facilitate 
researchers' compliance with applicable regulations for the 
protection of human subjects in research. Specifically, the 
Secretary would be required to make such modifications as may 
be necessary to reduce regulatory duplication and unnecessary 
delays, to modernize such provisions in the context of 
multisite and cooperative research projects, and to incorporate 
local considerations, community values, and mechanisms to 
protect vulnerable populations. Further, the Secretary would be 
required to issue such regulations and guidance and take such 
other actions as may be necessary to implement this section and 
help facilitate the broader use of single, central, or lead 
institutional review boards.
    This provision seeks to reduce regulatory duplication and 
delays for clinical trials by harmonizing the clinical trial 
rules imposed by HHS's Office of Human Research Protection 
(OHRP) and FDA, to the extent possible and consistent with 
other statutory provisions.

Section 2262. Use of non-local institutional review boards for review 
        of investigational device exemptions and human device 
        exemptions

    Section 2262 would amend section 520 of the FFDCA to remove 
the requirement to use local institutional review boards (IRB) 
for clinical testing of medical devices and the use of approved 
humanitarian use devices. By permitting the use of a central 
IRB in multi-site studies, when appropriate, such research can 
be facilitated and costs may be reduced, while still protecting 
the rights, safety, and welfare of study subjects. The ability 
to have non-local IRB review for approved humanitarian use 
devices should improve accessibility to these devices in 
facilities without an associated IRB, such as outpatient 
surgical clinics or small hospitals.

Section 2263. Alteration or waiver of informed consent for clinical 
        investigations

    Section 2263 would amend sections 520(g)(3) and 505(i)(4) 
of the FFDCA to specify that informed consent is not required 
for clinical testing of devices and drugs that pose no more 
than minimal risk to the human subjects and includes 
appropriate safeguards as prescribed by the Secretary to 
protect the rights, safety, and welfare of the participants.
    This provision will enable the FDA to further harmonize its 
regulations with the current Federal Policy for the Protection 
of Human Subjects (the Common Rule), by allowing a waiver of 
informed consent to conduct minimal-risk research under certain 
conditions, and in the absence of an emergency or serious or 
life-threatening risk to subjects, consistent with the Common 
Rule.

Section 2281. Silvio O. Conte Senior Biomedical Research Service

    This section would enable FDA to hire more efficiently and 
ensure that the agency has the staff required to ensure they 
keep up with the pace of innovation. One of the biggest 
challenges that FDA faces is hiring qualified and competitive 
individuals, and this provision enables the Agency to attract 
scientists that are designated as ``outstanding in their field 
of biomedical research, clinical research evaluation, and 
biomedical product assessment.'' Increasing the number of 
scientists in the biomedical research service will ensure that 
FDA can utilize the service to hire and retain experts in the 
biomedical field.

Section 2282. Enabling FDA scientific engagement

    This section expresses congressional support for 
eliminating barriers that prevent agency staff from attending 
scientific conferences and meetings. Allowing staff travel for 
their continued training and education will help the agency 
keep pace with the latest scientific developments. Such travel 
has been discouraged due to the resource intensive approval 
processes, which has negatively affected FDA's ability to 
review applications with the latest scientific knowledge.

Section 2283. Reagan-Udall Foundation for the Food and Drug 
        Administration

    The changes to the Reagan Udall Foundation (RUF) statute 
relate to issues of internal Foundation governance and 
management to ensure that RUF has access to the expertise and 
human capital it needs to fulfill its statutory mission of 
advancing FDA's scientific priorities. The section would 
clarify the ability of the RUF Board of Directors to expand the 
Board's size and add to the Board members of FDA Advisory 
Committees. It also would leave the matter of compensation for 
the RUF Executive Director to the discretion of the Board, as 
is the case with the Foundation for the NIH. These changes 
would help ensure that RUF has, both on its Board and in its 
senior management, persons who have the experience and skills 
to collaborate effectively with FDA in identifying and 
advancing RUF's core mission areas and who can be effective in 
locating the public and private resources needed to achieve 
those shared goals.
    RUF's purpose is to assist FDA in fulfilling its mission. 
Ensuring staff are educated and informed of what outside groups 
are doing and of the latest scientific innovation is essential 
to achieving that purpose.

Section 2284. Collection of certain voluntary information exempted from 
        Paperwork Reduction Act

    This section would exempt FDA from the PRA with respect to 
the collection from patients, industry, academia, and other 
stakeholders of voluntary information such as through voluntary 
surveys and questionnaires. This would enable FDA to more 
easily and efficiently receive patient input. The PRA has 
increased administrative burden at FDA, drained resources, and 
prohibited FDA from communicating effectively and efficiently 
with outside parties. Removing these burdens from FDA should 
enable the agency to utilize these resources for other 
important work.

Section 2285. Hiring authority for scientific, technical, and 
        professional personnel

    The Committee finds that, in order to have a modern and 
efficient regulatory system, FDA needs to have scientists 
trained and educated in the latest science and medical 
research. During the Subcommittee on Health hearing on H.R. 6, 
Janet Woodcock, M.D., Director of the Center for Drug 
Evaluation and Research at FDA, noted that hiring is a problem 
across FDA:

          The science right now is exploding; the new products 
        are extremely innovative. That is wonderful, but we 
        need to have some good scientists who can go toe-to-toe 
        with the best in industry, and industry can afford the 
        best scientists . . . we have extreme difficulty hiring 
        senior people who have worked outside the 
        government.\2\
---------------------------------------------------------------------------
    \2\http://docs.house.gov/neetings/IF/IF14/20150430/103400/HHRG-
1140IF14-Transcript020150430-U23.pdf.

    This provision would enable FDA to hire more efficiently by 
giving the agency broad and flexible new authority to recruit 
and retain the staff required to ensure that the agency keeps 
up with the pace of innovation. It also includes the ability to 
offer salaries competitive with those in the private sector and 
in academia. This authority is essential for FDA be able to 
hire in an effective manner and to avoid existing inefficient 
processes.

Section 2301. Exempting from sequestration certain user fees

    Section 2301 would permanently exempt the following FDA 
user fees from sequestration: fees for medical devices, 
prescription drugs, generics drugs, biosimilars, animal drugs, 
and generic animal drugs. This provision would provide 
certainty regarding access to FDA user fees and provide funding 
for drug and device review and other critical agency functions.

                          TITLE III--DELIVERY

Section 3001. Ensuring interoperability

    As evidenced by statements from numerous 21st Century Cures 
roundtable participants, the ability to share research and 
clinical data is a cornerstone of our drive for new cures. The 
Office of the National Coordinator (ONC) for Health Information 
Technology has led the charge, but recently has identified 
barriers to nationwide interoperability of health technology. 
Section 3001 would refocus national efforts on making systems 
interoperable and holding individuals responsible for blocking 
or otherwise inhibiting the flow of patient information 
throughout our healthcare system.

Section 3021. Telehealth service under the Medicare program

    The Energy and Commerce Bipartisan Telemedicine Member 
Working Group has been working to find a solution that has 
plagued Congress and our health system for decades: how to 
adopt new technologies into our delivery system in ways that 
promote greater quality care and fiscal integrity. Section 3021 
would support the efforts of the working group by requiring 
specific actions of government bodies identified as critical to 
developing a long-term solution to this problem.
    The Committee believes that continuing efforts to identify 
and adopt solutions that promote increased utilization of 
telemedicine services and technologies in the Medicare program 
is beneficial for Medicare beneficiaries. The Committee 
therefore will continue its efforts and those of the Bipartisan 
Working Group to effectuate such change.

Section 3041. Exempting from manufacturer transparency reporting 
        certain transfers used for educational purposes

    Section 3041 would amend section 1128G(e)(10)(B) of the 
Social Security Act to exempt certain transfers of value from 
reporting requirements that providers have noted had a chilling 
effect on their engagement in important continuing medical 
education activities.

Section 3061. Treatment of certain items and devices

    Today, seniors who receive their care in a home setting are 
not able to access certain services afforded others because of 
the nature of the durable medical equipment (DME) payment 
system. This section would ensure that those seniors receiving 
care in the home setting are not denied access to certain 
treatments that would otherwise be available to them based 
simply on the location in which they seek care.

Section 3081. Improvements in the Medicare local coverage determination 
        (LCD) process

    The local coverage determination (LCD) process is an 
important means by which seniors can access treatments that 
would not otherwise be covered by Medicare due to the length of 
time it takes for the national process to conclude its work. 
However, improvements are needed. Section 3081 would increase 
transparency around the LCD process and begin the process of 
bringing greater accountability to the actions of those 
contracting with the Centers for Medicare and Medicaid Services 
to manage the operation of the Medicare program.

Section 3101. Medicare pharmaceutical and technology ombudsman

    This section would create a new technology ombudsman within 
Medicare to address problems relating to coverage of new and 
life-saving technologies.

Section 3121. Medicare site-of-service price transparency

    The Medicare benefit currently pays varying rates for the 
same services depending on where they are delivered. As a 
result, seniors' out of pocket costs can be higher or lower for 
a given procedure based upon where the service is provided. 
This section would give seniors the ability to shop among 
certain sites of service for certain services so that they can 
identify the most cost-effective treatments. The Committee 
believes this is an important step in supporting seniors who 
wish to shop for the best value at the best cost.

Section 3141. Programs to prevent prescription drug abuse under 
        Medicare parts C and D

    This section would allow prescription drug plans in 
Medicare Part D to develop a safe prescribing and dispensing 
program for beneficiaries that are prescribed a high volume of 
controlled substances.

            TITLE IV--MEDICAID, MEDICARE, AND OTHER REFORMS

Section 4001. Limiting Federal Medicaid reimbursement to States for 
        durable medical equipment (DME) to Medicare payment rates

    Modeled after the policy in the President's FY 2016 budget 
and previous budget proposals from the Administration, this 
section would limit Federal matching funds for Medicaid 
payments for certain durable medical equipment, prosthetics, 
orthotics, and supplies (DMEPOS) to Medicare fee schedule 
rates, and where applicable, the market-based rates paid by 
Medicare under its competitive bidding program (CBP). The 
Federal upper payment limit established by this policy is not 
specific to payment for an individual DMEPOS claim, but would 
apply in the aggregate to classes of DMEPOS, as defined by the 
Secretary.
    This policy would take effect beginning January 1, 2020. 
The provision also directs the Medicare Ombudsman established 
by this legislation to evaluate the impact of this limit on 
Federal matching funds on beneficiary health status and 
outcomes. This policy should not be construed as limiting a 
State from covering or continuing to cover DME items that are 
not listed on the Medicare fee schedule. Rather, this policy 
establishes a Federal upper limit for DME in Medicaid to the 
applicable Medicare rate.

Section 4002. Medicare payment incentive for the transition from 
        traditional x-ray imaging to digital radiography and other 
        Medicare imaging payment provision

    Consistent with the Committee's goals of improving patient 
care and encouraging the adoption of innovative medical 
technologies, this section would implement differential 
Medicare reimbursement for film x-ray and computed radiography 
(CR) to incentivize the transition to digital radiography (DR). 
This policy would encourage providers' transition to modern 
digital technologies and improve patient safety and care as 
providers transition away from older technology, which may 
produce less detailed images, thus requiring another image to 
be taken which exposes patients to the negative clinical 
effects of additional scans. Additionally, as a matter of basic 
fairness and transparency, this policy would eliminate 
application of the multiple procedure payment reduction unless 
the Secretary conducts and publishes empirical analysis within 
the Medicare Physician Fee Schedule Proposed Rule in the prior 
year.

Section 4003. Implementation of Office of Inspector General 
        recommendations to delay certain Medicare prescription drug 
        plan prepayments

    Section 4003 would delay monthly reinsurance prepayments 
for prescription drug plans, beginning in January 2020. This 
policy implements an Office of Inspector General recommendation 
to adjust the timing of Medicare's prepayments to Medicare 
Advantage organizations to better reflect when payments are 
made to providers, as is currently the policy in the Federal 
Employees Health Benefits Program. However, this policy only 
applies to the reinsurance portion of the payment.

Section 4041. Cures Innovation Fund

    This section would establish a $110 million annual fund 
from FY 2016 through FY 2020 for research, regulatory 
modernization, and other activities authorized by the 21st 
Century Cures Act, including activities of FDA.

Section 4061. SPR drawdown

    This section would direct the Department of Energy to draw 
down and sell crude oil from the Strategic Petroleum Reserve 
(SPR).

Section 4081. Lyme disease and other tick-borne diseases

    This section would help to accelerate improved methods for 
prevention, diagnosis, and treatment of Lyme disease. It would 
establish a working group to prepare a report that would 
summarize Federal research efforts related to Lyme disease and 
other tick-borne diseases. Informed by the report prepared by 
the working group, the Secretary would develop a strategic plan 
to improve health outcomes.

         Changes in Existing Law Made by the Bill, as Reported

  In compliance with clause 3(e) of rule XIII of the Rules of 
the House of Representatives, changes in existing law made by 
the bill, as reported, are shown as follows (existing law 
proposed to be omitted is enclosed in black brackets, new 
matter is printed in italic, and existing law in which no 
change is proposed is shown in roman):

                       PUBLIC HEALTH SERVICE ACT



           *       *       *       *       *       *       *
         TITLE II--ADMINISTRATION AND MISCELLANEOUS PROVISIONS

Part A--Administration

           *       *       *       *       *       *       *


  silvio o. conte senior biomedical research  and biomedical product 
                           assessment service

  Sec. 228. (a)(1) There shall be in the Public Health Service 
a [Silvio O. Conte Senior Biomedical Research Service, not to 
exceed 500 members] Silvio O. Conte Senior Biomedical Research 
and Biomedical Product Assessment Service (in this section 
referred to as the ``Service''), the purpose of which is to 
recruit and retain competitive and qualified scientific and 
technical experts outstanding in the field of biomedical 
research, clinical research evaluation, and biomedical product 
assessment.
  [(2) The authority established in paragraph (1) regarding the 
number of members in the Silvio O. Conte Senior Biomedical 
Research Service is in addition to any authority established 
regarding the number of members in the commissioned Regular 
Corps, in the Reserve Corps, and in the Senior Executive 
Service. Such paragraph may not be construed to require that 
the number of members in the commissioned Regular Corps, in the 
Reserve Corps, or in the Senior Executive Service be reduced to 
offset the number of members serving in the Silvio O. Conte 
Senior Biomedical Research Service (in this section referred to 
as the ``Service'').]
  (2) The authority established in paragraph (1) may not be 
construed to require the Secretary to reduce the number of 
employees serving under any other employment system in order to 
offset the number of members serving in the Service.
  (b) The Service shall be appointed by the Secretary without 
regard to the provisions of title 5, United States Code, 
regarding appointment, and shall consist of individuals 
outstanding in the field of biomedical research [or clinical 
research evaluation], clinical research evaluation or 
biomedical product assessment. No individual may be appointed 
to the Service unless such individual (1) has earned a doctoral 
level degree in biomedicine or a related field, or a master's 
level degree in engineering, bioinformatics, or a related or 
emerging field, and (2) meets the qualification standards 
prescribed by the Office of Personnel Management for 
appointment to a position at GS-15 of the General Schedule. 
Notwithstanding any previous applicability to an individual who 
is a member of the Service, the provisions of subchapter I of 
chapter 35 (relating to retention preference), chapter 43 
(relating to performance appraisal and performance actions), 
chapter 51 (relating to classification), subchapter III of 
chapter 53 (relating to General Schedule pay rates), and 
chapter 75 (relating to adverse actions) of title 5, United 
States Code, shall not apply to any member of the Service.
  (c) The Secretary shall develop a performance appraisal 
system designed to--
          (1) provide for the systematic appraisal of the 
        performance of members, and
          (2) encourage excellence in performance by members.
  (d)(1) The Secretary shall determine, subject to the 
provisions of this subsection, the pay of members of the 
Service.
  (2) The pay of a member of the Service shall not be less than 
the minimum rate payable for GS-15 of the General Schedule [and 
shall not exceed the rate payable for level I of the Executive 
Schedule unless approved by the President under section 
5377(d)(2) of title 5, United States Code] and shall not exceed 
the rate payable for the President.
  [(e) The Secretary may, upon the request of a member who--
          [(1) performed service in the employ of an 
        institution of higher education immediately prior to 
        his appointment as a member of the Service, and
          [(2) retains the right to continue to make 
        contributions to the retirement system of such 
        institution,
contribute an amount not to exceed 10 percent per annum of the 
member's basic pay to such institution's retirement system on 
behalf of such member. A member who requests that such 
contribution be made shall not be covered by, or earn service 
credit under, any retirement system established for employees 
of the United States under title 5, United States Code, but 
such service shall be creditable for determining years of 
service under section 6303(a) of such title.]
  [(f)] (e) Subject to the following sentence, the Secretary 
may, notwithstanding the provisions of title 5, United States 
Code, regarding appointment, appoint an individual who is 
separated from the Service involuntarily and without cause to a 
position in the competitive civil service at GS-15 of the 
General Schedule, and such appointment shall be a career 
appointment. In the case of such an individual who immediately 
prior to his appointment to the Service was not a career 
appointee in the civil service or the Senior Executive Service, 
such appointment shall be in the excepted civil service and may 
not exceed a period of 2 years.
  [(g)] (f) The Secretary shall promulgate such rules and 
regulations, not inconsistent with this section, as may be 
necessary for the efficient administration of the Service.

           *       *       *       *       *       *       *


SEC. 229A. DATA ON NATURAL HISTORY OF DISEASES.

  (a) In General.--The Secretary may, for the purposes 
described in subsection (b)--
          (1) participate in public-private partnerships 
        engaged in one or more activities specified in 
        subsection (c); and
          (2) award grants to patient advocacy groups or other 
        organizations determined appropriate by the Secretary.
  (b) Purposes Described.--The purposes described in this 
subsection are to establish or facilitate the collection, 
maintenance, analysis, and interpretation of data regarding the 
natural history of diseases, with a particular focus on rare 
diseases.
  (c) Activities of Public-Private Partnerships.--The 
activities of public-private partnerships in which the 
Secretary may participate for purposes of this section 
include--
          (1) cooperating with other entities that sponsor or 
        maintain disease registries, including disease 
        registries and disease registry platforms for rare 
        diseases;
          (2) developing or enhancing a secure information 
        technology system that--
                  (A) has the capacity to support data needs 
                across a wide range of disease studies;
                  (B) is easily modified as knowledge is gained 
                during such studies; and
                  (C) is capable of handling increasing amounts 
                of data as more studies are carried out; and
          (3) providing advice to clinical researchers, patient 
        advocacy groups, and other entities with respect to--
                  (A) the design and conduct of disease 
                studies;
                  (B) the modification of any such ongoing 
                studies; and
                  (C) addressing associated patient privacy 
                issues.
  (d) Availability of Data on Natural History of Diseases.--
Data relating to the natural history of diseases obtained, 
aggregated, or otherwise maintained by a public-private 
partnership in which the Secretary participates under 
subsection (a) shall be made available, consistent with 
otherwise applicable Federal and State privacy laws, to the 
public (including patient advocacy groups, researchers, and 
drug developers) to help to facilitate and expedite medical 
product development programs.
  (e) Confidentiality.--Notwithstanding subsection (d), nothing 
in this section authorizes the disclosure of any information 
that is a trade secret or commercial or financial information 
that is privileged or confidential and subject to section 
552(b)(4) of title 5, United States Code, or section 1905 of 
title 18, United States Code.
  (f) Authorization of Appropriations.--There is authorized to 
be appropriated to carry out this section $5,000,000 for each 
of fiscal years 2016 through 2020.

           *       *       *       *       *       *       *


                 PART E--COUNCIL FOR 21ST CENTURY CURES

SEC. 281. ESTABLISHMENT.

  A nonprofit corporation to be known as the Council for 21st 
Century Cures (referred to in this part as the ``Council'') 
shall be established in accordance with this section. The 
Council shall be a public-private partnership headed by an 
Executive Director (referred to in this part as the ``Executive 
Director''), appointed by the members of the Board of 
Directors. The Council shall not be an agency or 
instrumentality of the United States Government.

SEC. 281A. PURPOSE.

  The purpose of the Council is to accelerate the discovery, 
development, and delivery in the United States of innovative 
cures, treatments, and preventive measures for patients.

SEC. 281B. DUTIES.

  For the purpose described in section 281A, the Council 
shall--
          (1) foster collaboration and coordination among the 
        entities that comprise the Council, including academia, 
        government agencies, industry, health care payors and 
        providers, patient advocates, and others engaged in the 
        cycle of discovery, development, and delivery of life-
        saving and health-enhancing innovative interventions;
          (2) undertake communication and dissemination 
        activities;
          (3) publish information on the activities funded 
        under section 281D;
          (4) establish a strategic agenda for accelerating the 
        discovery, development, and delivery in the United 
        States of innovative cures, treatments, and preventive 
        measures for patients;
          (5) identify gaps and opportunities within and across 
        the discovery, development, and delivery cycle;
          (6) develop and propose recommendations based on the 
        gaps and opportunities so identified;
          (7) facilitate the interoperability of the components 
        of the discovery, development, and delivery cycle;
          (8) propose recommendations that will facilitate 
        precompetitive collaboration;
          (9) identify opportunities to work with, but not 
        duplicate the efforts of, nonprofit organizations and 
        other public-private partnerships; and
          (10) identify opportunities for collaboration with 
        organizations operating outside of the United States, 
        such as the Innovative Medicines Initiative of the 
        European Union.

SEC. 281C. ORGANIZATION; ADMINISTRATION.

  (a) Board of Directors.--
          (1) Establishment.--
                  (A) In general.--The Council shall have a 
                Board of Directors (in this part referred to as 
                the ``Board of Directors''), which shall be 
                composed of the ex officio members under 
                subparagraph (B) and the appointed members 
                under subparagraph (C). All members of the 
                Board shall be voting members.
                  (B) Ex officio members.--The ex officio 
                members of the Board shall be the following 
                individuals or their designees:
                          (i) The Director of the National 
                        Institutes of Health.
                          (ii) The Commissioner of Food and 
                        Drugs.
                          (iii) The Administrator of the 
                        Centers for Medicare & Medicaid 
                        Services.
                          (iv) The heads of five other Federal 
                        agencies deemed by the Secretary to be 
                        engaged in biomedical research and 
                        development.
                  (C) Appointed members.--The appointed members 
                of the Board shall consist of 17 individuals, 
                of whom--
                          (i) 8 shall be appointed by the 
                        Comptroller General of the United 
                        States from a list of nominations 
                        submitted by leading trade 
                        associations--
                                  (I) 4 of whom shall be 
                                representatives of the 
                                biopharmaceutical industry;
                                  (II) 2 of whom shall be 
                                representatives of the medical 
                                device industry; and
                                  (III) 2 of whom shall be 
                                representatives of the 
                                information and digital 
                                technology industry; and
                          (ii) 9 shall be appointed by the 
                        Comptroller General of the United 
                        States, after soliciting nominations--
                                  (I) 2 of whom shall be 
                                representatives of academic 
                                researchers;
                                  (II) 3 of whom shall be 
                                representatives of patients;
                                  (III) 2 of whom shall be 
                                representatives of health care 
                                providers; and
                                  (IV) 2 of whom shall be 
                                representatives of health care 
                                plans and insurers.
                  (D) Chair.--The Chair of the Board shall be 
                selected by the members of the Board by 
                majority vote from among the members of the 
                Board.
          (2) Terms and vacancies.--
                  (A) In general.--The term of office of each 
                member of the Board appointed under paragraph 
                (1)(C) shall be 5 years.
                  (B) Vacancy.--Any vacancy in the membership 
                of the Board--
                          (i) shall not affect the power of the 
                        remaining members to execute the duties 
                        of the Board; and
                          (ii) shall be filled by appointment 
                        by the appointed members described in 
                        paragraph (1)(C) by majority vote.
                  (C) Partial term.--If a member of the Board 
                does not serve the full term applicable under 
                subparagraph (A), the individual appointed 
                under subparagraph (B) to fill the resulting 
                vacancy shall be appointed for the remainder of 
                the term of the predecessor of the individual.
          (3) Responsibilities.--Not later than 90 days after 
        the date on which the Council is incorporated and its 
        Board of Directors is fully constituted, the Board of 
        Directors shall establish bylaws and policies for the 
        Council that--
                  (A) are published in the Federal Register and 
                available for public comment;
                  (B) establish policies for the selection and, 
                as applicable, appointment of--
                          (i) the officers, employees, agents, 
                        and contractors of the Council; and
                          (ii) the members of any committees of 
                        the Council;
                  (C) establish policies, including ethical 
                standards, for the conduct of programs and 
                other activities under section 281D; and
                  (D) establish specific duties of the 
                Executive Director.
          (4) Meetings.--
                  (A) In general.--The Board of Directors 
                shall--
                          (i) meet on a quarterly basis; and
                          (ii) submit to Congress, and make 
                        publicly available, the minutes of such 
                        meetings.
                  (B) Agenda.--The Board of Directors shall, 
                not later than 3 months after the incorporation 
                of the Council--
                          (i) issue an agenda (in this part 
                        referred to as the ``agenda'') 
                        outlining how the Council will achieve 
                        the purpose described in section 281A; 
                        and
                          (ii) annually thereafter, in 
                        consultation with the Executive 
                        Director, review and update such 
                        agenda.
  (b) Appointment and Incorporation.--Not later than 6 months 
after the date of enactment of the 21st Century Cures Act--
          (1) the Comptroller General of the United States 
        shall appoint the appointed members of the Board of 
        Directors under subsection (a)(1)(C); and
          (2) the ex officio members of the Board of Directors 
        under subsection (a)(1)(B) shall serve as incorporators 
        and shall take whatever actions are necessary to 
        incorporate the Council.
  (c) Nonprofit Status.--In carrying out this part, the Board 
of Directors shall establish such policies and bylaws, and the 
Executive Director shall carry out such activities, as may be 
necessary to ensure that the Council maintains status as an 
organization that--
          (1) is described in subsection (c)(3) of section 501 
        of the Internal Revenue Code of 1986; and
          (2) is, under subsection (a) of such section, exempt 
        from taxation.
  (d) Executive Director.--The Executive Director shall--
          (1) be the chief executive officer of the Council; 
        and
          (2) subject to the oversight of the Board of 
        Directors, be responsible for the day-to-day management 
        of the Council.

SEC. 281D. OPERATIONAL ACTIVITIES AND ASSISTANCE.

  (a) In General.--The Council shall establish a sufficient 
operational infrastructure to fulfill the duties specified in 
section 281B.
  (b) Private Sector Matching Funds.--The Council may accept 
financial or in-kind support from participating entities or 
private foundations or organizations when such support is 
deemed appropriate.

SEC. 281E. TERMINATION; REPORT.

  (a) In General.--The Council shall terminate on September 30, 
2023.
  (b) Report.--Not later than one year after the date on which 
the Council is established and each year thereafter, the 
Executive Director shall submit to the appropriate 
congressional committees a report on the performance of the 
Council. In preparing such report, the Council shall consult 
with a nongovernmental consultant with appropriate expertise.

SEC. 281F. FUNDING.

  For the each of fiscal years 2016 through 2023, there is 
authorized to be appropriated $10,000,000 to the Council for 
purposes of carrying out the duties of the Council under this 
part.

     TITLE III--GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE

Part A--Research and Investigation

           *       *       *       *       *       *       *


          health conferences and health education information

  Sec. 310. (a) A conference of the health authorities in and 
among the several States shall be called annually by the 
Secretary. Whenever in his opinion the interests of the public 
health would be promoted by a conference, the Secretary may 
invite as many of such health authorities and officials of 
other State or local public or private agencies, institutions, 
or organizations to confer as he deems necessary or proper. 
Upon the application of health authorities of five or more 
States it shall be the duty of the Secretary to call a 
conference of all State health authorities joining in the 
request. Each State represented at any conference shall be 
entitled to a single vote. Whenever at any such conference 
matters relating to mental health are to be discussed, the 
mental health authorities of the respective States shall be 
invited to attend.
  (b) From time to time the Secretary shall issue information 
related to public health, in the form of publications or 
otherwise, for the use of the public, and shall publish weekly 
reports of health conditions in the United States and other 
countries and other pertinent health information for the use of 
persons and institutions concerned with health services.
  (c)(1) In this subsection, the term ``vaccine developer'' 
means a nongovernmental entity engaged in--
          (A)(i) the development of a vaccine with the intent 
        to pursue licensing of the vaccine by the Food and Drug 
        Administration; or
          (ii) the production of a vaccine licensed by the Food 
        and Drug Administration; and
          (B) vaccine research.
  (2)(A) Upon the submission of a written request for a meeting 
by a vaccine developer, that includes a justification for the 
meeting, the Secretary, acting through the Director of the 
Centers for Disease Control and Prevention, shall convene a 
meeting of representatives of the vaccine developer and experts 
from the Centers for Disease Control and Prevention in 
immunization programs, epidemiology, and other relevant areas 
at which the Director (or the Director's designee), for the 
purpose of informing the vaccine developer's understanding of 
public health needs and priorities, shall provide the 
perspectives of the Centers for Disease Control and Prevention 
and other relevant Federal agencies regarding--
          (i) public health needs, epidemiology, and 
        implementation considerations with regard to a vaccine 
        developer's potential vaccine profile; and
          (ii) potential implications of such perspectives for 
        the vaccine developer's vaccine research and 
        development planning.
  (B) In addition to the representatives specified in 
subparagraph (A), the Secretary may, with the agreement of the 
vaccine developer requesting a meeting under such subparagraph, 
include in such meeting representatives of--
          (i) the Food and Drug Administration; and
          (ii) the National Vaccine Program.
  (C) The Secretary shall convene a meeting requested under 
subparagraph (A) not later than 120 days after receipt of the 
request for the meeting.
  (3)(A) Upon the submission of a written request by a vaccine 
developer, the Secretary, acting through the Director of the 
Centers for Disease Control and Prevention, shall provide to 
the vaccine developer any age-based or other demographically 
assessed disease epidemiological analyses or data that--
          (i) are specified in the request;
          (ii) have been published;
          (iii) have been performed by or are in the possession 
        of the Centers;
          (iv) are not a trade secret or commercial or 
        financial information that is privileged or 
        confidential and subject to section 552(b)(4) of title 
        5, United States Code, or section 1905 of title 18, 
        United States Code; and
          (v) do not contain individually identifiable 
        information.
  (B) The Secretary shall provide analyses requested by a 
vaccine manufacturer under subparagraph (A) not later than 120 
calendar days after receipt of the request for the analyses.
  (4) The Secretary shall promptly notify a vaccine developer 
if--
          (A) the Secretary becomes aware of any change to 
        information that was--
                  (i) shared by the Secretary with the vaccine 
                developer during a meeting under paragraph (2); 
                or
                  (ii) provided by the Secretary to the vaccine 
                developer in one or more analyses under 
                paragraph (3); and
          (B) the change to such information may have 
        implications for the vaccine developer's vaccine 
        research and development.

           *       *       *       *       *       *       *


Part B--Federal-State Cooperation

           *       *       *       *       *       *       *


SEC. 317U. MONITORING ANTIBACTERIAL AND ANTIFUNGAL DRUG USE AND 
                    RESISTANCE.

  (a) Monitoring.--The Secretary shall use an appropriate 
monitoring system to monitor--
          (1) the use of antibacterial and antifungal drugs, 
        including those receiving approval or licensure for a 
        limited population pursuant to section 505(z) of the 
        Federal Food, Drug, and Cosmetic Act; and
          (2) changes in bacterial and fungal resistance to 
        drugs.
  (b) Public Availability of Data.--The Secretary shall make 
summaries of the data derived from monitoring under this 
section publicly available for the purposes of--
          (1) improving the monitoring of important trends in 
        antibacterial and antifungal resistance; and
          (2) ensuring appropriate stewardship of antibacterial 
        and antifungal drugs, including those receiving 
        approval or licensure for a limited population pursuant 
        to section 505(z) of the Federal Food, Drug, and 
        Cosmetic Act.

           *       *       *       *       *       *       *


    Part F--Licensing--Biological Products and Clinical Laboratories

                     Subpart 1--Biological Products

                   regulation of biological products

  Sec. 351. (a)(1) No person shall introduce or deliver for 
introduction into interstate commerce any biological product 
unless--
          (A) a biologics license under this subsection or 
        subsection (k) is in effect for the biological product; 
        and
          (B) each package of the biological product is plainly 
        marked with--
                  (i) the proper name of the biological product 
                contained in the package;
                  (ii) the name, address, and applicable 
                license number of the manufacturer of the 
                biological product; and
                  (iii) the expiration date of the biological 
                product.
  (2)(A) The Secretary shall establish, by regulation, 
requirements for the approval, suspension, and revocation of 
biologics licenses.
          (B) Pediatric studies.--A person that submits an 
        application for a license under this paragraph shall 
        submit to the Secretary as part of the application any 
        assessments required under section 505B of the Federal 
        Food, Drug, and Cosmetic Act.
  (C) The Secretary shall approve a biologics license 
application--
          (i) on the basis of a demonstration that--
                  (I) the biological product that is the 
                subject of the application is safe, pure, and 
                potent; and
                  (II) the facility in which the biological 
                product is manufactured, processed, packed, or 
                held meets standards designed to assure that 
                the biological product continues to be safe, 
                pure, and potent; and
          (ii) if the applicant (or other appropriate person) 
        consents to the inspection of the facility that is the 
        subject of the application, in accordance with 
        subsection (c).
  (D) Postmarket Studies and Clinical Trials; Labeling; Risk 
Evaluation and Mitigation Strategy.--A person that submits an 
application for a license under this paragraph is subject to 
sections 505(o), 505(p), and 505-1 of the Federal Food, Drug, 
and Cosmetic Act.
  (3) The Secretary shall prescribe requirements under which a 
biological product undergoing investigation shall be exempt 
from the requirements of paragraph (1).
  (b) No person shall falsely label or mark any package or 
container of any biological product or alter any label or mark 
on the package or container of the biological product so as to 
falsify the label or mark.
  (c) Any officer, agent, or employee of the Department of 
Health and Human Services, authorized by the Secretary for the 
purpose, may during all reasonable hours enter and inspect any 
establishment for the propagation or manufacture and 
preparation of any biological product.
  (d)(1) Upon a determination that a batch, lot, or other 
quantity of a product licensed under this section presents an 
imminent or substantial hazard to the public health, the 
Secretary shall issue an order immediately ordering the recall 
of such batch, lot, or other quantity of such product. An order 
under this paragraph shall be issued in accordance with section 
554 of title 5, United States Code.
  (2) Any violation of paragraph (1) shall subject the violator 
to a civil penalty of up to $100,000 per day of violation. The 
amount of a civil penalty under this paragraph shall, effective 
December 1 of each year beginning 1 year after the effective 
date of this paragraph, be increased by the percent change in 
the Consumer Price Index for the base quarter of such year over 
the Consumer Price Index for the base quarter of the preceding 
year, adjusted to the nearest \1/10\ of 1 percent. For purposes 
of this paragraph, the term ``base quarter'', as used with 
respect to a year, means the calendar quarter ending on 
September 30 of such year and the price index for a base 
quarter is the arithmetical mean of such index for the 3 months 
comprising such quarter.
  (e) No person shall interfere with any officer, agent, or 
employee of the Service in the performance of any duty imposed 
upon him by this section or by regulations made by authority 
thereof.
  (f) Any person who shall violate, or aid or abet in 
violating, any of the provisions of this section shall be 
punished upon conviction by a fine not exceeding $500 or by 
imprisonment not exceeding one year, or by both such fine and 
imprisonment, in the discretion of the court.
  (g) Nothing contained in this Act shall be construed as in 
any way affecting, modifying, repealing, or superseding the 
provisions of the Federal Food, Drug, and Cosmetic Act (U.S.C., 
1940 edition, title 21, ch. 9).
  (h) A partially processed biological product which--
          (1) is not in a form applicable to the prevention, 
        treatment, or cure of diseases or injuries of man;
          (2) is not intended for sale in the United States; 
        and
          (3) is intended for further manufacture into final 
        dosage form outside the United States,
shall be subject to no restriction on the export of the product 
under this Act or the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321 et. seq.) if the product is manufactured, processed, 
packaged, and held in conformity with current good 
manufacturing practice requirements or meets international 
manufacturing standards as certified by an international 
standards organization recognized by the Secretary and meets 
the requirements of section 801(e)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 381(e)).
  (i) In this section:
          (1) The term ``biological product'' means a virus, 
        therapeutic serum, toxin, antitoxin, vaccine, blood, 
        blood component or derivative, allergenic product, 
        protein (except any chemically synthesized 
        polypeptide), or analogous product, or arsphenamine or 
        derivative of arsphenamine (or any other trivalent 
        organic arsenic compound), applicable to the 
        prevention, treatment, or cure of a disease or 
        condition of human beings.
          (2) The term ``biosimilar'' or ``biosimilarity'', in 
        reference to a biological product that is the subject 
        of an application under subsection (k), means--
                  (A) that the biological product is highly 
                similar to the reference product 
                notwithstanding minor differences in clinically 
                inactive components; and
                  (B) there are no clinically meaningful 
                differences between the biological product and 
                the reference product in terms of the safety, 
                purity, and potency of the product.
          (3) The term ``interchangeable'' or 
        ``interchangeability'', in reference to a biological 
        product that is shown to meet the standards described 
        in subsection (k)(4), means that the biological product 
        may be substituted for the reference product without 
        the intervention of the health care provider who 
        prescribed the reference product.
          (4) The term ``reference product'' means the single 
        biological product licensed under subsection (a) 
        against which a biological product is evaluated in an 
        application submitted under subsection (k).
  (j)(1) The Federal Food, Drug, and Cosmetic Act, including 
the requirements under sections 505(o), 505(p), 505(z), and 
505-1 of such Act, applies to a biological product subject to 
regulation under this section, except that a product for which 
a license has been approved under subsection (a) shall not be 
required to have an approved application under section 505 of 
such Act.
  (2) In applying section 505(z) of the Federal Food, Drug, and 
Cosmetic Act to the licensure of biological products under this 
section--
          (A) references to an antibacterial or antifungal drug 
        that is intended to treat a serious or life-threatening 
        infection shall be construed to refer to a biological 
        product intended to treat a serious or life-threatening 
        bacterial or fungal infection; and
          (B) references to approval of a drug under section 
        505(c) of such Act shall be construed to refer to a 
        licensure of a biological product under subsection (a) 
        of this section.
  (k) Licensure of Biological Products as Biosimilar or 
Interchangeable.--
          (1) In general.--Any person may submit an application 
        for licensure of a biological product under this 
        subsection.
          (2) Content.--
                  (A) In general.--
                          (i) Required information.--An 
                        application submitted under this 
                        subsection shall include information 
                        demonstrating that--
                                  (I) the biological product is 
                                biosimilar to a reference 
                                product based upon data derived 
                                from--
                                          (aa) analytical 
                                        studies that 
                                        demonstrate that the 
                                        biological product is 
                                        highly similar to the 
                                        reference product 
                                        notwithstanding minor 
                                        differences in 
                                        clinically inactive 
                                        components;
                                          (bb) animal studies 
                                        (including the 
                                        assessment of 
                                        toxicity); and
                                          (cc) a clinical study 
                                        or studies (including 
                                        the assessment of 
                                        immunogenicity and 
                                        pharmacokinetics or 
                                        pharmacodynamics) that 
                                        are sufficient to 
                                        demonstrate safety, 
                                        purity, and potency in 
                                        1 or more appropriate 
                                        conditions of use for 
                                        which the reference 
                                        product is licensed and 
                                        intended to be used and 
                                        for which licensure is 
                                        sought for the 
                                        biological product;
                                  (II) the biological product 
                                and reference product utilize 
                                the same mechanism or 
                                mechanisms of action for the 
                                condition or conditions of use 
                                prescribed, recommended, or 
                                suggested in the proposed 
                                labeling, but only to the 
                                extent the mechanism or 
                                mechanisms of action are known 
                                for the reference product;
                                  (III) the condition or 
                                conditions of use prescribed, 
                                recommended, or suggested in 
                                the labeling proposed for the 
                                biological product have been 
                                previously approved for the 
                                reference product;
                                  (IV) the route of 
                                administration, the dosage 
                                form, and the strength of the 
                                biological product are the same 
                                as those of the reference 
                                product; and
                                  (V) the facility in which the 
                                biological product is 
                                manufactured, processed, 
                                packed, or held meets standards 
                                designed to assure that the 
                                biological product continues to 
                                be safe, pure, and potent.
                          (ii) Determination by secretary.--The 
                        Secretary may determine, in the 
                        Secretary's discretion, that an element 
                        described in clause (i)(I) is 
                        unnecessary in an application submitted 
                        under this subsection.
                          (iii) Additional information.--An 
                        application submitted under this 
                        subsection--
                                  (I) shall include publicly-
                                available information regarding 
                                the Secretary's previous 
                                determination that the 
                                reference product is safe, 
                                pure, and potent; and
                                  (II) may include any 
                                additional information in 
                                support of the application, 
                                including publicly-available 
                                information with respect to the 
                                reference product or another 
                                biological product.
                  (B) Interchangeability.--An application (or a 
                supplement to an application) submitted under 
                this subsection may include information 
                demonstrating that the biological product meets 
                the standards described in paragraph (4).
          (3) Evaluation by secretary.--Upon review of an 
        application (or a supplement to an application) 
        submitted under this subsection, the Secretary shall 
        license the biological product under this subsection 
        if--
                  (A) the Secretary determines that the 
                information submitted in the application (or 
                the supplement) is sufficient to show that the 
                biological product--
                          (i) is biosimilar to the reference 
                        product; or
                          (ii) meets the standards described in 
                        paragraph (4), and therefore is 
                        interchangeable with the reference 
                        product; and
                  (B) the applicant (or other appropriate 
                person) consents to the inspection of the 
                facility that is the subject of the 
                application, in accordance with subsection (c).
          (4) Safety standards for determining 
        interchangeability.--Upon review of an application 
        submitted under this subsection or any supplement to 
        such application, the Secretary shall determine the 
        biological product to be interchangeable with the 
        reference product if the Secretary determines that the 
        information submitted in the application (or a 
        supplement to such application) is sufficient to show 
        that--
                  (A) the biological product--
                          (i) is biosimilar to the reference 
                        product; and
                          (ii) can be expected to produce the 
                        same clinical result as the reference 
                        product in any given patient; and
                  (B) for a biological product that is 
                administered more than once to an individual, 
                the risk in terms of safety or diminished 
                efficacy of alternating or switching between 
                use of the biological product and the reference 
                product is not greater than the risk of using 
                the reference product without such alternation 
                or switch.
          (5) General rules.--
                  (A) One reference product per application.--A 
                biological product, in an application submitted 
                under this subsection, may not be evaluated 
                against more than 1 reference product.
                  (B) Review.--An application submitted under 
                this subsection shall be reviewed by the 
                division within the Food and Drug 
                Administration that is responsible for the 
                review and approval of the application under 
                which the reference product is licensed.
                  (C) Risk evaluation and mitigation 
                strategies.--The authority of the Secretary 
                with respect to risk evaluation and mitigation 
                strategies under the Federal Food, Drug, and 
                Cosmetic Act shall apply to biological products 
                licensed under this subsection in the same 
                manner as such authority applies to biological 
                products licensed under subsection (a).
          (6) Exclusivity for first interchangeable biological 
        product.--Upon review of an application submitted under 
        this subsection relying on the same reference product 
        for which a prior biological product has received a 
        determination of interchangeability for any condition 
        of use, the Secretary shall not make a determination 
        under paragraph (4) that the second or subsequent 
        biological product is interchangeable for any condition 
        of use until the earlier of--
                  (A) 1 year after the first commercial 
                marketing of the first interchangeable 
                biosimilar biological product to be approved as 
                interchangeable for that reference product;
                  (B) 18 months after--
                          (i) a final court decision on all 
                        patents in suit in an action instituted 
                        under subsection (l)(6) against the 
                        applicant that submitted the 
                        application for the first approved 
                        interchangeable biosimilar biological 
                        product; or
                          (ii) the dismissal with or without 
                        prejudice of an action instituted under 
                        subsection (l)(6) against the applicant 
                        that submitted the application for the 
                        first approved interchangeable 
                        biosimilar biological product; or
                  (C)(i) 42 months after approval of the first 
                interchangeable biosimilar biological product 
                if the applicant that submitted such 
                application has been sued under subsection 
                (l)(6) and such litigation is still ongoing 
                within such 42-month period; or
                  (ii) 18 months after approval of the first 
                interchangeable biosimilar biological product 
                if the applicant that submitted such 
                application has not been sued under subsection 
                (l)(6).
        For purposes of this paragraph, the term ``final court 
        decision'' means a final decision of a court from which 
        no appeal (other than a petition to the United States 
        Supreme Court for a writ of certiorari) has been or can 
        be taken.
          (7) Exclusivity for reference product.--
                  (A) Effective date of biosimilar application 
                approval.--Approval of an application under 
                this subsection may not be made effective by 
                the Secretary until the date that is 12 years 
                after the date on which the reference product 
                was first licensed under subsection (a).
                  (B) Filing period.--An application under this 
                subsection may not be submitted to the 
                Secretary until the date that is 4 years after 
                the date on which the reference product was 
                first licensed under subsection (a).
                  (C) First licensure.--Subparagraphs (A) and 
                (B) shall not apply to a license for or 
                approval of--
                          (i) a supplement for the biological 
                        product that is the reference product; 
                        or
                          (ii) a subsequent application filed 
                        by the same sponsor or manufacturer of 
                        the biological product that is the 
                        reference product (or a licensor, 
                        predecessor in interest, or other 
                        related entity) for--
                                  (I) a change (not including a 
                                modification to the structure 
                                of the biological product) that 
                                results in a new indication, 
                                route of administration, dosing 
                                schedule, dosage form, delivery 
                                system, delivery device, or 
                                strength; or
                                  (II) a modification to the 
                                structure of the biological 
                                product that does not result in 
                                a change in safety, purity, or 
                                potency.
          (8) Guidance documents.--
                  (A) In general.--The Secretary may, after 
                opportunity for public comment, issue guidance 
                in accordance, except as provided in 
                subparagraph (B)(i), with section 701(h) of the 
                Federal Food, Drug, and Cosmetic Act with 
                respect to the licensure of a biological 
                product under this subsection. Any such 
                guidance may be general or specific.
                  (B) Public comment.--
                          (i) In general.--The Secretary shall 
                        provide the public an opportunity to 
                        comment on any proposed guidance issued 
                        under subparagraph (A) before issuing 
                        final guidance.
                          (ii) Input regarding most valuable 
                        guidance.--The Secretary shall 
                        establish a process through which the 
                        public may provide the Secretary with 
                        input regarding priorities for issuing 
                        guidance.
                  (C) No requirement for application 
                consideration.--The issuance (or non-issuance) 
                of guidance under subparagraph (A) shall not 
                preclude the review of, or action on, an 
                application submitted under this subsection.
                  (D) Requirement for product class-specific 
                guidance.--If the Secretary issues product 
                class-specific guidance under subparagraph (A), 
                such guidance shall include a description of--
                          (i) the criteria that the Secretary 
                        will use to determine whether a 
                        biological product is highly similar to 
                        a reference product in such product 
                        class; and
                          (ii) the criteria, if available, that 
                        the Secretary will use to determine 
                        whether a biological product meets the 
                        standards described in paragraph (4).
                  (E) Certain product classes.--
                          (i) Guidance.--The Secretary may 
                        indicate in a guidance document that 
                        the science and experience, as of the 
                        date of such guidance, with respect to 
                        a product or product class (not 
                        including any recombinant protein) does 
                        not allow approval of an application 
                        for a license as provided under this 
                        subsection for such product or product 
                        class.
                          (ii) Modification or reversal.--The 
                        Secretary may issue a subsequent 
                        guidance document under subparagraph 
                        (A) to modify or reverse a guidance 
                        document under clause (i).
                          (iii) No effect on ability to deny 
                        license.--Clause (i) shall not be 
                        construed to require the Secretary to 
                        approve a product with respect to which 
                        the Secretary has not indicated in a 
                        guidance document that the science and 
                        experience, as described in clause (i), 
                        does not allow approval of such an 
                        application.
  (l) Patents.--
          (1) Confidential access to subsection (k) 
        application.--
                  (A) Application of paragraph.--Unless 
                otherwise agreed to by a person that submits an 
                application under subsection (k) (referred to 
                in this subsection as the ``subsection (k) 
                applicant'') and the sponsor of the application 
                for the reference product (referred to in this 
                subsection as the ``reference product 
                sponsor''), the provisions of this paragraph 
                shall apply to the exchange of information 
                described in this subsection.
                  (B) In general.--
                          (i) Provision of confidential 
                        information.--When a subsection (k) 
                        applicant submits an application under 
                        subsection (k), such applicant shall 
                        provide to the persons described in 
                        clause (ii), subject to the terms of 
                        this paragraph, confidential access to 
                        the information required to be produced 
                        pursuant to paragraph (2) and any other 
                        information that the subsection (k) 
                        applicant determines, in its sole 
                        discretion, to be appropriate (referred 
                        to in this subsection as the 
                        ``confidential information'').
                          (ii) Recipients of information.--The 
                        persons described in this clause are 
                        the following:
                                  (I) Outside counsel.--One or 
                                more attorneys designated by 
                                the reference product sponsor 
                                who are employees of an entity 
                                other than the reference 
                                product sponsor (referred to in 
                                this paragraph as the ``outside 
                                counsel''), provided that such 
                                attorneys do not engage, 
                                formally or informally, in 
                                patent prosecution relevant or 
                                related to the reference 
                                product.
                                  (II) In-house counsel.--One 
                                attorney that represents the 
                                reference product sponsor who 
                                is an employee of the reference 
                                product sponsor, provided that 
                                such attorney does not engage, 
                                formally or informally, in 
                                patent prosecution relevant or 
                                related to the reference 
                                product.
                          (iii) Patent owner access.--A 
                        representative of the owner of a patent 
                        exclusively licensed to a reference 
                        product sponsor with respect to the 
                        reference product and who has retained 
                        a right to assert the patent or 
                        participate in litigation concerning 
                        the patent may be provided the 
                        confidential information, provided that 
                        the representative informs the 
                        reference product sponsor and the 
                        subsection (k) applicant of his or her 
                        agreement to be subject to the 
                        confidentiality provisions set forth in 
                        this paragraph, including those under 
                        clause (ii).
                  (C) Limitation on disclosure.--No person that 
                receives confidential information pursuant to 
                subparagraph (B) shall disclose any 
                confidential information to any other person or 
                entity, including the reference product sponsor 
                employees, outside scientific consultants, or 
                other outside counsel retained by the reference 
                product sponsor, without the prior written 
                consent of the subsection (k) applicant, which 
                shall not be unreasonably withheld.
                  (D) Use of confidential information.--
                Confidential information shall be used for the 
                sole and exclusive purpose of determining, with 
                respect to each patent assigned to or 
                exclusively licensed by the reference product 
                sponsor, whether a claim of patent infringement 
                could reasonably be asserted if the subsection 
                (k) applicant engaged in the manufacture, use, 
                offering for sale, sale, or importation into 
                the United States of the biological product 
                that is the subject of the application under 
                subsection (k).
                  (E) Ownership of confidential information.--
                The confidential information disclosed under 
                this paragraph is, and shall remain, the 
                property of the subsection (k) applicant. By 
                providing the confidential information pursuant 
                to this paragraph, the subsection (k) applicant 
                does not provide the reference product sponsor 
                or the outside counsel any interest in or 
                license to use the confidential information, 
                for purposes other than those specified in 
                subparagraph (D).
                  (F) Effect of infringement action.--In the 
                event that the reference product sponsor files 
                a patent infringement suit, the use of 
                confidential information shall continue to be 
                governed by the terms of this paragraph until 
                such time as a court enters a protective order 
                regarding the information. Upon entry of such 
                order, the subsection (k) applicant may 
                redesignate confidential information in 
                accordance with the terms of that order. No 
                confidential information shall be included in 
                any publicly-available complaint or other 
                pleading. In the event that the reference 
                product sponsor does not file an infringement 
                action by the date specified in paragraph (6), 
                the reference product sponsor shall return or 
                destroy all confidential information received 
                under this paragraph, provided that if the 
                reference product sponsor opts to destroy such 
                information, it will confirm destruction in 
                writing to the subsection (k) applicant.
                  (G) Rule of construction.--Nothing in this 
                paragraph shall be construed--
                          (i) as an admission by the subsection 
                        (k) applicant regarding the validity, 
                        enforceability, or infringement of any 
                        patent; or
                          (ii) as an agreement or admission by 
                        the subsection (k) applicant with 
                        respect to the competency, relevance, 
                        or materiality of any confidential 
                        information.
                  (H) Effect of violation.--The disclosure of 
                any confidential information in violation of 
                this paragraph shall be deemed to cause the 
                subsection (k) applicant to suffer irreparable 
                harm for which there is no adequate legal 
                remedy and the court shall consider immediate 
                injunctive relief to be an appropriate and 
                necessary remedy for any violation or 
                threatened violation of this paragraph.
          (2) Subsection (k) application information.--Not 
        later than 20 days after the Secretary notifies the 
        subsection (k) applicant that the application has been 
        accepted for review, the subsection (k) applicant--
                  (A) shall provide to the reference product 
                sponsor a copy of the application submitted to 
                the Secretary under subsection (k), and such 
                other information that describes the process or 
                processes used to manufacture the biological 
                product that is the subject of such 
                application; and
                  (B) may provide to the reference product 
                sponsor additional information requested by or 
                on behalf of the reference product sponsor.
          (3) List and description of patents.--
                  (A) List by reference product sponsor.--Not 
                later than 60 days after the receipt of the 
                application and information under paragraph 
                (2), the reference product sponsor shall 
                provide to the subsection (k) applicant--
                          (i) a list of patents for which the 
                        reference product sponsor believes a 
                        claim of patent infringement could 
                        reasonably be asserted by the reference 
                        product sponsor, or by a patent owner 
                        that has granted an exclusive license 
                        to the reference product sponsor with 
                        respect to the reference product, if a 
                        person not licensed by the reference 
                        product sponsor engaged in the making, 
                        using, offering to sell, selling, or 
                        importing into the United States of the 
                        biological product that is the subject 
                        of the subsection (k) application; and
                          (ii) an identification of the patents 
                        on such list that the reference product 
                        sponsor would be prepared to license to 
                        the subsection (k) applicant.
                  (B) List and description by subsection (k) 
                applicant.--Not later than 60 days after 
                receipt of the list under subparagraph (A), the 
                subsection (k) applicant--
                          (i) may provide to the reference 
                        product sponsor a list of patents to 
                        which the subsection (k) applicant 
                        believes a claim of patent infringement 
                        could reasonably be asserted by the 
                        reference product sponsor if a person 
                        not licensed by the reference product 
                        sponsor engaged in the making, using, 
                        offering to sell, selling, or importing 
                        into the United States of the 
                        biological product that is the subject 
                        of the subsection (k) application;
                          (ii) shall provide to the reference 
                        product sponsor, with respect to each 
                        patent listed by the reference product 
                        sponsor under subparagraph (A) or 
                        listed by the subsection (k) applicant 
                        under clause (i)--
                                  (I) a detailed statement that 
                                describes, on a claim by claim 
                                basis, the factual and legal 
                                basis of the opinion of the 
                                subsection (k) applicant that 
                                such patent is invalid, 
                                unenforceable, or will not be 
                                infringed by the commercial 
                                marketing of the biological 
                                product that is the subject of 
                                the subsection (k) application; 
                                or
                                  (II) a statement that the 
                                subsection (k) applicant does 
                                not intend to begin commercial 
                                marketing of the biological 
                                product before the date that 
                                such patent expires; and
                          (iii) shall provide to the reference 
                        product sponsor a response regarding 
                        each patent identified by the reference 
                        product sponsor under subparagraph 
                        (A)(ii).
                  (C) Description by reference product 
                sponsor.--Not later than 60 days after receipt 
                of the list and statement under subparagraph 
                (B), the reference product sponsor shall 
                provide to the subsection (k) applicant a 
                detailed statement that describes, with respect 
                to each patent described in subparagraph 
                (B)(ii)(I), on a claim by claim basis, the 
                factual and legal basis of the opinion of the 
                reference product sponsor that such patent will 
                be infringed by the commercial marketing of the 
                biological product that is the subject of the 
                subsection (k) application and a response to 
                the statement concerning validity and 
                enforceability provided under subparagraph 
                (B)(ii)(I).
          (4) Patent resolution negotiations.--
                  (A) In general.--After receipt by the 
                subsection (k) applicant of the statement under 
                paragraph (3)(C), the reference product sponsor 
                and the subsection (k) applicant shall engage 
                in good faith negotiations to agree on which, 
                if any, patents listed under paragraph (3) by 
                the subsection (k) applicant or the reference 
                product sponsor shall be the subject of an 
                action for patent infringement under paragraph 
                (6).
                  (B) Failure to reach agreement.--If, within 
                15 days of beginning negotiations under 
                subparagraph (A), the subsection (k) applicant 
                and the reference product sponsor fail to agree 
                on a final and complete list of which, if any, 
                patents listed under paragraph (3) by the 
                subsection (k) applicant or the reference 
                product sponsor shall be the subject of an 
                action for patent infringement under paragraph 
                (6), the provisions of paragraph (5) shall 
                apply to the parties.
          (5) Patent resolution if no agreement.--
                  (A) Number of patents.--The subsection (k) 
                applicant shall notify the reference product 
                sponsor of the number of patents that such 
                applicant will provide to the reference product 
                sponsor under subparagraph (B)(i)(I).
                  (B) Exchange of patent lists.--
                          (i) In general.--On a date agreed to 
                        by the subsection (k) applicant and the 
                        reference product sponsor, but in no 
                        case later than 5 days after the 
                        subsection (k) applicant notifies the 
                        reference product sponsor under 
                        subparagraph (A), the subsection (k) 
                        applicant and the reference product 
                        sponsor shall simultaneously exchange--
                                  (I) the list of patents that 
                                the subsection (k) applicant 
                                believes should be the subject 
                                of an action for patent 
                                infringement under paragraph 
                                (6); and
                                  (II) the list of patents, in 
                                accordance with clause (ii), 
                                that the reference product 
                                sponsor believes should be the 
                                subject of an action for patent 
                                infringement under paragraph 
                                (6).
                          (ii) Number of patents listed by 
                        reference product sponsor.--
                                  (I) In general.--Subject to 
                                subclause (II), the number of 
                                patents listed by the reference 
                                product sponsor under clause 
                                (i)(II) may not exceed the 
                                number of patents listed by the 
                                subsection (k) applicant under 
                                clause (i)(I).
                                  (II) Exception.--If a 
                                subsection (k) applicant does 
                                not list any patent under 
                                clause (i)(I), the reference 
                                product sponsor may list 1 
                                patent under clause (i)(II).
          (6) Immediate patent infringement action.--
                  (A) Action if agreement on patent list.--If 
                the subsection (k) applicant and the reference 
                product sponsor agree on patents as described 
                in paragraph (4), not later than 30 days after 
                such agreement, the reference product sponsor 
                shall bring an action for patent infringement 
                with respect to each such patent.
                  (B) Action if no agreement on patent list.--
                If the provisions of paragraph (5) apply to the 
                parties as described in paragraph (4)(B), not 
                later than 30 days after the exchange of lists 
                under paragraph (5)(B), the reference product 
                sponsor shall bring an action for patent 
                infringement with respect to each patent that 
                is included on such lists.
                  (C) Notification and publication of 
                complaint.--
                          (i) Notification to secretary.--Not 
                        later than 30 days after a complaint is 
                        served to a subsection (k) applicant in 
                        an action for patent infringement 
                        described under this paragraph, the 
                        subsection (k) applicant shall provide 
                        the Secretary with notice and a copy of 
                        such complaint.
                          (ii) Publication by secretary.--The 
                        Secretary shall publish in the Federal 
                        Register notice of a complaint received 
                        under clause (i).
          (7) Newly issued or licensed patents.--In the case of 
        a patent that--
                  (A) is issued to, or exclusively licensed by, 
                the reference product sponsor after the date 
                that the reference product sponsor provided the 
                list to the subsection (k) applicant under 
                paragraph (3)(A); and
                  (B) the reference product sponsor reasonably 
                believes that, due to the issuance of such 
                patent, a claim of patent infringement could 
                reasonably be asserted by the reference product 
                sponsor if a person not licensed by the 
                reference product sponsor engaged in the 
                making, using, offering to sell, selling, or 
                importing into the United States of the 
                biological product that is the subject of the 
                subsection (k) application,
        not later than 30 days after such issuance or 
        licensing, the reference product sponsor shall provide 
        to the subsection (k) applicant a supplement to the 
        list provided by the reference product sponsor under 
        paragraph (3)(A) that includes such patent, not later 
        than 30 days after such supplement is provided, the 
        subsection (k) applicant shall provide a statement to 
        the reference product sponsor in accordance with 
        paragraph (3)(B), and such patent shall be subject to 
        paragraph (8).
          (8) Notice of commercial marketing and preliminary 
        injunction.--
                  (A) Notice of commercial marketing.--The 
                subsection (k) applicant shall provide notice 
                to the reference product sponsor not later than 
                180 days before the date of the first 
                commercial marketing of the biological product 
                licensed under subsection (k).
                  (B) Preliminary injunction.--After receiving 
                the notice under subparagraph (A) and before 
                such date of the first commercial marketing of 
                such biological product, the reference product 
                sponsor may seek a preliminary injunction 
                prohibiting the subsection (k) applicant from 
                engaging in the commercial manufacture or sale 
                of such biological product until the court 
                decides the issue of patent validity, 
                enforcement, and infringement with respect to 
                any patent that is--
                          (i) included in the list provided by 
                        the reference product sponsor under 
                        paragraph (3)(A) or in the list 
                        provided by the subsection (k) 
                        applicant under paragraph (3)(B); and
                          (ii) not included, as applicable, 
                        on--
                                  (I) the list of patents 
                                described in paragraph (4); or
                                  (II) the lists of patents 
                                described in paragraph (5)(B).
                  (C) Reasonable cooperation.--If the reference 
                product sponsor has sought a preliminary 
                injunction under subparagraph (B), the 
                reference product sponsor and the subsection 
                (k) applicant shall reasonably cooperate to 
                expedite such further discovery as is needed in 
                connection with the preliminary injunction 
                motion.
          (9) Limitation on declaratory judgment action.--
                  (A) Subsection (k) application provided.--If 
                a subsection (k) applicant provides the 
                application and information required under 
                paragraph (2)(A), neither the reference product 
                sponsor nor the subsection (k) applicant may, 
                prior to the date notice is received under 
                paragraph (8)(A), bring any action under 
                section 2201 of title 28, United States Code, 
                for a declaration of infringement, validity, or 
                enforceability of any patent that is described 
                in clauses (i) and (ii) of paragraph (8)(B).
                  (B) Subsequent failure to act by subsection 
                (k) applicant.--If a subsection (k) applicant 
                fails to complete an action required of the 
                subsection (k) applicant under paragraph 
                (3)(B)(ii), paragraph (5), paragraph (6)(C)(i), 
                paragraph (7), or paragraph (8)(A), the 
                reference product sponsor, but not the 
                subsection (k) applicant, may bring an action 
                under section 2201 of title 28, United States 
                Code, for a declaration of infringement, 
                validity, or enforceability of any patent 
                included in the list described in paragraph 
                (3)(A), including as provided under paragraph 
                (7).
                  (C) Subsection (k) application not 
                provided.--If a subsection (k) applicant fails 
                to provide the application and information 
                required under paragraph (2)(A), the reference 
                product sponsor, but not the subsection (k) 
                applicant, may bring an action under section 
                2201 of title 28, United States Code, for a 
                declaration of infringement, validity, or 
                enforceability of any patent that claims the 
                biological product or a use of the biological 
                product.
  (m) Pediatric Studies.--
          (1) Application of certain provisions.--The 
        provisions of subsections (a), (d), (e), (f), (h), (i), 
        (j), (k), (l), (n), and (p) of section 505A of the 
        Federal Food, Drug, and Cosmetic Act shall apply with 
        respect to the extension of a period under paragraphs 
        (2) and (3) to the same extent and in the same manner 
        as such provisions apply with respect to the extension 
        of a period under subsection (b) or (c) of section 505A 
        of the Federal Food, Drug, and Cosmetic Act.
          (2) Market exclusivity for new biological products.--
        If, prior to approval of an application that is 
        submitted under subsection (a), the Secretary 
        determines that information relating to the use of a 
        new biological product in the pediatric population may 
        produce health benefits in that population, the 
        Secretary makes a written request for pediatric studies 
        (which shall include a timeframe for completing such 
        studies), the applicant agrees to the request, such 
        studies are completed using appropriate formulations 
        for each age group for which the study is requested 
        within any such timeframe, and the reports thereof are 
        submitted and accepted in accordance with section 
        505A(d)(3) of the Federal Food, Drug, and Cosmetic 
        Act--
                  (A) the periods for such biological product 
                referred to in subsection (k)(7) are deemed to 
                be 4 years and 6 months rather than 4 years and 
                12 years and 6 months rather than 12 years; and
                  (B) if the biological product is designated 
                under section 526 for a rare disease or 
                condition, the period for such biological 
                product referred to in section 527(a) is deemed 
                to be 7 years and 6 months rather than 7 years.
          (3) Market exclusivity for already-marketed 
        biological products.--If the Secretary determines that 
        information relating to the use of a licensed 
        biological product in the pediatric population may 
        produce health benefits in that population and makes a 
        written request to the holder of an approved 
        application under subsection (a) for pediatric studies 
        (which shall include a timeframe for completing such 
        studies), the holder agrees to the request, such 
        studies are completed using appropriate formulations 
        for each age group for which the study is requested 
        within any such timeframe, and the reports thereof are 
        submitted and accepted in accordance with section 
        505A(d)(3) of the Federal Food, Drug, and Cosmetic 
        Act--
                  (A) the periods for such biological product 
                referred to in subsection (k)(7) are deemed to 
                be 4 years and 6 months rather than 4 years and 
                12 years and 6 months rather than 12 years; and
                  (B) if the biological product is designated 
                under section 526 for a rare disease or 
                condition, the period for such biological 
                product referred to in section 527(a) is deemed 
                to be 7 years and 6 months rather than 7 years.
          (4) Exception.--The Secretary shall not extend a 
        period referred to in paragraph (2)(A), (2)(B), (3)(A), 
        or (3)(B) if the determination under section 505A(d)(3) 
        is made later than 9 months prior to the expiration of 
        such period.
          (5) Relation to exclusivity for a biological product 
        approved for a new indication for a rare disease or 
        condition.--Notwithstanding the references in 
        paragraphs (2)(A), (2)(B), (3)(A), and (3)(B) to the 
        lengths of the exclusivity periods after application of 
        pediatric exclusivity, the 6-month extensions described 
        in such paragraphs shall be in addition to any 
        extensions under section 505G.

           *       *       *       *       *       *       *


PART P--ADDITIONAL PROGRAMS

           *       *       *       *       *       *       *


SEC. 399V-6 SURVEILLANCE OF NEUROLOGICAL DISEASES.

  (a) In General.--The Secretary, acting through the Director 
of the Centers for Disease Control and Prevention and in 
coordination with other agencies as determined appropriate by 
the Secretary, shall--
          (1) enhance and expand infrastructure and activities 
        to track the epidemiology of neurological diseases, 
        including multiple sclerosis and Parkinson's disease; 
        and
          (2) incorporate information obtained through such 
        activities into a statistically sound, scientifically 
        credible, integrated surveillance system, to be known 
        as the National Neurological Diseases Surveillance 
        System.
  (b) Research.--The Secretary shall ensure that the National 
Neurological Diseases Surveillance System is designed in a 
manner that facilitates further research on neurological 
diseases.
  (c) Content.--In carrying out subsection (a), the Secretary--
          (1) shall provide for the collection and storage of 
        information on the incidence and prevalence of 
        neurological diseases in the United States;
          (2) to the extent practicable, shall provide for the 
        collection and storage of other available information 
        on neurological diseases, such as information 
        concerning--
                  (A) demographics and other information 
                associated or possibly associated with 
                neurological diseases, such as age, race, 
                ethnicity, sex, geographic location, and family 
                history;
                  (B) risk factors associated or possibly 
                associated with neurological diseases, 
                including genetic and environmental risk 
                factors; and
                  (C) diagnosis and progression markers;
          (3) may provide for the collection and storage of 
        information relevant to analysis on neurological 
        diseases, such as information concerning--
                  (A) the epidemiology of the diseases;
                  (B) the natural history of the diseases;
                  (C) the prevention of the diseases;
                  (D) the detection, management, and treatment 
                approaches for the diseases; and
                  (E) the development of outcomes measures; and
          (4) may address issues identified during the 
        consultation process under subsection (d).
  (d) Consultation.--In carrying out this section, the 
Secretary shall consult with individuals with appropriate 
expertise, including--
          (1) epidemiologists with experience in disease 
        surveillance or registries;
          (2) representatives of national voluntary health 
        associations that--
                  (A) focus on neurological diseases, including 
                multiple sclerosis and Parkinson's disease; and
                  (B) have demonstrated experience in research, 
                care, or patient services;
          (3) health information technology experts or other 
        information management specialists;
          (4) clinicians with expertise in neurological 
        diseases; and
          (5) research scientists with experience conducting 
        translational research or utilizing surveillance 
        systems for scientific research purposes.
  (e) Grants.--The Secretary may award grants to, or enter into 
contracts or cooperative agreements with, public or private 
nonprofit entities to carry out activities under this section.
  (f) Coordination With Other Federal, State, and Local 
Agencies.--Subject to subsection (h), the Secretary shall make 
information and analysis in the National Neurological Diseases 
Surveillance System available, as appropriate--
          (1) to Federal departments and agencies, such as the 
        National Institutes of Health, the Food and Drug 
        Administration, the Centers for Medicare & Medicaid 
        Services, the Agency for Healthcare Research and 
        Quality, the Department of Veterans Affairs, and the 
        Department of Defense; and
          (2) to State and local agencies.
  (g) Public Access.--Subject to subsection (h), the Secretary 
shall make information and analysis in the National 
Neurological Diseases Surveillance System available, as 
appropriate, to the public, including researchers.
  (h) Privacy.--The Secretary shall ensure that privacy and 
security protections applicable to the National Neurological 
Diseases Surveillance System are at least as stringent as the 
privacy and security protections under HIPAA privacy and 
security law (as defined in section 3009(a)(2)).
  (i) Report.--Not later than 4 years after the date of the 
enactment of this section, the Secretary shall submit a report 
to the Congress concerning the implementation of this section. 
Such report shall include information on--
          (1) the development and maintenance of the National 
        Neurological Diseases Surveillance System;
          (2) the type of information collected and stored in 
        the System;
          (3) the use and availability of such information, 
        including guidelines for such use; and
          (4) the use and coordination of databases that 
        collect or maintain information on neurological 
        diseases.
  (j) Definition.--In this section, the term ``national 
voluntary health association'' means a national nonprofit 
organization with chapters, other affiliated organizations, or 
networks in States throughout the United States.
  (k) Authorization of Appropriations.--To carry out this 
section, there is authorized to be appropriated $5,000,000 for 
each of fiscal years 2016 through 2020.

           *       *       *       *       *       *       *


           PART W--LYME DISEASE AND OTHER TICK-BORNE DISEASES

SEC. 399OO. RESEARCH.

  (a) In General.--The Secretary shall conduct or support 
epidemiological, basic, translational, and clinical research 
regarding Lyme disease and other tick-borne diseases.
  (b) Biennial Reports.--The Secretary shall ensure that each 
biennial report under section 403 includes information on 
actions undertaken by the National Institutes of Health to 
carry out subsection (a) with respect to Lyme disease and other 
tick-borne diseases, including an assessment of the progress 
made in improving the outcomes of Lyme disease and such other 
tick-borne diseases.

SEC. 399OO-1. WORKING GROUP.

  (a) Establishment.--The Secretary shall establish a permanent 
working group, to be known as the Interagency Lyme and Tick-
Borne Disease Working Group (in this section and section 399OO-
2 referred to as the ``Working Group''), to review all efforts 
within the Department of Health and Human Services concerning 
Lyme disease and other tick-borne diseases to ensure 
interagency coordination, minimize overlap, and examine 
research priorities.
  (b) Responsibilities.--The Working Group shall--
          (1) not later than 24 months after the date of 
        enactment of this part, and every 24 months thereafter, 
        develop or update a summary of--
                  (A) ongoing Lyme disease and other tick-borne 
                disease research related to causes, prevention, 
                treatment, surveillance, diagnosis, 
                diagnostics, duration of illness, intervention, 
                and access to services and supports for 
                individuals with Lyme disease or other tick-
                borne diseases;
                  (B) advances made pursuant to such research;
                  (C) the engagement of the Department of 
                Health and Human Services with persons that 
                participate at the public meetings required by 
                paragraph (5); and
                  (D) the comments received by the Working 
                Group at such public meetings and the 
                Secretary's response to such comments;
          (2) ensure that a broad spectrum of scientific 
        viewpoints is represented in each such summary;
          (3) monitor Federal activities with respect to Lyme 
        disease and other tick-borne diseases;
          (4) make recommendations to the Secretary regarding 
        any appropriate changes to such activities; and
          (5) ensure public input by holding annual public 
        meetings that address scientific advances, research 
        questions, surveillance activities, and emerging 
        strains in species of pathogenic organisms.
  (c) Membership.--
          (1) In general.--The Working Group shall be composed 
        of a total of 14 members as follows:
                  (A) Federal members.--Seven Federal members, 
                consisting of one or more representatives of 
                each of--
                          (i) the Office of the Assistant 
                        Secretary for Health;
                          (ii) the Food and Drug 
                        Administration;
                          (iii) the Centers for Disease Control 
                        and Prevention;
                          (iv) the National Institutes of 
                        Health; and
                          (v) such other agencies and offices 
                        of the Department of Health and Human 
                        Services as the Secretary determines 
                        appropriate.
                  (B) Non-federal public members.--Seven non-
                Federal public members, consisting of 
                representatives of the following categories:
                          (i) Physicians and other medical 
                        providers with experience in diagnosing 
                        and treating Lyme disease and other 
                        tick-borne diseases.
                          (ii) Scientists or researchers with 
                        expertise.
                          (iii) Patients and their family 
                        members.
                          (iv) Nonprofit organizations that 
                        advocate for patients with respect to 
                        Lyme disease and other tick-borne 
                        diseases.
                          (v) Other individuals whose expertise 
                        is determined by the Secretary to be 
                        beneficial to the functioning of the 
                        Working Group.
          (2) Appointment.--The members of the Working Group 
        shall be appointed by the Secretary, except that of the 
        non-Federal public members under paragraph (1)(B)--
                  (A) one shall be appointed by the Speaker of 
                the House of Representatives; and
                  (B) one shall be appointed by the majority 
                leader of the Senate.
          (3) Diversity of scientific perspectives.--In making 
        appointments under paragraph (2), the Secretary, the 
        Speaker of the House of Representatives, and the 
        majority leader of the Senate shall ensure that the 
        non-Federal public members of the Working Group 
        represent a diversity of scientific perspectives.
          (4) Terms.--The non-Federal public members of the 
        Working Group shall each be appointed to serve a 4-year 
        term and may be reappointed at the end of such term.
  (d) Meetings.--The Working Group shall meet as often as 
necessary, as determined by the Secretary, but not less than 
twice each year.
  (e) Applicability of FACA.--The Working Group shall be 
treated as an advisory committee subject to the Federal 
Advisory Committee Act.
  (f) Reporting.--Not later than 24 months after the date of 
enactment of this part, and every 24 months thereafter, the 
Working Group--
          (1) shall submit a report on its activities, 
        including an up-to-date summary under subsection (b)(1) 
        and any recommendations under subsection (b)(4), to the 
        Secretary, the Committee on Energy and Commerce of the 
        House of Representatives, and the Committee on Health, 
        Education, Labor and Pensions of the Senate;
          (2) shall make each such report publicly available on 
        the website of the Department of Health and Human 
        Services; and
          (3) shall allow any member of the Working Group to 
        include in any such report minority views.

SEC. 399OO-2. STRATEGIC PLAN.

  Not later than 3 years after the date of enactment of this 
section, and every 5 years thereafter, the Secretary shall 
submit to the Congress a strategic plan, informed by the most 
recent summary under section 399OO-1(b)(1), for the conduct and 
support of Lyme disease and tick-borne disease research, 
including--
          (1) proposed budgetary requirements;
          (2) a plan for improving outcomes of Lyme disease and 
        other tick-borne diseases, including progress related 
        to chronic or persistent symptoms and chronic or 
        persistent infection and co-infections;
          (3) a plan for improving diagnosis, treatment, and 
        prevention;
          (4) appropriate benchmarks to measure progress on 
        achieving the improvements described in paragraphs (2) 
        and (3); and
          (5) a plan to disseminate each summary under section 
        399OO-1(b)(1) and other relevant information developed 
        by the Working Group to the public, including health 
        care providers, public health departments, and other 
        relevant medical groups.

                 TITLE IV--NATIONAL RESEARCH INSTITUTES

Part A--National Institutes of Health

           *       *       *       *       *       *       *


              appointment and authority of director of nih

  Sec. 402. (a) The National Institutes of Health shall be 
headed by the Director of NIH who shall be appointed by the 
President by and with the advice and consent of the Senate. The 
Director of NIH shall perform functions as provided under 
subsection (b) and as the Secretary may otherwise prescribe.
  (b) In carrying out the purposes of section 301, the 
Secretary, acting through the Director of NIH--
          (1) shall carry out this title, including being 
        responsible for the overall direction of the National 
        Institutes of Health and for the establishment and 
        implementation of general policies respecting the 
        management and operation of programs and activities 
        within the National Institutes of Health;
          (2) shall coordinate and oversee the operation of the 
        national research institutes, national centers, and 
        administrative entities within the National Institutes 
        of Health;
          (3) shall, in consultation with the heads of the 
        national research institutes and national centers, be 
        responsible for program coordination across the 
        national research institutes and national centers, 
        including conducting priority-setting reviews, to 
        ensure that the research portfolio of the National 
        Institutes of Health is balanced and free of 
        unnecessary duplication, and takes advantage of 
        collaborative, cross-cutting research;
          (4) shall assemble accurate data to be used to assess 
        research priorities, including information to better 
        evaluate scientific opportunity, public health burdens, 
        and progress in reducing minority and other health 
        disparities;
          [(5) shall ensure that scientifically based strategic 
        planning is implemented in support of research 
        priorities as determined by the agencies of the 
        National Institutes of Health;]
          (5) shall ensure that scientifically based strategic 
        planning is implemented in support of research 
        priorities as determined by the agencies of the 
        National Institutes of Health, including through 
        development, use, and updating of the research 
        strategic plan under subsection (m);
          (6) shall ensure that the resources of the National 
        Institutes of Health are sufficiently allocated for 
        research projects identified in strategic plans;
          (7)(A) shall, through the Division of Program 
        Coordination, Planning, and Strategic Initiatives--
                          (i) identify research that represents 
                        important areas of emerging scientific 
                        opportunities, rising public health 
                        challenges, or knowledge gaps that 
                        deserve special emphasis and would 
                        benefit from conducting or supporting 
                        additional research that involves 
                        collaboration between 2 or more 
                        national research institutes or 
                        national centers, or would otherwise 
                        benefit from strategic coordination and 
                        planning;
                          (ii) include information on such 
                        research in reports under section 403; 
                        and
                          (iii) in the case of such research 
                        supported with funds referred to in 
                        subparagraph (B)--
                                  (I) require as appropriate 
                                that proposals include 
                                milestones and goals for the 
                                research;
                                  (II) require that the 
                                proposals include timeframes 
                                for funding of the research; 
                                and
                                  (III) ensure appropriate 
                                consideration of proposals for 
                                which the principal 
                                investigator is an individual 
                                who has not previously served 
                                as the principal investigator 
                                of research conducted or 
                                supported by the National 
                                Institutes of Health;
                  (B)(i) may, with respect to funds reserved 
                under section 402A(c)(1) for the Common Fund, 
                allocate such funds to the national research 
                institutes and national centers for conducting 
                and supporting research that is identified 
                under subparagraph (A); and
          (ii) shall, with respect to funds appropriated to the 
        Common Fund pursuant to section 402A(a)(2), allocate 
        such funds to the national research institutes and 
        national centers for making grants for pediatric 
        research that is identified under subparagraph (A); and
                  (C) may assign additional functions to the 
                Division in support of responsibilities 
                identified in subparagraph (A), as determined 
                appropriate by the Director;
          (8) shall, in coordination with the heads of the 
        national research institutes and national centers, 
        ensure that such institutes and centers--
                  (A) preserve an emphasis on investigator-
                initiated research project grants, including 
                with respect to research involving 
                collaboration between 2 or more such institutes 
                or centers; and
                  (B) when appropriate, maximize investigator-
                initiated research project grants in their 
                annual research portfolios;
          (9) shall ensure that research conducted or supported 
        by the National Institutes of Health is subject to 
        review in accordance with section 492 and that, after 
        such review, the research is reviewed in accordance 
        with section 492A(a)(2) by the appropriate advisory 
        council under section 406 before the research proposals 
        are approved for funding;
          (10) shall have authority to review and approve the 
        establishment of all centers of excellence recommended 
        by the national research institutes;
          (11)(A) shall oversee research training for all of 
        the national research institutes and National Research 
        Service Awards in accordance with section 487; and
          (B) may conduct and support research training--
                  (i) for which fellowship support is not 
                provided under section 487; and
                  (ii) that does not consist of residency 
                training of physicians or other health 
                professionals;
          (12) may, from funds appropriated under section 
        402A(b), reserve funds to provide for research on 
        matters that have not received significant funding 
        relative to other matters, to respond to new issues and 
        scientific emergencies, and to act on research 
        opportunities of high priority;
          (13) may, subject to appropriations Acts, collect and 
        retain registration fees obtained from third parties to 
        defray expenses for scientific, educational, and 
        research-related conferences;
          (14) for the national research institutes and 
        administrative entities within the National Institutes 
        of Health--
                  (A) may acquire, construct, improve, repair, 
                operate, and maintain, at the site of such 
                institutes and entities, laboratories, and 
                other research facilities, other facilities, 
                equipment, and other real or personal property, 
                and
                  (B) may acquire, without regard to the Act of 
                March 3, 1877 (40 U.S.C. 34), by lease or 
                otherwise through the Administrator of General 
                Services, buildings or parts of buildings in 
                the District of Columbia or communities located 
                adjacent to the District of Columbia for use 
                for a period not to exceed ten years;
          (15) may secure resources for research conducted by 
        or through the National Institutes of Health;
          (16) may, without regard to the provisions of title 
        5, United States Code, governing appointments in the 
        competitive service, and without regard to the 
        provisions of chapter 51 and subchapter III of chapter 
        53 of such title relating to classification and General 
        Schedule pay rates, establish such technical and 
        scientific peer review groups and scientific program 
        advisory committees as are needed to carry out the 
        requirements of this title and appoint and pay the 
        members of such groups, except that officers and 
        employees of the United States shall not receive 
        additional compensation for service as members of such 
        groups;
          (17) may secure for the National Institutes of Health 
        consultation services and advice of persons from the 
        United States or abroad;
          (18) may use, with their consent, the services, 
        equipment, personnel, information, and facilities of 
        other Federal, State, or local public agencies, with or 
        without reimbursement therefor;
          (19) may, for purposes of study, admit and treat at 
        facilities of the National Institutes of Health 
        individuals not otherwise eligible for such treatment;
          (20) may accept voluntary and uncompensated services;
          (21) may perform such other administrative functions 
        as the Secretary determines are needed to effectively 
        carry out this title;
          (22) may appoint physicians, dentists, and other 
        health care professionals, subject to the provisions of 
        title 5, United States Code, relating to appointments 
        and classifications in the competitive service, and may 
        compensate such professionals subject to the provisions 
        of chapter 74 of title 38, United States Code;
          (23) shall designate a contact point or office to 
        help innovators and physicians identify sources of 
        funding available for pediatric medical device 
        development; [and]
          (24) implement the Cures Acceleration Network 
        described in section 480[.]; and
          (25) shall, with respect to funds appropriated under 
        section 402A(e) to the NIH Innovation Fund, allocate 
        such funds to the national research institutes and 
        national centers for conducting and supporting 
        innovation fund initiatives identified under paragraph 
        (3) of such section.
The Federal Advisory Committee Act shall not apply to the 
duration of a peer review group appointed under paragraph (16). 
The members of such a group shall be individuals who by virtue 
of their training or experience are eminently qualified to 
perform the review functions of such group. Not more than one-
fourth of the members of any such group shall be officers or 
employees of the United States.
  (c) The Director of NIH may make available to individuals and 
entities, for biomedical and behavioral research, substances 
and living organisms. Such substances and organisms shall be 
made available under such terms and conditions (including 
payment for them) as the Secretary determines appropriate.
  (d)(1) The Director of NIH may obtain (in accordance with 
section 3109 of title 5, United States Code, but without regard 
to the limitation in such section on the period of service) the 
services of not more than 220 experts or consultants, with 
scientific or other professional qualifications, for the 
National Institutes of Health.
  (2)(A) Except as provided in subparagraph (B), experts and 
consultants whose services are obtained under paragraph (1) 
shall be paid or reimbursed, in accordance with title 5, United 
States Code, for their travel to and from their place of 
service and for other expenses associated with their 
assignment.
  (B) Expenses specified in subparagraph (A) shall not be 
allowed in connection with the assignment of an expert or 
consultant whose services are obtained under paragraph (1) 
unless the expert or consultant has agreed in writing to 
complete the entire period of the assignment or one year of the 
assignment, whichever is shorter, unless separated or 
reassigned for reasons which are beyond the control of the 
expert or consultant and which are acceptable to the Secretary. 
If the expert or consultant violates the agreement, the money 
spent by the United States for such expenses is recoverable 
from the expert or consultant as a debt due the United States. 
The Secretary may waive in whole or in part a right of recovery 
under this subparagraph.
  (e) The Director of NIH shall--
          (1) advise the agencies of the National Institutes of 
        Health on medical applications of research;
          (2) coordinate, review, and facilitate the systematic 
        identification and evaluation of, clinically relevant 
        information from research conducted by or through the 
        national research institutes;
          (3) promote the effective transfer of the information 
        described in paragraph (2) to the health care community 
        and to entities that require such information;
          (4) monitor the effectiveness of the activities 
        described in paragraph (3); and
          (5) ensure that, after January 1, 1994, all new or 
        revised health education and promotion materials 
        developed or funded by the National Institutes of 
        Health and intended for the general public are in a 
        form that does not exceed a level of functional 
        literacy, as defined in the National Literacy Act of 
        1991 (Public Law 102-73).
  (f) There shall be in the National Institutes of Health an 
Associate Director for Prevention. The Director of NIH shall 
delegate to the Associate Director for Prevention the functions 
of the Director relating to the promotion of the disease 
prevention research programs of the national research 
institutes and the coordination of such programs among the 
national research institutes and between the national research 
institutes and other public and private entities, including 
elementary, secondary, and post-secondary schools. The 
Associate Director shall--
          (1) annually review the efficacy of existing policies 
        and techniques used by the national research institutes 
        to disseminate the results of disease prevention and 
        behavioral research programs; and
          (2) recommend, coordinate, and oversee the 
        modification or reconstruction of such policies and 
        techniques to ensure maximum dissemination, using 
        advanced technologies to the maximum extent 
        practicable, of research results to such entities.
  (h) The Secretary, acting through the Director of NIH and the 
Directors of the agencies of the National Institutes of Health, 
shall, in conducting and supporting programs for research, 
research training, recruitment, and other activities, provide 
for an increase in the number of women and individuals from 
disadvantaged backgrounds (including racial and ethnic 
minorities) in the fields of biomedical and behavioral 
research.
  (i)(1)(A) The Secretary, acting through the Director of NIH, 
shall establish, maintain, and operate a data bank of 
information on clinical trials for drugs for serious or life-
threatening diseases and conditions (in this subsection 
referred to as the ``data bank''). The activities of the data 
bank shall be integrated and coordinated with related 
activities of other agencies of the Department of Health and 
Human Services, and to the extent practicable, coordinated with 
other data banks containing similar information.
  (B) The Secretary shall establish the data bank after 
consultation with the Commissioner of Food and Drugs, the 
directors of the appropriate agencies of the National 
Institutes of Health (including the National Library of 
Medicine), and the Director of the Centers for Disease Control 
and Prevention.
  (2) In carrying out paragraph (1), the Secretary shall 
collect, catalog, store, and disseminate the information 
described in such paragraph. The Secretary shall disseminate 
such information through information systems, which shall 
include toll-free telephone communications, available to 
individuals with serious or life-threatening diseases and 
conditions, to other members of the public, to health care 
providers, and to researchers.
  (3) The data bank shall include the following:
          (A) A registry of clinical trials (whether federally 
        or privately funded) of experimental treatments for 
        serious or life-threatening diseases and conditions 
        under regulations promulgated pursuant to section 
        505(i) of the Federal Food, Drug, and Cosmetic Act, 
        which provides a description of the purpose of each 
        experimental drug, either with the consent of the 
        protocol sponsor, or when a trial to test effectiveness 
        begins. Information provided shall consist of 
        eligibility criteria for participation in the clinical 
        trials, a description of the location of trial sites, 
        and a point of contact for those wanting to enroll in 
        the trial, and shall be in a form that can be readily 
        understood by members of the public. Such information 
        shall be forwarded to the data bank by the sponsor of 
        the trial not later than 21 days after the approval of 
        the protocol.
          (B) Information pertaining to experimental treatments 
        for serious or life-threatening diseases and conditions 
        that may be available--
                  (i) under a treatment investigational new 
                drug application that has been submitted to the 
                Secretary under section 561(c) of the Federal 
                Food, Drug, and Cosmetic Act; or
                  (ii) as a Group C cancer drug (as defined by 
                the National Cancer Institute).
        The data bank may also include information pertaining 
        to the results of clinical trials of such treatments, 
        with the consent of the sponsor, including information 
        concerning potential toxicities or adverse effects 
        associated with the use or administration of such 
        experimental treatments.
  (4) The data bank shall not include information relating to 
an investigation if the sponsor has provided a detailed 
certification to the Secretary that disclosure of such 
information would substantially interfere with the timely 
enrollment of subjects in the investigation, unless the 
Secretary, after the receipt of the certification, provides the 
sponsor with a detailed written determination that such 
disclosure would not substantially interfere with such 
enrollment.
  (5) Fees collected under section 736 of the Federal Food, 
Drug, and Cosmetic Act shall not be used in carrying out this 
subsection.
  (j) Expanded Clinical Trial Registry Data Bank.--
          (1) Definitions; requirement.--
                  (A) Definitions.--In this subsection:
                          (i) Applicable clinical trial.--The 
                        term ``applicable clinical trial'' 
                        means an applicable device clinical 
                        trial or an applicable drug clinical 
                        trial.
                          (ii) Applicable device clinical 
                        trial.--The term ``applicable device 
                        clinical trial'' means--
                                  (I) a prospective clinical 
                                study of health outcomes 
                                comparing an intervention with 
                                a device subject to section 
                                510(k), 515, or 520(m) of the 
                                Federal Food, Drug, and 
                                Cosmetic Act against a control 
                                in human subjects (other than a 
                                small clinical trial to 
                                determine the feasibility of a 
                                device, or a clinical trial to 
                                test prototype devices where 
                                the primary outcome measure 
                                relates to feasibility and not 
                                to health outcomes); and
                                  (II) a pediatric postmarket 
                                surveillance as required under 
                                section 522 of the Federal 
                                Food, Drug, and Cosmetic Act.
                          (iii) Applicable drug clinical 
                        trial.--
                                  (I) In general.--The term 
                                ``applicable drug clinical 
                                trial'' means a controlled 
                                clinical investigation, other 
                                than a phase I clinical 
                                investigation, of a drug 
                                subject to section 505 of the 
                                Federal Food, Drug, and 
                                Cosmetic Act or to section 351 
                                of this Act.
                                  (II) Clinical 
                                investigation.--For purposes of 
                                subclause (I), the term 
                                ``clinical investigation'' has 
                                the meaning given that term in 
                                section 312.3 of title 21, Code 
                                of Federal Regulations (or any 
                                successor regulation).
                                  (III) Phase i.--For purposes 
                                of subclause (I), the term 
                                ``phase I'' has the meaning 
                                given that term in section 
                                312.21 of title 21, Code of 
                                Federal Regulations (or any 
                                successor regulation).
                          (iv) Clinical trial information.--The 
                        term ``clinical trial information'' 
                        means, with respect to an applicable 
                        clinical trial, those data elements 
                        that the responsible party is required 
                        to submit under paragraph (2) or under 
                        paragraph (3).
                          (v) Completion date.--The term 
                        ``completion date'' means, with respect 
                        to an applicable clinical trial, the 
                        date that the final subject was 
                        examined or received an intervention 
                        for the purposes of final collection of 
                        data for the primary outcome, whether 
                        the clinical trial concluded according 
                        to the prespecified protocol or was 
                        terminated.
                          (vi) Device.--The term ``device'' 
                        means a device as defined in section 
                        201(h) of the Federal Food, Drug, and 
                        Cosmetic Act.
                          (vii) Drug.--The term ``drug'' means 
                        a drug as defined in section 201(g) of 
                        the Federal Food, Drug, and Cosmetic 
                        Act or a biological product as defined 
                        in section 351 of this Act.
                          (viii) Ongoing.--The term ``ongoing'' 
                        means, with respect to a clinical trial 
                        of a drug or a device and to a date, 
                        that--
                                  (I) 1 or more patients is 
                                enrolled in the clinical trial; 
                                and
                                  (II) the date is before the 
                                completion date of the clinical 
                                trial.
                          (ix) Responsible party.--The term 
                        ``responsible party'', with respect to 
                        a clinical trial of a drug or device, 
                        means--
                                  (I) the sponsor of the 
                                clinical trial (as defined in 
                                section 50.3 of title 21, Code 
                                of Federal Regulations (or any 
                                successor regulation)); or
                                  (II) the principal 
                                investigator of such clinical 
                                trial if so designated by a 
                                sponsor, grantee, contractor, 
                                or awardee, so long as the 
                                principal investigator is 
                                responsible for conducting the 
                                trial, has access to and 
                                control over the data from the 
                                clinical trial, has the right 
                                to publish the results of the 
                                trial, and has the ability to 
                                meet all of the requirements 
                                under this subsection for the 
                                submission of clinical trial 
                                information.
                  (B) Requirement.--The Secretary shall develop 
                a mechanism by which the responsible party for 
                each applicable clinical trial shall submit the 
                identity and contact information of such 
                responsible party to the Secretary at the time 
                of submission of clinical trial information 
                under paragraph (2).
          (2) Expansion of clinical trial registry data bank 
        with respect to clinical trial information.--
                  (A) In general.--
                          (i) Expansion of data bank.--To 
                        enhance patient enrollment and provide 
                        a mechanism to track subsequent 
                        progress of clinical trials, the 
                        Secretary, acting through the Director 
                        of NIH, shall expand, in accordance 
                        with this subsection, the clinical 
                        trials registry of the data bank 
                        described under subsection (i)(1) 
                        (referred to in this subsection as the 
                        ``registry data bank''). The Director 
                        of NIH shall ensure that the registry 
                        data bank is made publicly available 
                        through the Internet.
                          (ii) Content.--The clinical trial 
                        information required to be submitted 
                        under this paragraph for an applicable 
                        clinical trial shall include--
                                  (I) descriptive information, 
                                including--
                                          (aa) a brief title, 
                                        intended for the lay 
                                        public;
                                          (bb) a brief summary, 
                                        intended for the lay 
                                        public;
                                          (cc) the primary 
                                        purpose;
                                          (dd) the study 
                                        design;
                                          (ee) for an 
                                        applicable drug 
                                        clinical trial, the 
                                        study phase;
                                          (ff) study type;
                                          (gg) the primary 
                                        disease or condition 
                                        being studied, or the 
                                        focus of the study;
                                          (hh) the intervention 
                                        name and intervention 
                                        type;
                                          (ii) the study start 
                                        date;
                                          (jj) the expected 
                                        completion date;
                                          (kk) the target 
                                        number of subjects; and
                                          (ll) outcomes, 
                                        including primary and 
                                        secondary outcome 
                                        measures;
                                  (II) recruitment information, 
                                including--
                                          (aa) eligibility 
                                        criteria;
                                          (bb) gender;
                                          (cc) age limits;
                                          (dd) whether the 
                                        trial accepts healthy 
                                        volunteers;
                                          (ee) overall 
                                        recruitment status;
                                          (ff) individual site 
                                        status; and
                                          (gg) in the case of 
                                        an applicable drug 
                                        clinical trial, if the 
                                        drug is not approved 
                                        under section 505 of 
                                        the Federal Food, Drug, 
                                        and Cosmetic Act or 
                                        licensed under section 
                                        351 of this Act, 
                                        specify whether or not 
                                        there is expanded 
                                        access to the drug 
                                        under section 561 of 
                                        the Federal Food, Drug, 
                                        and Cosmetic Act for 
                                        those who do not 
                                        qualify for enrollment 
                                        in the clinical trial 
                                        and how to obtain 
                                        information about such 
                                        access;
                                  (III) location and contact 
                                information, including--
                                          (aa) the name of the 
                                        sponsor;
                                          (bb) the responsible 
                                        party, by official 
                                        title; and
                                          (cc) the facility 
                                        name and facility 
                                        contact information 
                                        (including the city, 
                                        State, and zip code for 
                                        each clinical trial 
                                        location, or a toll-
                                        free number through 
                                        which such location 
                                        information may be 
                                        accessed); and
                                  (IV) administrative data 
                                (which the Secretary may make 
                                publicly available as 
                                necessary), including--
                                          (aa) the unique 
                                        protocol identification 
                                        number;
                                          (bb) other protocol 
                                        identification numbers, 
                                        if any; and
                                          (cc) the Food and 
                                        Drug Administration 
                                        IND/IDE protocol number 
                                        and the record 
                                        verification date.
                          (iii) Modifications.--The Secretary 
                        may by regulation modify the 
                        requirements for clinical trial 
                        information under this paragraph, if 
                        the Secretary provides a rationale for 
                        why such a modification improves and 
                        does not reduce such clinical trial 
                        information.
                  (B) Format and structure.--
                          (i) Searchable categories.--The 
                        Director of NIH shall ensure that the 
                        public may, in addition to keyword 
                        searching, search the entries in the 
                        registry data bank by 1 or more of the 
                        following criteria:
                                  (I) The disease or condition 
                                being studied in the clinical 
                                trial, using Medical Subject 
                                Headers (MeSH) descriptors.
                                  (II) The name of the 
                                intervention, including any 
                                drug or device being studied in 
                                the clinical trial.
                                  (III) The location of the 
                                clinical trial.
                                  (IV) The age group studied in 
                                the clinical trial, including 
                                pediatric subpopulations.
                                  (V) The study phase of the 
                                clinical trial.
                                  (VI) The sponsor of the 
                                clinical trial, which may be 
                                the National Institutes of 
                                Health or another Federal 
                                agency, a private industry 
                                source, or a university or 
                                other organization.
                                  (VII) The recruitment status 
                                of the clinical trial.
                                  (VIII) The National Clinical 
                                Trial number or other study 
                                identification for the clinical 
                                trial.
                          (ii) Additional searchable 
                        category.--Not later than 18 months 
                        after the date of the enactment of the 
                        Food and Drug Administration Amendments 
                        Act of 2007, the Director of NIH shall 
                        ensure that the public may search the 
                        entries of the registry data bank by 
                        the safety issue, if any, being studied 
                        in the clinical trial as a primary or 
                        secondary outcome.
                          (iii) Other elements.--The Director 
                        of NIH shall also ensure that the 
                        public may search the entries of the 
                        registry data bank by such other 
                        elements as the Director deems 
                        necessary on an ongoing basis.
                          (iv) Format.--The Director of the NIH 
                        shall ensure that the registry data 
                        bank is easily used by the public, and 
                        that entries are easily compared.
                  (C) Data submission.--The responsible party 
                for an applicable clinical trial, including an 
                applicable drug clinical trial for a serious or 
                life-threatening disease or condition, that is 
                initiated after, or is ongoing on the date that 
                is 90 days after, the date of the enactment of 
                the Food and Drug Administration Amendments Act 
                of 2007, shall submit to the Director of NIH 
                for inclusion in the registry data bank the 
                clinical trial information described in of 
                subparagraph (A)(ii) not later than the later 
                of--
                          (i) 90 days after such date of 
                        enactment;
                          (ii) 21 days after the first patient 
                        is enrolled in such clinical trial; or
                          (iii) in the case of a clinical trial 
                        that is not for a serious or life-
                        threatening disease or condition and 
                        that is ongoing on such date of 
                        enactment, 1 year after such date of 
                        enactment.
                  (D) Posting of data.--
                          (i) Applicable drug clinical trial.--
                        The Director of NIH shall ensure that 
                        clinical trial information for an 
                        applicable drug clinical trial 
                        submitted in accordance with this 
                        paragraph is posted in the registry 
                        data bank not later than 30 days after 
                        such submission.
                          (ii) Applicable device clinical 
                        trial.--The Director of NIH shall 
                        ensure that clinical trial information 
                        for an applicable device clinical trial 
                        submitted in accordance with this 
                        paragraph is posted publicly in the 
                        registry data bank--
                                  (I) not earlier than the date 
                                of clearance under section 
                                510(k) of the Federal Food, 
                                Drug, and Cosmetic Act, or 
                                approval under section 515 or 
                                520(m) of such Act, as 
                                applicable, for a device that 
                                was not previously cleared or 
                                approved, and not later than 30 
                                days after such date; or
                                  (II) for a device that was 
                                previously cleared or approved, 
                                not later than 30 days after 
                                the clinical trial information 
                                under paragraph (3)(C) is 
                                required to be posted by the 
                                Secretary.
          (3) Expansion of registry data bank to include 
        results of clinical trials.--
                  (A) Linking registry data bank to existing 
                results.--
                          (i) In general.--Beginning not later 
                        than 90 days after the date of the 
                        enactment of the Food and Drug 
                        Administration Amendments Act of 2007, 
                        for those clinical trials that form the 
                        primary basis of an efficacy claim or 
                        are conducted after the drug involved 
                        is approved or after the device 
                        involved is cleared or approved, the 
                        Secretary shall ensure that the 
                        registry data bank includes links to 
                        results information as described in 
                        clause (ii) for such clinical trial--
                                  (I) not earlier than 30 days 
                                after the date of the approval 
                                of the drug involved or 
                                clearance or approval of the 
                                device involved; or
                                  (II) not later than 30 days 
                                after the results information 
                                described in clause (ii) 
                                becomes publicly available.
                          (ii) Required information.--
                                  (I) FDA information.--The 
                                Secretary shall ensure that the 
                                registry data bank includes 
                                links to the following 
                                information:
                                          (aa) If an advisory 
                                        committee considered at 
                                        a meeting an applicable 
                                        clinical trial, any 
                                        posted Food and Drug 
                                        Administration summary 
                                        document regarding such 
                                        applicable clinical 
                                        trial.
                                          (bb) If an applicable 
                                        drug clinical trial was 
                                        conducted under section 
                                        505A or 505B of the 
                                        Federal Food, Drug, and 
                                        Cosmetic Act, a link to 
                                        the posted Food and 
                                        Drug Administration 
                                        assessment of the 
                                        results of such trial.
                                          (cc) Food and Drug 
                                        Administration public 
                                        health advisories 
                                        regarding the drug or 
                                        device that is the 
                                        subject of the 
                                        applicable clinical 
                                        trial, if any.
                                          (dd) For an 
                                        applicable drug 
                                        clinical trial, the 
                                        Food and Drug 
                                        Administration action 
                                        package for approval 
                                        document required under 
                                        section 505(l)(2) of 
                                        the Federal Food, Drug, 
                                        and Cosmetic Act.
                                          (ee) For an 
                                        applicable device 
                                        clinical trial, in the 
                                        case of a premarket 
                                        application under 
                                        section 515 of the 
                                        Federal Food, Drug, and 
                                        Cosmetic Act, the 
                                        detailed summary of 
                                        information respecting 
                                        the safety and 
                                        effectiveness of the 
                                        device required under 
                                        section 520(h)(1) of 
                                        such Act, or, in the 
                                        case of a report under 
                                        section 510(k) of such 
                                        Act, the section 510(k) 
                                        summary of the safety 
                                        and effectiveness data 
                                        required under section 
                                        807.95(d) of title 21, 
                                        Code of Federal 
                                        Regulations (or any 
                                        successor regulation).
                                  (II) NIH information.--The 
                                Secretary shall ensure that the 
                                registry data bank includes 
                                links to the following 
                                information:
                                          (aa) Medline 
                                        citations to any 
                                        publications focused on 
                                        the results of an 
                                        applicable clinical 
                                        trial.
                                          (bb) The entry for 
                                        the drug that is the 
                                        subject of an 
                                        applicable drug 
                                        clinical trial in the 
                                        National Library of 
                                        Medicine database of 
                                        structured product 
                                        labels, if available.
                          (iii) Results for existing data bank 
                        entries.--The Secretary may include the 
                        links described in clause (ii) for data 
                        bank entries for clinical trials 
                        submitted to the data bank prior to 
                        enactment of the Food and Drug 
                        Administration Amendments Act of 2007, 
                        as available.
                  (B) Inclusion of results.--The Secretary, 
                acting through the Director of NIH, shall--
                          (i) expand the registry data bank to 
                        include the results of applicable 
                        clinical trials (referred to in this 
                        subsection as the ``registry and 
                        results data bank'');
                          (ii) ensure that such results are 
                        made publicly available through the 
                        Internet;
                          (iii) post publicly a glossary for 
                        the lay public explaining technical 
                        terms related to the results of 
                        clinical trials; and
                          (iv) in consultation with experts on 
                        risk communication, provide information 
                        with the information included under 
                        subparagraph (C) in the registry and 
                        results data bank to help ensure that 
                        such information does not mislead the 
                        patients or the public.
                  (C) Basic results.--Not later than 1 year 
                after the date of the enactment of the Food and 
                Drug Administration Amendments Act of 2007, the 
                Secretary shall include in the registry and 
                results data bank for each applicable clinical 
                trial for a drug that is approved under section 
                505 of the Federal Food, Drug, and Cosmetic Act 
                or licensed under section 351 of this Act or a 
                device that is cleared under section 510(k) of 
                the Federal Food, Drug, and Cosmetic Act or 
                approved under section 515 or 520(m) of such 
                Act, the following elements:
                          (i) Demographic and baseline 
                        characteristics of patient sample.--A 
                        table of the demographic and baseline 
                        data collected overall and for each arm 
                        of the clinical trial to describe the 
                        patients who participated in the 
                        clinical trial, including the number of 
                        patients who dropped out of the 
                        clinical trial and the number of 
                        patients excluded from the analysis, if 
                        any.
                          (ii) Primary and secondary 
                        outcomes.--The primary and secondary 
                        outcome measures as submitted under 
                        paragraph (2)(A)(ii)(I)(ll), and a 
                        table of values for each of the primary 
                        and secondary outcome measures for each 
                        arm of the clinical trial, including 
                        the results of scientifically 
                        appropriate tests of the statistical 
                        significance of such outcome measures.
                          (iii) Point of contact.--A point of 
                        contact for scientific information 
                        about the clinical trial results.
                          (iv) Certain agreements.--Whether 
                        there exists an agreement (other than 
                        an agreement solely to comply with 
                        applicable provisions of law protecting 
                        the privacy of participants) between 
                        the sponsor or its agent and the 
                        principal investigator (unless the 
                        sponsor is an employer of the principal 
                        investigator) that restricts in any 
                        manner the ability of the principal 
                        investigator, after the completion date 
                        of the trial, to discuss the results of 
                        the trial at a scientific meeting or 
                        any other public or private forum, or 
                        to publish in a scientific or academic 
                        journal information concerning the 
                        results of the trial.
                  (D) Expanded registry and results data 
                bank.--
                          (i) Expansion by rulemaking.--To 
                        provide more complete results 
                        information and to enhance patient 
                        access to and understanding of the 
                        results of clinical trials, not later 
                        than 3 years after the date of the 
                        enactment of the Food and Drug 
                        Administration Amendments Act of 2007, 
                        the Secretary shall by regulation 
                        expand the registry and results data 
                        bank as provided under this 
                        subparagraph.
                          (ii) Clinical trials.--
                                  (I) Approved products.--The 
                                regulations under this 
                                subparagraph shall require the 
                                inclusion of the results 
                                information described in clause 
                                (iii) for--
                                          (aa) each applicable 
                                        drug clinical trial for 
                                        a drug that is approved 
                                        under section 505 of 
                                        the Federal Food, Drug, 
                                        and Cosmetic Act or 
                                        licensed under section 
                                        351 of this Act; and
                                          (bb) each applicable 
                                        device clinical trial 
                                        for a device that is 
                                        cleared under section 
                                        510(k) of the Federal 
                                        Food, Drug, and 
                                        Cosmetic Act or 
                                        approved under section 
                                        515 or 520(m) of such 
                                        Act.
                                  (II) Unapproved products.--
                                The regulations under this 
                                subparagraph shall establish 
                                whether or not the results 
                                information described in clause 
                                (iii) shall be required for--
                                          (aa) an applicable 
                                        drug clinical trial for 
                                        a drug that is not 
                                        approved under section 
                                        505 of the Federal 
                                        Food, Drug, and 
                                        Cosmetic Act and not 
                                        licensed under section 
                                        351 of this Act 
                                        (whether approval or 
                                        licensure was sought or 
                                        not); and
                                          (bb) an applicable 
                                        device clinical trial 
                                        for a device that is 
                                        not cleared under 
                                        section 510(k) of the 
                                        Federal Food, Drug, and 
                                        Cosmetic Act and not 
                                        approved under section 
                                        515 or section 520(m) 
                                        of such Act (whether 
                                        clearance or approval 
                                        was sought or not).
                          (iii) Required elements.--The 
                        regulations under this subparagraph 
                        shall require, in addition to the 
                        elements described in subparagraph (C), 
                        information within each of the 
                        following categories:
                                  (I) A summary of the clinical 
                                trial and its results that is 
                                written in non-technical, 
                                understandable language for 
                                patients, if the Secretary 
                                determines that such types of 
                                summary can be included without 
                                being misleading or 
                                promotional.
                                  (II) A summary of the 
                                clinical trial and its results 
                                that is technical in nature, if 
                                the Secretary determines that 
                                such types of summary can be 
                                included without being 
                                misleading or promotional.
                                  (III) The full protocol or 
                                such information on the 
                                protocol for the trial as may 
                                be necessary to help to 
                                evaluate the results of the 
                                trial.
                                  (IV) Such other categories as 
                                the Secretary determines 
                                appropriate.
                          (iv) Results submission.--The results 
                        information described in clause (iii) 
                        shall be submitted to the Director of 
                        NIH for inclusion in the registry and 
                        results data bank as provided by 
                        subparagraph (E), except that the 
                        Secretary shall by regulation 
                        determine--
                                  (I) whether the 1-year period 
                                for submission of clinical 
                                trial information described in 
                                subparagraph (E)(i) should be 
                                increased from 1 year to a 
                                period not to exceed 18 months;
                                  (II) whether the clinical 
                                trial information described in 
                                clause (iii) should be required 
                                to be submitted for an 
                                applicable clinical trial for 
                                which the clinical trial 
                                information described in 
                                subparagraph (C) is submitted 
                                to the registry and results 
                                data bank before the effective 
                                date of the regulations issued 
                                under this subparagraph; and
                                  (III) in the case when the 
                                clinical trial information 
                                described in clause (iii) is 
                                required to be submitted for 
                                the applicable clinical trials 
                                described in clause (ii)(II), 
                                the date by which such clinical 
                                trial information shall be 
                                required to be submitted, 
                                taking into account--
                                          (aa) the 
                                        certification process 
                                        under subparagraph 
                                        (E)(iii) when approval, 
                                        licensure, or clearance 
                                        is sought; and
                                          (bb) whether there 
                                        should be a delay of 
                                        submission when 
                                        approval, licensure, or 
                                        clearance will not be 
                                        sought.
                          (v) Additional provisions.--The 
                        regulations under this subparagraph 
                        shall also establish--
                                  (I) a standard format for the 
                                submission of clinical trial 
                                information under this 
                                paragraph to the registry and 
                                results data bank;
                                  (II) additional information 
                                on clinical trials and results 
                                that is written in 
                                nontechnical, understandable 
                                language for patients;
                                  (III) considering the 
                                experience under the pilot 
                                quality control project 
                                described in paragraph (5)(C), 
                                procedures for quality control, 
                                including using representative 
                                samples, with respect to 
                                completeness and content of 
                                clinical trial information 
                                under this subsection, to help 
                                ensure that data elements are 
                                not false or misleading and are 
                                non-promotional;
                                  (IV) the appropriate timing 
                                and requirements for updates of 
                                clinical trial information, and 
                                whether and, if so, how such 
                                updates should be tracked;
                                  (V) a statement to accompany 
                                the entry for an applicable 
                                clinical trial when the primary 
                                and secondary outcome measures 
                                for such clinical trial are 
                                submitted under paragraph 
                                (4)(A) after the date specified 
                                for the submission of such 
                                information in paragraph 
                                (2)(C); and
                                  (VI) additions or 
                                modifications to the manner of 
                                reporting of the data elements 
                                established under subparagraph 
                                (C).
                          (vi) Consideration of world health 
                        organization data set.--The Secretary 
                        shall consider the status of the 
                        consensus data elements set for 
                        reporting clinical trial results of the 
                        World Health Organization when issuing 
                        the regulations under this 
                        subparagraph.
                          (vii) Public meeting.--The Secretary 
                        shall hold a public meeting no later 
                        than 18 months after the date of the 
                        enactment of the Food and Drug 
                        Administration Amendments Act of 2007 
                        to provide an opportunity for input 
                        from interested parties with regard to 
                        the regulations to be issued under this 
                        subparagraph.
                  (E) Submission of results information.--
                          (i) In general.--Except as provided 
                        in clauses (iii), (iv), (v), and (vi) 
                        the responsible party for an applicable 
                        clinical trial that is described in 
                        clause (ii) shall submit to the 
                        Director of NIH for inclusion in the 
                        registry and results data bank the 
                        clinical trial information described in 
                        subparagraph (C) not later than 1 year, 
                        or such other period as may be provided 
                        by regulation under subparagraph (D), 
                        after the earlier of--
                                  (I) the estimated completion 
                                date of the trial as described 
                                in paragraph 
                                (2)(A)(ii)(I)(jj)); or
                                  (II) the actual date of 
                                completion.
                          (ii) Clinical trials described.--An 
                        applicable clinical trial described in 
                        this clause is an applicable clinical 
                        trial subject to--
                                  (I) paragraph (2)(C); and
                                  (II)(aa) subparagraph (C); or
                                  (bb) the regulations issued 
                                under subparagraph (D).
                          (iii) Delayed submission of results 
                        with certification.--If the responsible 
                        party for an applicable clinical trial 
                        submits a certification that clause 
                        (iv) or (v) applies to such clinical 
                        trial, the responsible party shall 
                        submit to the Director of NIH for 
                        inclusion in the registry and results 
                        data bank the clinical trial 
                        information described in subparagraphs 
                        (C) and (D) as required under the 
                        applicable clause.
                          (iv) Seeking initial approval of a 
                        drug or device.--With respect to an 
                        applicable clinical trial that is 
                        completed before the drug is initially 
                        approved under section 505 of the 
                        Federal Food, Drug, and Cosmetic Act or 
                        initially licensed under section 351 of 
                        this Act, or the device is initially 
                        cleared under section 510(k) or 
                        initially approved under section 515 or 
                        520(m) of the Federal Food, Drug, and 
                        Cosmetic Act, the responsible party 
                        shall submit to the Director of NIH for 
                        inclusion in the registry and results 
                        data bank the clinical trial 
                        information described in subparagraphs 
                        (C) and (D) not later than 30 days 
                        after the drug or device is approved 
                        under such section 505, licensed under 
                        such section 351, cleared under such 
                        section 510(k), or approved under such 
                        section 515 or 520(m), as applicable.
                          (v) Seeking approval of a new use for 
                        the drug or device.--
                                  (I) In general.--With respect 
                                to an applicable clinical trial 
                                where the manufacturer of the 
                                drug or device is the sponsor 
                                of an applicable clinical 
                                trial, and such manufacturer 
                                has filed, or will file within 
                                1 year, an application seeking 
                                approval under section 505 of 
                                the Federal Food, Drug, and 
                                Cosmetic Act, licensing under 
                                section 351 of this Act, or 
                                clearance under section 510(k), 
                                or approval under section 515 
                                or 520(m), of the Federal Food, 
                                Drug, and Cosmetic Act for the 
                                use studied in such clinical 
                                trial (which use is not 
                                included in the labeling of the 
                                approved drug or device), then 
                                the responsible party shall 
                                submit to the Director of NIH 
                                for inclusion in the registry 
                                and results data bank the 
                                clinical trial information 
                                described in subparagraphs (C) 
                                and (D) on the earlier of the 
                                date that is 30 days after the 
                                date--
                                          (aa) the new use of 
                                        the drug or device is 
                                        approved under such 
                                        section 505, licensed 
                                        under such section 351, 
                                        cleared under such 
                                        section 510(k), or 
                                        approved under such 
                                        section 515 or 520(m);
                                          (bb) the Secretary 
                                        issues a letter, such 
                                        as a complete response 
                                        letter, not approving 
                                        the submission or not 
                                        clearing the 
                                        submission, a not 
                                        approvable letter, or a 
                                        not substantially 
                                        equivalent letter for 
                                        the new use of the drug 
                                        or device under such 
                                        section 505, 351, 
                                        510(k), 515, or 520(m); 
                                        or
                                          (cc) except as 
                                        provided in subclause 
                                        (III), the application 
                                        or premarket 
                                        notification under such 
                                        section 505, 351, 
                                        510(k), 515, or 520(m) 
                                        is withdrawn without 
                                        resubmission for no 
                                        less than 210 days.
                                  (II) Requirement that each 
                                clinical trial in application 
                                be treated the same.--If a 
                                manufacturer makes a 
                                certification under clause 
                                (iii) that this clause applies 
                                with respect to a clinical 
                                trial, the manufacturer shall 
                                make such a certification with 
                                respect to each applicable 
                                clinical trial that is required 
                                to be submitted in an 
                                application or report for 
                                licensure, approval, or 
                                clearance (under section 351 of 
                                this Act or section 505, 
                                510(k), 515, or 520(m) of the 
                                Federal Food, Drug, and 
                                Cosmetic Act, as applicable) of 
                                the use studied in the clinical 
                                trial.
                                  (III) Two-year limitation.--
                                The responsible party shall 
                                submit to the Director of NIH 
                                for inclusion in the registry 
                                and results data bank the 
                                clinical trial information 
                                subject to subclause (I) on the 
                                date that is 2 years after the 
                                date a certification under 
                                clause (iii) was made to the 
                                Director of NIH, if an action 
                                referred to in item (aa), (bb), 
                                or (cc) of subclause (I) has 
                                not occurred by such date.
                          (vi) Extensions.--The Director of NIH 
                        may provide an extension of the 
                        deadline for submission of clinical 
                        trial information under clause (i) if 
                        the responsible party for the trial 
                        submits to the Director a written 
                        request that demonstrates good cause 
                        for the extension and provides an 
                        estimate of the date on which the 
                        information will be submitted. The 
                        Director of NIH may grant more than one 
                        such extension for a clinical trial.
                  (F) Notice to director of nih.--The 
                Commissioner of Food and Drugs shall notify the 
                Director of NIH when there is an action 
                described in subparagraph (E)(iv) or item (aa), 
                (bb), or (cc) of subparagraph (E)(v)(I) with 
                respect to an application or a report that 
                includes a certification required under 
                paragraph (5)(B) of such action not later than 
                30 days after such action.
                  (G) Posting of data.--The Director of NIH 
                shall ensure that the clinical trial 
                information described in subparagraphs (C) and 
                (D) for an applicable clinical trial submitted 
                in accordance with this paragraph is posted 
                publicly in the registry and results database 
                not later than 30 days after such submission.
                  (H) Waivers regarding certain clinical trial 
                results.--The Secretary may waive any 
                applicable requirements of this paragraph for 
                an applicable clinical trial, upon a written 
                request from the responsible party, if the 
                Secretary determines that extraordinary 
                circumstances justify the waiver and that 
                providing the waiver is consistent with the 
                protection of public health, or in the interest 
                of national security. Not later than 30 days 
                after any part of a waiver is granted, the 
                Secretary shall notify, in writing, the 
                appropriate committees of Congress of the 
                waiver and provide an explanation for why the 
                waiver was granted.
                  (I) Adverse events.--
                          (i) Regulations.--Not later than 18 
                        months after the date of the enactment 
                        of the Food and Drug Administration 
                        Amendments Act of 2007, the Secretary 
                        shall by regulation determine the best 
                        method for including in the registry 
                        and results data bank appropriate 
                        results information on serious adverse 
                        and frequent adverse events for 
                        applicable clinical trials described in 
                        subparagraph (C) in a manner and form 
                        that is useful and not misleading to 
                        patients, physicians, and scientists.
                          (ii) Default.--If the Secretary fails 
                        to issue the regulation required by 
                        clause (i) by the date that is 24 
                        months after the date of the enactment 
                        of the Food and Drug Administration 
                        Amendments Act of 2007, clause (iii) 
                        shall take effect.
                          (iii) Additional elements.--Upon the 
                        application of clause (ii), the 
                        Secretary shall include in the registry 
                        and results data bank for applicable 
                        clinical trials described in 
                        subparagraph (C), in addition to the 
                        clinical trial information described in 
                        subparagraph (C), the following 
                        elements:
                                  (I) Serious adverse events.--
                                A table of anticipated and 
                                unanticipated serious adverse 
                                events grouped by organ system, 
                                with number and frequency of 
                                such event in each arm of the 
                                clinical trial.
                                  (II) Frequent adverse 
                                events.--A table of anticipated 
                                and unanticipated adverse 
                                events that are not included in 
                                the table described in 
                                subclause (I) that exceed a 
                                frequency of 5 percent within 
                                any arm of the clinical trial, 
                                grouped by organ system, with 
                                number and frequency of such 
                                event in each arm of the 
                                clinical trial.
                          (iv) Posting of other information.--
                        In carrying out clause (iii), the 
                        Secretary shall, in consultation with 
                        experts in risk communication, post 
                        with the tables information to enhance 
                        patient understanding and to ensure 
                        such tables do not mislead patients or 
                        the lay public.
                          (v) Relation to subparagraph (c).--
                        Clinical trial information included in 
                        the registry and results data bank 
                        pursuant to this subparagraph is deemed 
                        to be clinical trial information 
                        included in such data bank pursuant to 
                        subparagraph (C).
          (4) Additional submissions of clinical trial 
        information.--
                  (A) Voluntary submissions.--A responsible 
                party for a clinical trial that is not an 
                applicable clinical trial, or that is an 
                applicable clinical trial that is not subject 
                to paragraph (2)(C), may submit complete 
                clinical trial information described in 
                paragraph (2) or paragraph (3) provided the 
                responsible party submits clinical trial 
                information for each applicable clinical trial 
                that is required to be submitted under section 
                351 or under section 505, 510(k), 515, or 
                520(m) of the Federal Food, Drug, and Cosmetic 
                Act in an application or report for licensure, 
                approval, or clearance of the drug or device 
                for the use studied in the clinical trial.
                  (B) Required submissions.--
                          (i) In general.--Notwithstanding 
                        paragraphs (2) and (3) and subparagraph 
                        (A), in any case in which the Secretary 
                        determines for a specific clinical 
                        trial described in clause (ii) that 
                        posting in the registry and results 
                        data bank of clinical trial information 
                        for such clinical trial is necessary to 
                        protect the public health--
                                  (I) the Secretary may require 
                                by notification that such 
                                information be submitted to the 
                                Secretary in accordance with 
                                paragraphs (2) and (3) except 
                                with regard to timing of 
                                submission;
                                  (II) unless the responsible 
                                party submits a certification 
                                under paragraph (3)(E)(iii), 
                                such information shall be 
                                submitted not later than 30 
                                days after the date specified 
                                by the Secretary in the 
                                notification; and
                                  (III) failure to comply with 
                                the requirements under 
                                subclauses (I) and (II) shall 
                                be treated as a violation of 
                                the corresponding requirement 
                                of such paragraphs.
                          (ii) Clinical trials described.--A 
                        clinical trial described in this clause 
                        is--
                                  (I) an applicable clinical 
                                trial for a drug that is 
                                approved under section 505 of 
                                the Federal Food, Drug, and 
                                Cosmetic Act or licensed under 
                                section 351 of this Act or for 
                                a device that is cleared under 
                                section 510(k) of the Federal 
                                Food, Drug, and Cosmetic Act or 
                                approved under section 515 or 
                                section 520(m) of such Act, 
                                whose completion date is on or 
                                after the date 10 years before 
                                the date of the enactment of 
                                the Food and Drug 
                                Administration Amendments Act 
                                of 2007; or
                                  (II) an applicable clinical 
                                trial that is described by both 
                                by paragraph (2)(C) and 
                                paragraph (3)(D)(ii)(II)).
                  (C) Updates to clinical trial data bank.--
                          (i) Submission of updates.--The 
                        responsible party for an applicable 
                        clinical trial shall submit to the 
                        Director of NIH for inclusion in the 
                        registry and results data bank updates 
                        to reflect changes to the clinical 
                        trial information submitted under 
                        paragraph (2). Such updates--
                                  (I) shall be provided not 
                                less than once every 12 months, 
                                unless there were no changes to 
                                the clinical trial information 
                                during the preceding 12-month 
                                period;
                                  (II) shall include 
                                identification of the dates of 
                                any such changes;
                                  (III) not later than 30 days 
                                after the recruitment status of 
                                such clinical trial changes, 
                                shall include an update of the 
                                recruitment status; and
                                  (IV) not later than 30 days 
                                after the completion date of 
                                the clinical trial, shall 
                                include notification to the 
                                Director that such clinical 
                                trial is complete.
                          (ii) Public availability of 
                        updates.--The Director of NIH shall 
                        make updates submitted under clause (i) 
                        publicly available in the registry data 
                        bank. Except with regard to overall 
                        recruitment status, individual site 
                        status, location, and contact 
                        information, the Director of NIH shall 
                        ensure that updates to elements 
                        required under subclauses (I) to (V) of 
                        paragraph (2)(A)(ii) do not result in 
                        the removal of any information from the 
                        original submissions or any preceding 
                        updates, and information in such 
                        databases is presented in a manner that 
                        enables users to readily access each 
                        original element submission and to 
                        track the changes made by the updates. 
                        The Director of NIH shall provide a 
                        link from the table of primary and 
                        secondary outcomes required under 
                        paragraph (3)(C)(ii) to the tracked 
                        history required under this clause of 
                        the primary and secondary outcome 
                        measures submitted under paragraph 
                        (2)(A)(ii)(I)(ll).
          (5) Coordination and compliance.--
                  (A) Clinical trials supported by grants from 
                federal agencies.--
                          (i) Grants from certain federal 
                        agencies.--If an applicable clinical 
                        trial is funded in whole or in part by 
                        a grant from any agency of the 
                        Department of Health and Human 
                        Services, including the Food and Drug 
                        Administration, the National Institutes 
                        of Health, or the Agency for Healthcare 
                        Research and Quality, any grant or 
                        progress report forms required under 
                        such grant shall include a 
                        certification that the responsible 
                        party has made all required submissions 
                        to the Director of NIH under paragraphs 
                        (2) and (3).
                          (ii) Verification by federal 
                        agencies.--The heads of the agencies 
                        referred to in clause (i), as 
                        applicable, shall verify that the 
                        clinical trial information for each 
                        applicable clinical trial for which a 
                        grantee is the responsible party has 
                        been submitted under paragraphs (2) and 
                        (3) before releasing any remaining 
                        funding for a grant or funding for a 
                        future grant to such grantee.
                          (iii) Notice and opportunity to 
                        remedy.--If the head of an agency 
                        referred to in clause (i), as 
                        applicable, verifies that a grantee has 
                        not submitted clinical trial 
                        information as described in clause 
                        (ii), such agency head shall provide 
                        notice to such grantee of such non-
                        compliance and allow such grantee 30 
                        days to correct such non-compliance and 
                        submit the required clinical trial 
                        information.
                          (iv) Consultation with other federal 
                        agencies.--The Secretary shall--
                                  (I) consult with other 
                                agencies that conduct research 
                                involving human subjects in 
                                accordance with any section of 
                                part 46 of title 45, Code of 
                                Federal Regulations (or any 
                                successor regulations), to 
                                determine if any such research 
                                is an applicable clinical 
                                trial; and
                                  (II) develop with such 
                                agencies procedures comparable 
                                to those described in clauses 
                                (i), (ii), and (iii) to ensure 
                                that clinical trial information 
                                for such applicable clinical 
                                trial is submitted under 
                                paragraphs (2) and (3).
                  (B) Certification to accompany drug, 
                biological product, and device submissions.--At 
                the time of submission of an application under 
                section 505 of the Federal Food, Drug, and 
                Cosmetic Act, section 515 of such Act, section 
                520(m) of such Act, or section 351 of this Act, 
                or submission of a report under section 510(k) 
                of such Act, such application or submission 
                shall be accompanied by a certification that 
                all applicable requirements of this subsection 
                have been met. Where available, such 
                certification shall include the appropriate 
                National Clinical Trial control numbers.
                  (C) Quality control.--
                          (i) Pilot quality control project.--
                        Until the effective date of the 
                        regulations issued under paragraph 
                        (3)(D), the Secretary, acting through 
                        the Director of NIH and the 
                        Commissioner of Food and Drugs, shall 
                        conduct a pilot project to determine 
                        the optimal method of verification to 
                        help to ensure that the clinical trial 
                        information submitted under paragraph 
                        (3)(C) is non-promotional and is not 
                        false or misleading in any particular 
                        under subparagraph (D). The Secretary 
                        shall use the publicly available 
                        information described in paragraph 
                        (3)(A) and any other information 
                        available to the Secretary about 
                        applicable clinical trials to verify 
                        the accuracy of the clinical trial 
                        information submitted under paragraph 
                        (3)(C).
                          (ii) Notice of compliance.--If the 
                        Secretary determines that any clinical 
                        trial information was not submitted as 
                        required under this subsection, or was 
                        submitted but is false or misleading in 
                        any particular, the Secretary shall 
                        notify the responsible party and give 
                        such party an opportunity to remedy 
                        such noncompliance by submitting the 
                        required revised clinical trial 
                        information not later than 30 days 
                        after such notification.
                  (D) Truthful clinical trial information.--
                          (i) In general.--The clinical trial 
                        information submitted by a responsible 
                        party under this subsection shall not 
                        be false or misleading in any 
                        particular.
                          (ii) Effect.--Clause (i) shall not 
                        have the effect of--
                                  (I) requiring clinical trial 
                                information with respect to an 
                                applicable clinical trial to 
                                include information from any 
                                source other than such clinical 
                                trial involved; or
                                  (II) requiring clinical trial 
                                information described in 
                                paragraph (3)(D) to be 
                                submitted for purposes of 
                                paragraph (3)(C).
                  (E) Public notices.--
                          (i) Notice of violations.--If the 
                        responsible party for an applicable 
                        clinical trial fails to submit clinical 
                        trial information for such clinical 
                        trial as required under paragraphs (2) 
                        or (3), the Director of NIH shall 
                        include in the registry and results 
                        data bank entry for such clinical trial 
                        a notice--
                                  (I) that the responsible 
                                party is not in compliance with 
                                this Act by--
                                          (aa) failing to 
                                        submit required 
                                        clinical trial 
                                        information; or
                                          (bb) submitting false 
                                        or misleading clinical 
                                        trial information;
                                  (II) of the penalties imposed 
                                for the violation, if any; and
                                  (III) whether the responsible 
                                party has corrected the 
                                clinical trial information in 
                                the registry and results data 
                                bank.
                          (ii) Notice of failure to submit 
                        primary and secondary outcomes.--If the 
                        responsible party for an applicable 
                        clinical trial fails to submit the 
                        primary and secondary outcomes as 
                        required under section 2(A)(ii)(I)(ll), 
                        the Director of NIH shall include in 
                        the registry and results data bank 
                        entry for such clinical trial a notice 
                        that the responsible party is not in 
                        compliance by failing to register the 
                        primary and secondary outcomes in 
                        accordance with this act, and that the 
                        primary and secondary outcomes were not 
                        publicly disclosed in the database 
                        before conducting the clinical trial.
                          (iii) Failure to submit statement.--
                        The notice under clause (i) for a 
                        violation described in clause 
                        (i)(I)(aa) shall include the following 
                        statement: ``The entry for this 
                        clinical trial was not complete at the 
                        time of submission, as required by law. 
                        This may or may not have any bearing on 
                        the accuracy of the information in the 
                        entry.''.
                          (iv) Submission of false information 
                        statement.--The notice under clause (i) 
                        for a violation described in clause 
                        (i)(I)(bb) shall include the following 
                        statement: ``The entry for this 
                        clinical trial was found to be false or 
                        misleading and therefore not in 
                        compliance with the law.''.
                          (v) Non-submission of statement.--The 
                        notice under clause (ii) for a 
                        violation described in clause (ii) 
                        shall include the following statement: 
                        ``The entry for this clinical trial did 
                        not contain information on the primary 
                        and secondary outcomes at the time of 
                        submission, as required by law. This 
                        may or may not have any bearing on the 
                        accuracy of the information in the 
                        entry.''.
                          (vi) Compliance searches.--The 
                        Director of NIH shall provide that the 
                        public may easily search the registry 
                        and results data bank for entries that 
                        include notices required under this 
                        subparagraph.
          (6) Limitation on disclosure of clinical trial 
        information.--
                  (A) In general.--Nothing in this subsection 
                (or under section 552 of title 5, United States 
                Code) shall require the Secretary to publicly 
                disclose, by any means other than the registry 
                and results data bank, information described in 
                subparagraph (B).
                  (B) Information described.--Information 
                described in this subparagraph is--
                          (i) information submitted to the 
                        Director of NIH under this subsection, 
                        or information of the same general 
                        nature as (or integrally associated 
                        with) the information so submitted; and
                          (ii) information not otherwise 
                        publicly available, including because 
                        it is protected from disclosure under 
                        section 552 of title 5, United States 
                        Code.
          (7) Standardization.--The Director of NIH shall--
                  (A) ensure that the registry and results data 
                bank is easily used by the public;
                  (B) ensure that entries in the registry and 
                results data bank are easily compared;
                  (C) ensure that information required to be 
                submitted to the registry and results data 
                bank, including recruitment information under 
                paragraph (2)(A)(ii)(II), is submitted by 
                persons and posted by the Director of NIH in a 
                standardized format and includes at least--
                          (i) the disease or indication being 
                        studied;
                          (ii) inclusion criteria such as age, 
                        gender, diagnosis or diagnoses, 
                        laboratory values, or imaging results; 
                        and
                          (iii) exclusion criteria such as 
                        specific diagnosis or diagnoses, 
                        laboratory values, or prohibited 
                        medications; and
                  (D) to the extent possible, in carrying out 
                this paragraph, make use of standard health 
                care terminologies, such as the International 
                Classification of Diseases or the Current 
                Procedural Terminology, that facilitate 
                electronic matching to data in electronic 
                health records or other relevant health 
                information technologies.
          [(7)] (8) Authorization of appropriations.--There are 
        authorized to be appropriated to carry out this 
        subsection $10,000,000 for each fiscal year.
  (k)(1) The Director of NIH may establish a program to provide 
day care services for the employees of the National Institutes 
of Health similar to those services provided by other Federal 
agencies (including the availability of day care service on a 
24-hour-a-day basis).
  (2) Any day care provider at the National Institutes of 
Health shall establish a sliding scale of fees that takes into 
consideration the income and needs of the employee.
  (3) For purposes regarding the provision of day care 
services, the Director of NIH may enter into rental or lease 
purchase agreements.
  (l) Council of Councils.--
          (1) Establishment.--Not later than 90 days after the 
        date of the enactment of the National Institutes of 
        Health Reform Act of 2006, the Director of NIH shall 
        establish within the Office of the Director an advisory 
        council to be known as the ``Council of Councils'' 
        (referred to in this subsection as the ``Council'') for 
        the purpose of advising the Director on matters related 
        to the policies and activities of the Division of 
        Program Coordination, Planning, and Strategic 
        Initiatives, including making recommendations with 
        respect to the conduct and support of research 
        described in subsection (b)(7).
          (2) Membership.--
                  (A) In general.--The Council shall be 
                composed of 27 members selected by the Director 
                of NIH with approval from the Secretary from 
                among the list of nominees under subparagraph 
                (C).
                  (B) Certain requirements.--In selecting the 
                members of the Council, the Director of NIH 
                shall ensure--
                          (i) the representation of a broad 
                        range of disciplines and perspectives; 
                        and
                          (ii) the ongoing inclusion of at 
                        least 1 representative from each 
                        national research institute whose 
                        budget is substantial relative to a 
                        majority of the other institutes.
                  (C) Nomination.--The Director of NIH shall 
                maintain an updated list of individuals who 
                have been nominated to serve on the Council, 
                which list shall consist of the following:
                          (i) For each national research 
                        institute and national center, 3 
                        individuals nominated by the head of 
                        such institute or center from among the 
                        members of the advisory council of the 
                        institute or center, of which--
                                  (I) two shall be scientists; 
                                and
                                  (II) one shall be from the 
                                general public or shall be a 
                                leader in the field of public 
                                policy, law, health policy, 
                                economics, or management.
                          (ii) For each office within the 
                        Division of Program Coordination, 
                        Planning, and Strategic Initiatives, 1 
                        individual nominated by the head of 
                        such office.
                          (iii) Members of the Council of 
                        Public Representatives.
          (3) Terms.--
                  (A) In general.--The term of service for a 
                member of the Council shall be 6 years, except 
                as provided in subparagraphs (B) and (C).
                  (B) Terms of initial appointees.--Of the 
                initial members selected for the Council, the 
                Director of NIH shall designate--
                          (i) nine for a term of 6 years;
                          (ii) nine for a term of 4 years; and
                          (iii) nine for a term of 2 years.
                  (C) Vacancies.--Any member appointed to fill 
                a vacancy occurring before the expiration of 
                the term for which the member's predecessor was 
                appointed shall be appointed only for the 
                remainder of that term. A member may serve 
                after the expiration of that member's term 
                until a successor has taken office.
  (m) Research Strategic Plan.--
          (1) Five-year plans for biomedical research 
        strategy.--
                  (A) In general.--For each successive five-
                year period beginning with the period of fiscal 
                years 2016 through 2020, the Director of NIH, 
                in consultation with the entities described in 
                subparagraph (B), shall develop and maintain a 
                biomedical research strategic plan that--
                          (i) is designed to increase the 
                        efficient and effective focus of 
                        biomedical research in a manner that 
                        leverages the best scientific 
                        opportunities through a deliberative 
                        planning process;
                          (ii) identifies areas, to be known as 
                        strategic focus areas, in which the 
                        resources of the National Institutes of 
                        Health can best contribute to the goal 
                        of expanding knowledge on human health 
                        in the United States through biomedical 
                        research; and
                          (iii) includes objectives for each 
                        such strategic focus area.
                  (B) Entities described.--The entities 
                described in this subparagraph are the 
                directors of the national research institutes 
                and national centers, researchers, patient 
                advocacy groups, and industry leaders.
          (2) Use of plan.--The Director of NIH and the 
        directors of the national research institutes and 
        national centers shall use the strategic plan--
                  (A) to identify research opportunities; and
                  (B) to develop individual strategic plans for 
                the research activities of each of the national 
                research institutes and national centers that--
                          (i) have a common template; and
                          (ii) identify strategic focus areas 
                        in which the resources of the national 
                        research institutes and national 
                        centers can best contribute to the goal 
                        of expanding knowledge on human health 
                        in the United States through biomedical 
                        research.
          (3) Contents of plans.--
                  (A) Strategic focus areas.--The strategic 
                focus areas identified pursuant to paragraph 
                (1)(A)(ii) shall--
                          (i) be identified in a manner that--
                                  (I) considers the return on 
                                investment to the United States 
                                public through the investments 
                                of the National Institutes of 
                                Health in biomedical research; 
                                and
                                  (II) contributes to expanding 
                                knowledge to improve the United 
                                States public's health through 
                                biomedical research; and
                          (ii) include overarching and trans-
                        National Institutes of Health strategic 
                        focus areas, to be known as Mission 
                        Priority Focus Areas, which best serve 
                        the goals of preventing or eliminating 
                        the burden of a disease or condition 
                        and scientifically merit enhanced and 
                        focused research over the next 5 years.
                  (B) Rare and pediatric diseases and 
                conditions.--In developing and maintaining a 
                strategic plan under this subsection, the 
                Director of NIH shall ensure that rare and 
                pediatric diseases and conditions remain a 
                priority.
                  (C) Workforce.--In developing and maintaining 
                a strategic plan under this subsection, the 
                Director of NIH shall ensure that maintaining 
                the biomedical workforce of the future, 
                including the participation by scientists from 
                groups traditionally underrepresented in the 
                scientific workforce, remains a priority.
          (4) Initial plan.--Not later than 270 days after the 
        date of enactment of this subsection, the Director of 
        NIH and the directors of the national research 
        institutes and national centers shall--
                  (A) complete the initial strategic plan 
                required by paragraphs (1) and (2); and
                  (B) make such initial strategic plan publicly 
                available on the website of the National 
                Institutes of Health.
          (5) Review; updates.--
                  (A) Progress reviews.--Not less than 
                annually, the Director of NIH, in consultation 
                with the directors of the national research 
                institutes and national centers, shall conduct 
                progress reviews for each strategic focus area 
                identified under paragraph (1)(A)(ii).
                  (B) Updates.--Not later than the end of the 
                5-year period covered by the initial strategic 
                plan under this subsection, and every 5 years 
                thereafter, the Director of NIH, in 
                consultation with the directors of the national 
                research institutes and national centers, 
                stakeholders in the scientific field, 
                advocates, and the public at large, shall--
                          (i) conduct a review of the plan, 
                        including each strategic focus area 
                        identified under paragraph (2)(B); and
                          (ii) update such plan in accordance 
                        with this section.
  (n) Sharing of Data Generated Through NIH-funded Research.--
          (1) Authority.--Subject to paragraph (2), the 
        Director of NIH may require recipients of the award of 
        an NIH grant or other financial support, provided that 
        the research is fully funded through such grant or 
        other support, to share scientific data generated from 
        research conducted through such support for research 
        purposes.
          (2) Limitation.--The Director of NIH shall not 
        require the sharing of data that is inconsistent with 
        applicable law and policy protecting--
                  (A) privacy and confidentiality;
                  (B) proprietary interests;
                  (C) business confidential information;
                  (D) intellectual property rights; and
                  (E) other relevant rights.

SEC. 402A. AUTHORIZATION OF APPROPRIATIONS.

  (a) In General.--
          (1) This title.--For purposes of carrying out this 
        title, there are authorized to be appropriated--
                  (A) $30,331,309,000 for fiscal year 2007;
                  (B) $32,831,309,000 for fiscal year 2008; 
                [and]
                  (C) such sums as may be necessary for fiscal 
                year 2009[.];
                  (D) $31,811,000,000 for fiscal year 2016;
                  (E) $33,331,000,000 for fiscal year 2017; and
                  (F) $34,851,000,000 for fiscal year 2018.
          (2) Funding for 10-year pediatric research initiative 
        through common fund.--For the purpose of carrying out 
        section 402(b)(7)(B)(ii), there is authorized to be 
        appropriated to the Common Fund, out of the 10-Year 
        Pediatric Research Initiative Fund described in section 
        9008 of the Internal Revenue Code of 1986, and in 
        addition to amounts otherwise made available under 
        paragraph (1) of this subsection and reserved under 
        subsection (c)(1)(B)(i) of this section, $12,600,000 
        for each of fiscal years 2014 through 2023.
  (b) Office of the Director.--Of the amount authorized to be 
appropriated under subsection (a) for a fiscal year, there are 
authorized to be appropriated for programs and activities under 
this title carried out through the Office of the Director of 
NIH such sums as may be necessary for each of the fiscal years 
2007 through 2009.
  (c) Trans-NIH Research.--
          (1) Common fund.--
                  (A) Account.--For the purpose of allocations 
                under section 402(b)(7)(B) (relating to 
                research identified by the Division of Program 
                Coordination, Planning, and Strategic 
                Initiatives), there is established an account 
                to be known as the Common Fund.
                  (B) Reservation.--
                          (i) In general.--Of the total amount 
                        appropriated under subsection (a)(1) 
                        for fiscal year 2007 or any subsequent 
                        fiscal year, the Director of NIH shall 
                        reserve an amount for the Common Fund, 
                        subject to any applicable provisions in 
                        appropriations Acts.
                          (ii) Minimum amount.--For each fiscal 
                        year, the percentage constituted by the 
                        amount reserved under clause (i) 
                        relative to the total amount 
                        appropriated under subsection (a)(1) 
                        for such year may not be less than the 
                        percentage constituted by the amount so 
                        reserved for the preceding fiscal year 
                        relative to the total amount 
                        appropriated under subsection (a)(1) 
                        for such preceding fiscal year, subject 
                        to any applicable provisions in 
                        appropriations Acts.
                  (C) Common fund strategic planning report.--
                Not later than June 1, 2007, and every 2 years 
                thereafter, the Secretary, acting through the 
                Director of NIH, shall submit a report to the 
                Congress containing a strategic plan for 
                funding research described in section 
                402(b)(7)(A)(i) (including personnel needs) 
                through the Common Fund. Each such plan shall 
                include the following:
                          (i) An estimate of the amounts 
                        determined by the Director of NIH to be 
                        appropriate for maximizing the 
                        potential of such research.
                          (ii) An estimate of the amounts 
                        determined by the Director of NIH to be 
                        sufficient only for continuing to fund 
                        research activities previously 
                        identified by the Division of Program 
                        Coordination, Planning, and Strategic 
                        Initiatives.
                          (iii) An estimate of the amounts 
                        determined by the Director of NIH to be 
                        necessary to fund research described in 
                        section 402(b)(7)(A)(i)--
                                  (I) that is in addition to 
                                the research activities 
                                described in clause (ii); and
                                  (II) for which there is the 
                                most substantial need.
                  (D) Evaluation.--During the 6-month period 
                following the end of the first fiscal year for 
                which the total amount reserved under 
                subparagraph (B) is equal to 5 percent of the 
                total amount appropriated under subsection 
                (a)(1) for such fiscal year, the Secretary, 
                acting through the Director of NIH, in 
                consultation with the advisory council 
                established under section 402(k), shall submit 
                recommendations to the Congress for changes 
                regarding amounts for the Common Fund.
          (2) Trans-nih research reporting.--
                  (A) Limitation.--With respect to the total 
                amount appropriated under subsection (a) for 
                fiscal year 2008 or any subsequent fiscal year, 
                if the head of a national research institute or 
                national center fails to submit the report 
                required by subparagraph (B) for the preceding 
                fiscal year, the amount made available for the 
                institute or center for the fiscal year 
                involved may not exceed the amount made 
                available for the institute or center for 
                fiscal year 2006.
                  (B) Reporting.--Not later than January 1, 
                2008, and each January 1st thereafter--
                          (i) the head of each national 
                        research institute or national center 
                        shall submit to the Director of NIH a 
                        report on the amount made available by 
                        the institute or center for conducting 
                        or supporting research that involves 
                        collaboration between the institute or 
                        center and 1 or more other national 
                        research institutes or national 
                        centers; and
                          (ii) the Secretary shall submit a 
                        report to the Congress identifying the 
                        percentage of funds made available by 
                        each national research institute and 
                        national center with respect to such 
                        fiscal year for conducting or 
                        supporting research described in clause 
                        (i).
                  (C) Determination.--For purposes of 
                determining the amount or percentage of funds 
                to be reported under subparagraph (B), any 
                amounts made available to an institute or 
                center under section 402(b)(7)(B) shall be 
                included.
                  (D) Verification of amounts.--Upon receipt of 
                each report submitted under subparagraph 
                (B)(i), the Director of NIH shall review and, 
                in cases of discrepancy, verify the accuracy of 
                the amounts specified in the report.
                  (E) Waiver.--At the request of any national 
                research institute or national center, the 
                Director of NIH may waive the application of 
                this paragraph to such institute or center if 
                the Director finds that the conduct or support 
                of research described in subparagraph (B)(i) is 
                inconsistent with the mission of such institute 
                or center.
  (d) Transfer Authority.--Of the total amount appropriated 
under subsection (a)(1) for a fiscal year, the Director of NIH 
may (in addition to the reservation under subsection (c)(1) for 
such year) transfer not more than 1 percent for programs or 
activities that are authorized in this title and identified by 
the Director to receive funds pursuant to this subsection. In 
making such transfers, the Director may not decrease any 
appropriation account under subsection (a)(1) by more than 1 
percent.
  (e) NIH Innovation Fund.--
          (1) Establishment.--For the purpose of allocations 
        under section 402(b)(25), there is established a fund 
        to be known as the NIH Innovation Fund. The Director of 
        NIH shall, with respect to funds appropriated to the 
        NIH Innovation Fund, allocate such funds to support 
        biomedical research through the funding of basic, 
        translational, and clinical research.
          (2) Amounts made available to fund.--
                  (A) In general.--Subject to subparagraph (B), 
                there is authorized to be appropriated, and 
                appropriated, to the NIH Innovation Fund out of 
                any funds in the Treasury not otherwise 
                appropriated, $2,000,000,000 for each of fiscal 
                years 2016 through 2020. The amounts 
                appropriated to the Fund by the preceding 
                sentence shall be in addition to any amounts 
                otherwise made available to the National 
                Institutes of Health.
                  (B) Availability subject to appropriations.--
                Amounts in the Fund shall not be available 
                except to the extent and in such amounts as are 
                provided in advance in appropriation Acts.
                  (C) Allocation of amounts.--Of the amounts 
                made available from the NIH Innovation Fund for 
                allocations under section 402(b)(25) for a 
                fiscal year--
                          (i) not less than $500,000,000 shall 
                        be for the Accelerating Advancement 
                        Program under paragraph (5);
                          (ii) not less than 35 percent of such 
                        amounts remaining after subtracting the 
                        allocation for the Accelerating 
                        Advancement Program shall be for early 
                        stage investigators (as defined in 
                        paragraph (7));
                          (iii) not less than 20 percent of 
                        such amounts remaining after 
                        subtracting the allocation for the 
                        Accelerating Advancement Program shall 
                        be for high-risk, high-reward research 
                        under section 409K; and
                          (iv) not more than 10 percent of such 
                        amounts (without subtracting the 
                        allocation for the Accelerating 
                        Advancement Program) shall be for 
                        intramural research.
                  (D) Inapplicability of certain provisions.--
                Amounts in the NIH Innovation Fund shall not be 
                subject to--
                          (i) any transfer authority of the 
                        Secretary or the Director of NIH under 
                        section 241, subsection (c), subsection 
                        (d), or any other provision of law 
                        (other than section 402(b)(25) and this 
                        subsection); or
                          (ii) the Nonrecurring expenses fund 
                        under section 223 of division G of the 
                        Consolidated Appropriations Act, 2008 
                        (42 U.S.C. 3514a).
          (3) Authorized uses.--Amounts in the NIH Innovation 
        Fund established under paragraph (1) may be used only 
        to conduct or support innovative biomedical research 
        through the following:
                  (A) Research in which--
                          (i) a principal investigator has a 
                        specific project or specific 
                        objectives; and
                          (ii) funding is tied to pursuit of 
                        such project or objectives.
                  (B) Research in which--
                          (i) a principal investigator has 
                        shown promise in biomedical research; 
                        and
                          (ii) funding is not tied to a 
                        specific project or specific 
                        objectives.
                  (C) Research to be carried out by an early 
                stage investigator (as defined in paragraph 
                (7)).
                  (D) Research to be carried out by a small 
                business concern (as defined in section 3 of 
                the Small Business Act).
                  (E) The Accelerating Advancement Program 
                under paragraph (5).
                  (F) Development and implementation of the 
                strategic plan under paragraph (6).
          (4) Coordination.--In funding programs and activities 
        through the NIH Innovation Fund, the Secretary, acting 
        through the Director of NIH, shall--
                  (A) ensure coordination among the national 
                research institutes, the national centers, and 
                other departments, agencies, and offices of the 
                Federal Government; and
                  (B) minimize unnecessary duplication.
          (5) Accelerating advancement program.--The Director 
        of NIH shall establish a program, to be known as the 
        Accelerating Advancement Program, under which--
                  (A) the Director of NIH partners with 
                national research institutes and national 
                centers to accomplish important biomedical 
                research objectives; and
                  (B) for every $1 made available by the 
                Director of NIH to a national research 
                institute or national center for a research 
                project, the institute or center makes $1 
                available for such project from funds that are 
                not derived from the NIH Innovation Fund.
          (6) Strategic plan.--
                  (A) In general.--The Director of NIH shall 
                ensure that scientifically based strategic 
                planning is implemented in support of research 
                priorities, including through development, use, 
                and updating of a research strategic plan 
                that--
                          (i) is designed to increase the 
                        efficient and effective focus of 
                        biomedical research in a manner that 
                        leverages the best scientific 
                        opportunities through a deliberative 
                        planning process;
                          (ii) identifies areas, to be known as 
                        strategic focus areas, in which the 
                        resources of the NIH Innovation Fund 
                        can contribute to the goals of 
                        expanding knowledge to address, and 
                        find more effective treatments for, 
                        unmet medical needs in the United 
                        States, including the areas of--
                                  (I) biomarkers;
                                  (II) precision medicine;
                                  (III) infectious diseases, 
                                including pathogens listed as a 
                                qualifying pathogen under 
                                section 505E(f) of the Federal 
                                Food, Drug, and Cosmetic Act or 
                                listed or designated as a 
                                tropical disease under section 
                                524 of such Act; and
                                  (IV) antibiotics;
                          (iii) includes objectives for each 
                        such strategic focus area; and
                          (iv) ensures that basic research 
                        remains a priority.
                  (B) Updates and reviews.--The Director shall 
                review and, as appropriate, update the research 
                strategic plan under subparagraph (A) not less 
                than every 18 months.
          (7) Definition.--In this subsection, the term ``early 
        stage investigator'' means an investigator who--
                  (A) will be the principal investigator or the 
                program director of the proposed research;
                  (B) has never been awarded, or has been 
                awarded only once, a substantial, competing 
                grant by the National Institutes of Health for 
                independent research; and
                  (C) is within 10 years of having completed--
                          (i) the investigator's terminal 
                        degree; or
                          (ii) a medical residency (or the 
                        equivalent).
  [(e)] (f) Rule of Construction.--This section may not be 
construed as affecting the authorities of the Director of NIH 
under section 401.

           *       *       *       *       *       *       *


   Part B--General Provisions Respecting National Research Institutes

  appointment and authority of the directors of the national research 
                               institutes

  Sec. 405. [(a) The Director of the National Cancer Institute 
shall be appointed by the President and the Directors of the 
other national research institutes shall be appointed by the 
Secretary. Each Director of a national research institute shall 
report directly to the Director of NIH.] (a) Appointment; 
Terms.--
          (1) Appointment.--The Director of the National Cancer 
        Institute shall be appointed by the President and the 
        directors of the other national research institutes, as 
        well as the directors of the national centers, shall be 
        appointed by the Director of NIH. The directors of the 
        national research institutes, as well as national 
        centers, shall report directly to the Director of NIH.
          (2) Terms.--
                  (A) In general.--The term of office of a 
                director of a national research institute or 
                national center shall be 5 years.
                  (B) Removal.--The director of a national 
                research institute or national center may be 
                removed from office by the Director of NIH 
                prior to the expiration of such director's 5-
                year term.
                  (C) Reappointment.--At the end of the term of 
                a director of a national research institute or 
                national center, the director may be 
                reappointed. There is no limit on the number of 
                terms a director may serve.
                  (D) Vacancies.--If the office of a director 
                of a national research institute or national 
                center becomes vacant before the end of such 
                director's term, the director appointed to fill 
                the vacancy shall be appointed for a 5-year 
                term starting on the date of such appointment.
                  (E) Transitional provision.--Each director of 
                a national research institute or national 
                center serving on the date of enactment of the 
                21st Century Cures Act is deemed to be 
                appointed for a 5-year term under this 
                subsection starting on such date of enactment. 
  (b)(1) In carrying out the purposes of section 301 with 
respect to human diseases or disorders or other aspects of 
human health for which the national research institutes were 
established, the Secretary, acting through the Director of each 
national research institute--
          (A) shall encourage and support research, 
        investigations, experiments, demonstrations, and 
        studies in the health sciences related to--
                  (i) the maintenance of health,
                  (ii) the detection, diagnosis, treatment, and 
                prevention of human diseases and disorders,
                  (iii) the rehabilitation of individuals with 
                human diseases, disorders, and disabilities, 
                and
                  (iv) the expansion of knowledge of the 
                processes underlying human diseases, disorders, 
                and disabilities, the processes underlying the 
                normal and pathological functioning of the body 
                and its organ systems, and the processes 
                underlying the interactions between the human 
                organism and the environment;
          (B) may, subject to the peer review prescribed under 
        section 492(b) and any advisory council review under 
        section 406(a)(3)(A)(i), conduct the research, 
        investigations, experiments, demonstrations, and 
        studies referred to in subparagraph (A);
          (C) may conduct and support research training (i) for 
        which fellowship support is not provided under section 
        487, and (ii) which is not residency training of 
        physicians or other health professionals;
          (D) may develop, implement, and support 
        demonstrations and programs for the application of the 
        results of the activities of the institute to clinical 
        practice and disease prevention activities;
          (E) may develop, conduct, and support public and 
        professional education and information programs;
          (F) may secure, develop and maintain, distribute, and 
        support the development and maintenance of resources 
        needed for research;
          (G) may make available the facilities of the 
        institute to appropriate entities and individuals 
        engaged in research activities and cooperate with and 
        assist Federal and State agencies charged with 
        protecting the public health;
          (H) may accept unconditional gifts made to the 
        institute for its activities, and, in the case of gifts 
        of a value in excess of $50,000, establish suitable 
        memorials to the donor;
          (I) may secure for the institute consultation 
        services and advice of persons from the United States 
        or abroad;
          (J) may use, with their consent, the services, 
        equipment, personnel, information, and facilities of 
        other Federal, State, or local public agencies, with or 
        without reimbursement therefor;
          (K) may accept voluntary and uncompensated services; 
        and
          (L) may perform such other functions as the Secretary 
        determines are needed to carry out effectively the 
        purposes of the institute.
The indemnification provisions of section 2354, title 10, 
United States Code, shall apply with respect to contracts 
entered into under this subsection and section 402(b).
  (2) Support for an activity or program under this subsection 
may be provided through grants, contracts, and cooperative 
agreements. The Secretary, acting through the Director of each 
national research institute--
          (A) may enter into a contract for research, training, 
        or demonstrations only if the contract has been 
        recommended after technical and scientific peer review 
        required by regulations under section 492;
          (B) may make grants and cooperative agreements under 
        paragraph (1) for research, training, or 
        demonstrations, except that--
                  (i) if the direct cost of the grant or 
                cooperative agreement to be made does not 
                exceed $50,000, such grant or cooperative 
                agreement may be made only if such grant or 
                cooperative agreement has been recommended 
                after technical and scientific peer review 
                required by regulations under section 492, and
                  (ii) if the direct cost of the grant or 
                cooperative agreement to be made exceeds 
                $50,000, such grant or cooperative agreement 
                may be made only if such grant or cooperative 
                agreement has been recommended after technical 
                and scientific peer review required by 
                regulations under section 492 and is 
                recommended under section 406(a)(3)(A)(ii) by 
                the advisory council for the national research 
                institute involved; and
          (C) shall, subject to section 2353(d)(2), receive 
        from the President and the Office of Management and 
        Budget directly all funds appropriated by the Congress 
        for obligation and expenditure by the Institute.
  (3) Before an award is made by a national research institute 
or by a national center for a grant for a research program or 
project (commonly referred to as an ``R-series grant''), other 
than an award constituting a noncompeting renewal of such 
grant, or a noncompeting administrative supplement to such 
grant, the director of such national research institute or 
national center--
          (A) shall review and approve the award; and
          (B) shall take into consideration--
                  (i) the mission of the national research 
                institute or national center and the scientific 
                priorities identified in the strategic plan 
                under section 402(m); and
                  (ii) whether other agencies are funding 
                programs or projects to accomplish the same 
                goal.
  (c) In carrying out subsection (b), each Director of a 
national research institute--
          (1) shall coordinate, as appropriate, the activities 
        of the institute with similar programs of other public 
        and private entities;
          (2) shall cooperate with the Directors of the other 
        national research institutes in the development and 
        support of multidisciplinary research and research that 
        involves more than one institute;
          (3) may, in consultation with the advisory council 
        for the Institute and with the approval of the Director 
        of NIH--
                  (A) establish technical and scientific peer 
                review groups in addition to those appointed 
                under section 402(b)(16); and
                  (B) appoint the members of peer review groups 
                established under subparagraph (A); and
          (4) may publish, or arrange for the publication of, 
        information with respect to the purpose of the 
        Institute without regard to section 501 of title 44, 
        United States Code.
The Federal Advisory Committee Act shall not apply to the 
duration of a peer review group appointed under paragraph (3).

           *       *       *       *       *       *       *


                     pediatric research initiative

  Sec. 409D. (a) Establishment.--The Secretary shall establish 
within the Office of the Director of NIH a Pediatric Research 
Initiative (referred to in this section as the ``Initiative'') 
to conduct and support research that is directly related to 
diseases, disorders, and other conditions in children. The 
Initiative shall be headed by the Director of NIH.
  (b) Purpose.--The purpose of the Initiative is to provide 
funds to enable the Director of NIH--
          (1) to increase support for pediatric biomedical 
        research within the National Institutes of Health to 
        realize the expanding opportunities for advancement in 
        scientific investigations and care for children;
          (2) to enhance collaborative efforts among the 
        Institutes to conduct and support multidisciplinary 
        research in the areas that the Director deems most 
        promising; and
          (3) in coordination with the Food and Drug 
        Administration, to increase the development of adequate 
        pediatric clinical trials and pediatric use information 
        to promote the safer and more effective use of 
        prescription drugs in the pediatric population.
  (c) Duties.--In carrying out subsection (b), the Director of 
NIH shall--
          (1) consult with the Director of the Eunice Kennedy 
        Shriver National Institute of Child Health and Human 
        Development and the other national research institutes, 
        in considering their requests for new or expanded 
        pediatric research efforts, and consult with the 
        Administrator of the Health Resources and Services 
        Administration and other advisors as the Director 
        determines to be appropriate;
          (2) have broad discretion in the allocation of any 
        Initiative assistance among the Institutes, among types 
        of grants, and between basic and clinical research so 
        long as the assistance is directly related to the 
        illnesses and conditions of children; and
          (3) be responsible for the oversight of any newly 
        appropriated Initiative funds and annually report to 
        Congress and the public on the extent of the total 
        funds obligated to conduct or support pediatric 
        research across the National Institutes of Health, 
        including the specific support and research awards 
        allocated through the Initiative.
  (d) National Pediatric Research Network.--
          (1) Network.--In carrying out the Initiative, the 
        Director of NIH, [in consultation with the Director of 
        the Eunice Kennedy Shriver National Institute of Child 
        Health and Human Development and in collaboration with 
        other appropriate national research institutes and 
        national centers that carry out activities involving 
        pediatric research] in collaboration with the national 
        research institutes and national centers that carry out 
        activities involving pediatric research, [may] shall 
        provide for the establishment of a National Pediatric 
        Research Network in order to more effectively support 
        pediatric research and optimize the use of Federal 
        resources. Such National Pediatric Research Network 
        [may be comprised of, as appropriate--]
                  [(A) the pediatric research consortia] may be 
                comprised of, as appropriate, the pediatric 
                research consortia receiving awards under 
                paragraph (2)[; or].
                  [(B) other consortia, centers, or networks 
                focused on pediatric research that are 
                recognized by the Director of NIH and 
                established pursuant to the authorities vested 
                in the National Institutes of Health by other 
                sections of this Act.]
          (2) Pediatric research consortia.--
                  (A) In general.--The Director of NIH [may] 
                shall award funding, including through grants, 
                contracts, or other mechanisms, to public or 
                private nonprofit entities for providing 
                support for pediatric research consortia, 
                including with respect to--
                          (i) basic, clinical, behavioral, or 
                        translational research to meet unmet 
                        needs for pediatric research; and
                          (ii) training researchers in 
                        pediatric research techniques in order 
                        to address unmet pediatric research 
                        needs.
                  (B) Research.--The Director of NIH shall, as 
                appropriate, ensure that--
                          (i) each consortium receiving an 
                        award under subparagraph (A) conducts 
                        or supports at least one category of 
                        research described in subparagraph 
                        (A)(i) and collectively such consortia 
                        conduct or support such categories of 
                        research; and
                          (ii) one or more such consortia 
                        provide training described in 
                        subparagraph (A)(ii).
                  (C) Organization of consortium.--Each 
                consortium receiving an award under 
                subparagraph (A) shall--
                          (i) be formed from a collaboration of 
                        cooperating institutions;
                          (ii) be coordinated by a lead 
                        institution or institutions;
                          (iii) agree to disseminate scientific 
                        findings, including from clinical 
                        trials, rapidly and efficiently, as 
                        appropriate, to--
                                  (I) other consortia;
                                  (II) the National Institutes 
                                of Health;
                                  (III) the Food and Drug 
                                Administration;
                                  (IV) and other relevant 
                                agencies; and
                          (iv) meet such requirements as may be 
                        prescribed by the Director of NIH.
                  (D) Supplement, not supplant.--Any support 
                received by a consortium under subparagraph (A) 
                shall be used to supplement, and not supplant, 
                other public or private support for activities 
                authorized to be supported under this 
                paragraph.
                  (E) Duration of support.--Support of a 
                consortium under subparagraph (A) [may] shall 
                be for a period of not to exceed 5 years. Such 
                period may be extended at the discretion of the 
                Director of NIH.
          (3) Coordination of consortia activities.--The 
        Director of NIH shall, as appropriate--
                  (A) provide for the coordination of 
                activities (including the exchange of 
                information and regular communication) among 
                the consortia established pursuant to paragraph 
                (2); and
                  (B) require the periodic preparation and 
                submission to the Director of reports on the 
                activities of each such consortium.
          (4) Assistance with registries.--Each consortium 
        receiving an award under paragraph (2)(A) may provide 
        assistance, as appropriate, to the Centers for Disease 
        Control and Prevention for activities related to 
        patient registries and other surveillance systems upon 
        request by the Director of the Centers for Disease 
        Control and Prevention.
  (e) Research on Pediatric Rare Diseases or Conditions.--In 
making awards under subsection (d)(2) for pediatric research 
consortia, the Director of NIH shall ensure that an appropriate 
number of such awards are awarded to such consortia that agree 
to--
          (1) consider pediatric rare diseases or conditions, 
        or those related to birth defects; and
          (2) conduct or coordinate one or more multisite 
        clinical trials of therapies for, or approaches to, the 
        prevention, diagnosis, or treatment of one or more 
        pediatric rare diseases or conditions.
  (f) Transfer of Funds.--The Director of NIH may transfer 
amounts appropriated under this section to any of the 
Institutes for a fiscal year to carry out the purposes of the 
Initiative under this section.

           *       *       *       *       *       *       *


SEC. 409K. HIGH-RISK, HIGH-REWARD RESEARCH PROGRAM.

  The director of each national research institute shall, as 
appropriate--
          (1) establish programs to conduct or support research 
        projects that pursue innovative approaches to major 
        contemporary challenges in biomedical research that 
        involve inherent high risk, but have the potential to 
        lead to breakthroughs; and
          (2) set aside a specific percentage of funding, to be 
        determined by the Director of NIH for each national 
        research institute, for such projects.

Part C--Specific Provisions Respecting National Research Institutes

           *       *       *       *       *       *       *


     Subpart 20--National Institute on Minority Health and Health 
Disparities

           *       *       *       *       *       *       *


SEC. 464Z-5. LOAN REPAYMENT PROGRAM FOR MINORITY HEALTH DISPARITIES 
                    RESEARCH.

  (a) In General.--The Director of the Institute shall 
establish a program of entering into contracts with qualified 
health professionals under which such health professionals 
agree to engage in minority health disparities research or 
other health disparities research in consideration of the 
Federal Government agreeing to repay, for each year of engaging 
in such research, not more than [$35,000] $50,000 of the 
principal and interest of the educational loans of such health 
professionals. Subsection (b) of section 487H shall apply with 
respect to the maximum amount specified in this subsection in 
the same manner as it applies to the maximum amount specified 
in subsection (a) of such section.
  (b) Service Provisions.--The provisions of sections 338B, 
338C, and 338E shall, except as inconsistent with subsection 
(a), apply to the program established in such subsection to the 
same extent and in the same manner as such provisions apply to 
the National Health Service Corps Loan Repayment Program 
established in subpart III of part D of title III.
  (c) Requirement Regarding Health Disparity Populations.--The 
Director of the Institute shall ensure that not fewer than 50 
percent of the contracts entered into under subsection (a) are 
for appropriately qualified health professionals who are 
members of a health disparity population.
  (d) Priority.--With respect to minority health disparities 
research and other health disparities research under subsection 
(a), the Secretary shall ensure that priority is given to 
conducting projects of biomedical research.

           *       *       *       *       *       *       *


                     Part E--Other Agencies of NIH

    Subpart 1--National Center for Advancing Translational Sciences

SEC. 479. NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES.

  (a) Purpose.--The purpose of the National Center for 
Advancing Translational Sciences (in this subpart referred to 
as the ``Center'') is to advance translational sciences, 
including by--
          (1) coordinating and developing resources that 
        leverage basic research in support of translational 
        science; and
          (2) developing partnerships and working cooperatively 
        to foster synergy in ways that do not create 
        duplication, redundancy, and competition with industry 
        activities.
  (b) Clinical Trial Activities.--
          (1) In general.--The Center may develop and provide 
        infrastructure and resources for all phases of clinical 
        trials research. Except as provided in paragraph (2), 
        the Center may support clinical trials only through the 
        end of phase [IIA] IIB.
          (2) Exception.--The Center may support clinical trial 
        activities through the end of phase [IIB] III for a 
        treatment for a rare disease or condition (as defined 
        in section 526 of the Federal Food, Drug, and Cosmetic 
        Act) so long as--
                  (A) the Center gives public notice for a 
                period of at least 120 days of the Center's 
                intention to support the clinical trial 
                activities in phase [IIB] III;
                  (B) no public or private organization 
                provides credible written intent to the Center 
                that the organization has timely plans to 
                further the clinical trial activities or 
                conduct clinical trials of a similar nature 
                beyond phase [IIA] IIB; and
                  (C) the Center ensures that support of the 
                clinical trial activities in phase [IIB] III 
                will not increase the Federal Government's 
                liability beyond the award value of the 
                Center's support.
  (c) Annual Report.--The Center shall publish an annual report 
that, with respect to all research supported by the Center, 
includes a complete list of--
          (1) the molecules being studied;
          (2) clinical trial activities being conducted;
          (3) the methods and tools in development;
          (4) ongoing partnerships, including--
                  (A) the rationale for each partnership;
                  (B) the status of each partnership;
                  (C) the funding provided by the Center to 
                other entities pursuant to each partnership, 
                and
                  (D) the activities which have been 
                transferred to industry pursuant to each 
                partnership; and
          (5) known research activity of other entities that is 
        or will expand upon research activity of the Center.

SEC. 480. CURES ACCELERATION NETWORK.

  (a) Definitions.--In this section:
          (1) Biological product.--The term ``biological 
        product'' has the meaning given such term in section 
        351 of the Public Health Service Act.
          (2) Drug; device.--The terms ``drug'' and ``device'' 
        have the meanings given such terms in section 201 of 
        the Federal Food, Drug, and Cosmetic Act.
          (3) High need cure.--The term ``high need cure'' 
        means a drug (as that term is defined by section 
        201(g)(1) of the Federal Food, Drug, and Cosmetic Act, 
        biological product (as that term is defined by section 
        262(i)), or device (as that term is defined by section 
        201(h) of the Federal Food, Drug, and Cosmetic Act) 
        that, in the determination of the Director of the 
        Center--
                  (A) is a priority to diagnose, mitigate, 
                prevent, or treat harm from any disease or 
                condition; and
                  (B) for which the incentives of the 
                commercial market are unlikely to result in its 
                adequate or timely development.
          (4) Medical product.--The term ``medical product'' 
        means a drug, device, biological product, or product 
        that is a combination of drugs, devices, and biological 
        products.
  (b) Establishment of the Cures Acceleration Network.--Subject 
to [the appropriation of funds as described in subsection (g)] 
the availability of funds as described in subsection (f), there 
is established within the Center a program to be known as the 
Cures Acceleration Network (referred to in this section as 
``CAN''), which shall--
          (1) be under the direction of the Director of the 
        Center, taking into account the recommendations of a 
        CAN Review Board (referred to in this section as the 
        ``Board''), described in subsection (d); and
          (2) award grants and contracts to eligible entities, 
        as described in subsection (e), to accelerate the 
        development of high need cures, including through the 
        development of medical products and behavioral 
        therapies.
  (c) Functions.--The functions of the CAN are to--
          (1) conduct and support revolutionary advances in 
        basic research, translating scientific discoveries from 
        bench to bedside;
          (2) award grants and contracts to eligible entities 
        to accelerate the development of high need cures;
          (3) provide the resources necessary for government 
        agencies, independent investigators, research 
        organizations, biotechnology companies, academic 
        research institutions, and other entities to develop 
        high need cures;
          (4) reduce the barriers between laboratory 
        discoveries and clinical trials for new therapies; and
          (5) facilitate review in the Food and Drug 
        Administration for the high need cures funded by the 
        CAN, through activities that may include--
                  (A) the facilitation of regular and ongoing 
                communication with the Food and Drug 
                Administration regarding the status of 
                activities conducted under this section;
                  (B) ensuring that such activities are 
                coordinated with the approval requirements of 
                the Food and Drug Administration, with the goal 
                of expediting the development and approval of 
                countermeasures and products; and
                  (C) connecting interested persons with 
                additional technical assistance made available 
                under section 565 of the Federal Food, Drug, 
                and Cosmetic Act.
  (d) CAN Board.--
          (1) Establishment.--There is established a Cures 
        Acceleration Network Review Board (referred to in this 
        section as the ``Board''), which shall advise the 
        Director of the Center on the conduct of the activities 
        of the Cures Acceleration Network.
          (2) Membership.--
                  (A) In general.--
                          (i) Appointment.--The Board shall be 
                        comprised of 24 members who are 
                        appointed by the Secretary and who 
                        serve at the pleasure of the Secretary.
                          (ii) Chairperson and vice 
                        chairperson.--The Secretary shall 
                        designate, from among the 24 members 
                        appointed under clause (i), one 
                        Chairperson of the Board (referred to 
                        in this section as the ``Chairperson'') 
                        and one Vice Chairperson.
                  (B) Terms.--
                          (i) In general.--Each member shall be 
                        appointed to serve a 4-year term, 
                        except that any member appointed to 
                        fill a vacancy occurring prior to the 
                        expiration of the term for which the 
                        member's predecessor was appointed 
                        shall be appointed for the remainder of 
                        such term.
                          (ii) Consecutive appointments; 
                        maximum terms.--A member may be 
                        appointed to serve not more than 3 
                        terms on the Board, and may not serve 
                        more than 2 such terms consecutively.
                  (C) Qualifications.--
                          (i) In general.--The Secretary shall 
                        appoint individuals to the Board based 
                        solely upon the individual's 
                        established record of distinguished 
                        service in one of the areas of 
                        expertise described in clause (ii). 
                        Each individual appointed to the Board 
                        shall be of distinguished achievement 
                        and have a broad range of disciplinary 
                        interests.
                          (ii) Expertise.--The Secretary shall 
                        select individuals based upon the 
                        following requirements:
                                  (I) For each of the fields 
                                of--
                                          (aa) basic research;
                                          (bb) medicine;
                                          (cc) 
                                        biopharmaceuticals;
                                          (dd) discovery and 
                                        delivery of medical 
                                        products;
                                          (ee) bioinformatics 
                                        and gene therapy;
                                          (ff) medical 
                                        instrumentation; and
                                          (gg) regulatory 
                                        review and approval of 
                                        medical products,
                                the Secretary shall select at 
                                least 1 individual who is 
                                eminent in such fields.
                                  (II) At least 4 individuals 
                                shall be recognized leaders in 
                                professional venture capital or 
                                private equity organizations 
                                and have demonstrated 
                                experience in private equity 
                                investing.
                                  (III) At least 8 individuals 
                                shall represent disease 
                                advocacy organizations.
          (3) Ex-officio members.--
                  (A) Appointment.--In addition to the 24 Board 
                members described in paragraph (2), the 
                Secretary shall appoint as ex-officio members 
                of the Board--
                          (i) a representative of the National 
                        Institutes of Health, recommended by 
                        the Secretary of the Department of 
                        Health and Human Services;
                          (ii) a representative of the Office 
                        of the Assistant Secretary of Defense 
                        for Health Affairs, recommended by the 
                        Secretary of Defense;
                          (iii) a representative of the Office 
                        of the Under Secretary for Health for 
                        the Veterans Health Administration, 
                        recommended by the Secretary of 
                        Veterans Affairs;
                          (iv) a representative of the National 
                        Science Foundation, recommended by the 
                        Chair of the National Science Board; 
                        and
                          (v) a representative of the Food and 
                        Drug Administration, recommended by the 
                        Commissioner of Food and Drugs.
                  (B) Terms.--Each ex-officio member shall 
                serve a 3-year term on the Board, except that 
                the Chairperson may adjust the terms of the 
                initial ex-officio members in order to provide 
                for a staggered term of appointment for all 
                such members.
          (4) Responsibilities of the board and the director of 
        the center.--
                  (A) Responsibilities of the board.--
                          (i) In general.--The Board shall 
                        advise, and provide recommendations to, 
                        the Director of the Center with respect 
                        to--
                                  (I) policies, programs, and 
                                procedures for carrying out the 
                                duties of the Director of the 
                                Center under this section; and
                                  (II) significant barriers to 
                                successful translation of basic 
                                science into clinical 
                                application (including issues 
                                under the purview of other 
                                agencies and departments).
                          (ii) Report.--In the case that the 
                        Board identifies a significant barrier, 
                        as described in clause (i)(II), the 
                        Board shall submit to the Secretary a 
                        report regarding such barrier.
                  (B) Responsibilities of the director of the 
                center.--With respect to each recommendation 
                provided by the Board under subparagraph 
                (A)(i), the Director of the Center shall 
                respond in writing to the Board, indicating 
                whether such Director will implement such 
                recommendation. In the case that the Director 
                of the Center indicates a recommendation of the 
                Board will not be implemented, such Director 
                shall provide an explanation of the reasons for 
                not implementing such recommendation.
          (5) Meetings.--
                  (A) In general.--The Board shall meet 4 times 
                per calendar year, at the call of the 
                Chairperson.
                  (B) Quorum; requirements; limitations.--
                          (i) Quorum.--A quorum shall consist 
                        of a total of 13 members of the Board, 
                        excluding ex-officio members, with 
                        diverse representation as described in 
                        clause (iii).
                          (ii) Chairperson or vice 
                        chairperson.--Each meeting of the Board 
                        shall be attended by either the 
                        Chairperson or the Vice Chairperson.
                          (iii) Diverse representation.--At 
                        each meeting of the Board, there shall 
                        be not less than one scientist, one 
                        representative of a disease advocacy 
                        organization, and one representative of 
                        a professional venture capital or 
                        private equity organization.
          (6) Compensation and travel expenses.--
                  (A) Compensation.--Members shall receive 
                compensation at a rate to be fixed by the 
                Chairperson but not to exceed a rate equal to 
                the daily equivalent of the annual rate of 
                basic pay prescribed for level IV of the 
                Executive Schedule under section 5315 of title 
                5, United States Code, for each day (including 
                travel time) during which the member is engaged 
                in the performance of the duties of the Board. 
                All members of the Board who are officers or 
                employees of the United States shall serve 
                without compensation in addition to that 
                received for their services as officers or 
                employees of the United States.
                  (B) Travel expenses.--Members of the Board 
                shall be allowed travel expenses, including per 
                diem in lieu of subsistence, at rates 
                authorized for persons employed intermittently 
                by the Federal Government under section 5703(b) 
                of title 5, United States Code, while away from 
                their homes or regular places of business in 
                the performance of services for the Board.
  (e) Grant Program.--
          (1) Supporting innovation.--To carry out the purposes 
        described in this section, the Director of the Center 
        shall award contracts, grants, or cooperative 
        agreements to the entities described in paragraph (2), 
        to--
                  (A) promote innovation in technologies 
                supporting the advanced research and 
                development and production of high need cures, 
                including through the development of medical 
                products and behavioral therapies.
                  (B) accelerate the development of high need 
                cures, including through the development of 
                medical products, behavioral therapies, and 
                biomarkers that demonstrate the safety or 
                effectiveness of medical products; or
                  (C) help the award recipient establish 
                protocols that comply with Food and Drug 
                Administration standards and otherwise permit 
                the recipient to meet regulatory requirements 
                at all stages of development, manufacturing, 
                review, approval, and safety surveillance of a 
                medical product.
          (2) Eligible entities.--To receive assistance under 
        paragraph (1), an entity shall--
                  (A) be a public or private entity, which may 
                include a private or public research 
                institution, an institution of higher 
                education, a medical center, a biotechnology 
                company, a pharmaceutical company, a disease 
                advocacy organization, a patient advocacy 
                organization, or an academic research 
                institution;
                  (B) submit an application containing--
                          (i) a detailed description of the 
                        project for which the entity seeks such 
                        grant or contract;
                          (ii) a timetable for such project;
                          (iii) an assurance that the entity 
                        will submit--
                                  (I) interim reports 
                                describing the entity's--
                                          (aa) progress in 
                                        carrying out the 
                                        project; and
                                          (bb) compliance with 
                                        all provisions of this 
                                        section and conditions 
                                        of receipt of such 
                                        grant or contract; and
                                  (II) a final report at the 
                                conclusion of the grant period, 
                                describing the outcomes of the 
                                project; and
                          (iv) a description of the protocols 
                        the entity will follow to comply with 
                        Food and Drug Administration standards 
                        and regulatory requirements at all 
                        stages of development, manufacturing, 
                        review, approval, and safety 
                        surveillance of a medical product; and
                  (C) provide such additional information as 
                the Director of the Center may require.
          (3) Awards.--
                  (A) The cures acceleration partnership 
                awards.--
                          (i) Initial award amount.--Each award 
                        under this subparagraph shall be not 
                        more than $15,000,000 per project for 
                        the first fiscal year for which the 
                        project is funded, which shall be 
                        payable in one payment.
                          (ii) Funding in subsequent fiscal 
                        years.--An eligible entity receiving an 
                        award under clause (i) may apply for 
                        additional funding for such project by 
                        submitting to the Director of the 
                        Center the information required under 
                        subparagraphs (B) and (C) of paragraph 
                        (2). The Director may fund a project of 
                        such eligible entity in an amount not 
                        to exceed $15,000,000 for a fiscal year 
                        subsequent to the initial award under 
                        clause (i).
                          (iii) Matching funds.--As a condition 
                        for receiving an award under this 
                        subsection, an eligible entity shall 
                        contribute to the project non-Federal 
                        funds in the amount of $1 for every $3 
                        awarded under clauses (i) and (ii), 
                        except that the Director of the Center 
                        may waive or modify such matching 
                        requirement in any case where the 
                        Director determines that the goals and 
                        objectives of this section cannot 
                        adequately be carried out unless such 
                        requirement is waived.
                  (B) The cures acceleration grant awards.--
                          (i) Initial award amount.--Each award 
                        under this subparagraph shall be not 
                        more than $15,000,000 per project for 
                        the first fiscal year for which the 
                        project is funded, which shall be 
                        payable in one payment.
                          (ii) Funding in subsequent fiscal 
                        years.--An eligible entity receiving an 
                        award under clause (i) may apply for 
                        additional funding for such project by 
                        submitting to the Board the information 
                        required under subparagraphs (B) and 
                        (C) of paragraph (2). The Director of 
                        the Center may fund a project of such 
                        eligible entity in an amount not to 
                        exceed $15,000,000 for a fiscal year 
                        subsequent to the initial award under 
                        clause (i).
                  [(C) The cures acceleration flexible research 
                awards.--If the Director of the Center 
                determines that the goals and objectives of 
                this section cannot adequately be carried out 
                through a contract, grant, or cooperative 
                agreement, the Director of the Center shall 
                have flexible research authority to use other 
                transactions to fund projects in accordance 
                with the terms and conditions of this section. 
                Awards made under such flexible research 
                authority for a fiscal year shall not exceed 20 
                percent of the total funds appropriated under 
                subsection (g)(1) for such fiscal year.]
                  (C) Other transactions authority.--The 
                Director of the Center shall have other 
                transactions authority in entering into 
                transactions to fund projects in accordance 
                with the terms and conditions of this section.
          (4) Suspension of awards for defaults, noncompliance 
        with provisions and plans, and diversion of funds; 
        repayment of funds.--The Director of the Center may 
        suspend the award to any entity upon noncompliance by 
        such entity with provisions and plans under this 
        section or diversion of funds.
          (5) Audits.--The Director of the Center may enter 
        into agreements with other entities to conduct periodic 
        audits of the projects funded by grants or contracts 
        awarded under this subsection.
          (6) Closeout procedures.--At the end of a grant or 
        contract period, a recipient shall follow the closeout 
        procedures under section 74.71 of title 45, Code of 
        Federal Regulations (or any successor regulation).
          (7) Review.--A determination by the Director of the 
        Center as to whether a drug, device, or biological 
        product is a high need cure (for purposes of subsection 
        (a)(3)) shall not be subject to judicial review.
  [(f) Competitive Basis of Awards.--Any grant, cooperative 
agreement, or contract awarded under this section shall be 
awarded on a competitive basis.]
  [(g)] (f) Authorization of Appropriations.--
          (1) In general.--For purposes of carrying out this 
        section, there are authorized to be appropriated 
        $500,000,000 for fiscal year 2010, and such sums as may 
        be necessary for subsequent fiscal years. Funds 
        appropriated under this section shall be available 
        until expended.
          (2) Limitation on use of funds otherwise 
        appropriated.--No funds appropriated under this Act, 
        other than funds appropriated under paragraph (1), may 
        be allocated to the Cures Acceleration Network.

           *       *       *       *       *       *       *


Part G--Awards and Training

           *       *       *       *       *       *       *


  loan repayment program for research with respect to acquired immune 
                          deficiency syndrome

  Sec. 487A. (a) In General.--The Secretary shall carry out a 
program of entering into agreements with appropriately 
qualified health professionals under which such health 
professionals agree to conduct, as employees of the National 
Institutes of Health, research with respect to acquired immune 
deficiency syndrome in consideration of the Federal Government 
agreeing to repay, for each year of such service, not more than 
[$35,000] $50,000 of the principal and interest of the 
educational loans of such health professionals. Subsection (b) 
of section 487H shall apply with respect to the maximum amount 
specified in this subsection in the same manner as it applies 
to the maximum amount specified in subsection (a) of such 
section.
  (b) Applicability of Certain Provisions.--With respect to the 
National Health Service Corps Loan Repayment Program 
established in subpart III of part D of title III, the 
provisions of such subpart shall, except as inconsistent with 
subsection (a) of this section, apply to the program 
established in such subsection (a) in the same manner and to 
the same extent as such provisions apply to the National Health 
Service Corps Loan Repayment Program established in such 
subpart.

 loan repayment program for research with respect to contraception and 
                              infertility

  Sec. 487B. (a) The Secretary, in consultation with the 
Director of the Eunice Kennedy Shriver National Institute of 
Child Health and Human Development, shall establish a program 
of entering into contracts with qualified health professionals 
(including graduate students) under which such health 
professionals agree to conduct research with respect to 
contraception, or with respect to infertility, in consideration 
of the Federal Government agreeing to repay, for each year of 
such service, not more than [$35,000] $50,000 of the principal 
and interest of the educational loans of such health 
professionals. Subsection (b) of section 487H shall apply with 
respect to the maximum amount specified in this subsection in 
the same manner as it applies to the maximum amount specified 
in such subsection (a) of such section.
  (b) The provisions of sections 338B, 338C, and 338E shall, 
except as inconsistent with subsection (a) of this section, 
apply to the program established in subsection (a) to the same 
extent and in the same manner as such provisions apply to the 
National Health Service Corps Loan Repayment Program 
established in subpart III of part D of title III.
  (c) Amounts available for carrying out this section shall 
remain available until the expiration of the second fiscal year 
beginning after the fiscal year for which the amounts were made 
available.

             loan repayment program for research generally

  Sec. 487C. (a) In General.--
          (1) Authority for program.--Subject to paragraph (2), 
        the Secretary shall carry out a program of entering 
        into contracts with appropriately qualified health 
        professionals under which such health professionals 
        agree to conduct research, as employees of the National 
        Institutes of Health, in consideration of the Federal 
        Government agreeing to repay, for each year of such 
        service, not more than [$35,000] $50,000 of the 
        principal and interest of the educational loans of such 
        health professionals. Subsection (b) of section 487H 
        shall apply with respect to the maximum amount 
        specified in this paragraph in the same manner as it 
        applies to the maximum amount specified in such 
        subsection (a) of such section.
          (2) Limitation.--The Secretary may not enter into an 
        agreement with a health professional pursuant to 
        paragraph (1) unless such professional--
                  (A) has a substantial amount of educational 
                loans relative to income; and
                  (B) agrees to serve as an employee of the 
                National Institutes of Health for purposes of 
                paragraph (1) for a period of not less than 3 
                years.
  (b) Applicability of Certain Provisions.--With respect to the 
National Health Service Corps Loan Repayment Program 
established in subpart III of part D of title III, the 
provisions of such subpart shall, except as inconsistent with 
subsection (a) of this section, apply to the program 
established in such subsection (a) in the same manner and to 
the same extent as such provisions apply to the National Health 
Service Corps Loan Repayment Program established in such 
subpart.

           *       *       *       *       *       *       *


      loan repayment program regarding clinical researchers from 
                       disadvantaged backgrounds

  Sec. 487E. (a) Implementation of Program.--
          (1) In general.--Subject to section 487(a)(1)(C), the 
        Secretary, acting through the Director of NIH may, 
        subject to paragraph (2), carry out a program of 
        entering into contracts with appropriately qualified 
        health professionals who are from disadvantaged 
        backgrounds under which such health professionals agree 
        to conduct clinical research in consideration of the 
        Federal Government agreeing to pay, for each year of 
        such service, not more than [$35,000] $50,000 of the 
        principal and interest of the educational loans of the 
        health professionals. Subsection (b) of section 487H 
        shall apply with respect to the maximum amount 
        specified in this paragraph in the same manner as it 
        applies to the maximum amount specified in such 
        subsection (a) of such section.
          (2) Limitation.--The Director of NIH may not enter 
        into a contract with a health professional pursuant to 
        paragraph (1) unless such professional has a 
        substantial amount of education loans relative to 
        income.
          (3) Applicability of certain provisions regarding 
        obligated service.--Except to the extent inconsistent 
        with this section, the provisions of sections 338B, 
        338C and 338E shall apply to the program established in 
        paragraph (1) to the same extent and in the same manner 
        as such provisions apply to the National Health Service 
        Corps Loan Repayment Program established in section 
        338B.
  (b) Availability of Authorization of Appropriations.--Amounts 
appropriated for a fiscal year for contracts under subsection 
(a) shall remain available until the expiration of the second 
fiscal year beginning after the fiscal year for which the 
amounts were appropriated.

SEC. 487F. LOAN REPAYMENT PROGRAM REGARDING CLINICAL RESEARCHERS.

  (a) In General.--The Secretary, acting through the Director 
of the National Institutes of Health, shall establish a program 
to enter into contracts with qualified health professionals 
under which such health professionals agree to conduct clinical 
research, in consideration of the Federal Government agreeing 
to repay, for each year of service conducting such research, 
not more than [$35,000] $50,000 of the principal and interest 
of the educational loans of such health professionals. 
Subsection (b) of section 487H shall apply with respect to the 
maximum amount specified in this subsection in the same manner 
as it applies to the maximum amount specified in such 
subsection (a) of such section.
  (b) Application of Provisions.--The provisions of sections 
338B, 338C, and 338E shall, except as inconsistent with 
subsection (a) of this section, apply to the program 
established under subsection (a) to the same extent and in the 
same manner as such provisions apply to the National Health 
Service Corps Loan Repayment Program established in subpart III 
of part D of title III.

               pediatric research loan repayment program

  Sec. [487F]  487G. (a) In General.--The Secretary, in 
consultation with the Director of NIH, may establish a 
pediatric research loan repayment program. Through such 
program--
          (1) the Secretary shall enter into contracts with 
        qualified health professionals under which such 
        professionals will agree to conduct pediatric research, 
        including pediatric pharmacological research, in 
        consideration of the Federal Government agreeing to 
        repay, for each year of such service, not more than 
        [$35,000] $50,000 of the principal and interest of the 
        educational loans of such professionals; and
          (2) the Secretary shall, for the purpose of providing 
        reimbursements for tax liability resulting from 
        payments made under paragraph (1) on behalf of an 
        individual, make payments, in addition to payments 
        under such paragraph, to the individual in an amount 
        equal to 39 percent of the total amount of loan 
        repayments made for the taxable year involved.
  (b) Application of Other Provisions.--The provisions of 
sections 338B, 338C, and 338E shall, except as inconsistent 
with paragraph (1), apply to the program established under such 
paragraph to the same extent and in the same manner as such 
provisions apply to the National Health Service Corps Loan 
Repayment Program established under subpart III of part D of 
title III. Subsection (b) of section 487H shall apply with 
respect to the maximum amount specified in this subsection in 
the same manner as it applies to the maximum amount specified 
in such subsection (a) of such section.
  (c) Funding.--
          (1) In general.--For the purpose of carrying out this 
        section with respect to a national research institute 
        the Secretary may reserve, from amounts appropriated 
        for such institute for the fiscal year involved, such 
        amounts as the Secretary determines to be appropriate.
          (2) Availability of funds.--Amounts made available to 
        carry out this section shall remain available until the 
        expiration of the second fiscal year beginning after 
        the fiscal year for which such amounts were made 
        available.

SEC. 487H. LOAN REPAYMENT PROGRAM.

  (a) In General.--The Secretary shall establish a program, 
based on workforce and scientific needs, of entering into 
contracts with qualified health professionals under which such 
health professionals agree to engage in research in 
consideration of the Federal Government agreeing to pay, for 
each year of engaging in such research, not more than $50,000 
of the principal and interest of the educational loans of such 
health professionals.
  (b) Adjustment for Inflation.--Beginning with respect to 
fiscal year 2017, the Secretary may increase the maximum amount 
specified in subsection (a) by an amount that is determined by 
the Secretary, on an annual basis, to reflect inflation.
  (c) Limitation.--The Secretary may not enter into a contract 
with a health professional pursuant to subsection (a) unless 
such professional has a substantial amount of educational loans 
relative to income.
  (d) Applicability of Certain Provisions Regarding Obligated 
Service.--Except to the extent inconsistent with this section, 
the provisions of sections 338B, 338C, and 338E shall apply to 
the program established under this section to the same extent 
and in the same manner as such provisions apply to the National 
Health Service Corps Loan Repayment Program established under 
section 338B.
  (e) Availability of Appropriations.--Amounts appropriated for 
a fiscal year for contracts under subsection (a) are authorized 
to remain available until the expiration of the second fiscal 
year beginning after the fiscal year for which the amounts were 
appropriated.

           *       *       *       *       *       *       *


SEC. 490. CAPSTONE AWARD.

  (a) In General.--The Secretary may make awards (each of 
which, hereafter in this section, referred to as a ``Capstone 
Award'') to support outstanding scientists who have been funded 
by the National Institutes of Health.
  (b) Purpose.--Capstone Awards shall be made to facilitate the 
successful transition or conclusion of research programs, or 
for other purposes, as determined by the Director of NIH, in 
consultation with the directors of the national research 
institutes and national centers.
  (c) Duration and Amount.--The duration and amount of each 
Capstone Award shall be determined by the Director of NIH in 
consultation with the directors of the national research 
institutes and national centers.
  (d) Limitation.--Individuals who have received a Capstone 
Award shall not be eligible to have principle investigator 
status on subsequent awards from the National Institutes of 
Health.

           *       *       *       *       *       *       *


                          TITLE XXI--VACCINES

Subtitle 1--National Vaccine Program

           *       *       *       *       *       *       *


                        PROGRAM RESPONSIBILITIES

  Sec. 2102. (a) The Director of the Program shall have the 
following responsibilities:
          (1) Vaccine research.--The Director of the Program 
        shall, through the plan issued under section 2103, 
        coordinate and provide direction for research carried 
        out in or through the National Institutes of Health, 
        the Centers for Disease Control and Prevention, the 
        Office of Biologics Research and Review of the Food and 
        Drug Administration, the Department of Defense, and the 
        Agency for International Development on means to induce 
        human immunity against naturally occurring infectious 
        diseases and to prevent adverse reactions to vaccines.
          (2) Vaccine development.--The Director of the Program 
        shall, through the plan issued under section 2103, 
        coordinate and provide direction for activities carried 
        out in or through the National Institutes of Health, 
        the Office of Biologics Research and Review of the Food 
        and Drug Administration, the Department of Defense, and 
        the Agency for International Development to develop the 
        techniques needed to produce safe and effective 
        vaccines.
          (3) Safety and efficacy testing of vaccines.--The 
        Director of the Program shall, through the plan issued 
        under section 2103, coordinate and provide direction 
        for safety and efficacy testing of vaccines carried out 
        in or through the National Institutes of Health, the 
        Centers for Disease Control and Prevention, the Office 
        of Biologics Research and Review of the Food and Drug 
        Administration, the Department of Defense, and the 
        Agency for International Development.
          (4) Licensing of vaccine manufacturers and 
        vaccines.--The Director of the Program shall, through 
        the plan issued under section 2103, coordinate and 
        provide direction for the allocation of resources in 
        the implementation of the licensing program under 
        section 353.
          (5) Production and procurement of vaccines.--The 
        Director of the Program shall, through the plan issued 
        under section 2103, ensure that the governmental and 
        non-governmental production and procurement of safe and 
        effective vaccines by the Public Health Service, the 
        Department of Defense, and the Agency for International 
        Development meet the needs of the United States 
        population and fulfill commitments of the United States 
        to prevent human infectious diseases in other 
        countries.
          (6) Distribution and use of vaccines.--The Director 
        of the Program shall, through the plan issued under 
        section 2103, coordinate and provide direction to the 
        Centers for Disease Control and Prevention and 
        assistance to States, localities, and health 
        practitioners in the distribution and use of vaccines, 
        including efforts to encourage public acceptance of 
        immunizations and to make health practitioners and the 
        public aware of potential adverse reactions and 
        contraindications to vaccines.
          (7) Evaluating the need for and the effectiveness and 
        adverse effects of vaccines and immunization 
        activities.--The Director of the Program shall, through 
        the plan issued under section 2103, coordinate and 
        provide direction to the National Institutes of Health, 
        the Centers for Disease Control and Prevention, the 
        Office of Biologics Research and Review of the Food and 
        Drug Administration, the National Center for Health 
        Statistics, the National Center for Health Services 
        Research and Health Care Technology Assessment, and the 
        Centers for Medicare & Medicaid Services in monitoring 
        the need for and the effectiveness and adverse effects 
        of vaccines and immunization activities.
          (8) Coordinating governmental and non-governmental 
        activities.--The Director of the Program shall, through 
        the plan issued under section 2103, provide for the 
        exchange of information between Federal agencies 
        involved in the implementation of the Program and non-
        governmental entities engaged in the development and 
        production of vaccines and in vaccine research and 
        encourage the investment of non-governmental resources 
        complementary to the governmental activities under the 
        Program.
          (9) Funding of federal agencies.--The Director of the 
        Program shall make available to Federal agencies 
        involved in the implementation of the plan issued under 
        section 2103 funds appropriated under section 2106 to 
        supplement the funds otherwise available to such 
        agencies for activities under the plan.
          (10) Advisory committee on immunization practices.--
                  (A) Standard periods of time for making 
                recommendations.--Upon the licensure of any 
                vaccine or any new indication for a vaccine, 
                the Director of the Program shall direct the 
                Advisory Committee on Immunization Practices, 
                at its next regularly scheduled meeting, to 
                consider the use of the vaccine.
                  (B) Expedited review pursuant to request by 
                sponsor or manufacturer.--If the Advisory 
                Committee does not make recommendations with 
                respect to the use of a vaccine at the Advisory 
                Committee's first regularly scheduled meeting 
                after the licensure of the vaccine or any new 
                indication for the vaccine, the Advisory 
                Committee, at the request of the sponsor of the 
                vaccine, shall make such recommendations on an 
                expedited basis.
                  (C) Expedited review for breakthrough 
                therapies and for use during public health 
                emergencies.--If a vaccine is designated as a 
                breakthrough therapy under section 506 of the 
                Federal Food, Drug, and Cosmetic Act and is 
                licensed under section 351 of this Act, the 
                Advisory Committee shall make recommendations 
                with respect to the use of the vaccine on an 
                expedited basis.
                  (D) Definition.--In this paragraph, the terms 
                ``Advisory Committee on Immunization 
                Practices'' and ``Advisory Committee'' mean the 
                advisory committee on immunization practices 
                established by the Secretary pursuant to 
                section 222, acting through the Director of the 
                Centers for Disease Control and Prevention.
  (b) In carrying out subsection (a) and in preparing the plan 
under section 2103, the Director shall consult with all Federal 
agencies involved in research on and development, testing, 
licensing, production, procurement, distribution, and use of 
vaccines.

           *       *       *       *       *       *       *


          TITLE XXX--HEALTH INFORMATION TECHNOLOGY AND QUALITY

SEC. 3000. DEFINITIONS.

   In this title:
          [(1) Certified ehr technology.--The term ``certified 
        EHR technology'' means a qualified electronic health 
        record that is certified pursuant to section 3001(c)(5) 
        as meeting standards adopted under section 3004 that 
        are applicable to the type of record involved (as 
        determined by the Secretary, such as an ambulatory 
        electronic health record for office-based physicians or 
        an inpatient hospital electronic health record for 
        hospitals).]
          (1) Certified ehr technology.--The term ``certified 
        EHR technology'' means a qualified electronic health 
        record that is certified pursuant to section 3001(c)(5) 
        as meeting the certification criteria defined in 
        subparagraph (B) of such section that are applicable to 
        the type of record involved (as determined by the 
        Secretary, such as an ambulatory electronic health 
        record for office-based physicians or an inpatient 
        hospital electronic health record for hospitals) 
        including, beginning January 1, 2018, with respect to 
        which the vendor or other entity offering such 
        technology is in compliance with the requirements under 
        section 3001(c)(5)(C)(i).
          (2) Enterprise integration.--The term ``enterprise 
        integration'' means the electronic linkage of health 
        care providers, health plans, the government, and other 
        interested parties, to enable the electronic exchange 
        and use of health information among all the components 
        in the health care infrastructure in accordance with 
        applicable law, and such term includes related 
        application protocols and other related standards.
          (3) Health care provider.--The term ``health care 
        provider'' includes a hospital, skilled nursing 
        facility, nursing facility, home health entity or other 
        long term care facility, health care clinic, community 
        mental health center (as defined in section 
        1913(b)(1)), renal dialysis facility, blood center, 
        ambulatory surgical center described in section 1833(i) 
        of the Social Security Act, emergency medical services 
        provider, Federally qualified health center, group 
        practice, a pharmacist, a pharmacy, a laboratory, a 
        physician (as defined in section 1861(r) of the Social 
        Security Act), a practitioner (as described in section 
        1842(b)(18)(C) of the Social Security Act), a provider 
        operated by, or under contract with, the Indian Health 
        Service or by an Indian tribe (as defined in the Indian 
        Self-Determination and Education Assistance Act), 
        tribal organization, or urban Indian organization (as 
        defined in section 4 of the Indian Health Care 
        Improvement Act), a rural health clinic, a covered 
        entity under section 340B, an ambulatory surgical 
        center described in section 1833(i) of the Social 
        Security Act, a therapist (as defined in section 
        1848(k)(3)(B)(iii) of the Social Security Act), and any 
        other category of health care facility, entity, 
        practitioner, or clinician determined appropriate by 
        the Secretary.
          (4) Health information.--The term ``health 
        information'' has the meaning given such term in 
        section 1171(4) of the Social Security Act.
          (5) Health information technology.--The term ``health 
        information technology'' means hardware, software, 
        integrated technologies or related licenses, 
        intellectual property, upgrades, or packaged solutions 
        sold as services that are designed for or support the 
        use by health care entities or patients for the 
        electronic creation, maintenance, access, or exchange 
        of health information
          (6) Health plan.--The term ``health plan'' has the 
        meaning given such term in section 1171(5) of the 
        Social Security Act.
          (7) HIT policy committee.--The term ``HIT Policy 
        Committee'' means such Committee established under 
        section 3002(a).
          (8) HIT standards committee.--The term ``HIT 
        Standards Committee'' means such Committee established 
        under section 3003(a).
          (9) Individually identifiable health information.--
        The term ``individually identifiable health 
        information'' has the meaning given such term in 
        section 1171(6) of the Social Security Act.
          (10) Laboratory.--The term ``laboratory'' has the 
        meaning given such term in section 353(a).
          (11) National coordinator.--The term ``National 
        Coordinator'' means the head of the Office of the 
        National Coordinator for Health Information Technology 
        established under section 3001(a).
          (12) Pharmacist.--The term ``pharmacist'' has the 
        meaning given such term in section 804(2) of the 
        Federal Food, Drug, and Cosmetic Act.
          (13) Qualified electronic health record.--The term 
        ``qualified electronic health record'' means an 
        electronic record of health-related information on an 
        individual that--
                  (A) includes patient demographic and clinical 
                health information, such as medical history and 
                problem lists; and
                  (B) has the capacity--
                          (i) to provide clinical decision 
                        support;
                          (ii) to support physician order 
                        entry;
                          (iii) to capture and query 
                        information relevant to health care 
                        quality; and
                          (iv) to exchange electronic health 
                        information with, and integrate such 
                        information from other sources.
          (14) State.--The term ``State'' means each of the 
        several States, the District of Columbia, Puerto Rico, 
        the Virgin Islands, Guam, American Samoa, and the 
        Northern Mariana Islands.
          (15) Widespread interoperability.--The term 
        ``widespread interoperability'' means that, on a 
        nationwide basis--
                  (A) health information technology is 
                interoperable, in accordance with section 3010; 
                and
                  (B) such technology is employed by meaningful 
                EHR users under the specified meaningful use 
                incentive programs (as defined in section 
                3010A(e)) and by other clinicians and health 
                care providers.

         Subtitle A--Promotion of Health Information Technology

SEC. 3001. OFFICE OF THE NATIONAL COORDINATOR FOR HEALTH INFORMATION 
                    TECHNOLOGY.

  (a) Establishment.--There is established within the 
Department of Health and Human Services an Office of the 
National Coordinator for Health Information Technology 
(referred to in this section as the ``Office''). The Office 
shall be headed by a National Coordinator who shall be 
appointed by the Secretary and shall report directly to the 
Secretary.
  (b) Purpose.--The National Coordinator shall perform the 
duties under subsection (c) in a manner consistent with the 
development of a nationwide health information technology 
infrastructure that allows for the electronic use and exchange 
of information and that--
          (1) ensures that each patient's health information is 
        secure and protected, in accordance with applicable 
        law;
          (2) improves health care quality, reduces medical 
        errors, reduces health disparities, and advances the 
        delivery of patient-centered medical care;
          (3) reduces health care costs resulting from 
        inefficiency, medical errors, inappropriate care, 
        duplicative care, and incomplete information;
          (4) provides appropriate information to help guide 
        medical decisions at the time and place of care;
          (5) ensures the inclusion of meaningful public input 
        in such development of such infrastructure;
          (6) improves the coordination of care and information 
        among hospitals, laboratories, physician offices, and 
        other entities through an effective infrastructure for 
        the secure and authorized exchange of health care 
        information;
          (7) improves public health activities and facilitates 
        the early identification and rapid response to public 
        health threats and emergencies, including bioterror 
        events and infectious disease outbreaks;
          (8) facilitates health and clinical research and 
        health care quality;
          (9) promotes early detection, prevention, and 
        management of chronic diseases;
          (10) promotes a more effective marketplace, greater 
        competition, greater systems analysis, increased 
        consumer choice, and improved outcomes in health care 
        services; and
          (11) improves efforts to reduce health disparities.
  (c) Duties of the National Coordinator.--
          (1) Standards.--The National Coordinator shall--
                  (A) for recommendations made before the date 
                of the enactment of the 21st Century Cures Act, 
                review and determine whether to endorse each 
                standard, implementation specification, and 
                certification criterion for the electronic 
                exchange and use of health information that is 
                recommended by the HIT Standards Committee 
                under section 3003 for purposes of adoption 
                under section 3004;
                  (B) make such determinations under 
                subparagraph (A), and report to the Secretary 
                such determinations, not later than 45 days 
                after the date the recommendation is received 
                by the Coordinator; and
                  (C) review Federal health information 
                technology investments to ensure that Federal 
                health information technology programs are 
                meeting the objectives of the strategic plan 
                published under paragraph (3).
          (2) HIT policy coordination.--
                  (A) In general.--The National Coordinator 
                shall coordinate health information technology 
                policy and programs of the Department with 
                those of other relevant executive branch 
                agencies with a goal of avoiding duplication of 
                efforts and of helping to ensure that each 
                agency undertakes health information technology 
                activities primarily within the areas of its 
                greatest expertise and technical capability and 
                in a manner towards a coordinated national 
                goal.
                  (B) HIT policy and standards committees.--The 
                National Coordinator shall be a leading member 
                in the establishment and operations of the HIT 
                Policy Committee and the HIT Standards 
                Committee and shall serve as a liaison among 
                those two Committees and the Federal 
                Government.
          (3) Strategic plan.--
                  (A) In general.--The National Coordinator 
                shall, in consultation with other appropriate 
                Federal agencies (including the National 
                Institute of Standards and Technology), update 
                the Federal Health IT Strategic Plan (developed 
                as of June 3, 2008) to include specific 
                objectives, milestones, and metrics with 
                respect to the following:
                          (i) The electronic exchange and use 
                        of health information and the 
                        enterprise integration of such 
                        information.
                          (ii) The utilization of an electronic 
                        health record for each person in the 
                        United States by 2014.
                          (iii) The incorporation of privacy 
                        and security protections for the 
                        electronic exchange of an individual's 
                        individually identifiable health 
                        information.
                          (iv) Ensuring security methods to 
                        ensure appropriate authorization and 
                        electronic authentication of health 
                        information and specifying technologies 
                        or methodologies for rendering health 
                        information unusable, unreadable, or 
                        indecipherable.
                          (v) Specifying a framework for 
                        coordination and flow of 
                        recommendations and policies under this 
                        subtitle among the Secretary, the 
                        National Coordinator, the HIT Policy 
                        Committee, the HIT Standards Committee, 
                        and other health information exchanges 
                        and other relevant entities.
                          (vi) Methods to foster the public 
                        understanding of health information 
                        technology.
                          (vii) Strategies to enhance the use 
                        of health information technology in 
                        improving the quality of health care, 
                        reducing medical errors, reducing 
                        health disparities, improving public 
                        health, increasing prevention and 
                        coordination with community resources, 
                        and improving the continuity of care 
                        among health care settings.
                          (viii) Specific plans for ensuring 
                        that populations with unique needs, 
                        such as children, are appropriately 
                        addressed in the technology design, as 
                        appropriate, which may include 
                        technology that automates enrollment 
                        and retention for eligible individuals.
                  (B) Collaboration.--The strategic plan shall 
                be updated through collaboration of public and 
                private entities.
                  (C) Measurable outcome goals.--The strategic 
                plan update shall include measurable outcome 
                goals.
                  (D) Publication.--The National Coordinator 
                shall republish the strategic plan, including 
                all updates.
          (4) Website.--The National Coordinator shall maintain 
        and frequently update an Internet website on which 
        there is posted information on the work, schedules, 
        reports, recommendations, and other information to 
        ensure transparency in promotion of a nationwide health 
        information technology infrastructure.
          (5) Certification.--
                  (A) In general.--The National Coordinator, in 
                consultation with the Director of the National 
                Institute of Standards and Technology, shall 
                keep or recognize a program or programs for the 
                voluntary certification of health information 
                technology as being in compliance with 
                applicable certification criteria adopted under 
                this subtitle. Such program shall include, as 
                appropriate, testing of the technology in 
                accordance with section 13201(b) of the Health 
                Information Technology for Economic and 
                Clinical Health Act.
                  [(B) Certification criteria described.--In 
                this title, the term ``certification criteria'' 
                means, with respect to standards and 
                implementation specifications for health 
                information technology, criteria to establish 
                that the technology meets such standards and 
                implementation specifications.]
                  (B) Certification criteria described.--In 
                this title, the term ``certification criteria'' 
                means, with respect to qualified electronic 
                health records--
                          (i) for certifications made before 
                        January 1, 2018, criteria to establish 
                        that the records meet standards and 
                        implementation specifications adopted 
                        under subsections (a) and (b) of 
                        section 3004 for qualified electronic 
                        health records; and
                          (ii) for certifications made on or 
                        after January 1, 2018, criteria 
                        described in clause (i) and criteria to 
                        establish that the records are 
                        interoperable, in accordance with 
                        section 3010, including by being in 
                        compliance with interoperability 
                        standards adopted under section 3004.
                  (C) Enforcement; decertifications.--
                          (i) Requirements.--Under any program 
                        kept or recognized under subparagraph 
                        (A), the Secretary shall ensure that 
                        any vendor of or other entity offering 
                        qualified electronic health records 
                        seeking a certification of such records 
                        under such program on or after January 
                        1, 2018, shall, as a condition of 
                        certification (and maintenance of 
                        certification) of such a record under 
                        such program--
                                  (I) provide to the Secretary 
                                an attestation--
                                          (aa) that the entity, 
                                        unless for a legitimate 
                                        purpose specified by 
                                        the Secretary, has not 
                                        taken any action, 
                                        including through any 
                                        financial, 
                                        administrative, or 
                                        technological barrier, 
                                        which the entity knows 
                                        or should know (as 
                                        defined in section 
                                        1128A(i)(7) of the 
                                        Social Security Act), 
                                        is to limit or restrict 
                                        the exchange of 
                                        information or to 
                                        prevent or 
                                        disincentivize 
                                        widespread 
                                        interoperability 
                                        between any providers 
                                        using such records or 
                                        other health 
                                        information technology 
                                        in connection with such 
                                        record;
                                          (bb) on the pricing 
                                        information described 
                                        in clause (v) for 
                                        purposes of the portal 
                                        created under paragraph 
                                        (9); that such 
                                        information will be 
                                        available on a public 
                                        Web site of such entity 
                                        and in marketing 
                                        materials, 
                                        communications 
                                        statements, and other 
                                        assertions of such 
                                        entity related to such 
                                        record; and that the 
                                        entity will voluntarily 
                                        provide such 
                                        information to 
                                        customers prior to 
                                        providing any qualified 
                                        electronic health 
                                        records or related 
                                        product or service 
                                        (including subsequent 
                                        updates, add-ons, or 
                                        additional products or 
                                        services to be provided 
                                        during the course of an 
                                        on-going contract), 
                                        prospective customers 
                                        (such as persons who 
                                        request or receive a 
                                        quotation, estimate, or 
                                        other similar marketing 
                                        or promotional 
                                        material), and other 
                                        persons who request 
                                        such information;
                                          (cc) that the 
                                        software with respect 
                                        to such records have 
                                        published application 
                                        programming interfaces 
                                        for medical records 
                                        data, search and 
                                        indexing, semantic 
                                        harmonization and 
                                        vocabulary translation, 
                                        and user interface 
                                        applications;
                                          (dd) that the entity 
                                        has successfully tested 
                                        the use of the record 
                                        in the type of setting 
                                        in which it would be 
                                        marketed;
                                          (ee) the entity has 
                                        in place implementation 
                                        guidelines for such 
                                        record that support 
                                        interoperability, 
                                        consistent with section 
                                        3010; and
                                          (ff) that the entity 
                                        has in place data 
                                        sharing programs or 
                                        capabilities based on 
                                        common data elements 
                                        through application 
                                        programming interfaces 
                                        without the requirement 
                                        for vendor-specific 
                                        interfaces;
                                  (II) publish application 
                                programming interfaces and 
                                associated documentation, with 
                                respect to such records, for 
                                medical records data, search 
                                and indexing, semantic 
                                harmonization and vocabulary 
                                translation, and user interface 
                                applications; and
                                  (III) demonstrate to the 
                                satisfaction of the Secretary 
                                that data from such records are 
                                able to be exchanged through 
                                the use of application 
                                programming interfaces and used 
                                in a manner that allows for 
                                exchange and everyday use, as 
                                authorized under applicable 
                                law, of such records.
                          (ii) Decertification.--Under any 
                        program kept or recognized under 
                        subparagraph (A), the Secretary shall 
                        ensure that beginning January 1, 2019, 
                        any qualified electronic health records 
                        that do not satisfy the certification 
                        criteria described in section 
                        3001(c)(5)(B)(ii) or with respect to 
                        which the vendor or other entity 
                        described in clause (i) does not 
                        satisfy the requirements under such 
                        clause (or is determined to be in 
                        violation of the terms of the 
                        attestation or other requirements under 
                        such clause) shall no longer be 
                        considered as certified under such 
                        program.
                          (iii) Annual publication.--For 2019 
                        and each subsequent year, the Secretary 
                        shall post on the public Internet 
                        website of the Department of Health and 
                        Human Services a list of any vendors of 
                        or other entities offering qualified 
                        electronic health records with respect 
                        to which certification has been 
                        withdrawn under clause (ii) during such 
                        year.
                          (iv) Periodic review.--The Secretary 
                        shall periodically review and confirm 
                        that vendors of and other entities 
                        offering qualified electronic health 
                        records have publicly published 
                        application programming interfaces and 
                        associated documentation as required by 
                        clause (i)(II) for purposes of 
                        certification and maintaining 
                        certification under any program kept or 
                        recognized under subparagraph (A).
                          (v) Pricing information.--For 
                        purposes of clause (i)(I)(bb), the 
                        pricing information described in this 
                        clause, with respect to a vendor of or 
                        other entity offering a qualified 
                        electronic health record, is the 
                        following:
                                  (I) Additional types of costs 
                                or fees (whether fixed, 
                                recurring, transaction based, 
                                or otherwise) imposed by the 
                                entity (or any third-party from 
                                whom the entity purchases, 
                                licenses, or obtains any 
                                technology, products, or 
                                services in connection with the 
                                qualified electronic health 
                                record) to purchase, license, 
                                implement, maintain, upgrade, 
                                use, or otherwise enable and 
                                support the use of capabilities 
                                to which such record is to be 
                                certified under this section; 
                                or in connection with any data 
                                generated in the course of 
                                using any capability to which 
                                the record is to be so 
                                certified.
                                  (II) Limitations, whether by 
                                contract or otherwise, on the 
                                use of any capability to which 
                                the record is to be certified 
                                under this section for any 
                                purpose within the scope of the 
                                record's certification; or in 
                                connection with any data 
                                generated in the course of 
                                using any capability to which 
                                the record is to be certified 
                                under this section.
                                  (III) Limitations, including 
                                technical or practical 
                                limitations of technology or 
                                its capabilities, that could 
                                prevent or impair the 
                                successful implementation, 
                                configuration, customization, 
                                maintenance, support, or use of 
                                any capabilities to which the 
                                record is to be certified under 
                                this section; or that could 
                                prevent or limit the use, 
                                exchange, or portability of any 
                                data generated in the course of 
                                using any capability to which 
                                the record is to be so 
                                certified.
          (6) Reports and publications.--
                  (A) Report on additional funding or authority 
                needed.--Not later than 12 months after the 
                date of the enactment of this title, the 
                National Coordinator shall submit to the 
                appropriate committees of jurisdiction of the 
                House of Representatives and the Senate a 
                report on any additional funding or authority 
                the Coordinator or the HIT Policy Committee or 
                HIT Standards Committee requires to evaluate 
                and develop standards, implementation 
                specifications, and certification criteria, or 
                to achieve full participation of stakeholders 
                in the adoption of a nationwide health 
                information technology infrastructure that 
                allows for the electronic use and exchange of 
                health information.
                  (B) Implementation report.--The National 
                Coordinator shall prepare a report that 
                identifies lessons learned from major public 
                and private health care systems in their 
                implementation of health information 
                technology, including information on whether 
                the technologies and practices developed by 
                such systems may be applicable to and usable in 
                whole or in part by other health care 
                providers.
                  (C) Assessment of impact of hit on 
                communities with health disparities and 
                uninsured, underinsured, and medically 
                underserved areas.--The National Coordinator 
                shall assess and publish the impact of health 
                information technology in communities with 
                health disparities and in areas with a high 
                proportion of individuals who are uninsured, 
                underinsured, and medically underserved 
                individuals (including urban and rural areas) 
                and identify practices to increase the adoption 
                of such technology by health care providers in 
                such communities, and the use of health 
                information technology to reduce and better 
                manage chronic diseases.
                  (D) Evaluation of benefits and costs of the 
                electronic use and exchange of health 
                information.--The National Coordinator shall 
                evaluate and publish evidence on the benefits 
                and costs of the electronic use and exchange of 
                health information and assess to whom these 
                benefits and costs accrue.
                  (E) Resource requirements.--The National 
                Coordinator shall estimate and publish 
                resources required annually to reach the goal 
                of utilization of an electronic health record 
                for each person in the United States by 2014, 
                including--
                          (i) the required level of Federal 
                        funding;
                          (ii) expectations for regional, 
                        State, and private investment;
                          (iii) the expected contributions by 
                        volunteers to activities for the 
                        utilization of such records; and
                          (iv) the resources needed to 
                        establish a health information 
                        technology workforce sufficient to 
                        support this effort (including 
                        education programs in medical 
                        informatics and health information 
                        management).
          (7) Assistance.--The National Coordinator may provide 
        financial assistance to consumer advocacy groups and 
        not-for-profit entities that work in the public 
        interest for purposes of defraying the cost to such 
        groups and entities to participate under, whether in 
        whole or in part, the National Technology Transfer Act 
        of 1995 (15 U.S.C. 272 note).
          (8) Governance for nationwide health information 
        network.--The National Coordinator shall establish a 
        governance mechanism for the nationwide health 
        information network.
          (9) Portal.--Not later than January 1, 2019, the 
        National Coordinator shall create a portal to make the 
        information described in paragraph (5)(C)(I)(i)(bb) 
        available to the public in a manner that allows for 
        comparison of price information among health 
        information technology products and that aids in making 
        informed decisions for purchasing such a product.
  (d) Detail of Federal Employees.--
          (1) In general.--Upon the request of the National 
        Coordinator, the head of any Federal agency is 
        authorized to detail, with or without reimbursement 
        from the Office, any of the personnel of such agency to 
        the Office to assist it in carrying out its duties 
        under this section.
          (2) Effect of detail.--Any detail of personnel under 
        paragraph (1) shall--
                  (A) not interrupt or otherwise affect the 
                civil service status or privileges of the 
                Federal employee; and
                  (B) be in addition to any other staff of the 
                Department employed by the National 
                Coordinator.
          (3) Acceptance of detailees.--Notwithstanding any 
        other provision of law, the Office may accept detailed 
        personnel from other Federal agencies without regard to 
        whether the agency described under paragraph (1) is 
        reimbursed.
  (e) Chief Privacy Officer of the Office of the National 
Coordinator.--Not later than 12 months after the date of the 
enactment of this title, the Secretary shall appoint a Chief 
Privacy Officer of the Office of the National Coordinator, 
whose duty it shall be to advise the National Coordinator on 
privacy, security, and data stewardship of electronic health 
information and to coordinate with other Federal agencies (and 
similar privacy officers in such agencies), with State and 
regional efforts, and with foreign countries with regard to the 
privacy, security, and data stewardship of electronic 
individually identifiable health information.

SEC. 3002. HIT POLICY COMMITTEE.

  (a) Establishment.--There is established a HIT Policy 
Committee to make policy recommendations to the [National 
Coordinator] Secretary, in consultation with the National 
Coordinator, relating to the implementation of a nationwide 
health information technology infrastructure, including 
implementation of the strategic plan described in section 
3001(c)(3). The HIT Policy Committee is authorized only to 
provide policy and priority recommendations to the Secretary 
and not authorized to otherwise affect the development or 
modification of any standard, implementation specification, or 
certification criterion under this title.
  (b) Duties.--
          (1) Recommendations on health information technology 
        infrastructure.--The HIT Policy Committee shall 
        recommend a policy framework for the development and 
        adoption of a nationwide health information technology 
        infrastructure that permits the electronic exchange and 
        use of health information as is consistent with the 
        strategic plan under section 3001(c)(3) and that 
        includes the recommendations under paragraph (2). The 
        Committee shall update such recommendations and make 
        new recommendations as appropriate.
          (2) Specific areas of standard development.--
                  (A) In general.--[The HIT Policy Committee] 
                Subject to subparagraph (D), the HIT Policy 
                Committee shall recommend the areas in which 
                standards, implementation specifications, and 
                certification criteria are needed for the 
                electronic exchange and use of health 
                information for purposes of adoption under 
                section 3004 (including the areas in which 
                modifications and additions to interoperability 
                standards under section 3010 are needed for the 
                electronic exchange and use of health 
                information for purposes of adoption of such 
                modifications and additions under section 3004) 
                and shall recommend an order of priority for 
                the development, harmonization, and recognition 
                of such standards, specifications, and 
                certification criteria among the areas so 
                recommended. Such standards and implementation 
                specifications shall include named standards, 
                architectures, and software schemes for the 
                authentication and security of individually 
                identifiable health information and other 
                information as needed to ensure the 
                reproducible development of common solutions 
                across disparate entities.
                  (B) Areas required for consideration.--For 
                purposes of subparagraph (A), the HIT Policy 
                Committee shall make recommendations for at 
                least the following areas:
                          (i) Technologies that protect the 
                        privacy of health information and 
                        promote security in a qualified 
                        electronic health record, including for 
                        the segmentation and protection from 
                        disclosure of specific and sensitive 
                        individually identifiable health 
                        information with the goal of minimizing 
                        the reluctance of patients to seek care 
                        (or disclose information about a 
                        condition) because of privacy concerns, 
                        in accordance with applicable law, and 
                        for the use and disclosure of limited 
                        data sets of such information.
                          (ii) A nationwide health information 
                        technology infrastructure that allows 
                        for the electronic use and accurate 
                        exchange of health information.
                          (iii) The utilization of a certified 
                        electronic health record for each 
                        person in the United States by 2014.
                          (iv) Technologies that as a part of a 
                        qualified electronic health record 
                        allow for an accounting of disclosures 
                        made by a covered entity (as defined 
                        for purposes of regulations promulgated 
                        under section 264(c) of the Health 
                        Insurance Portability and 
                        Accountability Act of 1996) for 
                        purposes of treatment, payment, and 
                        health care operations (as such terms 
                        are defined for purposes of such 
                        regulations).
                          (v) The use of certified electronic 
                        health records to improve the quality 
                        of health care, such as by promoting 
                        the coordination of health care and 
                        improving continuity of health care 
                        among health care providers, by 
                        reducing medical errors, by improving 
                        population health, by reducing health 
                        disparities, by reducing chronic 
                        disease, and by advancing research and 
                        education.
                          (vi) Technologies that allow 
                        individually identifiable health 
                        information to be rendered unusable, 
                        unreadable, or indecipherable to 
                        unauthorized individuals when such 
                        information is transmitted in the 
                        nationwide health information network 
                        or physically transported outside of 
                        the secured, physical perimeter of a 
                        health care provider, health plan, or 
                        health care clearinghouse.
                          (vii) The use of electronic systems 
                        to ensure the comprehensive collection 
                        of patient demographic data, including, 
                        at a minimum, race, ethnicity, primary 
                        language, and gender information.
                          (viii) Technologies that address the 
                        needs of children and other vulnerable 
                        populations.
                  (C) Other areas for consideration.--In making 
                recommendations under subparagraph (A), the HIT 
                Policy Committee may consider the following 
                additional areas:
                          (i) The appropriate uses of a 
                        nationwide health information 
                        infrastructure, including for purposes 
                        of--
                                  (I) the collection of quality 
                                data and public reporting;
                                  (II) biosurveillance and 
                                public health;
                                  (III) medical and clinical 
                                research; and
                                  (IV) drug safety.
                          (ii) Self-service technologies that 
                        facilitate the use and exchange of 
                        patient information and reduce wait 
                        times.
                          (iii) Telemedicine technologies, in 
                        order to reduce travel requirements for 
                        patients in remote areas.
                          (iv) Technologies that facilitate 
                        home health care and the monitoring of 
                        patients recuperating at home.
                          (v) Technologies that help reduce 
                        medical errors.
                          (vi) Technologies that facilitate the 
                        continuity of care among health 
                        settings.
                          (vii) Technologies that meet the 
                        needs of diverse populations.
                          (viii) Methods to facilitate secure 
                        access by an individual to such 
                        individual's protected health 
                        information.
                          (ix) Methods, guidelines, and 
                        safeguards to facilitate secure access 
                        to patient information by a family 
                        member, caregiver, or guardian acting 
                        on behalf of a patient due to age-
                        related and other disability, cognitive 
                        impairment, or dementia.
                          (x) Any other technology that the HIT 
                        Policy Committee finds to be among the 
                        technologies with the greatest 
                        potential to improve the quality and 
                        efficiency of health care.
                  (D) Special rule related to 
                interoperability.--Any recommendation made by 
                the HIT Policy Committee on or after the date 
                of the enactment of this subparagraph with 
                respect to interoperability of health 
                information technology shall be consistent with 
                the criteria described in subsection (a) of 
                section 3010.
          (3) Forum.--The HIT Policy Committee shall serve as a 
        forum for broad stakeholder input with specific 
        expertise in policies relating to the matters described 
        in paragraphs (1) and (2).
          (4) Consistency with evaluation conducted under 
        mippa.--
                  (A) Requirement for consistency.--The HIT 
                Policy Committee shall ensure that 
                recommendations made under paragraph (2)(B)(vi) 
                are consistent with the evaluation conducted 
                under section 1809(a) of the Social Security 
                Act.
                  (B) Scope.--Nothing in subparagraph (A) shall 
                be construed to limit the recommendations under 
                paragraph (2)(B)(vi) to the elements described 
                in section 1809(a)(3) of the Social Security 
                Act.
                  (C) Timing.--The requirement under 
                subparagraph (A) shall be applicable to the 
                extent that evaluations have been conducted 
                under section 1809(a) of the Social Security 
                Act, regardless of whether the report described 
                in subsection (b) of such section has been 
                submitted.
  (c) Membership and Operations.--
          (1) In general.--The National Coordinator shall take 
        a leading position in the establishment and operations 
        of the HIT Policy Committee.
          (2) Membership.--The HIT Policy Committee shall be 
        composed of members to be appointed as follows:
                  (A) 3 members shall be appointed by the 
                Secretary, 1 of whom shall be appointed to 
                represent the Department of Health and Human 
                Services and 1 of whom shall be a public health 
                official.
                  (B) 1 member shall be appointed by the 
                majority leader of the Senate.
                  (C) 1 member shall be appointed by the 
                minority leader of the Senate.
                  (D) 1 member shall be appointed by the 
                Speaker of the House of Representatives.
                  (E) 1 member shall be appointed by the 
                minority leader of the House of 
                Representatives.
                  (F) Such other members as shall be appointed 
                by the President as representatives of other 
                relevant Federal agencies.
                  (G) 13 members shall be appointed by the 
                Comptroller General of the United States of 
                whom--
                          (i) 3 members shall advocates for 
                        patients or consumers;
                          (ii) 2 members shall represent health 
                        care providers, one of which shall be a 
                        physician;
                          (iii) 1 member shall be from a labor 
                        organization representing health care 
                        workers;
                          (iv) 1 member shall have expertise in 
                        health information privacy and 
                        security;
                          (v) 1 member shall have expertise in 
                        improving the health of vulnerable 
                        populations;
                          (vi) 1 member shall be from the 
                        research community;
                          (vii) 1 member shall represent health 
                        plans or other third-party payers;
                          (viii) 1 member shall represent 
                        information technology vendors;
                          (ix) 1 member shall represent 
                        purchasers or employers; and
                          (x) 1 member shall have expertise in 
                        health care quality measurement and 
                        reporting.
          (3) Participation.--The members of the HIT Policy 
        Committee appointed under paragraph (2) shall represent 
        a balance among various sectors of the health care 
        system so that no single sector unduly influences the 
        recommendations of the Policy Committee.
          (4) Terms.--
                  (A) In general.--The terms of the members of 
                the HIT Policy Committee shall be for 3 years, 
                except that the Comptroller General shall 
                designate staggered terms for the members first 
                appointed.
                  (B) Vacancies.--Any member appointed to fill 
                a vacancy in the membership of the HIT Policy 
                Committee that occurs prior to the expiration 
                of the term for which the member's predecessor 
                was appointed shall be appointed only for the 
                remainder of that term. A member may serve 
                after the expiration of that member's term 
                until a successor has been appointed. A vacancy 
                in the HIT Policy Committee shall be filled in 
                the manner in which the original appointment 
                was made.
          (5) Outside involvement.--The HIT Policy Committee 
        shall ensure an opportunity for the participation in 
        activities of the Committee of outside advisors, 
        including individuals with expertise in the development 
        of policies for the electronic exchange and use of 
        health information, including in the areas of health 
        information privacy and security.
          (6) Quorum.--A majority of the member of the HIT 
        Policy Committee shall constitute a quorum for purposes 
        of voting, but a lesser number of members may meet and 
        hold hearings.
          (7) Failure of initial appointment.--If, on the date 
        that is 45 days after the date of enactment of this 
        title, an official authorized under paragraph (2) to 
        appoint one or more members of the HIT Policy Committee 
        has not appointed the full number of members that such 
        paragraph authorizes such official to appoint, the 
        Secretary is authorized to appoint such members.
          (8) Consideration.--The National Coordinator shall 
        ensure that the relevant and available recommendations 
        and comments from the National Committee on Vital and 
        Health Statistics are considered in the development of 
        policies.
  (d) Application of FACA.--The Federal Advisory Committee Act 
(5 U.S.C. App.), other than section 14 of such Act, shall apply 
to the HIT Policy Committee.
  (e) Publication.--The Secretary shall provide for publication 
in the Federal Register and the posting on the Internet website 
of the Office of the National Coordinator for Health 
Information Technology of all policy recommendations made by 
the HIT Policy Committee under this section.

SEC. 3003. HIT STANDARDS COMMITTEE.

  (a) Establishment.--There is established a committee to be 
known as the HIT Standards Committee to recommend to the 
National Coordinator standards, implementation specifications, 
and certification criteria for the electronic exchange and use 
of health information for purposes of adoption under section 
3004, consistent with the implementation of the strategic plan 
described in section 3001(c)(3) and beginning with the areas 
listed in section 3002(b)(2)(B) in accordance with policies 
developed by the HIT Policy Committee.
  (b) Duties.--
          (1) Standards development.--
                  (A) In general.--The HIT Standards Committee 
                shall recommend to the National Coordinator 
                standards, implementation specifications, and 
                certification criteria described in subsection 
                (a) that have been developed, harmonized, or 
                recognized by the HIT Standards Committee. The 
                HIT Standards Committee shall update such 
                recommendations and make new recommendations as 
                appropriate, including in response to a 
                notification sent under section 3004(a)(2)(B). 
                Such recommendations shall be consistent with 
                the latest recommendations made by the HIT 
                Policy Committee.
                  (B) Harmonization.--The HIT Standards 
                Committee recognize harmonized or updated 
                standards from an entity or entities for the 
                purpose of harmonizing or updating standards 
                and implementation specifications in order to 
                achieve uniform and consistent implementation 
                of the standards and implementation 
                specifications.
                  (C) Pilot testing of standards and 
                implementation specifications.--In the 
                development, harmonization, or recognition of 
                standards and implementation specifications, 
                the HIT Standards Committee shall, as 
                appropriate, provide for the testing of such 
                standards and specifications by the National 
                Institute for Standards and Technology under 
                section 13201(a) of the Health Information 
                Technology for Economic and Clinical Health 
                Act.
                  (D) Consistency.--The standards, 
                implementation specifications, and 
                certification criteria recommended under this 
                subsection shall be consistent with the 
                standards for information transactions and data 
                elements adopted pursuant to section 1173 of 
                the Social Security Act.
          (2) Forum.--The HIT Standards Committee shall serve 
        as a forum for the participation of a broad range of 
        stakeholders to provide input on the development, 
        harmonization, and recognition of standards, 
        implementation specifications, and certification 
        criteria necessary for the development and adoption of 
        a nationwide health information technology 
        infrastructure that allows for the electronic use and 
        exchange of health information.
          (3) Schedule.--Not later than 90 days after the date 
        of the enactment of this title, the HIT Standards 
        Committee shall develop a schedule for the assessment 
        of policy recommendations developed by the HIT Policy 
        Committee under section 3002. The HIT Standards 
        Committee shall update such schedule annually. The 
        Secretary shall publish such schedule in the Federal 
        Register.
          (4) Public input.--The HIT Standards Committee shall 
        conduct open public meetings and develop a process to 
        allow for public comment on the schedule described in 
        paragraph (3) and recommendations described in this 
        subsection. Under such process comments shall be 
        submitted in a timely manner after the date of 
        publication of a recommendation under this subsection.
          (5) Consideration.--The National Coordinator shall 
        ensure that the relevant and available recommendations 
        and comments from the National Committee on Vital and 
        Health Statistics are considered in the development of 
        standards.
  (c) Membership and Operations.--
          (1) In general.--The National Coordinator shall take 
        a leading position in the establishment and operations 
        of the HIT Standards Committee.
          (2) Membership.--The membership of the HIT Standards 
        Committee shall at least reflect providers, ancillary 
        healthcare workers, consumers, purchasers, health 
        plans, technology vendors, researchers, relevant 
        Federal agencies, and individuals with technical 
        expertise on health care quality, privacy and security, 
        and on the electronic exchange and use of health 
        information.
          (3) Participation.--The members of the HIT Standards 
        Committee appointed under this subsection shall 
        represent a balance among various sectors of the health 
        care system so that no single sector unduly influences 
        the recommendations of such Committee.
          (4) Outside involvement.--The HIT Policy Committee 
        shall ensure an opportunity for the participation in 
        activities of the Committee of outside advisors, 
        including individuals with expertise in the development 
        of standards for the electronic exchange and use of 
        health information, including in the areas of health 
        information privacy and security.
          (5) Balance among sectors.--In developing the 
        procedures for conducting the activities of the HIT 
        Standards Committee, the HIT Standards Committee shall 
        act to ensure a balance among various sectors of the 
        health care system so that no single sector unduly 
        influences the actions of the HIT Standards Committee.
          (6) Assistance.--For the purposes of carrying out 
        this section, the Secretary may provide or ensure that 
        financial assistance is provided by the HIT Standards 
        Committee to defray in whole or in part any membership 
        fees or dues charged by such Committee to those 
        consumer advocacy groups and not for profit entities 
        that work in the public interest as a part of their 
        mission.
  (d) Application of FACA.--The Federal Advisory Committee Act 
(5 U.S.C. App.), other than section 14, shall apply to the HIT 
Standards Committee.
  (e) Publication.--The Secretary shall provide for publication 
in the Federal Register and the posting on the Internet website 
of the Office of the National Coordinator for Health 
Information Technology of all recommendations made by the HIT 
Standards Committee under this section.
  (f) Termination.--The HIT Standards Committee shall terminate 
on the date that is 90 days after the date of the enactment of 
this subsection.

SEC. 3003A. RECOMMENDATIONS FOR STANDARDS THROUGH CONTRACTS WITH 
                    STANDARDS DEVELOPMENT ORGANIZATIONS.

  (a) Contracts.--
          (1) In general.--For purposes of activities conducted 
        under this title, the Secretary shall enter into 
        contracts with health care standards development 
        organizations accredited by the American National 
        Standards Institute to carry out the duties described 
        in subsection (b), as applicable.
          (2) Timing for first contract.--As soon as 
        practicable after the date of the enactment of this 
        section, the Secretary shall enter into the first 
        contract under paragraph (1).
          (3) Period of contract.--Each contract under 
        paragraph (1) shall be for a period determined 
        necessary by the Secretary, in consultation with the 
        National Coordinator, to carry out the applicable 
        duties described in subsection (b).
          (4) Appropriate organizations.--The Secretary shall 
        ensure the most appropriate organizations described in 
        paragraph (1) are selected for each contract under such 
        paragraph.
          (5) Allowance for variations.--Standards developed 
        pursuant to a contract under this subsection, and the 
        methods to test such standards, shall allow for 
        variations on such standards as long as such variations 
        are consistent with the standards so developed under 
        this section.
  (b) Duties.--
          (1) Initial contract.--Under the initial contract 
        under subsection (a)(1), the standards development 
        organizations--
                  (A) shall provide to the Secretary, in 
                consultation with the National Coordinator, for 
                adoption under section 3004, recommendations, 
                in accordance with section 3010, for 
                interoperability standards, and methods to test 
                such standards, consistent with the criteria 
                described in subsection (a) of such section and 
                with respect to the categories described in 
                subsection (b)(1) of such section; and
                  (B) may provide to the Secretary 
                recommendations described in paragraph (2).
          (2) Subsequent contracts.--Under each subsequent 
        contract, the organizations shall provide to the 
        Secretary, in consultation with the National 
        Coordinator, for adoption under section 3004 
        recommendations for any standards (including 
        interoperability standards and methods to test such 
        standards), implementation specifications, and 
        certification criteria (and modifications, including 
        additions, to such standards, specifications, and 
        criteria), which are in accordance with the policies 
        and priorities developed by the Secretary, in 
        consultation with the National Coordinator.
          (3) Multiple methods to test interoperability 
        standards.--For the purposes of developing methods to 
        test interoperability standards for adoption under 
        section 3004, the Secretary shall ensure that contracts 
        under this section allow for multiple methods to test 
        such standards to account for variations in the 
        adoption of such standards that do not conflict with 
        section 3010(a).
  (c) Modifications and Subsequent Contracts.--
          (1) In general.--The Secretary, in consultation with 
        the National Coordinator, shall periodically conduct 
        hearings to evaluate and review the standards, 
        implementation specifications, and certification 
        criteria adopted under section 3004 for purposes of 
        determining if modifications, including any additions, 
        are needed with respect to such standards, 
        specifications, and criteria.
          (2) Contract trigger.--Based on the needs for 
        standards, implementation specifications, and 
        certification criteria (and modifications, including 
        additions, to such standards, specifications, and 
        criteria) under this title, as determined by the 
        Secretary, in consultation with the National 
        Coordinator, the Secretary shall, as needed, enter into 
        contracts under subsection (a) in addition to the 
        initial contract.
  (d) Authorization of Appropriations.--There is authorized to 
be appropriated $10,000,000 for contracts under subsection (a), 
to remain available until expended.

SEC. 3004. PROCESS FOR ADOPTION OF ENDORSED RECOMMENDATIONS; ADOPTION 
                    OF INITIAL SET OF STANDARDS, IMPLEMENTATION 
                    SPECIFICATIONS, AND CERTIFICATION CRITERIA.

  (a) Process for Adoption of Endorsed Recommendations.--
          (1) Review of endorsed standards, implementation 
        specifications, and certification criteria.--Not later 
        than 90 days after the date of receipt of standards, 
        implementation specifications, or certification 
        criteria endorsed under section 3001(c) (or, subject to 
        subsection (c), in the case of a standard, 
        specification, or criterion recommended on or after the 
        date of the enactment of the 21st Century Cures Act, 
        after the date of submission of the recommendation to 
        the Secretary under section 3003A), the Secretary, in 
        consultation with representatives of other relevant 
        Federal agencies, shall jointly review such standards, 
        implementation specifications, or certification 
        criteria and shall determine whether or not to propose 
        adoption of such standards, implementation 
        specifications, or certification criteria.
          (2) Determination to adopt standards, implementation 
        specifications, and certification criteria.--If the 
        Secretary determines--
                  (A) to propose adoption of any grouping of 
                such standards, implementation specifications, 
                or certification criteria, the Secretary shall, 
                by regulation under section 553 of title 5, 
                United States Code, determine whether or not to 
                adopt such grouping of standards, 
                implementation specifications, or certification 
                criteria; or
                  (B) not to propose adoption of any grouping 
                of standards, implementation specifications, or 
                certification criteria, the Secretary shall 
                notify the National Coordinator [and the HIT 
                Standards Committee] in writing of such 
                determination and the reasons for not proposing 
                the adoption of such recommendation.
          (3) Publication.--The Secretary shall provide for 
        publication in the Federal Register of all 
        determinations made by the Secretary under paragraph 
        (1).
  (b) Adoption of Standards, Implementation Specifications, and 
Certification Criteria.--
          (1) In general.--Not later than December 31, 2009, 
        the Secretary shall, through the rulemaking process 
        consistent with subsection (a)(2)(A), adopt an initial 
        set of standards, implementation specifications, and 
        certification criteria for the areas required for 
        consideration under section 3002(b)(2)(B). The 
        rulemaking for the initial set of standards, 
        implementation specifications, and certification 
        criteria may be issued on an interim, final basis.
          (2) Application of current standards, implementation 
        specifications, and certification criteria.--The 
        standards, implementation specifications, and 
        certification criteria adopted before the date of the 
        enactment of this title through the process existing 
        through the Office of the National Coordinator for 
        Health Information Technology may be applied towards 
        meeting the requirement of paragraph (1).
          (3) Subsequent standards activity.--The Secretary 
        shall adopt additional standards, implementation 
        specifications, and certification criteria as necessary 
        and consistent with the schedule published under 
        section 3003(b)(2).
          (4) Limitation.--The Secretary may not adopt any 
        standards, implementation specifications, or 
        certification criteria under this subsection or 
        subsection (a) that are inconsistent with or 
        duplicative of an interoperability standard adopted 
        under this section, in accordance with subsections (c) 
        and (d). In the case of a standard, specification, or 
        criterion that has been adopted under this section and 
        is inconsistent or duplicative of such an 
        interoperability standard that is subsequently adopted 
        under this section, such interoperability standard 
        shall supercede such other standard, specification, or 
        criterion and such other standard, specification, or 
        criterion shall no longer be considered adopted under 
        this section beginning on the date that such 
        interoperability standard becomes effective.
  (c) Adoption of Initial Interoperability Standards.--
Notwithstanding the previous subsections of this section, the 
following shall apply in the case of the initial set of 
interoperability standards recommended under section 3003A:
          (1) Review of standards.--Not later than 90 days 
        after the date of receipt of recommendations for such 
        interoperability standards, the Secretary, in 
        consultation with the National Coordinator and 
        representatives of other relevant Federal agencies, 
        shall jointly review such standards and shall determine 
        whether or not to propose adoption of such standards.
          (2) Determination to adopt.--If the Secretary 
        determines--
                  (A) to propose adoption of such standards, 
                the Secretary shall, by regulation under 
                section 553 of title 5, United States Code, 
                determine whether or not to adopt such 
                standards; or
                  (B) not to propose adoption of such 
                standards, the Secretary shall notify the 
                applicable standards development organizations 
                with a contract under section 3003A in writing 
                of such determination and the reasons for not 
                proposing the adoption of the recommendation 
                for such standards.
          (3) Publication.--The Secretary shall provide for 
        publication in the Federal Register of all 
        determinations made by the Secretary under paragraph 
        (1).
          (4) Application.--Any standard adopted under this 
        subsection shall be effective 12 months after the date 
        of publication of the determination to adopt such 
        standard.
  (d) Rules for Adoption.--In the case of a standard (including 
interoperability standard), implementation specification, or 
certification criteria adopted under this section on or after 
the date of the enactment of the 21st Century Cures Act, the 
following shall apply:
          (1) In general.--Except as provided in paragraph (2), 
        any such standard (including interoperability 
        standard), implementation specification, or 
        certification criterion shall be a standard, 
        specification, or criterion that has been recommended 
        by the standards development organizations with which 
        the Secretary has entered into a contract under section 
        3003A.
          (2) Special rule if no standard, specification, or 
        criterion recommended.--If no standard is recommended 
        under paragraph (1)--
                  (A) in the case of interoperability 
                standards, relating to a category described in 
                section 3010(b)--
                          (i) paragraph (1) shall not apply; 
                        and
                          (ii) paragraph (4) shall apply; or
                  (B) in the case of any other standard, 
                implementation specification, or certification 
                criteria, relating to a policy or priority to 
                carry out this title, as determined by the 
                Secretary, in consultation with the National 
                Coordinator--
                          (i) paragraph (1) shall not apply; 
                        and
                          (ii) paragraph (4) shall apply.
          (3) Effective date.--Any standard, implementation 
        specification, or certification criterion adopted under 
        this section shall be effective 12 months after the 
        date of publication of the final rule to adopt such 
        standard, implementation specification, or 
        certification criterion.
          (4) Assistance to the secretary.--In complying with 
        the requirements of this subsection, the Secretary 
        shall rely on the recommendations of the National 
        Committee on Vital and Health Statistics established 
        under section 306(k), and shall consult with 
        appropriate Federal and State agencies and private 
        organizations. The Secretary shall publish in the 
        Federal Register any recommendation of the National 
        Committee on Vital and Health Statistics regarding the 
        adoption of a standard, implementation specification, 
        or certification criterion under this section. Any 
        standard, implementation specification, or 
        certification criterion adopted pursuant to this 
        paragraph shall be promulgated in accordance with the 
        rulemaking procedures of subchapter III of chapter 5 of 
        title 5, United States Code.

           *       *       *       *       *       *       *


SEC. 3006. VOLUNTARY APPLICATION AND USE OF ADOPTED STANDARDS AND 
                    IMPLEMENTATION SPECIFICATIONS BY PRIVATE ENTITIES.

  (a) In General.--Except as provided under section 13112 of 
the HITECH Act, nothing in such Act or in the amendments made 
by such Act shall be construed--
          (1) to require a private entity to adopt or comply 
        with a standard or implementation specification adopted 
        under section 3004, including an interoperability 
        standard adopted under such section; or
          (2) to provide a Federal agency authority, other than 
        the authority such agency may have under other 
        provisions of law, to require a private entity to 
        comply with such a standard or implementation 
        specification.
  (b) Rule of Construction.--Nothing in this subtitle shall be 
construed to require that a private entity that enters into a 
contract with the Federal Government apply or use the standards 
and implementation specifications adopted under section 3004, 
including the interoperability standards adopted under such 
section with respect to activities not related to the contract.

SEC. 3007. FEDERAL HEALTH INFORMATION TECHNOLOGY.

  (a) In General.--The National Coordinator shall support the 
development and routine updating of qualified electronic health 
record technology (as defined in section 3000) consistent with 
subsections (b) and (c) and make available such qualified 
electronic health record technology unless the Secretary 
determines through an assessment that the needs and demands of 
providers are being substantially and adequately met through 
the marketplace.
  (b) Certification.--In making such electronic health record 
technology publicly available, the National Coordinator shall 
ensure that the qualified electronic health record technology 
described in subsection (a) is certified under the program 
developed [under section 3001(c)(3) to be in compliance with 
applicable standards adopted under section 3003(a).] under 
section 3001(c)(3)--
          (1) for certifications made before January 1, 2018, 
        to be in compliance with applicable standards adopted 
        under subsections (a) and (b) of section 3004; and
          (2) for certifications made on or after January 1, 
        2018, to be in compliance with applicable standards 
        adopted under subsections (a) and (b) of section 3004 
        and to be interoperable in accordance with section 
        3010, including by being in compliance with 
        interoperability standards adopted under section 3004.
  (c) Authorization To Charge a Nominal Fee.--The National 
Coordinator may impose a nominal fee for the adoption by a 
health care provider of the health information technology 
system developed or approved under subsection (a) and (b). Such 
fee shall take into account the financial circumstances of 
smaller providers, low income providers, and providers located 
in rural or other medically underserved areas.
  (d) Rule of Construction.--Nothing in this section shall be 
construed to require that a private or government entity adopt 
or use the technology provided under this section.

           *       *       *       *       *       *       *


SEC. 3009. MISCELLANEOUS PROVISIONS.

  (a) Relation to HIPAA Privacy and Security Law.--
          (1) In general.--With respect to the relation of this 
        title to HIPAA privacy and security law:
                  (A) This title may not be construed as having 
                any effect on the authorities of the Secretary 
                under HIPAA privacy and security law.
                  (B) The purposes of this title include 
                ensuring that the health information technology 
                standards and implementation specifications 
                adopted under section 3004 take into account 
                the requirements of HIPAA privacy and security 
                law.
          (2) Definition.--For purposes of this section, the 
        term ``HIPAA privacy and security law'' means--
                  (A) the provisions of part C of title XI of 
                the Social Security Act, section 264 of the 
                Health Insurance Portability and Accountability 
                Act of 1996, and subtitle D of [title IV] title 
                XIII of the Health Information Technology for 
                Economic and Clinical Health Act; and
                  (B) regulations under such provisions.
  (b) Flexibility.--In administering the provisions of this 
title, the Secretary shall have flexibility in applying the 
definition of health care provider under section 3000(3), 
including the authority to omit certain entities listed in such 
definition when applying such definition under this title, 
where appropriate.

SEC. 3010. ENSURING INTEROPERABILITY OF HEALTH INFORMATION TECHNOLOGY.

  (a) Interoperability.--In order for health information 
technology to be considered interoperable, such technology must 
satisfy the following criteria:
          (1) Secure transfer.--The technology allows the 
        secure transfer of the entirety of a patient's data 
        from any and all health information technology for 
        authorized use under applicable law.
          (2) Complete access to health data.--The technology 
        allows access to the entirety of a patient's available 
        data for authorized use under applicable law without 
        special effort, as defined by recommendations for 
        interoperability standards adopted under section 3004, 
        by the requestor of such data unless such data is not 
        disclosable under applicable law.
          (3) No information blocking.--The technology is not 
        configured, set up, or implemented to engage in 
        information blocking, as defined in section 3010A(f).
  (b) Categories for Interoperability Standards.--The 
categories described in this subsection, with respect to 
standards for determining if health information technology is 
interoperable, consistent with the criteria described in 
subsection (a), include the following categories of standards:
          (1) Standards with respect to vocabulary and 
        terminology.
          (2) Standards with respect to content and structure.
          (3) Standards with respect to transport of 
        information.
          (4) Security standards.
          (5) Service standards.
  (c) Dissemination of Information.--
          (1) Initial summary report.--Not later than July 1, 
        2017, the Secretary, after consultation with relevant 
        stakeholders, shall submit to Congress and provide for 
        publication in the Federal Register and the posting on 
        the Internet website of the Office of the National 
        Coordinator for Health Information Technology of a 
        report on the following:
                  (A) The initial set of interoperability 
                standards adopted under section 3004(c).
                  (B) The strategies for achieving widespread 
                interoperability.
                  (C) An overview of the extent to which 
                electronic health records and health 
                information technology offered as of such date 
                satisfy such initial set.
                  (D) Any barriers that are preventing 
                widespread interoperability.
                  (E) The plan and milestones, including 
                specific steps, to achieve widespread 
                interoperability.
          (2) Followup determination and report on widespread 
        interoperability.--Not later than December 31, 2019, 
        the Secretary shall provide for publication in the 
        Federal Register and the posting on the Internet 
        website of the Office of the National Coordinator for 
        Health Information Technology of the following:
                  (A) A determination by the Secretary whether 
                the goal of widespread interoperability has 
                been achieved.
                  (B) A list identifying the vendors of, or 
                other entities offering, qualified electronic 
                health records, which categorizes such 
                entities, with respect to such records, as in 
                compliance or not in compliance with the 
                certification criteria described in section 
                3001(c)(5)(B)(ii) and with the requirements 
                under clause (i) of section 3001(c)(5)(C) 
                (including with the terms of the attestation 
                and other requirements under such clause).
                  (C) Actions that may be taken by entities 
                identified under subparagraph (B) as not being 
                in compliance with such criteria and 
                requirements in order for such entities to 
                become in compliance with such criteria and 
                requirements.
                  (D) Penalties described in section 3010A(d) 
                to which entities, with respect to such 
                qualified electronic health records, beginning 
                January 1, 2019, are subject if such technology 
                and entities are not in compliance with the 
                certification criteria described in section 
                3001(c)(5)(B)(ii) and with the requirements 
                under clause (i) of section 3001(c)(5)(C), 
                respectively.
          (3) Ongoing publication of recommendations.--The 
        Secretary shall provide for publication in the Federal 
        Register and the posting on the Internet website of the 
        Office of the National Coordinator for Health 
        Information Technology of all recommendations made 
        under this section.

SEC. 3010A. ENFORCEMENT MECHANISMS.

  (a) Inspector General Authority.--The Inspector General of 
the Department of Health and Human Services shall have the 
authority to investigate claims of--
          (1) vendors of, or other entities offering, qualified 
        electronic health records--
                  (A) being in violation of an attestation made 
                under section 3001(c)(5)(C)(i)(I), with respect 
                to the use of such records by a health care 
                provider under a specified meaningful use 
                incentive program; and
                  (B) having engaged in information blocking 
                (as defined in subsection (f)), unless for a 
                legitimate purpose specified by the Secretary, 
                with respect to the use of such records by a 
                health care provider under such a program;
          (2) health care providers, with respect to the use of 
        such records under a specified meaningful use incentive 
        program, having, unless for a legitimate purpose 
        specified by the Secretary, engaged in information 
        blocking (as so defined);
          (3) health information system providers described in 
        subsection (b) having engaged in information blocking 
        (as so defined), unless for a legitimate purpose 
        specified by the Secretary, with respect to the use of 
        such records under a specified meaningful use incentive 
        program; and
          (4) vendors of, or other entities offering, health 
        information technology (other than technology described 
        in paragraph (1)), health care providers, with respect 
        to the use of such technology, and health information 
        system providers, with respect to such technology, 
        unless for a legitimate purpose specified by the 
        Secretary, having engaged in information blocking (as 
        so defined).
  (b) Health Information System Providers.--The Inspector 
General of the Department of Health and Human Services shall, 
in coordination with the Federal Trade Commission, ensure that 
health information system providers (such as operators of 
health information exchanges and other systems that facilitate 
the exchange of information) investigate claims of information 
blocking, with respect to the use of such records under a 
specified meaningful use incentive program.
  (c) Information Sharing Provisions.--
          (1) In general.--The National Coordinator may serve 
        as a technical consultant to the Inspector General of 
        the Department of Health and Human Services and the 
        Federal Trade Commission for purposes of carrying out 
        this section. As such technical consultant, the 
        National Coordinator may, notwithstanding any other 
        provision of law, share information related to claims 
        or investigations under subsection (a) or (b) with the 
        Federal Trade Commission for purposes of such 
        investigations.
          (2) Protection from disclosure of information.--Any 
        information shared by the National Coordinator under 
        paragraph (1) shall not be subject to the provisions of 
        section 552 of title 5, United States Code (commonly 
        referred to as the Freedom of Information Act). Any 
        information acquired pursuant to paragraph (1) shall be 
        held in confidence and shall not be disclosed to any 
        person except as may be necessary to carry out the 
        purposes of subsection (a).
          (3) Non-application of paperwork reduction act.--
        Chapter 35 of title 44, United States Code (commonly 
        referred to as the Paperwork Reduction Act of 1995) 
        shall not apply to the National Coordinator or to the 
        Office of the National Coordinator for Health 
        Information Technology with respect to the collection 
        of complaints relating to claims described in 
        subsection (a).
  (d) Penalty.--Any person or entity determined to have 
committed an act described in paragraph (1), (2), or (3) of 
subsection (a), in connection with a specified meaningful use 
incentive program, shall be subject to a civil monetary penalty 
of not more than $10,000 for each such act. The provisions of 
section 1128A (other than subsections (a) and (b)) shall apply 
to a civil money penalty applied under this subsection in the 
same manner as they apply to a civil money penalty or 
proceeding under section 1128A(a).
  (e) Specified Meaningful Use Incentive Program.--For purposes 
of this section, the term ``specified meaningful use incentive 
program'' includes the following:
          (1) The incentive payments under subsection (o) of 
        section 1848 of the Social Security Act (42 U.S.C. 
        1395w-4) and adjustments under subsection (a)(7) of 
        such section.
          (2) The incentive payments under subsection (n) of 
        section 1848 of such Act (42 U.S.C. 1395ww) and 
        adjustments under subsection (b)(3)(B) of such section.
          (3) The incentive payments and adjustments made under 
        subsections (l) and (m) of section 1853 of such Act (42 
        U.S.C. 1395w-23).
          (4) The incentive payment under paragraph (3) of 
        section 1814(l) of such Act (42 U.S.C. 1395f(l)) and 
        adjustment under paragraph (4) of such section.
          (5) The shared savings program under section 1899 of 
        such Act (42 U.S.C. 1395jjj).
          (6) The payments to Medicaid providers described in 
        section 1903(t) of such Act (42 U.S.C. 1396b(t)).
  (f) Information Blocking.--
          (1) In general.--For purposes of this section and 
        section 3010, the term ``information blocking'' means, 
        with respect to the use of qualified electronic health 
        records or other health information technology under a 
        specified meaningful use incentive program, business, 
        technical, and organizational practices, including 
        practices described in paragraph (2), that--
                  (A) prevent or materially discourage the 
                exchange of electronic health information;
                  (B) the actor knows or should know (as 
                defined in section 1128A(i)(7) of the Social 
                Security Act) are likely to interfere with the 
                exchange or use of electronic health 
                information; and
                  (C) do not serve to protect patient safety, 
                maintain the privacy and security of 
                individuals' health information or promote 
                competition and consumer welfare.
          (2) Practices described.--For purposes of paragraph 
        (1), the practices described in this paragraph are the 
        following:
                  (A) Contract terms, policies, or other 
                business or organizational practices that 
                restrict individuals' access to their 
                electronic health information or restrict the 
                exchange or use of that information for 
                treatment and other permitted purposes.
                  (B) Charging prices or fees (such as for data 
                exchange, portability, and interfaces) that 
                make exchanging and using electronic health 
                information cost prohibitive.
                  (C) Developing or implementing health 
                information technology in nonstandard ways that 
                are likely to substantially increase the costs, 
                complexity, or burden of sharing electronic 
                health information, especially in cases in 
                which relevant interoperability standards or 
                methods to measure interoperability have been 
                adopted by the Secretary.
                  (D) Developing or implementing health 
                information technology in ways that are likely 
                to lock in users or electronic health 
                information, such as not allowing for the full 
                export of data; lead to fraud, waste, or abuse; 
                or impede innovations and advancements in 
                health information exchange and health 
                information technology-enabled care delivery.
  (g) Treatment of Vendors With Respect to Patient Safety 
Organizations.--In applying part C of title IX--
          (1) vendors shall be treated as a provider (as 
        defined in section 921) for purposes of reporting 
        requirements under such part, to the extent that such 
        reports are related to attestation requirements under 
        section 3001(c)(5)(C)(i)(I);
          (2) claims of information blocking described in 
        subsection (a) shall be treated as a patient safety 
        activity under such part for purposes of reporting 
        requirements under such part; and
          (3) health care providers that are not members of 
        patient safety organizations shall be treated in the 
        same manner as health care providers that are such 
        members for purposes of such reporting requirements 
        with respect to claims of information blocking 
        described in subsection (a).

           *       *       *       *       *       *       *

                              ----------                              


SECTION 202 OF THE DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND 
        EDUCATION, AND RELATED AGENCIES APPROPRIATIONS ACT, 1993

  Sec. 202. Appropriations in this or any other Act or 
subsequent Departments of Labor, Health and Human Services, and 
Education, and Related Agencies Appropriations Acts shall be 
available for expenses for active commissioned officers in the 
Public Health Service Reserve Corps and for commissioned 
officers in the Regular Corps; expenses incident to the 
dissemination of health information in foreign countries 
through exhibits and other appropriate means; advances of funds 
for compensation, travel, and subsistence expenses (or per diem 
in lieu thereof) for persons coming from abroad to participate 
in health or scientific activities of the Department pursuant 
to law; expenses of primary and secondary schooling of 
dependents in foreign countries, of Public Health Service 
commissioned officers stationed in foreign countries, at costs 
for any given area not in excess of those of the Department of 
Defense for the same area, when it is determined by the 
Secretary that the schools available in the locality are unable 
to provide adequately for the education of such dependents, and 
for the transportation of such dependents, between such schools 
and their places of residence when the schools are not 
accessible to such dependents by regular means of 
transportation; expenses for medical care for civilian and 
commissioned employees of the Public Health Service and their 
dependents assigned abroad on a permanent basis in accordance 
with such regulations as the Secretary may provide; rental or 
lease of living quarters (for periods not exceeding five 
years), and provision of heat, fuel, and light and maintenance, 
improvement, and repair of such quarters, and advance payments 
therefor, for civilian officers and employees of the Public 
Health Service who are United States citizens and who have a 
permanent station in a foreign country; purchase, erection, and 
maintenance of temporary or [portable structures; and for the 
payment of compensation to consultants or individual scientists 
appointed for limited periods of time pursuant to section 
207(f) or section 207(g) of the Public Health Service Act, at 
rates established by the Assistant Secretary for Health, or the 
Secretary where such action is required by statute, not to 
exceed the per diem rate equivalent to the maximum rate payable 
for senior-level positions under 5 U.S.C. 5376.] portable 
structures.
                              ----------                              


                      TITLE 44, UNITED STATES CODE



           *       *       *       *       *       *       *
         CHAPTER 35--COORDINATION OF FEDERAL INFORMATION POLICY

SUBCHAPTER I--FEDERAL INFORMATION POLICY

           *       *       *       *       *       *       *


Sec. 3518. Effect on existing laws and regulations

  (a) Except as otherwise provided in this subchapter, the 
authority of an agency under any other law to prescribe 
policies, rules, regulations, and procedures for Federal 
information resources management activities is subject to the 
authority of the Director under this subchapter.
  (b) Nothing in this subchapter shall be deemed to affect or 
reduce the authority of the Secretary of Commerce or the 
Director of the Office of Management and Budget pursuant to 
Reorganization Plan No. 1 of 1977 (as amended) and Executive 
order, relating to telecommunications and information policy, 
procurement and management of telecommunications and 
information systems, spectrum use, and related matters.
  (c)(1) Except as provided in paragraph (2), this subchapter 
shall not apply to the collection of information--
          (A) during the conduct of a Federal criminal 
        investigation or prosecution, or during the disposition 
        of a particular criminal matter;
          (B) during the conduct of--
                  (i) a civil action to which the United States 
                or any official or agency thereof is a party; 
                or
                  (ii) an administrative action or 
                investigation involving an agency against 
                specific individuals or entities;
          (C) by compulsory process pursuant to the Antitrust 
        Civil Process Act and section 13 of the Federal Trade 
        Commission Improvements Act of 1980[; or];
          (D) during the conduct of intelligence activities as 
        defined in section 3.4(e) of Executive Order No. 12333, 
        issued December 4, 1981, or successor orders, or during 
        the conduct of cryptologic activities that are 
        communications security activities[.]; or
          (E) during the conduct of research by the National 
        Institutes of Health.
  (2) This subchapter applies to the collection of information 
during the conduct of general investigations (other than 
information collected in an antitrust investigation to the 
extent provided in subparagraph (C) of paragraph (1)) 
undertaken with reference to a category of individuals or 
entities such as a class of licensees or an entire industry.
  (d) Nothing in this subchapter shall be interpreted as 
increasing or decreasing the authority conferred by sections 
11331 and 11332 of title 40 on the Secretary of Commerce or the 
Director of the Office of Management and Budget.
  (e) Nothing in this subchapter shall be interpreted as 
increasing or decreasing the authority of the President, the 
Office of Management and Budget or the Director thereof, under 
the laws of the United States, with respect to the substantive 
policies and programs of departments, agencies and offices, 
including the substantive authority of any Federal agency to 
enforce the civil rights laws.

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                              ----------                              


                  FEDERAL FOOD, DRUG, AND COSMETIC ACT



           *       *       *       *       *       *       *
                        CHAPTER II--DEFINITIONS

  Sec. 201. For the purposes of this Act--
  (a)(1) The term ``State'', except as used in the last 
sentence of section 702(a), means any State or Territory of the 
United States, the District of Columbia, and the Commonwealth 
of Puerto Rico.
  (2) The term ``Territory'' means any Territory or possession 
of the United States, including the District of Columbia, and 
excluding the Commonwealth of Puerto Rico and the Canal Zone.
  (b) The term ``interstate commerce'' means (1) commerce 
between any State or Territory and any place outside thereof, 
and (2) commerce within the District of Columbia or within any 
other Territory not organized with a legislative body.
  (c) The term ``Department'' means the Department of Health 
and Human Services.
  (d) The term ``Secretary'' means the Secretary of Health and 
Human Services.
  (e) The term ``person'' includes individual, partnership, 
corporation, and association.
  (f) The term ``food'' means (1) articles used for food or 
drink for man or other animals, (2) chewing gum, and (3) 
articles used for components of any such article.
  (g)(1) The term ``drug'' means (A) articles recognized in the 
official United States Pharmacopeia, official Homeopathic 
Pharmacopeia of the United States, or official National 
Formulary, or any supplement to any of them; and (B) articles 
intended for use in the diagnosis, cure, mitigation, treatment, 
or prevention of disease in man or other animals; and (C) 
articles (other than food) intended to affect the structure or 
any function of the body of man or other animals; and (D) 
articles intended for use as a component of any articles 
specified in clause (A), (B), or (C). A food or dietary 
supplement for which a claim, subject to sections 403(r)(1)(B) 
and 403(r)(3) or sections 403(r)(1)(B) and 403(r)(5)(D), is 
made in accordance with the requirements of section 403(r) is 
not a drug solely because the label or the labeling contains 
such a claim. A food, dietary ingredient, or dietary supplement 
for which a truthful and not misleading statement is made in 
accordance with section 403(r)(6) is not a drug under clause 
(C) solely because the label or the labeling contains such a 
statement.
  (2) The term ``counterfeit drug'' means a drug which, or the 
container or labeling of which, without authorization, bears 
the trademark, trade name, or other identifying mark, imprint, 
or device, or any likeness thereof, of a drug manufacturer, 
processor, packer, or distributor other than the person or 
persons who in fact manufactured, processed, packed, or 
distributed such drug and which thereby falsely purports or is 
represented to be the product of, or to have been packed or 
distributed by, such other drug manufacturer, processor, 
packer, or distributor.
  (h) The term ``device'' (except when used in paragraph (n) of 
this section and in sections 301(i), 403(f), 502(c), and 
602(c)) means an instrument, apparatus, implement, machine, 
contrivance, implant, in vitro reagent, or other similar or 
related article, including any component, part, or accessory, 
which is--
          (1) recognized in the official National Formulary, or 
        the United States Pharmacopeia, or any supplement to 
        them,
          (2) intended for use in the diagnosis of disease or 
        other conditions, or in the cure, mitigation, 
        treatment, or prevention of disease, in man or other 
        animals, [or]
          (3) intended to affect the structure or any function 
        of the body of man or other animals, [and] or
          (4) not health software (other than software 
        determined to be a risk to patient safety under section 
        524B(b)), and
which does not achieve its primary intended purposes through 
chemical action within or on the body of man or other animals 
and which is not dependent upon being metabolized for the 
achievement of its primary intended purposes.
  (i) The term ``cosmetic'' means (1) articles intended to be 
rubbed, poured, sprinkled, or sprayed on, introduced into, or 
otherwise applied to the human body or any part thereof for 
cleansing, beautifying, promoting attractiveness, or altering 
the appearance, and (2) articles intended for use as a 
component of any such articles; except that such term shall not 
include soap.
  (j) The term ``official compendium'' means the official 
United States Pharmacopeia, official Homeopathic Pharmacopeia 
of the United States, official National Formulary, or any 
supplement to any of them.
  (k) The term ``label'' means a display of written, printed, 
or graphic matter upon the immediate container of any article; 
and a requirement made by or under authority of this Act that 
any word, statement, or other information appear on the label 
shall not be considered to be complied with unless such word, 
statement, or other information also appears on the outside 
container or wrapper, if any there be, of the retail package of 
such article, or is easily legible through the outside 
container or wrapper.
  (l) The term ``immediate container'' does not include package 
liners.
  (m) The term ``labeling'' means all labels and other written, 
printed, or graphic matter (1) upon any article or any of its 
containers or wrappers, or (2) accompanying such article.
  (n) If an article is alleged to be misbranded because the 
labeling or advertising is misleading, then in determining 
whether the labeling or advertising is misleading there shall 
be taken into account (among other things) not only 
representations made or suggested by statement, word, design, 
device, or any combination thereof, but also the extent to 
which the labeling or advertising fails to reveal facts 
material in the light of such representations or material with 
respect to consequences which may result from the use of the 
article to which the labeling or advertising relates under the 
conditions of use prescribed in the labeling or advertising 
thereof or under such conditions of use as are customary or 
usual.
  (o) The representation of a drug, in its labeling, as an 
antiseptic shall be considered to be a representation that it 
is a germicide, except in the case of a drug purporting to be, 
or represented as, an antiseptic for inhibitory use as a wet 
dressing, ointment, dusting powder, or such other use as 
involves prolonged contact with the body.
  (p) The term ``new drug'' means--
          (1) Any drug (except a new animal drug or an animal 
        feed bearing or containing a new animal drug) the 
        composition of which is such that such drug is not 
        generally recognized, among experts qualified by 
        scientific training and experience to evaluate the 
        safety and effectiveness of drugs, as safe and 
        effective for use under the conditions prescribed, 
        recommended, or suggested in the labeling thereof, 
        except that such a drug not so recognized shall not be 
        deemed to be a ``new drug'' if at any time prior to the 
        enactment of this Act it was subject to the Food and 
        Drugs Act of June 30, 1906, as amended, and if at such 
        time its labeling contained the same representations 
        concerning the conditions of its use; or
          (2) Any drug (except a new animal drug or an animal 
        feed bearing or containing a new animal drug) the 
        composition of which is such that such drug, as a 
        result of investigations to determine its safety and 
        effectiveness for use under such conditions, has become 
        so recognized, but which has not, otherwise than in 
        such investigations, been used to a material extent or 
        for a material time under such conditions.
  (q)(1)(A) Except as provided in clause (B), the term 
``pesticide chemical'' means any substance that is a pesticide 
within the meaning of the Federal Insecticide, Fungicide, and 
Rodenticide Act, including all active and inert ingredients of 
such pesticide. Notwithstanding any other provision of law, the 
term ``pesticide'' within such meaning includes ethylene oxide 
and propylene oxide when such substances are applied on food.
  (B) In the case of the use, with respect to food, of a 
substance described in clause (A) to prevent, destroy, repel, 
or mitigate microorganisms (including bacteria, viruses, fungi, 
protozoa, algae, and slime), the following applies for purposes 
of clause (A):
          (i) The definition in such clause for the term 
        ``pesticide chemical'' does not include the substance 
        if the substance is applied for such use on food, or 
        the substance is included for such use in water that 
        comes into contact with the food, in the preparing, 
        packing, or holding of the food for commercial 
        purposes. The substance is not excluded under this 
        subclause from such definition if the substance is 
        ethylene oxide or propylene oxide, and is applied for 
        such use on food. The substance is not so excluded if 
        the substance is applied for such use on a raw 
        agricultural commodity, or the substance is included 
        for such use in water that comes into contact with the 
        commodity, as follows:
                  (I) The substance is applied in the field.
                  (II) The substance is applied at a treatment 
                facility where raw agricultural commodities are 
                the only food treated, and the treatment is in 
                a manner that does not change the status of the 
                food as a raw agricultural commodity (including 
                treatment through washing, waxing, fumigating, 
                and packing such commodities in such manner).
                  (III) The substance is applied during the 
                transportation of such commodity between the 
                field and such a treatment facility.
          (ii) The definition in such clause for the term 
        ``pesticide chemical'' does not include the substance 
        if the substance is a food contact substance as defined 
        in section 409(h)(6), and any of the following 
        circumstances exist: The substance is included for such 
        use in an object that has a food contact surface but is 
        not intended to have an ongoing effect on any portion 
        of the object; the substance is included for such use 
        in an object that has a food contact surface and is 
        intended to have an ongoing effect on a portion of the 
        object but not on the food contact surface; or the 
        substance is included for such use in or is applied for 
        such use on food packaging (without regard to whether 
        the substance is intended to have an ongoing effect on 
        any portion of the packaging). The food contact 
        substance is not excluded under this subclause from 
        such definition if any of the following circumstances 
        exist: The substance is applied for such use on a 
        semipermanent or permanent food contact surface (other 
        than being applied on food packaging); or the substance 
        is included for such use in an object that has a 
        semipermanent or permanent food contact surface (other 
        than being included in food packaging) and the 
        substance is intended to have an ongoing effect on the 
        food contact surface.
With respect to the definition of the term ``pesticide'' that 
is applicable to the Federal Insecticide, Fungicide, and 
Rodenticide Act, this clause does not exclude any substance 
from such definition.
  (2) The term ``pesticide chemical residue'' means a residue 
in or on raw agricultural commodity or processed food of--
          (A) a pesticide chemical; or
          (B) any other added substance that is present on or 
        in the commodity or food primarily as a result of the 
        metabolism or other degradation of a pesticide 
        chemical.
  (3) Notwithstanding subparagraphs (1) and (2), the 
Administrator may by regulation except a substance from the 
definition of ``pesticide chemical'' or ``pesticide chemical 
residue'' if--
          (A) its occurrence as a residue on or in a raw 
        agricultural commodity or processed food is 
        attributable primarily to natural causes or to human 
        activities not involving the use of any substances for 
        a pesticidal purpose in the production, storage, 
        processing, or transportation of any raw agricultural 
        commodity or processed food; and
          (B) the Administrator, after consultation with the 
        Secretary, determines that the substance more 
        appropriately should be regulated under one or more 
        provisions of this Act other than sections 402(a)(2)(B) 
        and 408.
  (r) The term ``raw agricultural commodity'' means any food in 
its raw or natural state, including all fruits that are washed, 
colored, or otherwise treated in their unpeeled natural form 
prior to marketing.
  (s) The term ``food additive'' means any substance the 
intended use of which results or may reasonably be expected to 
result, directly or indirectly, in its becoming a component or 
otherwise affecting the characteristics of any food (including 
any substance intended for use in producing, manufacturing, 
packing, processing, preparing, treating, packaging, 
transporting, or holding food; and including any source of 
radiation intended for any such use), if such substance is not 
generally recognized, among experts qualified by scientific 
training and experience to evaluate its safety, as having been 
adequately shown through scientific procedures (or, in the case 
of a substance used in food prior to January 1, 1958, through 
either scientific procedures or experience based on common use 
in food) to be safe under the conditions of its intended use; 
except that such term does not include--
          (1) a pesticide chemical residue in or on a raw 
        agricultural commodity or processed food; or
          (2) a pesticide chemical; or
          (3) a color additive; or
          (4) any substance used in accordance with a sanction 
        or approval granted prior to the enactment of this 
        paragraph pursuant to this Act, the Poultry Products 
        Inspection Act (21 U.S.C. 451 and the following) or the 
        Meat Inspection Act of March 4, 1907 (34 Stat. 1260), 
        as amended and extended (21 U.S.C. 71 and the 
        following);
          (5) a new animal drug; or
          (6) an ingredient described in paragraph (ff) in, or 
        intended for use in, a dietary supplement.
  (t)(1) The term ``color additive'' means a material which--
          (A) is a dye, pigment, or other substance made by a 
        process of synthesis or similar artifice, or extracted, 
        isolated, or otherwise derived, with or without 
        intermediate or final change of identity, from a 
        vegetable, animal, mineral, or other source, and
          (B) when added or applied to a food, drug, or 
        cosmetic, or to the human body or any part thereof, is 
        capable (alone or through reaction with other 
        substance) of imparting color thereto;
except that such term does not include any material which the 
Secretary, by regulation, determines is used (or intended to be 
used) solely for a purpose or purposes other than coloring.
  (2) The term ``color'' includes black, white, and 
intermediate grays.
  (3) Nothing in subparagraph (1) of this paragraph shall be 
construed to apply to any pesticide chemical, soil or plant 
nutrient, or other agricultural chemical solely because of its 
effect in aiding, retarding, or otherwise affecting, directly 
or indirectly, the growth or other natural physiological 
processes of produce of the soil and thereby affecting its 
color, whether before or after harvest.
  (u) The term ``safe,'' as used in paragraph (s) of this 
section and in sections 409, 512, 571, and 721, has reference 
to the health of man or animal.
  (v) The term ``new animal drug'' means any drug intended for 
use for animals other than man, including any drug intended for 
use in animal feed but not including such animal feed--
          (1) the composition of which is such that such drug 
        is not generally recognized, among experts qualified by 
        scientific training and experience to evaluate the 
        safety and effectiveness of animal drugs, as safe and 
        effective for use under the conditions prescribed, 
        recommended, or suggested in the labeling thereof; 
        except that such a drug not so recognized shall not be 
        deemed to be a ``new animal drug'' if at any time prior 
        to June 25, 1938, it was subject to the Food and Drug 
        Act of June 30, 1906, as amended, and if at such time 
        its labeling contained the same representations 
        concerning the conditions of its use; or
          (2) the composition of which is such that such drug, 
        as a result of investigations to determine its safety 
        and effectiveness for use under such conditions, has 
        become so recognized but which has not, otherwise than 
        in such investigations, been used to a material extent 
        or for a material time under such conditions.
Provided that any drug intended for minor use or use in a minor 
species that is not the subject of a final regulation published 
by the Secretary through notice and comment rulemaking finding 
that the criteria of paragraphs (1) and (2) have not been met 
(or that the exception to the criterion in paragraph (1) has 
been met) is a new animal drug.
  (w) The term ``animal feed'', as used in paragraph (w) of 
this section, in section 512, and in provisions of this Act 
referring to such paragraph or section, means an article which 
is intended for use for food for animals other than man and 
which is intended for use as a substantial source of nutrients 
in the diet of the animal, and is not limited to a mixture 
intended to be the sole ration of the animal.
  (x) The term ``informal hearing'' means a hearing which is 
not subject to section 554, 556, or 557 of title 5 of the 
United States Code and which provides for the following:
          (1) The presiding officer in the hearing shall be 
        designated by the Secretary from officers and employees 
        of the Department who have not participated in any 
        action of the Secretary which is the subject of the 
        hearing and who are not directly responsible to an 
        officer or employee of the Department who has 
        participated in any such action.
          (2) Each party to the hearing shall have the right at 
        all times to be advised and accompanied by an attorney.
          (3) Before the hearing, each party to the hearing 
        shall be given reasonable notice of the matters to be 
        considered at the hearing, including a comprehensive 
        statement of the basis for the action taken or proposed 
        by the Secretary which is the subject of the hearing 
        and a general summary of the information which will be 
        presented by the Secretary at the hearing in support of 
        such action.
          (4) At the hearing the parties to the hearing shall 
        have the right to hear a full and complete statement of 
        the action of the Secretary which is the subject of the 
        hearing together with the information and reasons 
        supporting such action, to conduct reasonable 
        questioning, and to present any oral or written 
        information relevant to such action.
          (5) The presiding officer in such hearing shall 
        prepare a written report of the hearing to which shall 
        be attached all written material presented at the 
        hearing. The participants in the hearing shall be given 
        the opportunity to review and correct or supplement the 
        presiding officer's report of the hearing.
          (6) The Secretary may require the hearing to be 
        transcribed. A party to the hearing shall have the 
        right to have the hearing transcribed at his expense. 
        Any transcription of a hearing shall be included in the 
        presiding officer's report of the hearing.
  (y) The term ``saccharin'' includes calcium saccharin, sodium 
saccharin, and ammonium saccharin.
  (z) The term ``infant formula'' means a food which purports 
to be or is represented for special dietary use solely as a 
food for infants by reason of its simulation of human milk or 
its suitability as a complete or partial substitute for human 
milk.
  (aa) The term ``abbreviated drug application'' means an 
application submitted under section 505(j) for the approval of 
a drug that relies on the approved application of another drug 
with the same active ingredient to establish safety and 
efficacy, and--
          (1) in the case of section 306, includes a supplement 
        to such an application for a different or additional 
        use of the drug but does not include a supplement to 
        such an application for other than a different or 
        additional use of the drug, and
          (2) in the case of sections 307 and 308, includes any 
        supplement to such an application.
  (bb) The term ``knowingly'' or ``knew'' means that a person, 
with respect to information--
          (1) has actual knowledge of the information, or
          (2) acts in deliberate ignorance or reckless 
        disregard of the truth or falsity of the information.
  (cc) For purposes of section 306, the term ``high managerial 
agent''--
          (1) means--
                  (A) an officer or director of a corporation 
                or an association,
                  (B) a partner of a partnership, or
                  (C) any employee or other agent of a 
                corporation, association, or partnership,
        having duties such that the conduct of such officer, 
        director, partner, employee, or agent may fairly be 
        assumed to represent the policy of the corporation, 
        association, or partnership, and
          (2) includes persons having management responsibility 
        for--
                  (A) submissions to the Food and Drug 
                Administration regarding the development or 
                approval of any drug product,
                  (B) production, quality assurance, or quality 
                control of any drug product, or
                  (C) research and development of any drug 
                product.
  (dd) For purposes of sections 306 and 307, the term ``drug 
product'' means a drug subject to regulation under section 505, 
512, or 802 of this Act or under section 351 of the Public 
Health Service Act.
  (ee) The term ``Commissioner'' means the Commissioner of Food 
and Drugs.
  (ff) The term ``dietary supplement''--
          (1) means a product (other than tobacco) intended to 
        supplement the diet that bears or contains one or more 
        of the following dietary ingredients:
                  (A) a vitamin;
                  (B) a mineral;
                  (C) an herb or other botanical;
                  (D) an amino acid;
                  (E) a dietary substance for use by man to 
                supplement the diet by increasing the total 
                dietary intake; or
                  (F) a concentrate, metabolite, constituent, 
                extract, or combination of any ingredient 
                described in clause (A), (B), (C), (D), or (E);
          (2) means a product that--
                  (A)(i) is intended for ingestion in a form 
                described in section 411(c)(1)(B)(i); or
                  (ii) complies with section 411(c)(1)(B)(ii);
                  (B) is not represented for use as a 
                conventional food or as a sole item of a meal 
                or the diet; and
                  (C) is labeled as a dietary supplement; and
          (3) does--
                  (A) include an article that is approved as a 
                new drug under section 505 or licensed as a 
                biologic under section 351 of the Public Health 
                Service Act (42 U.S.C. 262) and was, prior to 
                such approval, certification, or license, 
                marketed as a dietary supplement or as a food 
                unless the Secretary has issued a regulation, 
                after notice and comment, finding that the 
                article, when used as or in a dietary 
                supplement under the conditions of use and 
                dosages set forth in the labeling for such 
                dietary supplement, is unlawful under section 
                402(f); and
                  (B) not include--
                          (i) an article that is approved as a 
                        new drug under section 505, certified 
                        as an antibiotic under section 507, or 
                        licensed as a biologic under section 
                        351 of the Public Health Service Act 
                        (42 U.S.C. 262), or
                          (ii) an article authorized for 
                        investigation as a new drug, 
                        antibiotic, or biological for which 
                        substantial clinical investigations 
                        have been instituted and for which the 
                        existence of such investigations has 
                        been made public,
        which was not before such approval, certification, 
        licensing, or authorization marketed as a dietary 
        supplement or as a food unless the Secretary, in the 
        Secretary's discretion, has issued a regulation, after 
        notice and comment, finding that the article would be 
        lawful under this Act.
Except for purposes of sections 201(g) and 417, a dietary 
supplement shall be deemed to be a food within the meaning of 
this Act.
  (gg) The term ``processed food'' means any food other than a 
raw agricultural commodity and includes any raw agricultural 
commodity that has been subject to processing, such as canning, 
cooking, freezing, dehydration, or milling.
  (hh) The term ``Administrator'' means the Administrator of 
the United States Environmental Protection Agency.
  (ii) The term ``compounded positron emission tomography 
drug''--
          (1) means a drug that--
                  (A) exhibits spontaneous disintegration of 
                unstable nuclei by the emission of positrons 
                and is used for the purpose of providing dual 
                photon positron emission tomographic diagnostic 
                images; and
                  (B) has been compounded by or on the order of 
                a practitioner who is licensed by a State to 
                compound or order compounding for a drug 
                described in subparagraph (A), and is 
                compounded in accordance with that State's law, 
                for a patient or for research, teaching, or 
                quality control; and
          (2) includes any nonradioactive reagent, reagent kit, 
        ingredient, nuclide generator, accelerator, target 
        material, electronic synthesizer, or other apparatus or 
        computer program to be used in the preparation of such 
        a drug.
  (jj) The term ``antibiotic drug'' means any drug (except 
drugs for use in animals other than humans) composed wholly or 
partly of any kind of penicillin, streptomycin, 
chlortetracycline, chloramphenicol, bacitracin, or any other 
drug intended for human use containing any quantity of any 
chemical substance which is produced by a micro-organism and 
which has the capacity to inhibit or destroy micro-organisms in 
dilute solution (including a chemically synthesized equivalent 
of any such substance) or any derivative thereof.
          (kk) Priority supplement.--The term ``priority 
        supplement'' means a drug application referred to in 
        section 101(4) of the Food and Drug Administration 
        Modernization Act of 1997 (111 Stat. 2298).
  (ll)(1) The term ``single-use device'' means a device that is 
intended for one use, or on a single patient during a single 
procedure.
  (2)(A) The term ``reprocessed'', with respect to a single-use 
device, means an original device that has previously been used 
on a patient and has been subjected to additional processing 
and manufacturing for the purpose of an additional single use 
on a patient. The subsequent processing and manufacture of a 
reprocessed single-use device shall result in a device that is 
reprocessed within the meaning of this definition.
  (B) A single-use device that meets the definition under 
clause (A) shall be considered a reprocessed device without 
regard to any description of the device used by the 
manufacturer of the device or other persons, including a 
description that uses the term ``recycled'' rather than the 
term ``reprocessed''.
  (3) The term ``original device'' means a new, unused single-
use device.
  (mm)(1) The term ``critical reprocessed single-use device'' 
means a reprocessed single-use device that is intended to 
contact normally sterile tissue or body spaces during use.
  (2) The term ``semi-critical reprocessed single-use device'' 
means a reprocessed single-use device that is intended to 
contact intact mucous membranes and not penetrate normally 
sterile areas of the body.
  (nn) The term ``major species'' means cattle, horses, swine, 
chickens, turkeys, dogs, and cats, except that the Secretary 
may add species to this definition by regulation.
  (oo) The term ``minor species'' means animals other than 
humans that are not major species.
  (pp) The term ``minor use'' means the intended use of a drug 
in a major species for an indication that occurs infrequently 
and in only a small number of animals or in limited 
geographical areas and in only a small number of animals 
annually.
  (qq) The term ``major food allergen'' means any of the 
following:
          (1) Milk, egg, fish (e.g., bass, flounder, or cod), 
        Crustacean shellfish (e.g., crab, lobster, or shrimp), 
        tree nuts (e.g., almonds, pecans, or walnuts), wheat, 
        peanuts, and soybeans.
          (2) A food ingredient that contains protein derived 
        from a food specified in paragraph (1), except the 
        following:
                  (A) Any highly refined oil derived from a 
                food specified in paragraph (1) and any 
                ingredient derived from such highly refined 
                oil.
                  (B) A food ingredient that is exempt under 
                paragraph (6) or (7) of section 403(w).
  (rr)(1) The term ``tobacco product'' means any product made 
or derived from tobacco that is intended for human consumption, 
including any component, part, or accessory of a tobacco 
product (except for raw materials other than tobacco used in 
manufacturing a component, part, or accessory of a tobacco 
product).
  (2) The term ``tobacco product'' does not mean an article 
that is a drug under subsection (g)(1), a device under 
subsection (h), or a combination product described in section 
503(g).
  (3) The products described in paragraph (2) shall be subject 
to chapter V of this Act.
  (4) A tobacco product shall not be marketed in combination 
with any other article or product regulated under this Act 
(including a drug, biologic, food, cosmetic, medical device, or 
a dietary supplement).
  (ss)(1) The term ``health software'' means software that does 
not, through use of an in vitro diagnostic device or signal 
acquisition system, acquire, process, or analyze an image or 
physiological signal, is not an accessory, is not an integral 
part of a device necessary to support the use of the device, is 
not used in the manufacture and transfusion of blood and blood 
components to assist in the prevention of disease in humans, 
and--
          (A) is intended for use for administrative or 
        operational support or the processing and maintenance 
        of financial records;
          (B) is intended for use in clinical, laboratory, or 
        administrative workflow and related recordkeeping;
          (C)(i) is intended for use solely in the transfer, 
        aggregation, conversion (in accordance with a present 
        specification), storage, management, retrieval, or 
        transmission of data or information;
          (ii) utilizes a connectivity software platform, 
        electronic or electrical hardware, or a physical 
        communications infrastructure; and
          (iii) is not intended for use--
                  (I) in active patient monitoring; or
                  (II) in controlling or altering the functions 
                or parameters of a device that is connected to 
                such software;
          (D) is intended for use to organize and present 
        information for health or wellness education or for use 
        in maintaining a healthy lifestyle, including 
        medication adherence and health management tools;
          (E) is intended for use to analyze information to 
        provide general health information that does not 
        include patient-specific recommended options to 
        consider in the prevention, diagnosis, treatment, cure, 
        or mitigation of a particular disease or condition; or
          (F) is intended for use to analyze information to 
        provide patient-specific recommended options to 
        consider in the prevention, diagnosis, treatment, cure, 
        or mitigation of a particular disease or condition.
  (2) The term ``accessory'' means a product that--
          (A) is intended for use with one or more parent 
        devices;
          (B) is intended to support, supplement, or augment 
        the performance of one or more parent devices; and
          (C) shall be classified by the Secretary--
                  (i) according to its intended use; and
                  (ii) independently of any classification of 
                any parent device with which it is used.

           *       *       *       *       *       *       *


                      CHAPTER V--DRUGS AND DEVICES

Subchapter A--Drugs and Devices

           *       *       *       *       *       *       *


                      misbranded drugs and devices

  Sec. 502. A drug or device shall be deemed to be misbranded--
  [(a) If its] (a)(1) If its labeling is false or misleading in 
any particular. Health care economic information provided to [a 
formulary committee, or other similar entity, in the course of 
the committee or the entity carrying out its responsibilities 
for the selection of drugs for managed care or other similar 
organizations] a payor, formulary committee, or other similar 
entity with knowledge and expertise in the area of health care 
economic analysis, carrying out its responsibilities for the 
selection of drugs for coverage or reimbursement, shall not be 
considered to be false or misleading under this paragraph if 
the health care economic information [directly relates] relates 
to an indication approved under section 505 or under section 
351(a) of the Public Health Service Act for such drug [and is 
based on competent and reliable scientific evidence. The 
requirements set forth in section 505(a) or in section 351(a) 
of the Public Health Service Act shall not apply to health care 
economic information provided to such a committee or entity in 
accordance with this paragraph], is based on competent and 
reliable scientific evidence, and includes, where applicable, a 
conspicuous and prominent statement describing any material 
differences between the health care economic information and 
the labeling approved for the drug under section 505 or under 
section 351 of the Public Health Service Act. The requirements 
set forth in section 505(a) or in subsections (a) and (k) of 
section 351 of the Public Health Service Act shall not apply to 
health care economic information provided to such a payor, 
committee, or entity in accordance with this paragraph. 
Information that is relevant to the substantiation of the 
health care economic information presented pursuant to this 
paragraph shall be made available to the Secretary upon 
request. [In this paragraph, the term ``health care economic 
information'' means any analysis that identifies, measures, or 
compares the economic consequences, including the costs of the 
represented health outcomes, of the use of a drug to the use of 
another drug, to another health care intervention, or to no 
intervention.]
  (2)(A) For purposes of this paragraph, the term ``health care 
economic information'' means any analysis (including the 
clinical data, inputs, clinical or other assumptions, methods, 
results, and other components underlying or comprising the 
analysis) that identifies, measures, or describes the economic 
consequences, which may be based on the separate or aggregated 
clinical consequences of the represented health outcomes, of 
the use of a drug. Such analysis may be comparative to the use 
of another drug, to another health care intervention, or to no 
intervention.
  (B) Such term does not include any analysis that relates only 
to an indication that is not approved under section 505 or 
under section 351 of the Public Health Service Act for such 
drug.
  (b) If in a package form unless it bears a label containing 
(1) the name and place of business of the manufacturer, packer, 
or distributor; and (2) an accurate statement of the quantity 
of the contents in terms of weight, measure, or numerical 
count: Provided, That under clause (2) of this paragraph 
reasonable variations shall be permitted, and exemptions as to 
small packages shall be established, by regulations prescribed 
by the Secretary.
  (c) If any word, statement, or other information required by 
or under authority of this Act to appear on the label or 
labeling is not prominently placed thereon with such 
conspicuousness (as compared with other words, statements, 
designs, or devices, in the labeling) and in such terms as to 
render it likely to be read and understood by the ordinary 
individual under customary conditions of purchase and use.
  (e)(1)(A) If it is a drug, unless its label bears, to the 
exclusion of any other nonproprietary name (except the 
applicable systematic chemical name or the chemical formula)--
          (i) the established name (as defined in subparagraph 
        (3)) of the drug, if there is such a name;
          (ii) the established name and quantity or, if 
        determined to be appropriate by the Secretary, the 
        proportion of each active ingredient, including the 
        quantity, kind, and proportion of any alcohol, and also 
        including whether active or not the established name 
        and quantity or if determined to be appropriate by the 
        Secretary, the proportion of any bromides, ether, 
        chloroform, acetanilide, acetophenetidin, amidopyrine, 
        antipyrine, atropine, hyoscine, hyoscyamine, arsenic, 
        digitalis, digitalis glucosides, mercury, ouabain, 
        strophanthin, strychnine, thyroid, or any derivative or 
        preparation of any such substances, contained therein, 
        except that the requirement for stating the quantity of 
        the active ingredients, other than the quantity of 
        those specifically named in this subclause, shall not 
        apply to nonprescription drugs not intended for human 
        use; and
          (iii) the established name of each inactive 
        ingredient listed in alphabetical order on the outside 
        container of the retail package and, if determined to 
        be appropriate by the Secretary, on the immediate 
        container, as prescribed in regulation promulgated by 
        the Secretary, except that nothing in this subclause 
        shall be deemed to require that any trade secret be 
        divulged, and except that the requirements of this 
        subclause with respect to alphabetical order shall 
        apply only to nonprescription drugs that are not also 
        cosmetics and that this subclause shall not apply to 
        nonprescription drugs not intended for human use.
  (B) For any prescription drug the established name of such 
drug or ingredient, as the case may be, on such label (and on 
any labeling on which a name for such drug or ingredient is 
used) shall be printed prominently and in type at least half as 
large as that used thereon for any proprietary name or 
designation for such drug or ingredient, except that to the 
extent that compliance with the requirements of subclause (ii) 
or (iii) of clause (A) or this clause is impracticable, 
exemptions shall be established by regulations promulgated by 
the Secretary.
  (2) If it is a device and it has an established name, unless 
its label bears, to the exclusion of any other nonproprietary 
name, its established name (as defined in subparagraph (4)) 
prominently printed in type at least half as large as that used 
thereon for any proprietary name or designation for such 
device, except that to the extent compliance with the 
requirements of this subparagraph is impracticable, exemptions 
shall be established by regulations promulgated by the 
Secretary.
  (3) As used in subparagraph (1), the term ``established 
name'', with respect to a drug or ingredient thereof, means (A) 
the applicable official name designated pursuant to section 
508, or (B) if there is no such name and such drug, or such 
ingredient, is an article recognized in an official compendium, 
then the official title thereof in such compendium, or (C) if 
neither clause (A) nor clause (B) of this subparagraph applies, 
then the common or usual name, if any, of such drug or of such 
ingredient, except that where clause (B) of this subparagraph 
applies to an article recognized in the United States 
Pharmacopeia and in the Homeopathic Pharmacopeia under 
different official titles, the official title used in the 
United States Pharmacopeia shall apply unless it is labeled and 
offered for sale as a homeopathic drug, in which case the 
official title used in the Homeopathic Pharmacopeia shall 
apply.
  (4) As used in subparagraph (2), the term ``established 
name'' with respect to a device means (A) the applicable 
official name of the device designated pursuant to section 508, 
(B) if there is no such name and such device is an article 
recognized in an official compendium, then the official title 
thereof in such compendium, or (C) if neither clause (A) nor 
clause (B) of this subparagraph applies, then any common or 
usual name of such device.
  (f) Unless its labeling bears (1) adequate directions for 
use; and (2) such adequate warnings against use in those 
pathological conditions or by children where its use may be 
dangerous to health, or against unsafe dosage or methods or 
duration of administration or application, in such manner and 
form, as are necessary for the protection of users, except that 
where any requirement of clause (1) of this paragraph, as 
applied to any drug or device, is not necessary for the 
protection of the public health, the Secretary shall promulgate 
regulations exempting such drug or device from such 
requirement. Required labeling for prescription devices 
intended for use in health care facilities or by a health care 
professional and required labeling for in vitro diagnostic 
devices intended for use by health care professionals or in 
blood establishments may be made available solely by electronic 
means, provided that the labeling complies with all applicable 
requirements of law, and that the manufacturer affords such 
users the opportunity to request the labeling in paper form, 
and after such request, promptly provides the requested 
information without additional cost.
  (g) If it purports to be a drug the name of which is 
recognized in an official compendium, unless it is packaged and 
labeled as prescribed therein. The method of packing may be 
modified with the consent of the Secretary. Whenever a drug is 
recognized in both the United States Pharmacopeia and the 
Homeopathic Pharmacopeia of the United States, it shall be 
subject to the requirements of the United States Pharmacopeia 
with respect to packaging, and labeling unless it is labeled 
and offered for sale as a homeopathic drug, in which case it 
shall be subject to the provisions of the Homeopathic 
Pharmacopeia of the United States, and not to those of the 
United States Pharmacopeia, except that in the event of 
inconsistency between the requirements of this paragraph and 
those of paragraph (e) as to the name by which the drug or its 
ingredients shall be designated, the requirements of paragraph 
(e) shall prevail.
  (h) If it has been found by the Secretary to be a drug liable 
to deterioration, unless it is packaged in such form and 
manner, and its label bears a statement of such precautions, as 
the Secretary shall by regulations require as necessary for the 
protection of the public health. No such regulation shall be 
established for any drug recognized in an official compendium 
until the Secretary shall have informed the appropriate body 
charged with the revision of such compendium of the need for 
such packaging or labeling requirements and such body shall 
have failed within a reasonable time to prescribe such 
requirements.
  (i)(1) If it is a drug and its container is so made, formed, 
or filled as to be misleading; or (2) if it is an imitation of 
another drug; or (3) if it is offered for sale under the name 
of another drug.
  (j) If it is dangerous to health when used in the dosage or 
manner; or with the frequency or duration prescribed, 
recommended, or suggested in the labeling thereof.
  (m) If it is a color additive the intended use of which is 
for the purpose of coloring only, unless its packaging and 
labeling are in conformity with such packaging and labeling 
requirements applicable to such color additive, as may be 
contained in regulations issued under section 721.
  (n) In the case of any prescription drug distributed or 
offered for sale in any State, unless the manufacturer, packer, 
or distributor thereof includes in all advertisements and other 
descriptive printed matter issued or caused to be issued by the 
manufacturer, packer, or distributor with respect to that drug 
a true statement of (1) the established name as defined in 
section 502(e), printed prominently and in type at least half 
as large as that used for any trade or brand name thereof, (2) 
the formula showing quantitatively each ingredient of such drug 
to the extent required for labels under section 502(e), and (3) 
such other information in brie