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115th Congress   }                                     {        Report
                        HOUSE OF REPRESENTATIVES
 1st Session     }                                     {       115-201

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



 
                    FDA REAUTHORIZATION ACT OF 2017

                                _______
                                

 July 11, 2017.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

                                _______
                                

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

                              R E P O R T

                        [To accompany H.R. 2430]

    The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 2430) to amend the Federal Food, Drug, and 
Cosmetic Act to revise and extend the user-fee programs for 
prescription drugs, medical devices, generic drugs, and 
biosimilar biological products, 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..............................................    36
Background and Need for Legislation..............................    37
Hearings.........................................................    37
Committee Consideration..........................................    38
Committee Votes..................................................    39
Committee Oversight Findings.....................................    41
Statement of General Performance Goals and Objectives............    41
New Budget Authority, Entitlement Authority, and Tax Expenditures    41
Earmark, Limited Tax Benefits, and Limited Tariff Benefits.......    41
Committee Cost Estimate..........................................    41
Congressional Budget Office Estimate.............................    41
Federal Mandates Statement.......................................    41
Duplication of Federal Programs..................................    41
Disclosure of Directed Rule Makings..............................    41
Advisory Committee Statement.....................................    42
Applicability to Legislative Branch..............................    42
Section-by-Section Analysis of the Legislation...................    42
Changes in Existing Law Made by the Bill, as Reported............    50

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

SECTION 1. SHORT TITLE.

  This Act may be cited as the ``FDA Reauthorization Act of 2017''.

SEC. 2. TABLE OF CONTENTS.

  The table of contents for this Act is as follows:

Sec. 1. Short title.
Sec. 2. Table of contents.

                    TITLE I--FEES RELATING TO DRUGS

Sec. 101. Short title; finding.
Sec. 102. Authority to assess and use drug fees.
Sec. 103. Reauthorization; reporting requirements.
Sec. 104. Sunset dates.
Sec. 105. Effective date.
Sec. 106. Savings clause.

                   TITLE II--FEES RELATING TO DEVICES

Sec. 201. Short title; findings.
Sec. 202. Definitions.
Sec. 203. Authority to assess and use device fees.
Sec. 204. Reauthorization; reporting requirements.
Sec. 205. Conformity assessment pilot program.
Sec. 206. Reauthorization of review.
Sec. 207. Electronic format for submissions.
Sec. 208. Savings clause.
Sec. 209. Effective date.
Sec. 210. Sunset clause.

               TITLE III--FEES RELATING TO GENERIC DRUGS

Sec. 301. Short title; finding.
Sec. 302. Definitions.
Sec. 303. Authority to assess and use human generic drug fees.
Sec. 304. Reauthorization; reporting requirements.
Sec. 305. Sunset dates.
Sec. 306. Effective date.
Sec. 307. Savings clause.

       TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS

Sec. 401. Short title; finding.
Sec. 402. Definitions.
Sec. 403. Authority to assess and use biosimilar fees.
Sec. 404. Reauthorization; reporting requirements.
Sec. 405. Sunset dates.
Sec. 406. Effective date.
Sec. 407. Savings clause.

      TITLE V--REAUTHORIZATIONS AND IMPROVEMENTS RELATED TO DRUGS

Sec. 501. Reauthorization of provision relating to exclusivity of 
certain drugs containing single enantiomers.
Sec. 502. Reauthorization of orphan grants program.
Sec. 503. Reauthorization of pediatric study of drugs.
Sec. 504. Protecting and strengthening the drug supply chain.
Sec. 505. Sense of Congress on lowering the cost of prescription drugs.

        TITLE VI--DEVICE INSPECTION AND REGULATORY IMPROVEMENTS

      Subtitle A--Improving the Process for Inspections of Device 
                             Establishments

Sec. 601. Risk-based inspections for devices.
Sec. 602. Recognition of foreign government inspections.
Sec. 603. Improvements to inspections process for device 
establishments.
Sec. 604. Certificates to foreign governments for devices.
Sec. 605. Facilitating international harmonization.
Sec. 606. Reauthorization of inspection program.

                      Subtitle B--Other Provisions

Sec. 611. Reauthorization of pediatric humanitarian device exceptions.
Sec. 612. Reauthorization of pediatric device consortia.
Sec. 613. Regulation of over-the-counter hearing aids.
Sec. 614. Report on ensuring quality, safety, and continued 
effectiveness of devices that have been serviced.
Sec. 615. Device pilot projects to generate reliable and timely safety 
and active surveillance data.
Sec. 616. Risk-based classification of accessories.

             TITLE VII--GENERIC DRUG ACCESS AND COMPETITION

Sec. 701. Competitive Generic Therapies.
Sec. 702. Enhancing regulatory transparency To enhance generic 
competition.
Sec. 703. Incentivizing competitive generic therapy development.
Sec. 704. Tropical disease product application.
Sec. 705. GAO study of issues regarding first cycle approvals of 
generic medicines.

          TITLE VIII--FOSTERING INNOVATION IN MEDICAL IMAGING

Sec. 801. Approval of applications for certain diagnostic medical 
imaging devices.
Sec. 802. Applications for approval of contrast agents intended for use 
with certain diagnostic medical imaging devices.

                    TITLE IX--ADDITIONAL PROVISIONS

Sec. 901. Technical corrections.
Sec. 902. Reauthorization of the critical path public-private 
partnerships.

                    TITLE I--FEES RELATING TO DRUGS

SEC. 101. SHORT TITLE; FINDING.

  (a) Short Title.--This title may be cited as the ``Prescription Drug 
User Fee Amendments of 2017''.
  (b) Finding.--The Congress finds that the fees authorized by the 
amendments made in this title will be dedicated toward expediting the 
drug development process and the process for the review of human drug 
applications, including postmarket drug safety activities, as set forth 
in the goals identified for purposes of part 2 of subchapter C of 
chapter VII of the Federal Food, Drug, and Cosmetic Act, in the letters 
from the Secretary of Health and Human Services to the Chairman of the 
Committee on Health, Education, Labor, and Pensions of the Senate and 
the Chairman of the Committee on Energy and Commerce of the House of 
Representatives, as set forth in the Congressional Record.

SEC. 102. AUTHORITY TO ASSESS AND USE DRUG FEES.

  (a) Types of Fees.--
          (1) In general.--Section 736(a) of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 379h(a)) is amended--
                  (A) in the matter preceding paragraph (1), by 
                striking ``fiscal year 2013'' and inserting ``fiscal 
                year 2018'';
                  (B) in the heading of paragraph (1), by striking 
                ``and supplement'';
                  (C) in paragraph (1), by striking ``or a supplement'' 
                and ``or supplement'' each place either appears;
                  (D) in paragraph (1)(A)--
                          (i) in clause (i), by striking ``(c)(4)'' and 
                        inserting ``(c)(5)''; and
                          (ii) in clause (ii), by striking ``A fee 
                        established'' and all that follows through 
                        ``are required.'' and inserting the following: 
                        ``A fee established under subsection (c)(5) for 
                        a human drug application for which clinical 
                        data (other than bioavailability or 
                        bioequivalence studies) with respect to safety 
                        or effectiveness are not required for 
                        approval.'';
                  (E) in the heading of paragraph (1)(C), by striking 
                ``or supplement'';
                  (F) in paragraph (1)(F)--
                          (i) in the heading, by striking ``or 
                        indication''; and
                          (ii) by striking the second sentence;
                  (G) by striking paragraph (2) (relating to a 
                prescription drug establishment fee);
                  (H) by redesignating paragraph (3) as paragraph (2);
                  (I) in the heading of paragraph (2), as so 
                redesignated, by striking ``Prescription drug product 
                fee'' and inserting ``Prescription drug program fee'';
                  (J) in subparagraph (A) of such paragraph (2), by 
                amending the first sentence to read as follows: 
                ``Except as provided in subparagraphs (B) and (C), each 
                person who is named as the applicant in a human drug 
                application, and who, after September 1, 1992, had 
                pending before the Secretary a human drug application 
                or supplement, shall pay the annual prescription drug 
                program fee established for a fiscal year under 
                subsection (c)(5) for each prescription drug product 
                that is identified in such a human drug application 
                approved as of October 1 of such fiscal year.'';
                  (K) in subparagraph (B) of such paragraph (2)--
                          (i) in the heading of subparagraph (B), by 
                        inserting after ``Exception'' the following: 
                        ``for certain prescription drug products''; and
                          (ii) by striking ``A prescription drug 
                        product shall not be assessed a fee'' and 
                        inserting ``A prescription drug program fee 
                        shall not be assessed for a prescription drug 
                        product''; and
                  (L) by adding at the end of such paragraph (2) the 
                following:
                  ``(C) Limitation.--A person who is named as the 
                applicant in an approved human drug application shall 
                not be assessed more than 5 prescription drug program 
                fees for a fiscal year for prescription drug products 
                identified in such approved human drug application.''.
          (2) Conforming amendment.--Subparagraph (C) of section 
        740(a)(3) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 379j-12(a)(3)) is amended to read as follows:
                  ``(C) Limitation.--An establishment shall be assessed 
                only one fee per fiscal year under this section.''.
  (b) Fee Revenue Amounts.--Subsection (b) of section 736 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h) is amended to 
read as follows:
  ``(b) Fee Revenue Amounts.--
          ``(1) In general.--For each of the fiscal years 2018 through 
        2022, fees under subsection (a) shall, except as provided in 
        subsections (c), (d), (f), and (g), be established to generate 
        a total revenue amount under such subsection that is equal to 
        the sum of--
                  ``(A) the annual base revenue for the fiscal year (as 
                determined under paragraph (3));
                  ``(B) the dollar amount equal to the inflation 
                adjustment for the fiscal year (as determined under 
                subsection (c)(1));
                  ``(C) the dollar amount equal to the capacity 
                planning adjustment for the fiscal year (as determined 
                under subsection (c)(2));
                  ``(D) the dollar amount equal to the operating 
                reserve adjustment for the fiscal year, if applicable 
                (as determined under subsection (c)(3));
                  ``(E) the dollar amount equal to the additional 
                direct cost adjustment for the fiscal year (as 
                determined under subsection (c)(4)); and
                  ``(F) additional dollar amounts for each fiscal year 
                as follows:
                          ``(i) $20,077,793 for fiscal year 2018.
                          ``(ii) $21,317,472 for fiscal year 2019.
                          ``(iii) $16,953,329 for fiscal year 2020.
                          ``(iv) $5,426,896 for fiscal year 2021.
                          ``(v) $2,769,609 for fiscal year 2022.
          ``(2) Types of fees.--Of the total revenue amount determined 
        for a fiscal year under paragraph (1)--
                  ``(A) 20 percent shall be derived from human drug 
                application fees under subsection (a)(1); and
                  ``(B) 80 percent shall be derived from prescription 
                drug program fees under subsection (a)(2).
          ``(3) Annual base revenue.--For purposes of paragraph (1), 
        the dollar amount of the annual base revenue for a fiscal year 
        shall be--
                  ``(A) for fiscal year 2018, $878,590,000; and
                  ``(B) for fiscal years 2019 through 2022, the dollar 
                amount of the total revenue amount established under 
                paragraph (1) for the previous fiscal year, not 
                including any adjustments made under subsection (c)(3) 
                or (c)(4).''.
  (c) Adjustments; Annual Fee Setting.--Subsection (c) of section 736 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h) is amended 
to read as follows:
  ``(c) Adjustments; Annual Fee Setting.--
          ``(1) Inflation adjustment.--
                  ``(A) In general.--For purposes of subsection 
                (b)(1)(B), the dollar amount of the inflation 
                adjustment to the annual base revenue for each fiscal 
                year shall be equal to the product of--
                          ``(i) such annual base revenue for the fiscal 
                        year under subsection (b)(1)(A); and
                          ``(ii) the inflation adjustment percentage 
                        under subparagraph (B).
                  ``(B) Inflation adjustment percentage.--The inflation 
                adjustment percentage under this subparagraph for a 
                fiscal year is equal to the sum of--
                          ``(i) the average annual percent change in 
                        the cost, per full-time equivalent position of 
                        the Food and Drug Administration, of all 
                        personnel compensation and benefits paid with 
                        respect to such positions for the first 3 years 
                        of the preceding 4 fiscal years, multiplied by 
                        the proportion of personnel compensation and 
                        benefits costs to total costs of the process 
                        for the review of human drug applications (as 
                        defined in section 735(6)) for the first 3 
                        years of the preceding 4 fiscal years; and
                          ``(ii) the average annual percent change that 
                        occurred in the Consumer Price Index for urban 
                        consumers (Washington-Baltimore, DC-MD-VA-WV; 
                        Not Seasonally Adjusted; All items; Annual 
                        Index) for the first 3 years of the preceding 4 
                        years of available data multiplied by the 
                        proportion of all costs other than personnel 
                        compensation and benefits costs to total costs 
                        of the process for the review of human drug 
                        applications (as defined in section 735(6)) for 
                        the first 3 years of the preceding 4 fiscal 
                        years.
          ``(2) Capacity planning adjustment.--
                  ``(A) In general.--For each fiscal year, after the 
                annual base revenue established in subsection (b)(1)(A) 
                is adjusted for inflation in accordance with paragraph 
                (1), such revenue shall be adjusted further for such 
                fiscal year, in accordance with this paragraph, to 
                reflect changes in the resource capacity needs of the 
                Secretary for the process for the review of human drug 
                applications.
                  ``(B) Interim methodology.--
                          ``(i) In general.--Until the capacity 
                        planning methodology described in subparagraph 
                        (C) is effective, the adjustment under this 
                        paragraph for a fiscal year shall be based on 
                        the product of--
                                  ``(I) the annual base revenue for 
                                such year, as adjusted for inflation 
                                under paragraph (1); and
                                  ``(II) the adjustment percentage 
                                under clause (ii).
                          ``(ii) Adjustment percentage.--The adjustment 
                        percentage under this clause for a fiscal year 
                        is the weighted change in the 3-year average 
                        ending in the most recent year for which data 
                        are available, over the 3-year average ending 
                        in the previous year, for--
                                  ``(I) the total number of human drug 
                                applications, efficacy supplements, and 
                                manufacturing supplements submitted to 
                                the Secretary;
                                  ``(II) the total number of active 
                                commercial investigational new drug 
                                applications; and
                                  ``(III) the total number of formal 
                                meetings scheduled by the Secretary, 
                                and written responses issued by the 
                                Secretary in lieu of such formal 
                                meetings, as identified in section I.H 
                                of the letters described in section 
                                101(b) of the Prescription Drug User 
                                Fee Amendments of 2017.
                  ``(C) Capacity planning methodology.--
                          ``(i) Development; evaluation and report.--
                        The Secretary shall obtain, through a contract 
                        with an independent accounting or consulting 
                        firm, a report evaluating options and 
                        recommendations for a new methodology to 
                        accurately assess changes in the resource and 
                        capacity needs of the process for the review of 
                        human drug applications. The capacity planning 
                        methodological options and recommendations 
                        presented in such report shall utilize and be 
                        informed by personnel time reporting data as an 
                        input. The report shall be published for public 
                        comment no later than the end of fiscal year 
                        2020.
                          ``(ii) Establishment and implementation.--
                        After review of the report described in clause 
                        (i) and any public comments thereon, the 
                        Secretary shall establish a capacity planning 
                        methodology for purposes of this paragraph, 
                        which shall--
                                  ``(I) replace the interim methodology 
                                under subparagraph (B);
                                  ``(II) incorporate such approaches 
                                and attributes as the Secretary 
                                determines appropriate; and
                                  ``(III) be effective beginning with 
                                the first fiscal year for which fees 
                                are set after such capacity planning 
                                methodology is established.
                  ``(D) Limitation.--Under no circumstances shall an 
                adjustment under this paragraph result in fee revenue 
                for a fiscal year that is less than the sum of the 
                amounts under subsections (b)(1)(A) (the annual base 
                revenue for the fiscal year) and (b)(1)(B) (the dollar 
                amount of the inflation adjustment for the fiscal 
                year).
                  ``(E) Publication in federal register.--The Secretary 
                shall publish in the Federal Register notice under 
                paragraph (5) the fee revenue and fees resulting from 
                the adjustment and the methodologies under this 
                paragraph.
          ``(3) Operating reserve adjustment.--
                  ``(A) Increase.--For fiscal year 2018 and subsequent 
                fiscal years, the Secretary may, in addition to 
                adjustments under paragraphs (1) and (2), further 
                increase the fee revenue and fees if such an adjustment 
                is necessary to provide for not more than 14 weeks of 
                operating reserves of carryover user fees for the 
                process for the review of human drug applications.
                  ``(B) Decrease.--If the Secretary has carryover 
                balances for such process in excess of 14 weeks of such 
                operating reserves, the Secretary shall decrease such 
                fee revenue and fees to provide for not more than 14 
                weeks of such operating reserves.
                  ``(C) Notice of rationale.--If an adjustment under 
                subparagraph (A) or (B) is made, the rationale for the 
                amount of the increase or decrease (as applicable) in 
                fee revenue and fees shall be contained in the annual 
                Federal Register notice under paragraph (5) 
                establishing fee revenue and fees for the fiscal year 
                involved.
          ``(4) Additional direct cost adjustment.--
                  ``(A) In general.--The Secretary shall, in addition 
                to adjustments under paragraphs (1), (2), and (3), 
                further increase the fee revenue and fees--
                          ``(i) for fiscal year 2018, by $8,730,000; 
                        and
                          ``(ii) for fiscal year 2019 and subsequent 
                        fiscal years, by the amount determined under 
                        subparagraph (B).
                  ``(B) Amount.--The amount determined under this 
                subparagraph is--
                          ``(i) $8,730,000, multiplied by
                          ``(ii) the Consumer Price Index for urban 
                        consumers (Washington-Baltimore, DC-MD-VA-WV; 
                        Not Seasonally Adjusted; All Items; Annual 
                        Index) for the most recent year of available 
                        data, divided by such Index for 2016.
          ``(5) Annual fee setting.--The Secretary shall, not later 
        than 60 days before the start of each fiscal year that begins 
        after September 30, 2017--
                  ``(A) establish, for the next fiscal year, human drug 
                application fees and prescription drug program fees 
                under subsection (a), based on the revenue amounts 
                established under subsection (b) and the adjustments 
                provided under this subsection; and
                  ``(B) publish such fee revenue and fees in the 
                Federal Register.
          ``(6) Limit.--The total amount of fees charged, as adjusted 
        under this subsection, for a fiscal year may not exceed the 
        total costs for such fiscal year for the resources allocated 
        for the process for the review of human drug applications.''.
  (d) Fee Waiver or Reduction.--Section 736(d) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379h(d)) is amended--
          (1) in paragraph (1)--
                  (A) by inserting ``or'' at the end of subparagraph 
                (B);
                  (B) by striking subparagraph (C); and
                  (C) by redesignating subparagraph (D) as subparagraph 
                (C);
          (2) by striking paragraph (3) (relating to use of standard 
        costs);
          (3) by redesignating paragraph (4) as paragraph (3); and
          (4) in paragraph (3), as so redesignated--
                  (A) in subparagraphs (A) and (B), by striking 
                ``paragraph (1)(D)'' and inserting ``paragraph 
                (1)(C)''; and
                  (B) in subparagraph (B)--
                          (i) by striking clause (ii);
                          (ii) by striking ``shall pay'' through ``(i) 
                        application fees'' and inserting ``shall pay 
                        application fees''; and
                          (iii) by striking ``; and'' at the end and 
                        inserting a period.
  (e) Effect of Failure To Pay Fees.--Section 736(e) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379h(e)) is amended by striking 
``all fees'' and inserting ``all such fees''.
  (f) Limitations.--Section 736(f)(2) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379h(f)(2)) is amended by striking 
``supplements, prescription drug establishments, and prescription drug 
products'' and inserting ``prescription drug program fees''.
  (g) Crediting and Availability of Fees.--Section 736(g) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(g)) is amended--
          (1) in paragraph (3)--
                  (A) by striking ``2013 through 2017'' and inserting 
                ``2018 through 2022''; and
                  (B) by striking ``and paragraph (4) of this 
                subsection''; and
          (2) by striking paragraph (4).
  (h) Orphan Drugs.--Section 736(k) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379h(k)) is amended by striking ``product and 
establishment fees'' each place it appears and inserting ``prescription 
drug program fees''.

SEC. 103. REAUTHORIZATION; REPORTING REQUIREMENTS.

  Section 736B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379h-2) is amended--
          (1) in subsection (a)(1)--
                  (A) in the matter before subparagraph (A), by 
                striking ``2013'' and inserting ``2018''; and
                  (B) in subparagraph (A), by striking ``Prescription 
                Drug User Fee Amendments of 2012'' and inserting 
                ``Prescription Drug User Fee Amendments of 2017'';
          (2) in subsection (b), by striking ``2013'' and inserting 
        ``2018''; and
          (3) in subsection (d), by striking ``2017'' each place it 
        appears and inserting ``2022''.

SEC. 104. SUNSET DATES.

  (a) Authorization.--Sections 735 and 736 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379g; 379h) shall cease to be effective 
October 1, 2022.
  (b) Reporting Requirements.--Section 736B of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379h-2) shall cease to be effective January 
31, 2023.
  (c) Previous Sunset Provision.--Effective October 1, 2017, 
subsections (a) and (b) of section 105 of the Food and Drug 
Administration Safety and Innovation Act (Public Law 112-144) are 
repealed.

SEC. 105. EFFECTIVE DATE.

  The amendments made by this title shall take effect on October 1, 
2017, or the date of the enactment of this Act, whichever is later, 
except that fees under part 2 of subchapter C of chapter VII of the 
Federal Food, Drug, and Cosmetic Act shall be assessed for all human 
drug applications received on or after October 1, 2017, regardless of 
the date of the enactment of this Act.

SEC. 106. SAVINGS CLAUSE.

  Notwithstanding the amendments made by this title, part 2 of 
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic 
Act, as in effect on the day before the date of the enactment of this 
title, shall continue to be in effect with respect to human drug 
applications and supplements (as defined in such part as of such day) 
that on or after October 1, 2012, but before October 1, 2017, were 
accepted by the Food and Drug Administration for filing with respect to 
assessing and collecting any fee required by such part for a fiscal 
year prior to fiscal year 2018.

                   TITLE II--FEES RELATING TO DEVICES

SEC. 201. SHORT TITLE; FINDINGS.

  (a) Short Title.--This title may be cited as the ``Medical Device 
User Fee Amendments of 2017''.
  (b) Findings.--The Congress finds that the fees authorized under the 
amendments made by this title will be dedicated toward expediting the 
process for the review of device applications and for assuring the 
safety and effectiveness of devices, as set forth in the goals 
identified for purposes of part 3 of subchapter C of chapter VII of the 
Federal Food, Drug, and Cosmetic Act in the letters from the Secretary 
of Health and Human Services to the Chairman of the Committee on 
Health, Education, Labor, and Pensions of the Senate and the Chairman 
of the Committee on Energy and Commerce of the House of 
Representatives, as set forth in the Congressional Record.

SEC. 202. DEFINITIONS.

  Section 737 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379i) is amended--
          (1) by redesignating paragraphs (8) through (13) as 
        paragraphs (9) through (14), respectively;
          (2) by inserting after paragraph (7) the following new 
        paragraph:
          ``(8) The term `de novo classification request' means a 
        request made under section 513(f)(2)(A) with respect to the 
        classification of a device.'';
          (3) in subparagraph (D) of paragraph (10) (as redesignated by 
        paragraph (1)), by striking ``and submissions'' and inserting 
        ``submissions, and de novo classification requests''; and
          (4) in paragraph (11) (as redesignated by paragraph (1)), by 
        striking ``2011'' and inserting ``2016''.

SEC. 203. AUTHORITY TO ASSESS AND USE DEVICE FEES.

  (a) Types of Fees.--Section 738(a) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j(a)) is amended--
          (1) in paragraph (1), by striking ``fiscal year 2013'' and 
        inserting ``fiscal year 2018''; and
          (2) in paragraph (2)--
                  (A) in subparagraph (A)--
                          (i) in the matter preceding clause (i), by 
                        striking ``October 1, 2012'' and inserting 
                        ``October 1, 2017'';
                          (ii) in clause (viii), by striking ``2'' and 
                        inserting ``3.4''; and
                          (iii) by adding at the end the following new 
                        clause:
                          ``(xi) For a de novo classification request, 
                        a fee equal to 30 percent of the fee that 
                        applies under clause (i).''; and
                  (B) in subparagraph (B)(v)(I), by striking ``or 
                premarket notification submission'' and inserting 
                ``premarket notification submission, or de novo 
                classification request''.
  (b) Fee Amounts.--Section 738(b) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j(b)) is amended to read as follows:
  ``(b) Fee Amounts.--
          ``(1) In general.--Subject to subsections (c), (d), (e), and 
        (h), for each of fiscal years 2018 through 2022, fees under 
        subsection (a) shall be derived from the base fee amounts 
        specified in paragraph (2), to generate the total revenue 
        amounts specified in paragraph (3).
          ``(2) Base fee amounts specified.--For purposes of paragraph 
        (1), the base fee amounts specified in this paragraph are as 
        follows:

 
----------------------------------------------------------------------------------------------------------------
                                                             Fiscal     Fiscal     Fiscal     Fiscal     Fiscal
                        ``Fee Type                         Year 2018  Year 2019  Year 2020  Year 2021  Year 2022
----------------------------------------------------------------------------------------------------------------
Premarket Application....................................   $294,000   $300,000   $310,000   $328,000   $329,000
Establishment Registration...............................     $4,375     $4,548     $4,760     $4,975     $4,978
----------------------------------------------------------------------------------------------------------------


          ``(3) Total revenue amounts specified.--For purposes of 
        paragraph (1), the total revenue amounts specified in this 
        paragraph are as follows:
                  ``(A) $183,280,756 for fiscal year 2018.
                  ``(B) $190,654,875 for fiscal year 2019.
                  ``(C) $200,132,014 for fiscal year 2020.
                  ``(D) $211,748,789 for fiscal year 2021.
                  ``(E) $213,687,660 for fiscal year 2022.''.
  (c) Annual Fee Setting; Adjustments.--Section 738(c) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j(c)) is amended--
          (1) in paragraph (1), by striking ``2012'' and inserting 
        ``2017'';
          (2) in paragraph (2)--
                  (A) in subparagraph (A), by striking ``2014'' and 
                inserting ``2018'';
                  (B) by striking subparagraph (B) and inserting the 
                following new subparagraph:
                  ``(B) Applicable inflation adjustment.--The 
                applicable inflation adjustment for fiscal year 2018 
                and each subsequent fiscal year is the product of--
                          ``(i) the base inflation adjustment under 
                        subparagraph (C) for such fiscal year; and
                          ``(ii) the product of the base inflation 
                        adjustment under subparagraph (C) for each of 
                        the fiscal years preceding such fiscal year, 
                        beginning with fiscal year 2016.'';
                  (C) in subparagraph (C), in the heading, by striking 
                ``to total revenue amounts''; and
                  (D) by amending subparagraph (D) to read as follows:
                  ``(D) Adjustment to base fee amounts.--For each of 
                fiscal years 2018 through 2022, the Secretary shall--
                          ``(i) adjust the base fee amounts specified 
                        in subsection (b)(2) for such fiscal year by 
                        multiplying such amounts by the applicable 
                        inflation adjustment under subparagraph (B) for 
                        such year; and
                          ``(ii) if the Secretary determines necessary, 
                        increase (in addition to the adjustment under 
                        clause (i)) such base fee amounts, on a uniform 
                        proportionate basis, to generate the total 
                        revenue amounts under subsection (b)(3), as 
                        adjusted for inflation under subparagraph 
                        (A).''; and
          (3) in paragraph (3)--
                  (A) by striking ``2014 through 2017'' and inserting 
                ``2018 through 2022''; and
                  (B) by striking ``further adjusted'' and inserting 
                ``increased''.
  (d) Small Businesses; Fee Waiver and Fee Reduction Regarding 
Premarket Approval Fees.--Section 738(d) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j(d)) is amended--
          (1) in paragraph (1), by striking ``specified in clauses (i) 
        through (v) and clauses (vii), (ix), and (x)'' and inserting 
        ``specified in clauses (i) through (vii) and clauses (ix), (x), 
        and (xi)''; and
          (2) in paragraph (2)(C)--
                  (A) by striking ``supplement, or'' and inserting 
                ``supplement,''; and
                  (B) by inserting ``, or a de novo classification 
                request'' after ``class III device''.
  (e) Small Businesses; Fee Reduction Regarding Premarket Notification 
Submissions.--Section 738(e)(2)(C) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j(e)(2)(C)) is amended by striking ``50'' 
and inserting ``25''.
  (f) Fee Waiver or Reduction.--
          (1) Repeal.--Section 738 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 379j) is amended by striking subsection 
        (f).
          (2) Conforming changes.--
                  (A) Section 515(c)(4)(A) of the Federal Food, Drug, 
                and Cosmetic Act (21 U.S.C. 360e(c)(4)(A)) is amended 
                by striking ``738(h)'' and inserting ``738(g)''.
                  (B) Section 738 of the Federal Food, Drug, and 
                Cosmetic Act (21 U.S.C. 379j), as amended by paragraph 
                (1), is further amended--
                          (i) by redesignating subsections (g) through 
                        (l) as subsections (f) through (k);
                          (ii) in subsection (a)(2)(A), by striking 
                        ``(d), (e), and (f)'' and inserting ``(d) and 
                        (e)''; and
                          (iii) in subsection (a)(3)(A), by striking 
                        ``and subsection (f)''.
  (g) Effect of Failure To Pay Fees.--Subsection (f)(1), as 
redesignated, of section 738 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379j) is amended--
          (1) by striking ``or periodic reporting concerning a class 
        III device'' and inserting ``periodic reporting concerning a 
        class III device, or de novo classification request''; and
          (2) by striking ``all fees'' and inserting ``all such fees''.
  (h) Conditions.--Subsection (g)(1)(A), as redesignated, of section 
738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j) is 
amended by striking ``$280,587,000'' and inserting ``$320,825,000''.
  (i) Crediting and Availability of Fees.--Subsection (h), as 
redesignated, of section 738 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379j) is amended--
          (1) in paragraph (3)--
                  (A) by striking ``2013 through 2017'' and inserting 
                ``2018 through 2022''; and
                  (B) by striking ``subsection (c)'' and all that 
                follows through the period at the end and inserting 
                ``subsection (c).''; and
          (2) by striking paragraph (4).

SEC. 204. REAUTHORIZATION; REPORTING REQUIREMENTS.

  (a) Performance Reports.--Section 738A(a) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379j-1(a)) is amended--
          (1) in paragraph (1)--
                  (A) in subparagraph (A)--
                          (i) by striking ``2013'' and inserting 
                        ``2018''; and
                          (ii) by striking ``the Medical Device User 
                        Fee Amendments of 2012'' and inserting ``the 
                        Medical Device User Fee Amendments of 2017''; 
                        and
                  (B) in subparagraph (B), by striking ``the Medical 
                Device User Fee Amendments Act of 2012'' and inserting 
                ``the Medical Device User Fee Amendments of 2017''; and
          (2) in paragraph (2), by striking ``2013 through 2017'' and 
        inserting ``2018 through 2022''.
  (b) Reauthorization.--Section 738A(b) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j-1(b)) is amended--
          (1) in paragraph (1), by striking ``2017'' and inserting 
        ``2022''; and
          (2) in paragraph (5), by striking ``2017'' and inserting 
        ``2022''.

SEC. 205. CONFORMITY ASSESSMENT PILOT PROGRAM.

  (a) In General.--Section 514 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360d) is amended by adding at the end the following:
  ``(d) Pilot Accreditation Scheme for Conformity Assessment.--
          ``(1) In general.--The Secretary shall establish a pilot 
        program under which--
                  ``(A) testing laboratories may be accredited, by 
                accreditation bodies meeting criteria specified by the 
                Secretary, to assess the conformance of a device with 
                certain standards recognized under this section; and
                  ``(B) subject to paragraph (2), determinations by 
                testing laboratories so accredited that a device 
                conforms with such standard or standards shall be 
                accepted by the Secretary for purposes of demonstrating 
                such conformity under this section unless the Secretary 
                finds that a particular such determination shall not be 
                so accepted.
          ``(2) Secretarial review of accredited laboratory 
        determinations.--The Secretary may--
                  ``(A) review determinations by testing laboratories 
                accredited pursuant to this subsection, including by 
                conducting periodic audits of such determinations or 
                processes of accredited bodies or testing laboratories 
                and, following such review, taking additional measures 
                under this Act, such as suspension or withdrawal of 
                accreditation of such testing laboratory under 
                paragraph (1)(A) or requesting additional information 
                with respect to such device, as the Secretary 
                determines appropriate; and
                  ``(B) if the Secretary becomes aware of information 
                materially bearing on safety or effectiveness of a 
                device assessed for conformity by a testing laboratory 
                so accredited, take such additional measures under this 
                Act as the Secretary determines appropriate, such as 
                suspension or withdrawal of accreditation of such 
                testing laboratory under paragraph (1)(A), or 
                requesting additional information with regard to such 
                device.
          ``(3) Implementation and reporting.--
                  ``(A) Public meeting.--The Secretary shall publish in 
                the Federal Register a notice of a public meeting to be 
                held no later than September 30, 2018, to discuss and 
                obtain input and recommendations from stakeholders 
                regarding the goals and scope of, and a suitable 
                framework and procedures and requirements for, the 
                pilot program under this subsection.
                  ``(B) Pilot program guidance.--The Secretary shall--
                          ``(i) not later than September 30, 2019, 
                        issue draft guidance regarding the goals and 
                        implementation of the pilot program under this 
                        subsection; and
                          ``(ii) not later than September 30, 2021, 
                        issue final guidance with respect to the 
                        implementation of such program.
                  ``(C) Pilot program initiation.--Not later than 
                September 30, 2020, the Secretary shall initiate the 
                pilot program under this subsection.
                  ``(D) Report.--The Secretary shall make available on 
                the website of the Food and Drug Administration an 
                annual report on the progress of the pilot program 
                under this subsection.
          ``(4) Sunset.--As of October 1, 2022--
                  ``(A) the authority for accreditation bodies to 
                accredit testing laboratories pursuant to paragraph 
                (1)(A) shall cease to have force or effect;
                  ``(B) the Secretary--
                          ``(i) may not accept a determination pursuant 
                        to paragraph (1)(B) made by a testing 
                        laboratory after such date; and
                          ``(ii) may accept such a determination made 
                        prior to such date;
                  ``(C) except for purposes of accepting a 
                determination described in subparagraph (B)(ii), the 
                Secretary shall not continue to recognize the 
                accreditation of testing laboratories accredited under 
                paragraph (1)(A); and
                  ``(D) the Secretary may take actions in accordance 
                with paragraph (2) with respect to the determinations 
                made prior to such date and recognition of the 
                accreditation of testing laboratories pursuant to 
                determinations made prior to such date.''.

SEC. 206. REAUTHORIZATION OF REVIEW.

  Section 523 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360m) is amended--
          (1) in subsection (a)(3)--
                  (A) in subparagraph (A), by striking clauses (ii) and 
                (iii) and inserting the following:
                          ``(ii) a device classified under section 
                        513(f)(2) or designated under section 515C(d); 
                        or
                          ``(iii) a device that is of a type, or subset 
                        of a type, listed as not eligible for review 
                        under subparagraph (B)(iii).'';
                  (B) by striking subparagraph (B) and inserting the 
                following:
                  ``(B) Designation for review.--The Secretary shall--
                          ``(i) issue draft guidance on the factors the 
                        Secretary will use in determining whether a 
                        class I or class II device type, or subset of 
                        such device types, is eligible for review by an 
                        accredited person, including--
                                  ``(I) the risk of the device type, or 
                                subset of such device type; and
                                  ``(II) whether the device type, or 
                                subset of such device type, is 
                                permanently implantable, life 
                                sustaining, or life supporting;
                          ``(ii) not later than 24 months after the 
                        date on which the Secretary issues such draft 
                        guidance, finalize such guidance; and
                          ``(iii) beginning on the date such guidance 
                        is finalized, designate and post on the 
                        internet website of the Food and Drug 
                        Administration, an updated list of class I and 
                        class II device types, or subsets of such 
                        device types, and the Secretary's determination 
                        with respect to whether each such device type, 
                        or subset of a device type, is eligible or not 
                        eligible for review by an accredited person 
                        under this section based on the factors 
                        described in clause (i).''; and
                  (C) by adding at the end the following:
                  ``(C) Interim rule.--Until the date on which the 
                updated list is designated and posted in accordance 
                with subparagraph (B)(iii), the list in effect on the 
                date of enactment the Medical Device User Fee 
                Amendments of 2017 shall be in effect.'';
          (2) in subsection (b)--
                  (A) in paragraph (2)--
                          (i) by striking subparagraph (D); and
                          (ii) by redesignating subparagraph (E) as 
                        subparagraph (D); and
                  (B) in paragraph (3)--
                          (i) by redesignating subparagraph (E) as 
                        subparagraph (F);
                          (ii) in subparagraph (F) (as so 
                        redesignated), by striking ``The operations 
                        of'' and all that follows through ``it will--'' 
                        and inserting ``Such person shall agree, at a 
                        minimum, to include in its request for 
                        accreditation a commitment to, at the time of 
                        accreditation, and at any time it is performing 
                        any review pursuant to this section--''; and
                          (iii) by inserting after subparagraph (D) the 
                        following new subparagraph:
                  ``(E) The operations of such person shall be in 
                accordance with generally accepted professional and 
                ethical business practices.''; and
          (3) in subsection (c), by striking ``2017'' and inserting 
        ``2022''.

SEC. 207. ELECTRONIC FORMAT FOR SUBMISSIONS.

  Section 745A(b) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 379k-1(b)) is amended by adding at the end the following new 
paragraph:
          ``(3) Presubmissions and submissions solely in electronic 
        format.--
                  ``(A) In general.--Beginning on such date as the 
                Secretary specifies in final guidance issued under 
                subparagraph (C), presubmissions and submissions for 
                devices described in paragraph (1) (and any appeals of 
                action taken by the Secretary with respect to such 
                presubmissions or submissions) shall be submitted 
                solely in such electronic format as specified by the 
                Secretary in such guidance.
                  ``(B) Draft guidance.--The Secretary shall, not later 
                than October 1, 2019, issue draft guidance providing 
                for--
                          ``(i) any further standards for the 
                        submission by electronic format required under 
                        subparagraph (A);
                          ``(ii) a timetable for the establishment by 
                        the Secretary of such further standards; and
                          ``(iii) criteria for waivers of and 
                        exemptions from the requirements of this 
                        subsection.
                  ``(C) Final guidance.--The Secretary shall, not later 
                than 12 months after the close of the public comment 
                period on the draft guidance issued under subparagraph 
                (B), issue final guidance described in clauses (i) 
                through (iii) of such subparagraph.''.

SEC. 208. SAVINGS CLAUSE.

  Notwithstanding the amendments made by this title, part 3 of 
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 379i et seq.), as in effect on the day before the date of 
the enactment of this title, shall continue to be in effect with 
respect to the submissions listed in section 738(a)(2)(A) of such Act 
(as defined in such part as of such day) that on or after October 1, 
2012, but before October 1, 2017, were accepted by the Food and Drug 
Administration for filing with respect to assessing and collecting any 
fee required by such part for a fiscal year prior to fiscal year 2018.

SEC. 209. EFFECTIVE DATE.

  The amendments made by this title shall take effect on October 1, 
2017, or the date of the enactment of this Act, whichever is later, 
except that fees under part 3 of subchapter C of chapter VII of the 
Federal Food, Drug, and Cosmetic Act shall be assessed for all 
submissions listed in section 738(a)(2)(A) of such Act received on or 
after October 1, 2017, regardless of the date of the enactment of this 
Act.

SEC. 210. SUNSET CLAUSE.

  (a) Authorization.--Sections 737 and 738 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 739i; 739j) shall cease to be effective 
October 1, 2022.
  (b) Reporting Requirements.--Section 738A (21 U.S.C. 739j-1) of the 
Federal Food, Drug, and Cosmetic Act (regarding reauthorization and 
reporting requirements) shall cease to be effective January 31, 2023.
  (c) Previous Sunset Provision.--Effective October 1, 2017, section 
207(a) of the Medical Device User Fee Amendments of 2012 (Public Law 
112-144) is repealed.

               TITLE III--FEES RELATING TO GENERIC DRUGS

SEC. 301. SHORT TITLE; FINDING.

  (a) Short Title.--This title may be cited as the ``Generic Drug User 
Fee Amendments of 2017''.
  (b) Finding.--The Congress finds that the fees authorized by the 
amendments made in this title will be dedicated to human generic drug 
activities, as set forth in the goals identified for purposes of part 7 
of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic 
Act, in the letters from the Secretary of Health and Human Services to 
the Chairman of the Committee on Health, Education, Labor, and Pensions 
of the Senate and the Chairman of the Committee on Energy and Commerce 
of the House of Representatives, as set forth in the Congressional 
Record.

SEC. 302. DEFINITIONS.

  Section 744A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379j-41) is amended--
          (1) in paragraph (1)(B), by striking ``application for a 
        positron emission tomography drug.'' and inserting 
        ``application--
                          ``(i) for a positron emission tomography 
                        drug; or
                          ``(ii) submitted by a State or Federal 
                        governmental entity for a drug that is not 
                        distributed commercially.'';
          (2) by redesignating paragraphs (5) through (12) as 
        paragraphs (6) through (13), respectively; and
          (3) by inserting after paragraph (4) the following:
          ``(5) The term `contract manufacturing organization facility' 
        means a manufacturing facility of a finished dosage form of a 
        drug approved pursuant to an abbreviated new drug application, 
        where such manufacturing facility is not identified in an 
        approved abbreviated new drug application held by the owner of 
        such facility or an affiliate of such owner or facility.''.

SEC. 303. AUTHORITY TO ASSESS AND USE HUMAN GENERIC DRUG FEES.

  (a) Types of Fees.--Section 744B(a) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j-42(a)) is amended--
          (1) in the matter preceding paragraph (1), by striking 
        ``fiscal year 2013'' and inserting ``fiscal year 2018'';
          (2) in paragraph (1), by adding at the end the following:
                  ``(E) Sunset.--This paragraph shall cease to be 
                effective October 1, 2022.'';
          (3) in paragraph (2)--
                  (A) by amending subparagraph (C) to read as follows:
                  ``(C) Notice.--Not later than 60 days before the 
                start of each of fiscal years 2018 through 2022, the 
                Secretary shall publish in the Federal Register the 
                amount of the drug master file fee established by this 
                paragraph for such fiscal year.''; and
                  (B) in subparagraph (E)--
                          (i) in clause (i)--
                                  (I) by striking ``no later than the 
                                date'' and inserting ``on the earlier 
                                of--
                                  ``(I) the date'';
                                  (II) by striking the period and 
                                inserting ``; or''; and
                                  (III) by adding at the end the 
                                following:
                                  ``(II) the date on which the drug 
                                master file holder requests the initial 
                                completeness assessment.''; and
                          (ii) in clause (ii), by striking ``notice 
                        provided for in clause (i) or (ii) of 
                        subparagraph (C), as applicable'' and inserting 
                        ``notice provided for in subparagraph (C)'';
          (4) in paragraph (3)--
                  (A) in the heading, by striking ``and prior approval 
                supplement'';
                  (B) in subparagraph (A), by striking ``or a prior 
                approval supplement to an abbreviated new drug 
                application'';
                  (C) by amending subparagraphs (B) and (C) to read as 
                follows:
                  ``(B) Notice.--Not later than 60 days before the 
                start of each of fiscal years 2018 through 2022, the 
                Secretary shall publish in the Federal Register the 
                amount of the fees under subparagraph (A) for such 
                fiscal year.
                  ``(C) Fee due date.--The fees required by 
                subparagraphs (A) and (F) shall be due no later than 
                the date of submission of the abbreviated new drug 
                application or prior approval supplement for which such 
                fee applies.'';
                  (D) in subparagraph (D)--
                          (i) in the heading, by inserting ``, is 
                        withdrawn prior to being received, or is no 
                        longer received'' after ``received''; and
                          (ii) by striking ``The Secretary shall'' and 
                        all that follows through the period and 
                        inserting the following:
                          ``(i) Applications not considered to have 
                        been received and applications withdrawn prior 
                        to being received.--The Secretary shall refund 
                        75 percent of the fee paid under subparagraph 
                        (A) for any abbreviated new drug application 
                        that the Secretary considers not to have been 
                        received within the meaning of section 
                        505(j)(5)(A) for a cause other than failure to 
                        pay fees, or that has been withdrawn prior to 
                        being received within the meaning of section 
                        505(j)(5)(A).
                          ``(ii) Applications no longer received.--The 
                        Secretary shall refund 100 percent of the fee 
                        paid under subparagraph (A) for any abbreviated 
                        new drug application if the Secretary initially 
                        receives the application under section 
                        505(j)(5)(A) and subsequently determines that 
                        an exclusivity period for a listed drug should 
                        have prevented the Secretary from receiving 
                        such application, such that the abbreviated new 
                        drug application is no longer received within 
                        the meaning of section 505(j)(5)(A).'';
                  (E) in subparagraph (E), by striking ``or prior 
                approval supplement''; and
                  (F) in the matter preceding clause (i) of 
                subparagraph (F)--
                          (i) by striking ``2012'' and inserting 
                        ``2017''; and
                          (ii) by striking ``subsection (d)(3)'' and 
                        inserting ``subsection (d)(2)'';
          (5) in paragraph (4)--
                  (A) in subparagraph (A)--
                          (i) in the matter preceding clause (i) and in 
                        clause (iii), by striking ``, or intended to be 
                        identified, in at least one generic drug 
                        submission that is pending or'' and inserting 
                        ``in at least one generic drug submission that 
                        is'';
                          (ii) in clause (i), by striking ``or intended 
                        to be identified in at least one generic drug 
                        submission that is pending or'' and inserting 
                        ``in at least one generic drug submission that 
                        is'';
                          (iii) in clause (ii), by striking 
                        ``produces,'' and all that follows through 
                        ``such a'' and inserting ``is identified in at 
                        least one generic drug submission in which the 
                        facility is approved to produce one or more 
                        active pharmaceutical ingredients or in a Type 
                        II active pharmaceutical ingredient drug master 
                        file referenced in at least one such''; and
                          (iv) in clause (iii), by striking ``to fees 
                        under both such clauses'' and inserting ``only 
                        to the fee attributable to the manufacture of 
                        the finished dosage forms''; and
                  (B) by amending subparagraphs (C) and (D) to read as 
                follows:
                  ``(C) Notice.--Within the timeframe specified in 
                subsection (d)(1), the Secretary shall publish in the 
                Federal Register the amount of the fees under 
                subparagraph (A) for such fiscal year.
                  ``(D) Fee due date.--For each of fiscal years 2018 
                through 2022, the fees under subparagraph (A) for such 
                fiscal year shall be due on the later of--
                          ``(i) the first business day on or after 
                        October 1 of each such year; or
                          ``(ii) the first business day after the 
                        enactment of an appropriations Act providing 
                        for the collection and obligation of fees for 
                        such year under this section for such year.'';
          (6) by redesignating paragraph (5) as paragraph (6); and
          (7) by inserting after paragraph (4) the following:
          ``(5) Generic drug applicant program fee.--
                  ``(A) In general.--A generic drug applicant program 
                fee shall be assessed annually as described in 
                subsection (b)(2)(E).
                  ``(B) Amount.--The amount of fees established under 
                subparagraph (A) shall be established under subsection 
                (d).
                  ``(C) Notice.--Within the timeframe specified in 
                subsection (d)(1), the Secretary shall publish in the 
                Federal Register the amount of the fees under 
                subparagraph (A) for such fiscal year.
                  ``(D) Fee due date.--For each of fiscal years 2018 
                through 2022, the fees under subparagraph (A) for such 
                fiscal year shall be due on the later of--
                          ``(i) the first business day on or after 
                        October 1 of each such fiscal year; or
                          ``(ii) the first business day after the date 
                        of enactment of an appropriations Act providing 
                        for the collection and obligation of fees for 
                        such fiscal year under this section for such 
                        fiscal year.''.
  (b) Fee Revenue Amounts.--Section 744B(b) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379j-42(b)) is amended--
          (1) in paragraph (1)--
                  (A) in subparagraph (A)--
                          (i) in the heading, by striking ``2013'' and 
                        inserting ``2018'';
                          (ii) by striking ``2013'' and inserting 
                        ``2018'';
                          (iii) by striking ``$299,000,000'' and 
                        inserting ``$493,600,000''; and
                          (iv) by striking ``Of that amount'' and all 
                        that follows through the end of clause (ii); 
                        and
                  (B) in subparagraph (B)--
                          (i) in the heading, by striking ``2014 
                        through 2017'' and inserting ``2019 through 
                        2022'';
                          (ii) by striking ``2014 through 2017'' and 
                        inserting ``2019 through 2022'';
                          (iii) by striking ``paragraphs (2) through 
                        (4)'' and inserting ``paragraphs (2) through 
                        (5)''; and
                          (iv) by striking ``$299,000,000'' and 
                        inserting ``$493,600,000''; and
          (2) in paragraph (2)--
                  (A) in the matter preceding subparagraph (A)--
                          (i) by striking ``paragraph (1)(A)(ii) for 
                        fiscal year 2013 and paragraph (1)(B) for each 
                        of fiscal years 2014 through 2017'' and 
                        inserting ``such paragraph for a fiscal year''; 
                        and
                          (ii) by striking ``through (4)'' and 
                        inserting ``through (5)'';
                  (B) in subparagraph (A), by striking ``Six percent'' 
                and inserting ``Five percent'';
                  (C) by amending subparagraphs (B) and (C) to read as 
                follows:
                  ``(B) Thirty-three percent shall be derived from fees 
                under subsection (a)(3) (relating to abbreviated new 
                drug applications).
                  ``(C) Twenty percent shall be derived from fees under 
                subsection (a)(4)(A)(i) (relating to generic drug 
                facilities). The amount of the fee for a contract 
                manufacturing organization facility shall be equal to 
                one-third the amount of the fee for a facility that is 
                not a contract manufacturing organization facility. The 
                amount of the fee for a facility located outside the 
                United States and its territories and possessions shall 
                be $15,000 higher than the amount of the fee for a 
                facility located in the United States and its 
                territories and possessions.'';
                  (D) in subparagraph (D)--
                          (i) by striking ``Fourteen percent'' and 
                        inserting ``Seven percent'';
                          (ii) by striking ``not less than $15,000 and 
                        not more than $30,000'' and inserting 
                        ``$15,000''; and
                          (iii) by striking ``, as determined'' and all 
                        that follows through the period at the end and 
                        inserting a period; and
                  (E) by adding at the end the following:
                  ``(E)(i) Thirty-five percent shall be derived from 
                fees under subsection (a)(5) (relating to generic drug 
                applicant program fees). For purposes of this 
                subparagraph, if a person has affiliates, a single 
                program fee shall be assessed with respect to that 
                person, including its affiliates, and may be paid by 
                that person or any one of its affiliates. The Secretary 
                shall determine the fees as follows:
                          ``(I) If a person (including its affiliates) 
                        owns at least one but not more than 5 approved 
                        abbreviated new drug applications on the due 
                        date for the fee under this subsection, the 
                        person (including its affiliates) shall be 
                        assessed a small business generic drug 
                        applicant program fee equal to one-tenth of the 
                        large size operation generic drug applicant 
                        program fee.
                          ``(II) If a person (including its affiliates) 
                        owns at least 6 but not more than 19 approved 
                        abbreviated new drug applications on the due 
                        date for the fee under this subsection, the 
                        person (including its affiliates) shall be 
                        assessed a medium size operation generic drug 
                        applicant program fee equal to two-fifths of 
                        the large size operation generic drug applicant 
                        program fee.
                          ``(III) If a person (including its 
                        affiliates) owns 20 or more approved 
                        abbreviated new drug applications on the due 
                        date for the fee under this subsection, the 
                        person (including its affiliates) shall be 
                        assessed a large size operation generic drug 
                        applicant program fee.
                  ``(ii) For purposes of this subparagraph, an 
                abbreviated new drug application shall be deemed not to 
                be approved if the applicant has submitted a written 
                request for withdrawal of approval of such abbreviated 
                new drug application by April 1 of the previous fiscal 
                year.''.
  (c) Adjustments.--Section 744B(c) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j-42(c)) is amended--
          (1) in paragraph (1)--
                  (A) by striking ``2014'' and inserting ``2019'';
                  (B) by inserting ``to equal the product of the total 
                revenues established in such notice for the prior 
                fiscal year multiplied'' after ``a fiscal year,''; and
                  (C) by striking the flush text following subparagraph 
                (C); and
          (2) in paragraph (2)--
                  (A) by striking ``2017'' each place it appears and 
                inserting ``2022'';
                  (B) by striking ``the first 3 months of fiscal year 
                2018'' and inserting ``the first 3 months of fiscal 
                year 2023''; and
                  (C) by striking ``Such fees may only be used in 
                fiscal year 2018.''.
  (d) Annual Fee Setting.--Section 744B(d) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379j-42(d)) is amended--
          (1) by striking paragraphs (1) and (2) and inserting the 
        following:
          ``(1) Fiscal years 2018 through 2022.--Not more than 60 days 
        before the first day of each of fiscal years 2018 through 2022, 
        the Secretary shall establish the fees described in paragraphs 
        (2) through (5) of subsection (a), based on the revenue amounts 
        established under subsection (b) and the adjustments provided 
        under subsection (c).'';
          (2) by redesignating paragraph (3) as paragraph (2); and
          (3) in paragraph (2) (as so redesignated), in the matter 
        preceding subparagraph (A), by striking ``fees under paragraphs 
        (1) and (2)'' and inserting ``fee under paragraph (1)''.
  (e) Identification of Facilities.--Section 744B(f) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-42(f)) is amended--
          (1) by striking paragraph (1);
          (2) by redesignating paragraphs (2) through (4) as paragraphs 
        (1) through (3), respectively;
          (3) in paragraph (1) (as so redesignated)--
                  (A) by striking ``paragraph (4)'' and inserting 
                ``paragraph (3)''; and
                  (B) by striking ``Such information shall'' and all 
                that follows through the end of subparagraph (B) and 
                inserting ``Such information shall, for each fiscal 
                year, be submitted, updated, or reconfirmed on or 
                before June 1 of the previous fiscal year.''; and
          (4) in paragraph (2), as so redesignated--
                  (A) in the heading, by striking ``Contents of 
                notice'' and inserting ``Information required to be 
                submitted'';
                  (B) in the matter preceding subparagraph (A), by 
                striking ``paragraph (2)'' and inserting ``paragraph 
                (1)'';
                  (C) in subparagraph (A), by striking ``or intended to 
                be identified'';
                  (D) in subparagraph (D), by striking ``and'' at the 
                end;
                  (E) in subparagraph (E), by striking the period and 
                inserting ``; and''; and
                  (F) by adding at the end the following:
                  ``(F) whether the facility is a contract 
                manufacturing organization facility.''.
  (f) Effect of Failure To Pay Fees.--Section 744B(g) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379-42(g)) is amended--
          (1) in paragraph (1), by adding at the end the following: 
        ``This paragraph shall cease to be effective on October 1, 
        2022.'';
          (2) in paragraph (2)(C)(ii), by striking ``of 505(j)(5)(A)'' 
        and inserting ``of section 505(j)(5)(A)''; and
          (3) by adding at the end the following:
          ``(5) Generic drug applicant program fee.--
                  ``(A) In general.--A person who fails to pay a fee as 
                required under subsection (a)(5) by the date that is 20 
                calendar days after the due date, as specified in 
                subparagraph (D) of such subsection, shall be subject 
                to the following:
                          ``(i) The Secretary shall place the person on 
                        a publicly available arrears list.
                          ``(ii) Any abbreviated new drug application 
                        submitted by the generic drug applicant or an 
                        affiliate of such applicant shall not be 
                        received, within the meaning of section 
                        505(j)(5)(A).
                          ``(iii) All drugs marketed pursuant to any 
                        abbreviated new drug application held by such 
                        applicant or an affiliate of such applicant 
                        shall be deemed misbranded under section 
                        502(aa).
                  ``(B) Application of penalties.--The penalties under 
                subparagraph (A) shall apply until the fee required 
                under subsection (a)(5) is paid.''.
  (g) Limitations.--Section 744B(h)(2) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379-42(h)(2)) is amended by striking ``for Type 
II active pharmaceutical ingredient drug master files, abbreviated new 
drug applications and prior approval supplements, and generic drug 
facilities and active pharmaceutical ingredient facilities''.
  (h) Crediting and Availability of Fees.--Section 744B(i) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379-42(i)) is amended--
          (1) in paragraph (2)--
                  (A) by striking subparagraph (C) (relating to fee 
                collection during first program year);
                  (B) in subparagraph (D)--
                          (i) in the heading, by striking ``in 
                        subsequent years''; and
                          (ii) by striking ``(after fiscal year 
                        2013)''; and
                  (C) by redesignating subparagraph (D) as subparagraph 
                (C); and
          (2) in paragraph (3), by striking ``fiscal years 2013 through 
        2017'' and inserting ``fiscal years 2018 through 2022''.
  (i) Information on Abbreviated New Drug Applications Owned by 
Applicants and Their Affiliates.--Section 744B of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379-42) is amended by adding at the 
end the following:
  ``(o) Information on Abbreviated New Drug Applications Owned by 
Applicants and Their Affiliates.--
          ``(1) In general.--By April 1 of each year, each person that 
        owns an abbreviated new drug application, or any affiliate of 
        such person, shall submit, on behalf of the person and its 
        affiliates, to the Secretary a list of--
                  ``(A) all approved abbreviated new drug applications 
                owned by such person; and
                  ``(B) if any affiliate of such person also owns an 
                abbreviated new drug application, all affiliates that 
                own any such abbreviated new drug applications and all 
                approved abbreviated new drug applications owned by any 
                such affiliate.
          ``(2) Format and method.--The Secretary shall specify in 
        guidance the format and method for submission of lists under 
        this subsection.''.

SEC. 304. REAUTHORIZATION; REPORTING REQUIREMENTS.

  Section 744C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379j-43) is amended--
          (1) in subsection (a)--
                  (A) by striking ``2013'' and inserting ``2018''; and
                  (B) by striking ``Generic Drug User Fee Amendments of 
                2012'' and inserting ``Generic Drug User Fee Amendments 
                of 2017'';
          (2) in subsection (b), by striking ``2013'' and inserting 
        ``2018''; and
          (3) in subsection (d), by striking ``2017'' each place it 
        appears and inserting ``2022''.

SEC. 305. SUNSET DATES.

  (a) Authorization.--Sections 744A and 744B of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379j-41; 379j-42) shall cease to be 
effective October 1, 2022.
  (b) Reporting Requirements.--Section 744C of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379j-43) shall cease to be effective 
January 31, 2023.
  (c) Previous Sunset Provision.--Effective October 1, 2017, 
subsections (a) and (b) of section 304 of the Food and Drug 
Administration Safety and Innovation Act (Public Law 112-144) are 
repealed.

SEC. 306. EFFECTIVE DATE.

  The amendments made by this title shall take effect on October 1, 
2017, or the date of the enactment of this Act, whichever is later, 
except that fees under part 7 of subchapter C of chapter VII of the 
Federal Food, Drug, and Cosmetic Act shall be assessed for all 
abbreviated new drug applications received on or after October 1, 2017, 
regardless of the date of the enactment of this Act.

SEC. 307. SAVINGS CLAUSE.

  Notwithstanding the amendments made by this title, part 7 of 
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic 
Act, as in effect on the day before the date of the enactment of this 
title, shall continue to be in effect with respect to abbreviated new 
drug applications (as defined in such part as of such day) that on or 
after October 1, 2012, but before October 1, 2017, were received by the 
Food and Drug Administration within the meaning of section 505(j)(5)(A) 
of such Act (21 U.S.C. 355(j)(5)(A)), prior approval supplements that 
were submitted, and drug master files for Type II active pharmaceutical 
ingredients that were first referenced with respect to assessing and 
collecting any fee required by such part for a fiscal year prior to 
fiscal year 2018.

       TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS

SEC. 401. SHORT TITLE; FINDING.

  (a) Short Title.--This title may be cited as the ``Biosimilar User 
Fee Amendments of 2017''.
  (b) Finding.--The Congress finds that the fees authorized by the 
amendments made in this title will be dedicated to expediting the 
process for the review of biosimilar biological product applications, 
including postmarket safety activities, as set forth in the goals 
identified for purposes of part 8 of subchapter C of chapter VII of the 
Federal Food, Drug, and Cosmetic Act, in the letters from the Secretary 
of Health and Human Services to the Chairman of the Committee on 
Health, Education, Labor, and Pensions of the Senate and the Chairman 
of the Committee on Energy and Commerce of the House of 
Representatives, as set forth in the Congressional Record.

SEC. 402. DEFINITIONS.

  (a) Adjustment Factor.--Section 744G(1) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379j-51(1)) is amended to read as follows:
          ``(1) The term `adjustment factor' applicable to a fiscal 
        year is the Consumer Price Index for urban consumers 
        (Washington-Baltimore, DC-MD-VA-WV; Not Seasonally Adjusted; 
        All items; Annual Index) for October of the preceding fiscal 
        year divided by such Index for October 2011.''.
  (b) Biosimilar Biological Product.--Section 744G(3) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-51(3)) is amended by 
striking ``means a product'' and inserting ``means a specific strength 
of a biological product in final dosage form''.

SEC. 403. AUTHORITY TO ASSESS AND USE BIOSIMILAR FEES.

  (a) Types of Fees.--Section 744H(a) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j-52(a)) is amended--
          (1) in the matter preceding paragraph (1), by striking 
        ``fiscal year 2013'' and inserting ``fiscal year 2018'';
          (2) in the heading of paragraph (1), by striking 
        ``Biosimilar'' and inserting ``Biosimilar biological product'';
          (3) in paragraph (1)(A)(i), by striking ``(b)(1)(A)'' and 
        inserting ``(c)(5)'';
          (4) in paragraph (1)(B)(i), by striking ``(b)(1)(B) for 
        biosimilar biological product development'' and inserting 
        ``(c)(5) for the biosimilar biological product development 
        program'';
          (5) in paragraph (1)(B)(ii), by striking ``annual biosimilar 
        biological product development program fee'' and inserting 
        ``annual biosimilar biological product development fee'';
          (6) in paragraph (1)(B)(iii), by striking ``annual biosimilar 
        development program fee'' and inserting ``annual biosimilar 
        biological product development fee'';
          (7) in paragraph (1)(B), by adding at the end the following:
                          ``(iv) Refund.--If a person submits a 
                        marketing application for a biosimilar 
                        biological product before October 1 of a fiscal 
                        year and such application is accepted for 
                        filing on or after October 1 of such fiscal 
                        year, the person may request a refund equal to 
                        the annual biosimilar development fee paid by 
                        the person for the product for such fiscal 
                        year. To qualify for consideration for a refund 
                        under this clause, a person shall submit to the 
                        Secretary a written request for such refund not 
                        later than 180 days after the marketing 
                        application is accepted for filing.'';
          (8) in paragraph (1)(C), by striking ``for a product 
        effective October 1 of a fiscal year by,'' and inserting ``for 
        a product, effective October 1 of a fiscal year, by,'';
          (9) in paragraph (1)(D)--
                  (A) in clause (i) in the matter preceding subclause 
                (I), by inserting ``, if the person seeks to resume 
                participation in such program,'' before ``pay a fee'';
                  (B) in clause (i)(I), by inserting after ``grants a 
                request'' the following: ``by such person''; and
                  (C) in clause (i)(II), by inserting after 
                ``discontinued)'' the following: ``by such person'';
          (10) in the heading of paragraph (1)(E), by striking 
        ``biosimilar development program'';
          (11) in paragraph (1)(F)--
                  (A) in the subparagraph heading, by striking 
                ``biosimilar development program'' before ``fees''; and
                  (B) by amending clause (i) to read as follows:
                          ``(i) Refunds.--Except as provided in 
                        subparagraph (B)(iv), the Secretary shall not 
                        refund any initial or annual biosimilar 
                        biological product development fee paid under 
                        subparagraph (A) or (B), or any reactivation 
                        fee paid under subparagraph (D).'';
          (12) in paragraph (2)--
                  (A) in the paragraph heading, by striking ``and 
                supplement'';
                  (B) by amending subparagraphs (A) and (B) to read as 
                follows:
                  ``(A) In general.--Each person that submits, on or 
                after October 1, 2017, a biosimilar biological product 
                application shall be subject to the following fees:
                          ``(i) A fee established under subsection 
                        (c)(5) for a biosimilar biological product 
                        application for which clinical data (other than 
                        comparative bioavailability studies) with 
                        respect to safety or effectiveness are required 
                        for approval.
                          ``(ii) A fee established under subsection 
                        (c)(5) for a biosimilar biological product 
                        application for which clinical data (other than 
                        comparative bioavailability studies) with 
                        respect to safety or effectiveness are not 
                        required for approval. Such fee shall be equal 
                        to half of the amount of the fee described in 
                        clause (i).
                  ``(B) Rule of applicability; treatment of certain 
                previously paid fees.--Any person who pays a fee under 
                subparagraph (A), (B), or (D) of paragraph (1) for a 
                product before October 1, 2017, but submits a 
                biosimilar biological product application for that 
                product after such date, shall--
                          ``(i) be subject to any biosimilar biological 
                        product application fees that may be assessed 
                        at the time when such biosimilar biological 
                        product application is submitted; and
                          ``(ii) be entitled to no reduction of such 
                        application fees based on the amount of fees 
                        paid for that product before October 1, 2017, 
                        under such subparagraphs (A), (B), or (D).'';
                  (C) in the heading of subparagraph (D), by striking 
                ``or supplement'';
                  (D) in subparagraphs (C) through (F), by striking 
                ``or supplement'' each place it appears; and
                  (E) in subparagraph (D), by striking ``or a 
                supplement'';
          (13) by amending paragraph (3) to read as follows:
          ``(3) Biosimilar biological product program fee.--
                  ``(A) In general.--Each person who is named as the 
                applicant in a biosimilar biological product 
                application shall pay the annual biosimilar biological 
                product program fee established for a fiscal year under 
                subsection (c)(5) for each biosimilar biological 
                product that--
                          ``(i) is identified in such a biosimilar 
                        biological product application approved as of 
                        October 1 of such fiscal year; and
                          ``(ii) as of October 1 of such fiscal year, 
                        does not appear on a list, developed and 
                        maintained by the Secretary, of discontinued 
                        biosimilar biological products.
                  ``(B) Due date.--The biosimilar biological product 
                program fee for a fiscal year shall be due on the later 
                of--
                          ``(i) the first business day on or after 
                        October 1 of each such year; or
                          ``(ii) the first business day after the 
                        enactment of an appropriations Act providing 
                        for the collection and obligation of fees for 
                        such year under this section.
                  ``(C) One fee per product per year.--The biosimilar 
                biological product program fee shall be paid only once 
                for each product for each fiscal year.
                  ``(D) Limitation.--A person who is named as the 
                applicant in a biosimilar biological product 
                application shall not be assessed more than 5 
                biosimilar biological product program fees for a fiscal 
                year for biosimilar biological products identified in 
                such biosimilar biological product application.''.
  (b) Fee Revenue Amounts.--Subsection (b) of section 744H of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52) is amended to 
read as follows:
  ``(b) Fee Revenue Amounts.--
          ``(1) Fiscal year 2018.--For fiscal year 2018, fees under 
        subsection (a) shall be established to generate a total revenue 
        amount equal to the sum of--
                  ``(A) $45,000,000; and
                  ``(B) the dollar amount equal to the fiscal year 2018 
                adjustment (as determined under subsection (c)(4)).
          ``(2) Subsequent fiscal years.--For each of the fiscal years 
        2019 through 2022, fees under subsection (a) shall, except as 
        provided in subsection (c), be established to generate a total 
        revenue amount equal to the sum of--
                  ``(A) the annual base revenue for the fiscal year (as 
                determined under paragraph (4));
                  ``(B) the dollar amount equal to the inflation 
                adjustment for the fiscal year (as determined under 
                subsection (c)(1));
                  ``(C) the dollar amount equal to the capacity 
                planning adjustment for the fiscal year (as determined 
                under subsection (c)(2)); and
                  ``(D) the dollar amount equal to the operating 
                reserve adjustment for the fiscal year, if applicable 
                (as determined under subsection (c)(3)).
          ``(3) Allocation of revenue amount among fees; limitations on 
        fee amounts.--
                  ``(A) Allocation.--The Secretary shall determine the 
                percentage of the total revenue amount for a fiscal 
                year to be derived from, respectively--
                          ``(i) initial and annual biosimilar 
                        development fees and reactivation fees under 
                        subsection (a)(1);
                          ``(ii) biosimilar biological product 
                        application fees under subsection (a)(2); and
                          ``(iii) biosimilar biological product program 
                        fees under subsection (a)(3).
                  ``(B) Limitations on fee amounts.--Until the first 
                fiscal year for which the capacity planning adjustment 
                under subsection (c)(2) is effective, the amount of any 
                fee under subsection (a) for a fiscal year after fiscal 
                year 2018 shall not exceed 125 percent of the amount of 
                such fee for fiscal year 2018.
                  ``(C) Biosimilar biological product development 
                fees.--The initial biosimilar biological product 
                development fee under subsection (a)(1)(A) for a fiscal 
                year shall be equal to the annual biosimilar biological 
                product development fee under subsection (a)(1)(B) for 
                that fiscal year.
                  ``(D) Reactivation fee.--The reactivation fee under 
                subsection (a)(1)(D) for a fiscal year shall be equal 
                to twice the amount of the annual biosimilar biological 
                product development fee under subsection (a)(1)(B) for 
                that fiscal year.
          ``(4) Annual base revenue.--For purposes of paragraph (2), 
        the dollar amount of the annual base revenue for a fiscal year 
        shall be the dollar amount of the total revenue amount for the 
        previous fiscal year, excluding any adjustments to such revenue 
        amount under subsection (c)(3).''.
  (c) Adjustments; Annual Fee Setting.--Section 744H of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52) is amended--
          (1) by redesignating subsections (c) through (h) as 
        subsections (d) through (i), respectively;
          (2) in subsections (a)(2)(F) and (h) (as redesignated by 
        paragraph (1)), by striking ``subsection (c)'' and inserting 
        ``subsection (d)'';
          (3) in subsection (a)(4)(A), by striking ``subsection 
        (b)(1)(F)'' and inserting ``subsection (c)(5)''; and
          (4) by inserting after subsection (b) the following:
  ``(c) Adjustments; Annual Fee Setting.--
          ``(1) Inflation adjustment.--
                  ``(A) In general.--For purposes of subsection 
                (b)(2)(B), the dollar amount of the inflation 
                adjustment to the annual base revenue for each fiscal 
                year shall be equal to the product of--
                          ``(i) such annual base revenue for the fiscal 
                        year under subsection (b); and
                          ``(ii) the inflation adjustment percentage 
                        under subparagraph (B).
                  ``(B) Inflation adjustment percentage.--The inflation 
                adjustment percentage under this subparagraph for a 
                fiscal year is equal to the sum of--
                          ``(i) the average annual percent change in 
                        the cost, per full-time equivalent position of 
                        the Food and Drug Administration, of all 
                        personnel compensation and benefits paid with 
                        respect to such positions for the first 3 years 
                        of the preceding 4 fiscal years, multiplied by 
                        the proportion of personnel compensation and 
                        benefits costs to total costs of the process 
                        for the review of biosimilar biological product 
                        applications (as defined in section 744G(13)) 
                        for the first 3 years of the preceding 4 fiscal 
                        years; and
                          ``(ii) the average annual percent change that 
                        occurred in the Consumer Price Index for urban 
                        consumers (Washington-Baltimore, DC-MD-VA-WV; 
                        Not Seasonally Adjusted; All items; Annual 
                        Index) for the first 3 years of the preceding 4 
                        years of available data multiplied by the 
                        proportion of all costs other than personnel 
                        compensation and benefits costs to total costs 
                        of the process for the review of biosimilar 
                        biological product applications (as defined in 
                        section 744G(13)) for the first 3 years of the 
                        preceding 4 fiscal years.
          ``(2) Capacity planning adjustment.--
                  ``(A) In general.--Beginning with the fiscal year 
                described in subparagraph (B)(ii)(II), the Secretary 
                shall, in addition to the adjustment under paragraph 
                (1), further increase the fee revenue and fees under 
                this section for a fiscal year to reflect changes in 
                the resource capacity needs of the Secretary for the 
                process for the review of biosimilar biological product 
                applications.
                  ``(B) Capacity planning methodology.--
                          ``(i) Development; evaluation and report.--
                        The Secretary shall obtain, through a contract 
                        with an independent accounting or consulting 
                        firm, a report evaluating options and 
                        recommendations for a new methodology to 
                        accurately assess changes in the resource and 
                        capacity needs of the process for the review of 
                        biosimilar biological product applications. The 
                        capacity planning methodological options and 
                        recommendations presented in such report shall 
                        utilize and be informed by personnel time 
                        reporting data as an input. The report shall be 
                        published for public comment not later than 
                        September 30, 2020.
                          ``(ii) Establishment and implementation.--
                        After review of the report described in clause 
                        (i) and receipt and review of public comments 
                        thereon, the Secretary shall establish a 
                        capacity planning methodology for purposes of 
                        this paragraph, which shall--
                                  ``(I) incorporate such approaches and 
                                attributes as the Secretary determines 
                                appropriate; and
                                  ``(II) be effective beginning with 
                                the first fiscal year for which fees 
                                are set after such capacity planning 
                                methodology is established.
                  ``(C) Limitation.--Under no circumstances shall an 
                adjustment under this paragraph result in fee revenue 
                for a fiscal year that is less than the sum of the 
                amounts under subsections (b)(2)(A) (the annual base 
                revenue for the fiscal year) and (b)(2)(B) (the dollar 
                amount of the inflation adjustment for the fiscal 
                year).
                  ``(D) Publication in federal register.--The Secretary 
                shall publish in the Federal Register notice under 
                paragraph (5) the fee revenue and fees resulting from 
                the adjustment and the methodologies under this 
                paragraph.
          ``(3) Operating reserve adjustment.--
                  ``(A) Interim application; fee reduction.--Until the 
                first fiscal year for which the capacity planning 
                adjustment under paragraph (2) is effective, the 
                Secretary may, in addition to the adjustment under 
                paragraph (1), reduce the fee revenue and fees under 
                this section for a fiscal year as the Secretary 
                determines appropriate for long-term financial planning 
                purposes.
                  ``(B) General application and methodology.--Beginning 
                with the first fiscal year for which the capacity 
                planning adjustment under paragraph (2) is effective, 
                the Secretary may, in addition to the adjustments under 
                paragraphs (1) and (2)--
                          ``(i) reduce the fee revenue and fees under 
                        this section as the Secretary determines 
                        appropriate for long-term financial planning 
                        purposes; or
                          ``(ii) increase the fee revenue and fees 
                        under this section if such an adjustment is 
                        necessary to provide for not more than 21 weeks 
                        of operating reserves of carryover user fees 
                        for the process for the review of biosimilar 
                        biological product applications.
                  ``(C) Federal register notice.--If an adjustment 
                under subparagraph (A) or (B) is made, the rationale 
                for the amount of the increase or decrease (as 
                applicable) in fee revenue and fees shall be contained 
                in the annual Federal Register notice under paragraph 
                (5) establishing fee revenue and fees for the fiscal 
                year involved.
          ``(4) Fiscal year 2018 adjustment.--
                  ``(A) In general.--For fiscal year 2018, the 
                Secretary shall adjust the fee revenue and fees under 
                this section in such amount (if any) as needed to 
                reflect an updated assessment of the workload for the 
                process for the review of biosimilar biological product 
                applications.
                  ``(B) Methodology.--The Secretary shall publish under 
                paragraph (5) a description of the methodology used to 
                calculate the fiscal year 2018 adjustment under this 
                paragraph in the Federal Register notice establishing 
                fee revenue and fees for fiscal year 2018.
                  ``(C) Limitation.--No adjustment under this paragraph 
                shall result in an increase in fee revenue and fees 
                under this section in excess of $9,000,000.
          ``(5) Annual fee setting.--For fiscal year 2018 and each 
        subsequent fiscal year, the Secretary shall, not later than 60 
        days before the start of each such fiscal year--
                  ``(A) establish, for the fiscal year, initial and 
                annual biosimilar biological product development fees 
                and reactivation fees under subsection (a)(1), 
                biosimilar biological product application fees under 
                subsection (a)(2), and biosimilar biological product 
                program fees under subsection (a)(3), based on the 
                revenue amounts established under subsection (b) and 
                the adjustments provided under this subsection; and
                  ``(B) publish such fee revenue and fees in the 
                Federal Register.
          ``(6) Limit.--The total amount of fees assessed for a fiscal 
        year under this section may not exceed the total costs for such 
        fiscal year for the resources allocated for the process for the 
        review of biosimilar biological product applications.''.
  (d) Application Fee Waiver for Small Business.--Subsection (d)(1) of 
section 744H of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379j-52), as redesignated by subsection (c)(1), is amended--
          (1) by striking subparagraph (B);
          (2) by striking ``shall pay--'' and all that follows through 
        ``application fees'' and inserting ``shall pay application 
        fees''; and
          (3) by striking ``; and'' at the end and inserting a period.
  (e) Effect of Failure To Pay Fees.--Subsection (e) of section 744H of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52), as 
redesignated by subsection (c)(1), is amended by striking ``all fees'' 
and inserting ``all such fees''.
  (f) Crediting and Availability of Fees.--Subsection (f) of section 
744H of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52), 
as redesignated by subsection (c)(1), is amended--
          (1) in paragraph (2)--
                  (A) by striking subparagraph (C) (relating to fee 
                collection during first program year) and inserting the 
                following:
                  ``(C) Compliance.--The Secretary shall be considered 
                to have met the requirements of subparagraph (B) in any 
                fiscal year if the costs described in such subparagraph 
                are not more than 15 percent below the level specified 
                in such subparagraph.''; and
                  (B) in subparagraph (D)--
                          (i) in the heading, by striking ``in 
                        subsequent years''; and
                          (ii) by striking ``(after fiscal year 
                        2013)''; and
          (2) in paragraph (3), by striking ``2013 through 2017'' and 
        inserting ``2018 through 2022''.

SEC. 404. REAUTHORIZATION; REPORTING REQUIREMENTS.

  Section 744I of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379j-53) is amended--
          (1) in subsection (a)--
                  (A) by striking ``2013'' and inserting ``2018''; and
                  (B) by striking ``Biosimilar User Fee Act of 2012'' 
                and inserting ``Biosimilar User Fee Amendments of 
                2017'';
          (2) in subsection (b), by striking ``2013'' and inserting 
        ``2018'';
          (3) by striking subsection (d);
          (4) by redesignating subsection (e) as subsection (d); and
          (5) in subsection (d), as so redesignated, by striking 
        ``2017'' each place it appears and inserting ``2022''.

SEC. 405. SUNSET DATES.

  (a) Authorization.--Sections 744G and 744H of the Federal Food, Drug, 
and Cosmetic Act, as amended by section 403 of this Act, shall cease to 
be effective October 1, 2022.
  (b) Reporting Requirements.--Section 744I of the Federal Food, Drug, 
and Cosmetic Act, as amended by section 404 of this Act, shall cease to 
be effective January 31, 2023.
  (c) Previous Sunset Provision.--
          (1) In general.--Effective October 1, 2017, section 404 of 
        the Food and Drug Administration Safety and Innovation Act 
        (Public Law 112-144) is repealed.
          (2) Conforming amendment.--The Food and Drug Administration 
        Safety and Innovation Act (Public Law 112-144) is amended in 
        the table of contents in section 2 by striking the item 
        relating to section 404.

SEC. 406. EFFECTIVE DATE.

  The amendments made by this title shall take effect on October 1, 
2017, or the date of the enactment of this Act, whichever is later, 
except that fees under part 8 of subchapter C of chapter VII of the 
Federal Food, Drug, and Cosmetic Act shall be assessed for all 
biosimilar biological product applications received on or after October 
1, 2017, regardless of the date of the enactment of this Act.

SEC. 407. SAVINGS CLAUSE.

  Notwithstanding the amendments made by this title, part 8 of 
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic 
Act, as in effect on the day before the date of the enactment of this 
title, shall continue to be in effect with respect to biosimilar 
biological product applications and supplements (as defined in such 
part as of such day) that were accepted by the Food and Drug 
Administration for filing on or after October 1, 2012, but before 
October 1, 2017, with respect to assessing and collecting any fee 
required by such part for a fiscal year prior to fiscal year 2018.

      TITLE V--REAUTHORIZATIONS AND IMPROVEMENTS RELATED TO DRUGS

SEC. 501. REAUTHORIZATION OF PROVISION RELATING TO EXCLUSIVITY OF 
                    CERTAIN DRUGS CONTAINING SINGLE ENANTIOMERS.

  Section 505(u)(4) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(u)(4)) is amended by striking ``2017'' and inserting 
``2022''.

SEC. 502. REAUTHORIZATION OF ORPHAN GRANTS PROGRAM.

  Section 5(c) of the Orphan Drug Act (21 U.S.C. 360ee(c)) is amended 
by striking ``2013 through 2017'' and inserting ``2018 through 2022''.

SEC. 503. REAUTHORIZATION OF PEDIATRIC STUDY OF DRUGS.

  Section 409I(e)(1) of the Public Health Service Act (42 U.S.C. 
284m(e)(1)) is amended by striking ``2013 through 2017'' and inserting 
``2018 through 2022''.

SEC. 504. PROTECTING AND STRENGTHENING THE DRUG SUPPLY CHAIN.

  (a) Diverted Drugs.--Paragraph (1) of section 801(d) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 381(d)) is amended--
          (1) by striking ``(d)(1) Except as'' and inserting 
        ``(d)(1)(A) Except as''; and
          (2) by adding at the end the following:
  ``(B) Except as authorized by the Secretary in the case of a drug 
that appears on the drug shortage list in effect under section 506E, no 
drug that would be subject to section 503(b), and which is manufactured 
outside the United States and intended by the manufacturer or labeled 
to be marketed outside the United States, may be imported into the 
United States for sale or commercial use.''.
  (b) Counterfeit Drugs.--Subsection (b) of section 303 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amended by adding at 
the end the following:
  ``(8) Notwithstanding subsection (a), any person who violates section 
301(i)(3) by knowingly making, selling or dispensing, or holding for 
sale or dispensing, a counterfeit drug shall be imprisoned for not more 
than 10 years or fined in accordance with title 18, United States Code, 
or both.''.

SEC. 505. SENSE OF CONGRESS ON LOWERING THE COST OF PRESCRIPTION DRUGS.

  It is the sense of the Congress that the Secretary of Health and 
Human Services should commit to engaging with the House of 
Representatives and the Senate to take administrative actions and enact 
legislative changes that--
          (1) will lower the cost of prescription drugs for consumers 
        and reduce the burden of such cost on taxpayers; and
          (2) in lowering such cost, will--
                  (A) balance the need to encourage innovation with the 
                need to improve affordability; and
                  (B) strive to increase competition in the 
                pharmaceutical market, prevent anticompetitive 
                behavior, and promote the timely availability of 
                affordable, high-quality generic drugs and biosimilars.

        TITLE VI--DEVICE INSPECTION AND REGULATORY IMPROVEMENTS

      Subtitle A--Improving the Process for Inspections of Device 
                             Establishments

SEC. 601. RISK-BASED INSPECTIONS FOR DEVICES.

  Paragraph (2) of section 510(h) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360(h)) is amended to read as follows:
          ``(2) Risk-based schedule for devices.--
                  ``(A) In general.--The Secretary, acting through one 
                or more officers or employees duly designated by the 
                Secretary, shall inspect establishments described in 
                paragraph (1) that are engaged in the manufacture, 
                propagation, compounding, or processing of a device or 
                devices (referred to in this subsection as `device 
                establishments') in accordance with a risk-based 
                schedule established by the Secretary.
                  ``(B) Factors and considerations.--In establishing 
                the risk-based schedule under subparagraph (A), the 
                Secretary shall--
                          ``(i) apply, to the extent applicable for 
                        device establishments, the factors identified 
                        in paragraph (4); and
                          ``(ii) consider the participation of the 
                        device establishment, as applicable, in 
                        international device audit programs in which 
                        the United States participates or which the 
                        United States recognizes for purposes of 
                        inspecting device establishments.''.

SEC. 602. RECOGNITION OF FOREIGN GOVERNMENT INSPECTIONS.

  Subsection (a)(1) of section 809 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 384e(a)(1)) is amended by inserting ``or 
510(h)(2) (as applicable)'' before the semicolon at the end.

SEC. 603. IMPROVEMENTS TO INSPECTIONS PROCESS FOR DEVICE 
                    ESTABLISHMENTS.

  (a) In General.--Section 704 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 374) is amended by adding at the end the following:
  ``(h)(1) In the case of inspections other than for-cause inspections, 
the Secretary shall review processes and standards applicable to 
inspections of domestic and foreign device establishments in effect as 
of the date of the enactment of this subsection, and update such 
processes and standards through the adoption of uniform processes and 
standards applicable to such inspections. Such processes and standards 
shall provide for--
          ``(A) exceptions to such processes and standards, as 
        appropriate;
          ``(B) announcing the inspection of the establishment within a 
        reasonable time before such inspection occurs, including by 
        providing to the owner, operator, or agent in charge of the 
        establishment a notification regarding the type and nature of 
        the inspection;
          ``(C) a reasonable estimate of the timeframe for the 
        inspection, an opportunity for advance communications between 
        the officers or employees carrying out the inspection under 
        subsection (a)(1) and the owner, operator, or agent in charge 
        of the establishment concerning appropriate working hours 
        during the inspection, and, to the extent feasible, advance 
        notice of some records that will be requested in order to 
        expedite the inspection; and
          ``(D) regular communications during the inspection with the 
        owner, operator, or agent in charge of the establishment 
        regarding inspection status, which may be recorded by either 
        party with advance notice and mutual consent.
  ``(2)(A) The Secretary shall, with respect to a request described in 
subparagraph (B), provide nonbinding feedback with respect to such 
request not later than 45 days after the Secretary receives such 
request.
  ``(B) A request described in this subparagraph is a request for 
feedback--
          ``(i) that is made by the owner, operator, or agent in charge 
        of such establishment in a timely manner; and
          ``(ii) with respect to actions proposed to be taken by a 
        device establishment in a response to a report received by such 
        establishment pursuant to subsection (b) that involve a public 
        health priority, that implicate systemic or major actions, or 
        relate to emerging safety issues (as determined by the 
        Secretary).
  ``(3) Nothing in this subsection limits the authority of the 
Secretary to conduct inspections otherwise permitted under this Act in 
order to ensure compliance with this Act.''.
  (b) Guidance.--
          (1) Draft guidance.--Not later than 18 months after the date 
        of enactment of this section, the Secretary of Health and Human 
        Services shall issue draft guidance that--
                  (A) specifies how the Food and Drug Administration 
                will implement the process described in paragraph (1) 
                of subsection (h) of section 704 of the Federal Food, 
                Drug, and Cosmetic Act (21 U.S.C. 374), as added by 
                subsection (a), and the requirements described in 
                paragraph (2) of such subsection;
                  (B) provides for standardized methods for 
                communications described in such paragraphs;
                  (C) establishes, with respect to inspections of both 
                domestic and foreign device establishments (as referred 
                to in section 510(h)(2) of the Federal Food, Drug, and 
                Cosmetic Act, as amended by subsection (a)), a standard 
                timeframe for such inspections--
                          (i) that occurs over consecutive days; and
                          (ii) to which each investigator conducting 
                        such an inspection shall adhere unless the 
                        investigator identifies to the establishment 
                        involved a reason that more time is needed to 
                        conduct such investigation; and
                  (D) identifies practices for investigators and device 
                establishments to facilitate the continuity of 
                inspections of such establishments.
          (2) Final guidance.--Not later than 1 year after providing 
        notice and opportunity for public comment on the draft guidance 
        issued under paragraph (1), the Secretary of Health and Human 
        Services shall issue final guidance to implement subsection (h) 
        of section 704 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 374), as added by subsection (a).

SEC. 604. CERTIFICATES TO FOREIGN GOVERNMENTS FOR DEVICES.

  (a) In General.--Subsection (e)(4) of section 801 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 381(e)(4)) is amended--
          (1) by adding at the end the following:
  ``(E)(i) If the Secretary denies a request made under subparagraph 
(A)(ii) for certification with respect to a device, the Secretary shall 
provide, in writing, to the person seeking such certification the basis 
for such denial, and specifically identify the finding upon which such 
denial is based.
  ``(ii) If the denial of a request as described in clause (i) is based 
on--
          ``(I) grounds other than an injunction proceeding pursuant to 
        section 302, seizure action pursuant to section 304, or a 
        recall designated Class I or Class II pursuant to part 7, title 
        21, Code of Federal Regulations, and
          ``(II) an establishment being considered out of compliance 
        with part 820, title 21, Code of Federal Regulations,
the Secretary shall provide a substantive summary of the specific 
grounds for noncompliance so identified, if such grounds have not been 
previously communicated to the manufacturer.
  ``(iii) With respect to a device manufactured in an establishment 
that has received a report under section 704(b), the Secretary shall 
not deny a request for certification under subparagraph (A)(ii) based 
exclusively on the issuance of that report if the owner, operator, or 
agent in charge of such establishment has agreed to a plan of 
correction in response to such report.
  ``(F)(i) The Secretary shall provide a process for a person who is 
denied a certification as described in subparagraph (E)(i) to request a 
review that conforms to the standards of section 517A(b).
  ``(ii) Notwithstanding any previous review conducted pursuant to 
clause (i), a person who has been denied a certification for a device 
as described in subparagraph (E)(i) may, at any time, request a review 
of that denial in order to present new information relating to actions 
taken by such person to address the reasons identified by the Secretary 
for such denial, including evidence that corrective actions are being 
or have been implemented to address the grounds for noncompliance 
identified by the Secretary under subparagraph (E)(ii).
  ``(G)(i) This paragraph applies to requests for certification on 
behalf of any device establishment registered under section 510, 
whether the establishment is located in the United States or another 
country. 
  ``(ii) The Secretary may charge a fee for the issuance of a 
certification described in clause (i), and such fee is subject to the 
same conditions and requirements as a fee charged under subparagraph 
(B) for a certification issued under such subparagraph.''; and
          (2) by moving the margins of subparagraphs (C) and (D) 4 ems 
        to the left.
  (b) Guidance.--Not later than 1 year after date of the enactment of 
this section, the Secretary of Health and Human Services shall issue 
guidance providing for a process to carry out subparagraph (F) of 
section 801(e)(4) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 381(e)(4)), as added by subsection (a). Not later than 12 months 
after the comment period closes for the draft guidance, the Secretary 
shall issue final guidance.

SEC. 605. FACILITATING INTERNATIONAL HARMONIZATION.

  Section 704(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
374(g)) is amended by adding at the end the following:
  ``(15) Notwithstanding any other provision of this subsection, for 
purposes of conducting inspections of establishments that manufacture, 
prepare, propagate, compound, or process devices except types of 
devices licensed under section 351 of the Public Health Service Act, 
which inspections are required under section 510(h) or are inspections 
of such establishments required to register pursuant to section 510(i), 
the Secretary may recognize auditing organizations that are recognized 
by organizations established by governments to facilitate international 
harmonization. Nothing in this paragraph affects the authority of the 
Secretary to inspect any device establishment pursuant to this Act. 
Nothing in this paragraph affects the authority of the Secretary to 
determine the official classification of an inspection.''.

SEC. 606. REAUTHORIZATION OF INSPECTION PROGRAM.

  Section 704(g)(11) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 374(g)(11)) is amended by striking ``October 1, 2017'' and 
inserting ``October 1, 2022''.

                      Subtitle B--Other Provisions

SEC. 611. REAUTHORIZATION OF PEDIATRIC HUMANITARIAN DEVICE EXCEPTIONS.

  Section 520(m)(6)(A)(iv) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360j(m)(6)(A)(iv)) is amended by striking ``2017'' and 
inserting ``2022''.

SEC. 612. REAUTHORIZATION OF PEDIATRIC DEVICE CONSORTIA.

  Section 305(e) of the Pediatric Medical Device Safety and Improvement 
Act of 2007 (Public Law 110-85; 42 U.S.C. 282 note)) is amended by 
striking ``2013 through 2017'' and inserting ``2018 through 2022''.

SEC. 613. REGULATION OF OVER-THE-COUNTER HEARING AIDS.

  (a) In General.--Section 520 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360j) is amended by adding at the end the following:
  ``(p) Regulation of Over-the-Counter Hearing Aids.--
          ``(1) Definition.--
                  ``(A) In this subsection, the term `over-the-counter 
                hearing aid' means a device--
                          ``(i) that uses the same fundamental 
                        scientific technology as air conduction hearing 
                        aids (as defined in section 874.3300 of title 
                        21, Code of Federal Regulations) (or any 
                        successor regulation) or wireless air 
                        conduction hearing aids (as defined in section 
                        874.3305 of title 21, Code of Federal 
                        Regulations) (or any successor regulation);
                          ``(ii) that is intended to be used by adults 
                        over the age of 18 to compensate for perceived 
                        mild to moderate hearing impairment;
                          ``(iii) that, through tools, tests, or 
                        software, allows the user to control the over-
                        the-counter hearing aid and customize it to the 
                        user's hearing needs;
                          ``(iv) that may--
                                  ``(I) use wireless technology; or
                                  ``(II) include tests for self-
                                assessment of hearing loss; and
                          ``(v) that is available over-the-counter, 
                        without the supervision, prescription, or other 
                        order, involvement, or intervention of a 
                        licensed person, to consumers through in-person 
                        transactions, by mail, or online.
                  ``(B) Such term does not include a personal sound 
                amplification product intended to amplify sound for 
                nonhearing impaired consumers in situations including 
                hunting and bird-watching.
          ``(2) Regulation.--An over-the-counter hearing aid shall be 
        subject to the regulations promulgated in accordance with 
        section 613(b) of the FDA Reauthorization Act of 2017 and shall 
        be exempt from sections 801.420 and 801.421 of title 21, Code 
        of Federal Regulations (or any successor regulations).''.
  (b) Regulations To Establish Category.--
          (1) In general.--The Secretary of Health and Human Services 
        (referred to in this section as the ``Secretary''), not later 
        than 3 years after the date of enactment of this Act, shall 
        promulgate proposed regulations to establish a category of 
        over-the-counter hearing aids, as defined in subsection (p) of 
        section 520 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 360j) as amended by subsection (a), and, not later than 
        180 days after the date on which the public comment period on 
        the proposed regulations closes, shall issue such final 
        regulations.
          (2) Requirements.--In promulgating the regulations under 
        paragraph (1), the Secretary shall--
                  (A) include requirements that provide reasonable 
                assurances of the safety and efficacy of over-the-
                counter hearing aids;
                  (B) include requirements that establish or adopt 
                output limits appropriate for over-the-counter hearing 
                aids;
                  (C) include requirements for appropriate labeling of 
                the over-the-counter hearing aid, including 
                requirements that such labeling include a conspicuous 
                statement that the device is only intended for adults 
                over the age of 18, information on how consumers may 
                report adverse events, information on any 
                contraindications, conditions, or symptoms of medically 
                treatable causes of hearing loss, and advisements to 
                consult promptly with a licensed physician; and
                  (D) describe the requirements under which the sale of 
                over-the-counter hearing aids is permitted, without the 
                supervision, prescription, or other order, involvement, 
                or intervention of a licensed person, to consumers 
                through in-person transactions, by mail, or online.
          (3) Premarket notification.--The Secretary shall make 
        findings under section 510(m) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 360(m)) to determine whether over-the-
        counter hearing aids (as defined in section 520(p) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j), as 
        amended by subsection (a)) require a report under section 
        510(k) to provide reasonable assurance of safety and 
        effectiveness.
          (4) Effect on state law.--No State or local government shall 
        establish or continue in effect any law, regulation, order, or 
        other requirement specifically related to hearing products that 
        would restrict or interfere with the servicing, marketing, 
        sale, dispensing, use, customer support, or distribution of 
        over-the-counter hearing aids (as defined in section 520(p) of 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j), as 
        amended by subsection (a)) through in-person transactions, by 
        mail, or online, that is different from, in addition to, or 
        otherwise not identical to, the regulations promulgated under 
        this subsection, including any State or local requirement for 
        the supervision, prescription, or other order, involvement, or 
        intervention of a licensed person for consumers to access over-
        the-counter hearing aids.
          (5) No effect on private remedies.--Nothing in this section 
        shall be construed to modify or otherwise affect the ability of 
        any person to exercise a private right of action under any 
        State or Federal product liability, tort, warranty, contract, 
        or consumer protection law.
  (c) New Guidance Issued.--Not later than the date on which final 
regulations are issued under subsection (b), the Secretary shall update 
and finalize the draft guidance of the Department of Health and Human 
Services entitled ``Regulatory Requirements for Hearing Aid Devices and 
Personal Sound Amplification Products'', issued on November 7, 2013. 
Such updated and finalized guidance shall clarify which products, on 
the basis of claims or other marketing, advertising, or labeling 
material, meet the definition of a device in section 201 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321) and which products meet 
the definition of a personal sound amplification product, as set forth 
in such guidance.
  (d) Report.--Not later than 2 years after the date on which the final 
regulations described in subsection (b)(1) are issued, the Secretary of 
Health and Human Services shall submit to Congress a report analyzing 
any adverse events relating to over-the-counter hearing aids (as 
defined in subsection (p)(1) of section 520 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360j)).

SEC. 614. REPORT ON ENSURING QUALITY, SAFETY, AND CONTINUED 
                    EFFECTIVENESS OF DEVICES THAT HAVE BEEN SERVICED.

  (a) In General.--Not later than 180 days after the date of enactment 
of this Act, the Secretary of Health and Human Services, acting through 
the Commissioner of Food and Drugs, 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 how 
the Food and Drug Administration intends to ensure the quality, safety, 
and continued effectiveness of devices (as defined in section 201(h) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301(h))) with 
respect to which servicing (as defined in subsection (c)) has been 
performed by any entity engaging in such servicing.
  (b) Contents.--The report submitted under subsection (a) shall 
contain--
          (1) the status of, and findings to date with respect to, the 
        notice entitled ``Refurbishing, Reconditioning, Rebuilding, 
        Remarketing, Remanufacturing, and Servicing of Medical Devices 
        Performed by Third-Party Entities and Original Equipment 
        Manufacturers; Request for Comments'' published by the Food and 
        Drug Administration on April 25, 2016 (81 Fed. Reg. 24041 et 
        seq.), including how the Food and Drug Administration intends 
        to define the specific activities performed on a device by the 
        manufacturer of the device or other entities;
          (2) a description of the statutory or regulatory authority of 
        the Food and Drug Administration used to oversee and regulate 
        servicing conducted with respect to devices;
          (3) details on how the Food and Drug Administration intends 
        to protect the public health by ensuring consistent quality, 
        safety, and continued effectiveness of devices with respect to 
        which servicing has been performed by any entity engaging in 
        such servicing;
          (4) information on how the Food and Drug Administration can 
        better understand the device servicing industry, including the 
        size, scope, location, and composition of entities performing 
        such servicing and the rate of adverse events related to such 
        servicing;
          (5) information regarding the current regulation by States, 
        the Joint Commission, or other regulatory bodies of servicing 
        conducted with respect to devices by all entities, including 
        original equipment manufacturers, third-party entities, and 
        hospitals; and
          (6) any additional information determined by the Secretary 
        (acting through the Commissioner) to be relevant to ensuring 
        the quality, safety, and continued effectiveness of devices 
        with respect to which servicing has been performed, including 
        whether additional Federal statutory authority is necessary to 
        ensure such quality, safety, and continued effectiveness.
  (c) Servicing Defined.--In this section, the term ``servicing'' 
includes, with respect to a device, refurbishing, reconditioning, 
rebuilding, remarketing, remanufacturing, repairing, or other servicing 
of the device by a person other than the manufacturer of the device.

SEC. 615. DEVICE PILOT PROJECTS TO GENERATE RELIABLE AND TIMELY SAFETY 
                    AND ACTIVE SURVEILLANCE DATA.

  (a) In General.--Section 519 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360i) is amended by adding at the end the following:
  ``(i) Pilot Projects To Generate Reliable and Timely Safety and 
Active Surveillance Data.--
          ``(1) In general.--The Secretary shall, not later than one 
        year after the date of the enactment of the FDA Reauthorization 
        Act of 2017, initiate one or more pilot projects relating to 
        providing timely and reliable information on the safety and 
        effectiveness of devices approved under section 515, cleared 
        under section 510(k), or classified under section 513(f)(2), in 
        which a manufacturer or manufacturers of a device or device 
        type voluntarily participate. Any such project shall meet each 
        of the following criteria:
                  ``(A) The project is designed to efficiently generate 
                reliable and timely safety and active surveillance data 
                for use by the Secretary or manufacturers of the 
                devices that are involved in the pilot project.
                  ``(B) The project informs, to the extent applicable, 
                the development of methods, systems, data criteria, and 
                programs that could be used to support safety and 
                active surveillance activities for any device.
                  ``(C) The project shall be designed and conducted in 
                coordination with a comprehensive system for evaluating 
                device technology that operates under a governing board 
                with appropriate representation of stakeholders, 
                including patient groups and device manufacturers.
                  ``(D) The project uses electronic health data 
                including, as appropriate, claims data, patient survey 
                data, and any other data, as the Secretary determines 
                appropriate.
                  ``(E) The project prioritizes devices and device 
                types that meet one or more of the following criteria:
                          ``(i) Devices and device types for which the 
                        collection and analysis of real world evidence 
                        regarding a device's safety and effectiveness 
                        is likely to advance public health.
                          ``(ii) Devices and device types that are 
                        widely used.
                          ``(iii) Devices and device types, the failure 
                        of which has significant health consequences.
                          ``(iv) Devices and device types for which the 
                        Secretary--
                                  ``(I) has received public 
                                recommendations in accordance with 
                                paragraph (2)(B); and
                                  ``(II) has determined to meet one of 
                                the criteria under clause (i), (ii), or 
                                (iii) and is appropriate for such a 
                                pilot project.
          ``(2) Participation.--The Secretary shall establish the 
        conditions and processes--
                  ``(A) under which a manufacturer of a device may 
                voluntarily participate in a pilot project described in 
                paragraph (1); and
                  ``(B) for facilitating public recommendations for 
                devices to be prioritized under such a pilot project, 
                including requirements for the data necessary to 
                support such a recommendation.
          ``(3) Continuation of ongoing projects.--The Secretary may 
        continue or expand projects, with respect to providing timely 
        and reliable information on the safety and effectiveness of 
        devices approved under section 515, cleared under section 
        510(k), or classified under section 513(f)(2), that are being 
        carried out as of the date of the enactment of the FDA 
        Reauthorization Act of 2017. The Secretary shall, beginning on 
        such date of enactment, take such steps as may be necessary--
                  ``(A) to ensure such projects meet the requirements 
                of subparagraphs (A) through (E) of paragraph (1); and
                  ``(B) to increase the voluntary participation in such 
                projects of manufacturers of devices and facilitate 
                public recommendations for any devices prioritized 
                under such a project.
          ``(4) Implementation.--
                  ``(A) Contracting authority.--The Secretary may carry 
                out a pilot project meeting the criteria specified in 
                subparagraphs (A) through (E) of paragraph (1) or a 
                project continued or expanded under paragraph (3) by 
                entering into contracts, cooperative agreements, 
                grants, or other appropriate agreements with public or 
                private entities that have a significant presence in 
                the United States and meet the following conditions:
                          ``(i) If such an entity is a component of 
                        another organization, the entity and the 
                        organization have established an agreement 
                        under which appropriate security measures are 
                        implemented to maintain the confidentiality and 
                        privacy of the data described in paragraph 
                        (1)(D) and such agreement ensures that the 
                        entity will not make an unauthorized disclosure 
                        of such data to the other components of the 
                        organization in breach of requirements with 
                        respect to confidentiality and privacy of such 
                        data established under such security measures.
                          ``(ii) In the case of the termination or 
                        nonrenewal of such a contract, cooperative 
                        agreement, grant, or other appropriate 
                        agreement, the entity or entities involved 
                        shall comply with each of the following:
                                  ``(I) The entity or entities shall 
                                continue to comply with the 
                                requirements with respect to 
                                confidentiality and privacy referred to 
                                in clause (i) under this subparagraph 
                                with respect to all data disclosed to 
                                the entity under such an agreement.
                                  ``(II) The entity or entities shall 
                                return any data disclosed to such 
                                entity pursuant to this subsection and 
                                to which it would not otherwise have 
                                access or, if returning such data is 
                                not practicable, destroy the data.
                          ``(iii) The entity or entities shall have one 
                        or more qualifications with respect to--
                                  ``(I) research, statistical, 
                                epidemiologic, or clinical capability 
                                and expertise to conduct and complete 
                                the activities under this subsection, 
                                including the capability and expertise 
                                to provide the Secretary access to de-
                                identified data consistent with the 
                                requirements of this subsection;
                                  ``(II) an information technology 
                                infrastructure to support electronic 
                                data and operational standards to 
                                provide security for such data, as 
                                appropriate;
                                  ``(III) experience with, and 
                                expertise on, the development of 
                                research on, and surveillance of, 
                                device safety and effectiveness using 
                                electronic health data; or
                                  ``(IV) such other expertise which the 
                                Secretary determines necessary to carry 
                                out such a project.
                  ``(B) Review of contract in the event of a merger or 
                acquisition.--The Secretary shall review any contract, 
                cooperative agreement, grant, or other appropriate 
                agreement entered into under this paragraph with an 
                entity meeting the conditions specified in subparagraph 
                (A) in the event of a merger or acquisition of the 
                entity in order to ensure that the requirements 
                specified in this subsection will continue to be met.
          ``(5) Compliance with requirements for records or reports on 
        devices.--The participation of a manufacturer in pilot projects 
        under this subsection shall not affect the eligibility of such 
        manufacturer to participate in any quarterly reporting program 
        with respect to devices carried out under section 519 or 522. 
        The Secretary may determine that, for a specified time period 
        to be determined by the Secretary, a manufacturer's 
        participation in a pilot project under this subsection or a 
        project continued or expanded under paragraph (3) may meet the 
        applicable requirements of section 519 or 522, if--
                  ``(A) the project has demonstrated success in 
                capturing relevant adverse event information; and
                  ``(B) the Secretary has established procedures for 
                making adverse event and safety information collected 
                from such project public, to the extent possible.
          ``(6) Privacy requirements.--With respect to the disclosure 
        of any health information collected through a project conducted 
        under this subsection--
                  ``(A) individually identifiable health information so 
                collected shall not be disclosed when presenting any 
                information from such project; and
                  ``(B) any such disclosure shall be made in compliance 
                with regulations issued pursuant to section 264(c) of 
                the Health Insurance Portability and Accountability Act 
                of 1996 (42 U.S.C. 1320d-2 note) and sections 552 and 
                552a of title 5, United States Code.
          ``(7) Limitations.--
                  ``(A) In general.--No pilot project under this 
                subsection undertaken in coordination with the 
                comprehensive system described in paragraph (1)(C), 
                shall allow for an entity participating in such 
                program, other than the Secretary or the Secretary's 
                designee, to make determinations of safety or 
                effectiveness, or substantial equivalence, for purposes 
                of the Act.
                  ``(B) No use of fees.--Pilot projects initiated under 
                this subsection may not primarily utilize funds 
                collected pursuant to the Medical Device User Fee 
                Amendments of 2017.
          ``(8) Other projects required to comply.--Paragraphs (1)(B), 
        (4)(A)(i), (4)(A)(ii), (5), and (6) shall apply with respect to 
        any pilot program undertaken in coordination with the 
        comprehensive system described in paragraph (1)(C) that relates 
        to the use of real world evidence for devices in the same 
        manner and to the same extent as such paragraphs apply with 
        respect to pilot projects conducted under this subsection.
          ``(9) Report to congress.--Not later than 18 months after the 
        date of enactment of this Act, and annually thereafter, the 
        Secretary 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 
        a description of the pilot projects being conducted under this 
        subsection and projects continued or expanded pursuant to 
        paragraph (3), including for each such project--
                  ``(A) how the project is being implemented in 
                accordance with paragraph (4), including how such 
                project is being implemented through a contract, 
                cooperative agreement, grant, or other appropriate 
                agreement, if applicable;
                  ``(B) the number of manufacturers that have agreed to 
                participate in such project;
                  ``(C) the data sources used to conduct such project;
                  ``(D) the devices or device categories involved in 
                such project;
                  ``(E) the number of patients involved in such 
                project; and
                  ``(F) the findings of the project in relation to 
                device safety, including adverse events, malfunctions, 
                and other safety information.
          ``(10) Sunset.--The Secretary may not carry out a pilot 
        project initiated by the Secretary under this subsection after 
        October 1, 2022.''.
  (b) Report.--Not later than January 31, 2021, the Secretary of Health 
and Human Services, acting through the Commissioner of Food and Drugs, 
may  conduct a review through an independent third party to evaluate 
the strengths, limitations, and appropriate use of evidence collected 
pursuant to real world evidence pilot projects described in the letters 
described in section 201(b) of the Medical Device User Fee Amendments 
of 2017 and subsection (i) of section 519 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360i), as added by subsection (a)--
          (1) for purposes of informing premarket and postmarket 
        decisionmaking for multiple device types; and
          (2) to determine whether the methods, systems, and programs 
        carried out through such pilot projects efficiently generate 
        reliable and timely evidence about the effectiveness of the 
        surveillance of devices with respect to safety.

SEC. 616. RISK-BASED CLASSIFICATION OF ACCESSORIES.

  (a) In General.--Subsection (f) of section 513 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360c) is amended by adding at the end 
the following new paragraph:
  ``(6)(A) Subject to the succeeding subparagraphs of this paragraph, 
the Secretary shall, by written order, classify an accessory under this 
section based on the risks of the accessory when used as intended and 
the level of regulatory controls necessary to provide a reasonable 
assurance of safety and effectiveness of the accessory, notwithstanding 
the classification of any other device with which such accessory is 
intended to be used.
  ``(B) The classification of any accessory distinct from another 
device by regulation or written order issued prior to December 13, 
2016, shall continue to apply unless and until the accessory is 
reclassified by the Secretary, notwithstanding the classification of 
any other device with which such accessory is intended to be used. 
Nothing in this section shall preclude the Secretary's ability to 
initiate the classification of an accessory through regulation or 
written order, as appropriate.
  ``(C)(i) In the case of an accessory that has been granted marketing 
authorization as part of a submission under section 515(c), 510(k), or 
paragraph (2) of this subsection with another device with which such 
accessory is intended to be used, and with respect to which the 
Secretary has issued a written order classifying such accessory type 
distinct from another device in accordance with subparagraph (A), the 
manufacturer or importer of such accessory may, in lieu of submitting a 
request for classification of such accessory, submit a written request 
to the Secretary identifying such classification. A request under this 
clause shall include such information to support the request as may be 
specified by the Secretary.
  ``(ii) A request under clause (i) shall include a recommendation for 
the proper classification of the accessory pursuant to subparagraph 
(A), and shall include such information as may be necessary for the 
Secretary to evaluate, based on the least burdensome approach, the 
appropriate class for the accessory under subsection (a).
  ``(iii) The Secretary shall respond to a request under clause (i) 
within 90 calendar days by granting or denying the request for 
reclassification of the accessory.
  ``(iv) Within 30 calendar days after granting a request submitted 
under clause (i), the Secretary shall publish a notice in the Federal 
Register announcing such response.
  ``(v) A written notification that the Secretary disagrees with the 
classification recommended in a request pursuant to clause (ii) shall 
include a detailed description and justification for the determination 
to disagree.
  ``(D)(i) In the case of a device intended to be used with an 
accessory, where the accessory has been included in an application for 
premarket approval of such device under section 515 or a report under 
section 510(k) for clearance of such device and the Secretary has not 
classified such accessory distinctly from another device in accordance 
with subparagraph (A), the person filing the application or report (as 
applicable) at the time such application or report is filed--
          ``(I) may include a written request for the proper 
        classification of the accessory pursuant to subparagraph (A);
          ``(II) shall include in any such request such information as 
        may be necessary for the Secretary to evaluate, based on the 
        least burdensome approach, the appropriate class for the 
        accessory under subsection (a); and
          ``(III) shall, if the request under subclause (I) is 
        requesting classification of the accessory in class II, include 
        in the application an initial draft proposal for special 
        controls, if special controls would be required pursuant to 
        subsection (a)(1)(B).
  ``(ii) The Secretary's response under section 515(d) or section 
510(n) (as applicable) to an application or report described in clause 
(i) shall also contain the Secretary's granting or denial of the 
request for classification of the accessory involved.
  ``(iii) The Secretary's evaluation of an accessory under clause (i) 
shall constitute an order establishing a new classification for such 
accessory for the specified intended use or uses of such accessory and 
for any accessory with the same intended use or uses as such accessory.
  ``(E) For accessories that have been granted marketing authorization 
as part of a submission for another device with which the accessory 
involved is intended to be used, through an application for such other 
device under section 515(c), a report under section 510(k), or a 
request for classification under paragraph (2) of this subsection, and 
that have not been classified by the Secretary based on the risks and 
appropriate level of regulatory controls in accordance with 
subparagraph (A):
          ``(i) Not later than the date that is one year after the date 
        of enactment of the FDA Reauthorization Act of 2017 and at 
        least once every 5 years thereafter, and as the Secretary 
        otherwise deems appropriate, pursuant to this paragraph, the 
        Secretary shall publish in the Federal Register a notice 
        proposing a list of such accessories that the Secretary 
        believes may be suitable for a distinct classification in class 
        I and the proposed regulations for such classifications. In 
        developing such lists, the Secretary shall consider 
        recommendations from sponsors of device submissions and other 
        stakeholders for accessories to be included on such lists. The 
        notices shall provide for a period of not less than 60 calendar 
        days for public comment. Within 180 days after the end of the 
        comment period, the Secretary shall publish in the Federal 
        Register a final action classifying such suitable accessories 
        into class I.
          ``(ii) A manufacturer or importer of an accessory that has 
        been granted such marketing authorization may submit to the 
        Secretary a written request for the appropriate classification 
        of the accessory based on the risks and appropriate level of 
        regulatory controls as described in subparagraph (A) or (C), 
        and shall, if the request is requesting classification of the 
        accessory in class II, include in the submission an initial 
        draft proposal for special controls, if special controls would 
        be required pursuant to subsection (a)(1)(B). Such request 
        shall include such information as may be necessary for the 
        Secretary to evaluate, based on the least burdensome approach, 
        the appropriate class for the accessory under subsection (a). 
        The Secretary shall provide an opportunity for a manufacturer 
        or importer to meet with appropriate personnel of the Food and 
        Drug Administration to discuss the appropriate classification 
        of such accessory prior to submitting a written request under 
        this clause for classification of the accessory.
          ``(iii) The Secretary shall respond to a request made under 
        clause (ii) not later than 90 calendar days after receiving 
        such submission by granting or denying the request for 
        classification of the accessory, and the Secretary shall by 
        written order classify such accessory or deny the request. If 
        the Secretary does not agree with the recommendation for 
        classification submitted by the manufacturer or importer, the 
        response shall include a detailed description and justification 
        for such determination. Within 30 calendar days after granting 
        such a request, the Secretary shall publish a notice in the 
        Federal Register announcing such response.
  ``(F) Nothing in this paragraph may be construed as precluding a 
manufacturer of an accessory of a new type from using the 
classification process described in subsection (f)(2) to obtain 
classification of such accessory in accordance with the criteria and 
requirements set forth in that subsection.''.
  (b) Conforming Change.--Section 513(b) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360c(b)) is amended by striking paragraph (9) 
(relating to classification of an accessory).
  (c) Effective Date.--The amendments made by subsections (a) and (b) 
shall take effect on the date that is 60 days after the date of 
enactment of this Act.

             TITLE VII--GENERIC DRUG ACCESS AND COMPETITION

SEC. 701. COMPETITIVE GENERIC THERAPIES.

  (a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by inserting after section 506G 
the following:

``SEC. 506H. COMPETITIVE GENERIC THERAPIES.

  ``(a) In General.--The Secretary shall, at the request of the sponsor 
of a drug that is designated as a competitive generic therapy pursuant 
to subsection (b), expedite the development and review of such drug 
pursuant to section 505(j).
  ``(b) Designation Process.--
          ``(1) Request.--The sponsor of a drug may request the 
        Secretary to designate the drug as a competitive generic 
        therapy.
          ``(2) Timing.--A request under paragraph (1) may be made 
        concurrently with, or at any time prior to, the submission of 
        an abbreviated new drug application for the drug under section 
        505(j).
          ``(3) Criteria.--A drug is eligible for designation as a 
        competitive generic therapy under this section if the Secretary 
        determines that there is inadequate generic competition.
          ``(4) Designation.--Not later than 60 calendar days after the 
        receipt of a request under paragraph (1), the Secretary shall--
                  ``(A) determine whether the drug that is the subject 
                of the request meets the criteria described in 
                paragraph (3); and
                  ``(B) if the Secretary finds that the drug meets such 
                criteria, designate the drug as a competitive generic 
                therapy.
  ``(c) Actions.--In expediting the development and review of a drug 
under subsection (a), the Secretary shall, as requested by the sponsor, 
take actions including the following:
          ``(1) Hold meetings with the sponsor and the review team 
        throughout the development of the drug prior to submission of 
        the application for such drug under section 505(j).
          ``(2) Provide timely advice to, and interactive communication 
        with, the sponsor regarding the development of the drug to 
        ensure that the development program to gather the data 
        necessary for approval is as efficient as practicable.
          ``(3) Involve senior managers and experienced review staff, 
        as appropriate, in a collaborative, coordinated review, 
        including with respect to drug-device combination products and 
        other complex products.
          ``(4) Assign a cross-disciplinary project lead for the Food 
        and Drug Administration review team--
                  ``(A) to facilitate an efficient review of the 
                development program and application, including 
                manufacturing inspections; and
                  ``(B) to serve as a scientific liaison between the 
                review team and the sponsor.
  ``(d) Definitions.--In this section:
          ``(1) The term `generic drug' means a drug that is approved 
        pursuant to section 505(j).
          ``(2) The term `inadequate generic competition' means, with 
        respect to a product, there is not more than one approved drug 
        product on the list of products described in section 
        505(j)(7)(A) (not including products on the discontinued 
        section of such list) that is--
                  ``(A) the reference listed drug; or
                  ``(B) a generic drug with the same reference listed 
                drug as the drug for which designation as a competitive 
                generic therapy is sought.
          ``(3) The term `reference listed drug' means the listed drug 
        (as such term is used in section 505(j)) for the drug 
        involved.''.
  (b) Guidance; Amended Regulations.--
          (1) In general.--
                  (A) Issuance.--The Secretary of Health and Human 
                Services shall--
                          (i) not later than 18 months after the date 
                        of enactment of this Act, issue draft guidance 
                        on the provisions of section 506H of the 
                        Federal Food, Drug, and Cosmetic Act, as added 
                        by subsection (a); and
                          (ii) not later than 1 year after the close of 
                        the comment period for the draft guidance, 
                        issue final guidance on such provisions.
                  (B) Contents.--The guidance issued under this 
                subsection shall--
                          (i) specify the process and criteria by which 
                        the Secretary makes a designation under section 
                        506H of the Federal Food, Drug, and Cosmetic 
                        Act, as added by subsection (a);
                          (ii) specify the actions the Secretary will 
                        take to expedite the development and review of 
                        a competitive generic therapy pursuant to such 
                        a designation; and
                          (iii) include good review management 
                        practices for competitive generic therapies.
          (2) Amended regulations.--
                  (A) In general.--If the Secretary of Health and Human 
                Services determines that it is necessary to amend the 
                regulations under title 21, Code of Federal 
                Regulations, in order to implement section 506H of the 
                Federal Food, Drug, and Cosmetic Act, as added by 
                subsection (a), the Secretary shall amend such 
                regulations not later than 2 years after the date of 
                enactment of this Act.
                  (B) Procedure.--In carrying out subparagraph (A), and 
                in issuing any other regulations to implement such 
                section 506H, the Secretary shall--
                          (i) issue a notice of proposed rulemaking 
                        that includes the proposed regulation;
                          (ii) provide a period of not less than 60 
                        days for comments on the proposed regulation; 
                        and
                          (iii) publish the final regulation not less 
                        than 30 days before the effective date of the 
                        regulation.

SEC. 702. ENHANCING REGULATORY TRANSPARENCY TO ENHANCE GENERIC 
                    COMPETITION.

  Section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355) is amended by adding at the end the following:
  ``(11) Upon the request of an applicant regarding one or more 
specified pending applications under this subsection, the Secretary 
shall--
          ``(A) by telephone or electronic mail, provide review status 
        updates; and
          ``(B) indicate in such updates the categorical status of the 
        applications by each relevant review discipline.''.

SEC. 703. INCENTIVIZING COMPETITIVE GENERIC THERAPY DEVELOPMENT.

  Section 505(j)(5) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(j)(5)) is amended--
          (1) in subparagraph (B), by adding at the end the following:
          ``(v) 180-day exclusivity period for competitive generic 
        therapies.--
                  ``(I) Effectiveness of application.--Subject to 
                subparagraph (D)(iv), if the application is for a drug 
                that is the same as a competitive generic therapy for 
                which any first approved applicant has commenced 
                commercial marketing, the application shall be made 
                effective on the date that is 180 days after the date 
                of the first commercial marketing of the competitive 
                generic therapy (including the commercial marketing of 
                the listed drug) by any first approved applicant.
                  ``(II) Limitation.--The exclusivity period under 
                subclause (I) shall not apply with respect to a 
                competitive generic therapy that has previously 
                received an exclusivity period under subclause (I).
                  ``(III) Definitions.--In this clause and subparagraph 
                (D)(iv):
                          ``(aa) The term `competitive generic therapy' 
                        means a drug--
                                  ``(AA) that is designated as a 
                                competitive generic therapy under 
                                section 506H; and
                                  ``(BB) for which there are no 
                                unexpired patents or blocking 
                                exclusivities on the list of products 
                                described in section 505(j)(7)(A) at 
                                the time of approval.
                          ``(bb) The term `first approved applicant' 
                        means any applicant that has submitted an 
                        application that--
                                  ``(AA) is for a competitive generic 
                                therapy that is approved on the first 
                                day on which any application for such 
                                competitive generic therapy is 
                                approved;
                                  ``(BB) is not eligible for a 180-day 
                                exclusivity period under clause (iv) 
                                for the drug that is the subject of the 
                                application for the competitive generic 
                                therapy; and
                                  ``(CC) is not for a drug for which 
                                all drug versions have forfeited 
                                eligibility for a 180-day exclusivity 
                                period under clause (iv) pursuant to 
                                subparagraph (D).''; and
          (2) in subparagraph (D), by adding at the end the following:
                          ``(iv) Special forfeiture rule for 
                        competitive generic therapy.--The 180-day 
                        exclusivity period described in subparagraph 
                        (B)(v) shall be forfeited by a first approved 
                        applicant if the applicant fails to market the 
                        competitive generic therapy within 75 days 
                        after the date on which the approval of the 
                        first approved applicant's application for the 
                        competitive generic therapy is made 
                        effective.''.

SEC. 704. TROPICAL DISEASE PRODUCT APPLICATION.

  Subparagraph (A) of section 524(a)(4) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360n(a)(4)) is amended--
          (1) in clause (i), by striking ``and'' at the end; and
          (2) by adding at the end the following:
                          ``(iii) that contains reports of one or more 
                        new clinical investigations (other than 
                        bioavailability studies) that are essential to 
                        the approval of the application and conducted 
                        or sponsored by the sponsor of such 
                        application; and
                          ``(iv) that contains an attestation from the 
                        sponsor of the application that such reports 
                        were not submitted as part of an application 
                        for marketing approval or licensure by a 
                        regulatory authority in India, Brazil, 
                        Thailand, or any country that is a member of 
                        the Pharmaceutical Inspection Convention or the 
                        Pharmaceutical Inspection Cooperation Scheme 
                        prior to September 27, 2007.''.

SEC. 705. GAO STUDY OF ISSUES REGARDING FIRST CYCLE APPROVALS OF 
                    GENERIC MEDICINES.

  (a) Study by GAO.--The Comptroller General of the United States shall 
conduct a study to determine the following:
          (1) The rate of first cycle approvals and tentative approvals 
        for generic drug applications submitted during the period 
        beginning on October 1, 2012, and ending on September 30, 2017. 
        The rate of first cycle approvals and tentative approvals shall 
        be determined and reported per each GDUFA cohort year during 
        this period.
          (2) If the rate determined pursuant to paragraph (1) for any 
        GDUFA cohort year is lower than 20 percent, the reasons 
        contributing to the relatively low rate of first cycle 
        approvals and tentative approvals for generic drug applications 
        shall be itemized, assessed, and reported. In making the 
        assessment required by this paragraph, the Comptroller General 
        shall consider, among other things, the role played by--
                  (A) the Food and Drug Administration's implementation 
                of approval standards for generic drug applications;
                  (B) the extent to which those approval standards are 
                communicated clearly to industry and applied 
                consistently during the review process;
                  (C) the procedures for reviewing generic drug 
                applications, including timelines for review activities 
                by the Food and Drug Administration;
                  (D) the extent to which those procedures are followed 
                consistently (and those timelines are met) by the Food 
                and Drug Administration;
                  (E) the processes and practices for communication 
                between the Food and Drug Administration and sponsors 
                of generic drug applications; and
                  (F) the completeness and quality of original generic 
                drug applications submitted to the Food and Drug 
                Administration.
          (3) Taking into account the determinations made pursuant to 
        paragraphs (1) and (2) and any review process improvements 
        implemented pursuant to this Act, whether there are ways the 
        review process for generic drugs could be improved to increase 
        the rate of first cycle approvals and tentative approvals for 
        generic drug applications. In making this determination, the 
        Comptroller General shall consider, among other things, options 
        for increasing review efficiency and communication 
        effectiveness.
  (b) Completion Date.--Not later than the expiration of the 2-year 
period beginning on the date of enactment of this Act, the Comptroller 
General shall complete the study under subsection (a) and submit a 
report describing the findings and conclusions of the study 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.
  (c) Definitions.--For purposes of this section:
          (1) The term ``GDUFA cohort year'' means a fiscal year.
          (2) The term ``generic drug'' means a drug that is approved 
        or is seeking approval under section 505(j) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)).
          (3) The term ``generic drug application'' means an 
        abbreviated new drug application for the approval of a generic 
        drug under section 505(j) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 355(j)).
          (4) The term ``Secretary'' means the Secretary of Health and 
        Human Services.
          (5)(A) The term ``first cycle approvals and tentative 
        approvals'' means the approval or tentative approval of a 
        generic drug application after the Food and Drug 
        Administration's complete review of the application and without 
        issuance of one or more complete response letters.
          (B) For purposes of this paragraph, the term ``complete 
        response letter'' means a written communication to the sponsor 
        of a generic drug application or holder of a drug master file 
        (DMF) from the Food and Drug Administration describing all of 
        the deficiencies that the Administration has identified in the 
        generic drug application (including pending amendments) or drug 
        master file that must be satisfactorily addressed before the 
        generic drug application can be approved.

          TITLE VIII--FOSTERING INNOVATION IN MEDICAL IMAGING

SEC. 801. APPROVAL OF APPLICATIONS FOR CERTAIN DIAGNOSTIC MEDICAL 
                    IMAGING DEVICES.

  Section 520 of the Federal Food, Drug, and Cosmetic Act (42 U.S.C. 
360j), as amended by section 613, is further amended by adding at the 
end the following:
  ``(q) Diagnostic Imaging Devices Intended for Use With Contrast 
Agents.--
          ``(1) The Secretary may, subject to the succeeding provisions 
        of this subsection, approve an application (or a supplement to 
        such an application) submitted under section 515 with respect 
        to an applicable medical imaging device, or, in the case of an 
        applicable medical imaging device for which a notification is 
        submitted under section 510(k), may make a substantial 
        equivalence determination with respect to an applicable medical 
        imaging device, or may grant a request submitted under section 
        513(f)(2) for an applicable medical imaging device, if the 
        indications and conditions of use proposed in such application, 
        notification, or request involve the use of a contrast agent 
        that is not--
                  ``(A) in a concentration, rate of administration, or 
                route of administration that is different from those 
                described in the approved labeling of the contrast 
                agent, except that the Secretary may approve such 
                application, make such substantial equivalence 
                determination, or grant such request if the Secretary 
                determines that such differences in concentration, rate 
                of administration, or route of administration exist but 
                do not adversely affect the safety and effectiveness of 
                the contrast agent when used with the device;
                  ``(B) in a region, organ, or system of the body that 
                is different from those described in the approved 
                labeling of the contrast agent, except that the 
                Secretary may approve such application, make such 
                substantial equivalence determination, or grant such 
                request if the Secretary determines that such 
                differences in region, organ, or system of the body 
                exist but do not adversely affect the safety and 
                effectiveness of the contrast agent when used with the 
                device;
                  ``(C) in a patient population that is different from 
                those described in the approved labeling of the 
                contrast agent, except that the Secretary may approve 
                such application, make such substantial equivalence 
                determination, or grant such request if the Secretary 
                determines such differences in patient population exist 
                but do not adversely affect the safety and 
                effectiveness of the contrast agent when used with the 
                device; or
                  ``(D) in an imaging modality (such as an ultrasound, 
                an x-ray, diagnostic radiopharmaceutical-based 
                technologies, fluorescent imaging technology, or 
                magnetic resonance) that is different from those 
                described in the approved labeling of the contrast 
                agent.
          ``(2) The agency center charged with premarket review of 
        devices shall have primary jurisdiction with respect to the 
        review of an application, notification, or request described in 
        paragraph (1). In conducting such review, such agency center 
        may--
                  ``(A) consult with the agency center charged with the 
                premarket review of drugs or biological products; and
                  ``(B) review information and data provided to the 
                Secretary by the sponsor of a contrast agent in an 
                application submitted under section 505 of this Act or 
                section 351 of the Public Health Service Act, so long 
                as the sponsor of such contrast agent has provided to 
                the sponsor of the applicable medical imaging device 
                that is the subject of such review a right of reference 
                and the application is submitted in accordance with 
                this subsection.
          ``(3) An application submitted under section 515, a 
        notification submitted under section 510(k), or a request 
        submitted under section 513(f)(2), as described in paragraph 
        (1), with respect to an applicable medical imaging device shall 
        be subject to the requirements of such respective section. Such 
        application, notification, or request shall only be subject to 
        the requirements of this Act applicable to devices.
          ``(4) For purposes of this subsection and section 505(y)--
                  ``(A) the term `applicable medical imaging device' 
                means a device intended to be used in conjunction with 
                a contrast agent (or class of contrast agents) for an 
                imaging use that is not described in the approved 
                labeling of such contrast agent (or the approved 
                labeling of any contrast agent in the same class as 
                such contrast agent); and
                  ``(B) the term `contrast agent' means a drug that is 
                approved under section 505 or licensed under section 
                351 of the Public Health Service Act, is intended for 
                use in conjunction with an applicable medical imaging 
                device, and--
                          ``(i) is a diagnostic radiopharmaceutical, as 
                        defined in section 315.2 and 601.31 of title 
                        21, Code of Federal Regulations (or any 
                        successor regulations); or
                          ``(ii) is a diagnostic agent that improves 
                        the visualization of structure or function 
                        within the body by increasing the relative 
                        difference in signal intensity within the 
                        target tissue, structure, or fluid.''.

SEC. 802. APPLICATIONS FOR APPROVAL OF CONTRAST AGENTS INTENDED FOR USE 
                    WITH CERTAIN DIAGNOSTIC MEDICAL IMAGING DEVICES.

  Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355) is amended by adding at the end the following:
  ``(y) Contrast Agents Intended for Use With Applicable Medical 
Imaging Devices.--
          ``(1) The sponsor of a contrast agent for which an 
        application has been approved under this section may submit a 
        supplement to the application seeking approval for the use of 
        the contrast agent for a new indication and conditions of use 
        following the authorization of a premarket submission for an 
        applicable medical imaging device for that use with the 
        contrast agent pursuant to section 520(q)(1).
          ``(2) In reviewing a supplement submitted under this 
        subsection, the agency center charged with the premarket review 
        of drugs may--
                  ``(A) consult with the center charged with the 
                premarket review of devices; and
                  ``(B) review information and data submitted to the 
                Secretary by the sponsor of an applicable medical 
                imaging device pursuant to section 515, 510(k), or 
                513(f)(2) so long as the sponsor of such applicable 
                medical imaging device has provided to the sponsor of 
                the contrast agent a right of reference.
          ``(3) For purposes of this subsection--
                  ``(A) the term `new indication' means a use of a 
                contrast agent that is described in the approved 
                labeling of an applicable medical imaging device 
                described in section 520(q), but that is not described 
                in the approved labeling of the contrast agent; and
                  ``(B) the term `applicable medical imaging device' 
                and `contrast agent' have the meanings given such terms 
                in section 520(q).''.

                    TITLE IX--ADDITIONAL PROVISIONS

SEC. 901. TECHNICAL CORRECTIONS.

  (a) Section 3075(a) of the 21st Century Cures Act (Public Law 114-
255) is amended--
          (1) in the matter preceding paragraph (1), by striking ``as 
        amended by section 2074'' and inserting ``as amended by section 
        3102''; and
          (2) in paragraph (2), by striking ``section 2074(1)(C)'' and 
        inserting ``section 3102(1)(C)''.
  (b) Section 506G(b)(1)(A) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 356g(b)(1)(A)) is amended by striking ``identity'' and 
inserting ``identify''.
  (c) Section 505F(b) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355g(b)) is amended by striking ``randomized'' and inserting 
``traditional''.
  (d) Section 505F(d) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355g(d)) is amended by striking ``2'' and inserting ``3''.
  (e) Effective as of the enactment of the 21st Century Cures Act 
(Public Law 114-255)--
          (1) section 3051(a) of such Act is amended by striking ``by 
        inserting after section 515B'' and inserting ``by inserting 
        after section 515A''; and
          (2) section 515C of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 360e-3), as inserted by such section 3051(a), is 
        redesignated as section 515B.
  (f) Section 515B(f)(2) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360e-3(f)(2)), as redesignated by subsection (e)(2) of this 
section, is amended by striking ``a proposed guidance'' and inserting 
``a draft version of that guidance''.
  (g) Section 513(b)(5)(D) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360c(b)(5)(D)) is amended by striking ``medical device 
submissions'' and inserting ``medical devices that may be specifically 
the subject of a review by a classification panel''.

SEC. 902. REAUTHORIZATION OF THE CRITICAL PATH PUBLIC-PRIVATE 
                    PARTNERSHIPS.

  Section 566(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360bbb-5(f)) is amended by striking ``2013 through 2017'' and inserting 
``2018 through 2022''.

                          Purpose and Summary

    The Food and Drug Administration (FDA) Reauthorization Act 
of 2017 enables FDA to continue to collect user fees from 
regulated industry to supplement Congressional appropriations. 
Specifically, the bill revises and reauthorizes the 
Prescription Drug User Fee Act (PDUFA), the Medical Device User 
Fee Amendments (MDUFA), the Generic Drug User Fee Amendments 
(GDUFA), and the Biosimilars User Fee Act (BsUFA) through 2022. 
In addition, the bill makes a number of changes to improve the 
regulation of medical products, supports the development of 
pediatric drugs and medical devices, and will encourage 
increased generic competition.

                  Background and Need for Legislation

    Since 1992, pursuant to PDUFA, Congress has authorized FDA 
to collect fees from regulated industry to supplement 
Congressional appropriations. Revenues generated from these 
fees have been used on specific activities related to the 
review and regulation of medical products. FDA also commits to 
meeting certain performance goals, such as completing product 
reviews within specified timeframes. FDA's ability to collect 
such fees must be reauthorized every five years following a 
process laid out in statute that involves negotiations between 
the agency and regulated industry and recommendations provided 
to Congress. The reauthorization process allows for input for 
other interested stakeholders, including patient and consumer 
groups, and provides opportunity for broader public comment.
    Based in large part on the positive impact PDUFA had on 
expediting new drug product review times and improving related 
regulatory activities at FDA, medical device user fees were 
authorized in 2002 and the Medical Device User Fee Amendments 
(MDUFA) were reauthorized in 2007 and 2012, along with PDUFA.
    Due to growing concerns from a wide range of stakeholders 
about the time it was taking FDA to review generic drug 
applications (known as ``abbreviated new drug applications'' or 
``ANDAs'') and the backlog of such applications pending at the 
agency, Congress passed the Generic Drug User Fee Amendments 
(GDUFA) in 2012, as part of the Food and Drug Administration 
Safety and Innovation Act (FDASIA).
    Pursuant to the Biologics Price Competition and Innovation 
Act (BCPIA) of 2009, Congress established a new regulatory 
authority for FDA to create an abbreviated approval pathway for 
biological products demonstrated to be ``highly similar'' to, 
or ``interchangeable'' with, a previously licensed biological 
product. As part of FDASIA, Congress passed the BsUFA in 2012 
to authorize FDA to collect user fees from biosimilar product 
manufacturers.
    Each of these four user fee programs is due to expire at 
the end of this fiscal year and must be reauthorized through 
2022, which the FDA Reauthorization Act of 2017 would do. 
Throughout conversations and hearings related to the bill, 
members brought forward additional policies that would improve 
the regulation of certain medical products. A number of these 
policies are also included in the bill.

                                Hearings

    On March 2, 2017, the Subcommittee on Health held a hearing 
entitled ``Examining FDA's Generic Drug and Biosimilar User Fee 
Programs'' and received testimony from the following witnesses:
           Janet Woodcock, M.D., Director, Center for 
        Drug Evaluation and Research, Food and Drug 
        Administration;
           David Gaugh, Senior Vice President of 
        Sciences and Regulatory Sciences, Association for 
        Accessible Medicines;
           Bruce A. Leicher, Senior Vice President and 
        General Counsel, Momenta Pharmaceuticals, Inc., Chair, 
        The Biosimilars Council, a Division of the Association 
        for Accessible Medicines;
           Juliana Reed, Vice President of Government 
        Affairs, Coherus BioSciences, Immediate Past President, 
        The Biosimilars Forum;
           Kay Holcombe, Senior Vice President of 
        Science Policy, Biotechnology Industry Organization; 
        and,
           Allan Coukell, Senior Director, Health 
        Programs, The Pew Charitable Trusts.
    On March 20, 2017, the Subcommittee on Health held a 
hearing entitled ``Examining FDA's Prescription Drug User Fee 
Program'' and received testimony from the following witnesses:
           Janet Woodcock, M.D., Director, Center for 
        Drug Evaluation and Research, Food and Drug 
        Administration;
           Jeff Allen, President and CEO, Friends of 
        Cancer Research;
           Kay Holcombe, Senior Vice President of 
        Science Policy, Biotechnology Industry Organization; 
        and,
           Anne Pritchett, Vice President of Policy and 
        Research, Pharmaceutical Research and Manufacturers of 
        America.
    On March 28, 2017, the Subcommittee on Health held a 
hearing entitled ``Examining FDA's Medical Device User Fee 
Program'' and received testimony from the following witnesses:
           Jeffrey Shuren, M.D., J.D., Director, Center 
        for Devices and Radiological Health, Food and Drug 
        Administration;
           Cynthia Bens, Vice President of Public 
        Policy, Alliance for Aging Research;
           Robert Kieval, Founder and Chief Development 
        Officer, CVRx;
           Patrick Daly, President and CEO, Cohera 
        Medical; and,
           Diane Wurzburger, Executive, Regulatory 
        Affairs U.S. and Canada, Global Strategic Policy and 
        Programs, GE Healthcare.
    On May 2, 2017, the Subcommittee on Health held a hearing 
entitled ``Examining Improvements to the Regulation of Medical 
Technologies'' and received testimony from the following 
witnesses:
           Jeffrey Shuren, M.D., J.D., Director, Center 
        for Devices and Radiological Health, Food and Drug 
        Administration;
           Thomas Powers, Ph.D., Powers Consulting, 
        LLC;
           Frank Lin, M.D., Ph.D., Associate Professor 
        of Otolaryngology--Head and Neck Surgery, Geriatric 
        Medicine, Mental Health, and Epidemiology, Johns 
        Hopkins University;
           Joe Robinson, Senior Vice President, Health 
        Systems Solutions, Philips North America;
           Robert Kerwin, General Counsel, 
        International Association of Medical Equipment 
        Remarketers and Servicers; and,
           Patricia Shrader, Vice President, Global 
        Regulatory Affairs, Medtronic.

                        Committee Consideration

    On May 18, 2017, the Subcommittee on Health met in open 
markup session and forwarded H.R. 2430 to the full Committee, 
as amended, by a voice vote. On June 7, 2017, the full 
Committee on Energy and Commerce met in open markup session and 
ordered H.R. 2430 reported to the House, as amended, by a vote 
of 54 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 record votes 
on the motion to report legislation and amendments thereto. The 
following reflects the record votes taken during the Committee 
consideration:


[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

                      Committee Oversight Findings

    Pursuant to clause 3(c)(1) of rule XIII of the Rules of the 
House of Representatives, 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 reauthorize four 
important user fee programs at FDA and to improve the review 
and regulation of medical products.

   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. 
2430, 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. 2430 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. At the 
time this report was filed, the estimate was not available.

                  Congressional Budget Office Estimate

    Pursuant to clause 3(c)(3) of rule XIII, at the time this 
report was filed, the cost estimate prepared by the Director of 
the Congressional Budget Office pursuant to section 402 of the 
Congressional Budget Act of 1974 was not available.

                       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. 2430 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

    Pursuant to section 3(i) of H. Res. 5, the following 
directed rule makings are contained in H.R. 2430:
          1. Section 603 requires FDA to issue a draft and 
        final guidance document specifying how the agency will 
        implement the process changes for inspecting medical 
        device facilities pursuant to this section.
          2. Section 604 requires FDA to issue a draft and 
        final guidance document providing for a process for 
        resolving issues relating to certifications to foreign 
        government for medical devices being exported.
          3. Section 613 requires FDA, not later than three 
        years after the date of enactment, to promulgate 
        proposed regulations to establish a category of over-
        the-counter hearing aids. Not later than 180 days after 
        the date on which the public comment period on the 
        proposed regulations closes, FDA shall issue final 
        regulations.
          4. Section 613 also requires FDA to update and 
        finalize a draft guidance document clarifying which 
        products meet the definition of a medical device and 
        which products meet the definition of a personal sound 
        amplification product.
          5. Section 701 requires FDA to issue a draft and 
        final guidance document specifying the actions the 
        agency will take to expedite the development and review 
        of certain generic drug applications and, if FDA 
        determines that it is necessary to amend the 
        regulations, the agency shall do so not later than two 
        years after the date of enactment.

                      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--FEES RELATING TO DRUGS

Section 101. Short title; finding

    Section 101 establishes a short title--``Prescription Drug 
User Fee Amendments of 2017''--and provides that the fees 
authorized in the title will go toward human prescription drug 
activities as set forth in the commitment letter submitted to 
the Congressional Record.

Section 102. Authority to assess and use drug fees

    Section 102 reauthorizes FDA's ability to collect user fees 
at a higher level, and restructures such fees to reduce 
administrative burden and make funding more predictable.
    The section also modernizes the fee structure and updates 
the base fee amount. Historically, fees were derived one-third 
from facility fees, one-third from various application fees, 
and one-third from product fees. The new structure is derived 
from 20 percent application fees and 80 percent program fees 
for approved products. Supplemental application fees and 
facility fees are eliminated. In fiscal year (FY) 2018, the 
base fee amount will be $878,590,000.
    In addition, the section replaces the workload adjustment 
with a capacity planning adjuster so that fees more accurately 
reflect the workload and existing staff capacity at FDA.

Section 103. Reauthorization; reporting requirements

    Section 103 maintains the existing reauthorization process 
and reporting requirements. The Secretary of Health and Human 
Services (HHS) is required to provide recommendations to 
Congress by January 15, 2022, after an extensive process of 
public meetings. Performance and financial reports continue to 
be due to Congress every year.

Section 104. Sunset dates

    Section 104 sunsets the authority to collect fees on 
October 1, 2022, and the requirement to submit performance and 
financial reports on January 31, 2023.

Section 105. Effective date

    Section 105 clarifies that the effective date is October 1, 
2017, or date of enactment, whichever is later, and the fee 
structure and amount in this Act applies to all human drug 
applications received on or after October 1, 2017, regardless 
of the date of the enactment of this Act.

Section 106. Savings clause

    Section 106 clarifies that submissions made prior to 
October 1, 2017, will continue to be reviewed and assessed fees 
based on the agreement for FY 2012 to 2017.

                   TITLE II--FEES RELATING TO DEVICES

Section 201. Short title; findings

    Section 201 establishes a short title--``Medical Device 
Drug User Fee Amendments of 2017''--and provides that the fees 
authorized in the title will go toward medical device 
activities as set forth in the commitment letter submitted to 
the Congressional Record.

Section 202. Definitions

    Section 202 adds the term ``de novo classification 
request'' to enable new user fees specifically for review of de 
novo medical device classification requests.

Section 203. Authority to assess and use device fees

    Section 203 adds authority to collect fees for de novo 
classification request.
    The section also updates the target base fee amounts for 
each year. The FY 2018 base is increased to $183,280,756, 
ending at $213,687,660 in FY 2022.
    In addition, the section updates the adjustment for 
inflation and allows the Secretary of HHS to increase, if 
necessary, the fees to meet the base target.
    Section 203 also reauthorizes the authority to collect, and 
the availability and crediting, of fees.

Section 204. Reauthorization; reporting requirements

    Section 204 maintains the existing reauthorization and 
reporting requirements. The Secretary of HHS is required to 
provide recommendations to Congress by January 15, 2022, after 
an extensive process of public meetings. Performance and 
financial reports continue to be due to Congress every year.

Section 205. Conformity assessment pilot program

    Section 205 establishes a pilot program to provide FDA the 
authority to audit and certify laboratories who conduct device 
conformance testing to a recognized standard, and also to 
withdraw the certification if necessary. FDA is required to 
evaluate the use of this scheme in at least five device types, 
or device parts that are found in multiple devices. FDA is also 
required to obtain public input on the development of the 
pilot.
    The authority for the pilot project sunsets in 2022.

Section 206. Reauthorization of review

    Section 206 reauthorizes and provides flexibility for the 
Secretary of HHS to better target which device types are most 
appropriate for, third party review.
    The section also requires the Secretary of HHS to conduct a 
public guidance development process to identify the factors the 
Secretary of HHS will use to determine which devices are 
eligible for third party review.

Section 207. Electronic format for submissions

    FDA currently receives both paper and electronic 
submissions. Section 207 requires all submissions to be in 
electronic format by October 1, 2021. The Secretary of HHS has 
the authority to extend the date as late as April 1, 2023.

Section 208. Savings clause

    Section 208 clarifies that submissions made prior to 
October 1, 2017, will continue to be reviewed and assessed fees 
based on the agreement for FY 2012 to 2017.

Section 209. Effective date

    Section 209 clarifies that the effective date is October 1, 
2017, or date of enactment, whichever is later, and the fee 
structure and amount in this Act applies to all medical device 
applications received on or after October 1, 2017, regardless 
of the date of the enactment of this Act.

Section 210. Sunset clause

    The authority to collect fees sunsets on October 1, 2022, 
and the requirement to submit performance and financial reports 
on January 31, 2023.

               TITLE III--FEES RELATING TO GENERIC DRUGS

Section 301. Short title; finding

    Section 301 establishes a short title--``Generic Drug User 
Fee Amendments of 2017''--and provides that the fees authorized 
in the title will go toward human generic drug activities, as 
set forth in the commitment letter submitted to the 
Congressional Record.

Section 302. Definitions

    The definitions are amended to clarify that submissions by 
a State or Federal Government entity for drugs not intended for 
sale do not have to pay user fees. A definition for ``contract 
manufacturing organization facility'' is also included.

Section 303. Authority to assess and use human generic drug fees

    Section 303 updates the fee structure to provide more 
predictability for FDA and flexibility for small businesses.
    The section removes the fees for prior approval supplements 
and establishes a generic drug applicant program fee.
    Thirty-three percent of the total user fee revenue will 
come from application fees, 20 percent of such revenue will 
come from generic drug facility fees, seven percent of such 
revenue will come from active pharmaceutical ingredient 
facility fees, and 35 percent of such revenue will come from a 
new generic drug applicant program fee.
    The generic drug applicant program fee is determined by how 
many applications the applicant has approved by the FDA:
           a manufacturer with 20 or more approved 
        applications pays the full fee;
           a manufacturer with six-19 approved 
        applications pays 40 percent of the full fee; and
           a manufacturer with five or fewer approved 
        applications pays 10 percent of the full fee.
    The base fee amount is updated to $493,600,000 in FY 2018.

Section 304. Reauthorization; reporting requirements

    Section 304 maintains the existing reauthorization and 
reporting requirements. The Secretary of HHS is required to 
provide recommendations to Congress by January 15, 2022, after 
an extensive process of public meetings. Performance and 
financial reports continue to be due to Congress every year.

Section 305. Sunset dates

    The authority to collect fees sunsets on October 1, 2022, 
and the requirement to submit performance and financial reports 
on January 31, 2023.

Section 306. Effective date

    Section 306 clarifies that the effective date is October 1, 
2017, or date of enactment, whichever is later, and the fee 
structure and amount in this Act applies to all human generic 
drug applications received on or after October 1, 2017, 
regardless of the date of the enactment of this Act.

Section 307. Savings clause

    Section 307 clarifies that submissions made prior to 
October 1, 2017, will continue to be reviewed and assessed fees 
based on the agreement for FY 2012 to 2017.

       TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS

Section 401. Short title; finding

    Section 401 establishes a short title--``Biosimilar User 
Fee Amendments of 2017''--and that the fees authorized in the 
title will go toward biosimilar activities as set forth in the 
commitment letter submitted to the Congressional Record.

Section 402. Definitions

    Technical updates are made to the definitions of 
``adjustment factor'' and ``biosimilar biological product to 
provide clarity.''

Section 403. Authority to assess and use biosimilar fees

    Section 403 establishes an independent fee structure for 
biosimilars for the first time based on the following types of 
fees:
           Initial Biosimilar Development Fee for the 
        first year once a sponsor begins clinical trials for a 
        new biosimilar;
           Annual Biosimilar Development Fee for 
        subsequent years a sponsor is developing a new 
        biosimilar;
           Biosimilar Program Fee for sponsors of 
        approved biosimilars; and
           Application Fee for new biosimilar 
        applications.
    The section eliminates supplement and establishment fees 
and allows the Secretary of HHS to determine the appropriate 
percentage that will come from each of the fees, and each fee 
amount annually. The base fee amount is updated to $45,000,000.

Section 404. Reauthorization; reporting requirements

    Section 404 maintains the existing reauthorization and 
reporting requirements. The Secretary of HHS is required to 
provide recommendations to Congress by January 15, 2022, after 
an extensive process of public meetings. Performance and 
financial reports continue to be due to Congress every year.

Section 405. Sunset dates

    The authority to collect fees sunsets on October 1, 2022, 
and the requirement to submit performance and financial reports 
on January 31, 2023.

Section 406. Effective date

    Section 406 clarifies that the effective date is October 1, 
2017, or date of enactment, whichever is later, and the fee 
structure and amount in this Act applies to all biosimilar 
applications received on or after October 1, 2017, regardless 
of the date of the enactment of this Act.

Section 407. Savings clause

    Section 407 clarifies that submissions made prior to 
October 1, 2017, will continue to be reviewed and assessed fees 
based on the agreement for FY 2012 to 2017.

      TITLE V--REAUTHORIZATIONS AND IMPROVEMENTS RELATED TO DRUGS

Section 501. Reauthorization of provision relating to exclusivity of 
        certain drugs containing single enantiomers

    Section 501 reauthorizes section 505(u), which provides the 
Secretary of HHS the authority to grant exclusivity for drugs 
containing single enantiomers, until 2022.

Section 502. Reauthorization of orphan grants program

    Section 503 reauthorizes the authority of FDA to issue 
grants for orphan drug development until 2022.

Section 503. Reauthorization of pediatric study of drugs

    Section 503 reauthorizes funding for National Institutes of 
Health to conduct pediatric trials not being conducted by drug 
sponsors.

Section 504. Protecting and strengthening the drug supply chain

    Section 504 harmonizes the penalties for illegally 
diverting drugs into the U.S. that were manufactured abroad and 
intended for foreign markets with the penalties for diverting 
drugs that were initially manufactured in the U.S.
    The section raises the penalties for knowingly making, 
selling or dispensing, or holding for sale or dispensing, a 
counterfeit drug to conform with the penalties for illegally 
diverting drugs.

Section 505. Sense of Congress on lowering the cost of prescription 
        drugs

    Section 505 expresses a Sense of Congress that the 
Secretary of HHS should commit to engaging with Congress on 
administrative actions and legislative changes to lower the 
cost of prescription drugs.

        TITLE VI--DEVICE INSPECTION AND REGULATORY IMPROVEMENTS

Section 601. Risk-based inspections for devices

    Section 601 requires FDA to inspect medical device 
establishments using a risk-based inspection schedule based on 
a number of considerations.

Section 602. Recognition of foreign government inspections

    Section 602 applies changes made in section 603 to section 
809 of the FDCA, recognizing foreign government inspections.

Section 603. Improvements to inspections process for device 
        establishments

    Section 603 establishes standards to improve predictability 
for scheduled (not for-cause) inspections for medical device 
facilities.

Section 604. Certificates to foreign governments for devices

    Section 604 clarifies the process for issuance of foreign 
export certificates for medical devices. The section also 
establishes a pathway by which manufacturers denied a 
certificate can present information and work with FDA to 
correct any outstanding issue.

Section 605. Facilitating international harmonization

    Section 605 allows FDA to recognize auditors used by 
foreign governments to improve international harmonization of 
inspection standards and increase FDA access to audit data.

Section 606. Reauthorization of inspection program

    Section 606 reauthorizes the authority of FDA to conduct 
inspections via accredited organizations.

Section 611. Reauthorization of pediatric humanitarian device 
        exceptions

    Section 611 reauthorizes rules regarding the development of 
medical devices for rare pediatric conditions until 2022.

Section 612. Reauthorization of pediatric device consortia

    Section 612 reauthorizes the authority of FDA to issue 
grants to consortia working to develop medical devices for 
pediatric population at current law authorization levels until 
2022.

Section 613. Regulation of over-the-counter hearing aids

    Section 613 requires FDA to promulgate regulations to 
establish a category of over-the-counter (OTC) hearing aids. In 
doing so, FDA should consult with relevant stakeholders, 
including hearing aid manufacturers, licensed hearing 
professionals, patients, and others, during the rulemaking 
process.

Section 614. Report on ensuring quality, safety, and continued 
        effectiveness of devices that have been serviced

    Section 614 requires FDA to issue a report on how the 
agency intends to ensure the quality, safety, and effectiveness 
of medical devices that have been serviced, as well as whether 
FDA's current authority is sufficient is to oversee and 
regulate servicing or whether additional authority is 
necessary.

Section 615. Device pilot projects to generate reliable and timely 
        safety and active surveillance data

    Section 615 creates a new voluntary pilot program for 
medical device manufacturers who wish to meet FDA reporting or 
post-market study requirements using active surveillance. 
Requires FDA to report safety data from the pilot consistent 
with current reporting.

Section 616. Risk-based classification of accessories

    Section 616 clarifies a process by which FDA classifies 
medical device accessories based on the intended use of the 
accessory.

             TITLE VII--GENERIC DRUG ACCESS AND COMPETITION

Section 701. Competitive Generic Therapies

    Section 701 requires FDA to expedite the review and 
development of generic drugs if there is not more than one 
approved version of the drug actively being marketed.

Section 702. Enhancing regulatory transparency to enhance generic 
        competition

    Section 702 improves communication between FDA and generic 
drug application sponsors about the categorical status of their 
applications.

Section 703. Incentivizing competitive generic therapy development

    Section 703 provides a period of 180-day market exclusivity 
to certain generic drug manufacturers that enter the market 
where there is currently no blocking patents or exclusivities, 
incentivizing generic drug manufacturers to compete with off-
patent drugs.

Section 704. Tropical disease product application

    Section 704 clarifies the qualifying criteria for companies 
receiving a neglected tropical diseases priority review voucher 
(PRV) to ensure the PRV is awarded to sponsors that conduct new 
clinical investigations necessary for FDA approval.

Section 705. GAO study of issues regarding first cycle approvals of 
        generic medicines

    Section 705 directs the Government Accountability Office 
(GAO) to issue a report on the rate of generic drug 
applications that are approved on the first review cycle and 
related issues.

          TITLE VIII--FOSTERING INNOVATION IN MEDICAL IMAGING

Section 801. Approval of applications for certain diagnostic medical 
        imaging devices

    Section 801 allows the FDA to approve a medical imaging 
device with the use of a contrast agent as long as the contrast 
agent is used at the same dose, in the same patient population, 
with the same type of imaging technology, and does not pose any 
additional safety risk.

Section 802. Applications for approval of contrast agents intended for 
        use with certain diagnostic medical imaging devices

    Section 802 clarifies that a contrast agent for which an 
application has been approved may be approved for a new 
indication or condition of use following the authorization of a 
premarket submission for an applicable medical imaging device 
for that use.

                    TITLE IX--ADDITIONAL PROVISIONS

Section 901. Technical corrections

    Section 901 makes technical changes to provisions in 21st 
Century Cures.

Section 902. Reauthorization of the critical path public-private 
        partnerships

    Section 902 reauthorizes the critical path public-private 
partnership for an additional five years at current law 
authorization levels.

         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):

FEDERAL FOOD, DRUG, AND COSMETIC ACT

           *       *       *       *       *       *       *



CHAPTER III--PROHIBITED ACTS AND PENALTIES

           *       *       *       *       *       *       *



                               penalties

  Sec. 303. (a)(1) Any person who violates a provision of 
section 301 shall be imprisoned for not more than one year or 
fined not more than $1,000, or both.
  (2) Notwithstanding the provisions of paragraph (1) of this 
section, if any person commits such a violation after a 
conviction of him under this section has become final, or 
commits such a violation with the intent to defraud or mislead, 
such person shall be imprisoned for not more than three years 
or fined not more than $10,000 or both.
  (b)(1) Notwithstanding subsection (a), any person who 
violates section 301(t) by--
          (A) knowingly importing a drug in violation of 
        section 801(d)(1),
          (B) knowingly selling, purchasing, or trading a drug 
        or drug sample or knowingly offering to sell, purchase, 
        or trade a drug or drug sample, in violation of section 
        503(c)(1),
          (C) knowingly selling, purchasing, or trading a 
        coupon, knowingly offering to sell, purchase, or trade 
        such a coupon, or knowingly counterfeiting such a 
        coupon, in violation of section 503(c)(2), or
          (D) knowingly distributing drugs in violation of 
        section 503(e)(1),
shall be imprisoned for not more than 10 years or fined not 
more than $250,000, or both.
  (2) Any manufacturer or distributor who distributes drug 
samples by means other than the mail or common carrier whose 
representative, during the course of the representative's 
employment or association with that manufacturer or 
distributor, violated section 301(t) because of a violation of 
section 503(c)(1) or violated any State law prohibiting the 
sale, purchase, or trade of a drug sample subject to section 
503(b) or the offer to sell, purchase, or trade such a drug 
sample shall, upon conviction of the representative for such 
violation, be subject to the following civil penalties:
          (A) A civil penalty of not more than $50,000 for each 
        of the first two such violations resulting in a 
        conviction of any representative of the manufacturer or 
        distributor in any 10-year period.
          (B) A civil penalty of not more than $1,000,000 for 
        each violation resulting in a conviction of any 
        representative after the second conviction in any 10-
        year period.
For the purposes of this paragraph, multiple convictions of one 
or more persons arising out of the same event or transaction, 
or a related series of events or transactions, shall be 
considered as one violation.
  (3) Any manufacturer or distributor who violates section 
301(t) because of a failure to make a report required by 
section 503(d)(3)(E) shall be subject to a civil penalty of not 
more than $100,000.
  (4)(A) If a manufacturer or distributor or any representative 
of such manufacturer or distributor provides information 
leading to the institution of a criminal proceeding against, 
and conviction of, any representative of that manufacturer or 
distributor for a violation of section 301(t) because of a 
sale, purchase, or trade or offer to purchase, sell, or trade a 
drug sample in violation of section 503(c)(1) or for a 
violation of State law prohibiting the sale, purchase, or trade 
or offer to sell, purchase, or trade a drug sample, the 
conviction of such representative shall not be considered as a 
violation for purposes of paragraph (2).
  (B) If, in an action brought under paragraph (2) against a 
manufacturer or distributor relating to the conviction of a 
representative of such manufacturer or distributor for the 
sale, purchase, or trade of a drug or the offer to sell, 
purchase, or trade a drug, it is shown, by clear and convincing 
evidence--
          (i) that the manufacturer or distributor conducted, 
        before the institution of a criminal proceeding against 
        such representative for the violation which resulted in 
        such conviction, an investigation of events or 
        transactions which would have led to the reporting of 
        information leading to the institution of a criminal 
        proceeding against, and conviction of, such 
        representative for such purchase, sale, or trade or 
        offer to purchase, sell, or trade, or
          (ii) that, except in the case of the conviction of a 
        representative employed in a supervisory function, 
        despite diligent implementation by the manufacturer or 
        distributor of an independent audit and security system 
        designed to detect such a violation, the manufacturer 
        or distributor could not reasonably have been expected 
        to have detected such violation,
the conviction of such representative shall not be considered 
as a conviction for purposes of paragraph (2).
  (5) If a person provides information leading to the 
institution of a criminal proceeding against, and conviction 
of, a person for a violation of section 301(t) because of the 
sale, purchase, or trade of a drug sample or the offer to sell, 
purchase, or trade a drug sample in violation of section 
503(c)(1), such person shall be entitled to one-half of the 
criminal fine imposed and collected for such violation but not 
more than $125,000.
  (6) Notwithstanding subsection (a), any person who is a 
manufacturer or importer of a prescription drug under section 
804(b) and knowingly fails to comply with a requirement of 
section 804(e) that is applicable to such manufacturer or 
importer, respectively, shall be imprisoned for not more than 
10 years or fined not more than $250,000, or both.
  (7) Notwithstanding subsection (a)(2), any person that 
knowingly and intentionally adulterates a drug such that the 
drug is adulterated under subsection (a)(1), (b), (c), or (d) 
of section 501 and has a reasonable probability of causing 
serious adverse health consequences or death to humans or 
animals shall be imprisoned for not more than 20 years or fined 
not more than $1,000,000, or both.
  (8) Notwithstanding subsection (a), any person who violates 
section 301(i)(3) by knowingly making, selling or dispensing, 
or holding for sale or dispensing, a counterfeit drug shall be 
imprisoned for not more than 10 years or fined in accordance 
with title 18, United States Code, or both.
  (c) No person shall be subject to the penalties of subsection 
(a)(1) of this section, (1) for having received in interstate 
commerce any article and delivered it or proffered delivery of 
it, if such delivery or proffer was made in good faith, unless 
he refuses to furnish on request of an officer or employee duly 
designated by the Secretary the name and address of the person 
from whom he purchased or received such article and copies of 
all documents, if any there be, pertaining to the delivery of 
the article to him; or (2) for having violated section 301(a) 
or (d), if he establishes a guaranty or undertaking signed by, 
and containing the name and address of, the person residing in 
the United States from whom he received in good faith the 
article, to the effect, in case of an alleged violation of 
section 301(a), that such article is not adulterated or 
misbranded, within the meaning of this Act, designating this 
Act, or to the effect, in case of an alleged violation of 
section 301(d), that such article is not an article which may 
not, under the provisions of section 404 or 505, be introduced 
into interstate commerce; or (3) for having violated section 
301(a), where the violation exists because the article is 
adulterated by reason of containing a color additive not from a 
batch certified in accordance with regulations promulgated by 
the Secretary under this Act, if such person establishes a 
guaranty or undertaking signed by, and containing the name and 
address of, the manufacturer of the color additive, to the 
effect that such color additive was from a batch certified in 
accordance with the applicable regulations promulgated by the 
Secretary under this Act; or (4) for having violated section 
301 (b), (c), or (k) by failure to comply with section 502(f) 
in respect to an article received in interstate commerce to 
which neither section 503(a) nor section 503(b)(1) is 
applicable, if the delivery or proffered delivery was made in 
good faith and the labeling at the time thereof contained the 
same directions for use and warning statements as were 
contained in the labeling at the time of such receipt of such 
article; or (5) for having violated section 301(i)(2) if such 
person acted in good faith and had no reason to believe that 
use of the punch, die, plate, stone, or other thing involved 
would result in a drug being a counterfeit drug, or for having 
violated section 301(i)(3) if the person doing the act or 
causing it to be done acted in good faith and had no reason to 
believe that the drug was a counterfeit drug.
  (d) No person shall be subject to the penalties of subsection 
(a)(1) of this section for a violation of section 301 involving 
misbranded food if the violation exists solely because the food 
is misbranded under section 403(a)(2) because of its 
advertising.
  (e)(1) Except as provided in paragraph (2), whoever knowingly 
distributes, or possesses with intent to distribute, human 
growth hormone for any use in humans other than the treatment 
of a disease or other recognized medical condition, where such 
use has been authorized by the Secretary of Health and Human 
Services under section 505 and pursuant to the order of a 
physician, is guilty of an offense punishable by not more than 
5 years in prison, such fines as are authorized by title 18, 
United States Code, or both.
  (2) Whoever commits any offense set forth in paragraph (1) 
and such offense involves an individual under 18 years of age 
is punishable by not more than 10 years imprisonment, such 
fines as are authorized by title 18, United States Code, or 
both.
  (3) Any conviction for a violation of paragraphs (1) and (2) 
of this subsection shall be considered a felony violation of 
the Controlled Substances Act for the purposes of forfeiture 
under section 413 of such Act.
  (4) As used in this subsection the term ``human growth 
hormone'' means somatrem, somatropin, or an analogue of either 
of them.
  (5) The Drug Enforcement Administration is authorized to 
investigate offenses punishable by this subsection.
  (f)(1)(A) Except as provided in subparagraph (B), any person 
who violates a requirement of this Act which relates to devices 
shall be liable to the United States for a civil penalty in an 
amount not to exceed $15,000 for each such violation, and not 
to exceed $1,000,000 for all such violations adjudicated in a 
single proceeding. For purposes of the preceding sentence, a 
person accredited under paragraph (2) of section 704(g) who is 
substantially not in compliance with the standards of 
accreditation under such section, or who poses a threat to 
public health or fails to act in a manner that is consistent 
with the purposes of such section, shall be considered to have 
violated a requirement of this Act that relates to devices.
  (B) Subparagraph (A) shall not apply--
          (i) to any person who violates the requirements of 
        section 519(a) or 520(f) unless such violation 
        constitutes (I) a significant or knowing departure from 
        such requirements, or (II) a risk to public health,
          (ii) to any person who commits minor violations of 
        section 519(e) or 519(g) (only with respect to 
        correction reports) if such person demonstrates 
        substantial compliance with such section, or
          (iii) to violations of section 501(a)(2)(A) which 
        involve one or more devices which are not defective.
  (2)(A) Any person who introduces into interstate commerce or 
delivers for introduction into interstate commerce an article 
of food that is adulterated within the meaning of section 
402(a)(2)(B) or any person who does not comply with a recall 
order under section 423 shall be subject to a civil money 
penalty of not more than $50,000 in the case of an individual 
and $250,000 in the case of any other person for such 
introduction or delivery, not to exceed $500,000 for all such 
violations adjudicated in a single proceeding.
  (B) This paragraph shall not apply to any person who grew the 
article of food that is adulterated. If the Secretary assesses 
a civil penalty against any person under this paragraph, the 
Secretary may not use the criminal authorities under this 
section to sanction such person for the introduction or 
delivery for introduction into interstate commerce of the 
article of food that is adulterated. If the Secretary assesses 
a civil penalty against any person under this paragraph, the 
Secretary may not use the seizure authorities of section 304 or 
the injunction authorities of section 302 with respect to the 
article of food that is adulterated.
  (C) In a hearing to assess a civil penalty under this 
paragraph, the presiding officer shall have the same authority 
with regard to compelling testimony or production of documents 
as a presiding officer has under section 408(g)(2)(B). The 
third sentence of paragraph (5)(A) shall not apply to any 
investigation under this paragraph.
  (3)(A) Any person who violates section 301(jj) shall be 
subject to a civil monetary penalty of not more than $10,000 
for all violations adjudicated in a single proceeding.
  (B) If a violation of section 301(jj) is not corrected within 
the 30-day period following notification under section 
402(j)(5)(C)(ii), the person shall, in addition to any penalty 
under subparagraph (A), be subject to a civil monetary penalty 
of not more than $10,000 for each day of the violation after 
such period until the violation is corrected.
  (4)(A) Any responsible person (as such term is used in 
section 505-1) that violates a requirement of section 505(o), 
505(p), or 505-1 shall be subject to a civil monetary penalty 
of--
          (i) not more than $250,000 per violation, and not to 
        exceed $1,000,000 for all such violations adjudicated 
        in a single proceeding; or
          (ii) in the case of a violation that continues after 
        the Secretary provides written notice to the 
        responsible person, the responsible person shall be 
        subject to a civil monetary penalty of $250,000 for the 
        first 30-day period (or any portion thereof) that the 
        responsible person continues to be in violation, and 
        such amount shall double for every 30-day period 
        thereafter that the violation continues, not to exceed 
        $1,000,000 for any 30-day period, and not to exceed 
        $10,000,000 for all such violations adjudicated in a 
        single proceeding.
  (B) In determining the amount of a civil penalty under 
subparagraph (A)(ii), the Secretary shall take into 
consideration whether the responsible person is making efforts 
toward correcting the violation of the requirement of section 
505(o), 505(p), or 505-1 for which the responsible person is 
subject to such civil penalty.
  (5)(A) A civil penalty under paragraph (1), (2), (3), (4), or 
(9) shall be assessed, or a no-tobacco-sale order may be 
imposed, by the Secretary by an order made on the record after 
opportunity for a hearing provided in accordance with this 
subparagraph and section 554 of title 5, United States Code. 
Before issuing such an order, the Secretary shall give written 
notice to the person to be assessed a civil penalty, or upon 
whom a no-tobacco-sale order is to be imposed, under such order 
of the Secretary's proposal to issue such order and provide 
such person an opportunity for a hearing on the order. In the 
course of any investigation, the Secretary may issue subpoenas 
requiring the attendance and testimony of witnesses and the 
production of evidence that relates to the matter under 
investigation.
  (B) In determining the amount of a civil penalty, or the 
period to be covered by a no-tobacco-sale order, the Secretary 
shall take into account the nature, circumstances, extent, and 
gravity of the violation or violations and, with respect to the 
violator, ability to pay, effect on ability to continue to do 
business, any history of prior such violations, the degree of 
culpability, and such other matters as justice may require. A 
no-tobacco-sale order permanently prohibiting an individual 
retail outlet from selling tobacco products shall include 
provisions that allow the outlet, after a specified period of 
time, to request that the Secretary compromise, modify, or 
terminate the order.
  (C) The Secretary may compromise, modify, or remit, with or 
without conditions, any civil penalty which may be assessed 
under paragraph (1), (2), (3), (4), or (9). The amount of such 
penalty, when finally determined, or the amount agreed upon in 
compromise, may be deducted from any sums owing by the United 
States to the person charged.
  (D) The Secretary may compromise, modify, or terminate, with 
or without conditions, any no-tobacco-sale order.
  (6) Any person who requested, in accordance with paragraph 
(5)(A), a hearing respecting the assessment of a civil penalty 
or the imposition of a no-tobacco-sale order and who is 
aggrieved by an order assessing a civil penalty or the 
imposition of a no-tobacco-sale order may file a petition for 
judicial review of such order with the United States Court of 
Appeals for the District of Columbia Circuit or for any other 
circuit in which such person resides or transacts business. 
Such a petition may only be filed within the 60-day period 
beginning on the date the order making such assessment was 
issued, or on which the no-tobacco-sale order was imposed, as 
the case may be.
  (7) If any person fails to pay an assessment of a civil 
penalty--
          (A) after the order making the assessment becomes 
        final, and if such person does not file a petition for 
        judicial review of the order in accordance with 
        paragraph (6), or
          (B) after a court in an action brought under 
        paragraph (6) has entered a final judgment in favor of 
        the Secretary,
the Attorney General shall recover the amount assessed (plus 
interest at currently prevailing rates from the date of the 
expiration of the 60-day period referred to in paragraph (6) or 
the date of such final judgment, as the case may be) in an 
action brought in any appropriate district court of the United 
States. In such an action, the validity, amount, and 
appropriateness of such penalty shall not be subject to review.
  (8) If the Secretary finds that a person has committed 
repeated violations of restrictions promulgated under section 
906(d) at a particular retail outlet then the Secretary may 
impose a no-tobacco-sale order on that person prohibiting the 
sale of tobacco products in that outlet. A no-tobacco-sale 
order may be imposed with a civil penalty under paragraph (1). 
Prior to the entry of a no-sale order under this paragraph, a 
person shall be entitled to a hearing pursuant to the 
procedures established through regulations of the Food and Drug 
Administration for assessing civil money penalties, including 
at a retailer's request a hearing by telephone, or at the 
nearest regional or field office of the Food and Drug 
Administration, or at a Federal, State, or county facility 
within 100 miles from the location of the retail outlet, if 
such a facility is available.
  (9) Civil Monetary Penalties for Violation of Tobacco Product 
Requirements.--
          (A) In general.--Subject to subparagraph (B), any 
        person who violates a requirement of this Act which 
        relates to tobacco products shall be liable to the 
        United States for a civil penalty in an amount not to 
        exceed $15,000 for each such violation, and not to 
        exceed $1,000,000 for all such violations adjudicated 
        in a single proceeding.
          (B) Enhanced penalties.--
                  (i) Any person who intentionally violates a 
                requirement of section 902(5), 902(6), 904, 
                908(c), or 911(a), shall be subject to a civil 
                monetary penalty of--
                          (I) not to exceed $250,000 per 
                        violation, and not to exceed $1,000,000 
                        for all such violations adjudicated in 
                        a single proceeding; or
                          (II) in the case of a violation that 
                        continues after the Secretary provides 
                        written notice to such person, $250,000 
                        for the first 30-day period (or any 
                        portion thereof) that the person 
                        continues to be in violation, and such 
                        amount shall double for every 30-day 
                        period thereafter that the violation 
                        continues, not to exceed $1,000,000 for 
                        any 30-day period, and not to exceed 
                        $10,000,000 for all such violations 
                        adjudicated in a single proceeding.
                  (ii) Any person who violates a requirement of 
                section 911(g)(2)(C)(ii) or 911(i)(1), shall be 
                subject to a civil monetary penalty of--
                          (I) not to exceed $250,000 per 
                        violation, and not to exceed $1,000,000 
                        for all such violations adjudicated in 
                        a single proceeding; or
                          (II) in the case of a violation that 
                        continues after the Secretary provides 
                        written notice to such person, $250,000 
                        for the first 30-day period (or any 
                        portion thereof) that the person 
                        continues to be in violation, and such 
                        amount shall double for every 30-day 
                        period thereafter that the violation 
                        continues, not to exceed $1,000,000 for 
                        any 30-day period, and not to exceed 
                        $10,000,000 for all such violations 
                        adjudicated in a single proceeding.
                  (iii) In determining the amount of a civil 
                penalty under clause (i)(II) or (ii)(II), the 
                Secretary shall take into consideration whether 
                the person is making efforts toward correcting 
                the violation of the requirements of the 
                section for which such person is subject to 
                such civil penalty.
  (g)(1) With respect to a person who is a holder of an 
approved application under section 505 for a drug subject to 
section 503(b) or under section 351 of the Public Health 
Service Act, any such person who disseminates or causes another 
party to disseminate a direct-to-consumer advertisement that is 
false or misleading shall be liable to the United States for a 
civil penalty in an amount not to exceed $250,000 for the first 
such violation in any 3-year period, and not to exceed $500,000 
for each subsequent violation in any 3-year period. No other 
civil monetary penalties in this Act (including the civil 
penalty in section 303(f)(4)) shall apply to a violation 
regarding direct-to-consumer advertising. For purposes of this 
paragraph: (A) Repeated dissemination of the same or similar 
advertisement prior to the receipt of the written notice 
referred to in paragraph (2) for such advertisements shall be 
considered one violation. (B) On and after the date of the 
receipt of such a notice, all violations under this paragraph 
occurring in a single day shall be considered one violation. 
With respect to advertisements that appear in magazines or 
other publications that are published less frequently than 
daily, each issue date (whether weekly or monthly) shall be 
treated as a single day for the purpose of calculating the 
number of violations under this paragraph.
  (2) A civil penalty under paragraph (1) shall be assessed by 
the Secretary by an order made on the record after providing 
written notice to the person to be assessed a civil penalty and 
an opportunity for a hearing in accordance with this paragraph 
and section 554 of title 5, United States Code. If upon receipt 
of the written notice, the person to be assessed a civil 
penalty objects and requests a hearing, then in the course of 
any investigation related to such hearing, the Secretary may 
issue subpoenas requiring the attendance and testimony of 
witnesses and the production of evidence that relates to the 
matter under investigation, including information pertaining to 
the factors described in paragraph (3).
  (3) The Secretary, in determining the amount of the civil 
penalty under paragraph (1), shall take into account the 
nature, circumstances, extent, and gravity of the violation or 
violations, including the following factors:
          (A) Whether the person submitted the advertisement or 
        a similar advertisement for review under section 736A.
          (B) Whether the person submitted the advertisement 
        for review if required under section 503B.
          (C) Whether, after submission of the advertisement as 
        described in subparagraph (A) or (B), the person 
        disseminated or caused another party to disseminate the 
        advertisement before the end of the 45-day comment 
        period.
          (D) Whether the person incorporated any comments made 
        by the Secretary with regard to the advertisement into 
        the advertisement prior to its dissemination.
          (E) Whether the person ceased distribution of the 
        advertisement upon receipt of the written notice 
        referred to in paragraph (2) for such advertisement.
          (F) Whether the person had the advertisement reviewed 
        by qualified medical, regulatory, and legal reviewers 
        prior to its dissemination.
          (G) Whether the violations were material.
          (H) Whether the person who created the advertisement 
        or caused the advertisement to be created acted in good 
        faith.
          (I) Whether the person who created the advertisement 
        or caused the advertisement to be created has been 
        assessed a civil penalty under this provision within 
        the previous 1-year period.
          (J) The scope and extent of any voluntary, subsequent 
        remedial action by the person.
          (K) Such other matters, as justice may require.
  (4)(A) Subject to subparagraph (B), no person shall be 
required to pay a civil penalty under paragraph (1) if the 
person submitted the advertisement to the Secretary and 
disseminated or caused another party to disseminate such 
advertisement after incorporating each comment received from 
the Secretary.
  (B) The Secretary may retract or modify any prior comments 
the Secretary has provided to an advertisement submitted to the 
Secretary based on new information or changed circumstances, so 
long as the Secretary provides written notice to the person of 
the new views of the Secretary on the advertisement and 
provides a reasonable time for modification or correction of 
the advertisement prior to seeking any civil penalty under 
paragraph (1).
  (5) The Secretary may compromise, modify, or remit, with or 
without conditions, any civil penalty which may be assessed 
under paragraph (1). The amount of such penalty, when finally 
determined, or the amount charged upon in compromise, may be 
deducted from any sums owed by the United States to the person 
charged.
  (6) Any person who requested, in accordance with paragraph 
(2), a hearing with respect to the assessment of a civil 
penalty and who is aggrieved by an order assessing a civil 
penalty, may file a petition for de novo judicial review of 
such order with the United States Court of Appeals for the 
District of Columbia Circuit or for any other circuit in which 
such person resides or transacts business. Such a petition may 
only be filed within the 60-day period beginning on the date 
the order making such assessments was issued.
  (7) If any person fails to pay an assessment of a civil 
penalty under paragraph (1)--
          (A) after the order making the assessment becomes 
        final, and if such person does not file a petition for 
        judicial review of the order in accordance with 
        paragraph (6), or
          (B) after a court in an action brought under 
        paragraph (6) has entered a final judgment in favor of 
        the Secretary,
the Attorney General of the United States shall recover the 
amount assessed (plus interest at currently prevailing rates 
from the date of the expiration of the 60-day period referred 
to in paragraph (6) or the date of such final judgment, as the 
case may be) in an action brought in any appropriate district 
court of the United States. In such an action, the validity, 
amount, and appropriateness of such penalty shall not be 
subject to review.

           *       *       *       *       *       *       *


                      CHAPTER V--DRUGS AND DEVICES

Subchapter A--Drugs and Devices

           *       *       *       *       *       *       *


                               new drugs

  Sec. 505. (a) No person shall introduce or deliver for 
introduction into interstate commerce any new drug, unless an 
approval of an application filed pursuant to subsection (b) or 
(j) is effective with respect to such drug.
  (b)(1) Any person may file with the Secretary an application 
with respect to any drug subject to the provisions of 
subsection (a). Such persons shall submit to the Secretary as a 
part of the application (A) full reports of investigations 
which have been made to show whether or not such drug is safe 
for use and whether such drug is effective in use; (B) a full 
list of the articles used as components of such drug; (C) a 
full statement of the composition of such drug; (D) a full 
description of the methods used in, and the facilities and 
controls used for, the manufacture, processing, and packing of 
such drug; (E) such samples of such drug and of the articles 
used as components thereof as the Secretary may require; (F) 
specimens of the labeling proposed to be used for such drug, 
and (G) any assessments required under section 505B. The 
applicant shall file with the application the patent number and 
the expiration date of any patent which claims the drug for 
which the applicant submitted the application or which claims a 
method of using such drug and with respect to which a claim of 
patent infringement could reasonably be asserted if a person 
not licensed by the owner engaged in the manufacture use, or 
sale of the drug. If a application is filed under this 
subsection for a drug and a patent which claims such drug or a 
method of using such drug is issued after the filing date but 
before approval of the application, the applicant shall amend 
the application to include the information required by the 
preceding sentence. Upon approval of the application, the 
Secretary shall publish information submitted under the two 
preceding sentences. The Secretary shall, in consultation with 
the Director of the National Institutes of Health and with 
representatives of the drug manufacturing industry, review and 
develop guidance, as appropriate, on the inclusion of women and 
minorities in clinical trials required by clause (A).
  (2) An application submitted under paragraph (1) for a drug 
for which the investigations described in clause (A) of such 
paragraph and relied upon by the applicant for approval of the 
application were not conducted by or for the applicant and for 
which the applicant has not obtained a right of reference or 
use from the person by or for whom the investigations were 
conducted shall also include--
          (A) a certification, in the opinion of the applicant 
        and to the best of his knowledge, with respect to each 
        patent which claims the drug for which such 
        investigations were conducted or which claims a use for 
        such drug for which the applicant is seeking approval 
        under this subsection and for which information is 
        required to be filed under paragraph (1) or subsection 
        (c)--
                  (i) that such patent information has not been 
                filed,
                  (ii) that such patent has expired,
                  (iii) of the date on which such patent will 
                expire, or
                  (iv) that such patent is invalid or will not 
                be infringed by the manufacture, use, or sale 
                of the new drug for which the application is 
                submitted; and
          (B) if with respect to the drug for which 
        investigations described in paragraph (1)(A) were 
        conducted information was filed under paragraph (1) or 
        subsection (c) for a method of use patent which does 
        not claim a use for which the applicant is seeking 
        approval under this subsection, a statement that the 
        method of use patent does not claim such a use.
  (3) Notice of opinion that patent is invalid or will not be 
infringed.--
          (A) Agreement to give notice.--An applicant that 
        makes a certification described in paragraph (2)(A)(iv) 
        shall include in the application a statement that the 
        applicant will give notice as required by this 
        paragraph.
          (B) Timing of notice.--An applicant that makes a 
        certification described in paragraph (2)(A)(iv) shall 
        give notice as required under this paragraph--
                  (i) if the certification is in the 
                application, not later than 20 days after the 
                date of the postmark on the notice with which 
                the Secretary informs the applicant that the 
                application has been filed; or
                  (ii) if the certification is in an amendment 
                or supplement to the application, at the time 
                at which the applicant submits the amendment or 
                supplement, regardless of whether the applicant 
                has already given notice with respect to 
                another such certification contained in the 
                application or in an amendment or supplement to 
                the application.
          (C) Recipients of notice.--An applicant required 
        under this paragraph to give notice shall give notice 
        to--
                  (i) each owner of the patent that is the 
                subject of the certification (or a 
                representative of the owner designated to 
                receive such a notice); and
                  (ii) the holder of the approved application 
                under this subsection for the drug that is 
                claimed by the patent or a use of which is 
                claimed by the patent (or a representative of 
                the holder designated to receive such a 
                notice).
          (D) Contents of notice.--A notice required under this 
        paragraph shall--
                  (i) state that an application that contains 
                data from bioavailability or bioequivalence 
                studies has been submitted under this 
                subsection for the drug with respect to which 
                the certification is made to obtain approval to 
                engage in the commercial manufacture, use, or 
                sale of the drug before the expiration of the 
                patent referred to in the certification; and
                  (ii) include a detailed statement of the 
                factual and legal basis of the opinion of the 
                applicant that the patent is invalid or will 
                not be infringed.
  (4)(A) An applicant may not amend or supplement an 
application referred to in paragraph (2) to seek approval of a 
drug that is a different drug than the drug identified in the 
application as submitted to the Secretary.
  (B) With respect to the drug for which such an application is 
submitted, nothing in this subsection or subsection (c)(3) 
prohibits an applicant from amending or supplementing the 
application to seek approval of a different strength.
  (5)(A) The Secretary shall issue guidance for the individuals 
who review applications submitted under paragraph (1) or under 
section 351 of the Public Health Service Act, which shall 
relate to promptness in conducting the review, technical 
excellence, lack of bias and conflict of interest, and 
knowledge of regulatory and scientific standards, and which 
shall apply equally to all individuals who review such 
applications.
  (B) The Secretary shall meet with a sponsor of an 
investigation or an applicant for approval for a drug under 
this subsection or section 351 of the Public Health Service Act 
if the sponsor or applicant makes a reasonable written request 
for a meeting for the purpose of reaching agreement on the 
design and size--
          (i)(I) of clinical trials intended to form the 
        primary basis of an effectiveness claim; or
          (II) in the case where human efficacy studies are not 
        ethical or feasible, of animal and any associated 
        clinical trials which, in combination, are intended to 
        form the primary basis of an effectiveness claim; or
          (ii) with respect to an application for approval of a 
        biological product under section 351(k) of the Public 
        Health Service Act, of any necessary clinical study or 
        studies.
The sponsor or applicant shall provide information necessary 
for discussion and agreement on the design and size of the 
clinical trials. Minutes of any such meeting shall be prepared 
by the Secretary and made available to the sponsor or applicant 
upon request.
  (C) Any agreement regarding the parameters of the design and 
size of clinical trials of a new drug under this paragraph that 
is reached between the Secretary and a sponsor or applicant 
shall be reduced to writing and made part of the administrative 
record by the Secretary. Such agreement shall not be changed 
after the testing begins, except--
          (i) with the written agreement of the sponsor or 
        applicant; or
          (ii) pursuant to a decision, made in accordance with 
        subparagraph (D) by the director of the reviewing 
        division, that a substantial scientific issue essential 
        to determining the safety or effectiveness of the drug 
        has been identified after the testing has begun.
  (D) A decision under subparagraph (C)(ii) by the director 
shall be in writing and the Secretary shall provide to the 
sponsor or applicant an opportunity for a meeting at which the 
director and the sponsor or applicant will be present and at 
which the director will document the scientific issue involved.
  (E) The written decisions of the reviewing division shall be 
binding upon, and may not directly or indirectly be changed by, 
the field or compliance division personnel unless such field or 
compliance division personnel demonstrate to the reviewing 
division why such decision should be modified.
  (F) No action by the reviewing division may be delayed 
because of the unavailability of information from or action by 
field personnel unless the reviewing division determines that a 
delay is necessary to assure the marketing of a safe and 
effective drug.
  (G) For purposes of this paragraph, the reviewing division is 
the division responsible for the review of an application for 
approval of a drug under this subsection or section 351 of the 
Public Health Service Act (including all scientific and medical 
matters, chemistry, manufacturing, and controls).
          (6) An application submitted under this subsection 
        shall be accompanied by the certification required 
        under section 402(j)(5)(B) of the Public Health Service 
        Act. Such certification shall not be considered an 
        element of such application.
  (c)(1) Within one hundred and eighty days after the filing of 
an application under subsection (b), or such additional period 
as may be agreed upon by the Secretary and the applicant, the 
Secretary shall either--
          (A) approve the application if he then finds that 
        none of the grounds for denying approval specified in 
        subsection (d) applies, or
          (B) give the applicant notice of an opportunity for a 
        hearing before the Secretary under subsection (d) on 
        the question whether such application is approvable. If 
        the applicant elects to accept the opportunity for 
        hearing by written request within thirty days after 
        such notice, such hearing shall commence not more than 
        ninety days after the expiration of such thirty days 
        unless the Secretary and the applicant otherwise agree. 
        Any such hearing shall thereafter be conducted on an 
        expedited basis and the Secretary's order thereon shall 
        be issued within ninety days after the date fixed by 
        the Secretary for filing final briefs.
  (2) If the patent information described in subsection (b) 
could not be filed with the submission of an application under 
subsection (b) because the application was filed before the 
patent information was required under subsection (b) or a 
patent was issued after the application was approved under such 
subsection, the holder of an approved application shall file 
with the Secretary, the patent number and the expiration date 
of any patent which claims the drug for which the application 
was submitted or which claims a method of using such drug and 
with respect to which a claim of patent infringement could 
reasonably be asserted if a person not licensed by the owner 
engaged in the manufacture, use, or sale of the drug. If the 
holder of an approved application could not file patent 
information under subsection (b) because it was not required at 
the time the application was approved, the holder shall file 
such information under this subsection not later than thirty 
days after the date of the enactment of this sentence, and if 
the holder of an approved application could not file patent 
information under subsection (b) because no patent had been 
issued when an application was filed or approved, the holder 
shall file such information under this subsection not later 
than thirty days after after the date the patent involved is 
issued. Upon the submission of patent information under this 
subsection, the Secretary shall publish it.
  (3) The approval of an application filed under subsection (b) 
which contains a certification required by paragraph (2) of 
such subsection shall be made effective on the last applicable 
date determined by applying the following to each certification 
made under subsection (b)(2)(A):
          (A) If the applicant only made a certification 
        described in clause (i) or (ii) of subsection (b)(2)(A) 
        or in both such clauses, the approval may be made 
        effective immediately.
          (B) If the applicant made a certification described 
        in clause (iii) of subsection (b)(2)(A), the approval 
        may be made effective on the date certified under 
        clause (iii).
          (C) If the applicant made a certification described 
        in clause (iv) of subsection (b)(2)(A), the approval 
        shall be made effective immediately unless, before the 
        expiration of 45 days after the date on which the 
        notice described in subsection (b)(3) is received, an 
        action is brought for infringement of the patent that 
        is the subject of the certification and for which 
        information was submitted to the Secretary under 
        paragraph (2) or subsection (b)(1) before the date on 
        which the application (excluding an amendment or 
        supplement to the application) was submitted. If such 
        an action is brought before the expiration of such 
        days, the approval may be made effective upon the 
        expiration of the thirty-month period beginning on the 
        date of the receipt of the notice provided under 
        subsection (b)(3) or such shorter or longer period as 
        the court may order because either party to the action 
        failed to reasonably cooperate in expediting the 
        action, except that--
                  (i) if before the expiration of such period 
                the district court decides that the patent is 
                invalid or not infringed (including any 
                substantive determination that there is no 
                cause of action for patent infringement or 
                invalidity), the approval shall be made 
                effective on--
                          (I) the date on which the court 
                        enters judgment reflecting the 
                        decision; or
                          (II) the date of a settlement order 
                        or consent decree signed and entered by 
                        the court stating that the patent that 
                        is the subject of the certification is 
                        invalid or not infringed;
                  (ii) if before the expiration of such period 
                the district court decides that the patent has 
                been infringed--
                          (I) if the judgment of the district 
                        court is appealed, the approval shall 
                        be made effective on--
                                  (aa) the date on which the 
                                court of appeals decides that 
                                the patent is invalid or not 
                                infringed (including any 
                                substantive determination that 
                                there is no cause of action for 
                                patent infringement or 
                                invalidity); or
                                  (bb) the date of a settlement 
                                order or consent decree signed 
                                and entered by the court of 
                                appeals stating that the patent 
                                that is the subject of the 
                                certification is invalid or not 
                                infringed; or
                          (II) if the judgment of the district 
                        court is not appealed or is affirmed, 
                        the approval shall be made effective on 
                        the date specified by the district 
                        court in a court order under section 
                        271(e)(4)(A) of title 35, United States 
                        Code;
                  (iii) if before the expiration of such period 
                the court grants a preliminary injunction 
                prohibiting the applicant from engaging in the 
                commercial manufacture or sale of the drug 
                until the court decides the issues of patent 
                validity and infringement and if the court 
                decides that such patent is invalid or not 
                infringed, the approval shall be made effective 
                as provided in clause (i); or
                  (iv) if before the expiration of such period 
                the court grants a preliminary injunction 
                prohibiting the applicant from engaging in the 
                commercial manufacture or sale of the drug 
                until the court decides the issues of patent 
                validity and infringement and if the court 
                decides that such patent has been infringed, 
                the approval shall be made effective as 
                provided in clause (ii).
        In such an action, each of the parties shall reasonably 
        cooperate in expediting the action.
          (D) Civil action to obtain patent certainty.--
                  (i) Declaratory judgment absent infringement 
                action.--
                          (I) In general.--No action may be 
                        brought under section 2201 of title 28, 
                        United States Code, by an applicant 
                        referred to in subsection (b)(2) for a 
                        declaratory judgment with respect to a 
                        patent which is the subject of the 
                        certification referred to in 
                        subparagraph (C) unless--
                                  (aa) the 45-day period 
                                referred to in such 
                                subparagraph has expired;
                                  (bb) neither the owner of 
                                such patent nor the holder of 
                                the approved application under 
                                subsection (b) for the drug 
                                that is claimed by the patent 
                                or a use of which is claimed by 
                                the patent brought a civil 
                                action against the applicant 
                                for infringement of the patent 
                                before the expiration of such 
                                period; and
                                  (cc) in any case in which the 
                                notice provided under paragraph 
                                (2)(B) relates to 
                                noninfringement, the notice was 
                                accompanied by a document 
                                described in subclause (III).
                          (II) Filing of civil action.--If the 
                        conditions described in items (aa), 
                        (bb), and as applicable, (cc) of 
                        subclause (I) have been met, the 
                        applicant referred to in such subclause 
                        may, in accordance with section 2201 of 
                        title 28, United States Code, bring a 
                        civil action under such section against 
                        the owner or holder referred to in such 
                        subclause (but not against any owner or 
                        holder that has brought such a civil 
                        action against the applicant, unless 
                        that civil action was dismissed without 
                        prejudice) for a declaratory judgment 
                        that the patent is invalid or will not 
                        be infringed by the drug for which the 
                        applicant seeks approval, except that 
                        such civil action may be brought for a 
                        declaratory judgment that the patent 
                        will not be infringed only in a case in 
                        which the condition described in 
                        subclause (I)(cc) is applicable. A 
                        civil action referred to in this 
                        subclause shall be brought in the 
                        judicial district where the defendant 
                        has its principal place of business or 
                        a regular and established place of 
                        business.
                          (III) Offer of confidential access to 
                        application.--For purposes of subclause 
                        (I)(cc), the document described in this 
                        subclause is a document providing an 
                        offer of confidential access to the 
                        application that is in the custody of 
                        the applicant referred to in subsection 
                        (b)(2) for the purpose of determining 
                        whether an action referred to in 
                        subparagraph (C) should be brought. The 
                        document providing the offer of 
                        confidential access shall contain such 
                        restrictions as to persons entitled to 
                        access, and on the use and disposition 
                        of any information accessed, as would 
                        apply had a protective order been 
                        entered for the purpose of protecting 
                        trade secrets and other confidential 
                        business information. A request for 
                        access to an application under an offer 
                        of confidential access shall be 
                        considered acceptance of the offer of 
                        confidential access with the 
                        restrictions as to persons entitled to 
                        access, and on the use and disposition 
                        of any information accessed, contained 
                        in the offer of confidential access, 
                        and those restrictions and other terms 
                        of the offer of confidential access 
                        shall be considered terms of an 
                        enforceable contract. Any person 
                        provided an offer of confidential 
                        access shall review the application for 
                        the sole and limited purpose of 
                        evaluating possible infringement of the 
                        patent that is the subject of the 
                        certification under subsection 
                        (b)(2)(A)(iv) and for no other purpose, 
                        and may not disclose information of no 
                        relevance to any issue of patent 
                        infringement to any person other than a 
                        person provided an offer of 
                        confidential access. Further, the 
                        application may be redacted by the 
                        applicant to remove any information of 
                        no relevance to any issue of patent 
                        infringement.
                  (ii) Counterclaim to infringement action.--
                          (I) In general.--If an owner of the 
                        patent or the holder of the approved 
                        application under subsection (b) for 
                        the drug that is claimed by the patent 
                        or a use of which is claimed by the 
                        patent brings a patent infringement 
                        action against the applicant, the 
                        applicant may assert a counterclaim 
                        seeking an order requiring the holder 
                        to correct or delete the patent 
                        information submitted by the holder 
                        under subsection (b) or this subsection 
                        on the ground that the patent does not 
                        claim either--
                                  (aa) the drug for which the 
                                application was approved; or
                                  (bb) an approved method of 
                                using the drug.
                          (II) No independent cause of 
                        action.--Subclause (I) does not 
                        authorize the assertion of a claim 
                        described in subclause (I) in any civil 
                        action or proceeding other than a 
                        counterclaim described in subclause 
                        (I).
                  (iii) No damages.--An applicant shall not be 
                entitled to damages in a civil action under 
                clause (i) or a counterclaim under clause (ii).
          (E)(i) If an application (other than an abbreviated 
        new drug application) submitted under subsection (b) 
        for a drug, no active ingredient (including any ester 
        or salt of the active ingredient) of which has been 
        approved in any other application under subsection (b), 
        was approved during the period beginning January 1, 
        1982, and ending on the date of the enactment of this 
        subsection, the Secretary may not make the approval of 
        another application for a drug for which the 
        investigations described in clause (A) of subsection 
        (b)(1) and relied upon by the applicant for approval of 
        the application were not conducted by or for the 
        applicant and for which the applicant has not obtained 
        a right of reference or use from the person by or for 
        whom the investigations were conducted effective before 
        the expiration of ten years from the date of the 
        approval of the application previously approved under 
        subsection (b).
          (ii) If an application submitted under subsection (b) 
        for a drug, no active ingredient (including any ester 
        or salt of the active ingredient) of which has been 
        approved in any other application under subsection (b), 
        is approved after the date of the enactment of this 
        clause, no application which refers to the drug for 
        which the subsection (b) application was submitted and 
        for which the investigations described in clause (A) of 
        subsection (b)(1) and relied upon by the applicant for 
        approval of the application were not conducted by or 
        for the applicant and for which the applicant has not 
        obtained a right of reference or use from the person by 
        or for whom the investigations were conducted may be 
        submitted under subsection (b) before the expiration of 
        five years from the date of the approval of the 
        application under subsection (b), except that such an 
        application may be submitted under subsection (b) after 
        the expiration of four years from the date of the 
        approval of the subsection (b) application if it 
        contains a certification of patent invalidity or 
        noninfringement described in clause (iv) of subsection 
        (b)(2)(A). The approval of such an application shall be 
        made effective in accordance with this paragraph except 
        that, if an action for patent infringement is commenced 
        during the one-year period beginning forty-eight months 
        after the date of the approval of the subsection (b) 
        application, the thirty-month period referred to in 
        subparagraph (C) shall be extended by such amount of 
        time (if any) which is required for seven and one-half 
        years to have elapsed from the date of approval of the 
        subsection (b) application.
          (iii) If an application submitted under subsection 
        (b) for a drug, which includes an active ingredient 
        (including any ester or salt of the active ingredient) 
        that has been approved in another application approved 
        under subsection (b), is approved after the date of the 
        enactment of this clause and if such application 
        contains reports of new clinical investigations (other 
        than bioavailability studies) essential to the approval 
        of the application and conducted or sponsored by the 
        applicant, the Secretary may not make the approval of 
        an application submitted under subsection (b) for the 
        conditions of approval of such drug in the approved 
        subsection (b) application effective before the 
        expiration of three years from the date of the approval 
        of the application under subsection (b) if the 
        investigations described in clause (A) of subsection 
        (b)(1) and relied upon by the applicant for approval of 
        the application were not conducted by or for the 
        applicant and if the applicant has not obtained a right 
        of reference or use from the person by or for whom the 
        investigations were conducted.
          (iv) If a supplement to an application approved under 
        subsection (b) is approved after the date of enactment 
        of this clause and the supplement contains reports of 
        new clinical investigations (other than bioavailabilty 
        studies) essential to the approval of the supplement 
        and conducted or sponsored by the person submitting the 
        supplement, the Secretary may not make the approval of 
        an application submitted under subsection (b) for a 
        change approved in the supplement effective before the 
        expiration of three years from the date of the approval 
        of the supplement under subsection (b) if the 
        investigations described in clause (A) of subsection 
        (b)(1) and relied upon by the applicant for approval of 
        the application were not conducted by or for the 
        applicant and if the applicant has not obtained a right 
        of reference or use from the person by or for whom the 
        investigations were conducted.
          (v) If an application (or supplement to an 
        application) submitted under subsection (b) for a drug, 
        which includes an active ingredient (including any 
        ester or salt of the active ingredient) that has been 
        approved in another application under subsection (b), 
        was approved during the period beginning January 1, 
        1982, and ending on the date of the enactment of this 
        clause, the Secretary may not make the approval of an 
        application submitted under this subsection and for 
        which the investigations described in clause (A) of 
        subsection (b)(1) and relied upon by the applicant for 
        approval of the application were not conducted by or 
        for the applicant and for which the applicant has not 
        obtained a right of reference or use from the person by 
        or for whom the investigations were conducted and which 
        refers to the drug for which the subsection (b) 
        application was submitted effective before the 
        expiration of two years from the date of enactment of 
        this clause.
  (4) A drug manufactured in a pilot or other small facility 
may be used to demonstrate the safety and effectiveness of the 
drug and to obtain approval for the drug prior to manufacture 
of the drug in a larger facility, unless the Secretary makes a 
determination that a full scale production facility is 
necessary to ensure the safety or effectiveness of the drug.
  (5)(A) The Secretary may rely upon qualified data summaries 
to support the approval of a supplemental application, with 
respect to a qualified indication for a drug, submitted under 
subsection (b), if such supplemental application complies with 
subparagraph (B).
  (B) A supplemental application is eligible for review as 
described in subparagraph (A) only if--
          (i) there is existing data available and acceptable 
        to the Secretary demonstrating the safety of the drug; 
        and
          (ii) all data used to develop the qualified data 
        summaries are submitted to the Secretary as part of the 
        supplemental application.
  (C) The Secretary shall post on the Internet website of the 
Food and Drug Administration and update annually--
          (i) the number of applications reviewed solely under 
        subparagraph (A) or section 351(a)(2)(E) of the Public 
        Health Service Act;
          (ii) the average time for completion of review under 
        subparagraph (A) or section 351(a)(2)(E) of the Public 
        Health Service Act;
          (iii) the average time for review of supplemental 
        applications where the Secretary did not use review 
        flexibility under subparagraph (A) or section 
        351(a)(2)(E) of the Public Health Service Act; and
          (iv) the number of applications reviewed under 
        subparagraph (A) or section 351(a)(2)(E) of the Public 
        Health Service Act for which the Secretary made use of 
        full data sets in addition to the qualified data 
        summary.
  (D) In this paragraph--
          (i) the term ``qualified indication'' means an 
        indication for a drug that the Secretary determines to 
        be appropriate for summary level review under this 
        paragraph; and
          (ii) the term ``qualified data summary'' means a 
        summary of clinical data that demonstrates the safety 
        and effectiveness of a drug with respect to a qualified 
        indication.
  (d) If the Secretary finds, after due notice to the applicant 
in accordance with subsection (c) and giving him an opportunity 
for a hearing, in accordance with said subsection, that (1) the 
investigations, reports of which are required to be submitted 
to the Secretary pursuant to subsection (b), do not include 
adequate tests by all methods reasonably applicable to show 
whether or not such drug is safe for use under the conditions 
prescribed, recommended, or suggested in the proposed labeling 
thereof; (2) the results of such tests show that such drug is 
unsafe for use under such conditions or do not show that such 
drug is safe for use under such conditions; (3) the methods 
used in, and the facilities and controls used for, the 
manufacture, processing, and packing of such drug are 
inadequate to preserve its identity, strength, quality, and 
purity; (4) upon the basis of the information submitted to him 
as part of the application, or upon the basis of any other 
information before him with respect to such drug, he has 
insufficient information to determine whether such drug is safe 
for use under such conditions; or (5) evaluated on the basis of 
the information submitted to him as part of the application and 
any other information before him with respect to such drug, 
there is a lack of substantial evidence that the drug will have 
the effect it purports or is represented to have under the 
conditions of use prescribed, recommended, or suggested in the 
proposed labeling thereof; or (6) the application failed to 
contain the patent information prescribed by subsection (b); or 
(7) based on a fair evaluation of all material facts, such 
labeling is false or misleading in any particular; he shall 
issue an order refusing to approve the application. If, after 
such notice and opportunity for hearing, the Secretary finds 
that clauses (1) through (6) do not apply, he shall issue an 
order approving the application. As used in this subsection and 
subsection (e), the term ``substantial evidence'' means 
evidence consisting of adequate and well-controlled 
investigations, including clinical investigations, by experts 
qualified by scientific training and experience to evaluate the 
effectiveness of the drug involved, on the basis of which it 
could fairly and responsibly be concluded by such experts that 
the drug will have the effect it purports or is represented to 
have under the conditions of use prescribed, recommended, or 
suggested in the labeling or proposed labeling thereof. If the 
Secretary determines, based on relevant science, that data from 
one adequate and well-controlled clinical investigation and 
confirmatory evidence (obtained prior to or after such 
investigation) are sufficient to establish effectiveness, the 
Secretary may consider such data and evidence to constitute 
substantial evidence for purposes of the preceding sentence. 
The Secretary shall implement a structured risk-benefit 
assessment framework in the new drug approval process to 
facilitate the balanced consideration of benefits and risks, a 
consistent and systematic approach to the discussion and 
regulatory decisionmaking, and the communication of the 
benefits and risks of new drugs. Nothing in the preceding 
sentence shall alter the criteria for evaluating an application 
for marketing approval of a drug.
  (e) The Secretary shall, after due notice and opportunity for 
hearing to the applicant, withdraw approval of an application 
with respect to any drug under this section if the Secretary 
finds (1) that clinical or other experience, tests, or other 
scientific data show that such drug is unsafe for use under the 
conditions of use upon the basis of which the application was 
approved; (2) that new evidence of clinical experience, not 
contained in such application or not available to the Secretary 
until after such application was approved, or tests by new 
methods, or tests by methods not deemed reasonably applicable 
when such application was approved, evaluated together with the 
evidence available to the Secretary when the application was 
approved, shows that such drug is not shown to be safe for use 
under the conditions of use upon the basis of which the 
application was approved; or (3) on the basis of new 
information before him with respect to such drug, evaluated 
together with the evidence available to him when the 
application was approved, that there is a lack of substantial 
evidence that the drug will have the effect it purports or is 
represented to have under the conditions of use prescribed, 
recommended, or suggested in the labeling thereof; or (4) the 
patent information prescribed by subsection (c) was not filed 
within thirty days after the receipt of written notice from the 
Secretary specifying the failure to file such information; or 
(5) that the application contains any untrue statement of a 
material fact: Provided, That if the Secretary (or in his 
absence the officer acting as Secretary) finds that there is an 
imminent hazard to the public health, he may suspend the 
approval of such application immediately, and give the 
applicant prompt notice of his action and afford the applicant 
the opportunity for an expedited hearing under this subsection; 
but the authority conferred by this proviso to suspend the 
approval of an application shall not be delegated. The 
Secretary may also, after due notice and opportunity for 
hearing to the applicant, withdraw the approval of an 
application submitted under subsection (b) or (j) with respect 
to any drug under this section if the Secretary finds (1) that 
the applicant has failed to establish a system for maintaining 
required records, or has repeatedly or deliberately failed to 
maintain such records or to make required reports, in 
accordance with a regulation or order under subsection (k) or 
to comply with the notice requirements of section 510(k)(2), or 
the applicant has refused to permit access to, or copying or 
verification of, such records as required by paragraph (2) of 
such subsection; or (2) that on the basis of new information 
before him, evaluated together with the evidence before him 
when the application was approved, the methods used in, or the 
facilities and controls used for, the manufacture, processing, 
and packing of such drug are inadequate to assure and preserve 
its identity, strength, quality, and purity and were not made 
adequate within a reasonable time after receipt of written 
notice from the Secretary specifying the matter complained of; 
or (3) that on the basis of new information before him, 
evaluated together with the evidence before him when the 
application was approved, the labeling of such drug, based on a 
fair evaluation of all material facts, is false or misleading 
in any particular and was not corrected within a reasonable 
time after receipt of written notice from the Secretary 
specifying the matter complained of. Any order under this 
subsection shall state the findings upon which it is based. The 
Secretary may withdraw the approval of an application submitted 
under this section, or suspend the approval of such an 
application, as provided under this subsection, without first 
ordering the applicant to submit an assessment of the approved 
risk evaluation and mitigation strategy for the drug under 
section 505-1(g)(2)(D).
  (f) Whenever the Secretary finds that the facts so require, 
he shall revoke any previous order under subsection (d) or (e) 
refusing, withdrawing, or suspending approval of an application 
and shall approve such application or reinstate such approval, 
as may be appropriate.
  (g) Orders of the Secretary issued under this section shall 
be served (1) in person by any officer or employee of the 
Department designated by the Secretary or (2) by mailing the 
order by registered mail or by certified mail addressed to the 
applicant or respondent at his last-known address in the 
records of the Secretary.
  (h) An appeal may be taken by the applicant from an order of 
the Secretary refusing or withdrawing approval of an 
application under this section. Such appeal shall be taken by 
filing in the United States court of appeals for the circuit 
wherein such applicant resides or has his principal place of 
business, or in the United States Court of Appeals for the 
District of Columbia Circuit, within sixty days after the entry 
of such order, a written petition praying that the order of the 
Secretary be set aside. A copy of such petition shall be 
forthwith transmitted by the clerk of the court to the 
Secretary, or any officer designated by him for that purpose, 
and thereupon the Secretary shall certify and file in the court 
the record upon which the order complained of was entered, as 
provided in section 2112 of title 28, United States Code. Upon 
the filing of such petition such court shall have exclusive 
jurisdiction to affirm or set aside such order, except that 
until the filing of the record the Secretary may modify or set 
aside his order. No objection to the order of the Secretary 
shall be considered by the court unless such objection shall 
have been urged before the Secretary or unless there were 
reasonable grounds for failure so to do. The finding of the 
Secretary as to the facts, if supported by substantial 
evidence, shall be conclusive. If any person shall apply to the 
court for leave to adduce additional evidence, and shall show 
to the satisfaction of the court that such additional evidence 
is material and that there were reasonable grounds for failure 
to adduce such evidence in the proceeding before the Secretary, 
the court may order such additional evidence to be taken before 
the Secretary and to be adduced upon the hearing in such manner 
and upon such terms and conditions as to the court may seem 
proper. The Secretary may modify his findings as to the facts 
by reason of the additional evidence so taken, and he shall 
file with the court such modified findings which, if supported 
by substantial evidence, shall be conclusive, and his 
recommendation, if any, for the setting aside of the original 
order. The judgment of the court affirming or setting aside any 
such order of the Secretary shall be final, subject to review 
by the Supreme Court of the United States upon certiorari or 
certification as provided in section 1254 of title 28 of the 
United States Code. The commencement of proceedings under this 
subsection shall not, unless specifically ordered by the court 
to the contrary, operate as a stay of the Secretary's order.
  (i)(1) The Secretary shall promulgate regulations for 
exempting from the operation of the foregoing subsections of 
this section drugs intended solely for investigational use by 
experts qualified by scientific training and experience to 
investigate the safety and effectiveness of drugs. Such 
regulations may, within the discretion of the Secretary, among 
other conditions relating to the protection of the public 
health, provide for conditioning such exemption upon--
          (A) the submission to the Secretary, before any 
        clinical testing of a new drug is undertaken, of 
        reports, by the manufacturer or the sponsor of the 
        investigation of such drug, or preclinical tests 
        (including tests on animals) of such drug adequate to 
        justify the proposed clinical testing;
          (B) the manufacturer or the sponsor of the 
        investigation of a new drug proposed to be distributed 
        to investigators for clinical testing obtaining a 
        signed agreement from each of such investigators that 
        patients to whom the drug is administered will be under 
        his personal supervision, or under the supervision of 
        investigators responsible to him, and that he will not 
        supply such drug to any other investigator, or to 
        clinics, for administration to human beings;
          (C) the establishment and maintenance of such 
        records, and the making of such reports to the 
        Secretary, by the manufacturer or the sponsor of the 
        investigation of such drug, of data (including but not 
        limited to analytical reports by investigators) 
        obtained as the result of such investigational use of 
        such drug, as the Secretary finds will enable him to 
        evaluate the safety and effectiveness of such drug in 
        the event of the filing of an application pursuant to 
        subsection (b); and
                  (D) the submission to the Secretary by the 
                manufacturer or the sponsor of the 
                investigation of a new drug of a statement of 
                intent regarding whether the manufacturer or 
                sponsor has plans for assessing pediatric 
                safety and efficacy.
  (2) Subject to paragraph (3), a clinical investigation of a 
new drug may begin 30 days after the Secretary has received 
from the manufacturer or sponsor of the investigation a 
submission containing such information about the drug and the 
clinical investigation, including--
          (A) information on design of the investigation and 
        adequate reports of basic information, certified by the 
        applicant to be accurate reports, necessary to assess 
        the safety of the drug for use in clinical 
        investigation; and
          (B) adequate information on the chemistry and 
        manufacturing of the drug, controls available for the 
        drug, and primary data tabulations from animal or human 
        studies.
  (3)(A) At any time, the Secretary may prohibit the sponsor of 
an investigation from conducting the investigation (referred to 
in this paragraph as a ``clinical hold'') if the Secretary 
makes a determination described in subparagraph (B). The 
Secretary shall specify the basis for the clinical hold, 
including the specific information available to the Secretary 
which served as the basis for such clinical hold, and confirm 
such determination in writing.
  (B) For purposes of subparagraph (A), a determination 
described in this subparagraph with respect to a clinical hold 
is that--
          (i) the drug involved represents an unreasonable risk 
        to the safety of the persons who are the subjects of 
        the clinical investigation, taking into account the 
        qualifications of the clinical investigators, 
        information about the drug, the design of the clinical 
        investigation, the condition for which the drug is to 
        be investigated, and the health status of the subjects 
        involved; or
          (ii) the clinical hold should be issued for such 
        other reasons as the Secretary may by regulation 
        establish (including reasons established by regulation 
        before the date of the enactment of the Food and Drug 
        Administration Modernization Act of 1997).
  (C) Any written request to the Secretary from the sponsor of 
an investigation that a clinical hold be removed shall receive 
a decision, in writing and specifying the reasons therefor, 
within 30 days after receipt of such request. Any such request 
shall include sufficient information to support the removal of 
such clinical hold.
  (4) Regulations under paragraph (1) shall provide that such 
exemption shall be conditioned upon the manufacturer, or the 
sponsor of the investigation, requiring that experts using such 
drugs for investigational purposes certify to such manufacturer 
or sponsor that they will inform any human beings to whom such 
drugs, or any controls used in connection therewith, are being 
administered, or their representatives, that such drugs are 
being used for investigational purposes and will obtain the 
consent of such human beings or their representatives, 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. Nothing in this 
subsection shall be construed to require any clinical 
investigator to submit directly to the Secretary reports on the 
investigational use of drugs. The Secretary shall update such 
regulations to require inclusion in the informed consent 
documents and process a statement that clinical trial 
information for such clinical investigation has been or will be 
submitted for inclusion in the registry data bank pursuant to 
subsection (j) of section 402 of the Public Health Service Act.
  (j)(1) Any person may file with the Secretary an abbreviated 
application for the approval of a new drug.
  (2)(A) An abbreviated application for a new drug shall 
contain--
          (i) information to show that the conditions of use 
        prescribed, recommended, or suggested in the labeling 
        proposed for the new drug have been previously approved 
        for a drug listed under paragraph (7) (hereinafter in 
        this subsection referred to as a ``listed drug'');
          (ii)(I) if the listed drug referred to in clause (i) 
        has only one active ingredient, information to show 
        that the active ingredient of the new drug is the same 
        as that of the listed drug;
          (II) if the listed drug referred to in clause (i) has 
        more than one active ingredient, information to show 
        that the active ingredients of the new drug are the 
        same as those of the listed drug, or
          (III) if the listed drug referred to in clause (i) 
        has more than one active ingredient and if one of the 
        active ingredients of the new drug is different and the 
        application is filed pursuant to the approval of a 
        petition filed under subparagraph (C), information to 
        show that the other active ingredients of the new drug 
        are the same as the active ingredients of the listed 
        drug, information to show that the different active 
        ingredient is an active ingredient of a listed drug or 
        of a drug which does not meet the requirements of 
        section 201(p), and such other information respecting 
        the different active ingredient with respect to which 
        the petition was filed as the Secretary may require;
          (iii) information to show that the route of 
        administration, the dosage form, and the strength of 
        the new drug are the same as those of the listed drug 
        referred to in clause (i) or, if the route of 
        administration, the dosage form, or the strength of the 
        new drug is different and the application is filed 
        pursuant to the approval of a petition filed under 
        subparagraph (C), such information respecting the route 
        of administration, dosage form, or strength with 
        respect to which the petition was filed as the 
        Secretary may require;
          (iv) information to show that the new drug is 
        bioequivalent to the listed drug referred to in clause 
        (i), except that if the application is filed pursuant 
        to the approval of a petition filed under subparagraph 
        (C), information to show that the active ingredients of 
        the new drug are of the same pharmacological or 
        therapeutic class as those of the listed drug referred 
        to in clause (i) and the new drug can be expected to 
        have the same therapeutic effect as the listed drug 
        when administered to patients for a condition of use 
        referred to in clause (i);
          (v) information to show that the labeling proposed 
        for the new drug is the same as the labeling approved 
        for the listed drug referred to in clause (i) except 
        for changes required because of differences approved 
        under a petition filed under subparagraph (C) or 
        because the new drug and the listed drug are produced 
        or distributed by different manufacturers;
          (vi) the items specified in clauses (B) through (F) 
        of subsection (b)(1);
          (vii) a certification, in the opinion of the 
        applicant and to the best of his knowledge, with 
        respect to each patent which claims the listed drug 
        referred to in clause (i) or which claims a use for 
        such listed drug for which the applicant is seeking 
        approval under this subsection and for which 
        information is required to be filed under subsection 
        (b) or (c)--
                  (I) that such patent information has not been 
                filed,
                  (II) that such patent has expired,
                  (III) of the date on which such patent will 
                expire, or
                  (IV) that such patent is invalid or will not 
                be infringed by the manufacture, use, or sale 
                of the new drug for which the application is 
                submitted; and
          (viii) if with respect to the listed drug referred to 
        in clause (i) information was filed under subsection 
        (b) or (c) for a method of use patent which does not 
        claim a use for which the applicant is seeking approval 
        under this subsection, a statement that the method of 
        use patent does not claim such a use.
The Secretary may not require that an abbreviated application 
contain information in addition to that required by clauses (i) 
through (viii).
  (B) Notice of opinion that patent is invalid or will not be 
infringed.--
          (i) Agreement to give notice.--An applicant that 
        makes a certification described in subparagraph 
        (A)(vii)(IV) shall include in the application a 
        statement that the applicant will give notice as 
        required by this subparagraph.
          (ii) Timing of notice.--An applicant that makes a 
        certification described in subparagraph (A)(vii)(IV) 
        shall give notice as required under this subparagraph--
                  (I) if the certification is in the 
                application, not later than 20 days after the 
                date of the postmark on the notice with which 
                the Secretary informs the applicant that the 
                application has been filed; or
                  (II) if the certification is in an amendment 
                or supplement to the application, at the time 
                at which the applicant submits the amendment or 
                supplement, regardless of whether the applicant 
                has already given notice with respect to 
                another such certification contained in the 
                application or in an amendment or supplement to 
                the application.
          (iii) Recipients of notice.--An applicant required 
        under this subparagraph to give notice shall give 
        notice to--
                  (I) each owner of the patent that is the 
                subject of the certification (or a 
                representative of the owner designated to 
                receive such a notice); and
                  (II) the holder of the approved application 
                under subsection (b) for the drug that is 
                claimed by the patent or a use of which is 
                claimed by the patent (or a representative of 
                the holder designated to receive such a 
                notice).
          (iv) Contents of notice.--A notice required under 
        this subparagraph shall--
                  (I) state that an application that contains 
                data from bioavailability or bioequivalence 
                studies has been submitted under this 
                subsection for the drug with respect to which 
                the certification is made to obtain approval to 
                engage in the commercial manufacture, use, or 
                sale of the drug before the expiration of the 
                patent referred to in the certification; and
                  (II) include a detailed statement of the 
                factual and legal basis of the opinion of the 
                applicant that the patent is invalid or will 
                not be infringed.
  (C) If a person wants to submit an abbreviated application 
for a new drug which has a different active ingredient or whose 
route of administration, dosage form, or strength differ from 
that of a listed drug, such person shall submit a petition to 
the Secretary seeking permission to file such an application. 
The Secretary shall approve or disapprove a petition submitted 
under this subparagraph within ninety days of the date the 
petition is submitted. The Secretary shall approve such a 
petition unless the Secretary finds--
          (i) that investigations must be conducted to show the 
        safety and effectiveness of the drug or of any of its 
        active ingredients, the route of administration, the 
        dosage form, or strength which differ from the listed 
        drug; or
          (ii) that any drug with a different active ingredient 
        may not be adequately evaluated for approval as safe 
        and effective on the basis of the information required 
        to be submitted in an abbreviated application.
  (D)(i) An applicant may not amend or supplement an 
application to seek approval of a drug referring to a different 
listed drug from the listed drug identified in the application 
as submitted to the Secretary.
  (ii) With respect to the drug for which an application is 
submitted, nothing in this subsection prohibits an applicant 
from amending or supplementing the application to seek approval 
of a different strength.
  (iii) Within 60 days after the date of the enactment of the 
Medicare Prescription Drug, Improvement, and Modernization Act 
of 2003, the Secretary shall issue guidance defining the term 
``listed drug'' for purposes of this subparagraph.
  (3)(A) The Secretary shall issue guidance for the individuals 
who review applications submitted under paragraph (1), which 
shall relate to promptness in conducting the review, technical 
excellence, lack of bias and conflict of interest, and 
knowledge of regulatory and scientific standards, and which 
shall apply equally to all individuals who review such 
applications.
  (B) The Secretary shall meet with a sponsor of an 
investigation or an applicant for approval for a drug under 
this subsection if the sponsor or applicant makes a reasonable 
written request for a meeting for the purpose of reaching 
agreement on the design and size of bioavailability and 
bioequivalence studies needed for approval of such application. 
The sponsor or applicant shall provide information necessary 
for discussion and agreement on the design and size of such 
studies. Minutes of any such meeting shall be prepared by the 
Secretary and made available to the sponsor or applicant.
  (C) Any agreement regarding the parameters of design and size 
of bioavailability and bioequivalence studies of a drug under 
this paragraph that is reached between the Secretary and a 
sponsor or applicant shall be reduced to writing and made part 
of the administrative record by the Secretary. Such agreement 
shall not be changed after the testing begins, except--
          (i) with the written agreement of the sponsor or 
        applicant; or
          (ii) pursuant to a decision, made in accordance with 
        subparagraph (D) by the director of the reviewing 
        division, that a substantial scientific issue essential 
        to determining the safety or effectiveness of the drug 
        has been identified after the testing has begun.
  (D) A decision under subparagraph (C)(ii) by the director 
shall be in writing and the Secretary shall provide to the 
sponsor or applicant an opportunity for a meeting at which the 
director and the sponsor or applicant will be present and at 
which the director will document the scientific issue involved.
  (E) The written decisions of the reviewing division shall be 
binding upon, and may not directly or indirectly be changed by, 
the field or compliance office personnel unless such field or 
compliance office personnel demonstrate to the reviewing 
division why such decision should be modified.
  (F) No action by the reviewing division may be delayed 
because of the unavailability of information from or action by 
field personnel unless the reviewing division determines that a 
delay is necessary to assure the marketing of a safe and 
effective drug.
  (G) For purposes of this paragraph, the reviewing division is 
the division responsible for the review of an application for 
approval of a drug under this subsection (including scientific 
matters, chemistry, manufacturing, and controls).
  (4) Subject to paragraph (5), the Secretary shall approve an 
application for a drug unless the Secretary finds--
          (A) the methods used in, or the facilities and 
        controls used for, the manufacture, processing, and 
        packing of the drug are inadequate to assure and 
        preserve its identity, strength, quality, and purity;
          (B) information submitted with the application is 
        insufficient show that each of the proposed conditions 
        of use have been previously approved for the listed 
        drug referred to in the application;
          (C)(i) if the listed drug has only one active 
        ingredient, information submitted with the application 
        is insufficient to show that the active ingredient is 
        the same as that of the listed drug;
          (ii) if the listed drug has more than one active 
        ingredient, information submitted with the application 
        is insufficient to show that the active ingredients are 
        the same as the active ingredients of the listed drug, 
        or
          (iii) if the listed drug has more than one active 
        ingredient and if the application is for a drug which 
        has an active ingredient different from the listed 
        drug, information submitted with the application is 
        insufficient to show--
                  (I) that the other active ingredients are the 
                same as the active ingredients of the listed 
                drug, or
                  (II) that the different active ingredient is 
                an active ingredient of a listed drug or a drug 
                which does not meet the requirements of section 
                201(p),
        or no petition to file an application for the drug with 
        the different ingredient was approved under paragraph 
        (2)(C);
          (D)(i) if the application is for a drug whose route 
        of administration, dosage form, or strength of the drug 
        is the same as the route of administration, dosage 
        form, or strength of the listed drug referred to in the 
        application, information submitted in the application 
        is insufficient to show that the route of 
        administration, dosage form, or strength is the same as 
        that of the listed drug, or
          (ii) if the application is for a drug whose route of 
        administration, dosage form, or strength of the drug is 
        different from that of the listed drug referred to in 
        the application, no petition to file an application for 
        the drug with the different route of administration, 
        dosage form, or strength was approved under paragraph 
        (2)(C);
          (E) if the application was filed pursuant to the 
        approval of a petition under paragraph (2)(C), the 
        application did not contain the information required by 
        the Secretary respecting the active ingredient, route 
        of administration, dosage form, or strength which is 
        not the same;
          (F) information submitted in the application is 
        insufficient to show that the drug is bioequivalent to 
        the listed drug referred to in the application or, if 
        the application was filed pursuant to a petition 
        approved under paragraph (2)(C), information submitted 
        in the application is insufficient to show that the 
        active ingredients of the new drug are of the same 
        pharmacological or therapeutic class as those of the 
        listed drug referred to in paragraph (2)(A)(i) and that 
        the new drug can be expected to have the same 
        therapeutic effect as the listed drug when administered 
        to patients for a condition of use referred to in such 
        paragraph;
          (G) information submitted in the application is 
        insufficient to show that the labeling proposed for the 
        drug is the same as the labeling approved for the 
        listed drug referred to in the application except for 
        changes required because of differences approved under 
        a petition filed under paragraph (2)(C) or because the 
        drug and the listed drug are produced or distributed by 
        different manufacturers;
          (H) information submitted in the application or any 
        other information available to the Secretary shows that 
        (i) the inactive ingredients of the drug are unsafe for 
        use under the conditions prescribed, recommended, or 
        suggested in the labeling proposed for the drug, or 
        (ii) the composition of the drug is unsafe under such 
        conditions because of the type or quantity of inactive 
        ingredients included or the manner in which the 
        inactive ingredients are included;
          (I) the approval under subsection (c) of the listed 
        drug referred to in the application under this 
        subsection has been withdrawn or suspended for grounds 
        described in the first sentence of subsection (e), the 
        Secretary has published a notice of opportunity for 
        hearing to withdraw approval of the listed drug under 
        subsection (c) for grounds described in the first 
        sentence of subsection (e), the approval under this 
        subsection of the listed drug referred to in the 
        application under this subsection has been withdrawn or 
        suspended under paragraph (6), or the Secretary has 
        determined that the listed drug has been withdrawn from 
        sale for safety or effectiveness reasons;
          (J) the application does not meet any other 
        requirement of paragraph (2)(A); or
          (K) the application contains an untrue statement of 
        material fact.
  (5)(A) Within one hundred and eighty days of the initial 
receipt of an application under paragraph (2) or within such 
additional period as may be agreed upon by the Secretary and 
the applicant, the Secretary shall approve or disapprove the 
application.
  (B) The approval of an application submitted under paragraph 
(2) shall be made effective on the last applicable date 
determined by applying the following to each certification made 
under paragraph (2)(A)(vii):
          (i) If the applicant only made a certification 
        described in subclause (I) or (II) of paragraph 
        (2)(A)(vii) or in both such subclauses, the approval 
        may be made effective immediately.
          (ii) If the applicant made a certification described 
        in subclause (III) of paragraph (2)(A)(vii), the 
        approval may be made effective on the date certified 
        under subclause (III).
          (iii) If the applicant made a certification described 
        in subclause (IV) of paragraph (2)(A)(vii), the 
        approval shall be made effective immediately unless, 
        before the expiration of 45 days after the date on 
        which the notice described in paragraph (2)(B) is 
        received, an action is brought for infringement of the 
        patent that is the subject of the certification and for 
        which information was submitted to the Secretary under 
        subsection (b)(1) or (c)(2) before the date on which 
        the application (excluding an amendment or supplement 
        to the application), which the Secretary later 
        determines to be substantially complete, was submitted. 
        If such an action is brought before the expiration of 
        such days, the approval shall be made effective upon 
        the expiration of the thirty-month period beginning on 
        the date of the receipt of the notice provided under 
        paragraph (2)(B)(i) or such shorter or longer period as 
        the court may order because either party to the action 
        failed to reasonably cooperate in expediting the 
        action, except that--
                  (I) if before the expiration of such period 
                the district court decides that the patent is 
                invalid or not infringed (including any 
                substantive determination that there is no 
                cause of action for patent infringement or 
                invalidity), the approval shall be made 
                effective on--
                          (aa) the date on which the court 
                        enters judgment reflecting the 
                        decision; or
                          (bb) the date of a settlement order 
                        or consent decree signed and entered by 
                        the court stating that the patent that 
                        is the subject of the certification is 
                        invalid or not infringed;
                  (II) if before the expiration of such period 
                the district court decides that the patent has 
                been infringed--
                          (aa) if the judgment of the district 
                        court is appealed, the approval shall 
                        be made effective on--
                                  (AA) the date on which the 
                                court of appeals decides that 
                                the patent is invalid or not 
                                infringed (including any 
                                substantive determination that 
                                there is no cause of action for 
                                patent infringement or 
                                invalidity); or
                                  (BB) the date of a settlement 
                                order or consent decree signed 
                                and entered by the court of 
                                appeals stating that the patent 
                                that is the subject of the 
                                certification is invalid or not 
                                infringed; or
                          (bb) if the judgment of the district 
                        court is not appealed or is affirmed, 
                        the approval shall be made effective on 
                        the date specified by the district 
                        court in a court order under section 
                        271(e)(4)(A) of title 35, United States 
                        Code;
                  (III) if before the expiration of such period 
                the court grants a preliminary injunction 
                prohibiting the applicant from engaging in the 
                commercial manufacture or sale of the drug 
                until the court decides the issues of patent 
                validity and infringement and if the court 
                decides that such patent is invalid or not 
                infringed, the approval shall be made effective 
                as provided in subclause (I); or
                  (IV) if before the expiration of such period 
                the court grants a preliminary injunction 
                prohibiting the applicant from engaging in the 
                commercial manufacture or sale of the drug 
                until the court decides the issues of patent 
                validity and infringement and if the court 
                decides that such patent has been infringed, 
                the approval shall be made effective as 
                provided in subclause (II).
        In such an action, each of the parties shall reasonably 
        cooperate in expediting the action.
          (iv)  180-day exclusivity period.--
                  (I) Effectiveness of application.--Subject to 
                subparagraph (D), if the application contains a 
                certification described in paragraph 
                (2)(A)(vii)(IV) and is for a drug for which a 
                first applicant has submitted an application 
                containing such a certification, the 
                application shall be made effective on the date 
                that is 180 days after the date of the first 
                commercial marketing of the drug (including the 
                commercial marketing of the listed drug) by any 
                first applicant.
                  (II) Definitions.--In this paragraph:
                          (aa)  180-day exclusivity period.--
                        The term ``180-day exclusivity period'' 
                        means the 180-day period ending on the 
                        day before the date on which an 
                        application submitted by an applicant 
                        other than a first applicant could 
                        become effective under this clause.
                          (bb) First applicant.--As used in 
                        this subsection, the term ``first 
                        applicant'' means an applicant that, on 
                        the first day on which a substantially 
                        complete application containing a 
                        certification described in paragraph 
                        (2)(A)(vii)(IV) is submitted for 
                        approval of a drug, submits a 
                        substantially complete application that 
                        contains and lawfully maintains a 
                        certification described in paragraph 
                        (2)(A)(vii)(IV) for the drug.
                          (cc) Substantially complete 
                        application.--As used in this 
                        subsection, the term ``substantially 
                        complete application'' means an 
                        application under this subsection that 
                        on its face is sufficiently complete to 
                        permit a substantive review and 
                        contains all the information required 
                        by paragraph (2)(A).
                          (dd) Tentative approval.--
                                  (AA) In general.--The term 
                                ``tentative approval'' means 
                                notification to an applicant by 
                                the Secretary that an 
                                application under this 
                                subsection meets the 
                                requirements of paragraph 
                                (2)(A), but cannot receive 
                                effective approval because the 
                                application does not meet the 
                                requirements of this 
                                subparagraph, there is a period 
                                of exclusivity for the listed 
                                drug under subparagraph (F) or 
                                section 505A, or there is a 7-
                                year period of exclusivity for 
                                the listed drug under section 
                                527.
                                  (BB) Limitation.--A drug that 
                                is granted tentative approval 
                                by the Secretary is not an 
                                approved drug and shall not 
                                have an effective approval 
                                until the Secretary issues an 
                                approval after any necessary 
                                additional review of the 
                                application.
          (v) 180-day exclusivity period for competitive 
        generic therapies.--
                  (I) Effectiveness of application.--Subject to 
                subparagraph (D)(iv), if the application is for 
                a drug that is the same as a competitive 
                generic therapy for which any first approved 
                applicant has commenced commercial marketing, 
                the application shall be made effective on the 
                date that is 180 days after the date of the 
                first commercial marketing of the competitive 
                generic therapy (including the commercial 
                marketing of the listed drug) by any first 
                approved applicant.
                  (II) Limitation.--The exclusivity period 
                under subclause (I) shall not apply with 
                respect to a competitive generic therapy that 
                has previously received an exclusivity period 
                under subclause (I).
                  (III) Definitions.--In this clause and 
                subparagraph (D)(iv):
                          (aa) The term ``competitive generic 
                        therapy'' means a drug--
                                  (AA) that is designated as a 
                                competitive generic therapy 
                                under section 506H; and
                                  (BB) for which there are no 
                                unexpired patents or blocking 
                                exclusivities on the list of 
                                products described in section 
                                505(j)(7)(A) at the time of 
                                approval.
                          (bb) The term ``first approved 
                        applicant'' means any applicant that 
                        has submitted an application that--
                                  (AA) is for a competitive 
                                generic therapy that is 
                                approved on the first day on 
                                which any application for such 
                                competitive generic therapy is 
                                approved;
                                  (BB) is not eligible for a 
                                180-day exclusivity period 
                                under clause (iv) for the drug 
                                that is the subject of the 
                                application for the competitive 
                                generic therapy; and
                                  (CC) is not for a drug for 
                                which all drug versions have 
                                forfeited eligibility for a 
                                180-day exclusivity period 
                                under clause (iv) pursuant to 
                                subparagraph (D).
          (C) Civil action to obtain patent certainty.--
                  (i) Declaratory judgment absent infringement 
                action.--
                          (I) In general.--No action may be 
                        brought under section 2201 of title 28, 
                        United States Code, by an applicant 
                        under paragraph (2) for a declaratory 
                        judgment with respect to a patent which 
                        is the subject of the certification 
                        referred to in subparagraph (B)(iii) 
                        unless--
                                  (aa) the 45-day period 
                                referred to in such 
                                subparagraph has expired;
                                  (bb) neither the owner of 
                                such patent nor the holder of 
                                the approved application under 
                                subsection (b) for the drug 
                                that is claimed by the patent 
                                or a use of which is claimed by 
                                the patent brought a civil 
                                action against the applicant 
                                for infringement of the patent 
                                before the expiration of such 
                                period; and
                                  (cc) in any case in which the 
                                notice provided under paragraph 
                                (2)(B) relates to 
                                noninfringement, the notice was 
                                accompanied by a document 
                                described in subclause (III).
                          (II) Filing of civil action.--If the 
                        conditions described in items (aa), 
                        (bb), and as applicable, (cc) of 
                        subclause (I) have been met, the 
                        applicant referred to in such subclause 
                        may, in accordance with section 2201 of 
                        title 28, United States Code, bring a 
                        civil action under such section against 
                        the owner or holder referred to in such 
                        subclause (but not against any owner or 
                        holder that has brought such a civil 
                        action against the applicant, unless 
                        that civil action was dismissed without 
                        prejudice) for a declaratory judgment 
                        that the patent is invalid or will not 
                        be infringed by the drug for which the 
                        applicant seeks approval, except that 
                        such civil action may be brought for a 
                        declaratory judgment that the patent 
                        will not be infringed only in a case in 
                        which the condition described in 
                        subclause (I)(cc) is applicable. A 
                        civil action referred to in this 
                        subclause shall be brought in the 
                        judicial district where the defendant 
                        has its principal place of business or 
                        a regular and established place of 
                        business.
                          (III) Offer of confidential access to 
                        application.--For purposes of subclause 
                        (I)(cc), the document described in this 
                        subclause is a document providing an 
                        offer of confidential access to the 
                        application that is in the custody of 
                        the applicant under paragraph (2) for 
                        the purpose of determining whether an 
                        action referred to in subparagraph 
                        (B)(iii) should be brought. The 
                        document providing the offer of 
                        confidential access shall contain such 
                        restrictions as to persons entitled to 
                        access, and on the use and disposition 
                        of any information accessed, as would 
                        apply had a protective order been 
                        entered for the purpose of protecting 
                        trade secrets and other confidential 
                        business information. A request for 
                        access to an application under an offer 
                        of confidential access shall be 
                        considered acceptance of the offer of 
                        confidential access with the 
                        restrictions as to persons entitled to 
                        access, and on the use and disposition 
                        of any information accessed, contained 
                        in the offer of confidential access, 
                        and those restrictions and other terms 
                        of the offer of confidential access 
                        shall be considered terms of an 
                        enforceable contract. Any person 
                        provided an offer of confidential 
                        access shall review the application for 
                        the sole and limited purpose of 
                        evaluating possible infringement of the 
                        patent that is the subject of the 
                        certification under paragraph 
                        (2)(A)(vii)(IV) and for no other 
                        purpose, and may not disclose 
                        information of no relevance to any 
                        issue of patent infringement to any 
                        person other than a person provided an 
                        offer of confidential access. Further, 
                        the application may be redacted by the 
                        applicant to remove any information of 
                        no relevance to any issue of patent 
                        infringement.
                  (ii) Counterclaim to infringement action.--
                          (I) In general.--If an owner of the 
                        patent or the holder of the approved 
                        application under subsection (b) for 
                        the drug that is claimed by the patent 
                        or a use of which is claimed by the 
                        patent brings a patent infringement 
                        action against the applicant, the 
                        applicant may assert a counterclaim 
                        seeking an order requiring the holder 
                        to correct or delete the patent 
                        information submitted by the holder 
                        under subsection (b) or (c) on the 
                        ground that the patent does not claim 
                        either--
                                  (aa) the drug for which the 
                                application was approved; or
                                  (bb) an approved method of 
                                using the drug.
                          (II) No independent cause of 
                        action.--Subclause (I) does not 
                        authorize the assertion of a claim 
                        described in subclause (I) in any civil 
                        action or proceeding other than a 
                        counterclaim described in subclause 
                        (I).
                  (iii) No damages.--An applicant shall not be 
                entitled to damages in a civil action under 
                clause (i) or a counterclaim under clause (ii).
          (D) Forfeiture of 180-day exclusivity period.--
                  (i) Definition of forfeiture event.--In this 
                subparagraph, the term ``forfeiture event'', 
                with respect to an application under this 
                subsection, means the occurrence of any of the 
                following:
                          (I) Failure to market.--The first 
                        applicant fails to market the drug by 
                        the later of--
                                  (aa) the earlier of the date 
                                that is--
                                          (AA) 75 days after 
                                        the date on which the 
                                        approval of the 
                                        application of the 
                                        first applicant is made 
                                        effective under 
                                        subparagraph (B)(iii); 
                                        or
                                          (BB) 30 months after 
                                        the date of submission 
                                        of the application of 
                                        the first applicant; or
                                  (bb) with respect to the 
                                first applicant or any other 
                                applicant (which other 
                                applicant has received 
                                tentative approval), the date 
                                that is 75 days after the date 
                                as of which, as to each of the 
                                patents with respect to which 
                                the first applicant submitted 
                                and lawfully maintained a 
                                certification qualifying the 
                                first applicant for the 180-day 
                                exclusivity period under 
                                subparagraph (B)(iv), at least 
                                1 of the following has 
                                occurred:
                                          (AA) In an 
                                        infringement action 
                                        brought against that 
                                        applicant with respect 
                                        to the patent or in a 
                                        declaratory judgment 
                                        action brought by that 
                                        applicant with respect 
                                        to the patent, a court 
                                        enters a final decision 
                                        from which no appeal 
                                        (other than a petition 
                                        to the Supreme Court 
                                        for a writ of 
                                        certiorari) has been or 
                                        can be taken that the 
                                        patent is invalid or 
                                        not infringed.
                                          (BB) In an 
                                        infringement action or 
                                        a declaratory judgment 
                                        action described in 
                                        subitem (AA), a court 
                                        signs a settlement 
                                        order or consent decree 
                                        that enters a final 
                                        judgment that includes 
                                        a finding that the 
                                        patent is invalid or 
                                        not infringed.
                                          (CC) The patent 
                                        information submitted 
                                        under subsection (b) or 
                                        (c) is withdrawn by the 
                                        holder of the 
                                        application approved 
                                        under subsection (b).
                          (II) Withdrawal of application.--The 
                        first applicant withdraws the 
                        application or the Secretary considers 
                        the application to have been withdrawn 
                        as a result of a determination by the 
                        Secretary that the application does not 
                        meet the requirements for approval 
                        under paragraph (4).
                          (III) Amendment of certification.--
                        The first applicant amends or withdraws 
                        the certification for all of the 
                        patents with respect to which that 
                        applicant submitted a certification 
                        qualifying the applicant for the 180-
                        day exclusivity period.
                          (IV) Failure to obtain tentative 
                        approval.--The first applicant fails to 
                        obtain tentative approval of the 
                        application within 30 months after the 
                        date on which the application is filed, 
                        unless the failure is caused by a 
                        change in or a review of the 
                        requirements for approval of the 
                        application imposed after the date on 
                        which the application is filed.
                          (V) Agreement with another applicant, 
                        the listed drug application holder, or 
                        a patent owner.--The first applicant 
                        enters into an agreement with another 
                        applicant under this subsection for the 
                        drug, the holder of the application for 
                        the listed drug, or an owner of the 
                        patent that is the subject of the 
                        certification under paragraph 
                        (2)(A)(vii)(IV), the Federal Trade 
                        Commission or the Attorney General 
                        files a complaint, and there is a final 
                        decision of the Federal Trade 
                        Commission or the court with regard to 
                        the complaint from which no appeal 
                        (other than a petition to the Supreme 
                        Court for a writ of certiorari) has 
                        been or can be taken that the agreement 
                        has violated the antitrust laws (as 
                        defined in section 1 of the Clayton Act 
                        (15 U.S.C. 12), except that the term 
                        includes section 5 of the Federal Trade 
                        Commission Act (15 U.S.C. 45) to the 
                        extent that that section applies to 
                        unfair methods of competition).
                          (VI) Expiration of all patents.--All 
                        of the patents as to which the 
                        applicant submitted a certification 
                        qualifying it for the 180-day 
                        exclusivity period have expired.
                  (ii) Forfeiture.--The 180-day exclusivity 
                period described in subparagraph (B)(iv) shall 
                be forfeited by a first applicant if a 
                forfeiture event occurs with respect to that 
                first applicant.
                  (iii) Subsequent applicant.--If all first 
                applicants forfeit the 180-day exclusivity 
                period under clause (ii)--
                          (I) approval of any application 
                        containing a certification described in 
                        paragraph (2)(A)(vii)(IV) shall be made 
                        effective in accordance with 
                        subparagraph (B)(iii); and
                          (II) no applicant shall be eligible 
                        for a 180-day exclusivity period.
                  (iv) Special forfeiture rule for competitive 
                generic therapy.--The 180-day exclusivity 
                period described in subparagraph (B)(v) shall 
                be forfeited by a first approved applicant if 
                the applicant fails to market the competitive 
                generic therapy within 75 days after the date 
                on which the approval of the first approved 
                applicant's application for the competitive 
                generic therapy is made effective.
  (E) If the Secretary decides to disapprove an application, 
the Secretary shall give the applicant notice of an opportunity 
for a hearing before the Secretary on the question of whether 
such application is approvable. If the applicant elects to 
accept the opportunity for hearing by written request within 
thirty days after such notice, such hearing shall commence not 
more than ninety days after the expiration of such thirty days 
unless the Secretary and the applicant otherwise agree. Any 
such hearing shall thereafter be conducted on an expedited 
basis and the Secretary's order thereon shall be issued within 
ninety days after the date fixed by the Secretary for filing 
final briefs.
  (F)(i) If an application (other than an abbreviated new drug 
application) submitted under subsection (b) for a drug, no 
active ingredient (including any ester or salt of the active 
ingredient) of which has been approved in any other application 
under subsection (b), was approved during the period beginning 
January 1, 1982, and ending on the date of the enactment of 
this subsection, the Secretary may not make the approval of an 
application submitted under this subsection which refers to the 
drug for which the subsection (b) application was submitted 
effective before the expiration of ten years from the date of 
the approval of the application under subsection (b).
  (ii) If an application submitted under subsection (b) for a 
drug, no active ingredient (including any ester or salt of the 
active ingredient) of which has been approved in any other 
application under subsection (b), is approved after the date of 
the enactment of this subsection, no application may be 
submitted under this subsection which refers to the drug for 
which the subsection (b) application was submitted before the 
expiration of five years from the date of the approval of the 
application under subsection (b), except that such an 
application may be submitted under this subsection after the 
expiration of four years from the date of the approval of the 
subsection (b) application if it contains a certification of 
patent invalidity or noninfringement described in subclause 
(IV) of paragraph (2)(A)(vii). The approval of such an 
application shall be made effective in accordance with 
subparagraph (B) except that, if an action for patent 
infringement is commenced during the one-year period beginning 
forty-eight months after the date of the approval of the 
subsection (b) application, the thirty-month period referred to 
in subparagraph (B)(iii) shall be extended by such amount of 
time (if any) which is required for seven and one-half years to 
have elapsed from the date of approval of the subsection (b) 
application.
  (iii) If an application submitted under subsection (b) for a 
drug, which includes an active ingredient (including any ester 
or salt of the active ingredient) that has been approved in 
another application approved under subsection (b), is approved 
after the date of enactment of this subsection and if such 
application contains reports of new clinical investigations 
(other than bioavailability studies) essential to the approval 
of the application and conducted or sponsored by the applicant, 
the Secretary may not make the approval of an application 
submitted under this subsection for the conditions of approval 
of such drug in the subsection (b) application effective before 
the expiration of three years from the date of the approval of 
the application under subsection (b) for such drug.
  (iv) If a supplement to an application approved under 
subsection (b) is approved after the date of enactment of this 
subsection and the supplement contains reports of new clinical 
investigations (other than bioavailability studies) essential 
to the approval of the supplement and conducted or sponsored by 
the person submitting the supplement, the Secretary may not 
make the approval of an application submitted under this 
subsection for a change approved in the supplement effective 
before the expiration of three years from the date of the 
approval of the supplement under subsection (b).
  (v) If an application (or supplement to an application) 
submitted under subsection (b) for a drug, which includes an 
active ingredient (including any ester or salt of the active 
ingredient) that has been approved in another application under 
subsection (b), was approved during the period beginning 
January 1, 1982, and ending on the date of the enactment of 
this subsection, the Secretary may not make the approval of an 
application submitted under this subsection which refers to the 
drug for which the subsection (b) application was submitted or 
which refers to a change approved in a supplement to the 
subsection (b) application effective before the expiration of 
two years from the date of enactment of this subsection.
  (6) If a drug approved under this subsection refers in its 
approved application to a drug the approval of which was 
withdrawn or suspended for grounds described in the first 
sentence of subsection (e) or was withdrawn or suspended under 
this paragraph or which, as determined by the Secretary, has 
been withdrawn from sale for safety or effectiveness reasons, 
the approval of the drug under this subsection shall be 
withdrawn or suspended--
          (A) for the same period as the withdrawal or 
        suspension under subsection (e) or this paragraph, or
          (B) if the listed drug has been withdrawn from sale, 
        for the period of withdrawal from sale or, if earlier, 
        the period ending on the date the Secretary determines 
        that the withdrawal from sale is not for safety or 
        effectiveness reasons.
  (7)(A)(i) Within sixty days of the date of the enactment of 
this subsection, the Secretary shall publish and make available 
to the public--
          (I) a list in alphabetical order of the official and 
        proprietary name of each drug which has been approved 
        for safety and effectiveness under subsection (c) 
        before the date of the enactment of this subsection;
          (II) the date of approval if the drug is approved 
        after 1981 and the number of the application which was 
        approved; and
          (III) whether in vitro or in vivo bioequivalence 
        studies, or both such studies, are required for 
        applications filed under this subsection which will 
        refer to the drug published.
  (ii) Every thirty days after the publication of the first 
list under clause (i) the Secretary shall revise the list to 
include each drug which has been approved for safety and 
effectiveness under subsection (c) or approved under this 
subsection during the thirty-day period.
  (iii) When patent information submitted under subsection (b) 
or (c) respecting a drug included on the list is to be 
published by the Secretary, the Secretary shall, in revisions 
made under clause (ii), include such information for such drug.
  (B) A drug approved for safety and effectiveness under 
subsection (c) or approved under this subsection shall, for 
purposes of this subsection, be considered to have been 
published under subparagraph (A) on the date of its approval or 
the date of enactment, whichever is later.
  (C) If the approval of a drug was withdrawn or suspended for 
grounds described in the first sentence of subsection (e) or 
was withdrawn or suspended under paragraph (6) or if the 
Secretary determines that a drug has been withdrawn from sale 
for safety or effectiveness reasons, it may not be published in 
the list under subparagraph (A) or, if the withdrawal or 
suspension occurred after its publication in such list, it 
shall be immediately removed from such list--
          (i) for the same period as the withdrawal or 
        suspension under subsection (e) or paragraph (6), or
          (ii) if the listed drug has been withdrawn from sale, 
        for the period of withdrawal from sale or, if earlier, 
        the period ending on the date the Secretary determines 
        that the withdrawal from sale is not for safety or 
        effectiveness reasons.
A notice of the removal shall be published in the Federal 
Register.
  (8) For purposes of this subsection:
          (A)(i) The term ``bioavailability'' means the rate 
        and extent to which the active ingredient or 
        therapeutic ingredient is absorbed from a drug and 
        becomes available at the site of drug action.
          (ii) For a drug that is not intended to be absorbed 
        into the bloodstream, the Secretary may assess 
        bioavailability by scientifically valid measurements 
        intended to reflect the rate and extent to which the 
        active ingredient or therapeutic ingredient becomes 
        available at the site of drug action.
          (B) A drug shall be considered to be bioequivalent to 
        a listed drug if--
                  (i) the rate and extent of absorption of the 
                drug do not show a significant difference from 
                the rate and extent of absorption of the listed 
                drug when administered at the same molar dose 
                of the therapeutic ingredient under similar 
                experimental conditions in either a single dose 
                or multiple doses; or
                  (ii) the extent of absorption of the drug 
                does not show a significant difference from the 
                extent of absorption of the listed drug when 
                administered at the same molar dose of the 
                therapeutic ingredient under similar 
                experimental conditions in either a single dose 
                or multiple doses and the difference from the 
                listed drug in the rate of absorption of the 
                drug is intentional, is reflected in its 
                proposed labeling, is not essential to the 
                attainment of effective body drug 
                concentrations on chronic use, and is 
                considered medically insignificant for the 
                drug.
          (C) For a drug that is not intended to be absorbed 
        into the bloodstream, the Secretary may establish 
        alternative, scientifically valid methods to show 
        bioequivalence if the alternative methods are expected 
        to detect a significant difference between the drug and 
        the listed drug in safety and therapeutic effect.
  (9) The Secretary shall, with respect to each application 
submitted under this subsection, maintain a record of--
          (A) the name of the applicant,
          (B) the name of the drug covered by the application,
          (C) the name of each person to whom the review of the 
        chemistry of the application was assigned and the date 
        of such assignment, and
          (D) the name of each person to whom the 
        bioequivalence review for such application was assigned 
        and the date of such assignment.
The information the Secretary is required to maintain under 
this paragraph with respect to an application submitted under 
this subsection shall be made available to the public after the 
approval of such application.
  (10)(A) If the proposed labeling of a drug that is the 
subject of an application under this subsection differs from 
the listed drug due to a labeling revision described under 
clause (i), the drug that is the subject of such application 
shall, notwithstanding any other provision of this Act, be 
eligible for approval and shall not be considered misbranded 
under section 502 if--
          (i) the application is otherwise eligible for 
        approval under this subsection but for expiration of 
        patent, an exclusivity period, or of a delay in 
        approval described in paragraph (5)(B)(iii), and a 
        revision to the labeling of the listed drug has been 
        approved by the Secretary within 60 days of such 
        expiration;
          (ii) the labeling revision described under clause (i) 
        does not include a change to the ``Warnings'' section 
        of the labeling;
          (iii) the sponsor of the application under this 
        subsection agrees to submit revised labeling of the 
        drug that is the subject of such application not later 
        than 60 days after the notification of any changes to 
        such labeling required by the Secretary; and
          (iv) such application otherwise meets the applicable 
        requirements for approval under this subsection.
  (B) If, after a labeling revision described in subparagraph 
(A)(i), the Secretary determines that the continued presence in 
interstate commerce of the labeling of the listed drug (as in 
effect before the revision described in subparagraph (A)(i)) 
adversely impacts the safe use of the drug, no application 
under this subsection shall be eligible for approval with such 
labeling.
  (11) Upon the request of an applicant regarding one or more 
specified pending applications under this subsection, the 
Secretary shall--
          (A) by telephone or electronic mail, provide review 
        status updates; and
          (B) indicate in such updates the categorical status 
        of the applications by each relevant review discipline.
  (k)(1) In the case of any drug for which an approval of an 
application filed under subsection (b) or (j) is in effect, the 
applicant shall establish and maintain such records, and make 
such reports to the Secretary, of data relating to clinical 
experience and other data or information, received or otherwise 
obtained by such applicant with respect to such drug, as the 
Secretary may by general regulation, or by order with respect 
to such application, prescribe on the basis of a finding that 
such records and reports are necessary in order to enable the 
Secretary to determine, or facilitate a determination, whether 
there is or may be ground for invoking subsection (e) of this 
section. Regulations and orders issued under this subsection 
and under subsection (i) shall have due regard for the 
professional ethics of the medical profession and the interests 
of patients and shall provide, where the Secretary deems it to 
be appropriate, for the examination, upon request, by the 
persons to whom such regulations or orders are applicable, of 
similar information received or otherwise obtained by the 
Secretary.
  (2) Every person required under this section to maintain 
records, and every person in charge or custody thereof, shall, 
upon request of an officer or employee designated by the 
Secretary, permit such officer or employee at all reasonable 
times to have access to and copy and verify such records.
          (3) Active postmarket risk identification.--
                  (A) Definition.--In this paragraph, the term 
                ``data'' refers to information with respect to 
                a drug approved under this section or under 
                section 351 of the Public Health Service Act, 
                including claims data, patient survey data, 
                standardized analytic files that allow for the 
                pooling and analysis of data from disparate 
                data environments, and any other data deemed 
                appropriate by the Secretary.
                  (B) Development of postmarket risk 
                identification and analysis methods.--The 
                Secretary shall, not later than 2 years after 
                the date of the enactment of the Food and Drug 
                Administration Amendments Act of 2007, in 
                collaboration with public, academic, and 
                private entities--
                          (i) develop methods to obtain access 
                        to disparate data sources including the 
                        data sources specified in subparagraph 
                        (C);
                          (ii) develop validated methods for 
                        the establishment of a postmarket risk 
                        identification and analysis system to 
                        link and analyze safety data from 
                        multiple sources, with the goals of 
                        including, in aggregate--
                                  (I) at least 25,000,000 
                                patients by July 1, 2010; and
                                  (II) at least 100,000,000 
                                patients by July 1, 2012; and
                          (iii) convene a committee of experts, 
                        including individuals who are 
                        recognized in the field of protecting 
                        data privacy and security, to make 
                        recommendations to the Secretary on the 
                        development of tools and methods for 
                        the ethical and scientific uses for, 
                        and communication of, postmarketing 
                        data specified under subparagraph (C), 
                        including recommendations on the 
                        development of effective research 
                        methods for the study of drug safety 
                        questions.
                  (C) Establishment of the postmarket risk 
                identification and analysis system.--
                          (i) In general.--The Secretary shall, 
                        not later than 1 year after the 
                        development of the risk identification 
                        and analysis methods under subparagraph 
                        (B), establish and maintain 
                        procedures--
                                  (I) for risk identification 
                                and analysis based on 
                                electronic health data, in 
                                compliance with the regulations 
                                promulgated under section 
                                264(c) of the Health Insurance 
                                Portability and Accountability 
                                Act of 1996, and in a manner 
                                that does not disclose 
                                individually identifiable 
                                health information in violation 
                                of paragraph (4)(B);
                                  (II) for the reporting (in a 
                                standardized form) of data on 
                                all serious adverse drug 
                                experiences (as defined in 
                                section 505-1(b)) submitted to 
                                the Secretary under paragraph 
                                (1), and those adverse events 
                                submitted by patients, 
                                providers, and drug sponsors, 
                                when appropriate;
                                  (III) to provide for active 
                                adverse event surveillance 
                                using the following data 
                                sources, as available:
                                          (aa) Federal health-
                                        related electronic data 
                                        (such as data from the 
                                        Medicare program and 
                                        the health systems of 
                                        the Department of 
                                        Veterans Affairs);
                                          (bb) private sector 
                                        health-related 
                                        electronic data (such 
                                        as pharmaceutical 
                                        purchase data and 
                                        health insurance claims 
                                        data); and
                                          (cc) other data as 
                                        the Secretary deems 
                                        necessary to create a 
                                        robust system to 
                                        identify adverse events 
                                        and potential drug 
                                        safety signals;
                                  (IV) to identify certain 
                                trends and patterns with 
                                respect to data accessed by the 
                                system;
                                  (V) to provide regular 
                                reports to the Secretary 
                                concerning adverse event 
                                trends, adverse event patterns, 
                                incidence and prevalence of 
                                adverse events, and other 
                                information the Secretary 
                                determines appropriate, which 
                                may include data on comparative 
                                national adverse event trends; 
                                and
                                  (VI) to enable the program to 
                                export data in a form 
                                appropriate for further 
                                aggregation, statistical 
                                analysis, and reporting.
                          (ii) Timeliness of reporting.--The 
                        procedures established under clause (i) 
                        shall ensure that such data are 
                        accessed, analyzed, and reported in a 
                        timely, routine, and systematic manner, 
                        taking into consideration the need for 
                        data completeness, coding, cleansing, 
                        and standardized analysis and 
                        transmission.
                          (iii) Private sector resources.--To 
                        ensure the establishment of the active 
                        postmarket risk identification and 
                        analysis system under this subsection 
                        not later than 1 year after the 
                        development of the risk identification 
                        and analysis methods under subparagraph 
                        (B), as required under clause (i), the 
                        Secretary may, on a temporary or 
                        permanent basis, implement systems or 
                        products developed by private entities.
                          (iv) Complementary approaches.--To 
                        the extent the active postmarket risk 
                        identification and analysis system 
                        under this subsection is not sufficient 
                        to gather data and information relevant 
                        to a priority drug safety question, the 
                        Secretary shall develop, support, and 
                        participate in complementary approaches 
                        to gather and analyze such data and 
                        information, including--
                                  (I) approaches that are 
                                complementary with respect to 
                                assessing the safety of use of 
                                a drug in domestic populations 
                                not included, or 
                                underrepresented, in the trials 
                                used to approve the drug (such 
                                as older people, people with 
                                comorbidities, pregnant women, 
                                or children); and
                                  (II) existing approaches such 
                                as the Vaccine Adverse Event 
                                Reporting System and the 
                                Vaccine Safety Datalink or 
                                successor databases.
                          (v) Authority for contracts.--The 
                        Secretary may enter into contracts with 
                        public and private entities to fulfill 
                        the requirements of this subparagraph.
          (4) Advanced analysis of drug safety data.--
                  (A) Purpose.--The Secretary shall establish 
                collaborations with public, academic, and 
                private entities, which may include the Centers 
                for Education and Research on Therapeutics 
                under section 912 of the Public Health Service 
                Act, to provide for advanced analysis of drug 
                safety data described in paragraph (3)(C) and 
                other information that is publicly available or 
                is provided by the Secretary, in order to--
                          (i) improve the quality and 
                        efficiency of postmarket drug safety 
                        risk-benefit analysis;
                          (ii) provide the Secretary with 
                        routine access to outside expertise to 
                        study advanced drug safety questions; 
                        and
                          (iii) enhance the ability of the 
                        Secretary to make timely assessments 
                        based on drug safety data.
                  (B) Privacy.--Such analysis shall not 
                disclose individually identifiable health 
                information when presenting such drug safety 
                signals and trends or when responding to 
                inquiries regarding such drug safety signals 
                and trends.
                  (C) Public process for priority questions.--
                At least biannually, the Secretary shall seek 
                recommendations from the Drug Safety and Risk 
                Management Advisory Committee (or any successor 
                committee) and from other advisory committees, 
                as appropriate, to the Food and Drug 
                Administration on--
                          (i) priority drug safety questions; 
                        and
                          (ii) mechanisms for answering such 
                        questions, including through--
                                  (I) active risk 
                                identification under paragraph 
                                (3); and
                                  (II) when such risk 
                                identification is not 
                                sufficient, postapproval 
                                studies and clinical trials 
                                under subsection (o)(3).
                  (D) Procedures for the development of drug 
                safety collaborations.--
                          (i) In general.--Not later than 180 
                        days after the date of the 
                        establishment of the active postmarket 
                        risk identification and analysis system 
                        under this subsection, the Secretary 
                        shall establish and implement 
                        procedures under which the Secretary 
                        may routinely contract with one or more 
                        qualified entities to--
                                  (I) classify, analyze, or 
                                aggregate data described in 
                                paragraph (3)(C) and 
                                information that is publicly 
                                available or is provided by the 
                                Secretary;
                                  (II) allow for prompt 
                                investigation of priority drug 
                                safety questions, including--
                                          (aa) unresolved 
                                        safety questions for 
                                        drugs or classes of 
                                        drugs; and
                                          (bb) for a newly-
                                        approved drugs, safety 
                                        signals from clinical 
                                        trials used to approve 
                                        the drug and other 
                                        preapproval trials; 
                                        rare, serious drug side 
                                        effects; and the safety 
                                        of use in domestic 
                                        populations not 
                                        included, or 
                                        underrepresented, in 
                                        the trials used to 
                                        approve the drug (such 
                                        as older people, people 
                                        with comorbidities, 
                                        pregnant women, or 
                                        children);
                                  (III) perform advanced 
                                research and analysis on 
                                identified drug safety risks;
                                  (IV) focus postapproval 
                                studies and clinical trials 
                                under subsection (o)(3) more 
                                effectively on cases for which 
                                reports under paragraph (1) and 
                                other safety signal detection 
                                is not sufficient to resolve 
                                whether there is an elevated 
                                risk of a serious adverse event 
                                associated with the use of a 
                                drug; and
                                  (V) carry out other 
                                activities as the Secretary 
                                deems necessary to carry out 
                                the purposes of this paragraph.
                          (ii) Request for specific 
                        methodology.--The procedures described 
                        in clause (i) shall permit the 
                        Secretary to request that a specific 
                        methodology be used by the qualified 
                        entity. The qualified entity shall work 
                        with the Secretary to finalize the 
                        methodology to be used.
                  (E) Use of analyses.--The Secretary shall 
                provide the analyses described in this 
                paragraph, including the methods and results of 
                such analyses, about a drug to the sponsor or 
                sponsors of such drug.
                  (F) Qualified entities.--
                          (i) In general.--The Secretary shall 
                        enter into contracts with a sufficient 
                        number of qualified entities to develop 
                        and provide information to the 
                        Secretary in a timely manner.
                          (ii) Qualification.--The Secretary 
                        shall enter into a contract with an 
                        entity under clause (i) only if the 
                        Secretary determines that the entity 
                        has a significant presence in the 
                        United States and has one or more of 
                        the following qualifications:
                                  (I) The research, 
                                statistical, epidemiologic, or 
                                clinical capability and 
                                expertise to conduct and 
                                complete the activities under 
                                this paragraph, including the 
                                capability and expertise to 
                                provide the Secretary de-
                                identified data consistent with 
                                the requirements of this 
                                subsection.
                                  (II) An information 
                                technology infrastructure in 
                                place to support electronic 
                                data and operational standards 
                                to provide security for such 
                                data.
                                  (III) Experience with, and 
                                expertise on, the development 
                                of drug safety and 
                                effectiveness research using 
                                electronic population data.
                                  (IV) An understanding of drug 
                                development or risk/benefit 
                                balancing in a clinical 
                                setting.
                                  (V) Other expertise which the 
                                Secretary deems necessary to 
                                fulfill the activities under 
                                this paragraph.
                  (G) Contract requirements.--Each contract 
                with a qualified entity under subparagraph 
                (F)(i) shall contain the following 
                requirements:
                          (i) Ensuring privacy.--The qualified 
                        entity shall ensure that the entity 
                        will not use data under this subsection 
                        in a manner that--
                                  (I) violates the regulations 
                                promulgated under section 
                                264(c) of the Health Insurance 
                                Portability and Accountability 
                                Act of 1996;
                                  (II) violates sections 552 or 
                                552a of title 5, United States 
                                Code, with regard to the 
                                privacy of individually-
                                identifiable beneficiary health 
                                information; or
                                  (III) discloses individually 
                                identifiable health information 
                                when presenting drug safety 
                                signals and trends or when 
                                responding to inquiries 
                                regarding drug safety signals 
                                and trends.
                        Nothing in this clause prohibits lawful 
                        disclosure for other purposes.
                          (ii) Component of another 
                        organization.--If a qualified entity is 
                        a component of another organization--
                                  (I) the qualified entity 
                                shall establish appropriate 
                                security measures to maintain 
                                the confidentiality and privacy 
                                of such data; and
                                  (II) the entity shall not 
                                make an unauthorized disclosure 
                                of such data to the other 
                                components of the organization 
                                in breach of such 
                                confidentiality and privacy 
                                requirement.
                          (iii) Termination or nonrenewal.--If 
                        a contract with a qualified entity 
                        under this subparagraph is terminated 
                        or not renewed, the following 
                        requirements shall apply:
                                  (I) Confidentiality and 
                                privacy protections.--The 
                                entity shall continue to comply 
                                with the confidentiality and 
                                privacy requirements under this 
                                paragraph with respect to all 
                                data disclosed to the entity.
                                  (II) Disposition of data.--
                                The entity shall return any 
                                data disclosed to such entity 
                                under this subsection to which 
                                it would not otherwise have 
                                access or, if returning the 
                                data is not practicable, 
                                destroy the data.
                  (H) Competitive procedures.--The Secretary 
                shall use competitive procedures (as defined in 
                section 4(5) of the Federal Procurement Policy 
                Act) to enter into contracts under subparagraph 
                (G).
                  (I) Review of contract in the event of a 
                merger or acquisition.--The Secretary shall 
                review the contract with a qualified entity 
                under this paragraph in the event of a merger 
                or acquisition of the entity in order to ensure 
                that the requirements under this paragraph will 
                continue to be met.
                  (J) Coordination.--In carrying out this 
                paragraph, the Secretary shall provide for 
                appropriate communications to the public, 
                scientific, public health, and medical 
                communities, and other key stakeholders, and to 
                the extent practicable shall coordinate with 
                the activities of private entities, 
                professional associations, or other entities 
                that may have sources of drug safety data.
          (5) The Secretary shall--
                  (A) conduct regular screenings of the Adverse 
                Event Reporting System database and post a 
                quarterly report on the Adverse Event Reporting 
                System Web site of any new safety information 
                or potential signal of a serious risk 
                identified by Adverse Event Reporting System 
                within the last quarter; and
                  (B) on an annual basis, review the entire 
                backlog of postmarket safety commitments to 
                determine which commitments require revision or 
                should be eliminated, report to the Congress on 
                these determinations, and assign start dates 
                and estimated completion dates for such 
                commitments; and
          (C) make available on the Internet website of the 
        Food and Drug Administration--
                  (i) guidelines, developed with input from 
                experts qualified by scientific training and 
                experience to evaluate the safety and 
                effectiveness of drugs, that detail best 
                practices for drug safety surveillance using 
                the Adverse Event Reporting System; and
                  (ii) criteria for public posting of adverse 
                event signals.
  (l)(1) Safety and effectiveness data and information which 
has been submitted in an application under subsection (b) for a 
drug and which has not previously been disclosed to the public 
shall be made available to the public, upon request, unless 
extraordinary circumstances are shown--
          (A) if no work is being or will be undertaken to have 
        the application approved,
          (B) if the Secretary has determined that the 
        application is not approvable and all legal appeals 
        have been exhausted,
          (C) if approval of the application under subsection 
        (c) is withdrawn and all legal appeals have been 
        exhausted,
          (D) if the Secretary has determined that such drug is 
        not a new drug, or
          (E) upon the effective date of the approval of the 
        first application under subsection (j) which refers to 
        such drug or upon the date upon which the approval of 
        an application under subsection (j) which refers to 
        such drug could be made effective if such an 
        application had been submitted.
  (2) Action Package for Approval.--
          (A) Action package.--The Secretary shall publish the 
        action package for approval of an application under 
        subsection (b) or section 351 of the Public Health 
        Service Act on the Internet Web site of the Food and 
        Drug Administration--
                  (i) not later than 30 days after the date of 
                approval of such application for a drug no 
                active ingredient (including any ester or salt 
                of the active ingredient) of which has been 
                approved in any other application under this 
                section or section 351 of the Public Health 
                Service Act; and
                  (ii) not later than 30 days after the third 
                request for such action package for approval 
                received under section 552 of title 5, United 
                States Code, for any other drug.
          (B) Immediate publication of summary review.--
        Notwithstanding subparagraph (A), the Secretary shall 
        publish, on the Internet Web site of the Food and Drug 
        Administration, the materials described in subparagraph 
        (C)(iv) not later than 48 hours after the date of 
        approval of the drug, except where such materials 
        require redaction by the Secretary.
          (C) Contents.--An action package for approval of an 
        application under subparagraph (A) shall be dated and 
        shall include the following:
                  (i) Documents generated by the Food and Drug 
                Administration related to review of the 
                application.
                  (ii) Documents pertaining to the format and 
                content of the application generated during 
                drug development.
                  (iii) Labeling submitted by the applicant.
                  (iv) A summary review that documents 
                conclusions from all reviewing disciplines 
                about the drug, noting any critical issues and 
                disagreements with the applicant and within the 
                review team and how they were resolved, 
                recommendations for action, and an explanation 
                of any nonconcurrence with review conclusions.
                  (v) The Division Director and Office 
                Director's decision document which includes--
                          (I) a brief statement of concurrence 
                        with the summary review;
                          (II) a separate review or addendum to 
                        the review if disagreeing with the 
                        summary review; and
                          (III) a separate review or addendum 
                        to the review to add further analysis.
                  (vi) Identification by name of each officer 
                or employee of the Food and Drug Administration 
                who--
                          (I) participated in the decision to 
                        approve the application; and
                          (II) consents to have his or her name 
                        included in the package.
          (D) Review.--A scientific review of an application is 
        considered the work of the reviewer and shall not be 
        altered by management or the reviewer once final.
          (E) Confidential information.--This paragraph does 
        not authorize the disclosure of any trade secret, 
        confidential commercial or financial information, or 
        other matter listed in section 552(b) of title 5, 
        United States Code.
  (m) For purposes of this section, the term ``patent'' means a 
patent issued by the United States Patent and Trademark Office.
  (n)(1) For the purpose of providing expert scientific advice 
and recommendations to the Secretary regarding a clinical 
investigation of a drug or the approval for marketing of a drug 
under section 505 or section 351 of the Public Health Service 
Act, the Secretary shall establish panels of experts or use 
panels of experts established before the date of enactment of 
the Food and Drug Administration Modernization Act of 1997, or 
both.
  (2) The Secretary may delegate the appointment and oversight 
authority granted under section 1004 to a director of a center 
or successor entity within the Food and Drug Administration.
  (3) The Secretary shall make appointments to each panel 
established under paragraph (1) so that each panel shall 
consist of--
          (A) members who are qualified by training and 
        experience to evaluate the safety and effectiveness of 
        the drugs to be referred to the panel and who, to the 
        extent feasible, possess skill and experience in the 
        development, manufacture, or utilization of such drugs;
          (B) members with diverse expertise in such fields as 
        clinical and administrative medicine, pharmacy, 
        pharmacology, pharmacoeconomics, biological and 
        physical sciences, and other related professions;
          (C) a representative of consumer interests, and a 
        representative of interests of the drug manufacturing 
        industry not directly affected by the matter to be 
        brought before the panel; and
          (D) two or more members who are specialists or have 
        other expertise in the particular disease or condition 
        for which the drug under review is proposed to be 
        indicated.
Scientific, trade, and consumer organizations shall be afforded 
an opportunity to nominate individuals for appointment to the 
panels. No individual who is in the regular full-time employ of 
the United States and engaged in the administration of this Act 
may be a voting member of any panel. The Secretary shall 
designate one of the members of each panel to serve as chairman 
thereof.
  (4) The Secretary shall, as appropriate, provide education 
and training to each new panel member before such member 
participates in a panel's activities, including education 
regarding requirements under this Act and related regulations 
of the Secretary, and the administrative processes and 
procedures related to panel meetings.
  (5) Panel members (other than officers or employees of the 
United States), while attending meetings or conferences of a 
panel or otherwise engaged in its business, shall be entitled 
to receive compensation for each day so engaged, including 
traveltime, at rates to be fixed by the Secretary, but not to 
exceed the daily equivalent of the rate in effect for positions 
classified above grade GS-15 of the General Schedule. While 
serving away from their homes or regular places of business, 
panel members may be allowed travel expenses (including per 
diem in lieu of subsistence) as authorized by section 5703 of 
title 5, United States Code, for persons in the Government 
service employed intermittently.
  (6) The Secretary shall ensure that scientific advisory 
panels meet regularly and at appropriate intervals so that any 
matter to be reviewed by such a panel can be presented to the 
panel not more than 60 days after the matter is ready for such 
review. Meetings of the panel may be held using electronic 
communication to convene the meetings.
  (7) Within 90 days after a scientific advisory panel makes 
recommendations on any matter under its review, the Food and 
Drug Administration official responsible for the matter shall 
review the conclusions and recommendations of the panel, and 
notify the affected persons of the final decision on the 
matter, or of the reasons that no such decision has been 
reached. Each such final decision shall be documented including 
the rationale for the decision.
  (o) Postmarket Studies and Clinical Trials; Labeling.--
          (1) In general.--A responsible person may not 
        introduce or deliver for introduction into interstate 
        commerce the new drug involved if the person is in 
        violation of a requirement established under paragraph 
        (3) or (4) with respect to the drug.
          (2) Definitions.--For purposes of this subsection:
                  (A) Responsible person.--The term 
                ``responsible person'' means a person who--
                          (i) has submitted to the Secretary a 
                        covered application that is pending; or
                          (ii) is the holder of an approved 
                        covered application.
                  (B) Covered application.--The term ``covered 
                application'' means--
                          (i) an application under subsection 
                        (b) for a drug that is subject to 
                        section 503(b); and
                          (ii) an application under section 351 
                        of the Public Health Service Act.
                  (C) New safety information; serious risk.--
                The terms ``new safety information'', ``serious 
                risk'', and ``signal of a serious risk'' have 
                the meanings given such terms in section 505-
                1(b).
          (3) Studies and clinical trials.--
                  (A) In general.--For any or all of the 
                purposes specified in subparagraph (B), the 
                Secretary may, subject to subparagraph (D), 
                require a responsible person for a drug to 
                conduct a postapproval study or studies of the 
                drug, or a postapproval clinical trial or 
                trials of the drug, on the basis of scientific 
                data deemed appropriate by the Secretary, 
                including information regarding chemically-
                related or pharmacologically-related drugs.
                  (B) Purposes of study or clinical trial.--The 
                purposes referred to in this subparagraph with 
                respect to a postapproval study or postapproval 
                clinical trial are the following:
                          (i) To assess a known serious risk 
                        related to the use of the drug 
                        involved.
                          (ii) To assess signals of serious 
                        risk related to the use of the drug.
                          (iii) To identify an unexpected 
                        serious risk when available data 
                        indicates the potential for a serious 
                        risk.
                  (C) Establishment of requirement after 
                approval of covered application.--The Secretary 
                may require a postapproval study or studies or 
                postapproval clinical trial or trials for a 
                drug for which an approved covered application 
                is in effect as of the date on which the 
                Secretary seeks to establish such requirement 
                only if the Secretary becomes aware of new 
                safety information.
                  (D) Determination by secretary.--
                          (i) Postapproval studies.--The 
                        Secretary may not require the 
                        responsible person to conduct a study 
                        under this paragraph, unless the 
                        Secretary makes a determination that 
                        the reports under subsection (k)(1) and 
                        the active postmarket risk 
                        identification and analysis system as 
                        available under subsection (k)(3) will 
                        not be sufficient to meet the purposes 
                        set forth in subparagraph (B).
                          (ii) Postapproval clinical trials.--
                        The Secretary may not require the 
                        responsible person to conduct a 
                        clinical trial under this paragraph, 
                        unless the Secretary makes a 
                        determination that a postapproval study 
                        or studies will not be sufficient to 
                        meet the purposes set forth in 
                        subparagraph (B).
                  (E) Notification; timetables; periodic 
                reports.--
                          (i) Notification.--The Secretary 
                        shall notify the responsible person 
                        regarding a requirement under this 
                        paragraph to conduct a postapproval 
                        study or clinical trial by the target 
                        dates for communication of feedback 
                        from the review team to the responsible 
                        person regarding proposed labeling and 
                        postmarketing study commitments as set 
                        forth in the letters described in 
                        section 101(c) of the Food and Drug 
                        Administration Amendments Act of 2007.
                          (ii) Timetable; periodic reports.--
                        For each study or clinical trial 
                        required to be conducted under this 
                        paragraph, the Secretary shall require 
                        that the responsible person submit a 
                        timetable for completion of the study 
                        or clinical trial. With respect to each 
                        study required to be conducted under 
                        this paragraph or otherwise undertaken 
                        by the responsible person to 
                        investigate a safety issue, the 
                        Secretary shall require the responsible 
                        person to periodically report to the 
                        Secretary on the status of such study 
                        including whether any difficulties in 
                        completing the study have been 
                        encountered. With respect to each 
                        clinical trial required to be conducted 
                        under this paragraph or otherwise 
                        undertaken by the responsible person to 
                        investigate a safety issue, the 
                        Secretary shall require the responsible 
                        person to periodically report to the 
                        Secretary on the status of such 
                        clinical trial including whether 
                        enrollment has begun, the number of 
                        participants enrolled, the expected 
                        completion date, whether any 
                        difficulties completing the clinical 
                        trial have been encountered, and 
                        registration information with respect 
                        to the requirements under section 
                        402(j) of the Public Health Service 
                        Act. If the responsible person fails to 
                        comply with such timetable or violates 
                        any other requirement of this 
                        subparagraph, the responsible person 
                        shall be considered in violation of 
                        this subsection, unless the responsible 
                        person demonstrates good cause for such 
                        noncompliance or such other violation. 
                        The Secretary shall determine what 
                        constitutes good cause under the 
                        preceding sentence.
                  (F) Dispute resolution.--The responsible 
                person may appeal a requirement to conduct a 
                study or clinical trial under this paragraph 
                using dispute resolution procedures established 
                by the Secretary in regulation and guidance.
          (4) Safety labeling changes requested by secretary.--
                  (A) New safety information.--If the Secretary 
                becomes aware of new safety information that 
                the Secretary believes should be included in 
                the labeling of the drug, the Secretary shall 
                promptly notify the responsible person or, if 
                the same drug approved under section 505(b) is 
                not currently marketed, the holder of an 
                approved application under 505(j).
                  (B) Response to notification.--Following 
                notification pursuant to subparagraph (A), the 
                responsible person or the holder of the 
                approved application under section 505(j) shall 
                within 30 days--
                          (i) submit a supplement proposing 
                        changes to the approved labeling to 
                        reflect the new safety information, 
                        including changes to boxed warnings, 
                        contraindications, warnings, 
                        precautions, or adverse reactions; or
                          (ii) notify the Secretary that the 
                        responsible person or the holder of the 
                        approved application under section 
                        505(j) does not believe a labeling 
                        change is warranted and submit a 
                        statement detailing the reasons why 
                        such a change is not warranted.
                  (C) Review.--Upon receipt of such supplement, 
                the Secretary shall promptly review and act 
                upon such supplement. If the Secretary 
                disagrees with the proposed changes in the 
                supplement or with the statement setting forth 
                the reasons why no labeling change is 
                necessary, the Secretary shall initiate 
                discussions to reach agreement on whether the 
                labeling for the drug should be modified to 
                reflect the new safety information, and if so, 
                the contents of such labeling changes.
                  (D) Discussions.--Such discussions shall not 
                extend for more than 30 days after the response 
                to the notification under subparagraph (B), 
                unless the Secretary determines an extension of 
                such discussion period is warranted.
                  (E) Order.--Within 15 days of the conclusion 
                of the discussions under subparagraph (D), the 
                Secretary may issue an order directing the 
                responsible person or the holder of the 
                approved application under section 505(j) to 
                make such a labeling change as the Secretary 
                deems appropriate to address the new safety 
                information. Within 15 days of such an order, 
                the responsible person or the holder of the 
                approved application under section 505(j) shall 
                submit a supplement containing the labeling 
                change.
                  (F) Dispute resolution.--Within 5 days of 
                receiving an order under subparagraph (E), the 
                responsible person or the holder of the 
                approved application under section 505(j) may 
                appeal using dispute resolution procedures 
                established by the Secretary in regulation and 
                guidance.
                  (G) Violation.--If the responsible person or 
                the holder of the approved application under 
                section 505(j) has not submitted a supplement 
                within 15 days of the date of such order under 
                subparagraph (E), and there is no appeal or 
                dispute resolution proceeding pending, the 
                responsible person or holder shall be 
                considered to be in violation of this 
                subsection. If at the conclusion of any dispute 
                resolution procedures the Secretary determines 
                that a supplement must be submitted and such a 
                supplement is not submitted within 15 days of 
                the date of that determination, the responsible 
                person or holder shall be in violation of this 
                subsection.
                  (H) Public health threat.--Notwithstanding 
                subparagraphs (A) through (F), if the Secretary 
                concludes that such a labeling change is 
                necessary to protect the public health, the 
                Secretary may accelerate the timelines in such 
                subparagraphs.
                  (I) Rule of construction.--This paragraph 
                shall not be construed to affect the 
                responsibility of the responsible person or the 
                holder of the approved application under 
                section 505(j) to maintain its label in 
                accordance with existing requirements, 
                including subpart B of part 201 and sections 
                314.70 and 601.12 of title 21, Code of Federal 
                Regulations (or any successor regulations).
          (5) Non-delegation.--Determinations by the Secretary 
        under this subsection for a drug shall be made by 
        individuals at or above the level of individuals 
        empowered to approve a drug (such as division directors 
        within the Center for Drug Evaluation and Research).
  (p) Risk Evaluation and Mitigation Strategy.--
          (1) In general.--A person may not introduce or 
        deliver for introduction into interstate commerce a new 
        drug if--
                  (A)(i) the application for such drug is 
                approved under subsection (b) or (j) and is 
                subject to section 503(b); or
                  (ii) the application for such drug is 
                approved under section 351 of the Public Health 
                Service Act; and
                  (B) a risk evaluation and mitigation strategy 
                is required under section 505-1 with respect to 
                the drug and the person fails to maintain 
                compliance with the requirements of the 
                approved strategy or with other requirements 
                under section 505-1, including requirements 
                regarding assessments of approved strategies.
          (2) Certain postmarket studies.--The failure to 
        conduct a postmarket study under section 506, subpart H 
        of part 314, or subpart E of part 601 of title 21, Code 
        of Federal Regulations (or any successor regulations), 
        is deemed to be a violation of paragraph (1).
  (q) Petitions and Civil Actions Regarding Approval of Certain 
Applications.--
          (1) In general.--
                  (A) Determination.--The Secretary shall not 
                delay approval of a pending application 
                submitted under subsection (b)(2) or (j) of 
                this section or section 351(k) of the Public 
                Health Service Act because of any request to 
                take any form of action relating to the 
                application, either before or during 
                consideration of the request, unless--
                          (i) the request is in writing and is 
                        a petition submitted to the Secretary 
                        pursuant to section 10.30 or 10.35 of 
                        title 21, Code of Federal Regulations 
                        (or any successor regulations); and
                          (ii) the Secretary determines, upon 
                        reviewing the petition, that a delay is 
                        necessary to protect the public health.
                Consideration of the petition shall be separate 
                and apart from review and approval of any 
                application.
                  (B) Notification.--If the Secretary 
                determines under subparagraph (A) that a delay 
                is necessary with respect to an application, 
                the Secretary shall provide to the applicant, 
                not later than 30 days after making such 
                determination, the following information:
                          (i) Notification of the fact that a 
                        determination under subparagraph (A) 
                        has been made.
                          (ii) If applicable, any clarification 
                        or additional data that the applicant 
                        should submit to the docket on the 
                        petition to allow the Secretary to 
                        review the petition promptly.
                          (iii) A brief summary of the specific 
                        substantive issues raised in the 
                        petition which form the basis of the 
                        determination.
                  (C) Format.--The information described in 
                subparagraph (B) shall be conveyed via either, 
                at the discretion of the Secretary--
                          (i) a document; or
                          (ii) a meeting with the applicant 
                        involved.
                  (D) Public disclosure.--Any information 
                conveyed by the Secretary under subparagraph 
                (C) shall be considered part of the application 
                and shall be subject to the disclosure 
                requirements applicable to information in such 
                application.
                  (E) Denial based on intent to delay.--If the 
                Secretary determines that a petition or a 
                supplement to the petition was submitted with 
                the primary purpose of delaying the approval of 
                an application and the petition does not on its 
                face raise valid scientific or regulatory 
                issues, the Secretary may deny the petition at 
                any point based on such determination. The 
                Secretary may issue guidance to describe the 
                factors that will be used to determine under 
                this subparagraph whether a petition is 
                submitted with the primary purpose of delaying 
                the approval of an application.
                  (F) Final agency action.--The Secretary shall 
                take final agency action on a petition not 
                later than 150 days after the date on which the 
                petition is submitted. The Secretary shall not 
                extend such period for any reason, including--
                          (i) any determination made under 
                        subparagraph (A);
                          (ii) the submission of comments 
                        relating to the petition or 
                        supplemental information supplied by 
                        the petitioner; or
                          (iii) the consent of the petitioner.
                  (G) Extension of 30-month period.--If the 
                filing of an application resulted in first-
                applicant status under subsection 
                (j)(5)(D)(i)(IV) and approval of the 
                application was delayed because of a petition, 
                the 30-month period under such subsection is 
                deemed to be extended by a period of time equal 
                to the period beginning on the date on which 
                the Secretary received the petition and ending 
                on the date of final agency action on the 
                petition (inclusive of such beginning and 
                ending dates), without regard to whether the 
                Secretary grants, in whole or in part, or 
                denies, in whole or in part, the petition.
                  (H) Certification.--The Secretary shall not 
                consider a petition for review unless the party 
                submitting such petition does so in written 
                form and the subject document is signed and 
                contains the following certification: ``I 
                certify that, to my best knowledge and belief: 
                (a) this petition includes all information and 
                views upon which the petition relies; (b) this 
                petition includes representative data and/or 
                information known to the petitioner which are 
                unfavorable to the petition; and (c) I have 
                taken reasonable steps to ensure that any 
                representative data and/or information which 
                are unfavorable to the petition were disclosed 
                to me. I further certify that the information 
                upon which I have based the action requested 
                herein first became known to the party on whose 
                behalf this petition is submitted on or about 
                the following date: __________. If I received 
                or expect to receive payments, including cash 
                and other forms of consideration, to file this 
                information or its contents, I received or 
                expect to receive those payments from the 
                following persons or organizations: 
                _____________. I verify under penalty of 
                perjury that the foregoing is true and correct 
                as of the date of the submission of this 
                petition.'', with the date on which such 
                information first became known to such party 
                and the names of such persons or organizations 
                inserted in the first and second blank space, 
                respectively.
                  (I) Verification.--The Secretary shall not 
                accept for review any supplemental information 
                or comments on a petition unless the party 
                submitting such information or comments does so 
                in written form and the subject document is 
                signed and contains the following verification: 
                ``I certify that, to my best knowledge and 
                belief: (a) I have not intentionally delayed 
                submission of this document or its contents; 
                and (b) the information upon which I have based 
                the action requested herein first became known 
                to me on or about __________. If I received or 
                expect to receive payments, including cash and 
                other forms of consideration, to file this 
                information or its contents, I received or 
                expect to receive those payments from the 
                following persons or organizations: _____. I 
                verify under penalty of perjury that the 
                foregoing is true and correct as of the date of 
                the submission of this petition.'', with the 
                date on which such information first became 
                known to the party and the names of such 
                persons or organizations inserted in the first 
                and second blank space, respectively.
          (2) Exhaustion of administrative remedies.--
                  (A) Final agency action within 150 days.--The 
                Secretary shall be considered to have taken 
                final agency action on a petition if--
                          (i) during the 150-day period 
                        referred to in paragraph (1)(F), the 
                        Secretary makes a final decision within 
                        the meaning of section 10.45(d) of 
                        title 21, Code of Federal Regulations 
                        (or any successor regulation); or
                          (ii) such period expires without the 
                        Secretary having made such a final 
                        decision.
                  (B) Dismissal of certain civil actions.--If a 
                civil action is filed against the Secretary 
                with respect to any issue raised in the 
                petition before the Secretary has taken final 
                agency action on the petition within the 
                meaning of subparagraph (A), the court shall 
                dismiss without prejudice the action for 
                failure to exhaust administrative remedies.
                  (C) Administrative record.--For purposes of 
                judicial review related to the approval of an 
                application for which a petition under 
                paragraph (1) was submitted, the administrative 
                record regarding any issue raised by the 
                petition shall include--
                          (i) the petition filed under 
                        paragraph (1) and any supplements and 
                        comments thereto;
                          (ii) the Secretary's response to such 
                        petition, if issued; and
                          (iii) other information, as 
                        designated by the Secretary, related to 
                        the Secretary's determinations 
                        regarding the issues raised in such 
                        petition, as long as the information 
                        was considered by the agency no later 
                        than the date of final agency action as 
                        defined under subparagraph (2)(A), and 
                        regardless of whether the Secretary 
                        responded to the petition at or before 
                        the approval of the application at 
                        issue in the petition.
          (3) Annual report on delays in approvals per 
        petitions.--The Secretary shall annually submit to the 
        Congress a report that specifies--
                  (A) the number of applications that were 
                approved during the preceding 12-month period;
                  (B) the number of such applications whose 
                effective dates were delayed by petitions 
                referred to in paragraph (1) during such 
                period;
                  (C) the number of days by which such 
                applications were so delayed; and
                  (D) the number of such petitions that were 
                submitted during such period.
          (4) Exceptions.--
                  (A) This subsection does not apply to--
                          (i) a petition that relates solely to 
                        the timing of the approval of an 
                        application pursuant to subsection 
                        (j)(5)(B)(iv); or
                          (ii) a petition that is made by the 
                        sponsor of an application and that 
                        seeks only to have the Secretary take 
                        or refrain from taking any form of 
                        action with respect to that 
                        application.
                  (B) Paragraph (2) does not apply to a 
                petition addressing issues concerning an 
                application submitted pursuant to section 
                351(k) of the Public Health Service Act.
          (5) Definitions.--
                  (A) Application.--For purposes of this 
                subsection, the term ``application'' means an 
                application submitted under subsection (b)(2) 
                or (j) of this section or section 351(k) of the 
                Public Health Service Act.
                  (B) Petition.--For purposes of this 
                subsection, other than paragraph (1)(A)(i), the 
                term ``petition'' means a request described in 
                paragraph (1)(A)(i).
  (r) Postmarket Drug Safety Information for Patients and 
Providers.--
          (1) Establishment.--Not later than 1 year after the 
        date of the enactment of the Food and Drug 
        Administration Amendments Act of 2007, the Secretary 
        shall improve the transparency of information about 
        drugs and allow patients and health care providers 
        better access to information about drugs by developing 
        and maintaining an Internet Web site that--
                  (A) provides links to drug safety information 
                listed in paragraph (2) for prescription drugs 
                that are approved under this section or 
                licensed under section 351 of the Public Health 
                Service Act; and
                  (B) improves communication of drug safety 
                information to patients and providers.
          (2) Internet web site.--The Secretary shall carry out 
        paragraph (1) by--
                  (A) developing and maintaining an accessible, 
                consolidated Internet Web site with easily 
                searchable drug safety information, including 
                the information found on United States 
                Government Internet Web sites, such as the 
                United States National Library of Medicine's 
                Daily Med and Medline Plus Web sites, in 
                addition to other such Web sites maintained by 
                the Secretary;
                  (B) ensuring that the information provided on 
                the Internet Web site is comprehensive and 
                includes, when available and appropriate--
                          (i) patient labeling and patient 
                        packaging inserts;
                          (ii) a link to a list of each drug, 
                        whether approved under this section or 
                        licensed under such section 351, for 
                        which a Medication Guide, as provided 
                        for under part 208 of title 21, Code of 
                        Federal Regulations (or any successor 
                        regulations), is required;
                          (iii) a link to the registry and 
                        results data bank provided for under 
                        subsections (i) and (j) of section 402 
                        of the Public Health Service Act;
                          (iv) the most recent safety 
                        information and alerts issued by the 
                        Food and Drug Administration for drugs 
                        approved by the Secretary under this 
                        section, such as product recalls, 
                        warning letters, and import alerts;
                          (v) publicly available information 
                        about implemented RiskMAPs and risk 
                        evaluation and mitigation strategies 
                        under subsection (o);
                          (vi) guidance documents and 
                        regulations related to drug safety; and
                          (vii) other material determined 
                        appropriate by the Secretary;
                  (C) providing access to summaries of the 
                assessed and aggregated data collected from the 
                active surveillance infrastructure under 
                subsection (k)(3) to provide information of 
                known and serious side-effects for drugs 
                approved under this section or licensed under 
                such section 351;
                  (D) preparing and making publicly available 
                on the Internet website established under 
                paragraph (1) best practices for drug safety 
                surveillance activities for drugs approved 
                under this section or section 351 of the Public 
                Health Service Act;
                  (E) enabling patients, providers, and drug 
                sponsors to submit adverse event reports 
                through the Internet Web site;
                  (F) providing educational materials for 
                patients and providers about the appropriate 
                means of disposing of expired, damaged, or 
                unusable medications; and
                  (G) supporting initiatives that the Secretary 
                determines to be useful to fulfill the purposes 
                of the Internet Web site.
          (3) Posting of drug labeling.--The Secretary shall 
        post on the Internet Web site established under 
        paragraph (1) the approved professional labeling and 
        any required patient labeling of a drug approved under 
        this section or licensed under such section 351 not 
        later than 21 days after the date the drug is approved 
        or licensed, including in a supplemental application 
        with respect to a labeling change.
          (4) Private sector resources.--To ensure development 
        of the Internet Web site by the date described in 
        paragraph (1), the Secretary may, on a temporary or 
        permanent basis, implement systems or products 
        developed by private entities.
          (5) Authority for contracts.--The Secretary may enter 
        into contracts with public and private entities to 
        fulfill the requirements of this subsection.
          (6) Review.--The Advisory Committee on Risk 
        Communication under section 567 shall, on a regular 
        basis, perform a comprehensive review and evaluation of 
        the types of risk communication information provided on 
        the Internet Web site established under paragraph (1) 
        and, through other means, shall identify, clarify, and 
        define the purposes and types of information available 
        to facilitate the efficient flow of information to 
        patients and providers, and shall recommend ways for 
        the Food and Drug Administration to work with outside 
        entities to help facilitate the dispensing of risk 
        communication information to patients and providers.
  (s) Referral to Advisory Committee.--Prior to the approval of 
a drug no active ingredient (including any ester or salt of the 
active ingredient) of which has been approved in any other 
application under this section or section 351 of the Public 
Health Service Act, the Secretary shall--
          (1) refer such drug to a Food and Drug Administration 
        advisory committee for review at a meeting of such 
        advisory committee; or
          (2) if the Secretary does not refer such a drug to a 
        Food and Drug Administration advisory committee prior 
        to the approval of the drug, provide in the action 
        letter on the application for the drug a summary of the 
        reasons why the Secretary did not refer the drug to an 
        advisory committee prior to approval.
  (t) Database for Authorized Generic Drugs.--
          (1) In general.--
                  (A) Publication.--The Commissioner shall--
                          (i) not later than 9 months after the 
                        date of the enactment of the Food and 
                        Drug Administration Amendments Act of 
                        2007, publish a complete list on the 
                        Internet Web site of the Food and Drug 
                        Administration of all authorized 
                        generic drugs (including drug trade 
                        name, brand company manufacturer, and 
                        the date the authorized generic drug 
                        entered the market); and
                          (ii) update the list quarterly to 
                        include each authorized generic drug 
                        included in an annual report submitted 
                        to the Secretary by the sponsor of a 
                        listed drug during the preceding 3-
                        month period.
                  (B) Notification.--The Commissioner shall 
                notify relevant Federal agencies, including the 
                Centers for Medicare & Medicaid Services and 
                the Federal Trade Commission, when the 
                Commissioner first publishes the information 
                described in subparagraph (A) that the 
                information has been published and that the 
                information will be updated quarterly.
          (2) Inclusion.--The Commissioner shall include in the 
        list described in paragraph (1) each authorized generic 
        drug included in an annual report submitted to the 
        Secretary by the sponsor of a listed drug after January 
        1, 1999.
          (3) Authorized generic drug.--In this section, the 
        term ``authorized generic drug'' means a listed drug 
        (as that term is used in subsection (j)) that--
                  (A) has been approved under subsection (c); 
                and
                  (B) is marketed, sold, or distributed 
                directly or indirectly to retail class of trade 
                under a different labeling, packaging (other 
                than repackaging as the listed drug in blister 
                packs, unit doses, or similar packaging for use 
                in institutions), product code, labeler code, 
                trade name, or trade mark than the listed drug.
  (u) Certain Drugs Containing Single Enantiomers.--
          (1) In general.--For purposes of subsections 
        (c)(3)(E)(ii) and (j)(5)(F)(ii), if an application is 
        submitted under subsection (b) for a non-racemic drug 
        containing as an active ingredient (including any ester 
        or salt of the active ingredient) a single enantiomer 
        that is contained in a racemic drug approved in another 
        application under subsection (b), the applicant may, in 
        the application for such non-racemic drug, elect to 
        have the single enantiomer not be considered the same 
        active ingredient as that contained in the approved 
        racemic drug, if--
                  (A)(i) the single enantiomer has not been 
                previously approved except in the approved 
                racemic drug; and
                  (ii) the application submitted under 
                subsection (b) for such non-racemic drug--
                          (I) includes full reports of new 
                        clinical investigations (other than 
                        bioavailability studies)--
                                  (aa) necessary for the 
                                approval of the application 
                                under subsections (c) and (d); 
                                and
                                  (bb) conducted or sponsored 
                                by the applicant; and
                          (II) does not rely on any clinical 
                        investigations that are part of an 
                        application submitted under subsection 
                        (b) for approval of the approved 
                        racemic drug; and
                  (B) the application submitted under 
                subsection (b) for such non-racemic drug is not 
                submitted for approval of a condition of use--
                          (i) in a therapeutic category in 
                        which the approved racemic drug has 
                        been approved; or
                          (ii) for which any other enantiomer 
                        of the racemic drug has been approved.
          (2) Limitation.--
                  (A) No approval in certain therapeutic 
                categories.--Until the date that is 10 years 
                after the date of approval of a non-racemic 
                drug described in paragraph (1) and with 
                respect to which the applicant has made the 
                election provided for by such paragraph, the 
                Secretary shall not approve such non-racemic 
                drug for any condition of use in the 
                therapeutic category in which the racemic drug 
                has been approved.
                  (B) Labeling.--If applicable, the labeling of 
                a non-racemic drug described in paragraph (1) 
                and with respect to which the applicant has 
                made the election provided for by such 
                paragraph shall include a statement that the 
                non-racemic drug is not approved, and has not 
                been shown to be safe and effective, for any 
                condition of use of the racemic drug.
          (3) Definition.--
                  (A) In general.--For purposes of this 
                subsection, the term ``therapeutic category'' 
                means a therapeutic category identified in the 
                list developed by the United States 
                Pharmacopeia pursuant to section 1860D-
                4(b)(3)(C)(ii) of the Social Security Act and 
                as in effect on the date of the enactment of 
                this subsection.
                  (B) Publication by secretary.--The Secretary 
                shall publish the list described in 
                subparagraph (A) and may amend such list by 
                regulation.
          (4) Availability.--The election referred to in 
        paragraph (1) may be made only in an application that 
        is submitted to the Secretary after the date of the 
        enactment of this subsection and before October 1, 
        [2017] 2022.
  (v) Antibiotic Drugs Submitted Before November 21, 1997.--
          (1) Antibiotic drugs approved before november 21, 
        1997.--
                  (A) In general.--Notwithstanding any 
                provision of the Food and Drug Administration 
                Modernization Act of 1997 or any other 
                provision of law, a sponsor of a drug that is 
                the subject of an application described in 
                subparagraph (B)(i) shall be eligible for, with 
                respect to the drug, the 3-year exclusivity 
                period referred to under clauses (iii) and (iv) 
                of subsection (c)(3)(E) and under clauses (iii) 
                and (iv) of subsection (j)(5)(F), subject to 
                the requirements of such clauses, as 
                applicable.
                  (B) Application; antibiotic drug described.--
                          (i) Application.--An application 
                        described in this clause is an 
                        application for marketing submitted 
                        under this section after the date of 
                        the enactment of this subsection in 
                        which the drug that is the subject of 
                        the application contains an antibiotic 
                        drug described in clause (ii).
                          (ii) Antibiotic drug.--An antibiotic 
                        drug described in this clause is an 
                        antibiotic drug that was the subject of 
                        an application approved by the 
                        Secretary under section 507 of this Act 
                        (as in effect before November 21, 
                        1997).
          (2) Antibiotic drugs submitted before november 21, 
        1997, but not approved.--
                  (A) In general.--Notwithstanding any 
                provision of the Food and Drug Administration 
                Modernization Act of 1997 or any other 
                provision of law, a sponsor of a drug that is 
                the subject of an application described in 
                subparagraph (B)(i) may elect to be eligible 
                for, with respect to the drug--
                          (i)(I) the 3-year exclusivity period 
                        referred to under clauses (iii) and 
                        (iv) of subsection (c)(3)(E) and under 
                        clauses (iii) and (iv) of subsection 
                        (j)(5)(F), subject to the requirements 
                        of such clauses, as applicable; and
                          (II) the 5-year exclusivity period 
                        referred to under clause (ii) of 
                        subsection (c)(3)(E) and under clause 
                        (ii) of subsection (j)(5)(F), subject 
                        to the requirements of such clauses, as 
                        applicable; or
                          (ii) a patent term extension under 
                        section 156 of title 35, United States 
                        Code, subject to the requirements of 
                        such section.
                  (B) Application; antibiotic drug described.--
                          (i) Application.--An application 
                        described in this clause is an 
                        application for marketing submitted 
                        under this section after the date of 
                        the enactment of this subsection in 
                        which the drug that is the subject of 
                        the application contains an antibiotic 
                        drug described in clause (ii).
                          (ii) Antibiotic drug.--An antibiotic 
                        drug described in this clause is an 
                        antibiotic drug that was the subject of 
                        1 or more applications received by the 
                        Secretary under section 507 of this Act 
                        (as in effect before November 21, 
                        1997), none of which was approved by 
                        the Secretary under such section.
          (3) Limitations.--
                  (A) Exclusivities and extensions.--Paragraphs 
                (1)(A) and (2)(A) shall not be construed to 
                entitle a drug that is the subject of an 
                approved application described in subparagraphs 
                (1)(B)(i) or (2)(B)(i), as applicable, to any 
                market exclusivities or patent extensions other 
                than those exclusivities or extensions 
                described in paragraph (1)(A) or (2)(A).
                  (B) Conditions of use.--Paragraphs (1)(A) and 
                (2)(A)(i) shall not apply to any condition of 
                use for which the drug referred to in 
                subparagraph (1)(B)(i) or (2)(B)(i), as 
                applicable, was approved before the date of the 
                enactment of this subsection.
          (4) Application of certain provisions.--
        Notwithstanding section 125, or any other provision, of 
        the Food and Drug Administration Modernization Act of 
        1997, or any other provision of law, and subject to the 
        limitations in paragraphs (1), (2), and (3), the 
        provisions of the Drug Price Competition and Patent 
        Term Restoration Act of 1984 shall apply to any drug 
        subject to paragraph (1) or any drug with respect to 
        which an election is made under paragraph (2)(A).
  (w) Deadline for Determination on Certain Petitions.--The 
Secretary shall issue a final, substantive determination on a 
petition submitted pursuant to subsection (b) of section 
314.161 of title 21, Code of Federal Regulations (or any 
successor regulations), no later than 270 days after the date 
the petition is submitted.
  (x) Date of Approval in the Case of Recommended Controls 
Under the CSA.--
          (1) In general.--In the case of an application under 
        subsection (b) with respect to a drug for which the 
        Secretary provides notice to the sponsor that the 
        Secretary intends to issue a scientific and medical 
        evaluation and recommend controls under the Controlled 
        Substances Act, approval of such application shall not 
        take effect until the interim final rule controlling 
        the drug is issued in accordance with section 201(j) of 
        the Controlled Substances Act.
          (2) Date of approval.--For purposes of this section, 
        with respect to an application described in paragraph 
        (1), the term ``date of approval'' shall mean the later 
        of--
                  (A) the date an application under subsection 
                (b) is approved under subsection (c); or
                  (B) the date of issuance of the interim final 
                rule controlling the drug.
  (y) Contrast Agents Intended for Use With Applicable Medical 
Imaging Devices.--
          (1) The sponsor of a contrast agent for which an 
        application has been approved under this section may 
        submit a supplement to the application seeking approval 
        for the use of the contrast agent for a new indication 
        and conditions of use following the authorization of a 
        premarket submission for an applicable medical imaging 
        device for that use with the contrast agent pursuant to 
        section 520(q)(1).
          (2) In reviewing a supplement submitted under this 
        subsection, the agency center charged with the 
        premarket review of drugs may--
                  (A) consult with the center charged with the 
                premarket review of devices; and
                  (B) review information and data submitted to 
                the Secretary by the sponsor of an applicable 
                medical imaging device pursuant to section 515, 
                510(k), or 513(f)(2) so long as the sponsor of 
                such applicable medical imaging device has 
                provided to the sponsor of the contrast agent a 
                right of reference.
          (3) For purposes of this subsection--
                  (A) the term ``new indication'' means a use 
                of a contrast agent that is described in the 
                approved labeling of an applicable medical 
                imaging device described in section 520(q), but 
                that is not described in the approved labeling 
                of the contrast agent; and
                  (B) the term ``applicable medical imaging 
                device'' and ``contrast agent'' have the 
                meanings given such terms in section 520(q).

           *       *       *       *       *       *       *


SEC. 505F. UTILIZING REAL WORLD EVIDENCE.

  (a) In General.--The Secretary shall establish a program to 
evaluate the potential use of real world evidence--
          (1) to help to support the approval of a new 
        indication for a drug approved under section 505(c); 
        and
          (2) to help to support or satisfy postapproval study 
        requirements.
  (b) Real World Evidence Defined.--In this section, the term 
``real world evidence'' means data regarding the usage, or the 
potential benefits or risks, of a drug derived from sources 
other than [randomized] traditional clinical trials.
  (c) Program Framework.--
          (1) In general.--Not later than 2 years after the 
        date of enactment of the 21st Century Cures Act, 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 sources of real world evidence, 
                including ongoing safety surveillance, 
                observational studies, registries, claims, and 
                patient-centered outcomes research activities;
                  (B) the gaps in data collection activities;
                  (C) the standards and methodologies for 
                collection and analysis of real world evidence; 
                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, consumer 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;
                          (ii) a contract, grant, or other 
                        arrangement, as the Secretary 
                        determines appropriate, with such a 
                        partnership or an independent research 
                        organization; or
                          (iii) public workshops with the 
                        entities described in such 
                        subparagraph.
  (d) Program Implementation.--The Secretary shall, not later 
than [2] 3 years after the date of enactment of the 21st 
Century Cures Act and in accordance with the framework 
established under subsection (c), implement the program to 
evaluate the potential use of real world evidence.
  (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 real world 
                evidence for the purposes described in 
                paragraphs (1) and (2) of subsection (a); and
                  (B) the appropriate standards and 
                methodologies for collection and analysis of 
                real world evidence submitted for such 
                purposes;
          (2) not later than 5 years after the date of 
        enactment of the 21st Century Cures Act, issue draft 
        guidance for industry as described in paragraph (1); 
        and
          (3) not later than 18 months after the close of the 
        public comment period for the draft guidance described 
        in paragraph (2), issue revised draft guidance or final 
        guidance.
  (f) Rule of Construction.--
          (1) In general.--Subject to paragraph (2), nothing in 
        this section prohibits the Secretary from using real 
        world evidence for purposes not specified in this 
        section, provided the Secretary determines that 
        sufficient basis exists for any such nonspecified use.
          (2) Standards of evidence and secretary's 
        authority.--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. 506G. STANDARDS FOR REGENERATIVE MEDICINE AND REGENERATIVE 
                    ADVANCED THERAPIES.

  (a) In General.--Not later than 2 years after the date of 
enactment of the 21st Century Cures Act, the Secretary, in 
consultation with the National Institute of Standards and 
Technology and stakeholders (including regenerative medicine 
and advanced therapies manufacturers and clinical trial 
sponsors, contract manufacturers, academic institutions, 
practicing clinicians, regenerative medicine and advanced 
therapies industry organizations, and standard setting 
organizations), shall facilitate an effort to coordinate and 
prioritize the development of standards and consensus 
definition of terms, through a public process, to support, 
through regulatory predictability, the development, evaluation, 
and review of regenerative medicine therapies and regenerative 
advanced therapies, including with respect to the manufacturing 
processes and controls of such products.
  (b) Activities.--
          (1) In general.--In carrying out this section, the 
        Secretary shall continue to--
                  (A) [identity] identify opportunities to help 
                advance the development of regenerative 
                medicine therapies and regenerative advanced 
                therapies;
                  (B) identify opportunities for the 
                development of laboratory regulatory science 
                research and documentary standards that the 
                Secretary determines would help support the 
                development, evaluation, and review of 
                regenerative medicine therapies and 
                regenerative advanced therapies through 
                regulatory predictability; and
                  (C) work with stakeholders, such as those 
                described in subsection (a), as appropriate, in 
                the development of such standards.
          (2) Regulations and guidance.--Not later than 1 year 
        after the development of standards as described in 
        subsection (a), the Secretary shall review relevant 
        regulations and guidance and, through a public process, 
        update such regulations and guidance as the Secretary 
        determines appropriate.
  (c) Definitions.--For purposes of this section, the terms 
``regenerative medicine therapy'' and ``regenerative advanced 
therapy'' have the meanings given such terms in section 506(g).

SEC. 506H. COMPETITIVE GENERIC THERAPIES.

  (a) In General.--The Secretary shall, at the request of the 
sponsor of a drug that is designated as a competitive generic 
therapy pursuant to subsection (b), expedite the development 
and review of such drug pursuant to section 505(j).
  (b) Designation Process.--
          (1) Request.--The sponsor of a drug may request the 
        Secretary to designate the drug as a competitive 
        generic therapy.
          (2) Timing.--A request under paragraph (1) may be 
        made concurrently with, or at any time prior to, the 
        submission of an abbreviated new drug application for 
        the drug under section 505(j).
          (3) Criteria.--A drug is eligible for designation as 
        a competitive generic therapy under this section if the 
        Secretary determines that there is inadequate generic 
        competition.
          (4) Designation.--Not later than 60 calendar days 
        after the receipt of a request under paragraph (1), the 
        Secretary shall--
                  (A) determine whether the drug that is the 
                subject of the request meets the criteria 
                described in paragraph (3); and
                  (B) if the Secretary finds that the drug 
                meets such criteria, designate the drug as a 
                competitive generic therapy.
  (c) Actions.--In expediting the development and review of a 
drug under subsection (a), the Secretary shall, as requested by 
the sponsor, take actions including the following:
          (1) Hold meetings with the sponsor and the review 
        team throughout the development of the drug prior to 
        submission of the application for such drug under 
        section 505(j).
          (2) Provide timely advice to, and interactive 
        communication with, the sponsor regarding the 
        development of the drug to ensure that the development 
        program to gather the data necessary for approval is as 
        efficient as practicable.
          (3) Involve senior managers and experienced review 
        staff, as appropriate, in a collaborative, coordinated 
        review, including with respect to drug-device 
        combination products and other complex products.
          (4) Assign a cross-disciplinary project lead for the 
        Food and Drug Administration review team--
                  (A) to facilitate an efficient review of the 
                development program and application, including 
                manufacturing inspections; and
                  (B) to serve as a scientific liaison between 
                the review team and the sponsor.
  (d) Definitions.--In this section:
          (1) The term ``generic drug'' means a drug that is 
        approved pursuant to section 505(j).
          (2) The term ``inadequate generic competition'' 
        means, with respect to a product, there is not more 
        than one approved drug product on the list of products 
        described in section 505(j)(7)(A) (not including 
        products on the discontinued section of such list) that 
        is--
                  (A) the reference listed drug; or
                  (B) a generic drug with the same reference 
                listed drug as the drug for which designation 
                as a competitive generic therapy is sought.
          (3) The term ``reference listed drug'' means the 
        listed drug (as such term is used in section 505(j)) 
        for the drug involved.

           *       *       *       *       *       *       *

  Sec. 510. (a) As used in this section--
          (1) the term ``manufacture, preparation, propagation, 
        compounding, or processing'' shall include repackaging 
        or otherwise changing the container, wrapper, or 
        labeling of any drug package or device package in 
        furtherance of the distribution of the drug or device 
        from the original place of manufacture to the person 
        who makes final delivery or sale to the ultimate 
        consumer or user; and
          (2) the term ``name'' shall include in the case of a 
        partnership the name of each partner and, in the case 
        of a corporation, the name of each corporate officer 
        and director, and the State of incorporation.
  (b)(1) During the period beginning on October 1 and ending on 
December 31 of each year, every person who owns or operates any 
establishment in any State engaged in the manufacture, 
preparation, propagation, compounding, or processing of a drug 
or drugs shall register with the Secretary the name of such 
person, places of business of such person, all such 
establishments, the unique facility identifier of each such 
establishment, and a point of contact e-mail address.
  (2) During the period beginning on October 1 and ending on 
December 31 of each year, every person who owns or operates any 
establishment in any State engaged in the manufacture, 
preparation, propagation, compounding, or processing of a 
device or devices shall register with the Secretary his name, 
places of business, and all such establishments.
  (3) The Secretary shall specify the unique facility 
identifier system that shall be used by registrants under 
paragraph (1). The requirement to include a unique facility 
identifier in a registration under paragraph (1) shall not 
apply until the date that the identifier system is specified by 
the Secretary under the preceding sentence.
  (c) Every person upon first engaging in the manufacture, 
preparation, propagation, compounding, or processing of a drug 
or drugs or a device or devices in any establishment which he 
owns or operates in any State shall immediately register with 
the Secretary--
          (1) with respect to drugs, the information described 
        under subsection (b)(1); and
          (2) with respect to devices, the information 
        described under subsection (b)(2)..
  (d) Every person duly registered in accordance with the 
foregoing subsections of this section shall immediately 
register with the Secretary any additional establishment which 
he owns or operates in any State and in which he begins the 
manufacture, preparation, propagation, compounding, or 
processing of a drug or drugs or a device or devices.
  (e) The Secretary may assign a registration number to any 
person or any establishment registered in accordance with this 
section. The Secretary may also assign a listing number to each 
drug or class of drugs listed under subsection (j). Any number 
assigned pursuant to the preceding sentence shall be the same 
as that assigned pursuant to the National Drug Code. The 
Secretary may by regulation prescribe a uniform system for the 
identification of devices intended for human use and may 
require that persons who are required to list such devices 
pursuant to subsection (j) shall list such devices in 
accordance with such system.
  (f) The Secretary shall make available for inspection, to any 
person so requesting, any registration filed pursuant to this 
section; except that any list submitted pursuant to paragraph 
(3) of subsection (j) and the information accompanying any list 
or notice filed under paragraph (1) or (2) of that subsection 
shall be exempt from such inspection unless the Secretary finds 
that such an exemption would be inconsistent with protection of 
the public health.
  (g) The foregoing subsections of this section shall not apply 
to--
          (1) pharmacies which maintain establishments in 
        conformance with any applicable local laws regulating 
        the practice of pharmacy and medicine and which are 
        regularly engaged in dispensing prescription drugs or 
        devices, upon prescriptions of practitioners licensed 
        to administer such drugs or devices to patients under 
        the care of such practitioners in the course of their 
        professional practice, and which do not manufacture, 
        prepare, propagate, compound, or process drugs or 
        devices for sale other than in the regular course of 
        their business of dispensing or selling drugs or 
        devices at retail;
          (2) practitioners licensed by law to prescribe or 
        administer drugs or devices and who manufacture, 
        prepare, propagate, compound, or process drugs or 
        devices solely for use in the course of their 
        professional practice;
          (3) persons who manufacture, prepare, propagate, 
        compound, or process drugs or devices solely for use in 
        research, teaching, or chemical analysis and not for 
        sale;
          (4) any distributor who acts as a wholesale 
        distributor of devices, and who does not manufacture, 
        repackage, process, or relabel a device; or
          (5) such other classes of persons as the Secretary 
        may by regulation exempt from the application of this 
        section upon a finding that registration by such 
        classes of persons in accordance with this section is 
        not necessary for the protection of the public health.
In this subsection, the term ``wholesale distributor'' means 
any person (other than the manufacturer or the initial 
importer) who distributes a device from the original place of 
manufacture to the person who makes the final delivery or sale 
of the device to the ultimate consumer or user.
  (h) Inspections.--
          (1) In general.--Every establishment that is required 
        to be registered with the Secretary under this section 
        shall be subject to inspection pursuant to section 704.
          [(2) Biennial inspections for devices.--Every 
        establishment described in paragraph (1), in any State, 
        that is engaged in the manufacture, propagation, 
        compounding, or processing of a device or devices 
        classified in class II or III shall be so inspected by 
        one or more officers or employees duly designated by 
        the Secretary, or by persons accredited to conduct 
        inspections under section 704(g), at least once in the 
        2-year period beginning with the date of registration 
        of such establishment pursuant to this section and at 
        least once in every successive 2-year period 
        thereafter.]
          (2) Risk-based schedule for devices.--
                  (A) In general.--The Secretary, acting 
                through one or more officers or employees duly 
                designated by the Secretary, shall inspect 
                establishments described in paragraph (1) that 
                are engaged in the manufacture, propagation, 
                compounding, or processing of a device or 
                devices (referred to in this subsection as 
                ``device establishments'') in accordance with a 
                risk-based schedule established by the 
                Secretary.
                  (B) Factors and considerations.--In 
                establishing the risk-based schedule under 
                subparagraph (A), the Secretary shall--
                          (i) apply, to the extent applicable 
                        for device establishments, the factors 
                        identified in paragraph (4); and
                          (ii) consider the participation of 
                        the device establishment, as 
                        applicable, in international device 
                        audit programs in which the United 
                        States participates or which the United 
                        States recognizes for purposes of 
                        inspecting device establishments.
          (3) Risk-based schedule for drugs.--The Secretary, 
        acting through one or more officers or employees duly 
        designated by the Secretary, shall inspect 
        establishments described in paragraph (1) that are 
        engaged in the manufacture, preparation, propagation, 
        compounding, or processing of a drug or drugs (referred 
        to in this subsection as ``drug establishments'') in 
        accordance with a risk-based schedule established by 
        the Secretary.
          (4) Risk factors.--In establishing a risk-based 
        schedule under paragraph (3), the Secretary shall 
        inspect establishments according to the known safety 
        risks of such establishments, which shall be based on 
        the following factors:
                  (A) The compliance history of the 
                establishment.
                  (B) The record, history, and nature of 
                recalls linked to the establishment.
                  (C) The inherent risk of the drug 
                manufactured, prepared, propagated, compounded, 
                or processed at the establishment.
                  (D) The inspection frequency and history of 
                the establishment, including whether the 
                establishment has been inspected pursuant to 
                section 704 within the last 4 years.
                  (E) Whether the establishment has been 
                inspected by a foreign government or an agency 
                of a foreign government recognized under 
                section 809.
                  (F) Any other criteria deemed necessary and 
                appropriate by the Secretary for purposes of 
                allocating inspection resources.
          (5) Effect of status.--In determining the risk 
        associated with an establishment for purposes of 
        establishing a risk-based schedule under paragraph (3), 
        the Secretary shall not consider whether the drugs 
        manufactured, prepared, propagated, compounded, or 
        processed by such establishment are drugs described in 
        section 503(b).
          (6) Annual report on inspections of establishments.--
        Beginning in 2014, not later than February 1 of each 
        year, the Secretary shall make available on the 
        Internet Web site of the Food and Drug Administration a 
        report regarding--
                  (A)(i) the number of domestic and foreign 
                establishments registered pursuant to this 
                section in the previous calendar year; and
                  (ii) the number of such domestic 
                establishments and the number of such foreign 
                establishments that the Secretary inspected in 
                the previous calendar year;
                  (B) with respect to establishments that 
                manufacture, prepare, propagate, compound, or 
                process an active ingredient of a drug or a 
                finished drug product, the number of each such 
                type of establishment; and
                  (C) the percentage of the budget of the Food 
                and Drug Administration used to fund the 
                inspections described under subparagraph (A).
  (i)(1) Every person who owns or operates any establishment 
within any foreign country engaged in the manufacture, 
preparation, propagation, compounding, or processing of a drug 
or device that is imported or offered for import into the 
United States shall, through electronic means in accordance 
with the criteria of the Secretary--
          (A) upon first engaging in any such activity, 
        immediately submit a registration to the Secretary that 
        includes--
                  (i) with respect to drugs, the name and place 
                of business of such person, all such 
                establishments, the unique facility identifier 
                of each such establishment, a point of contact 
                e-mail address, the name of the United States 
                agent of each such establishment, the name of 
                each importer of such drug in the United States 
                that is known to the establishment, and the 
                name of each person who imports or offers for 
                import such drug to the United States for 
                purposes of importation; and
                  (ii) with respect to devices, the name and 
                place of business of the establishment, the 
                name of the United States agent for the 
                establishment, the name of each importer of 
                such device in the United States that is known 
                to the establishment, and the name of each 
                person who imports or offers for import such 
                device to the United States for purposes of 
                importation; and
          (B) each establishment subject to the requirements of 
        subparagraph (A) shall thereafter register with the 
        Secretary during the period beginning on October 1 and 
        ending on December 31 of each year.
  (2) The establishment shall also provide the information 
required by subsection (j).
  (3) The Secretary is authorized to enter into cooperative 
arrangements with officials of foreign countries to ensure that 
adequate and effective means are available for purposes of 
determining, from time to time, whether drugs or devices 
manufactured, prepared, propagated, compounded, or processed by 
an establishment described in paragraph (1), if imported or 
offered for import into the United States, shall be refused 
admission on any of the grounds set forth in section 801(a).
  (4) The Secretary shall specify the unique facility 
identifier system that shall be used by registrants under 
paragraph (1) with respect to drugs. The requirement to include 
a unique facility identifier in a registration under paragraph 
(1) with respect to drugs shall not apply until the date that 
the identifier system is specified by the Secretary under the 
preceding sentence.
  (j)(1) Every person who registers with the Secretary under 
subsection (b), (c), (d), or (i) shall, at the time of 
registration under any such subsection, file with the Secretary 
a list of all drugs and a list of all devices and a brief 
statement of the basis for believing that each device included 
in the list is a device rather than a drug (with each drug and 
device in each list listed by its established name (as defined 
in section 502(e)) and by any proprietary name) which are being 
manufactured, prepared, propagated, compounded, or processed by 
him for commercial distribution and which he has not included 
in any list of drugs or devices filed by him with the Secretary 
under this paragraph or paragraph (2) before such time of 
registration. Such list shall be prepared in such form and 
manner as the Secretary may prescribe and shall be accompanied 
by--
          (A) in the case of a drug contained in the applicable 
        list and subject to section 505 or 512, or a device 
        intended for human use contained in the applicable list 
        with respect to which a performance standard has been 
        established under section 514 or which is subject to 
        section 515, a reference to the authority for the 
        marketing of such drug or device and a copy of all 
        labeling for such drug or device;
          (B) in the case of any other drug or device contained 
        in an applicable list--
                  (i) which drug is subject to section 
                503(b)(1), or which device is a restricted 
                device, a copy of all labeling for such drug or 
                device, a representative sampling of 
                advertisements for such drug or device, and, 
                upon request made by the Secretary for good 
                cause, a copy of all advertisements for a 
                particular drug product or device, or
                  (ii) which drug is not subject to section 
                503(b)(1) or which device is not a restricted 
                device, the label and package insert for such 
                drug or device and a representative sampling of 
                any other labeling for such drug or device;
          (C) in the case of any drug contained in an 
        applicable list which is described in subparagraph (B), 
        a quantitative listing of its active ingredient or 
        ingredients, except that with respect to a particular 
        drug product the Secretary may require the submission 
        of a quantitative listing of all ingredients if he 
        finds that such submission is necessary to carry out 
        the purposes of this Act;
          (D) if the registrant filing a list has determined 
        that a particular drug product or device contained in 
        such list is not subject to section 505 or 512, or the 
        particular device contained in such list is not subject 
        to a performance standard established under section 514 
        or to section 515 or is not a restricted device, a 
        brief statement of the basis upon which the registrant 
        made such determination if the Secretary requests such 
        a statement with respect to that particular drug 
        product or device; and
          (E) in the case of a drug contained in the applicable 
        list, the name and place of business of each 
        manufacturer of an excipient of the listed drug with 
        which the person listing the drug conducts business, 
        including all establishments used in the production of 
        such excipient, the unique facility identifier of each 
        such establishment, and a point of contact e-mail 
        address for each such excipient manufacturer.
  (2) Each person who registers with the Secretary under this 
section shall report to the Secretary, with regard to drugs 
once during the month of June of each year and once during the 
month of December of each year, and with regard to devices once 
each year during the period beginning on October 1 and ending 
on December 31, the following information:
          (A) A list of each drug or device introduced by the 
        registrant for commercial distribution which has not 
        been included in any list previously filed by him with 
        the Secretary under this subparagraph or paragraph (1) 
        of this subsection. A list under this subparagraph 
        shall list a drug or device by its established name (as 
        defined in section 502(e)) and by any proprietary name 
        it may have and shall be accompanied by the other 
        information required by paragraph (1).
          (B) If since the date the registrant last made a 
        report under this paragraph (or if he has not made a 
        report under this paragraph, since the effective date 
        of this subsection) he has discontinued the 
        manufacture, preparation, propagation, compounding, or 
        processing for commercial distribution of a drug or 
        device included in a list filed by him under 
        subparagraph (A) or paragraph (1); notice of such 
        discontinuance, the date of such discontinuance, and 
        the identity (by established name (as defined in 
        section 502(e)) and by any proprietary name) of such 
        drug or device.
          (C) If since the date the registrant reported 
        pursuant to subparagraph (B) a notice of discontinuance 
        he has resumed the manufacture, preparation, 
        propagation, compounding, or processing for commercial 
        distribution of the drug or device with respect to 
        which such notice of discontinuance was reported; 
        notice of such resumption, the date of such resumption, 
        the identity of such drug or device (by established 
        name (as defined in section 502(e)) and by any 
        proprietary name), and the other information required 
        by paragraph (1), unless the registrant has previously 
        reported such resumption to the Secretary pursuant to 
        this subparagraph.
          (D) Any material change in any information previously 
        submitted pursuant to this paragraph or paragraph (1).
  (3) The Secretary may also require each registrant under this 
section to submit a list of each drug product which (A) the 
registrant is manufacturing, preparing, propagating, 
compounding, or processing for commercial distribution, and (B) 
contains a particular ingredient. The Secretary may not require 
the submission of such a list unless he has made a finding that 
the submission of such a list is necessary to carry out the 
purposes of this Act.
  (4) The Secretary shall require persons subject to this 
subsection to use, for purposes of this subsection, the unique 
facility identifier systems specified under subsections (b)(3) 
and (i)(4) with respect to drugs. Such requirement shall not 
apply until the date that the identifier system under 
subsection (b)(3) or (i)(4), as applicable, is specified by the 
Secretary.
  (k) Each person who is required to register under this 
section and who proposes to begin the introduction or delivery 
for introduction into interstate commerce for commercial 
distribution of a device intended for human use shall, at least 
ninety days before making such introduction or delivery, report 
to the Secretary or person who is accredited under section 
523(a) (in such form and manner as the Secretary shall by 
regulation prescribe)--
          (1) the class in which the device is classified under 
        section 513 or if such person determines that the 
        device is not classified under such section, a 
        statement of that determination and the basis for such 
        person's determination that the device is or is not so 
        classified, and
          (2) action taken by such person to comply with 
        requirements under section 514 or 515 which are 
        applicable to the device.
A notification submitted under this subsection that contains 
clinical trial data for an applicable device clinical trial (as 
defined in section 402(j)(1) of the Public Health Service Act) 
shall be accompanied by the certification required under 
section 402(j)(5)(B) of such Act. Such certification shall not 
be considered an element of such notification.
  (l)(1) A report under subsection (k) is not required for a 
device intended for human use that is exempted from the 
requirements of this subsection under subsection (m) or is 
within a type that has been classified into class I under 
section 513. The exception established in the preceding 
sentence does not apply to any class I device that is intended 
for a use which is of substantial importance in preventing 
impairment of human health, or to any class I device that 
presents a potential unreasonable risk of illness or injury.
  (2) Not later than 120 calendar days after the date of 
enactment of the 21st Century Cures Act and at least once every 
5 years thereafter, as the Secretary determines appropriate, 
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.
  (m)(1) The Secretary shall--
                  (A) not later than 90 days after the date of 
                enactment of the 21st Century Cures Act and at 
                least once every 5 years thereafter, as the 
                Secretary determines appropriate--
                          (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 calendar days for public 
                        comment beginning on the date of the 
                        publication of such notice; and
                  (B) not later than 210 calendar days after 
                the date of enactment of the 21st Century Cures 
                Act, publish in the Federal Register a list 
                representing the Secretary's final 
                determination with respect to the devices 
                contained in the list published under 
                subparagraph (A).
  (2) Beginning on the date that is 1 calendar day after the 
date of publication of the final list under paragraph (1)(B), 
the Secretary may exempt a class II device from the requirement 
to submit a report under subsection (k), upon the Secretary's 
own initiative or a petition of an interested person, if the 
Secretary determines that such report is not necessary to 
assure the safety and effectiveness of the device. The 
Secretary shall publish in the Federal Register notice of the 
intent of the Secretary to exempt the device, or of the 
petition, and provide a 60-calendar-day period for public 
comment. Within 120 days after the issuance of the notice in 
the Federal Register, the Secretary shall publish an order in 
the Federal Register that sets forth the final determination of 
the Secretary regarding the exemption of the device that was 
the subject of the notice. If the Secretary fails to respond to 
a petition within 180 days of receiving it, the petition shall 
be deemed to be granted.
  (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.
  (n)(1) The Secretary shall review the report required in 
subsection (k) and make a determination under section 513(f)(1) 
not later than 90 days after receiving the report.
          (2)(A) Not later than 18 months after the date of 
        enactment of this paragraph, the Secretary 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 regarding 
        when a premarket notification under subsection (k) 
        should be submitted for a modification or change to a 
        legally marketed device. The report shall include the 
        Secretary's interpretation of the following terms: 
        ``could significantly affect the safety or 
        effectiveness of the device'', ``a significant change 
        or modification in design, material, chemical 
        composition, energy source, or manufacturing process'', 
        and ``major change or modification in the intended use 
        of the device''. The report also shall discuss possible 
        processes for industry to use to determine whether a 
        new submission under subsection (k) is required and 
        shall analyze how to leverage existing quality system 
        requirements to reduce premarket burden, facilitate 
        continual device improvement, and provide reasonable 
        assurance of safety and effectiveness of modified 
        devices. In developing such report, the Secretary shall 
        consider the input of interested stakeholders.
          (B) The Secretary shall withdraw the Food and Drug 
        Administration draft guidance entitled ``Guidance for 
        Industry and FDA Staff--510(k) Device Modifications: 
        Deciding When to Submit a 510(k) for a Change to an 
        Existing Device'', dated July 27, 2011, and shall not 
        use this draft guidance as part of, or for the basis 
        of, any premarket review or any compliance or 
        enforcement decisions or actions. The Secretary shall 
        not issue--
                  (i) any draft guidance or proposed regulation 
                that addresses when to submit a premarket 
                notification submission for changes and 
                modifications made to a manufacturer's 
                previously cleared device before the receipt by 
                the Committee on Energy and Commerce of the 
                House of Representatives and the Committee on 
                Health, Education, Labor, and Pensions of the 
                Senate of the report required in subparagraph 
                (A); and
                  (ii) any final guidance or regulation on that 
                topic for one year after date of receipt of 
                such report by the Committee on Energy and 
                Commerce of the House of Representatives and 
                the Committee on Health, Education, Labor, and 
                Pensions of the Senate.
          (C) The Food and Drug Administration guidance 
        entitled ``Deciding When to Submit a 510(k) for a 
        Change to an Existing Device'', dated January 10, 1997, 
        shall be in effect until the subsequent issuance of 
        guidance or promulgation, if appropriate, of a 
        regulation described in subparagraph (B), and the 
        Secretary shall interpret such guidance in a manner 
        that is consistent with the manner in which the 
        Secretary has interpreted such guidance since 1997.
  (o)(1) With respect to reprocessed single-use devices for 
which reports are required under subsection (k):
          (A) The Secretary shall identify such devices or 
        types of devices for which reports under such 
        subsection must, in order to ensure that the device is 
        substantially equivalent to a predicate device, include 
        validation data, the types of which shall be specified 
        by the Secretary, regarding cleaning and sterilization, 
        and functional performance demonstrating that the 
        single-use device will remain substantially equivalent 
        to its predicate device after the maximum number of 
        times the device is reprocessed as intended by the 
        person submitting the premarket notification. Within 
        six months after enactment of this subsection, the 
        Secretary shall publish in the Federal Register a list 
        of the types so identified, and shall revise the list 
        as appropriate. Reports under subsection (k) for 
        devices or types of devices within a type included on 
        the list are, upon publication of the list, required to 
        include such validation data.
          (B) In the case of each report under subsection (k) 
        that was submitted to the Secretary before the 
        publication of the initial list under subparagraph (A), 
        or any revision thereof, and was for a device or type 
        of device included on such list, the person who 
        submitted the report under subsection (k) shall submit 
        validation data as described in subparagraph (A) to the 
        Secretary not later than nine months after the 
        publication of the list. During such nine-month period, 
        the Secretary may not take any action under this Act 
        against such device solely on the basis that the 
        validation data for the device have not been submitted 
        to the Secretary. After the submission of the 
        validation data to the Secretary, the Secretary may not 
        determine that the device is misbranded under section 
        502(o) or adulterated under section 501(f)(1)(B), or 
        take action against the device under section 301(p) for 
        failure to provide any information required by 
        subsection (k) until (i) the review is terminated by 
        withdrawal of the submission of the report under 
        subsection (k); (ii) the Secretary finds the data to be 
        acceptable and issues a letter; or (iii) the Secretary 
        determines that the device is not substantially 
        equivalent to a predicate device. Upon a determination 
        that a device is not substantially equivalent to a 
        predicate device, or if such submission is withdrawn, 
        the device can no longer be legally marketed.
          (C) In the case of a report under subsection (k) for 
        a device identified under subparagraph (A) that is of a 
        type for which the Secretary has not previously 
        received a report under such subsection, the Secretary 
        may, in advance of revising the list under subparagraph 
        (A) to include such type, require that the report 
        include the validation data specified in subparagraph 
        (A).
          (D) Section 502(o) applies with respect to the 
        failure of a report under subsection (k) to include 
        validation data required under subparagraph (A).
  (2) With respect to critical or semi-critical reprocessed 
single-use devices that, under subsection (l) or (m), are 
exempt from the requirement of submitting reports under 
subsection (k):
          (A) The Secretary shall identify such devices or 
        types of devices for which such exemptions should be 
        terminated in order to provide a reasonable assurance 
        of the safety and effectiveness of the devices. The 
        Secretary shall publish in the Federal Register a list 
        of the devices or types of devices so identified, and 
        shall revise the list as appropriate. The exemption for 
        each device or type included on the list is terminated 
        upon the publication of the list. For each report under 
        subsection (k) submitted pursuant to this subparagraph 
        the Secretary shall require the validation data 
        described in paragraph (1)(A).
          (B) For each device or type of device included on the 
        list under subparagraph (A), a report under subsection 
        (k) shall be submitted to the Secretary not later than 
        15 months after the publication of the initial list, or 
        a revision of the list, whichever terminates the 
        exemption for the device. During such 15-month period, 
        the Secretary may not take any action under this Act 
        against such device solely on the basis that such 
        report has not been submitted to the Secretary. After 
        the submission of the report to the Secretary the 
        Secretary may not determine that the device is 
        misbranded under section 502(o) or adulterated under 
        section 501(f)(1)(B), or take action against the device 
        under section 301(p) for failure to provide any 
        information required by subsection (k) until (i) the 
        review is terminated by withdrawal of the submission; 
        (ii) the Secretary determines by order that the device 
        is substantially equivalent to a predicate device; or 
        (iii) the Secretary determines by order that the device 
        is not substantially equivalent to a predicate device. 
        Upon a determination that a device is not substantially 
        equivalent to a predicate device, the device can no 
        longer be legally marketed.
          (C) In the case of semi-critical devices, the initial 
        list under subparagraph (A) shall be published not 
        later than 18 months after the effective date of this 
        subsection. In the case of critical devices, the 
        initial list under such subparagraph shall be published 
        not later than six months after such effective date.
          (D) Section 502(o) applies with respect to the 
        failure to submit a report under subsection (k) that is 
        required pursuant to subparagraph (A), including a 
        failure of the report to include validation data 
        required in such subparagraph.
          (E) The termination under subparagraph (A) of an 
        exemption under subsection (l) or (m) for a critical or 
        semi-critical reprocessed single-use device does not 
        terminate the exemption under subsection (l) or (m) for 
        the original device.
  (p) Electronic Registration and Listing.--
          (1) In general.--Registrations and listings under 
        this section (including the submission of updated 
        information) shall be submitted to the Secretary by 
        electronic means unless the Secretary grants a request 
        for waiver of such requirement because use of 
        electronic means is not reasonable for the person 
        requesting such waiver.
          (2) Electronic database.--Not later than 2 years 
        after the Secretary specifies a unique facility 
        identifier system under subsections (b) and (i), the 
        Secretary shall maintain an electronic database, which 
        shall not be subject to inspection under subsection 
        (f), populated with the information submitted as 
        described under paragraph (1) that--
                  (A) enables personnel of the Food and Drug 
                Administration to search the database by any 
                field of information submitted in a 
                registration described under paragraph (1), or 
                combination of such fields; and
                  (B) uses the unique facility identifier 
                system to link with other relevant databases 
                within the Food and Drug Administration, 
                including the database for submission of 
                information under section 801(r).
          (3) Risk-based information and coordination.--The 
        Secretary shall ensure the accuracy and coordination of 
        relevant Food and Drug Administration databases in 
        order to identify and inform risk-based inspections 
        under section 510(h).
  (q) Reusable Medical Devices.--
          (1) In general.--Not later than 180 days after the 
        date of enactment of the 21st Century Cures Act, the 
        Secretary shall identify and publish a list of reusable 
        device types for which reports under subsection (k) are 
        required to include--
                  (A) instructions for use, which have been 
                validated in a manner specified by the 
                Secretary; and
                  (B) validation data, the types of which shall 
                be specified by the Secretary;
        regarding cleaning, disinfection, and sterilization, 
        and for which a substantial equivalence determination 
        may be based.
          (2) Revision of list.--The Secretary shall revise the 
        list under paragraph (2), as the Secretary determines 
        appropriate, with notice in the Federal Register.
          (3) Content of reports.--Reports under subsection (k) 
        that are submitted after the publication of the list 
        described in paragraph (1), for devices or types of 
        devices included on such list, shall include such 
        instructions for use and validation data.

           *       *       *       *       *       *       *


            classification of devices intended for human use

                             Device Classes

  Sec. 513. (a)(1) There are established the following classes 
of devices intended for human use:
          (A) Class I, General Controls.--
                  (i) A device for which the controls 
                authorized by or under section 501, 502, 510, 
                516, 518, 519, or 520 or any combination of 
                such sections are sufficient to provide 
                reasonable assurance of the safety and 
                effectiveness of the device.
                  (ii) A device for which insufficient 
                information exists to determine that the 
                controls referred to in clause (i) are 
                sufficient to provide reasonable assurance of 
                the safety and effectiveness of the device or 
                to establish special controls to provide such 
                assurance, but because it--
                          (I) is not purported or represented 
                        to be for a use in supporting or 
                        sustaining human life or for a use 
                        which is of substantial importance in 
                        preventing impairment of human health, 
                        and
                          (II) does not present a potential 
                        unreasonable risk of illness or injury,
                is to be regulated by the controls referred to 
                in clause (i).
          (B) Class ii, special controls.--A device which 
        cannot be classified as a class I device because the 
        general controls by themselves are insufficient to 
        provide reasonable assurance of the safety and 
        effectiveness of the device, and for which there is 
        sufficient information to establish special controls to 
        provide such assurance, including the promulgation of 
        performance standards, postmarket surveillance, patient 
        registries, development and dissemination of guidelines 
        (including guidelines for the submission of clinical 
        data in premarket notification submissions in 
        accordance with section 510(k)), recommendations, and 
        other appropriate actions as the Secretary deems 
        necessary to provide such assurance. For a device that 
        is purported or represented to be for a use in 
        supporting or sustaining human life, the Secretary 
        shall examine and identify the special controls, if 
        any, that are necessary to provide adequate assurance 
        of safety and effectiveness and describe how such 
        controls provide such assurance.
          (C) Class III, Premarket Approval.--A device which 
        because--
                  (i) it (I) cannot be classified as a class I 
                device because insufficient information exists 
                to determine that the application of general 
                controls are sufficient to provide reasonable 
                assurance of the safety and effectiveness of 
                the device, and (II) cannot be classified as a 
                class II device because insufficient 
                information exists to determine that the 
                special controls described in subparagraph (B) 
                would provide reasonable assurance of its 
                safety and effectiveness, and
                  (ii)(I) is purported or represented to be for 
                a use in supporting or sustaining human life or 
                for a use which is of substantial importance in 
                preventing impairment of human health, or
                  (II) presents a potential unreasonable risk 
                of illness or injury,
        is to be subject, in accordance with section 515, to 
        premarket approval to provide reasonable assurance of 
        its safety and effectiveness.
If there is not sufficient information to establish a 
performance standard for a device to provide reasonable 
assurance of its safety and effectiveness, the Secretary may 
conduct such activities as may be necessary to develop or 
obtain such information.
  (2) For purposes of this section and sections 514 and 515, 
the safety and effectiveness of a device are to be determined--
          (A) with respect to the persons for whose use the 
        device is represented or intended,
          (B) with respect to the conditions of use prescribed, 
        recommended, or suggested in the labeling of the 
        device, and
          (C) weighing any probable benefit to health from the 
        use of the device against any probable risk of injury 
        or illness from such use.
  (3)(A) Except as authorized by subparagraph (B), the 
effectiveness of a device is, for purposes of this section and 
sections 514 and 515, to be determined, in accordance with 
regulations promulgated by the Secretary, on the basis of well-
controlled investigations, including 1 or more clinical 
investigations where appropriate, by experts qualified by 
training and experience to evaluate the effectiveness of the 
device, from which investigations it can fairly and responsibly 
be concluded by qualified experts that the device will have the 
effect it purports or is represented to have under the 
conditions of use prescribed, recommended, or suggested in the 
labeling of the device.
  (B) If the Secretary determines that there exists valid 
scientific evidence (other than evidence derived from 
investigations described in subparagraph (A))--
          (i) which is sufficient to determine the 
        effectiveness of a device, and
          (ii) from which it can fairly and responsibly be 
        concluded by qualified experts that the device will 
        have the effect it purports or is represented to have 
        under the conditions of use prescribed, recommended, or 
        suggested in the labeling of the device,
then, for purposes of this section and sections 514 and 515, 
the Secretary may authorize the effectiveness of the device to 
be determined on the basis of such evidence.
  (C) In making a determination of a reasonable assurance of 
the effectiveness of a device for which an application under 
section 515 has been submitted, the Secretary shall consider 
whether the extent of data that otherwise would be required for 
approval of the application with respect to effectiveness can 
be reduced through reliance on postmarket controls.
  (D)(i) The Secretary, upon the written request of any person 
intending to submit an application under section 515, shall 
meet with such person to determine the type of valid scientific 
evidence (within the meaning of subparagraphs (A) and (B)) that 
will be necessary to demonstrate for purposes of approval of an 
application the effectiveness of a device for the conditions of 
use proposed by such person. The written request shall include 
a detailed description of the device, a detailed description of 
the proposed conditions of use of the device, a proposed plan 
for determining whether there is a reasonable assurance of 
effectiveness, and, if available, information regarding the 
expected performance from the device. Within 30 days after such 
meeting, the Secretary shall specify in writing the type of 
valid scientific evidence that will provide a reasonable 
assurance that a device is effective under the conditions of 
use proposed by such person.
  (ii) Any clinical data, including one or more well-controlled 
investigations, specified in writing by the Secretary for 
demonstrating a reasonable assurance of device effectiveness 
shall be specified as result of a determination by the 
Secretary that such data are necessary to establish device 
effectiveness. The Secretary shall consider, in consultation 
with the applicant, the least burdensome appropriate means of 
evaluating device effectiveness that would have a reasonable 
likelihood of resulting in approval.
  (iii) For purposes of clause (ii), the term ``necessary'' 
means the minimum required information that would support a 
determination by the Secretary that an application provides 
reasonable assurance of the effectiveness of the device.
  (iv) Nothing in this subparagraph shall alter the criteria 
for evaluating an application for premarket approval of a 
device.
  (v) The determination of the Secretary with respect to the 
specification of valid scientific evidence under clauses (i) 
and (ii) shall be binding upon the Secretary, unless such 
determination by the Secretary could be contrary to the public 
health.

                 Classification; Classification Panels

  (b)(1) For purposes of--
          (A) determining which devices intended for human use 
        should be subject to the requirements of general 
        controls, performance standards, or premarket approval, 
        and
          (B) providing notice to the manufacturers and 
        importers of such devices to enable them to prepare for 
        the application of such requirements to devices 
        manufactured or imported by them,
the Secretary shall classify all such devices (other than 
devices classified by subsection (f)) into the classes 
established by subsection (a). For the purpose of securing 
recommendations with respect to the classification of devices, 
the Secretary shall establish panels of experts or use panels 
of experts established before the date of the enactment of this 
section, or both. Section 14 of the Federal Advisory Committee 
Act shall not apply to the duration of a panel established 
under this paragraph.
  (2) The Secretary shall appoint to each panel established 
under paragraph (1) persons who are qualified by training and 
experience to evaluate the safety and effectiveness of the 
devices to be referred to the panel and who, to the extent 
feasible, possess skill in the use of, or experience in the 
development, manufacture, or utilization of, such devices. The 
Secretary shall make appointments to each panel so that each 
panel shall consist of members with adequately diversified 
expertise in such fields as clinical and administrative 
medicine, engineering, biological and physical sciences, and 
other related professions. In addition, each panel shall 
include as nonvoting members a representative of consumer 
interests and a representative of interests of the device 
manufacturing industry. Scientific, trade, and consumer 
organizations shall be afforded an opportunity to nominate 
individuals for appointment to the panels. No individual who is 
in the regular full-time employ of the United States and 
engaged in the administration of this Act may be a member of 
any panel. The Secretary shall designate one of the members of 
each panel to serve as chairman thereof.
  (3) Panel members (other than officers or employees of the 
United States), while attending meetings or conferences of a 
panel or otherwise engaged in its business, shall be entitled 
to receive compensation at rates to be fixed by the Secretary, 
but not at rates exceeding the daily equivalent of the rate in 
effect for grade GS-18 of the General Schedule, for each day so 
engaged, including traveltime; and while so serving away from 
their homes or regular places of business each member may be 
allowed travel expenses (including per diem in lieu of 
subsistence) as authorized by section 5703 of title 5, United 
States Code, for persons in the Government service employed 
intermittently.
  (4) The Secretary shall furnish each panel with adequate 
clerical and other necessary assistance.
  (5)(A) Classification panels covering each type of device 
shall be scheduled to meet at such times as may be appropriate 
for the Secretary to meet applicable statutory deadlines.
  (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) provide an opportunity for the person whose 
        device is specifically the subject of panel review to 
        provide recommendations on the expertise needed among 
        the voting members of the panel.
  (C) For purposes of subparagraph (B)(i), the term ``adequate 
expertise'' means that the membership of the classification 
panel 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.
  (D) The Secretary shall provide an annual opportunity for 
patients, representatives of patients, and sponsors of [medical 
device submissions] medical devices that may be specifically 
the subject of a review by a classification panel to provide 
recommendations for individuals with appropriate expertise to 
fill voting member positions on classification panels.
  (6)(A) Any person whose device is specifically the subject of 
review by a classification panel shall have--
          (i) the same access to data and information submitted 
        to a classification panel (except for data and 
        information that are not available for public 
        disclosure under section 552 of title 5, United States 
        Code) as the Secretary;
          (ii) the opportunity to submit, for review by a 
        classification panel, information that is based on the 
        data or information provided in the application 
        submitted under section 515 by the person, which 
        information shall be submitted to the Secretary for 
        prompt transmittal to the classification panel; and
          (iii) the same opportunity as the Secretary to 
        participate in meetings of the panel, including, 
        subject to the discretion of the panel chairperson, by 
        designating a representative who will be provided a 
        time during the panel meeting to address the panel for 
        the purpose of correcting misstatements of fact or 
        providing clarifying information, and permitting the 
        person or representative to call on experts within the 
        person's organization to address such specific issues 
        in the time provided.
  (B)(i) Any meeting of a classification panel with respect to 
the review of a device shall--
          (I) provide adequate time for initial presentations 
        by the person whose device is specifically the subject 
        of such 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.
  (7) After receiving from a classification panel the 
conclusions and recommendations of the panel on a matter that 
the panel has reviewed, the Secretary shall review the 
conclusions and recommendations, shall make a final decision on 
the matter in accordance with section 515(d)(2), and shall 
notify the affected persons of the decision in writing and, if 
the decision differs from the conclusions and recommendations 
of the panel, shall include the reasons for the difference.
  (8) A classification panel under this subsection shall not be 
subject to the annual chartering and annual report requirements 
of the Federal Advisory Committee Act.
  [(9) The Secretary shall classify an accessory under this 
section based on the intended use of the accessory, 
notwithstanding the classification of any other device with 
which such accessory is intended to be used.]

            Classification Panel Organization and Operation

  (c)(1) The Secretary shall organize the panels according to 
the various fields of clinical medicine and fundamental 
sciences in which devices intended for human use are used. The 
Secretary shall refer a device to be classified under this 
section to an appropriate panel established or authorized to be 
used under subsection (b) for its review and for its 
recommendation respecting the classification of the device. The 
Secretary shall by regulation prescribe the procedure to be 
followed by the panels in making their reviews and 
recommendations. In making their reviews of devices, the 
panels, to the maximum extent practicable, shall provide an 
opportunity for interested persons to submit data and views on 
the classification of the devices.
  (2)(A) Upon completion of a panel's review of a device 
referred to it under paragraph (1), the panel shall, subject to 
subparagraphs (B) and (C), submit to the Secretary its 
recommendation for the classification of the device. Any such 
recommendation shall (i) contain (I) a summary of the reasons 
for the recommendation, (II) a summary of the data upon which 
the recommendation is based, and (III) an identification of the 
risks to health (if any) presented by the device with respect 
to which the recommendation is made, and (ii) to the extent 
practicable, include a recommendation for the assignment of a 
priority for the application of the requirements of section 514 
or 515 to a device recommended to be classified in class II or 
class III.
  (B) A recommendation of a panel for the classification of a 
device in class I shall include a recommendation as to whether 
the device should be exempted from the requirements of section 
510, 519, or 520(f).
  (C) In the case of a device which has been referred under 
paragraph (1) to a panel, and which--
          (i) is intended to be implanted in the human body or 
        is purported or represented to be for a use in 
        supporting or sustaining human life, and
          (ii)(I) has been introduced or delivered for 
        introduction into interstate commerce for commercial 
        distribution before the date of enactment of this 
        section, or
          (II) is within a type of device which was so 
        introduced or delivered before such date and is 
        substantially equivalent to another device within that 
        type,
such panel shall recommend to the Secretary that the device be 
classified in class III unless the panel determines that 
classification of the device in such class is not necessary to 
provide reasonable assurance of its safety and effectiveness. 
If a panel does not recommend that such a device be classified 
in class III, it shall in its recommendation to the Secretary 
for the classification of the device set forth the reasons for 
not recommending classification of the device in such class.
  (3) The panels shall submit to the Secretary within one year 
of the date funds are first appropriated for the implementation 
of this section their recommendations respecting all devices of 
a type introduced or delivered for introduction into interstate 
commerce for commercial distribution before the date of the 
enactment of this section.

                             Classification

  (d)(1) Upon receipt of a recommendation from a panel 
respecting a device, the Secretary shall publish in the Federal 
Register the panel's recommendation and a proposed regulation 
classifying such device and shall provide interested persons an 
opportunity to submit comments on such recommendation and the 
proposed regulation. After reviewing such comments, the 
Secretary shall, subject to paragraph (2), by regulation 
classify such device.
  (2)(A) A regulation under paragraph (1) classifying a device 
in class I shall prescribe which, if any, of the requirements 
of section 510, 519 or 520(f) shall not apply to the device. A 
regulation which makes a requirement of section 510, 519, or 
520(f) inapplicable to a device shall be accompanied by a 
statement of the reasons of the Secretary for making such 
requirement inapplicable.
  (B) A device described in subsection (c)(2)(C) shall be 
classified in class III unless the Secretary determines that 
classification of the device in such class is not necessary to 
provide reasonable assurance of its safety and effectiveness. A 
proposed regulation under paragraph (1) classifying such a 
device in a class other than class III shall be accompanied by 
a full statement of the reasons of the Secretary (and 
supporting documentation and data) for not classifying such 
device in such class and an identification of the risks to 
health (if any) presented by such device.
  (3) In the case of devices classified in class II and devices 
classified under this subsection in class III and described in 
section 515(b)(1) the Secretary may establish priorities which, 
in his discretion, shall be used in applying sections 514 and 
515, as appropriate, to such devices.

                         Classification Changes

  (e)(1)(A)(i) Based on new information respecting a device, 
the Secretary may, upon the initiative of the Secretary or upon 
petition of an interested person, change the classification of 
such device, and revoke, on account of the change in 
classification, any regulation or requirement in effect under 
section 514 or 515 with respect to such device, by 
administrative order published in the Federal Register 
following publication of a proposed reclassification order in 
the Federal Register, a meeting of a device classification 
panel described in subsection (b), and consideration of 
comments to a public docket, notwithstanding subchapter II of 
chapter 5 of title 5, United States Code. The proposed 
reclassification order published in the Federal Register shall 
set forth the proposed reclassification, and a substantive 
summary of the valid scientific evidence concerning the 
proposed reclassification, including--
          (I) the public health benefit of the use of the 
        device, and the nature and, if known, incidence of the 
        risk of the device;
          (II) in the case of a reclassification from class II 
        to class III, why general controls pursuant to 
        subsection (a)(1)(A) and special controls pursuant to 
        subsection (a)(1)(B) together are not sufficient to 
        provide a reasonable assurance of safety and 
        effectiveness for such device; and
          (III) in the case of reclassification from class III 
        to class II, why general controls pursuant to 
        subsection (a)(1)(A) and special controls pursuant to 
        subsection (a)(1)(B) together are sufficient to provide 
        a reasonable assurance of safety and effectiveness for 
        such device.
  (ii) An order under this subsection changing the 
classification of a device from class III to class II may 
provide that such classification shall not take effect until 
the effective date of a performance standard established under 
section 514 for such device.
  (B) Authority to issue such administrative order shall not be 
delegated below the Director of the Center for Devices and 
Radiological Health, acting in consultation with the 
Commissioner.
  (2) By an order issued under paragraph (1), the Secretary may 
change the classification of a device from class III--
          (A) to class II if the Secretary determines that 
        special controls would provide reasonable assurance of 
        the safety and effectiveness of the device and that 
        general controls would not provide reasonable assurance 
        of the safety and effectiveness of the device, or
          (B) to class I if the Secretary determines that 
        general controls would provide reasonable assurance of 
        the safety and effectiveness of the device.

     Initial Classification and Reclassification of Certain Devices

  (f)(1) Any device intended for human use which was not 
introduced or delivered for introduction into interstate 
commerce for commercial distribution before the date of the 
enactment of this section is classified in class III unless--
          (A) the device--
                  (i) is within a type of device (I) which was 
                introduced or delivered for introduction into 
                interstate commerce for commercial distribution 
                before such date and which is to be classified 
                pursuant to subsection (b), or (II) which was 
                not so introduced or delivered before such date 
                and has been classified in class I or II, and
                  (ii) is substantially equivalent to another 
                device within such type;
          (B) the Secretary in response to a petition submitted 
        under paragraph (3) has classified such device in class 
        I or II; or
          (C) the device is classified pursuant to a request 
        submitted under paragraph (2).
A device classified in class III under this paragraph shall be 
classified in that class until the effective date of an order 
of the Secretary under paragraph (2) or (3) classifying the 
device in class I or II.
  (2)(A)(i) Any person who submits a report under section 
510(k) for a type of device that has not been previously 
classified under this Act, and that is classified into class 
III under paragraph (1), may request, after receiving written 
notice of such a classification, the Secretary to classify the 
device.
  (ii) In lieu of submitting a report under section 510(k) and 
submitting a request for classification under clause (i) for a 
device, if a person determines there is no legally marketed 
device upon which to base a determination of substantial 
equivalence (as defined in subsection (i)), a person may submit 
a request under this clause for the Secretary to classify the 
device.
  (iii) Upon receipt of a request under clause (i) or (ii), the 
Secretary shall classify the device subject to the request 
under the criteria set forth in subparagraphs (A) through (C) 
of subsection (a)(1) within 120 days.
  (iv) Notwithstanding clause (iii), the Secretary may decline 
to undertake a classification request submitted under clause 
(ii) if the Secretary identifies a legally marketed device that 
could provide a reasonable basis for review of substantial 
equivalence under paragraph (1), or when the Secretary 
determines that the device submitted is not of low to moderate 
risk or that general controls would be inadequate to control 
the risks and special controls to mitigate the risks cannot be 
developed.
  (v) The person submitting the request for classification 
under this subparagraph may recommend to the Secretary a 
classification for the device and shall, if recommending 
classification in class II, include in the request an initial 
draft proposal for applicable special controls, as described in 
subsection (a)(1)(B), that are necessary, in conjunction with 
general controls, to provide reasonable assurance of safety and 
effectiveness and a description of how the special controls 
provide such assurance. Any such request shall describe the 
device and provide detailed information and reasons for the 
recommended classification.
  (B)(i) The Secretary shall by written order classify the 
device involved. Such classification shall be the initial 
classification of the device for purposes of paragraph (1) and 
any device classified under this paragraph shall be a predicate 
device for determining substantial equivalence under paragraph 
(1).
  (ii) A device that remains in class III under this 
subparagraph shall be deemed to be adulterated within the 
meaning of section 501(f)(1)(B) until approved under section 
515 or exempted from such approval under section 520(g).
  (C) Within 30 days after the issuance of an order classifying 
a device under this paragraph, the Secretary shall publish a 
notice in the Federal Register announcing such classification.
  (3)(A) The Secretary may initiate the reclassification of a 
device classified into class III under paragraph (1) of this 
subsection or the manufacturer or importer of a device 
classified under paragraph (1) may petition the Secretary (in 
such form and manner as he shall prescribe) for the issuance of 
an order classifying the device in class I or class II. Within 
thirty days of the filing of such a petition, the Secretary 
shall notify the petitioner of any deficiencies in the petition 
which prevent the Secretary from making a decision on the 
petition.
  (B)(i) Upon determining that a petition does not contain any 
deficiency which prevents the Secretary from making a decision 
on the petition, the Secretary may for good cause shown refer 
the petition to an appropriate panel established or authorized 
to be used under subsection (b). A panel to which such a 
petition has been referred shall not later than ninety days 
after the referral of the petition make a recommendation to the 
Secretary respecting approval or denial of the petition. Any 
such recommendation shall contain (I) a summary of the reasons 
for the recommendation, (II) a summary of the data upon which 
the recommendation is based, and (III) an identification of the 
risks to health (if any) presented by the device with respect 
to which the petition was filed. In the case of a petition for 
a device which is intended to be implanted in the human body or 
which is purported or represented to be for a use in supporting 
or sustaining human life, the panel shall recommend that the 
petition be denied unless the panel determines that the 
classification in class III of the device is not necessary to 
provide reasonable assurance of its safety and effectiveness. 
If the panel recommends that such petition be approved, it 
shall in its recommendation to the Secretary set forth its 
reasons for such recommendation.
  (ii) The requirements of paragraphs (1) and (2) of subsection 
(c) (relating to opportunities for submission of data and views 
and recommendations respecting priorities and exemptions from 
sections 510, 519, and 520(f)) shall apply with respect to 
consideration by panels of petitions submitted under 
subparagraph (A).
  (C)(i) Within ninety days from the date the Secretary 
receives the recommendation of a panel respecting a petition 
(but not later than 210 days after the filing of such petition) 
the Secretary shall by order deny or approve the petition. If 
the Secretary approves the petition, the Secretary shall order 
the classification of the device into class I or class II in 
accordance with the criteria prescribed by subsection (a)(1)(A) 
or (a)(1)(B). In the case of a petition for a device which is 
intended to be implanted in the human body or which is 
purported or represented to be for a use in supporting or 
sustaining human life, the Secretary shall deny the petition 
unless the Secretary determines that the classification in 
class III of the device is not necessary to provide reasonable 
assurance of its safety and effectiveness. An order approving 
such petition shall be accompanied by a full statement of the 
reasons of the Secretary (and supporting documentation and 
data) for approving the petition and an identification of the 
risks to health (if any) presented by the device to which such 
order applies.
  (ii) The requirements of paragraphs (1) and (2)(A) of 
subsection (d) (relating to publication of recommendations, 
opportunity for submission of comments, and exemption from 
sections 510, 519, and 520(f)) shall apply with respect to 
action by the Secretary on petitions submitted under 
subparagraph (A).
  (4) If a manufacturer reports to the Secretary under section 
510(k) that a device is substantially equivalent to another 
device--
          (A) which the Secretary has classified as a class III 
        device under subsection (b),
          (B) which was introduced or delivered for 
        introduction into interstate commerce for commercial 
        distribution before December 1, 1990, and
          (C) for which no final regulation requiring premarket 
        approval has been promulgated under section 515(b),
the manufacturer shall certify to the Secretary that the 
manufacturer has conducted a reasonable search of all 
information known or otherwise available to the manufacturer 
respecting such other device and has included in the report 
under section 510(k) a summary of and a citation to all adverse 
safety and effectiveness data respecting such other device and 
respecting the device for which the section 510(k) report is 
being made and which has not been submitted to the Secretary 
under section 519. The Secretary may require the manufacturer 
to submit the adverse safety and effectiveness data described 
in the report.
  (5) The Secretary may not withhold a determination of the 
initial classification of a device under paragraph (1) because 
of a failure to comply with any provision of this Act unrelated 
to a substantial equivalence decision, including a finding that 
the facility in which the device is manufactured is not in 
compliance with good manufacturing requirements as set forth in 
regulations of the Secretary under section 520(f) (other than a 
finding that there is a substantial likelihood that the failure 
to comply with such regulations will potentially present a 
serious risk to human health).
  (6)(A) Subject to the succeeding subparagraphs of this 
paragraph, the Secretary shall, by written order, classify an 
accessory under this section based on the risks of the 
accessory when used as intended and the level of regulatory 
controls necessary to provide a reasonable assurance of safety 
and effectiveness of the accessory, notwithstanding the 
classification of any other device with which such accessory is 
intended to be used.
  (B) The classification of any accessory distinct from another 
device by regulation or written order issued prior to December 
13, 2016, shall continue to apply unless and until the 
accessory is reclassified by the Secretary, notwithstanding the 
classification of any other device with which such accessory is 
intended to be used. Nothing in this section shall preclude the 
Secretary's ability to initiate the classification of an 
accessory through regulation or written order, as appropriate.
  (C)(i) In the case of an accessory that has been granted 
marketing authorization as part of a submission under section 
515(c), 510(k), or paragraph (2) of this subsection with 
another device with which such accessory is intended to be 
used, and with respect to which the Secretary has issued a 
written order classifying such accessory type distinct from 
another device in accordance with subparagraph (A), the 
manufacturer or importer of such accessory may, in lieu of 
submitting a request for classification of such accessory, 
submit a written request to the Secretary identifying such 
classification. A request under this clause shall include such 
information to support the request as may be specified by the 
Secretary.
  (ii) A request under clause (i) shall include a 
recommendation for the proper classification of the accessory 
pursuant to subparagraph (A), and shall include such 
information as may be necessary for the Secretary to evaluate, 
based on the least burdensome approach, the appropriate class 
for the accessory under subsection (a).
  (iii) The Secretary shall respond to a request under clause 
(i) within 90 calendar days by granting or denying the request 
for reclassification of the accessory.
  (iv) Within 30 calendar days after granting a request 
submitted under clause (i), the Secretary shall publish a 
notice in the Federal Register announcing such response.
  (v) A written notification that the Secretary disagrees with 
the classification recommended in a request pursuant to clause 
(ii) shall include a detailed description and justification for 
the determination to disagree.
  (D)(i) In the case of a device intended to be used with an 
accessory, where the accessory has been included in an 
application for premarket approval of such device under section 
515 or a report under section 510(k) for clearance of such 
device and the Secretary has not classified such accessory 
distinctly from another device in accordance with subparagraph 
(A), the person filing the application or report (as 
applicable) at the time such application or report is filed--
          (I) may include a written request for the proper 
        classification of the accessory pursuant to 
        subparagraph (A);
          (II) shall include in any such request such 
        information as may be necessary for the Secretary to 
        evaluate, based on the least burdensome approach, the 
        appropriate class for the accessory under subsection 
        (a); and
          (III) shall, if the request under subclause (I) is 
        requesting classification of the accessory in class II, 
        include in the application an initial draft proposal 
        for special controls, if special controls would be 
        required pursuant to subsection (a)(1)(B).
  (ii) The Secretary's response under section 515(d) or section 
510(n) (as applicable) to an application or report described in 
clause (i) shall also contain the Secretary's granting or 
denial of the request for classification of the accessory 
involved.
  (iii) The Secretary's evaluation of an accessory under clause 
(i) shall constitute an order establishing a new classification 
for such accessory for the specified intended use or uses of 
such accessory and for any accessory with the same intended use 
or uses as such accessory.
  (E) For accessories that have been granted marketing 
authorization as part of a submission for another device with 
which the accessory involved is intended to be used, through an 
application for such other device under section 515(c), a 
report under section 510(k), or a request for classification 
under paragraph (2) of this subsection, and that have not been 
classified by the Secretary based on the risks and appropriate 
level of regulatory controls in accordance with subparagraph 
(A):
          (i) Not later than the date that is one year after 
        the date of enactment of the FDA Reauthorization Act of 
        2017 and at least once every 5 years thereafter, and as 
        the Secretary otherwise deems appropriate, pursuant to 
        this paragraph, the Secretary shall publish in the 
        Federal Register a notice proposing a list of such 
        accessories that the Secretary believes may be suitable 
        for a distinct classification in class I and the 
        proposed regulations for such classifications. In 
        developing such lists, the Secretary shall consider 
        recommendations from sponsors of device submissions and 
        other stakeholders for accessories to be included on 
        such lists. The notices shall provide for a period of 
        not less than 60 calendar days for public comment. 
        Within 180 days after the end of the comment period, 
        the Secretary shall publish in the Federal Register a 
        final action classifying such suitable accessories into 
        class I.
          (ii) A manufacturer or importer of an accessory that 
        has been granted such marketing authorization may 
        submit to the Secretary a written request for the 
        appropriate classification of the accessory based on 
        the risks and appropriate level of regulatory controls 
        as described in subparagraph (A) or (C), and shall, if 
        the request is requesting classification of the 
        accessory in class II, include in the submission an 
        initial draft proposal for special controls, if special 
        controls would be required pursuant to subsection 
        (a)(1)(B). Such request shall include such information 
        as may be necessary for the Secretary to evaluate, 
        based on the least burdensome approach, the appropriate 
        class for the accessory under subsection (a). The 
        Secretary shall provide an opportunity for a 
        manufacturer or importer to meet with appropriate 
        personnel of the Food and Drug Administration to 
        discuss the appropriate classification of such 
        accessory prior to submitting a written request under 
        this clause for classification of the accessory.
          (iii) The Secretary shall respond to a request made 
        under clause (ii) not later than 90 calendar days after 
        receiving such submission by granting or denying the 
        request for classification of the accessory, and the 
        Secretary shall by written order classify such 
        accessory or deny the request. If the Secretary does 
        not agree with the recommendation for classification 
        submitted by the manufacturer or importer, the response 
        shall include a detailed description and justification 
        for such determination. Within 30 calendar days after 
        granting such a request, the Secretary shall publish a 
        notice in the Federal Register announcing such 
        response.
  (F) Nothing in this paragraph may be construed as precluding 
a manufacturer of an accessory of a new type from using the 
classification process described in subsection (f)(2) to obtain 
classification of such accessory in accordance with the 
criteria and requirements set forth in that subsection.

                              Information

  (g) Within sixty days of the receipt of a written request of 
any person for information respecting the class in which a 
device has been classified or the requirements applicable to a 
device under this Act, the Secretary shall provide such person 
a written statement of the classification (if any) of such 
device and the requirements of this Act applicable to the 
device.

                              Definitions

  (h) For purposes of this section and sections 501, 510, 514, 
515, 516, 519, and 520--
          (1) a reference to ``general controls'' is a 
        reference to the controls authorized by or under 
        sections 501, 502, 510, 516, 518, 519, and 520,
          (2) a reference to ``class I,''``class II,'' or 
        ``class III'' is a reference to a class of medical 
        devices described in subparagraph (A), (B), or (C) of 
        subsection (a)(1), and
          (3) a reference to a ``panel under section 513'' is a 
        reference to a panel established or authorized to be 
        used under this section.

                        Substantial Equivalence

  (i)(1)(A) For purposes of determinations of substantial 
equivalence under subsection (f) and section 520(l), the term 
``substantially equivalent'' or ``substantial equivalence'' 
means, with respect to a device being compared to a predicate 
device, that the device has the same intended use as the 
predicate device and that the Secretary by order has found that 
the device--
          (i) has the same technological characteristics as the 
        predicate device, or
          (ii)(I) has different technological characteristics 
        and the information submitted that the device is 
        substantially equivalent to the predicate device 
        contains information, including appropriate clinical or 
        scientific data if deemed necessary by the Secretary or 
        a person accredited under section 523, that 
        demonstrates that the device is as safe and effective 
        as a legally marketed device, and (II) does not raise 
        different questions of safety and effectiveness than 
        the predicate device.
  (B) For purposes of subparagraph (A), the term ``different 
technological characteristics'' means, with respect to a device 
being compared to a predicate device, that there is a 
significant change in the materials, design, energy source, or 
other features of the device from those of the predicate 
device.
  (C) To facilitate reviews of reports submitted to the 
Secretary under section 510(k), the Secretary shall consider 
the extent to which reliance on postmarket controls may 
expedite the classification of devices under subsection (f)(1) 
of this section.
  (D)(i) Whenever the Secretary requests information to 
demonstrate that devices with differing technological 
characteristics are substantially equivalent, the Secretary 
shall only request information that is necessary to making 
substantial equivalence determinations. In making such request, 
the Secretary shall consider the least burdensome means of 
demonstrating substantial equivalence and request information 
accordingly.
  (ii) For purposes of clause (i), the term ``necessary'' means 
the minimum required information that would support a 
determination of substantial equivalence between a new device 
and a predicate device.
  (iii) Nothing in this subparagraph shall alter the standard 
for determining substantial equivalence between a new device 
and a predicate device.
  (E)(i) Any determination by the Secretary of the intended use 
of a device shall be based upon the proposed labeling submitted 
in a report for the device under section 510(k). However, when 
determining that a device can be found substantially equivalent 
to a legally marketed device, the director of the 
organizational unit responsible for regulating devices (in this 
subparagraph referred to as the ``Director'') may require a 
statement in labeling that provides appropriate information 
regarding a use of the device not identified in the proposed 
labeling if, after providing an opportunity for consultation 
with the person who submitted such report, the Director 
determines and states in writing--
          (I) that there is a reasonable likelihood that the 
        device will be used for an intended use not identified 
        in the proposed labeling for the device; and
          (II) that such use could cause harm.
  (ii) Such determination shall--
          (I) be provided to the person who submitted the 
        report within 10 days from the date of the notification 
        of the Director's concerns regarding the proposed 
        labeling;
          (II) specify the limitations on the use of the device 
        not included in the proposed labeling; and
          (III) find the device substantially equivalent if the 
        requirements of subparagraph (A) are met and if the 
        labeling for such device conforms to the limitations 
        specified in subclause (II).
  (iii) The responsibilities of the Director under this 
subparagraph may not be delegated.
  (F) Not later than 270 days after the date of the enactment 
of the Food and Drug Administration Modernization Act of 1997, 
the Secretary shall issue guidance specifying the general 
principles that the Secretary will consider in determining when 
a specific intended use of a device is not reasonably included 
within a general use of such device for purposes of a 
determination of substantial equivalence under subsection (f) 
or section 520(l).
  (2) A device may not be found to be substantially equivalent 
to a predicate device that has been removed from the market at 
the initiative of the Secretary or that has been determined to 
be misbranded or adulterated by a judicial order.
  (3)(A) As part of a submission under section 510(k) 
respecting a device, the person required to file a premarket 
notification under such section shall provide an adequate 
summary of any information respecting safety and effectiveness 
or state that such information will be made available upon 
request by any person.
  (B) Any summary under subparagraph (A) respecting a device 
shall contain detailed information regarding data concerning 
adverse health effects and shall be made available to the 
public by the Secretary within 30 days of the issuance of a 
determination that such device is substantially equivalent to 
another device.
  (j) Training and Oversight of Least Burdensome 
Requirements.--
          (1) The Secretary shall--
                  (A) ensure that each employee of the Food and 
                Drug Administration who is involved in the 
                review of premarket submissions, including 
                supervisors, receives training regarding the 
                meaning and implementation of the least 
                burdensome requirements under subsections 
                (a)(3)(D) and (i)(1)(D) of this section and 
                section 515(c)(5); and
                  (B) periodically assess the implementation of 
                the least burdensome requirements, including 
                the employee training under subparagraph (A), 
                to ensure that the least burdensome 
                requirements are fully and consistently 
                applied.
          (2) Not later than 18 months after the date of 
        enactment of the 21st Century Cures Act, the ombudsman 
        for any organizational unit of the Food and Drug 
        Administration responsible for the premarket review of 
        devices shall--
                  (A) conduct an audit of the training 
                described in paragraph (1)(A), including the 
                effectiveness of such training in implementing 
                the least burdensome requirements;
                  (B) include in such audit interviews of 
                persons who are representatives of the device 
                industry regarding their experiences in the 
                device premarket review process, including with 
                respect to the application of least burdensome 
                concepts to premarket review and 
                decisionmaking;
                  (C) include in such audit a list of the 
                measurement tools the Secretary uses to assess 
                the implementation of the least burdensome 
                requirements, including under paragraph (1)(B) 
                and section 517A(a)(3), and may also provide 
                feedback on the effectiveness of such tools in 
                the implementation of the least burdensome 
                requirements;
                  (D) summarize the findings of such audit in a 
                final audit report; and
                  (E) within 30 calendar days of completion of 
                such final audit report, make such final audit 
                report available--
                          (i) to the Committee on Health, 
                        Education, Labor, and Pensions of the 
                        Senate and the Committee on Energy and 
                        Commerce of the House of 
                        Representatives; and
                          (ii) on the Internet website of the 
                        Food and Drug Administration.

                         performance standards

                        Provisions of Standards

  Sec. 514. (a)(1) The special controls required by section 
513(a)(1)(B) shall include performance standards for a class II 
device if the Secretary determines that a performance standard 
is necessary to provide reasonable assurance of the safety and 
effectiveness of the device. A class III device may also be 
considered a class II device for purposes of establishing a 
standard for the device under subsection (b) if the device has 
been reclassified as a class II device under an administrative 
order under section 513(e) (or a regulation promulgated under 
such section prior to the date of enactment of the Food and 
Drug Administration Safety and Innovation Act) but such order 
(or regulation) provides that the reclassification is not to 
take effect until the effective date of such a standard for the 
device.
  (2) A performance standard established under subsection (b) 
for a device--
          (A) shall include provisions to provide reasonable 
        assurance of its safe and effective performance;
          (B) shall, where necessary to provide reasonable 
        assurance of its safe and effective performance, 
        include--
                  (i) provisions respecting the construction, 
                components, ingredients, and properties of the 
                device and its compatibility with power systems 
                and connections to such systems,
                  (ii) provisions for the testing (on a sample 
                basis or, if necessary, on an individual basis) 
                of the device or, if it is determined that no 
                other more practicable means are available to 
                the Secretary to assure the conformity of the 
                device to the standard, provisions for the 
                testing (on a sample basis or, if necessary, on 
                an individual basis) by the Secretary or by 
                another person at the direction of the 
                Secretary,
                  (iii) provisions for the measurement of the 
                performance characteristics of the device,
                  (iv) provisions requiring that the results of 
                each or of certain of the tests of the device 
                required to be made under clause (ii) show that 
                the device is in conformity with the portions 
                of the standard for which the test or tests 
                were required, and
                  (v) a provision requiring that the sale and 
                distribution of the device be restricted but 
                only to the extent that the sale and 
                distribution of a device may be restricted 
                under a regulation under section 520(e); and
          (C) shall, where appropriate, require the use and 
        prescribe the form and content of labeling for the 
        proper installation, maintenance, operation, and use of 
        the device.
  (3) The Secretary shall provide for periodic evaluation of 
performance standards established under subsection (b) to 
determine if such standards should be changed to reflect new 
medical, scientific, or other technological data.
  (4) In carrying out his duties under this subsection and 
subsection (b), the Secretary shall, to the maximum extent 
practicable--
          (A) use personnel, facilities, and other technical 
        support available in other Federal agencies,
          (B) consult with other Federal agencies concerned 
        with standard-setting and other nationally or 
        internationally recognized standard-setting entities, 
        and
          (C) invite appropriate participation, through joint 
        or other conferences, workshops, or other means, by 
        informed persons representative of scientific, 
        professional, industry, or consumer organizations who 
        in his judgment can make a significant contribution.

                      Establishment of a Standard

  (b)(1)(A) The Secretary shall publish in the Federal Register 
a notice of proposed rulemaking for the establishment, 
amendment, or revocation of any performance standard for a 
device.
  (B) A notice of proposed rulemaking for the establishment or 
amendment of a performance standard for a device shall--
          (i) set forth a finding with supporting justification 
        that the performance standard is appropriate and 
        necessary to provide reasonable assurance of the safety 
        and effectiveness of the device,
          (ii) set forth proposed findings with respect to the 
        risk of illness or injury that the performance standard 
        is intended to reduce or eliminate,
          (iii) invite interested persons to submit to the 
        Secretary, within 30 days of the publication of the 
        notice, requests for changes in the classification of 
        the device pursuant to section 513(e) based on new 
        information relevant to the classification, and
          (iv) invite interested persons to submit an existing 
        performance standard for the device, including a draft 
        or proposed performance standard, for consideration by 
        the Secretary.
  (C) A notice of proposed rulemaking for the revocation of a 
performance standard shall set forth a finding with supporting 
justification that the performance standard is no longer 
necessary to provide reasonable assurance of the safety and 
effectiveness of a device.
  (D) The Secretary shall provide for a comment period of not 
less than 60 days.
  (2) If, after publication of a notice in accordance with 
paragraph (1), the Secretary receives a request for a change in 
the classification of the device, the Secretary shall, within 
60 days of the publication of the notice, after consultation 
with the appropriate panel under section 513, either deny the 
request or give notice of an intent to initiate such change 
under section 513(e).
  (3)(A) After the expiration of the period for comment on a 
notice of proposed rulemaking published under paragraph (1) 
respecting a performance standard and after consideration of 
such comments and any report from an advisory committee under 
paragraph (5), the Secretary shall (i) promulgate a regulation 
establishing a performance standard and publish in the Federal 
Register findings on the matters referred to in paragraph (1), 
or (ii) publish a notice terminating the proceeding for the 
development of the standard together with the reasons for such 
termination. If a notice of termination is published, the 
Secretary shall (unless such notice is issued because the 
device is a banned device under section 516) initiate a 
proceeding under section 513(e) to reclassify the device 
subject to the proceeding terminated by such notice.
  (B) A regulation establishing a performance standard shall 
set forth the date or dates upon which the standard shall take 
effect, but no such regulation may take effect before one year 
after the date of its publication unless (i) the Secretary 
determines that an earlier effective date is necessary for the 
protection of the public health and safety, or (ii) such 
standard has been established for a device which, effective 
upon the effective date of the standard, has been reclassified 
from class III to class II. Such date or dates shall be 
established so as to minimize, consistent with the public 
health and safety, economic loss to, and disruption or 
dislocation of, domestic and international trade.
  (4)(A) The Secretary, upon his own initiative or upon 
petition of an interested person may by regulation, promulgated 
in accordance with the requirements of paragraphs (1), (2), and 
(3)(B) of this subsection, amend or revoke a performance 
standard.
  (B) The Secretary may declare a proposed amendment of a 
performance standard to be effective on and after its 
publication in the Federal Register and until the effective 
date of any final action taken on such amendment if he 
determines that making it so effective is in the public 
interest. A proposed amendment of a performance standard made 
so effective under the preceding sentence may not prohibit, 
during the period in which it is so effective, the introduction 
or delivery for introduction into interstate commerce of a 
device which conforms to such standard without the change or 
changes provided by such proposed amendment.
  (5)(A) The Secretary--
          (i) may on his own initiative refer a proposed 
        regulation for the establishment, amendment, or 
        revocation of a performance standard, or
          (ii) shall, upon the request of an interested person 
        which demonstrates good cause for referral and which is 
        made before the expiration of the period for submission 
        of comments on such proposed regulation refer such 
        proposed regulation,
to an advisory committee of experts, established pursuant to 
subparagraph (B) for a report and recommendation with respect 
to any matter involved in the proposed regulation which 
requires the exercise of scientific judgment. If a proposed 
regulation is referred under this subparagraph to an advisory 
committee, the Secretary shall provide the advisory committee 
with the data and information on which such proposed regulation 
is based. The advisory committee shall, within sixty days of 
the referral of a proposed regulation and after independent 
study of the data and information furnished to it by the 
Secretary and other data and information before it, submit to 
the Secretary a report and recommendation respecting such 
regulation, together with all underlying data and information 
and a statement of the reason or basis for the recommendation. 
A copy of such report and recommendation shall be made public 
by the Secretary.
  (B) The Secretary shall establish advisory committees (which 
may not be panels under section 513) to receive referrals under 
subparagraph (A). The Secretary shall appoint as members of any 
such advisory committee persons qualified in the subject matter 
to be referred to the committee and of appropriately 
diversified professional background, except that the Secretary 
may not appoint to such a committee any individual who is in 
the regular full-time employ of the United States and engaged 
in the administration of this Act. Each such committee shall 
include as nonvoting members a representative of consumer 
interests and a representative of interests of the device 
manufacturing industry. Members of an advisory committee who 
are not officers or employees of the United States, while 
attending conferences or meetings of their committee or 
otherwise serving at the request of the Secretary, shall be 
entitled to receive compensation at rates to be fixed by the 
Secretary, which rates may not exceed the daily equivalent of 
the rate in effect for grade GS-18 of the General Schedule, for 
each day (including traveltime) they are so engaged; and while 
so serving away from their homes or regular places of business 
each member may be allowed travel expenses, including per diem 
in lieu of subsistence, as authorized by section 5703 of title 
5 of the United States Code for persons in the Government 
service employed intermittently. The Secretary shall designate 
one of the members of each advisory committee to serve as 
chairman thereof. The Secretary shall furnish each advisory 
committee with clerical and other assistance, and shall by 
regulation prescribe the procedures to be followed by each such 
committee in acting on referrals made under subparagraph (A).

                       Recognition of a Standard

  (c)(1)(A) In addition to establishing a performance standard 
under this section, the Secretary shall, by publication in the 
Federal Register (or, with respect to a susceptibility test 
interpretive criteria standard under section 511A, by posting 
on the Interpretive Criteria Website in accordance with such 
section), recognize all or part of an appropriate standard 
established by a nationally or internationally recognized 
standard development organization for which a person may submit 
a declaration of conformity in order to meet a premarket 
submission requirement or other requirement under this Act to 
which such standard is applicable.
  (B) If a person elects to use a standard recognized by the 
Secretary under subparagraph (A) to meet the requirements 
described in such subparagraph, the person shall provide a 
declaration of conformity to the Secretary that certifies that 
the device is in conformity with such standard. A person may 
elect to use data, or information, other than data required by 
a standard recognized under subparagraph (A) to meet any 
requirement regarding devices under this Act.
  (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 calendar 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 a 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 (ii)(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 all, part, or none of 
a standard, including the scientific, technical, regulatory, or 
other basis for the decision regarding such recognition.
  (2) The Secretary may withdraw such recognition of a standard 
through publication of a notice in the Federal Register if the 
Secretary determines that the standard is no longer appropriate 
for meeting a requirement regarding devices under this Act.
  (3)(A) Subject to subparagraph (B), the Secretary shall 
accept a declaration of conformity that a device is in 
conformity with a standard recognized under paragraph (1) 
unless the Secretary finds--
          (i) that the data or information submitted to support 
        such declaration does not demonstrate that the device 
        is in conformity with the standard identified in the 
        declaration of conformity; or
          (ii) that the standard identified in the declaration 
        of conformity is not applicable to the particular 
        device under review.
  (B) The Secretary may request, at any time, the data or 
information relied on by the person to make a declaration of 
conformity with respect to a standard recognized under 
paragraph (1).
  (C) A person making a declaration of conformity with respect 
to a standard recognized under paragraph (1) shall maintain the 
data and information demonstrating conformity of the device to 
the standard for a period of two years after the date of the 
classification or approval of the device by the Secretary or a 
period equal to the expected design life of the device, 
whichever is longer.
  (4) 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.
  (d) Pilot Accreditation Scheme for Conformity Assessment.--
          (1) In general.--The Secretary shall establish a 
        pilot program under which--
                  (A) testing laboratories may be accredited, 
                by accreditation bodies meeting criteria 
                specified by the Secretary, to assess the 
                conformance of a device with certain standards 
                recognized under this section; and
                  (B) subject to paragraph (2), determinations 
                by testing laboratories so accredited that a 
                device conforms with such standard or standards 
                shall be accepted by the Secretary for purposes 
                of demonstrating such conformity under this 
                section unless the Secretary finds that a 
                particular such determination shall not be so 
                accepted.
          (2) Secretarial review of accredited laboratory 
        determinations.--The Secretary may--
                  (A) review determinations by testing 
                laboratories accredited pursuant to this 
                subsection, including by conducting periodic 
                audits of such determinations or processes of 
                accredited bodies or testing laboratories and, 
                following such review, taking additional 
                measures under this Act, such as suspension or 
                withdrawal of accreditation of such testing 
                laboratory under paragraph (1)(A) or requesting 
                additional information with respect to such 
                device, as the Secretary determines 
                appropriate; and
                  (B) if the Secretary becomes aware of 
                information materially bearing on safety or 
                effectiveness of a device assessed for 
                conformity by a testing laboratory so 
                accredited, take such additional measures under 
                this Act as the Secretary determines 
                appropriate, such as suspension or withdrawal 
                of accreditation of such testing laboratory 
                under paragraph (1)(A), or requesting 
                additional information with regard to such 
                device.
          (3) Implementation and reporting.--
                  (A) Public meeting.--The Secretary shall 
                publish in the Federal Register a notice of a 
                public meeting to be held no later than 
                September 30, 2018, to discuss and obtain input 
                and recommendations from stakeholders regarding 
                the goals and scope of, and a suitable 
                framework and procedures and requirements for, 
                the pilot program under this subsection.
                  (B) Pilot program guidance.--The Secretary 
                shall--
                          (i) not later than September 30, 
                        2019, issue draft guidance regarding 
                        the goals and implementation of the 
                        pilot program under this subsection; 
                        and
                          (ii) not later than September 30, 
                        2021, issue final guidance with respect 
                        to the implementation of such program.
                  (C) Pilot program initiation.--Not later than 
                September 30, 2020, the Secretary shall 
                initiate the pilot program under this 
                subsection.
                  (D) Report.--The Secretary shall make 
                available on the website of the Food and Drug 
                Administration an annual report on the progress 
                of the pilot program under this subsection.
          (4) Sunset.--As of October 1, 2022--
                  (A) the authority for accreditation bodies to 
                accredit testing laboratories pursuant to 
                paragraph (1)(A) shall cease to have force or 
                effect;
                  (B) the Secretary--
                          (i) may not accept a determination 
                        pursuant to paragraph (1)(B) made by a 
                        testing laboratory after such date; and
                          (ii) may accept such a determination 
                        made prior to such date;
                  (C) except for purposes of accepting a 
                determination described in subparagraph 
                (B)(ii), the Secretary shall not continue to 
                recognize the accreditation of testing 
                laboratories accredited under paragraph (1)(A); 
                and
                  (D) the Secretary may take actions in 
                accordance with paragraph (2) with respect to 
                the determinations made prior to such date and 
                recognition of the accreditation of testing 
                laboratories pursuant to determinations made 
                prior to such date.

                           premarket approval

                          General Requirement

  Sec. 515. (a) A class III device--
          (1) which is subject to an order issued under 
        subsection (b) (or a regulation promulgated under such 
        subsection prior to the date of enactment of the Food 
        and Drug Administration Safety and Innovation Act); or
          (2) which is a class III device because of section 
        513(f),
is required to have, unless exempt under section 520(g), an 
approval under this section of an application for premarket 
approval or, as applicable, an approval under subsection (c)(2) 
of a report seeking premarket approval.

                  Order To Require Premarket Approval

  (b)(1) In the case of a class III device which--
          (A) was introduced or delivered for introduction into 
        interstate commerce for commercial distribution before 
        the date of enactment of this section; or
          (B) is (i) of a type so introduced or delivered, and 
        (ii) is substantially equivalent to another device 
        within that type;
the Secretary shall by administrative order following 
publication of a proposed order in the Federal Register, a 
meeting of a device classification panel described in section 
513(b), and consideration of comments from all affected 
stakeholders, including patients, payors, and providers, 
notwithstanding subchapter II of chapter 5 of title 5, United 
States Code, require that such device have an approval under 
this section of an application for premarket approval. 
Authority to issue such administrative order shall not be 
delegated below the Director of the Center for Devices and 
Radiological Health, acting in consultation with the 
Commissioner.
  (2) A proposed order required under paragraph (1) shall 
contain--
          (A) the proposed order;
          (B) proposed findings with respect to the degree of 
        risk of illness or injury designed to be eliminated or 
        reduced by requiring the device to have an approved 
        application for premarket approval and the benefit to 
        the public from use of the device;
          (C) opportunity for the submission of comments on the 
        proposed order and the proposed findings; and
          (D) opportunity to request a change in the 
        classification of the device based on new information 
        relevant to the classification of the device.
  (3) After the expiration of the period for comment on a 
proposed order and proposed findings published under paragraph 
(2), consideration of comments submitted on such proposed order 
and findings, and a meeting of a device classification panel 
described in section 513(b), the Secretary shall (A) issue an 
administrative order under paragraph (1) and publish in the 
Federal Register findings on the matters referred to in 
paragraph (2)(B), or (B) publish a notice terminating the 
proceeding for the issuance of the administrative order 
together with the reasons for such termination. If a notice of 
termination is published, the Secretary shall (unless such 
notice is issued because the device is a banned device under 
section 516) initiate a proceeding under section 513(e) to 
reclassify the device subject to the proceeding terminated by 
such notice.

                   Application for Premarket Approval

  (c)(1) Any person may file with the Secretary an application 
for premarket approval for a class III device. Such an 
application for a device shall contain--
          (A) full reports of all information, published or 
        known to or which should reasonably be known to the 
        applicant, concerning investigations which have been 
        made to show whether or not such device is safe and 
        effective;
          (B) a full statement of the components, ingredients, 
        and properties and of the principle or principles of 
        operation, of such device;
          (C) a full description of the methods used in, and 
        the facilities and controls used for, the manufacture, 
        processing, and, when relevant, packing and 
        installation of, such device;
          (D) an identifying reference to any performance 
        standard under section 514 which would be applicable to 
        any aspect of such device if it were a class II device, 
        and either adequate information to show that such 
        aspect of such device fully meets such performance 
        standard or adequate information to justify any 
        deviation from such standard;
          (E) such samples of such device and of components 
        thereof as the Secretary may reasonably require, except 
        that where the submission of such samples is 
        impracticable or unduly burdensome, the requirement of 
        this subparagraph may be met by the submission of 
        complete information concerning the location of one or 
        more such devices readily available for examination and 
        testing;
          (F) specimens of the labeling proposed to be used for 
        such device;
                  (G) the certification required under section 
                402(j)(5)(B) of the Public Health Service Act 
                (which shall not be considered an element of 
                such application); and
          (H) such other information relevant to the subject 
        matter of the application as the Secretary, with the 
        concurrence of the appropriate panel under section 513, 
        may require.
  (2)(A) Any person may file with the Secretary a report 
seeking premarket approval for a class III device referred to 
in subsection (a) that is a reprocessed single-use device. Such 
a report shall contain the following:
          (i) The device name, including both the trade or 
        proprietary name and the common or usual name.
          (ii) The establishment registration number of the 
        owner or operator submitting the report.
          (iii) Actions taken to comply with performance 
        standards under section 514.
          (iv) Proposed labels, labeling, and advertising 
        sufficient to describe the device, its intended use, 
        and directions for use.
          (v) Full reports of all information, published or 
        known to or which should be reasonably known to the 
        applicant, concerning investigations which have been 
        made to show whether or not the device is safe or 
        effective.
          (vi) A description of the device's components, 
        ingredients, and properties.
          (vii) A full description of the methods used in, and 
        the facilities and controls used for, the reprocessing 
        and packing of the device.
          (viii) Such samples of the device that the Secretary 
        may reasonably require.
          (ix) A financial certification or disclosure 
        statement or both, as required by part 54 of title 21, 
        Code of Federal Regulations.
          (x) A statement that the applicant believes to the 
        best of the applicant's knowledge that all data and 
        information submitted to the Secretary are truthful and 
        accurate and that no material fact has been omitted in 
        the report.
          (xi) Any additional data and information, including 
        information of the type required in paragraph (1) for 
        an application under such paragraph, that the Secretary 
        determines is necessary to determine whether there is 
        reasonable assurance of safety and effectiveness for 
        the reprocessed device.
          (xii) Validation data described in section 
        510(o)(1)(A) that demonstrates that the reasonable 
        assurance of the safety or effectiveness of the device 
        will remain after the maximum number of times the 
        device is reprocessed as intended by the person 
        submitting such report.
  (B) In the case of a class III device referred to in 
subsection (a) that is a reprocessed single-use device:
          (i) Subparagraph (A) of this paragraph applies in 
        lieu of paragraph (1).
          (ii) Subject to clause (i), the provisions of this 
        section apply to a report under subparagraph (A) to the 
        same extent and in the same manner as such provisions 
        apply to an application under paragraph (1).
          (iii) Each reference in other sections of this Act to 
        an application under this section, other than such a 
        reference in section 737 or 738, shall be considered to 
        be a reference to a report under subparagraph (A).
          (iv) Each reference in other sections of this Act to 
        a device for which an application under this section 
        has been approved, or has been denied, suspended, or 
        withdrawn, other than such a reference in section 737 
        or 738, shall be considered to be a reference to a 
        device for which a report under subparagraph (A) has 
        been approved, or has been denied, suspended, or 
        withdrawn, respectively.
  (3) Upon receipt of an application meeting the requirements 
set forth in paragraph (1), the Secretary--
          (A) may on the Secretary's own initiative, or
          (B) shall, upon the request of an applicant unless 
        the Secretary finds that the information in the 
        application which would be reviewed by a panel 
        substantially duplicates information which has 
        previously been reviewed by a panel appointed under 
        section 513,
refer such application to the appropriate panel under section 
513 for study and for submission (within such period as he may 
establish) of a report and recommendation respecting approval 
of the application, together with all underlying data and the 
reasons or basis for the recommendation. Where appropriate, the 
Secretary shall ensure that such panel includes, or consults 
with, one or more pediatric experts.
  (4)(A) Prior to the submission of an application under this 
subsection, the Secretary shall accept and review any portion 
of the application that the applicant and the Secretary agree 
is complete, ready, and appropriate for review, except that 
such requirement does not apply, and the Secretary has 
discretion whether to accept and review such portion, during 
any period in which, under section [738(h)] 738(g), the 
Secretary does not have the authority to collect fees under 
section 738(a).
  (B) Each portion of a submission reviewed under subparagraph 
(A) and found acceptable by the Secretary shall not be further 
reviewed after receipt of an application that satisfies the 
requirements of paragraph (1), unless a significant issue of 
safety or effectiveness provides the Secretary reason to review 
such accepted portion.
  (C) Whenever the Secretary determines that a portion of a 
submission under subparagraph (A) is unacceptable, the 
Secretary shall, in writing, provide to the applicant a 
description of any deficiencies in such portion and identify 
the information that is required to correct these deficiencies, 
unless the applicant is no longer pursuing the application.
  (5)(A) In requesting additional information with respect to 
an application under this section, the Secretary shall consider 
the least burdensome appropriate means necessary to demonstrate 
a reasonable assurance of device safety and effectiveness.
  (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) For purposes of this paragraph, the Secretary shall 
consider the role of postmarket information in determining the 
least burdensome means of demonstrating a reasonable assurance 
of device safety and effectiveness.
  (D) Nothing in this paragraph alters the standards for 
premarket approval of a device.

            Action on an Application for Premarket Approval

  (d)(1)(A) As promptly as possible, but in no event later than 
one hundred and eighty days after the receipt of an application 
under subsection (c) (except as provided in section 
520(l)(3)(D)(ii) or unless, in accordance with subparagraph 
(B)(i), an additional period as agreed upon by the Secretary 
and the applicant), the Secretary, after considering the report 
and recommendation submitted under paragraph (2) of such 
subsection, shall--
          (i) issue an order approving the application if he 
        finds that none of the grounds for denying approval 
        specified in paragraph (2) of this subsection applies; 
        or
          (ii) deny approval of the application if he finds 
        (and sets forth the basis for such finding as part of 
        or accompanying such denial) that one or more grounds 
        for denial specified in paragraph (2) of this 
        subsection apply.
In making the determination whether to approve or deny the 
application, the Secretary shall rely on the conditions of use 
included in the proposed labeling as the basis for determining 
whether or not there is a reasonable assurance of safety and 
effectiveness, if the proposed labeling is neither false nor 
misleading. In determining whether or not such labeling is 
false or misleading, the Secretary shall fairly evaluate all 
material facts pertinent to the proposed labeling.
  (B)(i) The Secretary may not enter into an agreement to 
extend the period in which to take action with respect to an 
application submitted for a device subject to a regulation 
promulgated under subsection (b) unless he finds that the 
continued availability of the device is necessary for the 
public health.
  (ii) An order approving an application for a device may 
require as a condition to such approval that the sale and 
distribution of the device be restricted but only to the extent 
that the sale and distribution of a device may be restricted 
under a regulation under section 520(e).
  (iii) The Secretary shall accept and review statistically 
valid and reliable data and any other information from 
investigations conducted under the authority of regulations 
required by section 520(g) to make a determination of whether 
there is a reasonable assurance of safety and effectiveness of 
a device subject to a pending application under this section 
if--
          (I) the data or information is derived from 
        investigations of an earlier version of the device, the 
        device has been modified during or after the 
        investigations (but prior to submission of an 
        application under subsection (c)) and such a 
        modification of the device does not constitute a 
        significant change in the design or in the basic 
        principles of operation of the device that would 
        invalidate the data or information; or
          (II) the data or information relates to a device 
        approved under this section, is available for use under 
        this Act, and is relevant to the design and intended 
        use of the device for which the application is pending.
  (2) The Secretary shall deny approval of an application for a 
device if, upon the basis of the information submitted to the 
Secretary as part of the application and any other information 
before him with respect to such device, the Secretary finds 
that--
          (A) there is a lack of a showing of reasonable 
        assurance that such device is safe under the conditions 
        of use prescribed, recommended, or suggested in the 
        proposed labeling thereof;
          (B) there is a lack of a showing of reasonable 
        assurance that the device is effective under the 
        conditions of use prescribed, recommended, or suggested 
        in the proposed labeling thereof;
          (C) the methods used in, or the facilities or 
        controls used for, the manufacture, processing, 
        packing, or installation of such device do not conform 
        to the requirements of section 520(f);
          (D) based on a fair evaluation of all material facts, 
        the proposed labeling is false or misleading in any 
        particular; or
          (E) such device is not shown to conform in all 
        respects to a performance standard in effect under 
        section 514 compliance with which is a condition to 
        approval of the application and there is a lack of 
        adequate information to justify the deviation from such 
        standard.
Any denial of an application shall, insofar as the Secretary 
determines to be practicable, be accompanied by a statement 
informing the applicant of the measures required to place such 
application in approvable form (which measures may include 
further research by the applicant in accordance with one or 
more protocols prescribed by the Secretary).
  (3)(A)(i) The Secretary shall, upon the written request of an 
applicant, meet with the applicant, not later than 100 days 
after the receipt of an application that has been filed as 
complete under subsection (c), to discuss the review status of 
the application.
  (ii) The Secretary shall, in writing and prior to the 
meeting, provide to the applicant a description of any 
deficiencies in the application that, at that point, have been 
identified by the Secretary based on an interim review of the 
entire application and identify the information that is 
required to correct those deficiencies.
  (iii) The Secretary shall notify the applicant promptly of--
          (I) any additional deficiency identified in the 
        application, or
          (II) any additional information required to achieve 
        completion of the review and final action on the 
        application,
that was not described as a deficiency in the written 
description provided by the Secretary under clause (ii).
  (B) The Secretary and the applicant may, by mutual consent, 
establish a different schedule for a meeting required under 
this paragraph.
  (4) An applicant whose application has been denied approval 
may, by petition filed on or before the thirtieth day after the 
date upon which he receives notice of such denial, obtain 
review thereof in accordance with either paragraph (1) or (2) 
of subsection (g), and any interested person may obtain review, 
in accordance with paragraph (1) or (2) of subsection (g), of 
an order of the Secretary approving an application.
  (5)(A)(i) A supplemental application shall be required for 
any change to a device subject to an approved application under 
this subsection that affects safety or effectiveness, unless 
such change is a modification in a manufacturing procedure or 
method of manufacturing and the holder of the approved 
application submits a written notice to the Secretary that 
describes in detail the change, summarizes the data or 
information supporting the change, and informs the Secretary 
that the change has been made under the requirements of section 
520(f).
  (ii) The holder of an approved application who submits a 
notice under clause (i) with respect to a manufacturing change 
of a device may distribute the device 30 days after the date on 
which the Secretary receives the notice, unless the Secretary 
within such 30-day period notifies the holder that the notice 
is not adequate and describes such further information or 
action that is required for acceptance of such change. If the 
Secretary notifies the holder that a supplemental application 
is required, the Secretary shall review the supplement within 
135 days after the receipt of the supplement. The time used by 
the Secretary to review the notice of the manufacturing change 
shall be deducted from the 135-day review period if the notice 
meets appropriate content requirements for premarket approval 
supplements.
  (B)(i) Subject to clause (ii), in reviewing a supplement to 
an approved application, for an incremental change to the 
design of a device that affects safety or effectiveness, the 
Secretary shall approve such supplement if--
          (I) nonclinical data demonstrate that the design 
        modification creates the intended additional capacity, 
        function, or performance of the device; and
          (II) clinical data from the approved application and 
        any supplement to the approved application provide a 
        reasonable assurance of safety and effectiveness for 
        the changed device.
  (ii) The Secretary may require, when necessary, additional 
clinical data to evaluate the design modification of the device 
to provide a reasonable assurance of safety and effectiveness.

     Withdrawal and Temporary Suspension of Approval of Application

  (e)(1) The Secretary shall, upon obtaining, where 
appropriate, advice on scientific matters from a panel or 
panels under section 513, and after due notice and opportunity 
for informal hearing to the holder of an approved application 
for a device, issue an order withdrawing approval of the 
application if the Secretary finds--
          (A) that such device is unsafe or ineffective under 
        the conditions of use prescribed, recommended, or 
        suggested in the labeling thereof;
          (B) on the basis of new information before him with 
        respect to such device, evaluated together with the 
        evidence available to him when the application was 
        approved, that there is a lack of a showing of 
        reasonable assurance that the device is safe or 
        effective under the conditions of use prescribed, 
        recommended, or suggested in the labeling thereof;
          (C) that the application contained or was accompanied 
        by an untrue statement of a material fact;
          (D) that the applicant (i) has failed to establish a 
        system for maintaining records, or has repeatedly or 
        deliberately failed to maintain records or to make 
        reports, required by an applicable regulation under 
        section 519(a), (ii) has refused to permit access to, 
        or copying or verification of, such records as required 
        by section 704, or (iii) has not complied with the 
        requirements of section 510;
          (E) on the basis of new information before him with 
        respect to such device, evaluated together with the 
        evidence before him when the application was approved, 
        that the methods used in, or the facilities and 
        controls used for, the manufacture, processing, 
        packing, or installation of such device do not conform 
        with the requirements of section 520(f) and were not 
        brought into conformity with such requirements within a 
        reasonable time after receipt of written notice from 
        the Secretary of nonconformity;
          (F) on the basis of new information before him, 
        evaluated together with the evidence before him when 
        the application was approved, that the labeling of such 
        device, based on a fair evaluation of all material 
        facts, is false or misleading in any particular and was 
        not corrected within a reasonable time after receipt of 
        written notice from the Secretary of such fact; or
          (G) on the basis of new information before him, 
        evaluated together with the evidence before him when 
        the application was approved, that such device is not 
        shown to conform in all respects to a performance 
        standard which is in effect under section 514 
        compliance with which was a condition to approval of 
        the application and that there is a lack of adequate 
        information to justify the deviation from such 
        standard.
  (2) The holder of an application subject to an order issued 
under paragraph (1) withdrawing approval of the application 
may, by petition filed on or before the thirtieth day after the 
date upon which he receives notice of such withdrawal, obtain 
review thereof in accordance with either paragraph (1) or (2) 
of subsection (g).
  (3) If, after providing an opportunity for an informal 
hearing, the Secretary determines there is reasonable 
probability that the continuation of distribution of a device 
under an approved application would cause serious, adverse 
health consequences or death, the Secretary shall by order 
temporarily suspend the approval of the application approved 
under this section. If the Secretary issues such an order, the 
Secretary shall proceed expeditiously under paragraph (1) to 
withdraw such application.

                      Product Development Protocol

  (f)(1) In the case of a class III device which is required to 
have an approval of an application submitted under subsection 
(c), such device shall be considered as having such an approval 
if a notice of completion of testing conducted in accordance 
with a product development protocol approved under paragraph 
(4) has been declared completed under paragraph (6).
  (2) Any person may submit to the Secretary a proposed product 
development protocol with respect to a device. Such a protocol 
shall be accompanied by data supporting it. If, within thirty 
days of the receipt of such a protocol, the Secretary 
determines that it appears to be appropriate to apply the 
requirements of this subsection to the device with respect to 
which the protocol is submitted, the Secretary--
          (A) may, at the initiative of the Secretary, refer 
        the proposed protocol to the appropriate panel under 
        section 513 for its recommendation respecting approval 
        of the protocol; or
          (B) shall so refer such protocol upon the request of 
        the submitter, unless the Secretary finds that the 
        proposed protocol and accompanying data which would be 
        reviewed by such panel substantially duplicate a 
        product development protocol and accompanying data 
        which have previously been reviewed by such a panel.
  (3) A proposed product development protocol for a device may 
be approved only if--
          (A) the Secretary determines that it is appropriate 
        to apply the requirements of this subsection to the 
        device in lieu of the requirement of approval of an 
        application submitted under subsection (c); and
          (B) the Secretary determines that the proposed 
        protocol provides--
                  (i) a description of the device and the 
                changes which may be made in the device,
                  (ii) a description of the preclinical trials 
                (if any) of the device and a specification of 
                (I) the results from such trials to be required 
                before the commencement of clinical trials of 
                the device, and (II) any permissible variations 
                in preclinical trials and the results 
                therefrom,
                  (iii) a description of the clinical trials 
                (if any) of the device and a specification of 
                (I) the results from such trials to be required 
                before the filing of a notice of completion of 
                the requirements of the protocol, and (II) any 
                permissible variations in such trials and the 
                results therefrom,
                  (iv) a description of the methods to be used 
                in, and the facilities and controls to be used 
                for, the manufacture, processing, and when 
                relevant, packing and installation of the 
                device,
                  (v) an identifying reference to any 
                performance standard under section 514 to be 
                applicable to any aspect of such device,
                  (vi) if appropriate, specimens of the 
                labeling proposed to be used for such device,
                  (vii) such other information relevant to the 
                subject matter of the protocol as the 
                Secretary, with the concurrence of the 
                appropriate panel or panels under section 513, 
                may require, and
                  (viii) a requirement for submission of 
                progress reports and, when completed, records 
                of the trials conducted under the protocol 
                which records are adequate to show compliance 
                with the protocol.
  (4) The Secretary shall approve or disapprove a proposed 
product development protocol submitted under paragraph (2) 
within one hundred and twenty days of its receipt unless an 
additional period is agreed upon by the Secretary and the 
person who submitted the protocol. Approval of a protocol or 
denial of approval of a protocol is final agency action subject 
to judicial review under chapter 7 of title 5, United States 
Code.
  (5) At any time after a product development protocol for a 
device has been approved pursuant to paragraph (4), the person 
for whom the protocol was approved may submit a notice of 
completion--
          (A) stating (i) his determination that the 
        requirements of the protocol have been fulfilled and 
        that, to the best of his knowledge, there is no reason 
        bearing on safety or effectiveness why the notice of 
        completion should not become effective, and (ii) the 
        data and other information upon which such 
        determination was made, and
          (B) setting forth the results of the trials required 
        by the protocol and all the information required by 
        subsection (c)(1).
  (6)(A) The Secretary may, after providing the person who has 
an approved protocol an opportunity for an informal hearing and 
at any time prior to receipt of notice of completion of such 
protocol, issue a final order to revoke such protocol if he 
finds that--
          (i) such person has failed substantially to comply 
        with the requirements of the protocol,
          (ii) the results of the trials obtained under the 
        protocol differ so substantially from the results 
        required by the protocol that further trials cannot be 
        justified, or
          (iii) the results of the trials conducted under the 
        protocol or available new information do not 
        demonstrate that the device tested under the protocol 
        does not present an unreasonable risk to health and 
        safety.
  (B) After the receipt of a notice of completion of an 
approved protocol the Secretary shall, within the ninety-day 
period beginning on the date such notice is received, by order 
either declare the protocol completed or declare it not 
completed. An order declaring a protocol not completed may take 
effect only after the Secretary has provided the person who has 
the protocol opportunity for an informal hearing on the order. 
Such an order may be issued only if the Secretary finds--
          (i) such person has failed substantially to comply 
        with the requirements of the protocol,
          (ii) the results of the trials obtained under the 
        protocol differ substantially from the results required 
        by the protocol, or
          (iii) there is a lack of a showing of reasonable 
        assurance of the safety and effectiveness of the device 
        under the conditions of use prescribed, recommended, or 
        suggested in the proposed labeling thereof.
  (C) A final order issued under subparagraph (A) or (B) shall 
be in writing and shall contain the reasons to support the 
conclusions thereof.
  (7) At any time after a notice of completion has become 
effective, the Secretary may issue an order (after due notice 
and opportunity for an informal hearing to the person for whom 
the notice is effective) revoking the approval of a device 
provided by a notice of completion which has become effective 
as provided in subparagraph (B) if he finds that any of the 
grounds listed in subparagraphs (A) through (G) of subsection 
(e)(1) of this section apply. Each reference in such 
subparagraphs to an application shall be considered for 
purposes of this paragraph as a reference to a protocol and the 
notice of completion of such protocol, and each reference to 
the time when an application was approved shall be considered 
for purposes of this paragraph as a reference to the time when 
a notice of completion took effect.
  (8) A person who has an approved protocol subject to an order 
issued under paragraph (6)(A) revoking such protocol, a person 
who has an approved protocol with respect to which an order 
under paragraph (6)(B) was issued declaring that the protocol 
had not been completed, or a person subject to an order issued 
under paragraph (7) revoking the approval of a device may, by 
petition filed on or before the thirtieth day after the date 
upon which he receives notice of such order, obtain review 
thereof in accordance with either paragraph (1) or (2) of 
subsection (g).

                                 Review

  (g)(1) Upon petition for review of--
          (A) an order under subsection (d) approving or 
        denying approval of an application or an order under 
        subsection (e) withdrawing approval of an application, 
        or
          (B) an order under subsection (f)(6)(A) revoking an 
        approved protocol, under subsection (f)(6)(B) declaring 
        that an approved protocol has not been completed, or 
        under subsection (f)(7) revoking the approval of a 
        device,
the Secretary shall, unless he finds the petition to be without 
good cause or unless a petition for review of such order has 
been submitted under paragraph (2), hold a hearing, in 
accordance with section 554 of title 5 of the United States 
Code, on the order. The panel or panels which considered the 
application, protocol, or device subject to such order shall 
designate a member to appear and testify at any such hearing 
upon request of the Secretary, the petitioner, or the officer 
conducting the hearing, but this requirement does not preclude 
any other member of the panel or panels from appearing and 
testifying at any such hearing. Upon completion of such hearing 
and after considering the record established in such hearing, 
the Secretary shall issue an order either affirming the order 
subject to the hearing or reversing such order and, as 
appropriate, approving or denying approval of the application, 
reinstating the application's approval, approving the protocol, 
or placing in effect a notice of completion.
  (2)(A) Upon petition for review of--
          (i) an order under subsection (d) approving or 
        denying approval of an application or an order under 
        subsection (e) withdrawing approval of an application, 
        or
          (ii) an order under subsection (f)(6)(A) revoking an 
        approved protocol, under subsection (f)(6)(B) declaring 
        that an approved protocol has not been completed, or 
        under subsection (f)(7) revoking the approval of a 
        device,
the Secretary shall refer the application or protocol subject 
to the order and the basis for the order to an advisory 
committee of experts established pursuant to subparagraph (B) 
for a report and recommendation with respect to the order. The 
advisory committee shall, after independent study of the data 
and information furnished to it by the Secretary and other data 
and information before it, submit to the Secretary a report and 
recommendation, together with all underlying data and 
information and a statement of the reasons or basis for the 
recommendation. A copy of such report shall be promptly 
supplied by the Secretary to any person who petitioned for such 
referral to the advisory committee.
  (B) The Secretary shall establish advisory committees (which 
may not be panels under section 513) to receive referrals under 
subparagraph (A). The Secretary shall appoint as members of any 
such advisory committee persons qualified in the subject matter 
to be referred to the committee and of appropriately 
diversified professional backgrounds, except that the Secretary 
may not appoint to such a committee any individual who is in 
the regular full-time employ of the United States and engaged 
in the administration of this Act. Members of an advisory 
committee (other than officers or employees of the United 
States), while attending conferences or meetings of their 
committee or otherwise serving at the request of the Secretary, 
shall be entitled to receive compensation at rates to be fixed 
by the Secretary which rates may not exceed the daily 
equivalent for grade GS-18 of the General Schedule for each day 
(including traveltime) they are so engaged; and while so 
serving away from their homes or regular places of business 
each member may be allowed travel expenses, including per diem 
in lieu of subsistence, as authorized by section 5703 of title 
5 of the United States Code for persons in the Government 
service employed intermittently. The Secretary shall designate 
the chairman of an advisory committee from its members. The 
Secretary shall furnish each advisory committee with clerical 
and other assistance, and shall by regulation prescribe the 
procedures to be followed by each such committee in acting on 
referrals made under subparagraph (A).
  (C) The Secretary shall make public the report and 
recommendation made by an advisory committee with respect to an 
application and shall by order, stating the reasons therefor, 
either affirm the order referred to the advisory committee or 
reverse such order and, if appropriate, approve or deny 
approval of the application, reinstate the application's 
approval, approve the protocol, or place in effect a notice of 
completion.

                           Service of Orders

  (h) Orders of the Secretary under this section shall be 
served (1) in person by any officer or employee of the 
department designated by the Secretary, or (2) by mailing the 
order by registered mail or certified mail addressed to the 
applicant at his last known address in the records of the 
Secretary.

                                Revision

  (i)(1) Before December 1, 1995, the Secretary shall by order 
require manufacturers of devices, which were introduced or 
delivered for introduction into interstate commerce for 
commercial distribution before May 28, 1976, and which are 
subject to revision of classification under paragraph (2), to 
submit to the Secretary a summary of and citation to any 
information known or otherwise available to the manufacturer 
respecting such devices, including adverse safety or 
effectiveness information which has not been submitted under 
section 519. The Secretary may require the manufacturer to 
submit the adverse safety or effectiveness data for which a 
summary and citation were submitted, if such data are available 
to the manufacturer.
  (2) After the issuance of an order under paragraph (1) but 
before the date that is 2 years after the date of enactment of 
the Food and Drug Administration Safety and Innovation Act, the 
Secretary shall issue an administrative order following 
publication of a proposed order in the Federal Register, a 
meeting of a device classification panel described in section 
513(b), and consideration of comments from all affected 
stakeholders, including patients, payors, and providers, 
notwithstanding subchapter II of chapter 5 of title 5, United 
States Code, for each device--
          (A) which the Secretary has classified as a class III 
        device, and
          (B) for which no administrative order has been issued 
        under subsection (b) (or no regulation has been 
        promulgated under such subsection prior to the date of 
        enactment of the Food and Drug Administration Safety 
        and Innovation Act),
revising the classification of the device so that the device is 
classified into class I or class II, unless the administrative 
order issued under this paragraph requires the device to remain 
in class III. In determining whether to revise the 
classification of a device or to require a device to remain in 
class III, the Secretary shall apply the criteria set forth in 
section 513(a).
  (3) The Secretary shall, as promptly as is reasonably 
achievable, but not later than 12 months after the effective 
date of the order requiring a device to remain in class III, 
establish a schedule for the issuance of an administrative 
order under subsection (b) for each device which is subject to 
the order requiring the device to remain in class III.

           *       *       *       *       *       *       *


SEC. [515C.]  515B. BREAKTHROUGH DEVICES.

  (a) Purpose.--The purpose of this section is to encourage the 
Secretary, and provide the Secretary with sufficient authority, 
to apply efficient and flexible approaches to expedite the 
development of, and prioritize the Food and Drug 
Administration's review of, devices that represent breakthrough 
technologies.
  (b) Establishment of Program.--The Secretary shall establish 
a program to expedite the development of, and provide for the 
priority review for, devices, as determined by the Secretary--
          (1) that provide for more effective treatment or 
        diagnosis of life-threatening or irreversibly 
        debilitating human disease or conditions; and
          (2)(A) that represent breakthrough technologies;
          (B) for which no approved or cleared alternatives 
        exist;
          (C) that offer significant advantages over existing 
        approved or cleared alternatives, including the 
        potential, compared to existing approved alternatives, 
        to 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
          (D) the availability of which is in the best interest 
        of patients.
  (c) Request for Designation.--A sponsor of a device may 
request that the Secretary designate such device for expedited 
development and 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 
notification under section 510(k), or a petition for 
classification under section 513(f)(2).
  (d) Designation Process.--
          (1) In general.--Not later than 60 calendar days 
        after the receipt of a request under subsection (c), 
        the Secretary shall determine whether the device that 
        is the subject of the request meets the criteria 
        described in subsection (b). If the Secretary 
        determines that the device meets the criteria, the 
        Secretary shall designate the device for expedited 
        development and priority review.
          (2) Review.--Review of a request under subsection (c) 
        shall be undertaken by a team that is composed of 
        experienced staff and senior managers of the Food and 
        Drug Administration.
          (3) Withdrawal.--The Secretary may not withdraw a 
        designation granted under this section on the basis of 
        the criteria under subsection (b) no longer applying 
        because of the subsequent clearance or approval of 
        another device that--
                  (A) was designated under this section; or
                  (B) was given priority review under section 
                515(d)(5), as in effect prior to the date of 
                enactment of the 21st Century Cures Act.
  (e) Expedited Development and Priority Review.--
          (1) Actions.--For purposes of expediting the 
        development and review of devices designated under 
        subsection (d) 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 
                (c);
                  (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 (c) for the device;
                  (C) adopt an efficient process for timely 
                dispute resolution;
                  (D) provide for interactive and timely 
                communication with the sponsor of the device 
                during the development program and review 
                process;
                  (E) expedite the Secretary's review of 
                manufacturing and quality systems compliance, 
                as applicable;
                  (F) disclose to the sponsor, not less than 5 
                business days in advance, the topics of any 
                consultation the Secretary intends to undertake 
                with external experts or an advisory committee 
                concerning the sponsor's device and provide the 
                sponsor the opportunity to recommend such 
                external experts;
                  (G) provide for advisory committee input, as 
                the Secretary determines appropriate (including 
                in response to the request of the sponsor) for 
                applications submitted under section 515(c); 
                and
                  (H) assign staff to be available within a 
                reasonable time to address questions 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 (d), 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 and flexible as 
                practicable, when scientifically appropriate;
                  (C) facilitate, when scientifically 
                appropriate, expedited and efficient 
                development and review of the device through 
                utilization of timely postmarket data 
                collection with regard to application for 
                approval under section 515(c); and
                  (D) agree in writing to clinical protocols 
                that the Secretary will consider binding on the 
                Secretary and the sponsor, subject to--
                          (i) changes to such protocols agreed 
                        to in writing by the sponsor and the 
                        Secretary; or
                          (ii) a decision, made by the director 
                        of the office responsible for reviewing 
                        the device submission, that a 
                        substantial scientific issue essential 
                        to determining the safety or 
                        effectiveness of such device exists, 
                        provided that such decision is in 
                        writing, and is made only after the 
                        Secretary provides to the device 
                        sponsor or applicant an opportunity for 
                        a meeting at which the director and the 
                        sponsor or applicant are present and at 
                        which the director documents the 
                        substantial scientific issue.
  (f) Priority Review Guidance.--
          (1) Content.--Not later than 1 year after the date of 
        enactment of the 21st Century Cures Act, the Secretary 
        shall issue guidance on the implementation of this 
        section. Such guidance shall--
                  (A) set forth the process by which a person 
                may seek a designation under subsection (d);
                  (B) provide a template for requests under 
                subsection (c);
                  (C) identify the criteria the Secretary will 
                use in evaluating a request for designation 
                under this section; and
                  (D) identify the criteria and processes the 
                Secretary will use to assign a team of staff, 
                including team leaders, to review devices 
                designated for expedited development and 
                priority review, including any training 
                required for such personnel to ensure effective 
                and efficient review.
          (2) Process.--Prior to finalizing the guidance under 
        paragraph (1), the Secretary shall seek public comment 
        on [a proposed guidance] a draft version of that 
        guidance.
  (g) Rule of Construction.--Nothing in this section shall be 
construed to affect--
          (1) 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 and 
        application of the least burdensome means of evaluating 
        device effectiveness or demonstrating substantial 
        equivalence between devices with differing 
        technological characteristics, as applicable;
          (2) the authority of the Secretary with respect to 
        clinical holds under section 520(g)(8)(A);
          (3) the authority of the Secretary to act on an 
        application pursuant to section 515(d) before 
        completion of an establishment inspection, as the 
        Secretary determines appropriate; or
          (4) the authority of the Secretary with respect to 
        postmarket surveillance under sections 519(h) and 522.

           *       *       *       *       *       *       *


                     records and reports on devices

                              General Rule

  Sec. 519. (a) Every person who is a manufacturer or importer 
of a device intended for human use shall establish and maintain 
such records, make such reports, and provide such information, 
as the Secretary may by regulation reasonably require to assure 
that such device is not adulterated or misbranded and to 
otherwise assure its safety and effectiveness. Regulations 
prescribed under the preceding sentence--
          (1) shall require a device manufacturer or importer 
        to report to the Secretary whenever the manufacturer or 
        importer receives or otherwise becomes aware of 
        information that reasonably suggests that one of its 
        marketed devices--
                  (A) may have caused or contributed to a death 
                or serious injury, or
                  (B) has malfunctioned and that such device or 
                a similar device marketed by the manufacturer 
                or importer would be likely to cause or 
                contribute to a death or serious injury if the 
                malfunction were to recur, which report under 
                this subparagraph--
                          (i) shall be submitted in accordance 
                        with part 803 of title 21, Code of 
                        Federal Regulations (or successor 
                        regulations), unless the Secretary 
                        grants an exemption or variance from, 
                        or an alternative to, a requirement 
                        under such regulations pursuant to 
                        section 803.19 of such part, if the 
                        device involved is--
                                  (I) a class III device;
                                  (II) a class II device that 
                                is permanently implantable, is 
                                life supporting, or is life 
                                sustaining; or
                                  (III) a type of device which 
                                the Secretary has, by notice 
                                published in the Federal 
                                Register or letter to the 
                                person who is the manufacturer 
                                or importer of the device, 
                                indicated should be subject to 
                                such part 803 in order to 
                                protect the public health;
                          (ii) shall, if the device is not 
                        subject to clause (i), be submitted in 
                        accordance with criteria established by 
                        the Secretary for reports made pursuant 
                        to this clause, which criteria shall 
                        require the reports to be in summary 
                        form and made on a quarterly basis; or
                          (iii) shall, if the device is 
                        imported into the United States and for 
                        which part 803 of title 21, Code of 
                        Federal Regulations (or successor 
                        regulations) requires an importer to 
                        submit a report to the manufacturer, be 
                        submitted by the importer to the 
                        manufacturer in accordance with part 
                        803 of title 21, Code of Federal 
                        Regulations (or successor regulations)
          (2) shall define the term ``serious injury'' to mean 
        an injury that--
                  (A) is life threatening,
                  (B) results in permanent impairment of a body 
                function or permanent damage to a body 
                structure, or
                  (C) necessitates medical or surgical 
                intervention to preclude permanent impairment 
                of a body function or permanent damage to a 
                body structure;
          (3) shall require reporting of other significant 
        adverse device experiences as determined by the 
        Secretary to be necessary to be reported;
          (4) shall not impose requirements unduly burdensome 
        to a device manufacturer or importer taking into 
        account his cost of complying with such requirements 
        and the need for the protection of the public health 
        and the implementation of this Act;
          (5) which prescribe the procedure for making requests 
        for reports or information shall require that each 
        request made under such regulations for submission of a 
        report or information to the Secretary state the reason 
        or purpose for such request and identify to the fullest 
        extent practicable such report or information;
          (6) which require submission of a report or 
        information to the Secretary shall state the reason or 
        purpose for the submission of such report or 
        information and identify to the fullest extent 
        practicable such report or information;
          (7) may not require that the identity of any patient 
        be disclosed in records, reports, or information 
        required under this subsection unless required for the 
        medical welfare of an individual, to determine the 
        safety or effectiveness of a device, or to verify a 
        record, report, or information submitted under this 
        Act; and
          (8) may not require a manufacturer or importer of a 
        class I device to--
                  (A) maintain for such a device records 
                respecting information not in the possession of 
                the manufacturer or importer, or
                  (B) to submit for such a device to the 
                Secretary any report or information--
                          (i) not in the possession of the 
                        manufacturer or importer, or
                          (ii) on a periodic basis,
        unless such report or information is necessary to 
        determine if the device should be reclassified or if 
        the device is adulterated or misbranded. and
In prescribing such regulations, the Secretary shall have due 
regard for the professional ethics of the medical profession 
and the interests of patients. The prohibitions of paragraph 
(7) of this subsection continue to apply to records, reports, 
and information concerning any individual who has been a 
patient, irrespective of whether or when he ceases to be a 
patient. The Secretary shall by regulation require distributors 
to keep records and make such records available to the 
Secretary upon request. Paragraphs (4) and (8) apply to 
distributors to the same extent and in the same manner as such 
paragraphs apply to manufacturers and importers.

                              User Reports

  (b)(1)(A) Whenever a device user facility receives or 
otherwise becomes aware of information that reasonably suggests 
that a device has or may have caused or contributed to the 
death of a patient of the facility, the facility shall, as soon 
as practicable but not later than 10 working days after 
becoming aware of the information, report the information to 
the Secretary and, if the identity of the manufacturer is 
known, to the manufacturer of the device. In the case of 
deaths, the Secretary may by regulation prescribe a shorter 
period for the reporting of such information.
  (B) Whenever a device user facility receives or otherwise 
becomes aware of--
          (i) information that reasonably suggests that a 
        device has or may have caused or contributed to the 
        serious illness of, or serious injury to, a patient of 
        the facility, or
          (ii) other significant adverse device experiences as 
        determined by the Secretary by regulation to be 
        necessary to be reported,
shall, as soon as practicable but not later than 10 working 
days after becoming aware of the information, report the 
information to the manufacturer of the device or to the 
Secretary if the identity of the manufacturer is not known.
  (C) Each device user facility shall submit to the Secretary 
on an annual basis a summary of the reports made under 
subparagraphs (A) and (B). Such summary shall be submitted on 
January 1 of each year. The summary shall be in such form and 
contain such information from such reports as the Secretary may 
require and shall include--
          (i) sufficient information to identify the facility 
        which made the reports for which the summary is 
        submitted,
          (ii) in the case of any product which was the subject 
        of a report, the product name, serial number, and model 
        number,
          (iii) the name and the address of the manufacturer of 
        such device, and
          (iv) a brief description of the event reported to the 
        manufacturer.
  (D) For purposes of subparagraphs (A), (B), and (C), a device 
user facility shall be treated as having received or otherwise 
become aware of information with respect to a device of that 
facility when medical personnel who are employed by or 
otherwise formally affiliated with the facility receive or 
otherwise become aware of information with respect to that 
device in the course of their duties.
  (2) The Secretary may not disclose the identity of a device 
user facility which makes a report under paragraph (1) except 
in connection with--
          (A) an action brought to enforce section 301(q), or
          (B) a communication to a manufacturer of a device 
        which is the subject of a report under paragraph (1).
This paragraph does not prohibit the Secretary from disclosing 
the identity of a device user facility making a report under 
paragraph (1) or any information in such a report to employees 
of the Department of Health and Human Services, to the 
Department of Justice, or to the duly authorized committees and 
subcommittees of the Congress.
  (3) No report made under paragraph (1) by--
          (A) a device user facility,
          (B) an individual who is employed by or otherwise 
        formally affiliated with such a facility, or
          (C) a physician who is not required to make such a 
        report,
shall be admissible into evidence or otherwise used in any 
civil action involving private parties unless the facility, 
individual, or physician who made the report had knowledge of 
the falsity of the information contained in the report.
  (4) A report made under paragraph (1) does not affect any 
obligation of a manufacturer who receives the report to file a 
report as required under subsection (a).
  (5) With respect to device user facilities:
          (A) The Secretary shall by regulation plan and 
        implement a program under which the Secretary limits 
        user reporting under paragraphs (1) through (4) to a 
        subset of user facilities that constitutes a 
        representative profile of user reports for device 
        deaths and serious illnesses or serious injuries.
          (B) During the period of planning the program under 
        subparagraph (A), paragraphs (1) through (4) continue 
        to apply.
          (C) During the period in which the Secretary is 
        providing for a transition to the full implementation 
        of the program, paragraphs (1) through (4) apply except 
        to the extent that the Secretary determines otherwise.
          (D) On and after the date on which the program is 
        fully implemented, paragraphs (1) through (4) do not 
        apply to a user facility unless the facility is 
        included in the subset referred to in subparagraph (A).
          (E) Not later than 2 years after the date of the 
        enactment of the Food and Drug Administration 
        Modernization Act of 1997, the Secretary shall submit 
        to the Committee on Commerce of the House of 
        Representatives, and to the Committee on Labor and 
        Human Resources of the Senate, a report describing the 
        plan developed by the Secretary under subparagraph (A) 
        and the progress that has been made toward the 
        implementation of the plan.
  (6) For purposes of this subsection:
          (A) The term ``device user facility'' means a 
        hospital, ambulatory surgical facility, nursing home, 
        or outpatient treatment facility which is not a 
        physician's office. The Secretary may by regulation 
        include an outpatient diagnostic facility which is not 
        a physician's office in such term.
          (B) The terms ``serious illness'' and ``serious 
        injury'' mean illness or injury, respectively, that--
                  (i) is life threatening,
                  (ii) results in permanent impairment of a 
                body function or permanent damage to a body 
                structure, or
                  (iii) necessitates medical or surgical 
                intervention to preclude permanent impairment 
                of a body function or permanent damage to a 
                body structure.

                             Persons Exempt

  (c) Subsection (a) shall not apply to--
          (1) any practitioner who is licensed by law to 
        prescribe or administer devices intended for use in 
        humans and who manufactures or imports devices solely 
        for use in the course of his professional practice;
          (2) any person who manufactures or imports devices 
        intended for use in humans solely for such person's use 
        in research or teaching and not for sale (including any 
        person who uses a device under an exemption granted 
        under section 520(g)); and
          (3) any other class of persons as the Secretary may 
        by regulation exempt from subsection (a) upon a finding 
        that compliance with the requirements of such 
        subsection by such class with respect to a device is 
        not necessary to (A) assure that a device is not 
        adulterated or misbranded or (B) otherwise to assure 
        its safety and effectiveness.

                            Device Tracking

  (e)(1) The Secretary may by order require a manufacturer to 
adopt a method of tracking a class II or class III device--
          (A) the failure of which would be reasonably likely 
        to have serious adverse health consequences; or
          (B) which is--
                  (i) intended to be implanted in the human 
                body for more than one year, or
                  (ii) a life sustaining or life supporting 
                device used outside a device user facility.
  (2) Any patient receiving a device subject to tracking under 
paragraph (1) may refuse to release, or refuse permission to 
release, the patient's name, address, social security number, 
or other identifying information for the purpose of tracking.

                  Unique Device Identification System

  (f) Not later than December 31, 2012, the Secretary shall 
issue proposed regulations establishing a unique device 
identification system for medical devices requiring the label 
of devices to bear a unique identifier, unless the Secretary 
requires an alternative placement or provides an exception for 
a particular device or type of device. The unique identifier 
shall adequately identify the device through distribution and 
use, and may include information on the lot or serial number. 
The Secretary shall finalize the proposed regulations not later 
than 6 months after the close of the comment period and shall 
implement the final regulations with respect to devices that 
are implantable, life-saving, or life sustaining not later than 
2 years after the regulations are finalized, taking into 
account patient access to medical devices and therapies.

                  Reports of Removals and Corrections

  (g)(1) Except as provided in paragraph (2), the Secretary 
shall by regulation require a manufacturer or importer of a 
device to report promptly to the Secretary any correction or 
removal of a device undertaken by such manufacturer or importer 
if the removal or correction was undertaken--
          (A) to reduce a risk to health posed by the device, 
        or
          (B) to remedy a violation of this Act caused by the 
        device which may present a risk to health.
A manufacturer or importer of a device who undertakes a 
correction or removal of a device which is not required to be 
reported under this paragraph shall keep a record of such 
correction or removal.
  (2) No report of the corrective action or removal of a device 
may be required under paragraph (1) if a report of the 
corrective action or removal is required and has been submitted 
under subsection (a).
  (3) For purposes of paragraphs (1) and (2), the terms 
``correction'' and ``removal'' do not include routine 
servicing.
  (h) Inclusion of Devices in the Postmarket Risk 
Identification and Analysis System.--
          (1) In general.--
                  (A) Application to devices.--The Secretary 
                shall amend the procedures established and 
                maintained under clauses (i), (ii), (iii), and 
                (v) of section 505(k)(3)(C) in order to expand 
                the postmarket risk identification and analysis 
                system established under such section to 
                include and apply to devices.
                  (B) Exception.--Subclause (II) of clause (i) 
                of section 505(k)(3)(C) shall not apply to 
                devices.
                  (C) Clarification.--With respect to devices, 
                the private sector health-related electronic 
                data provided under section 
                505(k)(3)(C)(i)(III)(bb) may include medical 
                device utilization data, health insurance 
                claims data, and procedure and device 
                registries.
          (2) Data.--In expanding the system as described in 
        paragraph (1)(A), the Secretary shall use relevant data 
        with respect to devices cleared under section 510(k) or 
        approved under section 515, including claims data, 
        patient survey data, and any other data deemed 
        appropriate by the Secretary.
          (3) Stakeholder input.--To help ensure effective 
        implementation of the system as described in paragraph 
        (1) with respect to devices, the Secretary shall engage 
        outside stakeholders in development of the system, and 
        gather information from outside stakeholders regarding 
        the content of an effective sentinel program, through a 
        public hearing, advisory committee meeting, maintenance 
        of a public docket, or other similar public measures.
          (4) Voluntary surveys.--Chapter 35 of title 44, 
        United States Code, shall not apply to the collection 
        of voluntary information from health care providers, 
        such as voluntary surveys or questionnaires, initiated 
        by the Secretary for purposes of postmarket risk 
        identification, mitigation, and analysis for devices.
  (i) Pilot Projects To Generate Reliable and Timely Safety and 
Active Surveillance Data.--
          (1) In general.--The Secretary shall, not later than 
        one year after the date of the enactment of the FDA 
        Reauthorization Act of 2017, initiate one or more pilot 
        projects relating to providing timely and reliable 
        information on the safety and effectiveness of devices 
        approved under section 515, cleared under section 
        510(k), or classified under section 513(f)(2), in which 
        a manufacturer or manufacturers of a device or device 
        type voluntarily participate. Any such project shall 
        meet each of the following criteria:
                  (A) The project is designed to efficiently 
                generate reliable and timely safety and active 
                surveillance data for use by the Secretary or 
                manufacturers of the devices that are involved 
                in the pilot project.
                  (B) The project informs, to the extent 
                applicable, the development of methods, 
                systems, data criteria, and programs that could 
                be used to support safety and active 
                surveillance activities for any device.
                  (C) The project shall be designed and 
                conducted in coordination with a comprehensive 
                system for evaluating device technology that 
                operates under a governing board with 
                appropriate representation of stakeholders, 
                including patient groups and device 
                manufacturers.
                  (D) The project uses electronic health data 
                including, as appropriate, claims data, patient 
                survey data, and any other data, as the 
                Secretary determines appropriate.
                  (E) The project prioritizes devices and 
                device types that meet one or more of the 
                following criteria:
                          (i) Devices and device types for 
                        which the collection and analysis of 
                        real world evidence regarding a 
                        device's safety and effectiveness is 
                        likely to advance public health.
                          (ii) Devices and device types that 
                        are widely used.
                          (iii) Devices and device types, the 
                        failure of which has significant health 
                        consequences.
                          (iv) Devices and device types for 
                        which the Secretary--
                                  (I) has received public 
                                recommendations in accordance 
                                with paragraph (2)(B); and
                                  (II) has determined to meet 
                                one of the criteria under 
                                clause (i), (ii), or (iii) and 
                                is appropriate for such a pilot 
                                project.
          (2) Participation.--The Secretary shall establish the 
        conditions and processes--
                  (A) under which a manufacturer of a device 
                may voluntarily participate in a pilot project 
                described in paragraph (1); and
                  (B) for facilitating public recommendations 
                for devices to be prioritized under such a 
                pilot project, including requirements for the 
                data necessary to support such a 
                recommendation.
          (3) Continuation of ongoing projects.--The Secretary 
        may continue or expand projects, with respect to 
        providing timely and reliable information on the safety 
        and effectiveness of devices approved under section 
        515, cleared under section 510(k), or classified under 
        section 513(f)(2), that are being carried out as of the 
        date of the enactment of the FDA Reauthorization Act of 
        2017. The Secretary shall, beginning on such date of 
        enactment, take such steps as may be necessary--
                  (A) to ensure such projects meet the 
                requirements of subparagraphs (A) through (E) 
                of paragraph (1); and
                  (B) to increase the voluntary participation 
                in such projects of manufacturers of devices 
                and facilitate public recommendations for any 
                devices prioritized under such a project.
          (4) Implementation.--
                  (A) Contracting authority.--The Secretary may 
                carry out a pilot project meeting the criteria 
                specified in subparagraphs (A) through (E) of 
                paragraph (1) or a project continued or 
                expanded under paragraph (3) by entering into 
                contracts, cooperative agreements, grants, or 
                other appropriate agreements with public or 
                private entities that have a significant 
                presence in the United States and meet the 
                following conditions:
                          (i) If such an entity is a component 
                        of another organization, the entity and 
                        the organization have established an 
                        agreement under which appropriate 
                        security measures are implemented to 
                        maintain the confidentiality and 
                        privacy of the data described in 
                        paragraph (1)(D) and such agreement 
                        ensures that the entity will not make 
                        an unauthorized disclosure of such data 
                        to the other components of the 
                        organization in breach of requirements 
                        with respect to confidentiality and 
                        privacy of such data established under 
                        such security measures.
                          (ii) In the case of the termination 
                        or nonrenewal of such a contract, 
                        cooperative agreement, grant, or other 
                        appropriate agreement, the entity or 
                        entities involved shall comply with 
                        each of the following:
                                  (I) The entity or entities 
                                shall continue to comply with 
                                the requirements with respect 
                                to confidentiality and privacy 
                                referred to in clause (i) under 
                                this subparagraph with respect 
                                to all data disclosed to the 
                                entity under such an agreement.
                                  (II) The entity or entities 
                                shall return any data disclosed 
                                to such entity pursuant to this 
                                subsection and to which it 
                                would not otherwise have access 
                                or, if returning such data is 
                                not practicable, destroy the 
                                data.
                          (iii) The entity or entities shall 
                        have one or more qualifications with 
                        respect to--
                                  (I) research, statistical, 
                                epidemiologic, or clinical 
                                capability and expertise to 
                                conduct and complete the 
                                activities under this 
                                subsection, including the 
                                capability and expertise to 
                                provide the Secretary access to 
                                de-identified data consistent 
                                with the requirements of this 
                                subsection;
                                  (II) an information 
                                technology infrastructure to 
                                support electronic data and 
                                operational standards to 
                                provide security for such data, 
                                as appropriate;
                                  (III) experience with, and 
                                expertise on, the development 
                                of research on, and 
                                surveillance of, device safety 
                                and effectiveness using 
                                electronic health data; or
                                  (IV) such other expertise 
                                which the Secretary determines 
                                necessary to carry out such a 
                                project.
                  (B) Review of contract in the event of a 
                merger or acquisition.--The Secretary shall 
                review any contract, cooperative agreement, 
                grant, or other appropriate agreement entered 
                into under this paragraph with an entity 
                meeting the conditions specified in 
                subparagraph (A) in the event of a merger or 
                acquisition of the entity in order to ensure 
                that the requirements specified in this 
                subsection will continue to be met.
          (5) Compliance with requirements for records or 
        reports on devices.--The participation of a 
        manufacturer in pilot projects under this subsection 
        shall not affect the eligibility of such manufacturer 
        to participate in any quarterly reporting program with 
        respect to devices carried out under section 519 or 
        522. The Secretary may determine that, for a specified 
        time period to be determined by the Secretary, a 
        manufacturer's participation in a pilot project under 
        this subsection or a project continued or expanded 
        under paragraph (3) may meet the applicable 
        requirements of section 519 or 522, if--
                  (A) the project has demonstrated success in 
                capturing relevant adverse event information; 
                and
                  (B) the Secretary has established procedures 
                for making adverse event and safety information 
                collected from such project public, to the 
                extent possible.
          (6) Privacy requirements.--With respect to the 
        disclosure of any health information collected through 
        a project conducted under this subsection--
                  (A) individually identifiable health 
                information so collected shall not be disclosed 
                when presenting any information from such 
                project; and
                  (B) any such disclosure shall be made in 
                compliance with regulations issued pursuant to 
                section 264(c) of the Health Insurance 
                Portability and Accountability Act of 1996 (42 
                U.S.C. 1320d-2 note) and sections 552 and 552a 
                of title 5, United States Code.
          (7) Limitations.--
                  (A) In general.--No pilot project under this 
                subsection undertaken in coordination with the 
                comprehensive system described in paragraph 
                (1)(C), shall allow for an entity participating 
                in such program, other than the Secretary or 
                the Secretary's designee, to make 
                determinations of safety or effectiveness, or 
                substantial equivalence, for purposes of the 
                Act.
                  (B) No use of fees.--Pilot projects initiated 
                under this subsection may not primarily utilize 
                funds collected pursuant to the Medical Device 
                User Fee Amendments of 2017.
          (8) Other projects required to comply.--Paragraphs 
        (1)(B), (4)(A)(i), (4)(A)(ii), (5), and (6) shall apply 
        with respect to any pilot program undertaken in 
        coordination with the comprehensive system described in 
        paragraph (1)(C) that relates to the use of real world 
        evidence for devices in the same manner and to the same 
        extent as such paragraphs apply with respect to pilot 
        projects conducted under this subsection.
          (9) Report to congress.--Not later than 18 months 
        after the date of enactment of this Act, and annually 
        thereafter, the Secretary 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 a 
        description of the pilot projects being conducted under 
        this subsection and projects continued or expanded 
        pursuant to paragraph (3), including for each such 
        project--
                  (A) how the project is being implemented in 
                accordance with paragraph (4), including how 
                such project is being implemented through a 
                contract, cooperative agreement, grant, or 
                other appropriate agreement, if applicable;
                  (B) the number of manufacturers that have 
                agreed to participate in such project;
                  (C) the data sources used to conduct such 
                project;
                  (D) the devices or device categories involved 
                in such project;
                  (E) the number of patients involved in such 
                project; and
                  (F) the findings of the project in relation 
                to device safety, including adverse events, 
                malfunctions, and other safety information.
          (10) Sunset.--The Secretary may not carry out a pilot 
        project initiated by the Secretary under this 
        subsection after October 1, 2022.

general provisions respecting control of devices intended for human use

                              General Rule

  Sec. 520. (a) Any requirement authorized by or under section 
501, 502, 510, or 519 applicable to a device intended for human 
use shall apply to such device until the applicability of the 
requirement to the device has been changed by action taken 
under section 513, 514, or 515 or under subsection (g) of this 
section, and any requirement established by or under section 
501, 502, 510, or 519 which is inconsistent with a requirement 
imposed on such device under section 514 or 515 or under 
subsection (g) of this section shall not apply to such device.
  (b) Custom Devices.--
          (1) In general.--The requirements of sections 514 and 
        515 shall not apply to a device that--
                  (A) is created or modified in order to comply 
                with the order of an individual physician or 
                dentist (or any other specially qualified 
                person designated under regulations promulgated 
                by the Secretary after an opportunity for an 
                oral hearing);
                  (B) in order to comply with an order 
                described in subparagraph (A), necessarily 
                deviates from an otherwise applicable 
                performance standard under section 514 or 
                requirement under section 515;
                  (C) is not generally available in the United 
                States in finished form through labeling or 
                advertising by the manufacturer, importer, or 
                distributor for commercial distribution;
                  (D) is designed to treat a unique pathology 
                or physiological condition that no other device 
                is domestically available to treat;
                  (E)(i) is intended to meet the special needs 
                of such physician or dentist (or other 
                specially qualified person so designated) in 
                the course of the professional practice of such 
                physician or dentist (or other specially 
                qualified person so designated); or
                  (ii) is intended for use by an individual 
                patient named in such order of such physician 
                or dentist (or other specially qualified person 
                so designated);
                  (F) is assembled from components or 
                manufactured and finished on a case-by-case 
                basis to accommodate the unique needs of 
                individuals described in clause (i) or (ii) of 
                subparagraph (E); and
                  (G) may have common, standardized design 
                characteristics, chemical and material 
                compositions, and manufacturing processes as 
                commercially distributed devices.
          (2) Limitations.--Paragraph (1) shall apply to a 
        device only if--
                  (A) such device is for the purpose of 
                treating a sufficiently rare condition, such 
                that conducting clinical investigations on such 
                device would be impractical;
                  (B) production of such device under paragraph 
                (1) is limited to no more than 5 units per year 
                of a particular device type, provided that such 
                replication otherwise complies with this 
                section; and
                  (C) the manufacturer of such device notifies 
                the Secretary on an annual basis, in a manner 
                prescribed by the Secretary, of the manufacture 
                of such device.
          (3) Guidance.--Not later than 2 years after the date 
        of enactment of this section, the Secretary shall issue 
        final guidance on replication of multiple devices 
        described in paragraph (2)(B).

                             Trade Secrets

  (c) Any information reported to or otherwise obtained by the 
Secretary or his representative under section 513, 514, 515, 
516, 518, 519, or 704 or under subsection (f) or (g) of this 
section which is exempt from disclosure pursuant to subsection 
(a) of section 552 of title 5, United States Code, by reason of 
subsection (b)(4) of such section shall be considered 
confidential and shall not be disclosed and may not be used by 
the Secretary as the basis for the reclassification of a device 
from class III to class II or class I or as the basis for the 
establishment or amendment of a performance standard under 
section 514 for a device reclassified from class III to class 
II, except (1) in accordance with subsection (h), and (2) that 
such information may be disclosed to other officers or 
employees concerned with carrying out this Act or when relevant 
in any proceeding under this Act (other than section 513 or 514 
thereof).

                          Notices and Findings

  (d) Each notice of proposed rulemaking under section 513, 
514, 515, 516, 518, or 519, or under this section, any other 
notice which is published in the Federal Register with respect 
to any other action taken under any such section and which 
states the reasons for such action, and each publication of 
findings required to be made in connection with rulemaking 
under any such section shall set forth--
          (1) the manner in which interested persons may 
        examine data and other information on which the notice 
        or findings is based, and
          (2) the period within which interested persons may 
        present their comments on the notice or findings 
        (including the need therefor) orally or in writing, 
        which period shall be at least sixty days but may not 
        exceed ninety days unless the time is extended by the 
        Secretary by a notice published in the Federal Register 
        stating good cause therefor.

                           Restricted Devices

  (e)(1) The Secretary may by regulation require that a device 
be restricted to sale, distribution, or use--
          (A) only upon the written or oral authorization of a 
        practitioner licensed by law to administer or use such 
        device, or
          (B) upon such other conditions as the Secretary may 
        prescribe in such regulation,
if, because of its potentiality for harmful effect or the 
collateral measures necessary to its use, the Secretary 
determines that there cannot otherwise be reasonable assurance 
of its safety and effectiveness. No condition prescribed under 
subparagraph (B) may restrict the use of a device to persons 
with specific training or experience in its use or to persons 
for use in certain facilities unless the Secretary determines 
that such a restriction is required for the safe and effective 
use of the device. No such condition may exclude a person from 
using a device solely because the person does not have the 
training or experience to make him eligible for certification 
by a certifying board recognized by the American Board of 
Medical Specialties or has not been certified by such a Board. 
A device subject to a regulation under this subsection is a 
restricted device.
  (2) The label of a restricted device shall bear such 
appropriate statements of the restrictions required by a 
regulation under paragraph (1) as the Secretary may in such 
regulation prescribe.

                Good Manufacturing Practice Requirements

  (f)(1)(A) The Secretary may, in accordance with subparagraph 
(B), prescribe regulations requiring that the methods used in, 
and the facilities and controls used for, the manufacture, pre-
production design validation (including a process to assess the 
performance of a device but not including an evaluation of the 
safety or effectiveness of a device), packing, storage, and 
installation of a device conform to current good manufacturing 
practice, as prescribed in such regulations, to assure that the 
device will be safe and effective and otherwise in compliance 
with this Act.
  (B) Before the Secretary may promulgate any regulation under 
subparagraph (A) he shall--
          (i) afford the advisory committee established under 
        paragraph (3) an opportunity to submit recommendations 
        to him with respect to the regulation proposed to be 
        promulgated;
          (ii) afford opportunity for an oral hearing; and
          (iii) ensure that such regulation conforms, to the 
        extent practicable, with internationally recognized 
        standards defining quality systems, or parts of the 
        standards, for medical devices.
The Secretary shall provide the advisory committee a reasonable 
time to make its recommendation with respect to proposed 
regulations under subparagraph (A).
  (2)(A) Any person subject to any requirement prescribed by 
regulations under paragraph (1) may petition the Secretary for 
an exemption or variance from such requirement. Such a petition 
shall be submitted to the Secretary in such form and manner as 
he shall prescribe and shall--
          (i) in the case of a petition for an exemption from a 
        requirement, set forth the basis for the petitioner's 
        determination that compliance with the requirement is 
        not required to assure that the device will be safe and 
        effective and otherwise in compliance with this Act,
          (ii) in the case of a petition for a variance from a 
        requirement, set forth the methods proposed to be used 
        in, and the facilities and controls proposed to be used 
        for, the manufacture, packing, storage, and 
        installation of the device in lieu of the methods, 
        facilities, and controls prescribed by the requirement, 
        and
          (iii) contain such other information as the Secretary 
        shall prescribe.
  (B) The Secretary may refer to the advisory committee 
established under paragraph (3) any petition submitted under 
subparagraph (A). The advisory committee shall report its 
recommendations to the Secretary with respect to a petition 
referred to it within sixty days of the date of the petition's 
referral. Within sixty days after--
          (i) the date the petition was submitted to the 
        Secretary under subparagraph (A), or
          (ii) if the petition was referred to an advisory 
        committee, the expiration of the sixty-day period 
        beginning on the date the petition was referred to the 
        advisory committee,
whichever occurs later, the Secretary shall by order either 
deny the petition or approve it.
  (C) The Secretary may approve--
          (i) a petition for an exemption for a device from a 
        requirement if he determines that compliance with such 
        requirement is not required to assure that the device 
        will be safe and effective and otherwise in compliance 
        with this Act, and
          (ii) a petition for a variance for a device from a 
        requirement if he determines that the methods to be 
        used in, and the facilities and controls to be used 
        for, the manufacture, packing, storage, and 
        installation of the device in lieu of the methods, 
        controls, and facilities prescribed by the requirement 
        are sufficient to assure that the device will be safe 
        and effective and otherwise in compliance with this 
        Act.
An order of the Secretary approving a petition for a variance 
shall prescribe such conditions respecting the methods used in, 
and the facilities and controls used for, the manufacture, 
packing, storage, and installation of the device to be granted 
the variance under the petition as may be necessary to assure 
that the device will be safe and effective and otherwise in 
compliance with this Act.
  (D) After the issuance of an order under subparagraph (B) 
respecting a petition, the petitioner shall have an opportunity 
for an informal hearing on such order.
  (3) The Secretary shall establish an advisory committee for 
the purpose of advising and making recommendations to him with 
respect to regulations proposed to be promulgated under 
paragraph (1)(A) and the approval or disapproval of petitions 
submitted under paragraph (2). The advisory committee shall be 
composed of nine members as follows:
          (A) Three of the members shall be appointed from 
        persons who are officers or employees of any State or 
        local government or of the Federal Government.
          (B) Two of the members shall be appointed from 
        persons who are representative of interests of the 
        device manufacturing industry; two of the members shall 
        be appointed from persons who are representative of the 
        interests of physicians and other health professionals; 
        and two of the members shall be representative of the 
        interests of the general public.
Members of the advisory committee who are not officers or 
employees of the United States, while attending conferences or 
meetings of the committee or otherwise engaged in its business, 
shall be entitled to receive compensation at rates to be fixed 
by the Secretary, which rates may not exceed the daily 
equivalent of the rate in effect for grade GS-18 of the General 
Schedule, for each day (including traveltime) they are so 
engaged; and while so serving away from their homes or regular 
places of business each member may be allowed travel expenses, 
including per diem in lieu of subsistence, as authorized by 
section 5703 of title 5 of the United States Code for persons 
in the Government service employed intermittently. The 
Secretary shall designate one of the members of the advisory 
committee to serve as its chairman. The Secretary shall furnish 
the advisory committee with clerical and other assistance. 
Section 14 of the Federal Advisory Committee Act shall not 
apply with respect to the duration of the advisory committee 
established under this paragraph.

             Exemption for Devices for Investigational Use

  (g)(1) It is the purpose of this subsection to encourage to 
the extent consistent with the protection of the public health 
and safety and with ethical standards, the discovery and 
development of useful devices intended for human use and to 
that end to maintain optimum freedom for scientific 
investigators in their pursuit of that purpose.
  (2)(A) The Secretary shall, within the one hundred and 
twenty-day period beginning on the date of the enactment of 
this section, by regulation prescribe procedures and conditions 
under which devices intended for human use may upon application 
be granted an exemption from the requirements of section 502, 
510, 514, 515, 516, 519, or 721 or subsection (e) or (f) of 
this section or from any combination of such requirements to 
permit the investigational use of such devices by experts 
qualified by scientific training and experience to investigate 
the safety and effectiveness of such devices.
  (B) The conditions prescribed pursuant to subparagraph (A) 
shall include the following:
          (i) A requirement that an application be submitted to 
        the Secretary before an exemption may be granted and 
        that the application be submitted in such form and 
        manner as the Secretary shall specify.
          (ii) A requirement that the person applying for an 
        exemption for a device assure the establishment and 
        maintenance of such records, and the making of such 
        reports to the Secretary of safety or effectiveness 
        data obtained as a result of the investigational use of 
        the device during the exemption, as the Secretary 
        determines will enable him to assure compliance with 
        such conditions, review the progress of the 
        investigation, and evaluate the safety and 
        effectiveness of the device.
          (iii) Such other requirements as the Secretary may 
        determine to be necessary for the protection of the 
        public health and safety.
  (C) Procedures and conditions prescribed pursuant to 
subparagraph (A) for an exemption may appropriately vary 
depending on (i) the scope and duration of clinical testing to 
be conducted under such exemption, (ii) the number of human 
subjects that are to be involved in such testing, (iii) the 
need to permit changes to be made in the device subject to the 
exemption during testing conducted in accordance with a 
clinical testing plan required under paragraph (3)(A), and (iv) 
whether the clinical testing of such device is for the purpose 
of developing data to obtain approval for the commercial 
distribution of such device.
  (3) Procedures and conditions prescribed pursuant to 
paragraph (2)(A) shall require, as a condition to the exemption 
of any device to be the subject of testing involving human 
subjects, that the person applying for the exemption--
          (A) submit a plan for any proposed clinical testing 
        of the device and a report of prior investigations of 
        the device (including, where appropriate, tests on 
        animals) adequate to justify the proposed clinical 
        testing--
                  (i) to the institutional review committee 
                established in accordance with regulations of 
                the Secretary to supervise clinical testing of 
                devices in the facilities where the proposed 
                clinical testing is to be conducted, or
                  (ii) to the Secretary, if--
                          (I) no such committee exists, or
                          (II) the Secretary finds that the 
                        process of review by such committee is 
                        inadequate (whether or not the plan for 
                        such testing has been approved by such 
                        committee),
        for review for adequacy to justify the commencement of 
        such testing; and, unless the plan and report are 
        submitted to the Secretary, submit to the Secretary a 
        summary of the plan and a report of prior 
        investigations of the device (including, where 
        appropriate, tests on animals);
          (B) promptly notify the Secretary (under such 
        circumstances and in such manner as the Secretary 
        prescribes) of approval by an institutional review 
        committee of any clinical testing plan submitted to it 
        in accordance with subparagraph (A);
          (C) in the case of a device to be distributed to 
        investigators for testing, obtain signed agreements 
        from each of such investigators that any testing of the 
        device involving human subjects will be under such 
        investigator's supervision and in accordance with 
        subparagraph (D) and submit such agreements to the 
        Secretary; and
          (D) assure that informed consent will be obtained 
        from each human subject (or his representative) of 
        proposed clinical testing involving such device, 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 conducting or 
                supervising the proposed clinical testing of 
                the device determines in writing that there 
                exists a life threatening situation involving 
                the human subject of such testing which 
                necessitates the use of such device and it is 
                not feasible to obtain informed consent from 
                the subject and there is not sufficient time to 
                obtain such consent from his representative.
The determination required by subparagraph (D)(ii) shall be 
concurred in by a licensed physician who is not involved in the 
testing of the human subject with respect to which such 
determination is made unless immediate use of the device is 
required to save the life of the human subject of such testing 
and there is not sufficient time to obtain such concurrence.
  (4)(A) An application, submitted in accordance with the 
procedures prescribed by regulations under paragraph (2), for 
an exemption for a device (other than an exemption from section 
516) shall be deemed approved on the thirtieth day after the 
submission of the application to the Secretary unless on or 
before such day the Secretary by order disapproves the 
application and notifies the applicant of the disapproval of 
the application.
  (B) The Secretary may disapprove an application only if he 
finds that the investigation with respect to which the 
application is submitted does not conform to procedures and 
conditions prescribed under regulations under paragraph (2). 
Such a notification shall contain the order of disapproval and 
a complete statement of the reasons for the Secretary's 
disapproval of the application and afford the applicant 
opportunity for an informal hearing on the disapproval order.
  (C) Consistent with paragraph (1), the Secretary shall not 
disapprove an application under this subsection because the 
Secretary determines that--
          (i) the investigation may not support a substantial 
        equivalence or de novo classification determination or 
        approval of the device;
          (ii) the investigation may not meet a requirement, 
        including a data requirement, relating to the approval 
        or clearance of a device; or
          (iii) an additional or different investigation may be 
        necessary to support clearance or approval of the 
        device.
  (5) The Secretary may by order withdraw an exemption granted 
under this subsection for a device if the Secretary determines 
that the conditions applicable to the device under this 
subsection for such exemption are not met. Such an order may be 
issued only after opportunity for an informal hearing, except 
that such an order may be issued before the provision of an 
opportunity for an informal hearing if the Secretary determines 
that the continuation of testing under the exemption with 
respect to which the order is to be issued will result in an 
unreasonable risk to the public health.
  (6)(A) Not later than 1 year after the date of the enactment 
of the Food and Drug Administration Modernization Act of 1997, 
the Secretary shall by regulation establish, with respect to a 
device for which an exemption under this subsection is in 
effect, procedures and conditions that, without requiring an 
additional approval of an application for an exemption or the 
approval of a supplement to such an application, permit--
          (i) developmental changes in the device (including 
        manufacturing changes) that do not constitute a 
        significant change in design or in basic principles of 
        operation and that are made in response to information 
        gathered during the course of an investigation; and
          (ii) changes or modifications to clinical protocols 
        that do not affect--
                  (I) the validity of data or information 
                resulting from the completion of an approved 
                protocol, or the relationship of likely patient 
                risk to benefit relied upon to approve a 
                protocol;
                  (II) the scientific soundness of an 
                investigational plan submitted under paragraph 
                (3)(A); or
                  (III) the rights, safety, or welfare of the 
                human subjects involved in the investigation.
  (B) Regulations under subparagraph (A) shall provide that a 
change or modification described in such subparagraph may be 
made if--
          (i) the sponsor of the investigation determines, on 
        the basis of credible information (as defined by the 
        Secretary) that the applicable conditions under 
        subparagraph (A) are met; and
          (ii) the sponsor submits to the Secretary, not later 
        than 5 days after making the change or modification, a 
        notice of the change or modification.
  (7)(A) In the case of a person intending to investigate the 
safety or effectiveness of a class III device or any 
implantable device, the Secretary shall ensure that the person 
has an opportunity, prior to submitting an application to the 
Secretary or to an institutional review committee, to submit to 
the Secretary, for review, an investigational plan (including a 
clinical protocol). If the applicant submits a written request 
for a meeting with the Secretary regarding such review, the 
Secretary shall, not later than 30 days after receiving the 
request, meet with the applicant for the purpose of reaching 
agreement regarding the investigational plan (including a 
clinical protocol). The written request shall include a 
detailed description of the device, a detailed description of 
the proposed conditions of use of the device, a proposed plan 
(including a clinical protocol) for determining whether there 
is a reasonable assurance of effectiveness, and, if available, 
information regarding the expected performance from the device.
  (B) Any agreement regarding the parameters of an 
investigational plan (including a clinical protocol) that is 
reached between the Secretary and a sponsor or applicant shall 
be reduced to writing and made part of the administrative 
record by the Secretary. Any such agreement shall not be 
changed, except--
          (i) with the written agreement of the sponsor or 
        applicant; or
          (ii) pursuant to a decision, made in accordance with 
        subparagraph (C) by the director of the office in which 
        the device involved is reviewed, that a substantial 
        scientific issue essential to determining the safety or 
        effectiveness of the device involved has been 
        identified.
  (C) A decision under subparagraph (B)(ii) by the director 
shall be in writing, and may be made only after the Secretary 
has provided to the sponsor or applicant an opportunity for a 
meeting at which the director and the sponsor or applicant are 
present and at which the director documents the scientific 
issue involved.
  (8)(A) At any time, the Secretary may prohibit the sponsor of 
an investigation from conducting the investigation (referred to 
in this paragraph as a ``clinical hold'') if the Secretary 
makes a determination described in subparagraph (B). The 
Secretary shall specify the basis for the clinical hold, 
including the specific information available to the Secretary 
which served as the basis for such clinical hold, and confirm 
such determination in writing.
  (B) For purposes of subparagraph (A), a determination 
described in this subparagraph with respect to a clinical hold 
is a determination that--
          (i) the device involved represents an unreasonable 
        risk to the safety of the persons who are the subjects 
        of the clinical investigation, taking into account the 
        qualifications of the clinical investigators, 
        information about the device, the design of the 
        clinical investigation, the condition for which the 
        device is to be investigated, and the health status of 
        the subjects involved; or
          (ii) the clinical hold should be issued for such 
        other reasons as the Secretary may by regulation 
        establish.
  (C) Any written request to the Secretary from the sponsor of 
an investigation that a clinical hold be removed shall receive 
a decision, in writing and specifying the reasons therefor, 
within 30 days after receipt of such request. Any such request 
shall include sufficient information to support the removal of 
such clinical hold.

            Release of Safety and Effectiveness Information

  (h)(1) The Secretary shall promulgate regulations under which 
a detailed summary of information respecting the safety and 
effectiveness of a device which information was submitted to 
the Secretary and which was the basis for--
          (A) an order under section 515(d)(1)(A) approving an 
        application for premarket approval for the device or 
        denying approval of such an application or an order 
        under section 515(e) withdrawing approval of such an 
        application for the device,
          (B) an order under section 515(f)(6)(A) revoking an 
        approved protocol for the device, an order under 
        section 515(f)(6)(B) declaring a protocol for the 
        device completed or not completed, or an order under 
        section 515(f)(7) revoking the approval of the device, 
        or
          (C) an order approving an application under 
        subsection (g) for an exemption for the device from 
        section 516 or an order disapproving, or withdrawing 
        approval of, an application for an exemption under such 
        subsection for the device,
shall be made available to the public upon issuance of the 
order. Summaries of information made available pursuant to this 
paragraph respecting a device shall include information 
respecting any adverse effects on health of the device.
  (2) The Secretary shall promulgate regulations under which 
each advisory committee established under section 515(g)(2)(B) 
shall make available to the public a detailed summary of 
information respecting the safety and effectiveness of a device 
which information was submitted to the advisory committee and 
which was the basis for its recommendation to the Secretary 
made pursuant to section 515(g)(2)(A). A summary of information 
upon which such a recommendation is based shall be made 
available pursuant to this paragraph only after the issuance of 
the order with respect to which the recommendation was made and 
each summary shall include information respecting any adverse 
effect on health of the device subject to such order.
  (3) Except as provided in paragraph (4), any information 
respecting a device which is made available pursuant to 
paragraph (1) or (2) of this subsection (A) may not be used to 
establish the safety or effectiveness of another device for 
purposes of this Act by any person other than the person who 
submitted the information so made available, and (B) shall be 
made available subject to subsection (c) of this section.
  (4)(A) Subject to subparagraph (C), any information contained 
in an application for premarket approval filed with the 
Secretary pursuant to section 515(c) (including information 
from clinical and preclinical tests or studies that demonstrate 
the safety and effectiveness of a device, but excluding 
descriptions of methods of manufacture and product composition 
and other trade secrets) shall be available, 6 years after the 
application has been approved by the Secretary, for use by the 
Secretary in--
          (i) approving another device;
          (ii) determining whether a product development 
        protocol has been completed, under section 515 for 
        another device;
          (iii) establishing a performance standard or special 
        control under this Act; or
          (iv) classifying or reclassifying another device 
        under section 513 and subsection (l)(2).
  (B) The publicly available detailed summaries of information 
respecting the safety and effectiveness of devices required by 
paragraph (1)(A) shall be available for use by the Secretary as 
the evidentiary basis for the agency actions described in 
subparagraph (A).
  (C) No information contained in an application for premarket 
approval filed with the Secretary pursuant to section 515(c) 
may be used to approve or clear any application submitted under 
section 515 or 510(k) or to classify a product under section 
513(f)(2) for a combination product containing as a constituent 
part an approved drug (as defined in section 503(g)(5)(B)) 
unless--
          (i) the application includes the certification or 
        statement referenced in section 503(g)(5)(A);
          (ii) the applicant provides notice as described in 
        section 503(g)(5)(A); and
          (iii) the Secretary's approval of such application is 
        subject to the provisions in section 503(g)(5)(C).

             Proceedings of Advisory Panels and Committees

  (i) Each panel under section 513 and each advisory committee 
established under section 514(b)(5)(B) or 515(g) or under 
subsection (f) of this section shall make and maintain a 
transcript of any proceeding of the panel or committee. Each 
such panel and committee shall delete from any transcript made 
pursuant to this subsection information which under subsection 
(c) of this section is to be considered confidential.

                       Traceability Requirements

  (j) Except as provided in section 519(e), no regulation under 
this Act may impose on a type or class of device requirements 
for the traceability of such type or class of device unless 
such requirements are necessary to assure the protection of the 
public health.

                        Research and Development

  (k) The Secretary may enter into contracts for research, 
testing, and demonstrations respecting devices and may obtain 
devices for research, testing, and demonstration purposes 
without regard to sections 3648 and 3709 of the Revised 
Statutes (31 U.S.C. 529, 41 U.S.C. 5).

      Transitional Provisions for Devices Considered as New Drugs

  (l)(1) Any device intended for human use--
          (A) for which on the date of enactment of the Medical 
        Device Amendments of 1976 (hereinafter in this 
        subsection referred to as the ``enactment date'') an 
        approval of an application submitted under section 
        505(b) was in effect;
          (B) for which such an application was filed on or 
        before the enactment date and with respect to which 
        application no order of approval or refusing to approve 
        had been issued on such date under subsection (c) or 
        (d) of such section;
          (C) for which on the enactment date an exemption 
        under subsection (i) of such section was in effect;
          (D) which is within a type of device described in 
        subparagraph (A), (B), or (C) and is substantially 
        equivalent to another device within that type;
          (E) which the Secretary in a notice published in the 
        Federal Register before the enactment date has declared 
        to be a new drug subject to section 505; or
          (F) with respect to which on the enactment date an 
        action is pending in a United States court under 
        section 302, 303, or 304 for an alleged violation of a 
        provision of section 301 which enforces a requirement 
        of section 505 or for an alleged violation of section 
        505(a),
is classified in class III unless the Secretary in response to 
a petition submitted under paragraph (2) has classified such 
device in class I or II.
  (2) The Secretary may initiate the reclassification of a 
device classified into class III under paragraph (1) of this 
subsection or the manufacturer or importer of a device 
classified under paragraph (1) may petition the Secretary (in 
such form and manner as he shall prescribe) for the issuance of 
an order classifying the device in class I or class II. Within 
thirty days of the filing of such a petition, the Secretary 
shall notify the petitioner of any deficiencies in the petition 
which prevent the Secretary from making a decision on the 
petition. Except as provided in paragraph (3)(D)(ii), within 
one hundred and eighty days after the filing of a petition 
under this paragraph, the Secretary shall, after consultation 
with the appropriate panel under section 513, by order either 
deny the petition or order the classification, in accordance 
with the criteria prescribed by section 513(a)(1)(A) or 
513(a)(1)(B), of the device in class I or class II.
  (3)(A) In the case of a device which is described in 
paragraph (1)(A) and which is in class III--
          (i) such device shall on the enactment date be 
        considered a device with an approved application under 
        section 515, and
          (ii) the requirements applicable to such device 
        before the enactment date under section 505 shall 
        continue to apply to such device until changed by the 
        Secretary as authorized by this Act.
  (B) In the case of a device which is described in paragraph 
(1)(B) and which is in class III, an application for such 
device shall be considered as having been filed under section 
515 on the enactment date. The period in which the Secretary 
shall act on such application in accordance with section 
515(d)(1) shall be one hundred and eighty days from the 
enactment date (or such greater period as the Secretary and the 
applicant may agree upon after the Secretary has made the 
finding required by section 515(d)(1)(B)(i)) less the number of 
days in the period beginning on the date an application for 
such device was filed under section 505 and ending on the 
enactment date. After the expiration of such period such device 
is required, unless exempt under subsection (g), to have in 
effect an approved application under section 515.
  (C) A device which is described in paragraph (1)(C) and which 
is in class III shall be considered a new drug until the 
expiration of the ninety-day period beginning on the date of 
the promulgation of regulations under subsection (g) of this 
section. After the expiration of such period such device is 
required, unless exempt under subsection (g), to have in effect 
an approved application under section 515.
  (D)(i) Except as provided in clauses (ii) and (iii), a device 
which is described in subparagraph (D), (E), or (F) of 
paragraph (1) and which is in class III is required, unless 
exempt under subsection (g) of this section, to have on and 
after sixty days after the enactment date in effect an approved 
application under section 515.
  (ii) If--
          (I) a petition is filed under paragraph (2) for a 
        device described in subparagraph (D), (E), or (F) of 
        paragraph (1), or
          (II) an application for premarket approval is filed 
        under section 515 for such a device,
within the sixty-day period beginning on the enactment date (or 
within such greater period as the Secretary, after making the 
finding required under section 515(d)(1)(B), and the petitioner 
or applicant may agree upon), the Secretary shall act on such 
petition or application in accordance with paragraph (2) or 
section 515 except that the period within which the Secretary 
must act on the petition or application shall be within the one 
hundred and twenty-day period beginning on the date the 
petition or application is filed. If such a petition or 
application is filed within such sixty-day (or greater) period, 
clause (i) of this subparagraph shall not apply to such device 
before the expiration of such one hundred and twenty-day 
period, or if such petition is denied or such application is 
denied approval, before the date of such denial, whichever 
occurs first.
  (iii) In the case of a device which is described in 
subparagraph (E) of paragraph (1), which the Secretary in a 
notice published in the Federal Register after March 31, 1976, 
declared to be a new drug subject to section 505, and which is 
in class III--
          (I) the device shall, after eighteen months after the 
        enactment date, have in effect an approved application 
        under section 515 unless exempt under subsection (g) of 
        this section, and
          (II) the Secretary may, during the period beginning 
        one hundred and eighty days after the enactment date 
        and ending eighteen months after such date, restrict 
        the use of the device to investigational use by experts 
        qualified by scientific training and experience to 
        investigate the safety and effectiveness of such 
        device, and to investigational use in accordance with 
        the requirements applicable under regulations under 
        subsection (g) of this section to investigational use 
        of devices granted an exemption under such subsection.
If the requirements under subsection (g) of this section are 
made applicable to the investigational use of such a device, 
they shall be made applicable in such a manner that the device 
shall be made reasonably available to physicians meeting 
appropriate qualifications prescribed by the Secretary.
  (5)(A) Before December 1, 1991, the Secretary shall by order 
require manufacturers of devices described in paragraph (1), 
which are subject to revision of classification under 
subparagraph (B), to submit to the Secretary a summary of and 
citation to any information known or otherwise available to the 
manufacturers respecting the devices, including adverse safety 
or effectiveness information which has not been submitted under 
section 519. The Secretary may require a manufacturer to submit 
the adverse safety or effectiveness data for which a summary 
and citation were submitted, if such data are available to the 
manufacturer.
  (B) Except as provided in subparagraph (C), after the 
issuance of an order under subparagraph (A) but before December 
1, 1992, the Secretary shall publish a regulation in the 
Federal Register for each device which is classified in class 
III under paragraph (1) revising the classification of the 
device so that the device is classified into class I or class 
II, unless the regulation requires the device to remain in 
class III. In determining whether to revise the classification 
of a device or to require a device to remain in class III, the 
Secretary shall apply the criteria set forth in section 513(a). 
Before the publication of a regulation requiring a device to 
remain in class III or revising its classification, the 
Secretary shall publish a proposed regulation respecting the 
classification of a device under this subparagraph and provide 
an opportunity for the submission of comments on any such 
regulation. No regulation under this subparagraph requiring a 
device to remain in class III or revising its classification 
may take effect before the expiration of 90 days from the date 
of the publication in the Federal Register of the proposed 
regulation.
  (C) The Secretary may by notice published in the Federal 
Register extend the period prescribed by subparagraph (B) for a 
device for an additional period not to exceed 1 year.

                     Humanitarian Device Exemption

  (m)(1) To the extent consistent with the protection of the 
public health and safety and with ethical standards, it is the 
purpose of this subsection to encourage the discovery and use 
of devices intended to benefit patients in the treatment and 
diagnosis of diseases or conditions that affect not more than 
8,000 individuals in the United States.
  (2) The Secretary may grant a request for an exemption from 
the effectiveness requirements of sections 514 and 515 for a 
device for which the Secretary finds that--
          (A) the device is designed to treat or diagnose a 
        disease or condition that affects not more than 8,000 
        individuals in the United States,
          (B) the device would not be available to a person 
        with a disease or condition referred to in subparagraph 
        (A) unless the Secretary grants such an exemption and 
        there is no comparable device, other than under this 
        exemption, available to treat or diagnose such disease 
        or condition, and
          (C) the device will not expose patients to an 
        unreasonable or significant risk of illness or injury 
        and the probable benefit to health from the use of the 
        device outweighs the risk of injury or illness from its 
        use, taking into account the probable risks and 
        benefits of currently available devic or alternative 
        forms of treatment.
The request shall be in the form of an application submitted to 
the Secretary and such application shall include the 
certification required under section 402(j)(5)(B) of the Public 
Health Service Act (which shall not be considered an element of 
such application). Not later than 75 days after the date of the 
receipt of the application, the Secretary shall issue an order 
approving or denying the application.
  (3) Except as provided in paragraph (6), no person granted an 
exemption under paragraph (2) with respect to a device may sell 
the device for an amount that exceeds the costs of research and 
development, fabrication, and distribution of the device.
  (4) Devices granted an exemption under paragraph (2) may only 
be used--
          (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) if, before the use of a device, an institutional 
        review committee approves the use in the treatment or 
        diagnosis of a disease or condition referred to in 
        paragraph (2)(A), unless a physician determines in an 
        emergency situation that approval from an institutional 
        review committee can not be obtained in time to prevent 
        serious harm or death to a patient.
In a case described in subparagraph (B) in which a physician 
uses a device without an approval from an institutional review 
committee, the physician shall, after the use of the device, 
notify the chairperson of the institutional review committee of 
such use. Such notification shall include the identification of 
the patient involved, the date on which the device was used, 
and the reason for the use.
  (5) The Secretary may require a person granted an exemption 
under paragraph (2) to demonstrate continued compliance with 
the requirements of this subsection if the Secretary believes 
such demonstration to be necessary to protect the public 
health, if the Secretary has reason to believe that the 
requirements of paragraph (6) are no longer met, or if the 
Secretary has reason to believe that the criteria for the 
exemption are no longer met. If the person granted an exemption 
under paragraph (2) fails to demonstrate continued compliance 
with the requirements of this subsection, the Secretary may 
suspend or withdraw the exemption from the effectiveness 
requirements of sections 514 and 515 for a humanitarian device 
only after providing notice and an opportunity for an informal 
hearing.
  (6)(A) Except as provided in subparagraph (D), the 
prohibition in paragraph (3) shall not apply with respect to a 
person granted an exemption under paragraph (2) if each of the 
following conditions apply:
          (i) The device with respect to which the exemption is 
        granted--
                  (I) is intended for the treatment or 
                diagnosis of a disease or condition that occurs 
                in pediatric patients or in a pediatric 
                subpopulation, and such device is labeled for 
                use in pediatric patients or in a pediatric 
                subpopulation in which the disease or condition 
                occurs; or
                  (II) is intended for the treatment or 
                diagnosis of a disease or condition that does 
                not occur in pediatric patients or that occurs 
                in pediatric patients in such numbers that the 
                development of the device for such patients is 
                impossible, highly impracticable, or unsafe.
          (ii) During any calendar year, the number of such 
        devices distributed during that year under each 
        exemption granted under this subsection does not exceed 
        the annual distribution number for such device. In this 
        paragraph, the term ``annual distribution number'' 
        means the number of such devices reasonably needed to 
        treat, diagnose, or cure a population of 8,000 
        individuals in the United States. The Secretary shall 
        determine the annual distribution number when the 
        Secretary grants such exemption.
          (iii) Such person immediately notifies the Secretary 
        if the number of such devices distributed during any 
        calendar year exceeds the annual distribution number 
        referred to in clause (ii).
          (iv) The request for such exemption is submitted on 
        or before October 1, [2017] 2022.
  (B) The Secretary may inspect the records relating to the 
number of devices distributed during any calendar year of a 
person granted an exemption under paragraph (2) for which the 
prohibition in paragraph (3) does not apply.
  (C) A person may petition the Secretary to modify the annual 
distribution number determined by the Secretary under 
subparagraph (A)(ii) with respect to a device if additional 
information arises, and the Secretary may modify such annual 
distribution number.
  (D) If a person notifies the Secretary, or the Secretary 
determines through an inspection under subparagraph (B), that 
the number of devices distributed during any calendar year 
exceeds the annual distribution number, as required under 
subparagraph (A)(iii), and modified under subparagraph (C), if 
applicable, then the prohibition in paragraph (3) shall apply 
with respect to such person for such device for any sales of 
such device after such notification.
  (E)(i) In this subsection, the term ``pediatric patients'' 
means patients who are 21 years of age or younger at the time 
of the diagnosis or treatment.
  (ii) In this subsection, the term ``pediatric subpopulation'' 
means 1 of the following populations:
          (I) Neonates.
          (II) Infants.
          (III) Children.
          (IV) Adolescents.
  (7) The Secretary shall refer any report of an adverse event 
regarding a device described in paragraph (6)(A)(i)(I) for 
which the prohibition under paragraph (3) does not apply 
pursuant to paragraph (6)(A) that the Secretary receives to the 
Office of Pediatric Therapeutics, established under section 6 
of the Best Pharmaceuticals for Children Act (Public Law 107-
109). In considering the report, the Director of the Office of 
Pediatric Therapeutics, in consultation with experts in the 
Center for Devices and Radiological Health, shall provide for 
periodic review of the report by the Pediatric Advisory 
Committee, including obtaining any recommendations of such 
committee regarding whether the Secretary should take action 
under this Act in response to the report.
  (8) The Secretary, acting through the Office of Pediatric 
Therapeutics and the Center for Devices and Radiological 
Health, shall provide for an annual review by the Pediatric 
Advisory Committee of all devices described in paragraph 
(6)(A)(i)(I) to ensure that the exemption under paragraph (2) 
remains appropriate for the pediatric populations for which it 
is granted.

                 Regulation of Contact Lens as Devices

  (n)(1) All contact lenses shall be deemed to be devices under 
section 201(h).
  (2) Paragraph (1) shall not be construed as bearing on or 
being relevant to the question of whether any product other 
than a contact lens is a device as defined by section 201(h) or 
a drug as defined by section 201(g).
  (o) Regulation of Medical and Certain Decisions Support 
Software.--
          (1) The term device, as defined in section 201(h), 
        shall not include a software function that is 
        intended--
                  (A) for administrative support of a health 
                care facility, including the processing and 
                maintenance of financial records, claims or 
                billing information, appointment schedules, 
                business analytics, information about patient 
                populations, admissions, practice and inventory 
                management, analysis of historical claims data 
                to predict future utilization or cost-
                effectiveness, determination of health benefit 
                eligibility, population health management, and 
                laboratory workflow;
                  (B) for maintaining or encouraging a healthy 
                lifestyle and is unrelated to the diagnosis, 
                cure, mitigation, prevention, or treatment of a 
                disease or condition;
                  (C) to serve as electronic patient records, 
                including patient-provided information, to the 
                extent that such records are intended to 
                transfer, store, convert formats, or display 
                the equivalent of a paper medical chart, so 
                long as--
                          (i) such records were created, 
                        stored, transferred, or reviewed by 
                        health care professionals, or by 
                        individuals working under supervision 
                        of such professionals;
                          (ii) such records are part of health 
                        information technology that is 
                        certified under section 3001(c)(5) of 
                        the Public Health Service Act; and
                          (iii) such function is not intended 
                        to interpret or analyze patient 
                        records, including medical image data, 
                        for the purpose of the diagnosis, cure, 
                        mitigation, prevention, or treatment of 
                        a disease or condition;
                  (D) for transferring, storing, converting 
                formats, or displaying clinical laboratory test 
                or other device data and results, findings by a 
                health care professional with respect to such 
                data and results, general information about 
                such findings, and general background 
                information about such laboratory test or other 
                device, unless such function is intended to 
                interpret or analyze clinical laboratory test 
                or other device data, results, and findings; or
                  (E) unless the function is intended to 
                acquire, process, or analyze a medical image or 
                a signal from an in vitro diagnostic device or 
                a pattern or signal from a signal acquisition 
                system, for the purpose of--
                          (i) displaying, analyzing, or 
                        printing medical information about a 
                        patient or other medical information 
                        (such as peer-reviewed clinical studies 
                        and clinical practice guidelines);
                          (ii) supporting or providing 
                        recommendations to a health care 
                        professional about prevention, 
                        diagnosis, or treatment of a disease or 
                        condition; and
                          (iii) enabling such health care 
                        professional to independently review 
                        the basis for such recommendations that 
                        such software presents so that it is 
                        not the intent that such health care 
                        professional rely primarily on any of 
                        such recommendations to make a clinical 
                        diagnosis or treatment decision 
                        regarding an individual patient.
          (2) In the case of a product with multiple functions 
        that contains--
                  (A) at least one software function that meets 
                the criteria under paragraph (1) or that 
                otherwise does not meet the definition of 
                device under section 201(h); and
                  (B) at least one function that does not meet 
                the criteria under paragraph (1) and that 
                otherwise meets the definition of a device 
                under section 201(h),
        the Secretary shall not regulate the software function 
        of such product described in subparagraph (A) as a 
        device. Notwithstanding the preceding sentence, when 
        assessing the safety and effectiveness of the device 
        function or functions of such product described in 
        subparagraph (B), the Secretary may assess the impact 
        that the software function or functions described in 
        subparagraph (A) have on such device function or 
        functions.
          (3)(A) Notwithstanding paragraph (1), a software 
        function described in subparagraph (C), (D), or (E) of 
        paragraph (1) shall not be excluded from the definition 
        of device under section 201(h) if--
                  (i) the Secretary makes a finding that use of 
                such software function would be reasonably 
                likely to have serious adverse health 
                consequences; and
                  (ii) the software function has been 
                identified in a final order issued by the 
                Secretary under subparagraph (B).
          (B) Subparagraph (A) shall apply only if the 
        Secretary--
                  (i) publishes a notification and proposed 
                order in the Federal Register;
                  (ii) includes in such notification the 
                Secretary's finding, including the rationale 
                and identification of the evidence on which 
                such finding was based, as described in 
                subparagraph (A)(i); and
                  (iii) provides for a period of not less than 
                30 calendar days for public comment before 
                issuing a final order or withdrawing such 
                proposed order.
          (C) In making a finding under subparagraph (A)(i) 
        with respect to a software function, the Secretary 
        shall consider--
                  (i) the likelihood and severity of patient 
                harm if the software function were to not 
                perform as intended;
                  (ii) the extent to which the software 
                function is intended to support the clinical 
                judgment of a health care professional;
                  (iii) whether there is a reasonable 
                opportunity for a health care professional to 
                review the basis of the information or 
                treatment recommendation provided by the 
                software function; and
                  (iv) the intended user and user environment, 
                such as whether a health care professional will 
                use a software function of a type described in 
                subparagraph (E) of paragraph (1).
          (4) Nothing in this subsection shall be construed as 
        limiting the authority of the Secretary to--
                  (A) exercise enforcement discretion as to any 
                device subject to regulation under this Act;
                  (B) regulate software used in the manufacture 
                and transfusion of blood and blood components 
                to assist in the prevention of disease in 
                humans; or
                  (C) regulate software as a device under this 
                Act if such software meets the criteria under 
                section 513(a)(1)(C).
  (p) Regulation of Over-the-Counter Hearing Aids.--
          (1) Definition.--
                  (A) In this subsection, the term ``over-the-
                counter hearing aid'' means a device--
                          (i) that uses the same fundamental 
                        scientific technology as air conduction 
                        hearing aids (as defined in section 
                        874.3300 of title 21, Code of Federal 
                        Regulations) (or any successor 
                        regulation) or wireless air conduction 
                        hearing aids (as defined in section 
                        874.3305 of title 21, Code of Federal 
                        Regulations) (or any successor 
                        regulation);
                          (ii) that is intended to be used by 
                        adults over the age of 18 to compensate 
                        for perceived mild to moderate hearing 
                        impairment;
                          (iii) that, through tools, tests, or 
                        software, allows the user to control 
                        the over-the-counter hearing aid and 
                        customize it to the user's hearing 
                        needs;
                          (iv) that may--
                                  (I) use wireless technology; 
                                or
                                  (II) include tests for self-
                                assessment of hearing loss; and
                          (v) that is available over-the-
                        counter, without the supervision, 
                        prescription, or other order, 
                        involvement, or intervention of a 
                        licensed person, to consumers through 
                        in-person transactions, by mail, or 
                        online.
                  (B) Such term does not include a personal 
                sound amplification product intended to amplify 
                sound for nonhearing impaired consumers in 
                situations including hunting and bird-watching.
          (2) Regulation.--An over-the-counter hearing aid 
        shall be subject to the regulations promulgated in 
        accordance with section 613(b) of the FDA 
        Reauthorization Act of 2017 and shall be exempt from 
        sections 801.420 and 801.421 of title 21, Code of 
        Federal Regulations (or any successor regulations).
  (q) Diagnostic Imaging Devices Intended for Use With Contrast 
Agents.--
          (1) The Secretary may, subject to the succeeding 
        provisions of this subsection, approve an application 
        (or a supplement to such an application) submitted 
        under section 515 with respect to an applicable medical 
        imaging device, or, in the case of an applicable 
        medical imaging device for which a notification is 
        submitted under section 510(k), may make a substantial 
        equivalence determination with respect to an applicable 
        medical imaging device, or may grant a request 
        submitted under section 513(f)(2) for an applicable 
        medical imaging device, if the indications and 
        conditions of use proposed in such application, 
        notification, or request involve the use of a contrast 
        agent that is not--
                  (A) in a concentration, rate of 
                administration, or route of administration that 
                is different from those described in the 
                approved labeling of the contrast agent, except 
                that the Secretary may approve such 
                application, make such substantial equivalence 
                determination, or grant such request if the 
                Secretary determines that such differences in 
                concentration, rate of administration, or route 
                of administration exist but do not adversely 
                affect the safety and effectiveness of the 
                contrast agent when used with the device;
                  (B) in a region, organ, or system of the body 
                that is different from those described in the 
                approved labeling of the contrast agent, except 
                that the Secretary may approve such 
                application, make such substantial equivalence 
                determination, or grant such request if the 
                Secretary determines that such differences in 
                region, organ, or system of the body exist but 
                do not adversely affect the safety and 
                effectiveness of the contrast agent when used 
                with the device;
                  (C) in a patient population that is different 
                from those described in the approved labeling 
                of the contrast agent, except that the 
                Secretary may approve such application, make 
                such substantial equivalence determination, or 
                grant such request if the Secretary determines 
                such differences in patient population exist 
                but do not adversely affect the safety and 
                effectiveness of the contrast agent when used 
                with the device; or
                  (D) in an imaging modality (such as an 
                ultrasound, an x-ray, diagnostic 
                radiopharmaceutical-based technologies, 
                fluorescent imaging technology, or magnetic 
                resonance) that is different from those 
                described in the approved labeling of the 
                contrast agent.
          (2) The agency center charged with premarket review 
        of devices shall have primary jurisdiction with respect 
        to the review of an application, notification, or 
        request described in paragraph (1). In conducting such 
        review, such agency center may--
                  (A) consult with the agency center charged 
                with the premarket review of drugs or 
                biological products; and
                  (B) review information and data provided to 
                the Secretary by the sponsor of a contrast 
                agent in an application submitted under section 
                505 of this Act or section 351 of the Public 
                Health Service Act, so long as the sponsor of 
                such contrast agent has provided to the sponsor 
                of the applicable medical imaging device that 
                is the subject of such review a right of 
                reference and the application is submitted in 
                accordance with this subsection.
          (3) An application submitted under section 515, a 
        notification submitted under section 510(k), or a 
        request submitted under section 513(f)(2), as described 
        in paragraph (1), with respect to an applicable medical 
        imaging device shall be subject to the requirements of 
        such respective section. Such application, 
        notification, or request shall only be subject to the 
        requirements of this Act applicable to devices.
          (4) For purposes of this subsection and section 
        505(y)--
                  (A) the term ``applicable medical imaging 
                device'' means a device intended to be used in 
                conjunction with a contrast agent (or class of 
                contrast agents) for an imaging use that is not 
                described in the approved labeling of such 
                contrast agent (or the approved labeling of any 
                contrast agent in the same class as such 
                contrast agent); and
                  (B) the term ``contrast agent'' means a drug 
                that is approved under section 505 or licensed 
                under section 351 of the Public Health Service 
                Act, is intended for use in conjunction with an 
                applicable medical imaging device, and--
                          (i) is a diagnostic 
                        radiopharmaceutical, as defined in 
                        section 315.2 and 601.31 of title 21, 
                        Code of Federal Regulations (or any 
                        successor regulations); or
                          (ii) is a diagnostic agent that 
                        improves the visualization of structure 
                        or function within the body by 
                        increasing the relative difference in 
                        signal intensity within the target 
                        tissue, structure, or fluid.

           *       *       *       *       *       *       *


SEC. 523. ACCREDITED PERSONS.

  (a) In General.--
          (1) Review and classification of devices.--Not later 
        than 1 year after the date of the enactment of the Food 
        and Drug Administration Modernization Act of 1997, the 
        Secretary shall, subject to paragraph (3), accredit 
        persons for the purpose of reviewing reports submitted 
        under section 510(k) and making recommendations to the 
        Secretary regarding the initial classification of 
        devices under section 513(f)(1).
          (2) Requirements regarding review.--
                  (A) In general.--In making a recommendation 
                to the Secretary under paragraph (1), an 
                accredited person shall notify the Secretary in 
                writing of the reasons for the recommendation.
                  (B) Time period for review.--Not later than 
                30 days after the date on which the Secretary 
                is notified under subparagraph (A) by an 
                accredited person with respect to a 
                recommendation of an initial classification of 
                a device, the Secretary shall make a 
                determination with respect to the initial 
                classification.
                  (C) Special rule.--The Secretary may change 
                the initial classification under section 
                513(f)(1) that is recommended under paragraph 
                (1) by an accredited person, and in such case 
                shall provide to such person, and the person 
                who submitted the report under section 510(k) 
                for the device, a statement explaining in 
                detail the reasons for the change.
          (3) Certain devices.--
                  (A) In general.--An accredited person may not 
                be used to perform a review of--
                          (i) a class III device;
                          [(ii) a class II device which is 
                        intended to be permanently implantable 
                        or life sustaining or life supporting; 
                        or
                          [(iii) a class II device which 
                        requires clinical data in the report 
                        submitted under section 510(k) for the 
                        device, except that the number of class 
                        II devices to which the Secretary 
                        applies this clause for a year, less 
                        the number of such reports to which 
                        clauses (i) and (ii) apply, may not 
                        exceed 6 percent of the number that is 
                        equal to the total number of reports 
                        submitted to the Secretary under such 
                        section for such year less the number 
                        of such reports to which such clauses 
                        apply for such year.]
                          (ii) a device classified under 
                        section 513(f)(2) or designated under 
                        section 515C(d); or
                          (iii) a device that is of a type, or 
                        subset of a type, listed as not 
                        eligible for review under subparagraph 
                        (B)(iii).
                  [(B) Adjustment.--In determining for a year 
                the ratio described in subparagraph (A)(iii), 
                the Secretary shall not include in the 
                numerator class III devices that the Secretary 
                reclassified into class II, and the Secretary 
                shall include in the denominator class II 
                devices for which reports under section 510(k) 
                were not required to be submitted by reason of 
                the operation of section 510(m).]
                  (B) Designation for review.--The Secretary 
                shall--
                          (i) issue draft guidance on the 
                        factors the Secretary will use in 
                        determining whether a class I or class 
                        II device type, or subset of such 
                        device types, is eligible for review by 
                        an accredited person, including--
                                  (I) the risk of the device 
                                type, or subset of such device 
                                type; and
                                  (II) whether the device type, 
                                or subset of such device type, 
                                is permanently implantable, 
                                life sustaining, or life 
                                supporting;
                          (ii) not later than 24 months after 
                        the date on which the Secretary issues 
                        such draft guidance, finalize such 
                        guidance; and
                          (iii) beginning on the date such 
                        guidance is finalized, designate and 
                        post on the internet website of the 
                        Food and Drug Administration, an 
                        updated list of class I and class II 
                        device types, or subsets of such device 
                        types, and the Secretary's 
                        determination with respect to whether 
                        each such device type, or subset of a 
                        device type, is eligible or not 
                        eligible for review by an accredited 
                        person under this section based on the 
                        factors described in clause (i).
                  (C) Interim rule.--Until the date on which 
                the updated list is designated and posted in 
                accordance with subparagraph (B)(iii), the list 
                in effect on the date of enactment the Medical 
                Device User Fee Amendments of 2017 shall be in 
                effect.
  (b) Accreditation.--
          (1) Programs.--The Secretary shall provide for such 
        accreditation through programs administered by the Food 
        and Drug Administration, other government agencies, or 
        by other qualified nongovernment organizations.
          (2) Accreditation.--
                  (A) In general.--Not later than 180 days 
                after the date of the enactment of the Food and 
                Drug Administration Modernization Act of 1997, 
                the Secretary shall establish and publish in 
                the Federal Register criteria to accredit or 
                deny accreditation to persons who request to 
                perform the duties specified in subsection (a). 
                The Secretary shall respond to a request for 
                accreditation within 60 days of the receipt of 
                the request. The accreditation of such person 
                shall specify the particular activities under 
                subsection (a) for which such person is 
                accredited.
                  (B) Withdrawal of accreditation.--The 
                Secretary may suspend or withdraw accreditation 
                of any person accredited under this paragraph, 
                after providing notice and an opportunity for 
                an informal hearing, when such person is 
                substantially not in compliance with the 
                requirements of this section or poses a threat 
                to public health or fails to act in a manner 
                that is consistent with the purposes of this 
                section.
                  (C) Performance auditing.--To ensure that 
                persons accredited under this section will 
                continue to meet the standards of 
                accreditation, the Secretary shall--
                          (i) make onsite visits on a periodic 
                        basis to each accredited person to 
                        audit the performance of such person; 
                        and
                          (ii) take such additional measures as 
                        the Secretary determines to be 
                        appropriate.
                  [(D) Annual report.--The Secretary shall 
                include in the annual report required under 
                section 1003(g) the names of all accredited 
                persons and the particular activities under 
                subsection (a) for which each such person is 
                accredited and the name of each accredited 
                person whose accreditation has been withdrawn 
                during the year.]
                  [(E)] (D) Periodic reaccreditation.--
                          (i) Period.--Subject to suspension or 
                        withdrawal under subparagraph (B), any 
                        accreditation under this section shall 
                        be valid for a period of 3 years after 
                        its issuance.
                          (ii) Response to reaccreditation 
                        request.--Upon the submission of a 
                        request by an accredited person for 
                        reaccreditation under this section, the 
                        Secretary shall approve or deny such 
                        request not later than 60 days after 
                        receipt of the request.
                          (iii) Criteria.--Not later than 120 
                        days after the date of the enactment of 
                        this subparagraph, the Secretary shall 
                        establish and publish in the Federal 
                        Register criteria to reaccredit or deny 
                        reaccreditation to persons under this 
                        section. The reaccreditation of persons 
                        under this section shall specify the 
                        particular activities under subsection 
                        (a), and the devices, for which such 
                        persons are reaccredited.
          (3) Qualifications.--An accredited person shall, at a 
        minimum, meet the following requirements:
                  (A) Such person may not be an employee of the 
                Federal Government.
                  (B) Such person shall be an independent 
                organization which is not owned or controlled 
                by a manufacturer, supplier, or vendor of 
                devices and which has no organizational, 
                material, or financial affiliation with such a 
                manufacturer, supplier, or vendor.
                  (C) Such person shall be a legally 
                constituted entity permitted to conduct the 
                activities for which it seeks accreditation.
                  (D) Such person shall not engage in the 
                design, manufacture, promotion, or sale of 
                devices.
                  (E) The operations of such person shall be in 
                accordance with generally accepted professional 
                and ethical business practices.
                  [(E)] (F) [The operations of such person 
                shall be in accordance with generally accepted 
                professional and ethical business practices and 
                shall agree in writing that as a minimum it 
                will--] Such person shall agree, at a minimum, 
                to include in its request for accreditation a 
                commitment to, at the time of accreditation, 
                and at any time it is performing any review 
                pursuant to this section--
                          (i) certify that reported information 
                        accurately reflects data reviewed;
                          (ii) limit work to that for which 
                        competence and capacity are available;
                          (iii) treat information received, 
                        records, reports, and recommendations 
                        as proprietary information;
                          (iv) promptly respond and attempt to 
                        resolve complaints regarding its 
                        activities for which it is accredited; 
                        and
                          (v) protect against the use, in 
                        carrying out subsection (a) with 
                        respect to a device, of any officer or 
                        employee of the person who has a 
                        financial conflict of interest 
                        regarding the device, and annually make 
                        available to the public disclosures of 
                        the extent to which the person, and the 
                        officers and employees of the person, 
                        have maintained compliance with 
                        requirements under this clause relating 
                        to financial conflicts of interest.
          (4) Selection of accredited persons.--The Secretary 
        shall provide each person who chooses to use an 
        accredited person to receive a section 510(k) report a 
        panel of at least two or more accredited persons from 
        which the regulated person may select one for a 
        specific regulatory function.
          (5) Compensation of accredited persons.--Compensation 
        for an accredited person shall be determined by 
        agreement between the accredited person and the person 
        who engages the services of the accredited person, and 
        shall be paid by the person who engages such services.
  (c) Duration.--The authority provided by this section 
terminates October 1, [2017] 2022.

SEC. 524. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR TROPICAL 
                    DISEASES.

  (a) Definitions.--In this section:
          (1) Priority review.--The term ``priority review'', 
        with respect to a human drug application as defined in 
        section 735(1), means review and action by the 
        Secretary on such application not later than 6 months 
        after receipt by the Secretary of such application, as 
        described in the Manual of Policies and Procedures of 
        the Food and Drug Administration and goals identified 
        in the letters described in section 101(c) of the Food 
        and Drug Administration Amendments Act of 2007.
          (2) Priority review voucher.--The term ``priority 
        review voucher'' means a voucher issued by the 
        Secretary to the sponsor of a tropical disease product 
        application that entitles the holder of such voucher to 
        priority review of a single human drug application 
        submitted under section 505(b)(1) or section 351 of the 
        Public Health Service Act after the date of approval of 
        the tropical disease product application.
          (3) Tropical disease.--The term ``tropical disease'' 
        means any of the following:
                  (A) Tuberculosis.
                  (B) Malaria.
                  (C) Blinding trachoma.
                  (D) Buruli Ulcer.
                  (E) Cholera.
                  (F) Dengue/dengue haemorrhagic fever.
                  (G) Dracunculiasis (guinea-worm disease).
                  (H) Fascioliasis.
                  (I) Human African trypanosomiasis.
                  (J) Leishmaniasis.
                  (K) Leprosy.
                  (L) Lymphatic filariasis.
                  (M) Onchocerciasis.
                  (N) Schistosomiasis.
                  (O) Soil transmitted helmithiasis.
                  (P) Yaws.
                  (Q) Filovirus Diseases.
                  (R) Zika Virus Disease.
                  (S) Any other infectious disease for which 
                there is no significant market in developed 
                nations and that disproportionately affects 
                poor and marginalized populations, designated 
                by order of the Secretary.
          (4) Tropical disease product application.--The term 
        ``tropical disease product application'' means an 
        application that--
                  (A) is a human drug application as defined in 
                section 735(1)--
                          (i) for prevention or treatment of a 
                        tropical disease; [and]
                          (ii) the Secretary deems eligible for 
                        priority review;
                          (iii) that contains reports of one or 
                        more new clinical investigations (other 
                        than bioavailability studies) that are 
                        essential to the approval of the 
                        application and conducted or sponsored 
                        by the sponsor of such application; and
                          (iv) that contains an attestation 
                        from the sponsor of the application 
                        that such reports were not submitted as 
                        part of an application for marketing 
                        approval or licensure by a regulatory 
                        authority in India, Brazil, Thailand, 
                        or any country that is a member of the 
                        Pharmaceutical Inspection Convention or 
                        the Pharmaceutical Inspection 
                        Cooperation Scheme prior to September 
                        27, 2007.
                  (B) is approved after the date of the 
                enactment of the Food and Drug Administration 
                Amendments Act of 2007, by the Secretary for 
                use in the prevention, detection, or treatment 
                of a tropical disease; and
                  (C) is for a human drug, no active ingredient 
                (including any ester or salt of the active 
                ingredient) of which has been approved in any 
                other application under section 505(b)(1) or 
                section 351 of the Public Health Service Act.
  (b) Priority Review Voucher.--
          (1) In general.--The Secretary shall award a priority 
        review voucher to the sponsor of a tropical disease 
        product application upon approval by the Secretary of 
        such tropical disease product application.
          (2) Transferability.--The sponsor of a tropical 
        disease product that receives a priority review voucher 
        under this section may transfer (including by sale) the 
        entitlement to such voucher to a sponsor of a human 
        drug for which an application under section 505(b)(1) 
        or section 351 of the Public Health Service Act will be 
        submitted after the date of the approval of the 
        tropical disease product application. There is no limit 
        on the number of times a priority review voucher may be 
        transferred before such voucher is used.
          (3) Limitation.--
                  (A) No award for prior approved 
                application.--A sponsor of a tropical disease 
                product may not receive a priority review 
                voucher under this section if the tropical 
                disease product application was submitted to 
                the Secretary prior to the date of the 
                enactment of this section.
                  (B) One-year waiting period.--The Secretary 
                shall issue a priority review voucher to the 
                sponsor of a tropical disease product no 
                earlier than the date that is 1 year after the 
                date of the enactment of the Food and Drug 
                Administration Amendments Act of 2007.
          (4) Notification.--The sponsor of a human drug 
        application shall notify the Secretary not later than 
        90 days prior to submission of the human drug 
        application that is the subject of a priority review 
        voucher of an intent to submit the human drug 
        application, including the date on which the sponsor 
        intends to submit the application. Such notification 
        shall be a legally binding commitment to pay for the 
        user fee to be assessed in accordance with this 
        section.
  (c) Priority Review User Fee.--
          (1) In general.--The Secretary shall establish a user 
        fee program under which a sponsor of a human drug 
        application that is the subject of a priority review 
        voucher shall pay to the Secretary a fee determined 
        under paragraph (2). Such fee shall be in addition to 
        any fee required to be submitted by the sponsor under 
        chapter VII.
          (2) Fee amount.--The amount of the priority review 
        user fee shall be determined each fiscal year by the 
        Secretary and based on the average cost incurred by the 
        agency in the review of a human drug application 
        subject to priority review in the previous fiscal year.
          (3) Annual fee setting.--The Secretary shall 
        establish, before the beginning of each fiscal year 
        beginning after September 30, 2007, for that fiscal 
        year, the amount of the priority review user fee.
          (4) Payment.--
                  (A) In general.--The priority review user fee 
                required by this subsection shall be due upon 
                the submission of a human drug application 
                under section 505(b)(1) or section 351 of the 
                Public Health Service Act for which the 
                priority review voucher is used.
                  (B) Complete application.--An application 
                described under subparagraph (A) for which the 
                sponsor requests the use of a priority review 
                voucher shall be considered incomplete if the 
                fee required by this subsection and all other 
                applicable user fees are not paid in accordance 
                with the Secretary's procedures for paying such 
                fees.
                  (C) No waivers, exemptions, reductions, or 
                refunds.--The Secretary may not grant a waiver, 
                exemption, reduction, or refund of any fees due 
                and payable under this section.
          (5) Offsetting collections.--Fees collected pursuant 
        to this subsection for any fiscal year--
                  (A) shall be deposited and credited as 
                offsetting collections to the account providing 
                appropriations to the Food and Drug 
                Administration; and
                  (B) shall not be collected for any fiscal 
                year except to the extent provided in advance 
                in appropriation Acts.

           *       *       *       *       *       *       *


Subchapter E--General Provisions Relating to Drugs and Devices

           *       *       *       *       *       *       *


SEC. 566. CRITICAL PATH PUBLIC-PRIVATE PARTNERSHIPS.

  (a) Establishment.--The Secretary, acting through the 
Commissioner of Food and Drugs, may enter into collaborative 
agreements, to be known as Critical Path Public-Private 
Partnerships, with one or more eligible entities to implement 
the Critical Path Initiative of the Food and Drug 
Administration by developing innovative, collaborative projects 
in research, education, and outreach for the purpose of 
fostering medical product innovation, enabling the acceleration 
of medical product development, manufacturing, and 
translational therapeutics, and enhancing medical product 
safety.
  (b) Eligible Entity.--In this section, the term ``eligible 
entity'' means an entity that meets each of the following:
          (1) The entity is--
                  (A) an institution of higher education (as 
                such term is defined in section 101 of the 
                Higher Education Act of 1965) or a consortium 
                of such institutions; or
                  (B) an organization described in section 
                501(c)(3) of the Internal Revenue Code of 1986 
                and exempt from tax under section 501(a) of 
                such Code.
          (2) The entity has experienced personnel and clinical 
        and other technical expertise in the biomedical 
        sciences, which may include graduate training programs 
        in areas relevant to priorities of the Critical Path 
        Initiative.
          (3) The entity demonstrates to the Secretary's 
        satisfaction that the entity is capable of--
                  (A) developing and critically evaluating 
                tools, methods, and processes--
                          (i) to increase efficiency, 
                        predictability, and productivity of 
                        medical product development; and
                          (ii) to more accurately identify the 
                        benefits and risks of new and existing 
                        medical products;
                  (B) establishing partnerships, consortia, and 
                collaborations with health care practitioners 
                and other providers of health care goods or 
                services; pharmacists; pharmacy benefit 
                managers and purchasers; health maintenance 
                organizations and other managed health care 
                organizations; health care insurers; government 
                agencies; patients and consumers; manufacturers 
                of prescription drugs, biological products, 
                diagnostic technologies, and devices; and 
                academic scientists; and
                  (C) securing funding for the projects of a 
                Critical Path Public-Private Partnership from 
                Federal and nonfederal governmental sources, 
                foundations, and private individuals.
  (c) Funding.--The Secretary may not enter into a 
collaborative agreement under subsection (a) unless the 
eligible entity involved provides an assurance that the entity 
will not accept funding for a Critical Path Public-Private 
Partnership project from any organization that manufactures or 
distributes products regulated by the Food and Drug 
Administration unless the entity provides assurances in its 
agreement with the Food and Drug Administration that the 
results of the Critical Path Public-Private Partnership project 
will not be influenced by any source of funding.
  (d) Annual Report.--Not later than 18 months after the date 
of the enactment of this section, and annually thereafter, the 
Secretary, in collaboration with the parties to each Critical 
Path Public-Private Partnership, shall submit a report to the 
Committee on Health, Education, Labor, and Pensions of the 
Senate and the Committee on Energy and Commerce of the House of 
Representatives--
          (1) reviewing the operations and activities of the 
        Partnerships in the previous year; and
          (2) addressing such other issues relating to this 
        section as the Secretary determines to be appropriate.
  (e) Definition.--In this section, the term ``medical 
product'' includes a drug, a biological product as defined in 
section 351 of the Public Health Service Act, a device, and any 
combination of such products.
  (f) Authorization of Appropriations.--To carry out this 
section, there is authorized to be appropriated $6,000,000 for 
each of fiscal years [2013 through 2017] 2018 through 2022.

           *       *       *       *       *       *       *


                     CHAPTER VII--GENERAL AUTHORITY

Subchapter A--General Administrative Provisions

           *       *       *       *       *       *       *


                           factory inspection

  Sec. 704. (a)(1) For purposes of enforcement of this Act, 
officers or employees duly designated by the Secretary, upon 
presenting appropriate credentials and a written notice to the 
owner, operator, or agent in charge, are authorized (A) to 
enter, at reasonable times, any factory, warehouse, or 
establishment in which food, drugs, devices, tobacco products, 
or cosmetics are manufactured, processed, packed, or held, for 
introduction into interstate commerce or after such 
introduction, or to enter any vehicle, being used to transport 
or hold such food, drugs, devices, tobacco products, or 
cosmetics in interstate commerce; and (B) to inspect, at 
reasonable times and within reasonable limits and in a 
reasonable manner, such factory, warehouse, establishment, or 
vehicle and all pertinent equipment, finished and unfinished 
materials, containers, and labeling therein. In the case of any 
person (excluding farms and restaurants) who manufactures, 
processes, packs, transports, distributes, holds, or imports 
foods, the inspection shall extend to all records and other 
information described in section 414, when the standard for 
records inspection under paragraph (1) or (2) of section 414(a) 
applies, subject to the limitations established in section 
414(d). In the case of any factory, warehouse, establishment, 
or consulting laboratory in which prescription drugs, 
nonprescription drugs intended for human use, restricted 
devices, or tobacco products are manufactured, processed, 
packed, or held, inspection shall extend to all things therein 
(including records, files, papers, processes, controls, and 
facilities) bearing on whether prescription drugs, 
nonprescription drugs intended for human use, restricted 
devices, or tobacco products which are adulterated or 
misbranded within the meaning of this Act, or which may not be 
manufactured, introduced into interstate commerce, or sold, or 
offered for sale by reason of any provision of this Act, have 
been or are being manufactured, processed, packed, transported, 
or held in any such place, or otherwise bearing on violation of 
this Act. No inspection authorized by the preceding sentence or 
by paragraph (3) shall extend to financial data, sales data 
other than shipment data, pricing data, personnel data (other 
than data as to qualifications of technical and professional 
personnel performing functions subject to this Act), and 
research data (other than data relating to new drugs, 
antibiotic drugs, devices, and tobacco products and subject to 
reporting and inspection under regulations lawfully issued 
pursuant to section 505 (i) or (k), section 519, section 
520(g), or chapter IX and data relating to other drugs, 
devices, or tobacco products which in the case of a new drug 
would be subject to reporting or inspection under lawful 
regulations issued pursuant to section 505(j)). A separate 
notice shall be given for each such inspection, but a notice 
shall not be required for each entry made during the period 
covered by the inspection. Each such inspection shall be 
commenced and completed with reasonable promptness.
  (2) The provisions of the third sentence of paragraph (1) 
shall not apply to--
          (A) pharmacies which maintain establishments in 
        conformance with any applicable local laws regulating 
        the practice of pharmacy and medicine and which are 
        regularly engaged in dispensing prescription drugs or 
        devices, upon prescriptions of practitioners licensed 
        to administer such drugs or devices to patients under 
        the care of such practitioners in the course of their 
        professional practice, and which do not, either through 
        a subsidiary or otherwise, manufacture, prepare, 
        propagate, compound, or process drugs or devices for 
        sale other than in the regular course of their business 
        of dispensing or selling drugs or devices at retail;
          (B) practitioners licensed by law to prescribe or 
        administer drugs, or prescribe or use devices, as the 
        case may be, and who manufacture, prepare, propagate, 
        compound, or process drugs, or manufacture or process 
        devices solely for use in the course of their 
        professional practice;
          (C) persons who manufacture, prepare, propagate, 
        compound, or process drugs, or manufacture or process 
        devices solely for use in research, teaching, or 
        chemical analysis and not for sale;
          (D) such other classes of persons as the Secretary 
        may by regulation exempt from the application of this 
        section upon a finding that inspection as applied to 
        such classes of persons in accordance with this section 
        is not necessary for the protection of the public 
        health.
  (3) An officer or employee making an inspection under 
paragraph (1) for purposes of enforcing the requirements of 
section 412 applicable to infant formulas shall be permitted, 
at all reasonable times, to have access to and to copy and 
verify any records--
          (A) bearing on whether the infant formula 
        manufactured or held in the facility inspected meets 
        the requirements of section 412, or
          (B) required to be maintained under section 412.
  (4)(A) Any records or other information that the Secretary 
may inspect under this section from a person that owns or 
operates an establishment that is engaged in the manufacture, 
preparation, propagation, compounding, or processing of a drug 
shall, upon the request of the Secretary, be provided to the 
Secretary by such person, in advance of or in lieu of an 
inspection, within a reasonable timeframe, within reasonable 
limits, and in a reasonable manner, and in either electronic or 
physical form, at the expense of such person. The Secretary's 
request shall include a sufficient description of the records 
requested.
  (B) Upon receipt of the records requested under subparagraph 
(A), the Secretary shall provide to the person confirmation of 
receipt.
  (C) Nothing in this paragraph supplants the authority of the 
Secretary to conduct inspections otherwise permitted under this 
Act in order to ensure compliance with this Act.
  (b) Upon completion of any such inspection of a factory, 
warehouse, consulting laboratory, or other establishment, and 
prior to leaving the premises, the officer or employee making 
the inspection shall give to the owner, operator, or agent in 
charge a report in writing setting forth any conditions or 
practices observed by him which, in his judgment, indicate that 
any food, drug, device, tobacco product, or cosmetic in such 
establishment (1) consists in whole or in part of any filthy, 
putrid, or decomposed substance, or (2) has been prepared, 
packed, or held under insanitary conditions whereby it may have 
become contaminated with filth, or whereby it may have been 
rendered injurious to health. A copy of such report shall be 
sent promptly to the Secretary.
  (c) If the officer or employee making any such inspection of 
a factory, warehouse, or other establishment has obtained any 
sample in the course of the inspection, upon completion of the 
inspection and prior to leaving the premises he shall give to 
the owner, operator, or agent in charge a receipt describing 
the samples obtained.
  (d) Whenever in the course of any such inspection of a 
factory or other establishment where food is manufactured, 
processed, or packed, the officer or employee making the 
inspection obtains a sample of any such food, and an analysis 
is made of such sample for the purpose of ascertaining whether 
such food consists in whole or in part of any filthy, putrid, 
or decomposed substance, or is otherwise unfit for food, a copy 
of the results of such analysis shall be furnished promptly to 
the owner, operator, or agent in charge.
  (e) Every person required under section 519 or 520(g) to 
maintain records and every person who is in charge or custody 
of such records shall, upon request of an officer or employee 
designated by the Secretary, permit such officer or employee at 
all reasonable times to have access to, and to copy and verify, 
such records.
  (f)(1) An accredited person described in paragraph (3) shall 
maintain records documenting the training qualifications of the 
person and the employees of the person, the procedures used by 
the person for handling confidential information, the 
compensation arrangements made by the person, and the 
procedures used by the person to identify and avoid conflicts 
of interest. Upon the request of an officer or employee 
designated by the Secretary, the person shall permit the 
officer or employee, at all reasonable times, to have access 
to, to copy, and to verify, the records.
  (2) Within 15 days after the receipt of a written request 
from the Secretary to an accredited person described in 
paragraph (3) for copies of records described in paragraph (1), 
the person shall produce the copies of the records at the place 
designated by the Secretary.
  (3) For purposes of paragraphs (1) and (2), an accredited 
person described in this paragraph is a person who--
          (A) is accredited under subsection (g); or
          (B) is accredited under section 523.
  (g)(1) The Secretary shall, subject to the provisions of this 
subsection, accredit persons for the purpose of conducting 
inspections of establishments that manufacture, prepare, 
propagate, compound, or process class II or class III devices, 
which inspections are required under section 510(h) or are 
inspections of such establishments required to register under 
section 510(i). The owner or operator of such an establishment 
that is eligible under paragraph (6) may, from the list 
published under paragraph (4), select an accredited person to 
conduct such inspections.
  (2) The Secretary shall publish in the Federal Register 
criteria to accredit or deny accreditation to persons who 
request to perform the duties specified in paragraph (1). 
Thereafter, the Secretary shall inform those requesting 
accreditation, within 60 days after the receipt of such 
request, whether the request for accreditation is adequate for 
review, and the Secretary shall promptly act on the request for 
accreditation. Any resulting accreditation shall state that 
such person is accredited to conduct inspections at device 
establishments identified in paragraph (1). The accreditation 
of such person shall specify the particular activities under 
this subsection for which such person is accredited.
  (3) An accredited person shall, at a minimum, meet the 
following requirements:
          (A) Such person may not be an employee of the Federal 
        Government.
          (B) Such person shall be an independent organization 
        which is not owned or controlled by a manufacturer, 
        supplier, or vendor of articles regulated under this 
        Act and which has no organizational, material, or 
        financial affiliation (including a consultative 
        affiliation) with such a manufacturer, supplier, or 
        vendor.
          (C) Such person shall be a legally constituted entity 
        permitted to conduct the activities for which it seeks 
        accreditation.
          (D) Such person shall not engage in the design, 
        manufacture, promotion, or sale of articles regulated 
        under this Act.
          (E) The operations of such person shall be in 
        accordance with generally accepted professional and 
        ethical business practices, and such person shall agree 
        in writing that at a minimum the person will--
                  (i) certify that reported information 
                accurately reflects data reviewed, inspection 
                observations made, other matters that relate to 
                or may influence compliance with this Act, and 
                recommendations made during an inspection or at 
                an inspection's closing meeting;
                  (ii) limit work to that for which competence 
                and capacity are available;
                  (iii) treat information received, records, 
                reports, and recommendations as confidential 
                commercial or financial information or trade 
                secret information, except such information may 
                be made available to the Secretary;
                  (iv) promptly respond and attempt to resolve 
                complaints regarding its activities for which 
                it is accredited; and
                  (v) protect against the use, in carrying out 
                paragraph (1), of any officer or employee of 
                the accredited person who has a financial 
                conflict of interest regarding any product 
                regulated under this Act, and annually make 
                available to the public disclosures of the 
                extent to which the accredited person, and the 
                officers and employees of the person, have 
                maintained compliance with requirements under 
                this clause relating to financial conflicts of 
                interest.
          (F) Such person shall notify the Secretary of any 
        withdrawal, suspension, restriction, or expiration of 
        certificate of conformance with the quality systems 
        standard referred to in paragraph (7) for any device 
        establishment that such person inspects under this 
        subsection not later than 30 days after such 
        withdrawal, suspension, restriction, or expiration.
          (G) Such person may conduct audits to establish 
        conformance with the quality systems standard referred 
        to in paragraph (7).
  (4) The Secretary shall publish on the Internet site of the 
Food and Drug Administration a list of persons who are 
accredited under paragraph (2). Such list shall be updated to 
ensure that the identity of each accredited person, and the 
particular activities for which the person is accredited, is 
known to the public. The updating of such list shall be no 
later than one month after the accreditation of a person under 
this subsection or the suspension or withdrawal of 
accreditation, or the modification of the particular activities 
for which the person is accredited.
  (5)(A) To ensure that persons accredited under this 
subsection continue to meet the standards of accreditation, the 
Secretary shall (i) audit the performance of such persons on a 
periodic basis through the review of inspection reports and 
inspections by persons designated by the Secretary to evaluate 
the compliance status of a device establishment and the 
performance of accredited persons, and (ii) take such 
additional measures as the Secretary determines to be 
appropriate.
  (B) The Secretary may withdraw accreditation of any person 
accredited under paragraph (2), after providing notice and an 
opportunity for an informal hearing, when such person is 
substantially not in compliance with the standards of 
accreditation, poses a threat to public health, fails to act in 
a manner that is consistent with the purposes of this 
subsection, or where the Secretary determines that there is a 
financial conflict of interest in the relationship between the 
accredited person and the owner or operator of a device 
establishment that the accredited person has inspected under 
this subsection. The Secretary may suspend the accreditation of 
such person during the pendency of the process under the 
preceding sentence.
  (6)(A) Subject to subparagraphs (B) and (C), a device 
establishment is eligible for inspection by persons accredited 
under paragraph (2) if the following conditions are met:
          (i) The Secretary classified the results of the most 
        recent inspection of the establishment as ``no action 
        indicated'' or ``voluntary action indicated''.
          (ii) With respect to inspections of the establishment 
        to be conducted by an accredited person, the owner or 
        operator of the establishment submits to the Secretary 
        a notice that--
                  (I) provides the date of the last inspection 
                of the establishment by the Secretary and the 
                classification of that inspection;
                  (II) states the intention of the owner or 
                operator to use an accredited person to conduct 
                inspections of the establishment;
                  (III) identifies the particular accredited 
                person the owner or operator intends to select 
                to conduct such inspections; and
                  (IV) includes a certification that, with 
                respect to the devices that are manufactured, 
                prepared, propagated, compounded, or processed 
                in the establishment--
                          (aa) at least 1 of such devices is 
                        marketed in the United States; and
                          (bb) at least 1 of such devices is 
                        marketed, or is intended to be 
                        marketed, in 1 or more foreign 
                        countries, 1 of which countries 
                        certifies, accredits, or otherwise 
                        recognizes the person accredited under 
                        paragraph (2) and identified under 
                        subclause (III) as a person authorized 
                        to conduct inspections of device 
                        establishments.
  (B)(i) Except with respect to the requirement of subparagraph 
(A)(i), a device establishment is deemed to have clearance to 
participate in the program and to use the accredited person 
identified in the notice under subparagraph (A)(ii) for 
inspections of the establishment unless the Secretary, not 
later than 30 days after receiving such notice, issues a 
response that--
          (I) denies clearance to participate as provided under 
        subparagraph (C); or
          (II) makes a request under clause (ii).
  (ii) The Secretary may request from the owner or operator of 
a device establishment in response to the notice under 
subparagraph (A)(ii) with respect to the establishment, or from 
the particular accredited person identified in such notice--
          (I) compliance data for the establishment in 
        accordance with clause (iii)(I); or
          (II) information concerning the relationship between 
        the owner or operator of the establishment and the 
        accredited person identified in such notice in 
        accordance with clause (iii)(II).
The owner or operator of the establishment, or such accredited 
person, as the case may be, shall respond to such a request not 
later than 60 days after receiving such request.
  (iii)(I) The compliance data to be submitted by the owner or 
operator of a device establishment in response to a request 
under clause (ii)(I) are data describing whether the quality 
controls of the establishment have been sufficient for ensuring 
consistent compliance with current good manufacturing practice 
within the meaning of section 501(h) and with other applicable 
provisions of this Act. Such data shall include complete 
reports of inspectional findings regarding good manufacturing 
practice or other quality control audits that, during the 
preceding 2-year period, were conducted at the establishment by 
persons other than the owner or operator of the establishment, 
together with all other compliance data the Secretary deems 
necessary. Data under the preceding sentence shall demonstrate 
to the Secretary whether the establishment has facilitated 
consistent compliance by promptly correcting any compliance 
problems identified in such inspections.
  (II) A request to an accredited person under clause (ii)(II) 
may not seek any information that is not required to be 
maintained by such person in records under subsection (f)(1).
  (iv) A device establishment is deemed to have clearance to 
participate in the program and to use the accredited person 
identified in the notice under subparagraph (A)(ii) for 
inspections of the establishment unless the Secretary, not 
later than 60 days after receiving the information requested 
under clause (ii), issues a response that denies clearance to 
participate as provided under subparagraph (C).
  (C)(i) The Secretary may deny clearance to a device 
establishment if the Secretary has evidence that the 
certification under subparagraph (A)(ii)(IV) is untrue and the 
Secretary provides to the owner or operator of the 
establishment a statement summarizing such evidence.
  (ii) The Secretary may deny clearance to a device 
establishment if the Secretary determines that the 
establishment has failed to demonstrate consistent compliance 
for purposes of subparagraph (B)(iii)(I) and the Secretary 
provides to the owner or operator of the establishment a 
statement of the reasons for such determination.
  (iii)(I) The Secretary may reject the selection of the 
accredited person identified in the notice under subparagraph 
(A)(ii) if the Secretary provides to the owner or operator of 
the establishment a statement of the reasons for such 
rejection. Reasons for the rejection may include that the 
establishment or the accredited person, as the case may be, has 
failed to fully respond to the request, or that the Secretary 
has concerns regarding the relationship between the 
establishment and such accredited person.
  (II) If the Secretary rejects the selection of an accredited 
person by the owner or operator of a device establishment, the 
owner or operator may make an additional selection of an 
accredited person by submitting to the Secretary a notice that 
identifies the additional selection. Clauses (i) and (ii) of 
subparagraph (B), and subclause (I) of this clause, apply to 
the selection of an accredited person through a notice under 
the preceding sentence in the same manner and to the same 
extent as such provisions apply to a selection of an accredited 
person through a notice under subparagraph (A)(ii).
  (iv) In the case of a device establishment that is denied 
clearance under clause (i) or (ii) or with respect to which the 
selection of the accredited person is rejected under clause 
(iii), the Secretary shall designate a person to review the 
statement of reasons, or statement summarizing such evidence, 
as the case may be, of the Secretary under such clause if, 
during the 30-day period beginning on the date on which the 
owner or operator of the establishment receives such statement, 
the owner or operator requests the review. The review shall 
commence not later than 30 days after the owner or operator 
requests the review, unless the Secretary and the owner or 
operator otherwise agree.
  (7)(A) Persons accredited under paragraph (2) to conduct 
inspections shall record in writing their inspection 
observations and shall present the observations to the device 
establishment's designated representative and describe each 
observation. Additionally, such accredited person shall prepare 
an inspection report in a form and manner designated by the 
Secretary to conduct inspections, taking into consideration the 
goals of international harmonization of quality systems 
standards. Any official classification of the inspection shall 
be determined by the Secretary.
  (B) At a minimum, an inspection report under subparagraph (A) 
shall identify the persons responsible for good manufacturing 
practice compliance at the inspected device establishment, the 
dates of the inspection, the scope of the inspection, and shall 
describe in detail each observation identified by the 
accredited person, identify other matters that relate to or may 
influence compliance with this Act, and describe any 
recommendations during the inspection or at the inspection's 
closing meeting.
  (C) An inspection report under subparagraph (A) shall be sent 
to the Secretary and to the designated representative of the 
inspected device establishment at the same time, but under no 
circumstances later than three weeks after the last day of the 
inspection. The report to the Secretary shall be accompanied by 
all written inspection observations previously provided to the 
designated representative of the establishment.
  (D) Any statement or representation made by an employee or 
agent of a device establishment to a person accredited under 
paragraph (2) to conduct inspections shall be subject to 
section 1001 of title 18, United States Code.
  (E) If at any time during an inspection by an accredited 
person the accredited person discovers a condition that could 
cause or contribute to an unreasonable risk to the public 
health, the accredited person shall immediately notify the 
Secretary of the identification of the device establishment 
subject to inspection and such condition.
  (F) For the purpose of setting risk-based inspectional 
priorities, the Secretary shall accept voluntary submissions of 
reports of audits assessing conformance with appropriate 
quality systems standards set by the International Organization 
for Standardization (ISO) and identified by the Secretary in 
public notice. If the owner or operator of an establishment 
elects to submit audit reports under this subparagraph, the 
owner or operator shall submit all such audit reports with 
respect to the establishment during the preceding 2-year 
periods.
  (8) Compensation for an accredited person shall be determined 
by agreement between the accredited person and the person who 
engages the services of the accredited person, and shall be 
paid by the person who engages such services.
  (9) Nothing in this subsection affects the authority of the 
Secretary to inspect any device establishment pursuant to this 
Act.
  (10)(A) For fiscal year 2005 and each subsequent fiscal year, 
no device establishment may be inspected during the fiscal year 
involved by a person accredited under paragraph (2) if--
          (i) of the amounts appropriated for salaries and 
        expenses of the Food and Drug Administration for the 
        preceding fiscal year (referred to in this subparagraph 
        as the ``first prior fiscal year''), the amount 
        obligated by the Secretary for inspections of device 
        establishments by the Secretary was less than the 
        adjusted base amount applicable to such first prior 
        fiscal year; and
          (ii) of the amounts appropriated for salaries and 
        expenses of the Food and Drug Administration for the 
        fiscal year preceding the first prior fiscal year 
        (referred to in this subparagraph as the ``second prior 
        fiscal year''), the amount obligated by the Secretary 
        for inspections of device establishments by the 
        Secretary was less than the adjusted base amount 
        applicable to such second prior fiscal year.
  (B)(i) Subject to clause (ii), the Comptroller General of the 
United States shall determine the amount that was obligated by 
the Secretary for fiscal year 2002 for compliance activities of 
the Food and Drug Administration with respect to devices 
(referred to in this subparagraph as the ``compliance 
budget''), and of such amount, the amount that was obligated 
for inspections by the Secretary of device establishments 
(referred to in this subparagraph as the ``inspection 
budget'').
  (ii) For purposes of determinations under clause (i), the 
Comptroller General shall not include in the compliance budget 
or the inspection budget any amounts obligated for inspections 
of device establishments conducted as part of the process of 
reviewing applications under section 515.
  (iii) Not later than March 31, 2003, the Comptroller General 
shall complete the determinations required in this subparagraph 
and submit to the Secretary and the Congress a report 
describing the findings made through such determinations.
  (C) For purposes of this paragraph:
          (i) The term ``base amount'' means the inspection 
        budget determined under subparagraph (B) for fiscal 
        year 2002.
          (ii) The term ``adjusted base amount'', in the case 
        of applicability to fiscal year 2003, means an amount 
        equal to the base amount increased by 5 percent.
          (iii) The term ``adjusted base amount'', with respect 
        to applicability to fiscal year 2004 or any subsequent 
        fiscal year, means the adjusted base amount applicable 
        to the preceding year increased by 5 percent.
  (11) The authority provided by this subsection terminates on 
[October 1, 2017] October 1, 2022.
  (12) No later than four years after the enactment of this 
subsection the Comptroller General shall report 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) the number of inspections conducted by accredited 
        persons pursuant to this subsection and the number of 
        inspections conducted by Federal employees pursuant to 
        section 510(h) and of device establishments required to 
        register under section 510(i);
          (B) the number of persons who sought accreditation 
        under this subsection, as well as the number of persons 
        who were accredited under this subsection;
          (C) the reasons why persons who sought accreditation, 
        but were denied accreditation, were denied;
          (D) the number of audits conducted by the Secretary 
        of accredited persons, the quality of inspections 
        conducted by accredited persons, whether accredited 
        persons are meeting their obligations under this Act, 
        and whether the number of audits conducted is 
        sufficient to permit these assessments;
          (E) whether this subsection is achieving the goal of 
        ensuring more information about device establishment 
        compliance is being presented to the Secretary, and 
        whether that information is of a quality consistent 
        with information obtained by the Secretary pursuant to 
        inspections conducted by Federal employees;
          (F) whether this subsection is advancing efforts to 
        allow device establishments to rely upon third-party 
        inspections for purposes of compliance with the laws of 
        foreign governments; and
          (G) whether the Congress should continue, modify, or 
        terminate the program under this subsection.
  (13) The Secretary shall include in the annual report 
required under section 1003(g) the names of all accredited 
persons and the particular activities under this subsection for 
which each such person is accredited and the name of each 
accredited person whose accreditation has been withdrawn during 
the year.
  (14) Notwithstanding any provision of this subsection, this 
subsection does not have any legal effect on any agreement 
described in section 803(b) between the Secretary and a foreign 
country.
  (15) Notwithstanding any other provision of this subsection, 
for purposes of conducting inspections of establishments that 
manufacture, prepare, propagate, compound, or process devices 
except types of devices licensed under section 351 of the 
Public Health Service Act, which inspections are required under 
section 510(h) or are inspections of such establishments 
required to register pursuant to section 510(i), the Secretary 
may recognize auditing organizations that are recognized by 
organizations established by governments to facilitate 
international harmonization. Nothing in this paragraph affects 
the authority of the Secretary to inspect any device 
establishment pursuant to this Act. Nothing in this paragraph 
affects the authority of the Secretary to determine the 
official classification of an inspection.
  (h)(1) In the case of inspections other than for-cause 
inspections, the Secretary shall review processes and standards 
applicable to inspections of domestic and foreign device 
establishments in effect as of the date of the enactment of 
this subsection, and update such processes and standards 
through the adoption of uniform processes and standards 
applicable to such inspections. Such processes and standards 
shall provide for--
          (A) exceptions to such processes and standards, as 
        appropriate;
          (B) announcing the inspection of the establishment 
        within a reasonable time before such inspection occurs, 
        including by providing to the owner, operator, or agent 
        in charge of the establishment a notification regarding 
        the type and nature of the inspection;
          (C) a reasonable estimate of the timeframe for the 
        inspection, an opportunity for advance communications 
        between the officers or employees carrying out the 
        inspection under subsection (a)(1) and the owner, 
        operator, or agent in charge of the establishment 
        concerning appropriate working hours during the 
        inspection, and, to the extent feasible, advance notice 
        of some records that will be requested in order to 
        expedite the inspection; and
          (D) regular communications during the inspection with 
        the owner, operator, or agent in charge of the 
        establishment regarding inspection status, which may be 
        recorded by either party with advance notice and mutual 
        consent.
  (2)(A) The Secretary shall, with respect to a request 
described in subparagraph (B), provide nonbinding feedback with 
respect to such request not later than 45 days after the 
Secretary receives such request.
  (B) A request described in this subparagraph is a request for 
feedback--
          (i) that is made by the owner, operator, or agent in 
        charge of such establishment in a timely manner; and
          (ii) with respect to actions proposed to be taken by 
        a device establishment in a response to a report 
        received by such establishment pursuant to subsection 
        (b) that involve a public health priority, that 
        implicate systemic or major actions, or relate to 
        emerging safety issues (as determined by the 
        Secretary).
  (3) Nothing in this subsection limits the authority of the 
Secretary to conduct inspections otherwise permitted under this 
Act in order to ensure compliance with this Act.

           *       *       *       *       *       *       *


Subchapter C--Fees

           *       *       *       *       *       *       *


PART 2--FEES RELATING TO DRUGS

           *       *       *       *       *       *       *


SEC. 736. AUTHORITY TO ASSESS AND USE DRUG FEES.

  (a) Types of Fees.--Beginning in [fiscal year 2013] fiscal 
year 2018, the Secretary shall assess and collect fees in 
accordance with this section as follows:
          (1) Human drug application [and supplement] fee.--
                  (A) In general.--Each person that submits, on 
                or after September 1, 1992, a human drug 
                application [or a supplement] shall be subject 
                to a fee as follows:
                          (i) A fee established under 
                        subsection [(c)(4)] (c)(5) for a human 
                        drug application for which clinical 
                        data (other than bioavailability or 
                        bioequivalence studies) with respect to 
                        safety or effectiveness are required 
                        for approval.
                          (ii) [A fee established under 
                        subsection (c)(4) for a human drug 
                        application for which clinical data 
                        with respect to safety or effectiveness 
                        are not required or a supplement for 
                        which clinical data (other than 
                        bioavailability or bioequivalence 
                        studies) with respect to safety or 
                        effectiveness are required.] A fee 
                        established under subsection (c)(5) for 
                        a human drug application for which 
                        clinical data (other than 
                        bioavailability or bioequivalence 
                        studies) with respect to safety or 
                        effectiveness are not required for 
                        approval. Such fee shall be half of the 
                        amount of the fee established under 
                        clause (i).
                  (B) Payment.--The fee required by 
                subparagraph (A) shall be due upon submission 
                of the application [or supplement].
                  (C) Exception for previously filed 
                application [or supplement].--If a human drug 
                application [or supplement] was submitted by a 
                person that paid the fee for such application 
                [or supplement], was accepted for filing, and 
                was not approved or was withdrawn (without a 
                waiver), the submission of a human drug 
                application [or a supplement] for the same 
                product by the same person (or the person's 
                licensee, assignee, or successor) shall not be 
                subject to a fee under subparagraph (A).
                  (D) Refund of fee if application refused for 
                filing or withdrawn before filing.--The 
                Secretary shall refund 75 percent of the fee 
                paid under subparagraph (B) for any application 
                [or supplement] which is refused for filing or 
                withdrawn without a waiver before filing.
                  (E) Fees for applications previously refused 
                for filing or withdrawn before filing.--A human 
                drug application [or supplement] that was 
                submitted but was refused for filing, or was 
                withdrawn before being accepted or refused for 
                filing, shall be subject to the full fee under 
                subparagraph (A) upon being resubmitted or 
                filed over protest, unless the fee is waived or 
                reduced under subsection (d).
                  (F) Exception for designated orphan drug [or 
                indication].--A human drug application for a 
                prescription drug product that has been 
                designated as a drug for a rare disease or 
                condition pursuant to section 526 shall not be 
                subject to a fee under subparagraph (A), unless 
                the human drug application includes an 
                indication for other than a rare disease or 
                condition. [A supplement proposing to include a 
                new indication for a rare disease or condition 
                in a human drug application shall not be 
                subject to a fee under subparagraph (A), if the 
                drug has been designated pursuant to section 
                526 as a drug for a rare disease or condition 
                with regard to the indication proposed in such 
                supplement.]
                  (G) Refund of fee if application withdrawn.--
                If an application [or supplement] is withdrawn 
                after the application [or supplement] was 
                filed, the Secretary may refund the fee or a 
                portion of the fee if no substantial work was 
                performed on the application [or supplement] 
                after the application [or supplement] was 
                filed. The Secretary shall have the sole 
                discretion to refund a fee or a portion of the 
                fee under this subparagraph. A determination by 
                the Secretary concerning a refund under this 
                paragraph shall not be reviewable.
          [(2) Prescription drug establishment fee.--
                  [(A) In general.--Except as provided in 
                subparagraphs (B) and (C), each person that--
                          [(i) is named as the applicant in a 
                        human drug application; and
                          [(ii) after September 1, 1992, had 
                        pending before the Secretary a human 
                        drug application or supplement,
                shall be assessed an annual fee established 
                under subsection (c)(4) for each prescription 
                drug establishment listed in its approved human 
                drug application as an establishment that 
                manufactures the prescription drug product 
                named in the application. The annual 
                establishment fee shall be assessed in each 
                fiscal year in which the prescription drug 
                product named in the application is assessed a 
                fee under paragraph (3) unless the prescription 
                drug establishment listed in the application 
                does not engage in the manufacture of the 
                prescription drug product during the fiscal 
                year. The establishment fee shall be due on the 
                later of the first business day on or after 
                October 1 of each fiscal year or the first 
                business day after the enactment of an 
                appropriations Act providing for the collection 
                and obligation of fees for such fiscal year 
                under this section. Each such establishment 
                shall be assessed only one fee per 
                establishment, notwithstanding the number of 
                prescription drug products manufactured at the 
                establishment. In the event an establishment is 
                listed in a human drug application by more than 
                one applicant, the establishment fee for the 
                fiscal year shall be divided equally and 
                assessed among the applicants whose 
                prescription drug products are manufactured by 
                the establishment during the fiscal year and 
                assessed product fees under paragraph (3).
                  [(B) Exception.--If, during the fiscal year, 
                an applicant initiates or causes to be 
                initiated the manufacture of a prescription 
                drug product at an establishment listed in its 
                human drug application--
                          [(i) that did not manufacture the 
                        product in the previous fiscal year; 
                        and
                          [(ii) for which the full 
                        establishment fee has been assessed in 
                        the fiscal year at a time before 
                        manufacture of the prescription drug 
                        product was begun;
                the applicant will not be assessed a share of 
                the establishment fee for the fiscal year in 
                which the manufacture of the product began.
                  [(C) Special rules for positron emission 
                tomography drugs.--
                          [(i) In general.--Except as provided 
                        in clause (ii), each person who is 
                        named as the applicant in an approved 
                        human drug application for a positron 
                        emission tomography drug shall be 
                        subject under subparagraph (A) to one-
                        sixth of an annual establishment fee 
                        with respect to each such establishment 
                        identified in the application as 
                        producing positron emission tomography 
                        drugs under the approved application.
                          [(ii) Exception from annual 
                        establishment fee.--Each person who is 
                        named as the applicant in an 
                        application described in clause (i) 
                        shall not be assessed an annual 
                        establishment fee for a fiscal year if 
                        the person certifies to the Secretary, 
                        at a time specified by the Secretary 
                        and using procedures specified by the 
                        Secretary, that--
                                  [(I) the person is a not-for-
                                profit medical center that has 
                                only 1 establishment for the 
                                production of positron emission 
                                tomography drugs; and
                                  [(II) at least 95 percent of 
                                the total number of doses of 
                                each positron emission 
                                tomography drug produced by 
                                such establishment during such 
                                fiscal year will be used within 
                                the medical center.
                          [(iii) Definition.--For purposes of 
                        this subparagraph, the term ``positron 
                        emission tomography drug'' has the 
                        meaning given to the term ``compounded 
                        positron emission tomography drug'' in 
                        section 201(ii), except that paragraph 
                        (1)(B) of such section shall not apply.
          [(3)] (2) Prescription drug [product fee] program 
        fee.--
                  (A) In general.--[Except as provided in 
                subparagraph (B), each person who is named as 
                the applicant in a human drug application, and 
                who, after September 1, 1992, had pending 
                before the Secretary a human drug application 
                or supplement, shall pay for each such 
                prescription drug product the annual fee 
                established under subsection (c)(4).] Except as 
                provided in subparagraphs (B) and (C), each 
                person who is named as the applicant in a human 
                drug application, and who, after September 1, 
                1992, had pending before the Secretary a human 
                drug application or supplement, shall pay the 
                annual prescription drug program fee 
                established for a fiscal year under subsection 
                (c)(5) for each prescription drug product that 
                is identified in such a human drug application 
                approved as of October 1 of such fiscal year. 
                Such fee shall be due on the later of the first 
                business day on or after October 1 of each 
                fiscal year or the first business day after the 
                enactment of an appropriations Act providing 
                for the collection and obligation of fees for 
                such fiscal year under this section. Such fee 
                shall be paid only once for each product for a 
                fiscal year in which the fee is payable.
                  (B) Exception for certain prescription drug 
                products.--[A prescription drug product shall 
                not be assessed a fee] A prescription drug 
                program fee shall not be assessed for a 
                prescription drug product under subparagraph 
                (A) if such product is--
                          (i) identified on the list compiled 
                        under section 505(j)(7) with a potency 
                        described in terms of per 100 mL;
                          (ii) the same product as another 
                        product that--
                                  (I) was approved under an 
                                application filed under section 
                                505(b) or 505(j); and
                                  (II) is not in the list of 
                                discontinued products compiled 
                                under section 505(j)(7);
                          (iii) the same product as another 
                        product that was approved under an 
                        abbreviated application filed under 
                        section 507 (as in effect on the day 
                        before the date of enactment of the 
                        Food and Drug Administration 
                        Modernization Act of 1997); or
                          (iv) the same product as another 
                        product that was approved under an 
                        abbreviated new drug application 
                        pursuant to regulations in effect prior 
                        to the implementation of the Drug Price 
                        Competition and Patent Term Restoration 
                        Act of 1984.
                  (C) Limitation.--A person who is named as the 
                applicant in an approved human drug application 
                shall not be assessed more than 5 prescription 
                drug program fees for a fiscal year for 
                prescription drug products identified in such 
                approved human drug application.
  [(b) Fee Revenue Amounts.--
          [(1) In general.--For each of the fiscal years 2013 
        through 2017, fees under subsection (a) shall, except 
        as provided in subsections (c), (d), (f), and (g), be 
        established to generate a total revenue amount under 
        such subsection that is equal to the sum of--
                  [(A) $693,099,000;
                  [(B) the dollar amount equal to the inflation 
                adjustment for fiscal year 2013 (as determined 
                under paragraph (3)(A)); and
                  [(C) the dollar amount equal to the workload 
                adjustment for fiscal year 2013 (as determined 
                under paragraph (3)(B)).
          [(2) Types of fees.--Of the total revenue amount 
        determined for a fiscal year under paragraph (1)--
                  [(A) one-third shall be derived from fees 
                under subsection (a)(1) (relating to human drug 
                applications and supplements);
                  [(B) one-third shall be derived from fees 
                under subsection (a)(2) (relating to 
                prescription drug establishments); and
                  [(C) one-third shall be derived from fees 
                under subsection (a)(3) (relating to 
                prescription drug products).
          [(3) Fiscal year 2013 inflation and workload 
        adjustments.--For purposes of paragraph (1), the dollar 
        amount of the inflation and workload adjustments for 
        fiscal year 2013 shall be determined as follows:
                  [(A) Inflation adjustment.--The inflation 
                adjustment for fiscal year 2013 shall be the 
                sum of--
                          [(i) $652,709,000 multiplied by the 
                        result of an inflation adjustment 
                        calculation determined using the 
                        methodology described in subsection 
                        (c)(1)(B); and
                          [(ii) $652,709,000 multiplied by the 
                        result of an inflation adjustment 
                        calculation determined using the 
                        methodology described in subsection 
                        (c)(1)(C).
                  [(B) Workload adjustment.--Subject to 
                subparagraph (C), the workload adjustment for 
                fiscal 2013 shall be--
                          [(i) $652,709,000 plus the amount of 
                        the inflation adjustment calculated 
                        under subparagraph (A); multiplied by
                          [(ii) the amount (if any) by which a 
                        percentage workload adjustment for 
                        fiscal year 2013, as determined using 
                        the methodology described in subsection 
                        (c)(2)(A), would exceed the percentage 
                        workload adjustment (as so determined) 
                        for fiscal year 2012, if both such 
                        adjustment percentages were calculated 
                        using the 5-year base period consisting 
                        of fiscal years 2003 through 2007.
                  [(C) Limitation.--Under no circumstances 
                shall the adjustment under subparagraph (B) 
                result in fee revenues for fiscal year 2013 
                that are less than the sum of the amount under 
                paragraph (1)(A) and the amount under paragraph 
                (1)(B).
  [(c) Adjustments.--
          [(1) Inflation adjustment.--For fiscal year 2014 and 
        subsequent fiscal years, the revenues established in 
        subsection (b) shall be adjusted by the Secretary by 
        notice, published in the Federal Register, for a fiscal 
        year by the amount equal to the sum of--
                  [(A) one;
                  [(B) the average annual percent change in the 
                cost, per full-time equivalent position of the 
                Food and Drug Administration, of all personnel 
                compensation and benefits paid with respect to 
                such positions for the first 3 years of the 
                preceding 4 fiscal years, multiplied by the 
                proportion of personnel compensation and 
                benefits costs to total costs of the process 
                for the review of human drug applications (as 
                defined in section 735(6)) for the first 3 
                years of the preceding 4 fiscal years, and
                  [(C) the average annual percent change that 
                occurred in the Consumer Price Index for urban 
                consumers (Washington-Baltimore, DC-MD-VA-WV; 
                Not Seasonally Adjusted; All items; Annual 
                Index) for the first 3 years of the preceding 4 
                years of available data multiplied by the 
                proportion of all costs other than personnel 
                compensation and benefits costs to total costs 
                of the process for the review of human drug 
                applications (as defined in section 735(6)) for 
                the first 3 years of the preceding 4 fiscal 
                years.
        The adjustment made each fiscal year under this 
        paragraph shall be added on a compounded basis to the 
        sum of all adjustments made each fiscal year after 
        fiscal year 2013 under this paragraph.
          [(2) Workload adjustment.--For fiscal year 2014 and 
        subsequent fiscal years, after the fee revenues 
        established in subsection (b) are adjusted for a fiscal 
        year for inflation in accordance with paragraph (1), 
        the fee revenues shall be adjusted further for such 
        fiscal year to reflect changes in the workload of the 
        Secretary for the process for the review of human drug 
        applications. With respect to such adjustment:
                  [(A) The adjustment shall be determined by 
                the Secretary based on a weighted average of 
                the change in the total number of human drug 
                applications (adjusted for changes in review 
                activities, as described in the notice that the 
                Secretary is required to publish in the Federal 
                Register under this subparagraph), efficacy 
                supplements, and manufacturing supplements 
                submitted to the Secretary, and the change in 
                the total number of active commercial 
                investigational new drug applications (adjusted 
                for changes in review activities, as so 
                described) during the most recent 12-month 
                period for which data on such submissions is 
                available. The Secretary shall publish in the 
                Federal Register the fee revenues and fees 
                resulting from the adjustment and the 
                supporting methodologies.
                  [(B) Under no circumstances shall the 
                adjustment result in fee revenues for a fiscal 
                year that are less than the sum of the amount 
                under subsection (b)(1)(A) and the amount under 
                subsection (b)(1)(B), as adjusted for inflation 
                under paragraph (1).
                  [(C) The Secretary shall contract with an 
                independent accounting or consulting firm to 
                periodically review the adequacy of the 
                adjustment and publish the results of those 
                reviews. The first review shall be conducted 
                and published by the end of fiscal year 2013 
                (to examine the performance of the adjustment 
                since fiscal year 2009), and the second review 
                shall be conducted and published by the end of 
                fiscal year 2015 (to examine the continued 
                performance of the adjustment). The reports 
                shall evaluate whether the adjustment 
                reasonably represents actual changes in 
                workload volume and complexity and present 
                options to discontinue, retain, or modify any 
                elements of the adjustment. The reports shall 
                be published for public comment. After review 
                of the reports and receipt of public comments, 
                the Secretary shall, if warranted, adopt 
                appropriate changes to the methodology. If the 
                Secretary adopts changes to the methodology 
                based on the first report, the changes shall be 
                effective for the first fiscal year for which 
                fees are set after the Secretary adopts such 
                changes and each subsequent fiscal year.
          [(3) Final year adjustment.--For fiscal year 2017, 
        the Secretary may, in addition to adjustments under 
        this paragraph and paragraphs (1) and (2), further 
        increase the fee revenues and fees established in 
        subsection (b) if such an adjustment is necessary to 
        provide for not more than 3 months of operating 
        reserves of carryover user fees for the process for the 
        review of human drug applications for the first 3 
        months of fiscal year 2018. If such an adjustment is 
        necessary, the rationale for the amount of the increase 
        shall be contained in the annual notice establishing 
        fee revenues and fees for fiscal year 2017. If the 
        Secretary has carryover balances for such process in 
        excess of 3 months of such operating reserves, the 
        adjustment under this paragraph shall not be made.
          [(4) Annual fee setting.--The Secretary shall, not 
        later than 60 days before the start of each fiscal year 
        that begins after September 30, 2012, establish, for 
        the next fiscal year, application, product, and 
        establishment fees under subsection (a), based on the 
        revenue amounts established under subsection (b) and 
        the adjustments provided under this subsection.
          [(5) Limit.--The total amount of fees charged, as 
        adjusted under this subsection, for a fiscal year may 
        not exceed the total costs for such fiscal year for the 
        resources allocated for the process for the review of 
        human drug applications.]
  (b) Fee Revenue Amounts.--
          (1) In general.--For each of the fiscal years 2018 
        through 2022, fees under subsection (a) shall, except 
        as provided in subsections (c), (d), (f), and (g), be 
        established to generate a total revenue amount under 
        such subsection that is equal to the sum of--
                  (A) the annual base revenue for the fiscal 
                year (as determined under paragraph (3));
                  (B) the dollar amount equal to the inflation 
                adjustment for the fiscal year (as determined 
                under subsection (c)(1));
                  (C) the dollar amount equal to the capacity 
                planning adjustment for the fiscal year (as 
                determined under subsection (c)(2));
                  (D) the dollar amount equal to the operating 
                reserve adjustment for the fiscal year, if 
                applicable (as determined under subsection 
                (c)(3));
                  (E) the dollar amount equal to the additional 
                direct cost adjustment for the fiscal year (as 
                determined under subsection (c)(4)); and
                  (F) additional dollar amounts for each fiscal 
                year as follows:
                          (i) $20,077,793 for fiscal year 2018.
                          (ii) $21,317,472 for fiscal year 
                        2019.
                          (iii) $16,953,329 for fiscal year 
                        2020.
                          (iv) $5,426,896 for fiscal year 2021.
                          (v) $2,769,609 for fiscal year 2022.
          (2) Types of fees.--Of the total revenue amount 
        determined for a fiscal year under paragraph (1)--
                  (A) 20 percent shall be derived from human 
                drug application fees under subsection (a)(1); 
                and
                  (B) 80 percent shall be derived from 
                prescription drug program fees under subsection 
                (a)(2).
          (3) Annual base revenue.--For purposes of paragraph 
        (1), the dollar amount of the annual base revenue for a 
        fiscal year shall be--
                  (A) for fiscal year 2018, $878,590,000; and
                  (B) for fiscal years 2019 through 2022, the 
                dollar amount of the total revenue amount 
                established under paragraph (1) for the 
                previous fiscal year, not including any 
                adjustments made under subsection (c)(3) or 
                (c)(4).
  (c) Adjustments; Annual Fee Setting.--
          (1) Inflation adjustment.--
                  (A) In general.--For purposes of subsection 
                (b)(1)(B), the dollar amount of the inflation 
                adjustment to the annual base revenue for each 
                fiscal year shall be equal to the product of--
                          (i) such annual base revenue for the 
                        fiscal year under subsection (b)(1)(A); 
                        and
                          (ii) the inflation adjustment 
                        percentage under subparagraph (B).
                  (B) Inflation adjustment percentage.--The 
                inflation adjustment percentage under this 
                subparagraph for a fiscal year is equal to the 
                sum of--
                          (i) the average annual percent change 
                        in the cost, per full-time equivalent 
                        position of the Food and Drug 
                        Administration, of all personnel 
                        compensation and benefits paid with 
                        respect to such positions for the first 
                        3 years of the preceding 4 fiscal 
                        years, multiplied by the proportion of 
                        personnel compensation and benefits 
                        costs to total costs of the process for 
                        the review of human drug applications 
                        (as defined in section 735(6)) for the 
                        first 3 years of the preceding 4 fiscal 
                        years; and
                          (ii) the average annual percent 
                        change that occurred in the Consumer 
                        Price Index for urban consumers 
                        (Washington-Baltimore, DC-MD-VA-WV; Not 
                        Seasonally Adjusted; All items; Annual 
                        Index) for the first 3 years of the 
                        preceding 4 years of available data 
                        multiplied by the proportion of all 
                        costs other than personnel compensation 
                        and benefits costs to total costs of 
                        the process for the review of human 
                        drug applications (as defined in 
                        section 735(6)) for the first 3 years 
                        of the preceding 4 fiscal years.
          (2) Capacity planning adjustment.--
                  (A) In general.--For each fiscal year, after 
                the annual base revenue established in 
                subsection (b)(1)(A) is adjusted for inflation 
                in accordance with paragraph (1), such revenue 
                shall be adjusted further for such fiscal year, 
                in accordance with this paragraph, to reflect 
                changes in the resource capacity needs of the 
                Secretary for the process for the review of 
                human drug applications.
                  (B) Interim methodology.--
                          (i) In general.--Until the capacity 
                        planning methodology described in 
                        subparagraph (C) is effective, the 
                        adjustment under this paragraph for a 
                        fiscal year shall be based on the 
                        product of--
                                  (I) the annual base revenue 
                                for such year, as adjusted for 
                                inflation under paragraph (1); 
                                and
                                  (II) the adjustment 
                                percentage under clause (ii).
                          (ii) Adjustment percentage.--The 
                        adjustment percentage under this clause 
                        for a fiscal year is the weighted 
                        change in the 3-year average ending in 
                        the most recent year for which data are 
                        available, over the 3-year average 
                        ending in the previous year, for--
                                  (I) the total number of human 
                                drug applications, efficacy 
                                supplements, and manufacturing 
                                supplements submitted to the 
                                Secretary;
                                  (II) the total number of 
                                active commercial 
                                investigational new drug 
                                applications; and
                                  (III) the total number of 
                                formal meetings scheduled by 
                                the Secretary, and written 
                                responses issued by the 
                                Secretary in lieu of such 
                                formal meetings, as identified 
                                in section I.H of the letters 
                                described in section 101(b) of 
                                the Prescription Drug User Fee 
                                Amendments of 2017.
                  (C) Capacity planning methodology.--
                          (i) Development; evaluation and 
                        report.--The Secretary shall obtain, 
                        through a contract with an independent 
                        accounting or consulting firm, a report 
                        evaluating options and recommendations 
                        for a new methodology to accurately 
                        assess changes in the resource and 
                        capacity needs of the process for the 
                        review of human drug applications. The 
                        capacity planning methodological 
                        options and recommendations presented 
                        in such report shall utilize and be 
                        informed by personnel time reporting 
                        data as an input. The report shall be 
                        published for public comment no later 
                        than the end of fiscal year 2020.
                          (ii) Establishment and 
                        implementation.--After review of the 
                        report described in clause (i) and any 
                        public comments thereon, the Secretary 
                        shall establish a capacity planning 
                        methodology for purposes of this 
                        paragraph, which shall--
                                  (I) replace the interim 
                                methodology under subparagraph 
                                (B);
                                  (II) incorporate such 
                                approaches and attributes as 
                                the Secretary determines 
                                appropriate; and
                                  (III) be effective beginning 
                                with the first fiscal year for 
                                which fees are set after such 
                                capacity planning methodology 
                                is established.
                  (D) Limitation.--Under no circumstances shall 
                an adjustment under this paragraph result in 
                fee revenue for a fiscal year that is less than 
                the sum of the amounts under subsections 
                (b)(1)(A) (the annual base revenue for the 
                fiscal year) and (b)(1)(B) (the dollar amount 
                of the inflation adjustment for the fiscal 
                year).
                  (E) Publication in federal register.--The 
                Secretary shall publish in the Federal Register 
                notice under paragraph (5) the fee revenue and 
                fees resulting from the adjustment and the 
                methodologies under this paragraph.
          (3) Operating reserve adjustment.--
                  (A) Increase.--For fiscal year 2018 and 
                subsequent fiscal years, the Secretary may, in 
                addition to adjustments under paragraphs (1) 
                and (2), further increase the fee revenue and 
                fees if such an adjustment is necessary to 
                provide for not more than 14 weeks of operating 
                reserves of carryover user fees for the process 
                for the review of human drug applications.
                  (B) Decrease.--If the Secretary has carryover 
                balances for such process in excess of 14 weeks 
                of such operating reserves, the Secretary shall 
                decrease such fee revenue and fees to provide 
                for not more than 14 weeks of such operating 
                reserves.
                  (C) Notice of rationale.--If an adjustment 
                under subparagraph (A) or (B) is made, the 
                rationale for the amount of the increase or 
                decrease (as applicable) in fee revenue and 
                fees shall be contained in the annual Federal 
                Register notice under paragraph (5) 
                establishing fee revenue and fees for the 
                fiscal year involved.
          (4) Additional direct cost adjustment.--
                  (A) In general.--The Secretary shall, in 
                addition to adjustments under paragraphs (1), 
                (2), and (3), further increase the fee revenue 
                and fees--
                          (i) for fiscal year 2018, by 
                        $8,730,000; and
                          (ii) for fiscal year 2019 and 
                        subsequent fiscal years, by the amount 
                        determined under subparagraph (B).
                  (B) Amount.--The amount determined under this 
                subparagraph is--
                          (i) $8,730,000, multiplied by
                          (ii) the Consumer Price Index for 
                        urban consumers (Washington-Baltimore, 
                        DC-MD-VA-WV; Not Seasonally Adjusted; 
                        All Items; Annual Index) for the most 
                        recent year of available data, divided 
                        by such Index for 2016.
          (5) Annual fee setting.--The Secretary shall, not 
        later than 60 days before the start of each fiscal year 
        that begins after September 30, 2017--
                  (A) establish, for the next fiscal year, 
                human drug application fees and prescription 
                drug program fees under subsection (a), based 
                on the revenue amounts established under 
                subsection (b) and the adjustments provided 
                under this subsection; and
                  (B) publish such fee revenue and fees in the 
                Federal Register.
          (6) Limit.--The total amount of fees charged, as 
        adjusted under this subsection, for a fiscal year may 
        not exceed the total costs for such fiscal year for the 
        resources allocated for the process for the review of 
        human drug applications.
  (d) Fee Waiver or Reduction.--
          (1) In general.--The Secretary shall grant to a 
        person who is named as the applicant in a human drug 
        application a waiver from or a reduction of one or more 
        fees assessed to that person under subsection (a) where 
        the Secretary finds that--
                  (A) such waiver or reduction is necessary to 
                protect the public health,
                  (B) the assessment of the fee would present a 
                significant barrier to innovation because of 
                limited resources available to such person or 
                other circumstances, or
                  [(C) the fees to be paid by such person will 
                exceed the anticipated present and future costs 
                incurred by the Secretary in conducting the 
                process for the review of human drug 
                applications for such person, or]
                  [(D)] (C) the applicant involved is a small 
                business submitting its first human drug 
                application to the Secretary for review.
          (2) Considerations.--In determining whether to grant 
        a waiver or reduction of a fee under paragraph (1), the 
        Secretary shall consider only the circumstances and 
        assets of the applicant involved and any affiliate of 
        the applicant.
          [(3) Use of standard costs.--In making the finding in 
        paragraph (1)(C), the Secretary may use standard 
        costs.]
          [(4)] (3) Rules relating to small businesses.--
                  (A) Definition.--In [paragraph (1)(D)] 
                paragraph (1)(C), the term ``small business'' 
                means an entity that has fewer than 500 
                employees, including employees of affiliates, 
                and that does not have a drug product that has 
                been approved under a human drug application 
                and introduced or delivered for introduction 
                into interstate commerce.
                  (B) Waiver of application fee.--The Secretary 
                shall waive under [paragraph (1)(D)] paragraph 
                (1)(C) the application fee for the first human 
                drug application that a small business or its 
                affiliate submits to the Secretary for review. 
                After a small business or its affiliate is 
                granted such a waiver, the small business or 
                its affiliate [shall pay--]
                          [(i)] [application fees] shall pay 
                        application fees for all subsequent 
                        human drug applications submitted to 
                        the Secretary for review in the same 
                        manner as an entity that does not 
                        qualify as a small business[; and].
                          [(ii) all supplement fees for all 
                        supplements to human drug applications 
                        submitted to the Secretary for review 
                        in the same manner as an entity that 
                        does not qualify as a small business.]
  (e) Effect of Failure To Pay Fees.--A human drug application 
or supplement submitted by a person subject to fees under 
subsection (a) shall be considered incomplete and shall not be 
accepted for filing by the Secretary until [all fees] all such 
fees owed by such person have been paid.
  (f) Limitations.--
          (1) In general.--Fees under subsection (a) shall be 
        refunded for a fiscal year beginning after fiscal year 
        1997 unless appropriations for salaries and expenses of 
        the Food and Drug Administration for such fiscal year 
        (excluding the amount of fees appropriated for such 
        fiscal year) are equal to or greater than the amount of 
        appropriations for the salaries and expenses of the 
        Food and Drug Administration for the fiscal year 1997 
        (excluding the amount of fees appropriated for such 
        fiscal year) multiplied by the adjustment factor 
        applicable to the fiscal year involved.
          (2) Authority.--If the Secretary does not assess fees 
        under subsection (a) during any portion of a fiscal 
        year because of paragraph (1) and if at a later date in 
        such fiscal year the Secretary may assess such fees, 
        the Secretary may assess and collect such fees, without 
        any modification in the rate, for human drug 
        applications and [supplements, prescription drug 
        establishments, and prescription drug products] 
        prescription drug program fees at any time in such 
        fiscal year notwithstanding the provisions of 
        subsection (a) relating to the date fees are to be 
        paid.
  (g) Crediting and Availability of Fees.--
          (1) In general.--Subject to paragraph (2)(C), fees 
        authorized under subsection (a) shall be collected and 
        available for obligation only to the extent and in the 
        amount provided in advance in appropriations Acts. Such 
        fees are authorized to remain available until expended. 
        Such sums as may be necessary may be transferred from 
        the Food and Drug Administration salaries and expenses 
        appropriation account without fiscal year limitation to 
        such appropriation account for salaries and expenses 
        with such fiscal year limitation. The sums transferred 
        shall be available solely for the process for the 
        review of human drug applications.
          (2) Collections and appropriation acts.--
                  (A) In general.--The fees authorized by this 
                section--
                          (i) subject to subparagraph (C), 
                        shall be collected and available in 
                        each fiscal year in an amount not to 
                        exceed the amount specified in 
                        appropriation Acts, or otherwise made 
                        available for obligation, for such 
                        fiscal year, and
                          (ii) shall be available to defray 
                        increases in the costs of the resources 
                        allocated for the process for the 
                        review of human drug applications 
                        (including increases in such costs for 
                        an additional number of full-time 
                        equivalent positions in the Department 
                        of Health and Human Services to be 
                        engaged in such process) over such 
                        costs, excluding costs paid from fees 
                        collected under this section, for 
                        fiscal year 1997 multiplied by the 
                        adjustment factor.
                  (B) Compliance.--The Secretary shall be 
                considered to have met the requirements of 
                subparagraph (A)(ii) in any fiscal year if the 
                costs funded by appropriations and allocated 
                for the process for the review of human drug 
                applications--
                          (i) are not more than 3 percent below 
                        the level specified in subparagraph 
                        (A)(ii); or
                          (ii)(I) are more than 3 percent below 
                        the level specified in subparagraph 
                        (A)(ii), and fees assessed for the 
                        fiscal year following the subsequent 
                        fiscal year are decreased by the amount 
                        in excess of 3 percent by which such 
                        costs fell below the level specified in 
                        such subparagraph; and
                          (II) such costs are not more than 5 
                        percent below the level specified in 
                        such subparagraph.
                  (C) Provision for early payments.--Payment of 
                fees authorized under this section for a fiscal 
                year, prior to the due date for such fees, may 
                be accepted by the Secretary in accordance with 
                authority provided in advance in a prior year 
                appropriations Act.
          (3) Authorization of appropriations.--For each of the 
        fiscal years [2013 through 2017] 2018 through 2022, 
        there is authorized to be appropriated for fees under 
        this section an amount equal to the total revenue 
        amount determined under subsection (b) for the fiscal 
        year, as adjusted or otherwise affected under 
        subsection (c) [and paragraph (4) of this subsection].
          [(4) Offset.--If the sum of the cumulative amount of 
        fees collected under this section for the fiscal years 
        2013 through 2015 and the amount of fees estimated to 
        be collected under this section for fiscal year 2016 
        exceeds the cumulative amount appropriated under 
        paragraph (3) for the fiscal years 2013 through 2016, 
        the excess shall be credited to the appropriation 
        account of the Food and Drug Administration as provided 
        in paragraph (1), and shall be subtracted from the 
        amount of fees that would otherwise be authorized to be 
        collected under this section pursuant to appropriation 
        Acts for fiscal year 2017.]
  (h) Collection of Unpaid Fees.--In any case where the 
Secretary does not receive payment of a fee assessed under 
subsection (a) within 30 days after it is due, such fee shall 
be treated as a claim of the United States Government subject 
to subchapter II of chapter 37 of title 31, United States Code.
  (i) Written Requests for Waivers, Reductions, and Refunds.--
To qualify for consideration for a waiver or reduction under 
subsection (d), or for a refund of any fee collected in 
accordance with subsection (a), a person shall submit to the 
Secretary a written request for such waiver, reduction, or 
refund not later than 180 days after such fee is due.
  (j) Construction.--This section may not be construed to 
require that the number of full-time equivalent positions in 
the Department of Health and Human Services, for officers, 
employers, and advisory committees not engaged in the process 
of the review of human drug applications, be reduced to offset 
the number of officers, employees, and advisory committees so 
engaged.
  (k) Orphan Drugs.--
          (1) Exemption.--A drug designated under section 526 
        for a rare disease or condition and approved under 
        section 505 or under section 351 of the Public Health 
        Service Act shall be exempt from [product and 
        establishment fees] prescription drug program fees 
        under this section, if the drug meets all of the 
        following conditions:
                  (A) The drug meets the public health 
                requirements contained in this Act as such 
                requirements are applied to requests for 
                waivers for [product and establishment fees] 
                prescription drug program fees.
                  (B) The drug is owned or licensed and is 
                marketed by a company that had less than 
                $50,000,000 in gross worldwide revenue during 
                the previous year.
          (2) Evidence of qualification.--An exemption under 
        paragraph (1) applies with respect to a drug only if 
        the applicant involved submits a certification that its 
        gross annual revenues did not exceed $50,000,000 for 
        the preceding 12 months before the exemption was 
        requested.

           *       *       *       *       *       *       *


SEC. 736B. REAUTHORIZATION; REPORTING REQUIREMENTS.

  (a) Performance Report.--
          (1) In general.--Beginning with fiscal year [2013] 
        2018, not later than 120 days after the end of each 
        fiscal year for which fees are collected under this 
        part, the Secretary shall prepare and 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 concerning--
                  (A) the progress of the Food and Drug 
                Administration in achieving the goals 
                identified in the letters described in section 
                101(b) of the [Prescription Drug User Fee 
                Amendments of 2012] Prescription Drug User Fee 
                Amendments of 2017 during such fiscal year and 
                the future plans of the Food and Drug 
                Administration for meeting the goals, including 
                the status of the independent assessment 
                described in such letters; and
                  (B) the progress of the Center for Drug 
                Evaluation and Research and the Center for 
                Biologics Evaluation and Research in achieving 
                the goals, and future plans for meeting the 
                goals, including, for each review division--
                          (i) the number of original standard 
                        new drug applications and biologics 
                        license applications filed per fiscal 
                        year for each review division;
                          (ii) the number of original priority 
                        new drug applications and biologics 
                        license applications filed per fiscal 
                        year for each review division;
                          (iii) the number of standard efficacy 
                        supplements filed per fiscal year for 
                        each review division;
                          (iv) the number of priority efficacy 
                        supplements filed per fiscal year for 
                        each review division;
                          (v) the number of applications filed 
                        for review under accelerated approval 
                        per fiscal year for each review 
                        division;
                          (vi) the number of applications filed 
                        for review as fast track products per 
                        fiscal year for each review division;
                          (vii) the number of applications 
                        filed for orphan-designated products 
                        per fiscal year for each review 
                        division; and
                          (viii) the number of breakthrough 
                        designations for a fiscal year for each 
                        review division.
          (2) Inclusion.--The report under this subsection for 
        a fiscal year shall include information on all previous 
        cohorts for which the Secretary has not given a 
        complete response on all human drug applications and 
        supplements in the cohort.
  (b) Fiscal Report.--Beginning with fiscal year [2013] 2018, 
not later than 120 days after the end of each fiscal year for 
which fees are collected under this part, the Secretary shall 
prepare and 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 
implementation of the authority for such fees during such 
fiscal year and the use, by the Food and Drug Administration, 
of the fees collected for such fiscal year.
  (c) Public Availability.--The Secretary shall make the 
reports required under subsections (a) and (b) available to the 
public on the Internet Web site of the Food and Drug 
Administration.
  (d) Reauthorization.--
          (1) Consultation.--In developing recommendations to 
        present to the Congress with respect to the goals, and 
        plans for meeting the goals, for the process for the 
        review of human drug applications for the first 5 
        fiscal years after fiscal year [2017] 2022, and for the 
        reauthorization of this part for such fiscal years, the 
        Secretary shall consult with--
                  (A) the Committee on Energy and Commerce of 
                the House of Representatives;
                  (B) the Committee on Health, Education, 
                Labor, and Pensions of the Senate;
                  (C) scientific and academic experts;
                  (D) health care professionals;
                  (E) representatives of patient and consumer 
                advocacy groups; and
                  (F) the regulated industry.
          (2) Prior public input.--Prior to beginning 
        negotiations with the regulated industry on the 
        reauthorization of this part, the Secretary shall--
                  (A) publish a notice in the Federal Register 
                requesting public input on the reauthorization;
                  (B) hold a public meeting at which the public 
                may present its views on the reauthorization, 
                including specific suggestions for changes to 
                the goals referred to in subsection (a);
                  (C) provide a period of 30 days after the 
                public meeting to obtain written comments from 
                the public suggesting changes to this part; and
                  (D) publish the comments on the Food and Drug 
                Administration's Internet Web site.
          (3) Periodic consultation.--Not less frequently than 
        once every month during negotiations with the regulated 
        industry, the Secretary shall hold discussions with 
        representatives of patient and consumer advocacy groups 
        to continue discussions of their views on the 
        reauthorization and their suggestions for changes to 
        this part as expressed under paragraph (2).
          (4) Public review of recommendations.--After 
        negotiations with the regulated industry, the Secretary 
        shall--
                  (A) present the recommendations developed 
                under paragraph (1) to the Congressional 
                committees specified in such paragraph;
                  (B) publish such recommendations in the 
                Federal Register;
                  (C) provide for a period of 30 days for the 
                public to provide written comments on such 
                recommendations;
                  (D) hold a meeting at which the public may 
                present its views on such recommendations; and
                  (E) after consideration of such public views 
                and comments, revise such recommendations as 
                necessary.
          (5) Transmittal of recommendations.--Not later than 
        January 15, [2017] 2022, the Secretary shall transmit 
        to the Congress the revised recommendations under 
        paragraph (4), a summary of the views and comments 
        received under such paragraph, and any changes made to 
        the recommendations in response to such views and 
        comments.
          (6) Minutes of negotiation meetings.--
                  (A) Public availability.--Before presenting 
                the recommendations developed under paragraphs 
                (1) through (5) to the Congress, the Secretary 
                shall make publicly available, on the public 
                Web site of the Food and Drug Administration, 
                minutes of all negotiation meetings conducted 
                under this subsection between the Food and Drug 
                Administration and the regulated industry.
                  (B) Content.--The minutes described under 
                subparagraph (A) shall summarize any 
                substantive proposal made by any party to the 
                negotiations as well as significant 
                controversies or differences of opinion during 
                the negotiations and their resolution.

                    PART 3--FEES RELATING TO DEVICES

SEC. 737. DEFINITIONS.

   For purposes of this part:
          (1) The term ``premarket application'' means--
                  (A) an application for approval of a device 
                submitted under section 515(c) or section 351 
                of the Public Health Service Act; or
                  (B) a product development protocol described 
                in section 515(f).
        Such term does not include a supplement, a premarket 
        report, or a premarket notification submission.
          (2) The term ``premarket report'' means a report 
        submitted under section 515(c)(2).
          (3) The term ``premarket notification submission'' 
        means a report submitted under section 510(k).
          (4)(A) The term ``supplement'', with respect to a 
        panel-track supplement, a 180-day supplement, a real-
        time supplement, or an efficacy supplement, means a 
        request to the Secretary to approve a change in a 
        device for which--
                  (i) an application or report has been 
                approved under section 515(d), or an 
                application has been approved under section 351 
                of the Public Health Service Act; or
                  (ii) a notice of completion has become 
                effective under section 515(f).
          (B) The term ``panel-track supplement'' means a 
        supplement to an approved premarket application or 
        premarket report under section 515 that requests a 
        significant change in design or performance of the 
        device, or a new indication for use of the device, and 
        for which substantial clinical data are necessary to 
        provide a reasonable assurance of safety and 
        effectiveness.
          (C) The term ``180-day supplement'' means a 
        supplement to an approved premarket application or 
        premarket report under section 515 that is not a panel-
        track supplement and requests a significant change in 
        components, materials, design, specification, software, 
        color additives, or labeling.
          (D) The term ``real-time supplement'' means a 
        supplement to an approved premarket application or 
        premarket report under section 515 that requests a 
        minor change to the device, such as a minor change to 
        the design of the device, software, sterilization, or 
        labeling, and for which the applicant has requested and 
        the agency has granted a meeting or similar forum to 
        jointly review and determine the status of the 
        supplement.
          (E) The term ``efficacy supplement'' means a 
        supplement to an approved premarket application under 
        section 351 of the Public Health Service Act that 
        requires substantive clinical data.
          (5) The term ``30-day notice'' means a notice under 
        section 515(d)(5) that is limited to a request to make 
        modifications to manufacturing procedures or methods of 
        manufacture affecting the safety and effectiveness of 
        the device.
          (6) The term ``request for classification 
        information'' means a request made under section 513(g) 
        for information respecting the class in which a device 
        has been classified or the requirements applicable to a 
        device.
          (7) The term ``annual fee'', for periodic reporting 
        concerning a class III device, means the annual fee 
        associated with periodic reports required by a 
        premarket application approval order.
          (8) The term ``de novo classification request'' means 
        a request made under section 513(f)(2)(A) with respect 
        to the classification of a device.
          [(8)] (9) The term ``process for the review of device 
        applications'' means the following activities of the 
        Secretary with respect to the review of premarket 
        applications, premarket reports, supplements, and 
        premarket notification submissions:
                  (A) The activities necessary for the review 
                of premarket applications, premarket reports, 
                supplements, and premarket notification 
                submissions.
                  (B) The issuance of action letters that allow 
                the marketing of devices or which set forth in 
                detail the specific deficiencies in such 
                applications, reports, supplements, or 
                submissions and, where appropriate, the actions 
                necessary to place them in condition for 
                approval.
                  (C) The inspection of manufacturing 
                establishments and other facilities undertaken 
                as part of the Secretary's review of pending 
                premarket applications, premarket reports, and 
                supplements.
                  (D) Monitoring of research conducted in 
                connection with the review of such 
                applications, reports, supplements, and 
                submissions.
                  (E) Review of device applications subject to 
                section 351 of the Public Health Service Act 
                for an investigational new drug application 
                under section 505(i) or for an investigational 
                device exemption under section 520(g) and 
                activities conducted in anticipation of the 
                submission of such applications under section 
                505(i) or 520(g).
                  (F) The development of guidance, policy 
                documents, or regulations to improve the 
                process for the review of premarket 
                applications, premarket reports, supplements, 
                and premarket notification submissions.
                  (G) The development of voluntary test 
                methods, consensus standards, or mandatory 
                performance standards under section 514 in 
                connection with the review of such 
                applications, reports, supplements, or 
                submissions and related activities.
                  (H) The provision of technical assistance to 
                device manufacturers in connection with the 
                submission of such applications, reports, 
                supplements, or submissions.
                  (I) Any activity undertaken under section 513 
                or 515(i) in connection with the initial 
                classification or reclassification of a device 
                or under section 515(b) in connection with any 
                requirement for approval of a device.
                  (J) Evaluation of postmarket studies required 
                as a condition of an approval of a premarket 
                application or premarket report under section 
                515 or a premarket application under section 
                351 of the Public Health Service Act.
                  (K) Compiling, developing, and reviewing 
                information on relevant devices to identify 
                safety and effectiveness issues for devices 
                subject to premarket applications, premarket 
                reports, supplements, or premarket notification 
                submissions.
          [(9)] (10) The term ``costs of resources allocated 
        for the process for the review of device applications'' 
        means the expenses in connection with the process for 
        the review of device applications for--
                  (A) officers and employees of the Food and 
                Drug Administration, contractors of the Food 
                and Drug Administration, advisory committees, 
                and costs related to such officers, employees, 
                and committees and to contracts with such 
                contractors;
                  (B) management of information, and the 
                acquisition, maintenance, and repair of 
                computer resources;
                  (C) leasing, maintenance, renovation, and 
                repair of facilities and acquisition, 
                maintenance, and repair of fixtures, furniture, 
                scientific equipment, and other necessary 
                materials and supplies; and
                  (D) collecting fees and accounting for 
                resources allocated for the review of premarket 
                applications, premarket reports, supplements, 
                [and submissions] submissions, and de novo 
                classification requests.
          [(10)] (11) The term ``adjustment factor'' applicable 
        to a fiscal year is the Consumer Price Index for all 
        urban consumers (all items; United States city average) 
        for October of the preceding fiscal year divided by 
        such Index for October [2011] 2016.
          [(11)] (12) The term ``person'' includes an affiliate 
        thereof.
          [(12)] (13) The term ``affiliate'' means a business 
        entity that has a relationship with a second business 
        entity (whether domestic or international) if, directly 
        or indirectly--
                  (A) one business entity controls, or has the 
                power to control, the other business entity; or
                  (B) a third party controls, or has power to 
                control, both of the business entities.
          [(13)] (14) The term ``establishment subject to a 
        registration fee'' means an establishment that is 
        registered (or is required to register) with the 
        Secretary under section 510 because such establishment 
        is engaged in the manufacture, preparation, 
        propagation, compounding, or processing of a device.

SEC. 738. AUTHORITY TO ASSESS AND USE DEVICE FEES.

  (a) Types of Fees.--
          (1) In general.--Beginning in [fiscal year 2013] 
        fiscal year 2018, the Secretary shall assess and 
        collect fees in accordance with this section.
          (2) Premarket application, premarket report, 
        supplement, and submission fee, and annual fee for 
        periodic reporting concerning a class iii device.--
                  (A) In general.--Except as provided in 
                subparagraph (B) and subsections [(d), (e), and 
                (f)] (d) and (e) each person who submits any of 
                the following, on or after [October 1, 2012] 
                October 1, 2017, shall be subject to a fee 
                established under subsection (c) for the fiscal 
                year involved in accordance with the following:
                          (i) A premarket application.
                          (ii) For a premarket report, a fee 
                        equal to the fee that applies under 
                        clause (i).
                          (iii) For a panel track supplement, a 
                        fee equal to 75 percent of the fee that 
                        applies under clause (i).
                          (iv) For a 180-day supplement, a fee 
                        equal to 15 percent of the fee that 
                        applies under clause (i).
                          (v) For a real-time supplement, a fee 
                        equal to 7 percent of the fee that 
                        applies under clause (i).
                          (vi) For a 30-day notice, a fee equal 
                        to 1.6 percent of the fee that applies 
                        under clause (i).
                          (vii) For an efficacy supplement, a 
                        fee equal to the fee that applies under 
                        clause (i).
                          (viii) For a premarket notification 
                        submission, a fee equal to [2] 3.4 
                        percent of the fee that applies under 
                        clause (i).
                          (ix) For a request for classification 
                        information, a fee equal to 1.35 
                        percent of the fee that applies under 
                        clause (i).
                          (x) For periodic reporting concerning 
                        a class III device, an annual fee equal 
                        to 3.5 percent of the fee that applies 
                        under clause (i).
                          (xi) For a de novo classification 
                        request, a fee equal to 30 percent of 
                        the fee that applies under clause (i).
                  (B) Exceptions.--
                          (i) Humanitarian device exemption.--
                        An application under section 520(m) is 
                        not subject to any fee under 
                        subparagraph (A).
                          (ii) Further manufacturing use.--No 
                        fee shall be required under 
                        subparagraph (A) for the submission of 
                        a premarket application under section 
                        351 of the Public Health Service Act 
                        for a product licensed for further 
                        manufacturing use only.
                          (iii) State or federal government 
                        sponsors.--No fee shall be required 
                        under subparagraph (A) for a premarket 
                        application, premarket report, 
                        supplement, or premarket notification 
                        submission submitted by a State or 
                        Federal Government entity unless the 
                        device involved is to be distributed 
                        commercially.
                          (iv) Premarket notifications by third 
                        parties.--No fee shall be required 
                        under subparagraph (A) for a premarket 
                        notification submission reviewed by an 
                        accredited person pursuant to section 
                        523.
                          (v) Pediatric conditions of use.--
                                  (I) In general.--No fee shall 
                                be required under subparagraph 
                                (A) for a premarket 
                                application, premarket report, 
                                [or premarket notification 
                                submission] premarket 
                                notification submission, or de 
                                novo classification request if 
                                the proposed conditions of use 
                                for the device involved are 
                                solely for a pediatric 
                                population. No fee shall be 
                                required under such 
                                subparagraph for a supplement 
                                if the sole purpose of the 
                                supplement is to propose 
                                conditions of use for a 
                                pediatric population.
                                  (II) Subsequent proposal of 
                                adult conditions of use.--In 
                                the case of a person who 
                                submits a premarket application 
                                or premarket report for which, 
                                under subclause (I), a fee 
                                under subparagraph (A) is not 
                                required, any supplement to 
                                such application that proposes 
                                conditions of use for any adult 
                                population is subject to the 
                                fee that applies under such 
                                subparagraph for a premarket 
                                application.
                  (C) Payment.--The fee required by 
                subparagraph (A) shall be due upon submission 
                of the premarket application, premarket report, 
                supplement, premarket notification submission, 
                30-day notice, request for classification 
                information, or periodic reporting concerning a 
                class III device. Applicants submitting 
                portions of applications pursuant to section 
                515(c)(4) shall pay such fees upon submission 
                of the first portion of such applications.
                  (D) Refunds.--
                          (i) Application refused for filing.--
                        The Secretary shall refund 75 percent 
                        of the fee paid under subparagraph (A) 
                        for any application, report, or 
                        supplement that is refused for filing.
                          (ii) Application withdrawn before 
                        filing.--The Secretary shall refund 75 
                        percent of the fee paid under 
                        subparagraph (A) for any application, 
                        report, or supplement that is withdrawn 
                        prior to the filing decision of the 
                        Secretary.
                          (iii) Application withdrawn before 
                        first action.--After receipt of a 
                        request for a refund of the fee paid 
                        under subparagraph (A) for a premarket 
                        application, premarket report, or 
                        supplement that is withdrawn after 
                        filing but before a first action, the 
                        Secretary may return some or all of the 
                        fee. The amount of refund, if any, 
                        shall be based on the level of effort 
                        already expended on the review of such 
                        application, report, or supplement.
                          (iv) Modular applications withdrawn 
                        before first action.--The Secretary 
                        shall refund 75 percent of the 
                        application fee paid for an application 
                        submitted under section 515(c)(4) that 
                        is withdrawn before a second portion is 
                        submitted and before a first action on 
                        the first portion.
                          (v) Later withdrawn modular 
                        applications.--If an application 
                        submitted under section 515(c)(4) is 
                        withdrawn after a second or subsequent 
                        portion is submitted but before any 
                        first action, the Secretary may return 
                        a portion of the fee. The amount of 
                        refund, if any, shall be based on the 
                        level of effort already expended on the 
                        review of the portions submitted.
                          (vi) Sole discretion to refund.--The 
                        Secretary shall have sole discretion to 
                        refund a fee or portion of the fee 
                        under clause (iii) or (v). A 
                        determination by the Secretary 
                        concerning a refund under clause (iii) 
                        or (v) shall not be reviewable.
          (3) Annual establishment registration fee.--
                  (A) In general.--Except as provided in 
                subparagraph (B) [and subsection (f)], each 
                establishment subject to a registration fee 
                shall be subject to a fee for each initial or 
                annual registration under section 510 beginning 
                with its registration for fiscal year 2008.
                  (B) Exception.--No fee shall be required 
                under subparagraph (A) for an establishment 
                operated by a State or Federal governmental 
                entity or an Indian tribe (as defined in the 
                Indian Self Determination and Educational 
                Assistance Act), unless a device manufactured 
                by the establishment is to be distributed 
                commercially.
                  (C) Payment.--The fee required under 
                subparagraph (A) shall be due once each fiscal 
                year, upon the later of--
                          (i) the initial or annual 
                        registration (as applicable) of the 
                        establishment under section 510; or
                          (ii) the first business day after the 
                        date of enactment of an appropriations 
                        Act providing for the collection and 
                        obligation of fees for such year under 
                        this section.
  [(b) Fee Amounts.--
          [(1) In general.--Subject to subsections (c), (d), 
        (e), (f), and (i), for each of fiscal years 2013 
        through 2017, fees under subsection (a) shall be 
        derived from the base fee amounts specified in 
        paragraph (2), to generate the total revenue amounts 
        specified in paragraph (3).
          [(2) Base fee amounts specified.--For purposes of 
        paragraph (1), the base fee amounts specified in this 
        paragraph are as follows:


----------------------------------------------------------------------------------------------------------------
                                                             Fiscal     Fiscal     Fiscal     Fiscal     Fiscal
                        [Fee Type                          Year 2013  Year 2014  Year 2015  Year 2016  Year 2017
----------------------------------------------------------------------------------------------------------------
[Premarket Application...................................   $248,000   $252,960   $258,019   $263,180   $268,443
Establishment Registration...............................     $2,575     $3,200     $3,750     $3,872     $3,872
----------------------------------------------------------------------------------------------------------------

          [(3) Total revenue amounts specified.--For purposes 
        of paragraph (1), the total revenue amounts specified 
        in this paragraph are as follows:
                  [(A) $97,722,301 for fiscal year 2013.
                  [(B) $112,580,497 for fiscal year 2014.
                  [(C) $125,767,107 for fiscal year 2015.
                  [(D) $129,339,949 for fiscal year 2016.
                  [(E) $130,184,348 for fiscal year 2017.]
  (b) Fee Amounts.--
          (1) In general.--Subject to subsections (c), (d), 
        (e), and (h), for each of fiscal years 2018 through 
        2022, fees under subsection (a) shall be derived from 
        the base fee amounts specified in paragraph (2), to 
        generate the total revenue amounts specified in 
        paragraph (3).
          (2) Base fee amounts specified.--For purposes of 
        paragraph (1), the base fee amounts specified in this 
        paragraph are as follows:


----------------------------------------------------------------------------------------------------------------
                                                             Fiscal     Fiscal     Fiscal     Fiscal     Fiscal
                         Fee Type                          Year 2018  Year 2019  Year 2020  Year 2021  Year 2022
----------------------------------------------------------------------------------------------------------------
Premarket Application....................................   $294,000   $300,000   $310,000   $328,000   $329,000
Establishment Registration...............................     $4,375     $4,548     $4,760     $4,975     $4,978
----------------------------------------------------------------------------------------------------------------

          (3) Total revenue amounts specified.--For purposes of 
        paragraph (1), the total revenue amounts specified in 
        this paragraph are as follows:
                  (A) $183,280,756 for fiscal year 2018.
                  (B) $190,654,875 for fiscal year 2019.
                  (C) $200,132,014 for fiscal year 2020.
                  (D) $211,748,789 for fiscal year 2021.
                  (E) $213,687,660 for fiscal year 2022.
  (c) Annual Fee Setting; Adjustments.--
          (1) In general.--The Secretary shall, 60 days before 
        the start of each fiscal year after September 30, 
        [2012] 2017, establish fees under subsection (a), based 
        on amounts specified under subsection (b) and the 
        adjustments provided under this subsection, and publish 
        such fees, and the rationale for any adjustments to 
        such fees, in the Federal Register.
          (2) Inflation adjustments.--
                  (A) Adjustment to total revenue amounts.--For 
                fiscal year [2014] 2018 and each subsequent 
                fiscal year, the Secretary shall adjust the 
                total revenue amount specified in subsection 
                (b)(3) for such fiscal year by multiplying such 
                amount by the applicable inflation adjustment 
                under subparagraph (B) for such year.
                  [(B) Applicable inflation adjustment to total 
                revenue amounts.--The applicable inflation 
                adjustment for a fiscal year is--
                          [(i) for fiscal year 2014, the base 
                        inflation adjustment under subparagraph 
                        (C) for such fiscal year; and
                          [(ii) for fiscal year 2015 and each 
                        subsequent fiscal year, the product 
                        of--
                                  [(I) the base inflation 
                                adjustment under subparagraph 
                                (C) for such fiscal year; and
                                  [(II) the product of the base 
                                inflation adjustment under 
                                subparagraph (C) for each of 
                                the fiscal years preceding such 
                                fiscal year, beginning with 
                                fiscal year 2014.]
                  (B) Applicable inflation adjustment.--The 
                applicable inflation adjustment for fiscal year 
                2018 and each subsequent fiscal year is the 
                product of--
                          (i) the base inflation adjustment 
                        under subparagraph (C) for such fiscal 
                        year; and
                          (ii) the product of the base 
                        inflation adjustment under subparagraph 
                        (C) for each of the fiscal years 
                        preceding such fiscal year, beginning 
                        with fiscal year 2016.
                  (C) Base inflation adjustment [to total 
                revenue amounts].--
                          (i) In general.--Subject to further 
                        adjustment under clause (ii), the base 
                        inflation adjustment for a fiscal year 
                        is the sum of one plus--
                                  (I) the average annual 
                                percent change in the cost, per 
                                full-time equivalent position 
                                of the Food and Drug 
                                Administration, of all 
                                personnel compensation and 
                                benefits paid with respect to 
                                such positions for the first 3 
                                years of the preceding 4 fiscal 
                                years, multiplied by 0.60; and
                                  (II) the average annual 
                                percent change that occurred in 
                                the Consumer Price Index for 
                                urban consumers (Washi