Text: H.R.34 — 114th Congress (2015-2016)All Bill Information (Except Text)

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H. R. 34


AT THE SECOND SESSION

Begun and held at the City of Washington on Monday,
the fourth day of January, two thousand and sixteen

    To accelerate the discovery, development, and delivery of 21st century cures, and for other purposes.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. Short title; table of contents.

(a) Short title.—This Act may be cited as the “21st Century Cures Act”.

(b) Table of contents.—The table of contents for this Act is as follows:


Sec. 1. Short title; table of contents.

Sec. 1000. Short title.

Sec. 1001. Beau Biden Cancer Moonshot and NIH innovation projects.

Sec. 1002. FDA innovation projects.

Sec. 1003. Account for the state response to the opioid abuse crisis.

Sec. 1004. Budgetary treatment.

Sec. 2001. National Institutes of Health Reauthorization.

Sec. 2002. EUREKA prize competitions.

Sec. 2011. Precision Medicine Initiative.

Sec. 2012. Privacy protection for human research subjects.

Sec. 2013. Protection of identifiable and sensitive information.

Sec. 2014. Data sharing.

Sec. 2021. Investing in the next generation of researchers.

Sec. 2022. Improvement of loan repayment program.

Sec. 2031. National Institutes of Health strategic plan.

Sec. 2032. Triennial reports.

Sec. 2033. Increasing accountability at the National Institutes of Health.

Sec. 2034. Reducing administrative burden for researchers.

Sec. 2035. Exemption for the National Institutes of Health from the Paperwork Reduction Act requirements.

Sec. 2036. High-risk, high-reward research.

Sec. 2037. National Center for Advancing Translational Sciences.

Sec. 2038. Collaboration and coordination to enhance research.

Sec. 2039. Enhancing the rigor and reproducibility of scientific research.

Sec. 2040. Improving medical rehabilitation research at the National Institutes of Health.

Sec. 2041. Task force on research specific to pregnant women and lactating women.

Sec. 2042. Streamlining National Institutes of Health reporting requirements.

Sec. 2043. Reimbursement for research substances and living organisms.

Sec. 2044. Sense of Congress on increased inclusion of underrepresented populations in clinical trials.

Sec. 2051. Technical updates to clinical trials database.

Sec. 2052. Compliance activities reports.

Sec. 2053. Updates to policies to improve data.

Sec. 2054. Consultation.

Sec. 2061. National neurological conditions surveillance system.

Sec. 2062. Tick-borne diseases.

Sec. 2063. Accessing, sharing, and using health data for research purposes.

Sec. 2071. National pediatric research network.

Sec. 2072. Global pediatric clinical study network.

Sec. 3001. Patient experience data.

Sec. 3002. Patient-focused drug development guidance.

Sec. 3003. Streamlining patient input.

Sec. 3004. Report on patient experience drug development.

Sec. 3011. Qualification of drug development tools.

Sec. 3012. Targeted drugs for rare diseases.

Sec. 3013. Reauthorization of program to encourage treatments for rare pediatric diseases.

Sec. 3014. GAO study of priority review voucher programs.

Sec. 3015. Amendments to the Orphan Drug grants.

Sec. 3016. Grants for studying continuous drug manufacturing.

Sec. 3021. Novel clinical trial designs.

Sec. 3022. Real world evidence.

Sec. 3023. Protection of human research subjects.

Sec. 3024. Informed consent waiver or alteration for clinical investigations.

Sec. 3031. Summary level review.

Sec. 3032. Expanded access policy.

Sec. 3033. Accelerated approval for regenerative advanced therapies.

Sec. 3034. Guidance regarding devices used in the recovery, isolation, or delivery of regenerative advanced therapies.

Sec. 3035. Report on regenerative advanced therapies.

Sec. 3036. Standards for regenerative medicine and regenerative advanced therapies.

Sec. 3037. Health care economic information.

Sec. 3038. Combination product innovation.

Sec. 3041. Antimicrobial resistance monitoring.

Sec. 3042. Limited population pathway.

Sec. 3043. Prescribing authority.

Sec. 3044. Susceptibility test interpretive criteria for microorganisms; antimicrobial susceptibility testing devices.

Sec. 3051. Breakthrough devices.

Sec. 3052. Humanitarian device exemption.

Sec. 3053. Recognition of standards.

Sec. 3054. Certain class I and class II devices.

Sec. 3055. Classification panels.

Sec. 3056. Institutional review board flexibility.

Sec. 3057. CLIA waiver improvements.

Sec. 3058. Least burdensome device review.

Sec. 3059. Cleaning instructions and validation data requirement.

Sec. 3060. Clarifying medical software regulation.

Sec. 3071. Silvio O. Conte Senior Biomedical Research and Biomedical Product Assessment Service.

Sec. 3072. Hiring authority for scientific, technical, and professional personnel.

Sec. 3073. Establishment of Food and Drug Administration Intercenter Institutes.

Sec. 3074. Scientific engagement.

Sec. 3075. Drug surveillance.

Sec. 3076. Reagan-Udall Foundation for the Food and Drug Administration.

Sec. 3081. Medical countermeasure guidelines.

Sec. 3082. Clarifying BARDA contracting authority.

Sec. 3083. Countermeasure budget plan.

Sec. 3084. Medical countermeasures innovation.

Sec. 3085. Streamlining Project BioShield procurement.

Sec. 3086. Encouraging treatments for agents that present a national security threat.

Sec. 3087. Paperwork Reduction Act waiver during a public health emergency.

Sec. 3088. Clarifying Food and Drug Administration emergency use authorization.

Sec. 3091. Predictable review timelines of vaccines by the Advisory Committee on Immunization Practices.

Sec. 3092. Review of processes and consistency of Advisory Committee on Immunization Practices recommendations.

Sec. 3093. Encouraging vaccine innovation.

Sec. 3101. Technical corrections.

Sec. 3102. Completed studies.

Sec. 4001. Assisting doctors and hospitals in improving quality of care for patients.

Sec. 4002. Transparent reporting on usability, security, and functionality.

Sec. 4003. Interoperability.

Sec. 4004. Information blocking.

Sec. 4005. Leveraging electronic health records to improve patient care.

Sec. 4006. Empowering patients and improving patient access to their electronic health information.

Sec. 4007. GAO study on patient matching.

Sec. 4008. GAO study on patient access to health information.

Sec. 4009. Improving Medicare local coverage determinations.

Sec. 4010. Medicare pharmaceutical and technology ombudsman.

Sec. 4011. Medicare site-of-service price transparency.

Sec. 4012. Telehealth services in Medicare.

Sec. 5001. Savings in the Medicare Improvement Fund.

Sec. 5002. Medicaid reimbursement to States for durable medical equipment.

Sec. 5003. Penalties for violations of grants, contracts, and other agreements.

Sec. 5004. Reducing overpayments of infusion drugs.

Sec. 5005. Increasing oversight of termination of Medicaid providers.

Sec. 5006. Requiring publication of fee-for-service provider directory.

Sec. 5007. Fairness in Medicaid supplemental needs trusts.

Sec. 5008. Eliminating Federal financial participation with respect to expenditures under Medicaid for agents used for cosmetic purposes or hair growth.

Sec. 5009. Amendment to the Prevention and Public Health Fund.

Sec. 5010. Strategic Petroleum Reserve drawdown.

Sec. 5011. Rescission of portion of ACA territory funding.

Sec. 5012. Medicare coverage of home infusion therapy.

Sec. 6000. Short title.

Sec. 6001. Assistant Secretary for Mental Health and Substance Use.

Sec. 6002. Strengthening the leadership of the Substance Abuse and Mental Health Services Administration.

Sec. 6003. Chief Medical Officer.

Sec. 6004. Improving the quality of behavioral health programs.

Sec. 6005. Strategic plan.

Sec. 6006. Biennial report concerning activities and progress.

Sec. 6007. Authorities of centers for mental health services, substance abuse prevention, and substance abuse treatment.

Sec. 6008. Advisory councils.

Sec. 6009. Peer review.

Sec. 6021. Improving oversight of mental and substance use disorders programs through the Assistant Secretary for Planning and Evaluation.

Sec. 6022. Reporting for protection and advocacy organizations.

Sec. 6023. GAO study.

Sec. 6031. Interdepartmental Serious Mental Illness Coordinating Committee.

Sec. 7001. Encouraging innovation and evidence-based programs.

Sec. 7002. Promoting access to information on evidence-based programs and practices.

Sec. 7003. Priority mental health needs of regional and national significance.

Sec. 7004. Priority substance use disorder treatment needs of regional and national significance.

Sec. 7005. Priority substance use disorder prevention needs of regional and national significance.

Sec. 8001. Community mental health services block grant.

Sec. 8002. Substance abuse prevention and treatment block grant.

Sec. 8003. Additional provisions related to the block grants.

Sec. 8004. Study of distribution of funds under the substance abuse prevention and treatment block grant and the community mental health services block grant.

Sec. 9001. Grants for treatment and recovery for homeless individuals.

Sec. 9002. Grants for jail diversion programs.

Sec. 9003. Promoting integration of primary and behavioral health care.

Sec. 9004. Projects for assistance in transition from homelessness.

Sec. 9005. National Suicide Prevention Lifeline Program.

Sec. 9006. Connecting individuals and families with care.

Sec. 9007. Strengthening community crisis response systems.

Sec. 9008. Garrett Lee Smith Memorial Act reauthorization.

Sec. 9009. Adult suicide prevention.

Sec. 9010. Mental health awareness training grants.

Sec. 9011. Sense of Congress on prioritizing American Indians and Alaska Native youth within suicide prevention programs.

Sec. 9012. Evidence-based practices for older adults.

Sec. 9013. National violent death reporting system.

Sec. 9014. Assisted outpatient treatment.

Sec. 9015. Assertive community treatment grant program.

Sec. 9016. Sober truth on preventing underage drinking reauthorization.

Sec. 9017. Center and program repeals.

Sec. 9021. Mental and behavioral health education and training grants.

Sec. 9022. Strengthening the mental and substance use disorders workforce.

Sec. 9023. Clarification on current eligibility for loan repayment programs.

Sec. 9024. Minority fellowship program.

Sec. 9025. Liability protections for health professional volunteers at community health centers.

Sec. 9026. Reports.

Sec. 9031. Mental health and substance use disorder services on campus.

Sec. 9032. Interagency Working Group on College Mental Health.

Sec. 9033. Improving mental health on college campuses.

Sec. 10001. Programs for children with a serious emotional disturbance.

Sec. 10002. Increasing access to pediatric mental health care.

Sec. 10003. Substance use disorder treatment and early intervention services for children and adolescents.

Sec. 10004. Children’s recovery from trauma.

Sec. 10005. Screening and treatment for maternal depression.

Sec. 10006. Infant and early childhood mental health promotion, intervention, and treatment.

Sec. 11001. Sense of Congress.

Sec. 11002. Confidentiality of records.

Sec. 11003. Clarification on permitted uses and disclosures of protected health information.

Sec. 11004. Development and dissemination of model training programs.

Sec. 12001. Rule of construction related to Medicaid coverage of mental health services and primary care services furnished on the same day.

Sec. 12002. Study and report related to Medicaid managed care regulation.

Sec. 12003. Guidance on opportunities for innovation.

Sec. 12004. Study and report on Medicaid emergency psychiatric demonstration project.

Sec. 12005. Providing EPSDT services to children in IMDs.

Sec. 12006. Electronic visit verification system required for personal care services and home health care services under Medicaid.

Sec. 13001. Enhanced compliance with mental health and substance use disorder coverage requirements.

Sec. 13002. Action plan for enhanced enforcement of mental health and substance use disorder coverage.

Sec. 13003. Report on investigations regarding parity in mental health and substance use disorder benefits.

Sec. 13004. GAO study on parity in mental health and substance use disorder benefits.

Sec. 13005. Information and awareness on eating disorders.

Sec. 13006. Education and training on eating disorders.

Sec. 13007. Clarification of existing parity rules.

Sec. 14001. Law enforcement grants for crisis intervention teams, mental health purposes.

Sec. 14002. Assisted outpatient treatment programs.

Sec. 14003. Federal drug and mental health courts.

Sec. 14004. Mental health in the judicial system.

Sec. 14005. Forensic assertive community treatment initiatives.

Sec. 14006. Assistance for individuals transitioning out of systems.

Sec. 14007. Co-occurring substance abuse and mental health challenges in drug courts.

Sec. 14008. Mental health training for Federal uniformed services.

Sec. 14009. Advancing mental health as part of offender reentry.

Sec. 14010. School mental health crisis intervention teams.

Sec. 14011. Active-shooter training for law enforcement.

Sec. 14012. Co-occurring substance abuse and mental health challenges in residential substance abuse treatment programs.

Sec. 14013. Mental health and drug treatment alternatives to incarceration programs.

Sec. 14014. National criminal justice and mental health training and technical assistance.

Sec. 14015. Improving Department of Justice data collection on mental illness involved in crime.

Sec. 14016. Reports on the number of mentally ill offenders in prison.

Sec. 14017. Codification of due process for determinations by secretary of veterans affairs of mental capacity of beneficiaries.

Sec. 14018. Reauthorization of appropriations.

Sec. 14021. Sequential intercept model.

Sec. 14022. Prison and jails.

Sec. 14023. Allowable uses.

Sec. 14024. Law enforcement training.

Sec. 14025. Federal law enforcement training.

Sec. 14026. GAO report.

Sec. 14027. Evidence based practices.

Sec. 14028. Transparency, program accountability, and enhancement of local authority.

Sec. 14029. Grant accountability.

Sec. 15000. Short title.

Sec. 15001. Development of Medicare HCPCS version of MS–DRG codes for similar hospital services.

Sec. 15002. Establishing beneficiary equity in the Medicare hospital readmission program.

Sec. 15003. Five-year extension of the rural community hospital demonstration program.

Sec. 15004. Regulatory relief for LTCHs.

Sec. 15005. Savings from IPPS MACRA pay-for through not applying documentation and coding adjustments.

Sec. 15006. Extension of certain LTCH Medicare payment rules.

Sec. 15007. Application of rules on the calculation of hospital length of stay to all LTCHs.

Sec. 15008. Change in Medicare classification for certain hospitals.

Sec. 15009. Temporary exception to the application of the Medicare LTCH site neutral provisions for certain spinal cord specialty hospitals.

Sec. 15010. Temporary extension to the application of the Medicare LTCH site neutral provisions for certain discharges with severe wounds.

Sec. 16001. Continuing Medicare payment under HOPD prospective payment system for services furnished by mid-build off-campus outpatient departments of providers.

Sec. 16002. Treatment of cancer hospitals in off-campus outpatient department of a provider policy.

Sec. 16003. Treatment of eligible professionals in ambulatory surgical centers for meaningful use and MIPS.

Sec. 16004. Continuing Access to Hospitals Act of 2016.

Sec. 16005. Delay of implementation of Medicare fee schedule adjustments for wheelchair accessories and seating systems when used in conjunction with complex rehabilitation technology (CRT) wheelchairs.

Sec. 16006. Allowing physical therapists to utilize locum tenens arrangements under Medicare.

Sec. 16007. Extension of the transition to new payment rates for durable medical equipment under the Medicare program.

Sec. 16008. Requirements in determining adjustments using information from competitive bidding programs.

Sec. 17001. Delay in authority to terminate contracts for Medicare Advantage plans failing to achieve minimum quality ratings.

Sec. 17002. Requirement for enrollment data reporting for Medicare.

Sec. 17003. Updating the Welcome to Medicare package.

Sec. 17004. No payment for items and services furnished by newly enrolled providers or suppliers within a temporary moratorium area.

Sec. 17005. Preservation of Medicare beneficiary choice under Medicare Advantage.

Sec. 17006. Allowing end-stage renal disease beneficiaries to choose a Medicare Advantage plan.

Sec. 17007. Improvements to the assignment of beneficiaries under the Medicare Shared Savings Program.

Sec. 18001. Exception from group health plan requirements for qualified small employer health reimbursement arrangements.

SEC. 1000. Short title.

This Division may be cited as the “21st Century Cures Act”.

SEC. 1001. Beau Biden cancer Moonshot and NIH innovation projects.

(a) In general.—The Director of the National Institutes of Health (referred to in this section as the “Director of NIH”) shall use any funds appropriated pursuant to the authorization of appropriations in subsection (b)(3) to carry out the National Institutes of Health innovation projects described in subsection (b)(4) (referred to in this section as the “NIH Innovation Projects”).

(b) National institutes of health innovation account.—

(1) ESTABLISHMENT OF NIH INNOVATION ACCOUNT.—There is established in the Treasury an account, to be known as the “NIH Innovation Account” (referred to in this subsection as the “Account”), for purposes of carrying out the NIH Innovation Projects described in paragraph (4).

(2) TRANSFER OF DIRECT SPENDING SAVINGS.—

(A) IN GENERAL.—The following amounts shall be transferred to the Account from the general fund of the Treasury:

(i) For fiscal year 2017, $352,000,000.

(ii) For fiscal year 2018, $496,000,000.

(iii) For fiscal year 2019, $711,000,000.

(iv) For fiscal year 2020, $492,000,000.

(v) For fiscal year 2021, $404,000,000.

(vi) For fiscal year 2022, $496,000,000.

(vii) For fiscal year 2023, $1,085,000,000.

(viii) For fiscal year 2024, $407,000,000.

(ix) For fiscal year 2025, $127,000,000.

(x) For fiscal year 2026, $226,000,000.

(B) AMOUNTS DEPOSITED.—Any amounts transferred under subparagraph (A) shall remain unavailable in the Account until such amounts are appropriated pursuant to paragraph (3).

(3) APPROPRIATIONS.—

(A) AUTHORIZATION OF APPROPRIATIONS.—For each of the fiscal years 2017 through 2026, there is authorized to be appropriated from the Account to the Director of NIH, for the purpose of carrying out the NIH Innovation Projects, an amount not to exceed the total amount transferred to the Account under paragraph (2)(A), to remain available until expended.

(B) OFFSETTING FUTURE APPROPRIATIONS.—For any of fiscal years 2017 through 2026, for any discretionary appropriation under the heading “NIH Innovation Account” provided to the Director of NIH pursuant to the authorization of appropriations under subparagraph (A) for the purpose of carrying out the NIH Innovation Projects, the total amount of such appropriations for the applicable fiscal year (not to exceed the total amount remaining in the Account) shall be subtracted from the estimate of discretionary budget authority and the resulting outlays for any estimate under the Congressional Budget and Impoundment Control Act of 1974 or the Balanced Budget and Emergency Deficit Control Act of 1985, and the amount transferred to the Account shall be reduced by the same amount.

(4) NIH INNOVATION PROJECTS.—NIH Innovation Projects authorized to be funded under this section shall consist of the following and, of the total amounts authorized to be appropriated under paragraph (3), there are authorized to be appropriated to each such project a total amount not to exceed the following, over the period of fiscal years 2017 through 2026:

(A) For the Precision Medicine Initiative, including for the advancement of a cohort of individuals to support the goals of the Precision Medicine Initiative, not to exceed a total of $1,455,000,000, as follows:

(i) For fiscal year 2017, $40,000,000.

(ii) For fiscal year 2018, $100,000,000.

(iii) For fiscal year 2019, $186,000,000.

(iv) For fiscal year 2020, $149,000,000.

(v) For fiscal year 2021, $109,000,000.

(vi) For fiscal year 2022, $150,000,000.

(vii) For fiscal year 2023, $419,000,000.

(viii) For fiscal year 2024, $235,000,000.

(ix) For fiscal year 2025, $36,000,000.

(x) For fiscal year 2026, $31,000,000.

(B) For the Brain Research through Advancing Innovative Neurotechnologies Initiative (known as the “BRAIN Initiative”), not to exceed a total of $1,511,000,000, as follows:

(i) For fiscal year 2017, $10,000,000.

(ii) For fiscal year 2018, $86,000,000.

(iii) For fiscal year 2019, $115,000,000.

(iv) For fiscal year 2020, $140,000,000.

(v) For fiscal year 2021, $100,000,000.

(vi) For fiscal year 2022, $152,000,000.

(vii) For fiscal year 2023, $450,000,000.

(viii) For fiscal year 2024, $172,000,000.

(ix) For fiscal year 2025, $91,000,000.

(x) For fiscal year 2026, $195,000,000.

(C) To support cancer research, such as the development of cancer vaccines, the development of more sensitive diagnostic tests for cancer, immunotherapy and the development of combination therapies, and research that has the potential to transform the scientific field, that has inherently higher risk, and that seeks to address major challenges related to cancer, not to exceed a total of $1,800,000,000, as follows:

(i) For fiscal year 2017, $300,000,000.

(ii) For fiscal year 2018, $300,000,000.

(iii) For fiscal year 2019, $400,000,000.

(iv) For fiscal year 2020, $195,000,000.

(v) For fiscal year 2021, $195,000,000.

(vi) For fiscal year 2022, $194,000,000.

(vii) For fiscal year 2023, $216,000,000.

(D) For the National Institutes of Health, in coordination with the Food and Drug Administration, to award grants and contracts for clinical research to further the field of regenerative medicine using adult stem cells, including autologous stem cells, for which grants and contracts shall be contingent upon the recipient making available non-Federal contributions toward the costs of such research in an amount not less than $1 for each $1 of Federal funds provided in the award, not to exceed a total of $30,000,000, as follows:

(i) For fiscal year 2017, $2,000,000.

(ii) For each of fiscal years 2018 and 2019, $10,000,000.

(iii) For fiscal year 2020, $8,000,000.

(iv) For each of fiscal years 2021 through 2026, $0.

(c) Accountability and oversight.—

(1) WORK PLAN.—

(A) IN GENERAL.—Not later than 180 days after the date of enactment of this Act, the Director of NIH shall submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives, a work plan including the proposed allocation of funds authorized to be appropriated pursuant to subsection (b)(3) for each of fiscal years 2017 through 2026 for the NIH Innovation Projects and the contents described in subparagraph (B).

(B) CONTENTS.—The work plan submitted under subparagraph (A) shall include—

(i) recommendations from the Advisory Committee described in subparagraph (C);

(ii) the amount of money to be obligated or expended in each fiscal year for each NIH Innovation Project;

(iii) a description and justification of each such project; and

(iv) a description of how each such project supports the strategic research priorities identified in the NIH Strategic Plan under subsection (m) of section 402 of the Public Health Service Act (42 U.S.C. 282), as added by section 2031.

(C) RECOMMENDATIONS.—Prior to submitting the work plan under this paragraph, the Director of NIH shall seek recommendations from the Advisory Committee to the Director of NIH appointed under section 222 of the Public Health Service Act (42 U.S.C. 217a) on—

(i) the allocations of funds appropriated pursuant to the authorization of appropriations under subsection (b)(3) for each of fiscal years 2017 through 2026; and

(ii) on the contents of the proposed work plan.

(2) REPORTS.—

(A) ANNUAL REPORTS.—Not later than October 1 of each of fiscal years 2018 through 2027, the Director of NIH shall submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives, a report including—

(i) the amount of money obligated or expended in the prior fiscal year for each NIH Innovation Project;

(ii) a description of any such project using funds provided pursuant to the authorization of appropriations under subsection (b)(3); and

(iii) whether such projects are advancing the strategic research priorities identified in the NIH Strategic Plan under subsection (m) of section 402 of the Public Health Service Act (42 U.S.C. 282), as added by section 2031.

(B) ADDITIONAL REPORTS.—At the request of the Committee on Health, Education, Labor, and Pensions or the Committee on Appropriations of the Senate, or the Committee on Energy and Commerce or the Committee on Appropriations of the House of Representatives, the Director of NIH shall provide an update in the form of testimony and any additional reports to the respective congressional committee regarding the allocation of funding under this section or the description of the NIH Innovation Projects.

(d) Limitations.—Notwithstanding any transfer authority authorized by this Act or any appropriations Act, any funds made available pursuant to the authorization of appropriations under subsection (b)(3) may not be used for any purpose other than a NIH Innovation Project.

(e) Sunset.—This section shall expire on September 30, 2026.

SEC. 1002. FDA innovation projects.

(a) In general.—The Commissioner of Food and Drugs (referred to in this section as the “Commissioner”) shall use any funds appropriated pursuant to the authorization of appropriations under subsection (b)(3) to carry out the activities described in subsection (b)(4).

(b) FDA innovation account.—

(1) ESTABLISHMENT OF FDA INNOVATION ACCOUNT.—There is established in the Treasury an account, to be known as the “FDA Innovation Account” (referred to in this subsection as the “Account”), for purposes of carrying out the activities described in paragraph (4).

(2) TRANSFER OF DIRECT SPENDING SAVINGS.—

(A) IN GENERAL.—For each of fiscal years 2017 through 2025, the following amounts shall be transferred to the Account from the general fund of the Treasury:

(i) For fiscal year 2017, $20,000,000.

(ii) For fiscal year 2018, $60,000,000.

(iii) For fiscal year 2019, $70,000,000.

(iv) For fiscal year 2020, $75,000,000.

(v) For fiscal year 2021, $70,000,000.

(vi) For fiscal year 2022, $50,000,000.

(vii) For fiscal year 2023, $50,000,000.

(viii) For fiscal year 2024, $50,000,000.

(ix) For fiscal year 2025, $55,000,000.

(B) AMOUNTS DEPOSITED.—Any amounts transferred under subparagraph (A) shall remain unavailable in the Account until such amounts are appropriated pursuant to paragraph (3).

(3) APPROPRIATIONS.—

(A) AUTHORIZATION OF APPROPRIATIONS.—For each of the fiscal years 2017 through 2025, there is authorized to be appropriated from the Account to the Commissioner, for the purpose of carrying out the activities described in paragraph (5), an amount not to exceed the total amount transferred to the Account under paragraph (2)(A), to remain available until expended.

(B) OFFSETTING FUTURE APPROPRIATIONS.—For any of fiscal years 2017 through 2025, for any discretionary appropriation under the heading “FDA Innovation Account” provided to the Commissioner pursuant to the authorization of appropriations under subparagraph (A) for the purpose of carrying out the projects activities described in paragraph (4), the total amount of such appropriations in the applicable fiscal year (not to exceed the total amount remaining in the Account) shall be subtracted from the estimate of discretionary budget authority and the resulting outlays for any estimate under the Congressional Budget and Impoundment Control Act of 1974 or the Balanced Budget and Emergency Deficit Control Act of 1985, and the amount transferred to the Account shall be reduced by the same amount.

(4) FDA ACTIVITIES.—The activities authorized to be funded under this section are the activities under subtitles A through F (including the amendments made by such subtitles) of title III of this Act and section 1014 of the Federal Food, Drug, and Cosmetic Act, as added by section 3073 of this Act.

(c) Accountability and oversight.—

(1) WORK PLAN.—

(A) IN GENERAL.—Not later than 180 days after the date of enactment of this Act, the Commissioner shall submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives, a work plan including the proposed allocation of funds appropriated pursuant to the authorization of appropriations under subsection (b)(3) for each of fiscal years 2017 through 2025 and the contents described in subparagraph (B).

(B) CONTENTS.—The work plan submitted under subparagraph (A) shall include—

(i) recommendations from the Advisory Committee described in subparagraph (C);

(ii) the amount of money to be obligated or expended in each fiscal year for each activity described in subsection (b)(4); and

(iii) a description and justification of each such project activity.

(C) RECOMMENDATIONS.—Prior to submitting the work plan under this paragraph, the Commissioner shall seek recommendations from the Science Board to the Food and Drug Administration, on the proposed allocation of funds appropriated pursuant to the authorization of appropriations under subsection (b)(3) for each of fiscal years 2017 through 2025 and on the contents of the proposed work plan.

(2) REPORTS.—

(A) ANNUAL REPORTS.—Not later than October 1 of each of fiscal years 2018 through 2026, the Commissioner shall submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives, a report including—

(i) the amount of money obligated or expended in the prior fiscal year for each activity described in subsection (b)(4);

(ii) a description of all such activities using funds provided pursuant to the authorization of appropriations under subsection (b)(3); and

(iii) how the activities are advancing public health.

(B) ADDITIONAL REPORTS.—At the request of the Committee on Health, Education, Labor, and Pensions or the Committee on Appropriations of the Senate, or the Committee on Energy and Commerce or the Committee on Appropriations of the House of Representatives, the Commissioner shall provide an update in the form of testimony and any additional reports to the respective congressional committee regarding the allocation of funding under this section or the description of the activities undertaken with such funding.

(d) Limitations.—Notwithstanding any transfer authority authorized by this Act or any appropriations Act, any funds made available pursuant to the authorization of appropriations in subsection (b)(3) shall not be used for any purpose other than an activity described in subsection (b)(4).

(e) Sunset.—This section shall expire on September 30, 2025.

SEC. 1003. Account for the state response to the opioid abuse crisis.

(a) In general.—The Secretary of Health and Human Services (referred to in this section as the “Secretary”) shall use any funds appropriated pursuant to the authorization of appropriations under subsection (b) to carry out the grant program described in subsection (c) for purposes of addressing the opioid abuse crisis within the States.

(b) Account for the state response to the opioid abuse crisis.—

(1) ESTABLISHMENT.—There is established in the Treasury an account, to be known as the “Account For the State Response to the Opioid Abuse Crisis” (referred to in this subsection as the “Account”), to carry out the opioid grant program described in subsection (c).

(2) TRANSFER OF DIRECT SPENDING SAVINGS.—

(A) IN GENERAL.—The following amounts shall be transferred to the Account from the general fund of the Treasury:

(i) For fiscal year 2017, $500,000,000.

(ii) For fiscal year 2018, $500,000,000.

(B) AMOUNTS DEPOSITED.—Any amounts transferred under subparagraph (A) shall remain unavailable in the Account until such amounts are appropriated pursuant to paragraph (3).

(3) APPROPRIATIONS.—

(A) AUTHORIZATION OF APPROPRIATIONS.—In each of the fiscal years 2017 and 2018, there is authorized to be appropriated from the Account to the Secretary, for the grant program described in subsection (c), an amount not to exceed the total amount transferred to the Account under paragraph (2)(A), to remain available until expended.

(B) OFFSETTING FUTURE APPROPRIATIONS.—In each of fiscal years 2017 and 2018, for any discretionary appropriation under the heading “Account For the State Response to the Opioid Abuse Crisis” for the grant program described in subsection (c), the total amount of such appropriations in the applicable fiscal year (not to exceed the total amount remaining in the Account) shall be subtracted from the estimate of discretionary budget authority and the resulting outlays for any estimate under the Congressional Budget and Impoundment Control Act of 1974 or the Balanced Budget and Emergency Deficit Control Act of 1985, and the amount transferred to the Account shall be reduced by the same amount.

(c) Opioid grant program.—

(1) STATE RESPONSE TO THE OPIOID ABUSE CRISIS.—Subject to the availability of appropriations, the Secretary shall award grants to States for the purpose of addressing the opioid abuse crisis within such States, in accordance with subparagraph (B). In awarding such grants, the Secretary shall give preference to States with an incidence or prevalence of opioid use disorders that is substantially higher relative to other States.

(2) OPIOID GRANTS.—Grants awarded to a State under this subsection shall be used for carrying out activities that supplement activities pertaining to opioids undertaken by the State agency responsible for administering the substance abuse prevention and treatment block grant under subpart II of part B of title XIX of the Public Health Service Act (42 U.S.C. 300x–21 et seq.), which may include public health-related activities such as the following:

(A) Improving State prescription drug monitoring programs.

(B) Implementing prevention activities, and evaluating such activities to identify effective strategies to prevent opioid abuse.

(C) Training for health care practitioners, such as best practices for prescribing opioids, pain management, recognizing potential cases of substance abuse, referral of patients to treatment programs, and overdose prevention.

(D) Supporting access to health care services, including those services provided by Federally certified opioid treatment programs or other appropriate health care providers to treat substance use disorders.

(E) Other public health-related activities, as the State determines appropriate, related to addressing the opioid abuse crisis within the State.

(d) Accountability and oversight.—A State receiving a grant under subsection (c) shall include in a report related to substance abuse submitted to the Secretary pursuant to section 1942 of the Public Health Service Act (42 U.S.C. 300x–52), a description of—

(1) the purposes for which the grant funds received by the State under such subsection for the preceding fiscal year were expended and a description of the activities of the State under the program; and

(2) the ultimate recipients of amounts provided to the State in the grant.

(e) Limitations.—Any funds made available pursuant to the authorization of appropriations under subsection (b)—

(1) notwithstanding any transfer authority in any appropriations Act, shall not be used for any purpose other than the grant program in subsection (c); and

(2) shall be subject to the same requirements as substance abuse prevention and treatment programs under titles V and XIX of the Public Health Service Act (42 U.S.C. 290aa et seq., 300w et seq.).

(f) Sunset.—This section shall expire on September 30, 2026.

SEC. 1004. Budgetary treatment.

(a) Statutory paygo scorecards.—The budgetary effects of division A of this Act shall not be entered on either PAYGO scorecard maintained pursuant to section 4(d) of the Statutory Pay-As-You-Go Act of 2010.

(b) Senate paygo scorecards.—The budgetary effects of division A of this Act shall not be entered on any PAYGO scorecard maintained for purposes of section 201 of S. Con. Res. 21 (110th Congress).

(c) Reservation of savings.—None of the funds in the NIH Innovation Account, the FDA Innovation Account, or the Account For the State Response to the Opioid Abuse Crisis established by this title shall be made available except to the extent provided in advance in appropriations Acts, and legislation or an Act that rescinds or reduces amounts in such accounts shall not be estimated as a reduction in direct spending under the Congressional Budget and Impoundment Control Act of 1974 or the Balanced Budget and Emergency Deficit Control Act of 1985.

SEC. 2001. National Institutes of Health Reauthorization.

Section 402A(a)(1) of the Public Health Service Act (42 U.S.C. 282a(a)(1)) is amended—

(1) in subparagraph (B), by striking “and” at the end;

(2) in subparagraph (C), by striking the period at the end and inserting a semicolon; and

(3) by adding at the end the following new subparagraphs:

    “(D) $34,851,000,000 for fiscal year 2018;

    “(E) $35,585,871,000 for fiscal year 2019; and

    “(F) $36,472,442,775 for fiscal year 2020.”.

SEC. 2002. EUREKA prize competitions.

(a) In general.—Pursuant to the authorities and processes established under section 24 of the Stevenson-Wydler Technology Innovation Act of 1980 (15 U.S.C. 3719), the Director of the National Institutes of Health shall support prize competitions for one or both of the following goals:

(1) Identifying and funding areas of biomedical science that could realize significant advancements through a prize competition.

(2) Improving health outcomes, particularly with respect to human diseases and conditions—

(A) for which public and private investment in research is disproportionately small relative to Federal Government expenditures on prevention and treatment activities with respect to such diseases and conditions, such that Federal expenditures on health programs would be reduced;

(B) that are serious and represent a significant disease burden in the United States; or

(C) for which there is potential for significant return on investment to the United States.

(b) Tracking; reporting.—The Director of the National Institutes of Health shall—

(1) collect information on—

(A) the effect of innovations funded through the prize competitions under this section in advancing biomedical science or improving health outcomes pursuant to subsection (a); and

(B) the effect of the innovations on Federal expenditures; and

(2) include the information collected under paragraph (1) in the triennial report under section 403 of the Public Health Service Act (42 U.S.C. 283) (as amended by section 2032).

SEC. 2011. Precision Medicine Initiative.

Part H of title IV of the Public Health Service Act (42 U.S.C. 289 et seq.) is amended by adding at the end the following:

“SEC. 498E. Precision Medicine Initiative.

“(a) In general.—The Secretary is encouraged to establish and carry out an initiative, to be known as the ‘Precision Medicine Initiative’ (in this section referred to as the ‘Initiative’), to augment efforts to address disease prevention, diagnosis, and treatment.

“(b) Components.—The Initiative described under subsection (a) may include—

“(1) developing a network of scientists to assist in carrying out the purposes of the Initiative;

“(2) developing new approaches for addressing scientific, medical, public health, and regulatory science issues;

“(3) applying genomic technologies, such as whole genomic sequencing, to provide data on the molecular basis of disease;

“(4) collecting information voluntarily provided by a diverse cohort of individuals that can be used to better understand health and disease; and

“(5) other activities to advance the goals of the Initiative, as the Secretary determines appropriate.

“(c) Authority of the secretary.—In carrying out this section, the Secretary may—

“(1) coordinate with the Secretary of Energy, private industry, and others, as the Secretary determines appropriate, to identify and address the advanced supercomputing and other advanced technology needs for the Initiative;

“(2) develop and utilize public-private partnerships; and

“(3) leverage existing data sources.

“(d) Requirements.—In the implementation of the Initiative under subsection (a), the Secretary shall—

“(1) ensure the collaboration of the National Institutes of Health, the Food and Drug Administration, the Office of the National Coordinator for Health Information Technology, and the Office for Civil Rights of the Department of Health and Human Services;

“(2) comply with existing laws and regulations for the protection of human subjects involved in research, including the protection of participant privacy;

“(3) implement policies and mechanisms for appropriate secure data sharing across systems that include protections for privacy and security of data;

“(4) consider the diversity of the cohort to ensure inclusion of a broad range of participants, including consideration of biological, social, and other determinants of health that contribute to health disparities;

“(5) ensure that only authorized individuals may access controlled or sensitive, identifiable biological material and associated information collected or stored in connection with the Initiative; and

“(6) on the appropriate Internet website of the Department of Health and Human Services, identify any entities with access to such information and provide information with respect to the purpose of such access, a summary of the research project for which such access is granted, as applicable, and a description of the biological material and associated information to which the entity has access.

“(e) Report.—Not later than 1 year after the date of enactment of the 21st Century Cures Act, the Secretary shall submit a report on the relevant data access policies and procedures to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives. Such report shall include steps the Secretary has taken to consult with experts or other heads of departments or agencies of the Federal Government in the development of such policies.”.

SEC. 2012. Privacy protection for human research subjects.

(a) In general.—Subsection (d) of section 301 of the Public Health Service Act (42 U.S.C. 241) is amended to read as follows:

“(d)(1)(A) If a person is engaged in biomedical, behavioral, clinical, or other research, in which identifiable, sensitive information is collected (including research on mental health and research on the use and effect of alcohol and other psychoactive drugs), the Secretary, in coordination with other agencies, as applicable—

“(i) shall issue to such person a certificate of confidentiality to protect the privacy of individuals who are the subjects of such research if the research is funded wholly or in part by the Federal Government; and

“(ii) may, upon application by a person engaged in research, issue to such person a certificate of confidentiality to protect the privacy of such individuals if the research is not so funded.

“(B) Except as provided in subparagraph (C), any person to whom a certificate is issued under subparagraph (A) to protect the privacy of individuals described in such subparagraph shall not disclose or provide to any other person not connected with the research the name of such an individual or any information, document, or biospecimen that contains identifiable, sensitive information about such an individual and that was created or compiled for purposes of the research.

“(C) The disclosure prohibition in subparagraph (B) shall not apply to disclosure or use that is—

“(i) required by Federal, State, or local laws, excluding instances described in subparagraph (D);

“(ii) necessary for the medical treatment of the individual to whom the information, document, or biospecimen pertains and made with the consent of such individual;

“(iii) made with the consent of the individual to whom the information, document, or biospecimen pertains; or

“(iv) made for the purposes of other scientific research that is in compliance with applicable Federal regulations governing the protection of human subjects in research.

“(D) Any person to whom a certificate is issued under subparagraph (A) to protect the privacy of an individual described in such subparagraph shall not, in any Federal, State, or local civil, criminal, administrative, legislative, or other proceeding, disclose or provide the name of such individual or any such information, document, or biospecimen that contains identifiable, sensitive information about the individual and that was created or compiled for purposes of the research, except in the circumstance described in subparagraph (C)(iii).

“(E) Identifiable, sensitive information protected under subparagraph (A), and all copies thereof, shall be immune from the legal process, and shall not, without the consent of the individual to whom the information pertains, be admissible as evidence or used for any purpose in any action, suit, or other judicial, legislative, or administrative proceeding.

“(F) Identifiable, sensitive information collected by a person to whom a certificate has been issued under subparagraph (A), and all copies thereof, shall be subject to the protections afforded by this section for perpetuity.

“(G) The Secretary shall take steps to minimize the burden to researchers, streamline the process, and reduce the time it takes to comply with the requirements of this subsection.

“(2) The Secretary shall coordinate with the heads of other applicable Federal agencies to ensure that such departments have policies in place with respect to the issuance of a certificate of confidentiality pursuant to paragraph (1) and other requirements of this subsection.

“(3) Nothing in this subsection shall be construed to limit the access of an individual who is a subject of research to information about himself or herself collected during such individual's participation in the research.

“(4) For purposes of this subsection, the term ‘identifiable, sensitive information’ means information that is about an individual and that is gathered or used during the course of research described in paragraph (1)(A) and—

“(A) through which an individual is identified; or

“(B) for which there is at least a very small risk, as determined by current scientific practices or statistical methods, that some combination of the information, a request for the information, and other available data sources could be used to deduce the identity of an individual.”.

(b) Applicability.—Beginning 180 days after the date of enactment of this Act, all persons engaged in research and authorized by the Secretary of Health and Human Services to protect information under section 301(d) of the Public Health Service Act (42 U.S.C. 241(d)) prior to the date of enactment of this Act shall be subject to the requirements of such section (as amended by this Act).

SEC. 2013. Protection of identifiable and sensitive information.

Section 301 of the Public Health Service Act (42 U.S.C. 241) is amended by adding at the end the following:

“(f)(1) The Secretary may exempt from disclosure under section 552(b)(3) of title 5, United States Code, biomedical information that is about an individual and that is gathered or used during the course of biomedical research if—

“(A) an individual is identified; or

“(B) there is at least a very small risk, as determined by current scientific practices or statistical methods, that some combination of the information, the request, and other available data sources could be used to deduce the identity of an individual.

“(2)(A) Each determination of the Secretary under paragraph (1) to exempt information from disclosure shall be made in writing and accompanied by a statement of the basis for the determination.

“(B) Each such determination and statement of basis shall be available to the public, upon request, through the Office of the Chief FOIA Officer of the Department of Health and Human Services.

“(3) Nothing in this subsection shall be construed to limit a research participant's access to information about such participant collected during the participant's participation in the research.”.

SEC. 2014. Data sharing.

(a) In general.—Section 402(b) of the Public Health Service Act (42 U.S.C. 282(b)) is amended—

(1) in paragraph (23), by striking “and” at the end;

(2) in paragraph (24), by striking the period and inserting “; and”; and

(3) by inserting after paragraph (24) the following:

“(25) may require recipients of National Institutes of Health awards to share scientific data, to the extent feasible, generated from such National Institutes of Health awards in a manner that is consistent with all applicable Federal laws and regulations, including such laws and regulations for the protection of—

“(A) human research participants, including with respect to privacy, security, informed consent, and protected health information; and

“(B) proprietary interests, confidential commercial information, and the intellectual property rights of the funding recipient.”.

(b) Confidentiality.—Nothing in the amendments made by subsection (a) authorizes the Secretary of Health and Human Services to disclose any information that is a trade secret, or other privileged or confidential information, described in section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code, or be construed to require recipients of grants or cooperative agreements through the National Institutes of Health to share such information.

SEC. 2021. Investing in the next generation of researchers.

(a) In general.—Part A of title IV of the Public Health Service Act (42 U.S.C. 281 et seq.) is amended by adding at the end the following:

“SEC. 404M. Next generation of researchers.

“(a) Next Generation of Researchers Initiative.—There shall be established within the Office of the Director of the National Institutes of Health, the Next Generation of Researchers Initiative (referred to in this section as the ‘Initiative’), through which the Director shall coordinate all policies and programs within the National Institutes of Health that are focused on promoting and providing opportunities for new researchers and earlier research independence.

“(b) Activities.—The Director of the National Institutes of Health, through the Initiative shall—

“(1) promote policies and programs within the National Institutes of Health that are focused on improving opportunities for new researchers and promoting earlier research independence, including existing policies and programs, as appropriate;

“(2) develop, modify, or prioritize policies, as needed, within the National Institutes of Health to promote opportunities for new researchers and earlier research independence, such as policies to increase opportunities for new researchers to receive funding, enhance training and mentorship programs for researchers, and enhance workforce diversity;

“(3) coordinate, as appropriate, with relevant agencies, professional and academic associations, academic institutions, and others, to improve and update existing information on the biomedical research workforce in order to inform programs related to the training, recruitment, and retention of biomedical researchers; and

“(4) carry out other activities, including evaluation and oversight of existing programs, as appropriate, to promote the development of the next generation of researchers and earlier research independence.”.

(b) Consideration of recommendations.—In carrying out activities under section 404M(b) of the Public Health Service Act, the Director of the National Institutes of Health shall take into consideration the recommendations made by the National Academies of Sciences, Engineering, and Medicine as part of the comprehensive study on policies affecting the next generation of researchers under the Department of Health and Human Services Appropriations Act, 2016 (Public Law 114–113), and submit a report to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate, and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives, with respect to any actions taken by the National Institutes of Health based on the recommendations not later than 2 years after the completion of the study required pursuant to the Department of Health and Human Services Appropriations Act, 2016.

SEC. 2022. Improvement of loan repayment program.

(a) Intramural loan repayment program.—Section 487A of the Public Health Service Act (42 U.S.C. 288–1) is amended—

(1) by amending the section heading to read as follows: “Intramural loan repayment program”;

(2) in subsection (a)—

(A) by striking “The Secretary shall carry out a program” and inserting “The Director of the National Institutes of Health shall, as appropriate and based on workforce and scientific priorities, carry out a program through the subcategories listed in subsection (b)(1) (or modified subcategories as provided for in subsection (b)(2))”;

(B) by striking “conduct” and inserting “conduct research”;

(C) by striking “research with respect to acquired immune deficiency syndrome”; and

(D) by striking “$35,000” and inserting “$50,000”;

(3) by redesignating subsection (b) as subsection (d);

(4) by inserting after subsection (a), the following:

“(b) Subcategories of research.—

“(1) IN GENERAL.—In carrying out the program under subsection (a), the Director of the National Institutes of Health—

“(A) shall continue to focus on—

“(i) general research;

“(ii) research on acquired immune deficiency syndrome; and

“(iii) clinical research conducted by appropriately qualified health professional who are from disadvantaged backgrounds; and

“(B) may focus on an area of emerging scientific or workforce need.

“(2) ELIMINATION OR ESTABLISHMENT OF SUBCATEGORIES.—The Director of the National Institutes of Health may eliminate one or more subcategories provided for in paragraph (1) due to changes in workforce or scientific needs related to biomedical research. The Director may establish other subcategory areas based on workforce and scientific priorities if the total number of subcategories does not exceed the number of subcategories listed in paragraph (1).

“(c) Limitation.—The Director of the National Institutes of Health may not enter into a contract with a health professional pursuant to subsection (a) unless such professional has a substantial amount of education loans relative to income (as determined pursuant to guidelines issued by the Director).”; and

(5) by adding at the end the following:

“(e) Availability of appropriations.—Amounts available for carrying out this section shall remain available until the expiration of the second fiscal year beginning after the fiscal year for which such amounts are made available.”.

(b) Extramural loan repayment program.—Section 487B of the Public Health Service Act (42 U.S.C. 288–2) is amended—

(1) by amending the section heading to read as follows: “Extramural loan repayment program”;

(2) in subsection (a)—

(A) by striking “The Secretary, in consultation with the Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, shall establish a program” and inserting “In general.—The Director of the National Institutes of Health shall, as appropriate and based on workforce and scientific priorities, carry out a program through the subcategories listed in subsection (b)(1) (or modified subcategories as provided for in subsection (b)(2)),”;

(B) by striking “(including graduate students)”;

(C) by striking “with respect to contraception, or with respect to infertility,”; and

(D) by striking “service, not more than $35,000” and inserting “research, not more than $50,000”;

(3) by redesignating subsections (b) and (c) as subsections (d) and (e), respectively;

(4) by inserting after subsection (a), the following:

“(b) Subcategories of research.—

“(1) IN GENERAL.—In carrying out the program under subsection (a), the Director of the National Institutes of Health—

“(A) shall continue to focus on—

“(i) contraception or infertility research;

“(ii) pediatric research, including pediatric pharmacological research;

“(iii) minority health disparities research;

“(iv) clinical research; and

“(v) clinical research conducted by appropriately qualified health professional who are from disadvantaged backgrounds; and

“(B) may focus on an area of emerging scientific or workforce need.

“(2) ELIMINATION OR ESTABLISHMENT OF SUBCATEGORIES.—The Director of the National Institutes of Health may eliminate one or more subcategories provided for in paragraph (1) due to changes in workforce or scientific needs related to biomedical research. The Director may establish other subcategory areas based on workforce and scientific priorities if the total number of subcategories does not exceed the number of subcategories listed in paragraph (1).

“(c) Limitation.—The Director of the National Institutes of Health may not enter into a contract with a health professional pursuant to subsection (a) unless such professional has a substantial amount of education loans relative to income (as determined pursuant to guidelines issued by the Director).”;

(5) in subsection (d) (as so redesignated), by striking “The provisions” and inserting “Applicability of certain provisions regarding obligated service.—The provisions”; and

(6) in subsection (e) (as so redesignated), by striking “Amounts” and inserting “Availability of appropriations.—Amounts”.

(c) Technical and conforming amendments.—Title IV of the Public Health Service Act is amended—

(1) by striking section 464z–5 (42 U.S.C. 285t–2);

(2) by striking section 487C (42 U.S.C. 288–3);

(3) by striking section 487E (42 U.S.C. 288–5);

(4) by striking section 487F (42 U.S.C. 288–5a), as added by section 205 of Public Law 106–505, relating to loan repayment for clinical researchers; and

(5) by striking section 487F (42 U.S.C. 288–6), as added by section 1002(b) of Public Law 106–310 relating to pediatric research loan repayment.

(d) GAO report.—Not later than 18 months after the date of enactment of this Act, the Comptroller General of the United States shall submit to Congress a report on the efforts of the National Institutes of Health to attract, retain, and develop emerging scientists, including underrepresented individuals in the sciences, such as women, racial and ethnic minorities, and other groups. Such report shall include an analysis of the impact of the additional authority provided to the Secretary of Health and Human Services under this Act to address workforce shortages and gaps in priority research areas, including which centers and research areas offered loan repayment program participants the increased award amount.

SEC. 2031. National Institutes of Health strategic plan.

(a) Strategic plan.—Section 402 of the Public Health Service Act (42 U.S.C. 282) is amended—

(1) in subsection (b)(5), by inserting before the semicolon the following: “, and through the development, implementation, and updating of the strategic plan developed under subsection (m)”; and

(2) by adding at the end the following:

“(m) National Institutes of Health strategic plan.—

“(1) IN GENERAL.—Not later than 2 years after the date of enactment of the 21st Century Cures Act, and at least every 6 years thereafter, the Director of the National Institutes of Health shall develop and submit to the appropriate committees of Congress and post on the Internet website of the National Institutes of Health, a coordinated strategy (to be known as the ‘National Institutes of Health Strategic Plan’) to provide direction to the biomedical research investments made by the National Institutes of Health, to facilitate collaboration across the institutes and centers, to leverage scientific opportunity, and to advance biomedicine.

“(2) REQUIREMENTS.—The strategy under paragraph (1) shall—

“(A) identify strategic research priorities and objectives across biomedical research, including—

“(i) an assessment of the state of biomedical and behavioral research, including areas of opportunity with respect to basic, clinical, and translational research;

“(ii) priorities and objectives to advance the treatment, cure, and prevention of health conditions;

“(iii) emerging scientific opportunities, rising public health challenges, and scientific knowledge gaps; and

“(iv) the identification of near-, mid-, and long-term scientific needs;

“(B) consider, in carrying out subparagraph (A)—

“(i) disease burden in the United States and the potential for return on investment to the United States;

“(ii) rare diseases and conditions;

“(iii) biological, social, and other determinants of health that contribute to health disparities; and

“(iv) other factors the Director of National Institutes of Health determines appropriate;

“(C) include multi-institute priorities, including coordination of research among institutes and centers;

“(D) include strategic priorities for funding research through the Common Fund, in accordance with section 402A(c)(1)(C);

“(E) address the National Institutes of Health's proposed and ongoing activities related to training and the biomedical workforce; and

“(F) describe opportunities for collaboration with other agencies and departments, as appropriate.

“(3) USE OF PLANS.—Strategic plans developed and updated by the national research institutes and national centers of the National Institutes of Health shall be prepared regularly and in such a manner that such plans will be informed by the strategic plans developed and updated under this subsection. Such plans developed by and updated by the national research institutes and national centers shall have a common template.

“(4) CONSULTATION.—The Director of National Institutes of Health shall develop the strategic plan under paragraph (1) in consultation with the directors of the national research institutes and national centers, researchers, patient advocacy groups, and industry leaders.”.

(b) Conforming amendment.—Section 402A(c)(1)(C) of the Public Health Service Act (42 U.S.C. 282a(c)(1)(C)) is amended by striking “Not later than June 1, 2007, and every 2 years thereafter,” and inserting “As part of the National Institutes of Health Strategic Plan required under section 402(m),”.

(c) Strategic plan.—Section 492B(a) of the Public Health Service Act (42 U.S.C. 289a–2(a)) is amended by adding at the end the following:

“(3) STRATEGIC PLANNING.—

“(A) IN GENERAL.—The directors of the national institutes and national centers shall consult at least once annually with the Director of the National Institute on Minority Health and Health Disparities and the Director of the Office of Research on Women's Health regarding objectives of the national institutes and national centers to ensure that future activities by such institutes and centers take into account women and minorities and are focused on reducing health disparities.

“(B) STRATEGIC PLANS.—Any strategic plan issued by a national institute or national center shall include details on the objectives described in subparagraph (A).”.

SEC. 2032. Triennial reports.

Section 403 of the Public Health Service Act (42 U.S.C. 283) is amended—

(1) in the section heading, by striking “Biennial” and inserting “Triennial” ; and

(2) in subsection (a)—

(A) in the matter preceding paragraph (1), by striking “biennial” and inserting “triennial”;

(B) by amending paragraph (3) to read as follows:

“(3) A description of intra-National Institutes of Health activities, including—

“(A) identification of the percentage of funds made available by each national research institute and national center with respect to each applicable fiscal year for conducting or supporting research that involves collaboration between the institute or center and 1 or more other national research institutes or national centers; and

“(B) recommendations for promoting coordination of information among the centers of excellence.”;

(C) in paragraph (4)—

(i) in subparagraph (B), by striking “demographic variables and other variables” and inserting “demographic variables, including biological and social variables and relevant age categories (such as pediatric subgroups), and determinants of health,”; and

(ii) in subparagraph (C)(v)—

(I) by striking “demographic variables and such” and inserting “demographic variables, including relevant age categories (such as pediatric subgroups), information submitted by each national research institute and national center to the Director of National Institutes of Health under section 492B(f), and such”; and

(II) by striking “(regarding inclusion of women and minorities in clinical research)” and inserting “and other applicable requirements regarding inclusion of demographic groups”; and

(D) in paragraph (6)—

(i) in the matter preceding subparagraph (A), by striking “the following:” and inserting “the following—”;

(ii) in subparagraph (A)—

(I) by striking “An evaluation” and inserting “an evaluation”; and

(II) by striking the period and inserting “; and”;

(iii) by striking subparagraphs (B) and (D);

(iv) by redesignating subparagraph (C) as subparagraph (B); and

(v) in subparagraph (B), as redesignated by clause (iv), by striking “Recommendations” and inserting “recommendations”.

SEC. 2033. Increasing accountability at the National Institutes of Health.

(a) Appointment and terms of directors of national research institutes and national centers.—Subsection (a) of section 405 of the Public Health Service Act (42 U.S.C. 284) is amended to read as follows:

“(a) Appointment.—

“(1) IN GENERAL.—The Director of the National Cancer Institute shall be appointed by the President, and the Directors of the other national research institutes and national centers shall be appointed by the Secretary, acting through the Director of National Institutes of Health. Each Director of a national research institute or national center shall report directly to the Director of National Institutes of Health.

“(2) APPOINTMENT.—

“(A) TERM.—A Director of a national research institute or national center who is appointed by the Secretary, acting through the Director of National Institutes of Health, shall be appointed for 5 years.

“(B) REAPPOINTMENT.—At the end of the term of a Director of a national research institute or national center, the Director may be reappointed in accordance with standards applicable to the relevant appointment mechanism. There shall be no limit on the number of terms that a Director may serve.

“(C) VACANCIES.—If the office of a Director of a national research institute or national center becomes vacant before the end of such Director's term, the Director appointed to fill the vacancy shall be appointed for a 5-year term starting on the date of such appointment.

“(D) CURRENT DIRECTORS.—Each Director of a national research institute or national center who is serving on the date of enactment of the 21st Century Cures Act shall be deemed to be appointed for a 5-year term under this subsection beginning on such date of enactment.

“(E) RULE OF CONSTRUCTION.—Nothing in this subsection shall be construed to limit the authority of the Secretary or the Director of National Institutes of Health to terminate the appointment of a director referred to in subparagraph (A) before the expiration of such director’s 5-year term.

“(F) NATURE OF APPOINTMENT.—Appointments and reappointments under this subsection shall be made on the basis of ability and experience as it relates to the mission of the National Institutes of Health and its components, including compliance with any legal requirement that the Secretary or Director of National Institutes of Health determines relevant.

“(3) NONAPPLICATION OF CERTAIN PROVISION.—The restrictions contained in section 202 of the Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 1993 (Public Law 102–394; 42 U.S.C. 238f note) related to consultants and individual scientists appointed for limited periods of time shall not apply to Directors appointed under this subsection.”.

(b) Review of certain awards by directors.—Section 405(b) of the Public Health Service Act (42 U.S.C. 284(b)) is amended by adding at the end the following:

“(3) Before an award is made by a national research institute or by a national center for a grant for a research program or project (commonly referred to as an ‘R-series grant’), other than an award constituting a noncompetitive renewal of such a grant, or a noncompetitive administrative supplement to such a grant, the Director of such national research institute or national center shall, consistent with the peer review process—

“(A) review and make the final decision with respect to making the award; and

“(B) take into consideration, as appropriate—

“(i) the mission of the national research institute or national center and the scientific priorities identified in the strategic plan under section 402(m);

“(ii) programs or projects funded by other agencies on similar research topics; and

“(iii) advice by staff and the advisory council or board of such national research institute or national center.”.

(c) Report on duplication in Federal biomedical research.—The Secretary of Health and Human Services (referred to in this subsection as the “Secretary”), shall, not later than 2 years after the date of enactment of this Act, submit a report to Congress on efforts to prevent and eliminate duplicative biomedical research that is not necessary for scientific purposes. Such report shall—

(1) describe the procedures in place to identify such duplicative research, including procedures for monitoring research applications and funded research awards to prevent unnecessary duplication;

(2) describe the steps taken to improve the procedures described in paragraph (1), in response to relevant recommendations made by the Comptroller General of the United States;

(3) describe how the Secretary operationally distinguishes necessary and appropriate scientific replication from unnecessary duplication; and

(4) provide examples of instances where the Secretary has identified unnecessarily duplicative research and the steps taken to eliminate the unnecessary duplication.

SEC. 2034. Reducing administrative burden for researchers.

(a) Plan Preparation and implementation of measures To reduce administrative burdens.—

(1) IN GENERAL.—Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the “Secretary”) shall—

(A) lead a review by research funding agencies of all regulations and policies related to the disclosure of financial conflicts of interest, including the minimum threshold for reporting financial conflicts of interest;

(B) make revisions, as appropriate, to harmonize existing policies and reduce administrative burden on researchers while maintaining the integrity and credibility of research findings and protections of human participants; and

(C) confer with the Office of the Inspector General about the activities of such office related to financial conflicts of interest involving research funding agencies.

(2) CONSIDERATIONS.—In updating policies under paragraph (1)(B), the Secretary shall consider—

(A) modifying the timelines for the reporting of financial conflicts of interest to just-in-time information by institutions receiving grant or cooperative agreement funding from the National Institutes of Health;

(B) ensuring that financial interest disclosure reporting requirements are appropriate for, and relevant to, awards that will directly fund research, which may include modification of the definition of the term “investigator” for purposes of the regulations and policies described in subparagraphs (A) and (B) of paragraph (1); and

(C) updating any applicable training modules of the National Institutes of Health related to Federal financial interest disclosure.

(b) Monitoring of subrecipients of funding from the national institutes of health.—The Director of the National Institutes of Health (referred to in this section as the “Director of National Institutes of Health”) shall implement measures to reduce the administrative burdens related to monitoring of subrecipients of grants by primary awardees of funding from the National Institutes of Health, which may incorporate findings and recommendations from existing and ongoing activities. Such measures may include, as appropriate—

(1) an exemption from subrecipient monitoring requirements, upon request from the primary awardees, provided that—

(A) the subrecipient is subject to Federal audit requirements pursuant to the Uniform Guidance of the Office of Management and Budget;

(B) the primary awardee conducts, pursuant to guidance of the National Institutes of Health, a pre-award evaluation of each subrecipient's risk of noncompliance with Federal statutes and regulations, the conditions of the subaward, and any recurring audit findings; and

(C) such exemption does not absolve the primary awardee of liability for misconduct by subrecipients; and

(2) the implementation of alternative grant structures that obviate the need for subrecipient monitoring, which may include collaborative grant models allowing for multiple primary awardees.

(c) Reporting of financial expenditures.—The Secretary, in consultation with the Director of National Institutes of Health, shall evaluate financial expenditure reporting procedures and requirements for recipients of funding from the National Institutes of Health and take action, as appropriate, to avoid duplication between department and agency procedures and requirements and minimize burden to funding recipients.

(d) Animal care and use in research.—Not later than 2 years after the date of enactment of this Act, the Director of National Institutes of Health, in collaboration with the Secretary of Agriculture and the Commissioner of Food and Drugs, shall complete a review of applicable regulations and policies for the care and use of laboratory animals and make revisions, as appropriate, to reduce administrative burden on investigators while maintaining the integrity and credibility of research findings and protection of research animals. In carrying out this effort, the Director of the National Institutes of Health shall seek the input of experts, as appropriate. The Director of the National Institutes of Health shall—

(1) identify ways to ensure such regulations and policies are not inconsistent, overlapping, or unnecessarily duplicative, including with respect to inspection and review requirements by Federal agencies and accrediting associations;

(2) take steps to eliminate or reduce identified inconsistencies, overlap, or duplication among such regulations and policies; and

(3) take other actions, as appropriate, to improve the coordination of regulations and policies with respect to research with laboratory animals.

(e) Documentation of personnel expenses.—The Secretary shall clarify the applicability of the requirements under the Office of Management and Budget Uniform Guidance for management and certification systems adopted by entities receiving Federal research grants through the Department of Health and Human Services regarding documentation of personnel expenses, including clarification of the extent to which any flexibility to such requirements specified in such Uniform Guidance applies to entities receiving grants through the Department of Health and Human Services.

(f) Research policy board.—

(1) ESTABLISHMENT.—Not later than 1 year after the date of enactment of this Act, the Director of the Office of Management and Budget shall establish an advisory committee, to be known as the “Research Policy Board” (referred to in this subsection as the “Board”), to provide Federal Government officials with information on the effects of regulations related to Federal research requirements.

(2) MEMBERSHIP.—

(A) IN GENERAL.—The Board shall include not more than 10 Federal members, including each of the following Federal members or their designees:

(i) The Administrator of the Office of Information and Regulatory Affairs of the Office of Management and Budget.

(ii) The Director of the Office of Science and Technology Policy.

(iii) The Secretary of Health and Human Services.

(iv) The Director of the National Science Foundation.

(v) The secretaries and directors of other departments and agencies that support or regulate scientific research, as determined by the Director of the Office of Management and Budget.

(B) NON-FEDERAL MEMBERS.—The Board shall be comprised of not less than 9 and not more than 12 representatives of academic research institutions, other private, nonprofit research institutions, or other nonprofit organizations with relevant expertise. Such members shall be appointed by a formal process, to be established by the Director of the Office of Management and Budget, in consultation with the Federal membership, and that incorporates—

(i) nomination by members of the nonprofit scientific research community, including academic research institutions; and

(ii) procedures to fill membership positions vacated before the end of a member's term.

(3) PURPOSE AND RESPONSIBILITIES.—The Board shall make recommendations regarding the modification and harmonization of regulations and policies having similar purposes across research funding agencies to ensure that the administrative burden of such research policy and regulation is minimized to the greatest extent possible and consistent with maintaining responsible oversight of federally funded research. Activities of the Board may include—

(A) providing thorough and informed analysis of regulations and policies;

(B) identifying negative or adverse consequences of existing policies and making actionable recommendations regarding possible improvement of such policies;

(C) making recommendations with respect to efforts within the Federal Government to improve coordination of regulation and policy related to research;

(D) creating a forum for the discussion of research policy or regulatory gaps, challenges, clarification, or harmonization of such policies or regulation, and best practices; and

(E) conducting ongoing assessment and evaluation of regulatory burden, including development of metrics, periodic measurement, and identification of process improvements and policy changes.

(4) EXPERT SUBCOMMITTEES.—The Board may form temporary expert subcommittees, as appropriate, to develop timely analysis on pressing issues and assist the Board in anticipating future regulatory challenges, including challenges emerging from new scientific advances.

(5) REPORTING REQUIREMENTS.—Not later than 2 years after the date of enactment of this Act, and once thereafter, the Board shall submit a report to the Director of the Office of Management and Budget, the Administrator of the Office of Information and Regulatory Affairs of the Office of Management and Budget, the Director of the Office of Science and Technology Policy, the heads of relevant Federal departments and agencies, the Committee on Health, Education, Labor, and Pensions of the Senate, and the Committee on Energy and Commerce of the House of Representatives containing formal recommendations on the conceptualization, development, harmonization, and reconsideration of scientific research policy, including the regulatory benefits and burdens.

(6) SUNSET.—The Board shall terminate on September 30, 2021.

(7) GAO REPORT.—Not later than 4 years after the date of enactment of this Act, the Comptroller General of the United States shall conduct an independent evaluation of the activities carried out by the Board pursuant to this subsection and submit to the appropriate committees of Congress a report regarding the results of the independent evaluation. Such report shall review and assess the Board's activities with respect to the responsibilities described in paragraph (3).

SEC. 2035. Exemption for the National Institutes of Health from the Paperwork Reduction Act requirements.

Section 301 of the Public Health Service Act (42 U.S.C. 241), as amended by section 2013, is further amended by adding at the end the following:

“(g) Subchapter I of chapter 35 of title 44, United States Code, shall not apply to the voluntary collection of information during the conduct of research by the National Institutes of Health.”.

SEC. 2036. High-risk, high-reward research.

(a) In general.—Section 402 of the Public Health Service Act (42 U.S.C. 282), as amended by section 2031, is further amended by adding at the end the following:

“(n) Unique research initiatives.—

“(1) IN GENERAL.—The Director of NIH may approve, after consideration of a proposal under paragraph (2)(A), requests by the national research institutes and centers, or program officers within the Office of the Director to engage in transactions other than a contract, grant, or cooperative agreement with respect to projects that carry out—

“(A) the Precision Medicine Initiative under section 498E; or

“(B) section 402(b)(7), except that not more than 50 percent of the funds available for a fiscal year through the Common Fund under section 402A(c)(1) for purposes of carrying out such section 402(b)(7) may be used to engage in such other transactions.

“(2) REQUIREMENTS.—The authority provided under this subsection may be used to conduct or support high impact cutting-edge research described in paragraph (1) using the other transactions authority described in such paragraph if the institute, center, or office—

“(A) submits a proposal to the Director of NIH for the use of such authority before conducting or supporting the research, including why the use of such authority is essential to promoting the success of the project;

“(B) receives approval for the use of such authority from the Director of NIH; and

“(C) for each year in which the institute, center, or office has used such authority in accordance with this subsection, submits a report to the Director of NIH on the activities of the institute, center, or office relating to such research.”.

(b) Report to Congress.—Not later than September 30, 2020, the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, shall conduct an evaluation of the activities under subsection (n) of section 402 of the Public Health Service Act (42 U.S.C. 282), as added by subsection (a), and 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 on the results of such evaluation.

(c) Duties of directors of institutes.—Section 405(b)(1) of the Public Health Service Act (42 U.S.C. 284(b)(1)) is amended—

(1) by redesignating subparagraphs (C) through (L) as subparagraphs (D) through (M), respectively; and

(2) by inserting after subparagraph (B), the following:

“(C) shall, as appropriate, conduct and support research that has the potential to transform the scientific field, has inherently higher risk, and that seeks to address major current challenges;”.

SEC. 2037. National Center for Advancing Translational Sciences.

(a) In general.—Section 479(b) of the Public Health Service Act (42 U.S.C. 287(b)) is amended—

(1) in paragraph (1), by striking “phase IIA” and inserting “phase IIB”; and

(2) in paragraph (2)—

(A) in the matter preceding subparagraph (A), by striking “phase IIB” and inserting “phase III”;

(B) in subparagraph (A), by striking “phase IIB” and inserting “phase III”;

(C) in subparagraph (B), by striking “phase IIA” and inserting “phase IIB”; and

(D) in subparagraph (C), by striking “phase IIB” and inserting “phase III”.

(b) Increased transparency.—Section 479 of the Public Health Service Act (42 U.S.C. 287) is amended—

(1) in subsection (c)—

(A) in paragraph (4)(D), by striking “and” at the end;

(B) in paragraph (5), by striking the period and inserting a semicolon; and

(C) by adding at the end the following:

“(6) the methods and tools, if any, that have been developed since the last biennial report was prepared; and

“(7) the methods and tools, if any, that have been developed and are being utilized by the Food and Drug Administration to support medical product reviews.”; and

(2) by adding at the end the following:

“(d) Inclusion of list.—The first biennial report submitted under this section after the date of enactment of the 21st Century Cures Act shall include a complete list of all of the methods and tools, if any, which have been developed by research supported by the Center.

“(e) Rule of construction.—Nothing in this section shall be construed as authorizing the Secretary to disclose any information that is a trade secret, or other privileged or confidential information subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code.”.

SEC. 2038. Collaboration and coordination to enhance research.

(a) Research priorities; collaborative research projects.—Section 402(b) of the Public Health Service Act (42 U.S.C. 282(b)) is amended—

(1) by amending paragraph (4) to read as follows:

“(4) shall assemble accurate data to be used to assess research priorities, including—

“(A) information to better evaluate scientific opportunity, public health burdens, and progress in reducing health disparities; and

“(B) data on study populations of clinical research, funded by or conducted at each national research institute and national center, which—

“(i) specifies the inclusion of—

“(I) women;

“(II) members of minority groups;

“(III) relevant age categories, including pediatric subgroups; and

“(IV) other demographic variables as the Director of the National Institutes of Health determines appropriate;

“(ii) is disaggregated by research area, condition, and disease categories; and

“(iii) is to be made publicly available on the Internet website of the National Institutes of Health;”; and

(2) in paragraph (8)—

(A) in subparagraph (A), by striking “and” at the end; and

(B) by adding at the end the following:

“(C) foster collaboration between clinical research projects funded by the respective national research institutes and national centers that—

“(i) conduct research involving human subjects; and

“(ii) collect similar data; and

“(D) encourage the collaboration described in subparagraph (C) to—

“(i) allow for an increase in the number of subjects studied; and

“(ii) utilize diverse study populations, with special consideration to biological, social, and other determinants of health that contribute to health disparities;”.

(b) Reporting.—Section 492B(f) of the Public Health Service Act (42 U.S.C. 289a–2(f)) is amended—

(1) by striking “biennial” each place such term appears and inserting “triennial”;

(2) by striking “The advisory council” and inserting the following:

“(1) IN GENERAL.—The advisory council”; and

(3) by adding at the end the following:

“(2) CONTENTS.—Each triennial report prepared by an advisory council of each national research institute as described in paragraph (1) shall include each of the following:

“(A) The number of women included as subjects, and the proportion of subjects that are women, in any project of clinical research conducted during the applicable reporting period, disaggregated by categories of research area, condition, or disease, and accounting for single-sex studies.

“(B) The number of members of minority groups included as subjects, and the proportion of subjects that are members of minority groups, in any project of clinical research conducted during the applicable reporting period, disaggregated by categories of research area, condition, or disease and accounting for single-race and single-ethnicity studies.

“(C) For the applicable reporting period, the number of projects of clinical research that include women and members of minority groups and that—

“(i) have been completed during such reporting period; and

“(ii) are being carried out during such reporting period and have not been completed.

“(D) The number of studies completed during the applicable reporting period for which reporting has been submitted in accordance with subsection (c)(2)(A).”.

(c) Coordination.—Section 486(c)(2) of the Public Health Service Act (42 U.S.C. 287d(c)(2)) is amended by striking “designees” and inserting “senior-level staff designees”.

(d) In general.—Part A of title IV of the Public Health Service Act (42 U.S.C. 281 et seq.), as amended by section 2021, is further amended by adding at the end the following:

“SEC. 404N. Population focused research.

“The Director of the National Institutes of Health shall, as appropriate, encourage efforts to improve research related to the health of sexual and gender minority populations, including by—

“(1) facilitating increased participation of sexual and gender minority populations in clinical research supported by the National Institutes of Health, and reporting on such participation, as applicable;

“(2) facilitating the development of valid and reliable methods for research relevant to sexual and gender minority populations; and

“(3) addressing methodological challenges.”.

(e) Reporting.—

(1) IN GENERAL.—The Secretary, in collaboration with the Director of the National Institutes of Health, shall as appropriate—

(A) continue to support research for the development of appropriate measures related to reporting health information about sexual and gender minority populations; and

(B) not later than 2 years after the date of enactment of this Act, disseminate and make public such measures.

(2) NATIONAL ACADEMY OF MEDICINE RECOMMENDATIONS.—In developing the measures described in paragraph (1)(A), the Secretary shall take into account recommendations made by the National Academy of Medicine.

(f) Improving coordination related to minority health and health disparities.—Section 464z–3 of the Public Health Service Act (42 U.S.C. 285t) is amended—

(1) by redesignating subsection (h), relating to interagency coordination, that follows subsection (j) as subsection (k); and

(2) in subsection (k) (as so redesignated)—

(A) in the subsection heading, by striking “Interagency” and inserting “Intra-National Institutes of Health”;

(B) by striking “as the primary Federal officials” and inserting “as the primary Federal official”;

(C) by inserting a comma after “review”;

(D) by striking “Institutes and Centers of the National Institutes of Health” and inserting “national research institutes and national centers”; and

(E) by adding at the end the following: “The Director of the Institute may foster partnerships between the national research institutes and national centers and may encourage the funding of collaborative research projects to achieve the goals of the National Institutes of Health that are related to minority health and health disparities.”.

(g) Basic research.—

(1) DEVELOPING POLICIES.—Not later than 2 years after the date of enactment of this Act, the Director of the National Institutes of Health (referred to in this section as the “Director of the National Institutes of Health”), taking into consideration the recommendations developed under section 2039, shall develop policies for projects of basic research funded by National Institutes of Health to assess—

(A) relevant biological variables including sex, as appropriate; and

(B) how differences between male and female cells, tissues, or animals may be examined and analyzed.

(2) REVISING POLICIES.—The Director of the National Institutes of Health may update or revise the policies developed under paragraph (1) as appropriate.

(3) CONSULTATION AND OUTREACH.—In developing, updating, or revising the policies under this section, the Director of the National Institutes of Health shall—

(A) consult with—

(i) the Office of Research on Women's Health;

(ii) the Office of Laboratory Animal Welfare; and

(iii) appropriate members of the scientific and academic communities; and

(B) conduct outreach to solicit feedback from members of the scientific and academic communities on the influence of sex as a variable in basic research, including feedback on when it is appropriate for projects of basic research involving cells, tissues, or animals to include both male and female cells, tissues, or animals.

(4) ADDITIONAL REQUIREMENTS.—The Director of the National Institutes of Health shall—

(A) ensure that projects of basic research funded by the National Institutes of Health are conducted in accordance with the policies developed, updated, or revised under this section, as applicable; and

(B) encourage that the results of such research, when published or reported, be disaggregated as appropriate with respect to the analysis of any sex differences.

(h) Clinical research.—

(1) IN GENERAL.—Not later than 1 year after the date of enactment of this Act, the Director of the National Institutes of Health, in consultation with the Director of the Office of Research on Women's Health and the Director of the National Institute on Minority Health and Health Disparities, shall update the guidelines established under section 492B(d) of Public Health Service Act (42 U.S.C. 289a–2(d)) in accordance with paragraph (2).

(2) REQUIREMENTS.—The updated guidelines described in paragraph (1) shall—

(A) reflect the science regarding sex differences;

(B) improve adherence to the requirements under section 492B of the Public Health Service Act (42 U.S.C. 289a–2), including the reporting requirements under subsection (f) of such section; and

(C) clarify the circumstances under which studies should be designed to support the conduct of analyses to detect significant differences in the intervention effect due to demographic factors related to section 492B of the Public Health Service Act, including in the absence of prior studies that demonstrate a difference in study outcomes on the basis of such factors and considering the effects of the absence of such analyses on the availability of data related to demographic differences.

(i) Appropriate age groupings in clinical research.—

(1) INPUT FROM EXPERTS.—Not later than 180 days after the date of enactment of this Act, the Director of the National Institutes of Health shall convene a workshop of experts on pediatric and older populations to provide input on—

(A) appropriate age groups to be included in research studies involving human subjects; and

(B) acceptable justifications for excluding participants from a range of age groups from human subjects research studies.

(2) POLICY UPDATES.—Not later than 180 days after the conclusion of the workshop under paragraph (1), the Director of the National Institutes of Health shall make a determination with respect to whether the policies of the National Institutes of Health on the inclusion of relevant age groups in clinical studies need to be updated, and shall update such policies as appropriate. In making the determination, the Director of the National Institutes of Health shall take into consideration whether such policies—

(A) address the consideration of age as an inclusion variable in research involving human subjects; and

(B) identify the criteria for justification for any age-related exclusions in such research.

(3) PUBLIC AVAILABILITY OF FINDINGS AND CONCLUSIONS.—The Director of the National Institutes of Health shall—

(A) make the findings and conclusions resulting from the workshop under paragraph (1) and updates to policies in accordance with paragraph (2), as applicable, available to the public on the Internet website of the National Institutes of Health; and

(B) ensure that age-related data reported in the triennial report under section 403 of the Public Health Service Act (42 U.S.C. 283) (as amended by section 2032) are made available to the public on the Internet website of the National Institutes of Health.

SEC. 2039. Enhancing the rigor and reproducibility of scientific research.

(a) Establishment.—Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, shall convene a working group under the Advisory Committee to the Director of the National Institutes of Health (referred to in this section as the “Advisory Committee”), appointed under section 222 of the Public Health Service Act (42 U.S.C. 217a), to develop and issue recommendations through the Advisory Committee for a formal policy, which may incorporate or be informed by relevant existing and ongoing activities, to enhance rigor and reproducibility of scientific research funded by the National Institutes of Health.

(b) Considerations.—In developing and issuing recommendations through the Advisory Committee under subsection (a), the working group established under such subsection shall consider, as appropriate—

(1) preclinical experiment design, including analysis of sex as a biological variable;

(2) clinical experiment design, including—

(A) the diversity of populations studied for clinical research, with respect to biological, social, and other determinants of health that contribute to health disparities;

(B) the circumstances under which summary information regarding biological, social, and other factors that contribute to health disparities should be reported; and

(C) the circumstances under which clinical studies, including clinical trials, should conduct an analysis of the data collected during the study on the basis of biological, social, and other factors that contribute to health disparities;

(3) applicable levels of rigor in statistical methods, methodology, and analysis;

(4) data and information sharing in accordance with applicable privacy laws and regulations; and

(5) any other matter the working group determines relevant.

(c) Policies.—Not later than 18 months after the date of enactment of this Act, the Director of the National Institutes of Health shall consider the recommendations developed by the working group and issued by the Advisory Committee under subsection (a) and develop or update policies as appropriate.

(d) Report.—Not later than 2 years after the date of enactment of this Act, the Director of the National Institutes of Health shall issue a report to the Secretary of Health and Human Services, the Committee on Health, Education, Labor, and Pensions of the Senate, and the Committee on Energy and Commerce of the House of Representatives regarding recommendations developed under subsection (a) and any subsequent policy changes implemented, to enhance rigor and reproducibility in scientific research funded by the National Institutes of Health.

(e) Confidentiality.—Nothing in this section authorizes the Secretary of Health and Human Services to disclose any information that is a trade secret, or other privileged or confidential information, described in section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code.

SEC. 2040. Improving medical rehabilitation research at the National Institutes of Health.

(a) In general.—Section 452 of the Public Health Service Act (42 U.S.C. 285g–4) is amended—

(1) in subsection (b), by striking “conduct and support” and inserting “conduct, support, and coordination”;

(2) in subsection (c)(1)(C), by striking “of the Center” and inserting “within the Center”;

(3) in subsection (d)—

(A) by striking “(d)(1) In consultation” and all that follows through the end of paragraph (1) and inserting the following:

“(d)(1) The Director of the Center, in consultation with the Director of the Institute, the coordinating committee established under subsection (e), and the advisory board established under subsection (f), shall develop a comprehensive plan (referred to in this section as the ‘Research Plan’) for the conduct, support, and coordination of medical rehabilitation research.”;

(B) in paragraph (2)—

(i) in subparagraph (A), by striking “; and” and inserting a semicolon;

(ii) in subparagraph (B), by striking the period and inserting “; and”; and

(iii) by adding at the end the following:

“(C) include goals and objectives for conducting, supporting, and coordinating medical rehabilitation research, consistent with the purpose described in subsection (b).”;

(C) by striking paragraph (4) and inserting the following:

“(4) The Director of the Center, in consultation with the Director of the Institute, the coordinating committee established under subsection (e), and the advisory board established under subsection (f), shall revise and update the Research Plan periodically, as appropriate, or not less than every 5 years. Not later than 30 days after the Research Plan is so revised and updated, the Director of the Center shall transmit the revised and updated Research Plan to the President, the Committee on Health, Education, Labor, and Pensions of the Senate, and the Committee on Energy and Commerce of the House of Representatives.”; and

(D) by adding at the end the following:

“(5) The Director of the Center, in consultation with the Director of the Institute, shall, prior to revising and updating the Research Plan, prepare a report for the coordinating committee established under subsection (e) and the advisory board established under subsection (f) that describes and analyzes the progress during the preceding fiscal year in achieving the goals and objectives described in paragraph (2)(C) and includes expenditures for rehabilitation research at the National Institutes of Health. The report shall include recommendations for revising and updating the Research Plan, and such initiatives as the Director of the Center and the Director of the Institute determine appropriate. In preparing the report, the Director of the Center and the Director of the Institute shall consult with the Director of the National Institutes of Health.”;

(4) in subsection (e)—

(A) in paragraph (2), by inserting “periodically host a scientific conference or workshop on medical rehabilitation research and” after “The Coordinating Committee shall”; and

(B) in paragraph (3), by inserting “the Director of the Division of Program Coordination, Planning, and Strategic Initiatives within the Office of the Director of the National Institutes of Health,” after “shall be composed of”;

(5) in subsection (f)(3)(B)—

(A) by redesignating clauses (ix) through (xi) as clauses (x) through (xii), respectively; and

(B) by inserting after clause (viii) the following:

“(ix) The Director of the Division of Program Coordination, Planning, and Strategic Initiatives.”; and

(6) by adding at the end the following:

“(g)(1) The Secretary and the heads of other Federal agencies shall jointly review the programs carried out (or proposed to be carried out) by each such official with respect to medical rehabilitation research and, as appropriate, enter into agreements preventing duplication among such programs.

“(2) The Secretary shall, as appropriate, enter into interagency agreements relating to the coordination of medical rehabilitation research conducted by agencies of the National Institutes of Health and other agencies of the Federal Government.

“(h) For purposes of this section, the term ‘medical rehabilitation research’ means the science of mechanisms and interventions that prevent, improve, restore, or replace lost, underdeveloped, or deteriorating function.”.

(b) Conforming amendment.—Section 3 of the National Institutes of Health Amendments of 1990 (42 U.S.C. 285g–4 note) is amended—

(1) in subsection (a), by striking “In General.—”; and

(2) by striking subsection (b).

SEC. 2041. Task force on research specific to pregnant women and lactating women.

(a) Task force on research specific to pregnant women and lactating women.—

(1) ESTABLISHMENT.—Not later than 90 days after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the “Secretary”) shall establish a task force, in accordance with the Federal Advisory Committee Act (5 U.S.C. App.), to be known as the “Task Force on Research Specific to Pregnant Women and Lactating Women” (in this section referred to as the “Task Force”).

(2) DUTIES.—The Task Force shall provide advice and guidance to the Secretary regarding Federal activities related to identifying and addressing gaps in knowledge and research regarding safe and effective therapies for pregnant women and lactating women, including the development of such therapies and the collaboration on and coordination of such activities.

(3) MEMBERSHIP.—

(A) FEDERAL MEMBERS.—The Task Force shall be composed of each of the following Federal members, or the designees of such members:

(i) The Director of the Centers for Disease Control and Prevention.

(ii) The Director of the National Institutes of Health, the Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the directors of such other appropriate national research institutes.

(iii) The Commissioner of Food and Drugs.

(iv) The Director of the Office on Women's Health.

(v) The Director of the National Vaccine Program Office.

(vi) The head of any other research-related agency or department not described in clauses (i) through (v) that the Secretary determines appropriate, which may include the Department of Veterans Affairs and the Department of Defense.

(B) NON-FEDERAL MEMBERS.—The Task Force shall be composed of each of the following non-Federal members, including—

(i) representatives from relevant medical societies with subject matter expertise on pregnant women, lactating women, or children;

(ii) nonprofit organizations with expertise related to the health of women and children;

(iii) relevant industry representatives; and

(iv) other representatives, as appropriate.

(C) LIMITATIONS.—The non-Federal members described in subparagraph (B) shall—

(i) compose not more than one-half, and not less than one-third, of the total membership of the Task Force; and

(ii) be appointed by the Secretary.

(4) TERMINATION.—

(A) IN GENERAL.—Subject to subparagraph (B), the Task Force shall terminate on the date that is 2 years after the date on which the Task Force is established under paragraph (1).

(B) EXTENSION.—The Secretary may extend the operation of the Task Force for one additional 2-year period following the 2-year period described in subparagraph (A), if the Secretary determines that the extension is appropriate for carrying out the purpose of this section.

(5) MEETINGS.—The Task Force shall meet not less than 2 times each year and shall convene public meetings, as appropriate, to fulfill its duties under paragraph (2).

(6) TASK FORCE REPORT TO CONGRESS.—Not later than 18 months after the date on which the Task Force is established under paragraph (1), the Task Force shall prepare and submit to the Secretary, the Committee on Health, Education, Labor, and Pensions of the Senate, and the Committee on Energy and Commerce of the House of Representatives a report that includes each of the following:

(A) A plan to identify and address gaps in knowledge and research regarding safe and effective therapies for pregnant women and lactating women, including the development of such therapies.

(B) Ethical issues surrounding the inclusion of pregnant women and lactating women in clinical research.

(C) Effective communication strategies with health care providers and the public on information relevant to pregnant women and lactating women.

(D) Identification of Federal activities, including—

(i) the state of research on pregnancy and lactation;

(ii) recommendations for the coordination of, and collaboration on research related to pregnant women and lactating women;

(iii) dissemination of research findings and information relevant to pregnant women and lactating women to providers and the public; and

(iv) existing Federal efforts and programs to improve the scientific understanding of the health impacts on pregnant women, lactating women, and related birth and pediatric outcomes, including with respect to pharmacokinetics, pharmacodynamics, and toxicities.

(E) Recommendations to improve the development of safe and effective therapies for pregnant women and lactating women.

(b) Confidentiality.—Nothing in this section shall authorize the Secretary of Health and Human Services to disclose any information that is a trade secret, or other privileged or confidential information, described in section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code.

(c) Updating protections for pregnant women and lactating women in research.—

(1) IN GENERAL.—Not later than 2 years after the date of enactment of this Act, the Secretary, considering any recommendations of the Task Force available at such time and in consultation with the heads of relevant agencies of the Department of Health and Human Services, shall, as appropriate, update regulations and guidance, as applicable, regarding the inclusion of pregnant women and lactating women in clinical research.

(2) CRITERIA FOR EXCLUDING PREGNANT OR LACTATING WOMEN.—In updating any regulations or guidance described in paragraph (1), the Secretary shall consider any appropriate criteria to be used by institutional review boards and individuals reviewing grant proposals for excluding pregnant women or lactating women as a study population requiring additional protections from participating in human subject research.

SEC. 2042. Streamlining National Institutes of Health reporting requirements.

(a) Trans-National Institutes of Health research reporting.—Section 402A(c)(2) of the Public Health Service Act (42 U.S.C. 282a(c)(2)) is amended—

(1) by amending subparagraph (B) to read as follows:

“(B) REPORTING.—Not later than 2 years after the date of enactment of 21st Century Cures Act, the head of each national research institute or national center shall submit to the Director of the National Institutes of Health a report, to be included in the triennial report under section 403, on the amount made available by the institute or center for conducting or supporting research that involves collaboration between the institute or center and 1 or more other national research institutes or national centers.”; and

(2) in subparagraphs (D) and (E) by striking “(B)(i)” each place it appears and inserting “(B)”.

(b) Fraud and abuse reporting.—Section 403B of the Public Health Service Act (42 U.S.C. 283a–1) is amended—

(1) by striking subsection (b);

(2) by redesignating subsection (c) as subsection (b); and

(3) in subsection (b) (as so redesignated), by striking “subsections (a) and (b)” and inserting “subsection (a)”.

(c) Doctoral degrees reporting.—Section 403C(a)(2) of the Public Health Service Act (42 U.S.C. 283a–2(a)(2)) is amended by striking “(not including any leaves of absence)”.

(d) Vaccine reporting.—Section 404B of the Public Health Service Act (42 U.S.C. 283d) is amended—

(1) by striking subsection (b); and

(2) by striking “(a) Development of New Vaccines.—The Secretary” and inserting “The Secretary”.

(e) National center for advancing translational sciences.—Section 479(c) of the Public Health Service Act (42 U.S.C. 287(c)) is amended—

(1) in the subsection heading, by striking “Annual” and inserting “Biennial”; and

(2) in the matter preceding paragraph (1), by striking “an annual report” and inserting “a report on a biennial basis”.

(f) Review of centers of excellence.—

(1) REPEAL.—Section 404H of the Public Health Service Act (42 U.S.C. 283j) is repealed.

(2) CONFORMING AMENDMENT.—Section 399EE(c) of the Public Health Service Act (42 U.S.C. 280–4(c)) is amended by striking “399CC, 404H,” and inserting “399CC”.

(g) Rapid HIV test report.—Section 502(a) of the Ryan White CARE Act Amendments of 2000 (42 U.S.C. 300cc note) is amended—

(1) by striking paragraph (2); and

(2) by redesignating paragraph (3) as paragraph (2).

(h) National Institute of Nursing Research.—

(1) REPEAL.—Section 464Y of the Public Health Service Act (42 U.S.C. 285q–3) is repealed.

(2) CONFORMING AMENDMENT.—Section 464X(g) of the Public Health Service Act (42 U.S.C. 285q–2(g)) is amended by striking “biennial report made under section 464Y,” and inserting “triennial report made under section 403”.

SEC. 2043. Reimbursement for research substances and living organisms.

Section 301 of the Public Health Service Act (42 U.S.C. 241), as amended by section 2035, is further amended—

(1) in the flush matter at the end of subsection (a)—

(A) by redesignating such matter as subsection (h)(1); and

(B) by moving such matter so as to appear at the end of such section; and

(2) in subsection (h) (as so redesignated), by adding at the end the following:

“(2) Where research substances and living organisms are made available under paragraph (1) through contractors, the Secretary may direct such contractors to collect payments on behalf of the Secretary for the costs incurred to make available such substances and organisms and to forward amounts so collected to the Secretary, in the time and manner specified by the Secretary.

“(3) Amounts collected under paragraph (2) shall be credited to the appropriations accounts that incurred the costs to make available the research substances and living organisms involved, and shall remain available until expended for carrying out activities under such accounts.”.

SEC. 2044. Sense of Congress on increased inclusion of underrepresented populations in clinical trials.

It is the sense of Congress that the National Institute on Minority Health and Health Disparities should include within its strategic plan under section 402(m) of the Public Health Service Act (42 U.S.C. 282(m)) ways to increase representation of underrepresented populations in clinical trials.

SEC. 2051. Technical updates to clinical trials database.

Section 402(j)(2)(D) of the Public Health Service Act (42 U.S.C. 282(j)(2)(D)) is amended—

(1) in clause (ii)(I), by inserting before the semicolon “, unless the responsible party affirmatively requests that the Director of the National Institutes of Health publicly post such clinical trial information for an applicable device clinical trial prior to such date of clearance or approval”; and

(2) by adding at the end the following:

    “(iii) OPTION TO MAKE CERTAIN CLINICAL TRIAL INFORMATION AVAILABLE EARLIER.—The Director of the National Institutes of Health shall inform responsible parties of the option to request that clinical trial information for an applicable device clinical trial be publicly posted prior to the date of clearance or approval, in accordance with clause (ii)(I).

    “(iv) COMBINATION PRODUCTS.—An applicable clinical trial for a product that is a combination of drug, device, or biological product shall be considered—

    “(I) an applicable drug clinical trial, if the Secretary determines under section 503(g) of the Federal Food, Drug, and Cosmetic Act that the primary mode of action of such product is that of a drug or biological product; or

    “(II) an applicable device clinical trial, if the Secretary determines under such section that the primary mode of action of such product is that of a device.”.

SEC. 2052. Compliance activities reports.

(a) Definitions.—In this section:

(1) APPLICABLE CLINICAL TRIAL.—The term “applicable clinical trial” has the meaning given the term in section 402(j) of the Public Health Service Act (42 U.S.C. 282(j)).

(2) SECRETARY.—The term “Secretary” means the Secretary of Health and Human Services.

(b) Report on activities To encourage compliance.—Not later than 2 years after the date of enactment of this Act, the Secretary, acting through the Director of the National Institutes of Health and in collaboration with the Commissioner of Food and Drugs, shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report that describes education and outreach, guidance, enforcement, and other activities undertaken to encourage compliance with section 402(j) of the Public Health Service Act (42 U.S.C. 282(j)).

(c) Reports on clinical trials.—

(1) IN GENERAL.—Not later than 2 years after the final compliance date under the final rule implementing section 402(j) of the Public Health Service Act, and every 2 years thereafter for the next 4 years, the Secretary, acting through the Director of the National Institutes of Health and in collaboration with the Commissioner of Food and Drugs, shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report describing—

(A) the total number of applicable clinical trials with complete data bank registration information registered during the period for which the report is being prepared (broken down by each year of such reporting period);

(B) the total number of applicable clinical trials registered during the period for which the report is being prepared for which results have been submitted to the data bank (broken down by each year of such reporting period);

(C) the activities undertaken by the Secretary to educate responsible persons about data bank registration and results submission requirements, including through issuance of guidance documents, informational meetings, and training sessions; and

(D) the activities described in the report submitted under subsection (b).

(2) ACTIONS TO ENFORCE COMPLIANCE.—After the Secretary has undertaken the educational activities described in paragraph (1)(C), the Secretary shall include in subsequent reports submitted under paragraph (1) the number of actions taken by the Secretary during the period for which the report is being prepared to enforce compliance with data bank registration and results submission requirements.

SEC. 2053. Updates to policies to improve data.

Section 492B(c) of the Public Health Service Act (42 U.S.C. 289a–2(c)) is amended—

(1) by striking “In the case” and inserting the following:

“(1) IN GENERAL.—In the case”; and

(2) by adding at the end the following:

“(2) REPORTING REQUIREMENTS.—For any new and competing project of clinical research subject to the requirements under this section that receives a grant award 1 year after the date of enactment of the 21st Century Cures Act, or any date thereafter, for which a valid analysis is provided under paragraph (1)—

“(A) and which is an applicable clinical trial as defined in section 402(j), the entity conducting such clinical research shall submit the results of such valid analysis to the clinical trial registry data bank expanded under section 402(j)(3), and the Director of the National Institutes of Health shall, as appropriate, consider whether such entity has complied with the reporting requirement described in this subparagraph in awarding any future grant to such entity, including pursuant to section 402(j)(5)(A)(ii) when applicable; and

“(B) the Director of the National Institutes of Health shall encourage the reporting of the results of such valid analysis described in paragraph (1) through any additional means determined appropriate by the Director.”.

SEC. 2054. Consultation.

Not later than 90 days after the date of enactment of this Act, the Secretary of Health and Human Services shall consult with relevant Federal agencies, including the Food and Drug Administration, the Office of the National Coordinator for Health Information Technology, and the National Institutes of Health, as well as other stakeholders (including patients, researchers, physicians, industry representatives, and developers of health information technology) to receive recommendations with respect to enhancements to the clinical trial registry data bank under section 402(j) of the Public Health Service Act (42 U.S.C. 282(j)), including with respect to usability, functionality, and search capability.

SEC. 2061. National neurological conditions surveillance system.

Part P of title III of the Public Health Service Act (42 U.S.C. 280g et seq.) is amended by inserting after section 399S the following:

“SEC. 399S–1. Surveillance of neurological diseases.

“(a) In general.—The Secretary, acting through the Director of the Centers for Disease Control and Prevention and in coordination with other agencies as the Secretary determines, shall, as appropriate—

“(1) enhance and expand infrastructure and activities to track the epidemiology of neurological diseases; and

“(2) incorporate information obtained through such activities into an integrated surveillance system, which may consist of or include a registry, to be known as the National Neurological Conditions Surveillance System.

“(b) Research.—The Secretary shall ensure that the National Neurological Conditions Surveillance System is designed in a manner that facilitates further research on neurological diseases.

“(c) Content.—In carrying out subsection (a), the Secretary—

“(1) shall provide for the collection and storage of information on the incidence and prevalence of neurological diseases in the United States;

“(2) to the extent practicable, shall provide for the collection and storage of other available information on neurological diseases, including information related to persons living with neurological diseases who choose to participate, such as—

“(A) demographics, such as age, race, ethnicity, sex, geographic location, family history, and other information, as appropriate;

“(B) risk factors that may be associated with neurological diseases, such as genetic and environmental risk factors and other information, as appropriate; and

“(C) diagnosis and progression markers;

“(3) may provide for the collection and storage of information relevant to analysis on neurological diseases, such as information concerning—

“(A) the natural history of the diseases;

“(B) the prevention of the diseases;

“(C) the detection, management, and treatment approaches for the diseases; and

“(D) the development of outcomes measures;

“(4) may address issues identified during the consultation process under subsection (d); and

“(5) initially may address a limited number of neurological diseases.

“(d) Consultation.—In carrying out this section, the Secretary shall consult with individuals with appropriate expertise, which may include—

“(1) epidemiologists with experience in disease surveillance or registries;

“(2) representatives of national voluntary health associations that—

“(A) focus on neurological diseases; and

“(B) have demonstrated experience in research, care, or patient services;

“(3) health information technology experts or other information management specialists;

“(4) clinicians with expertise in neurological diseases; and

“(5) research scientists with experience conducting translational research or utilizing surveillance systems for scientific research purposes.

“(e) Grants.—The Secretary may award grants to, or enter into contracts or cooperative agreements with, public or private nonprofit entities to carry out activities under this section.

“(f) Coordination with other federal, state, and local agencies.—Subject to subsection (h), the Secretary shall—

“(1) make information and analysis in the National Neurological Conditions Surveillance System available, as appropriate—

“(A) to Federal departments and agencies, such as the National Institutes of Health and the Department of Veterans Affairs; and

“(B) to State and local agencies; and

“(2) identify, build upon, leverage, and coordinate among existing data and surveillance systems, surveys, registries, and other Federal public health infrastructure, wherever practicable.

“(g) Public access.—Subject to subsection (h), the Secretary shall ensure that information and analysis in the National Neurological Conditions Surveillance System are available, as appropriate, to the public, including researchers.

“(h) Privacy.—The Secretary shall ensure that information and analysis in the National Neurological Conditions Surveillance System are made available only to the extent permitted by applicable Federal and State law, and in a manner that protects personal privacy, to the extent required by applicable Federal and State privacy law, at a minimum.

“(i) Reports.—

“(1) REPORT ON INFORMATION AND ANALYSES.—Not later than 1 year after the date on which any system is established under this section, the Secretary shall submit an interim 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 regarding aggregate information collected pursuant to this section and epidemiological analyses, as appropriate. Such report shall be posted on the Internet website of the Department of Health and Human Services and shall be updated biennially.

“(2) IMPLEMENTATION REPORT.—Not later than 4 years after the date of the enactment of this section, the Secretary shall submit a report to the Congress concerning the implementation of this section. Such report shall include information on—

“(A) the development and maintenance of the National Neurological Conditions Surveillance System;

“(B) the type of information collected and stored in the surveillance system;

“(C) the use and availability of such information, including guidelines for such use; and

“(D) the use and coordination of databases that collect or maintain information on neurological diseases.

“(j) Definition.—In this section, the term ‘national voluntary health association’ means a national nonprofit organization with chapters, other affiliated organizations, or networks in States throughout the United States with experience serving the population of individuals with neurological disease and have demonstrated experience in neurological disease research, care, and patient services.

“(k) Authorization of appropriations.—To carry out this section, there is authorized to be appropriated $5,000,000 for each of fiscal years 2018 through 2022.”.

SEC. 2062. Tick-borne diseases.

(a) In general.—The Secretary of Health and Human Services (referred to in this section as “the Secretary”) shall continue to conduct or support epidemiological, basic, translational, and clinical research related to vector-borne diseases, including tick-borne diseases.

(b) Reports.—The Secretary shall ensure that each triennial report under section 403 of the Public Health Service Act (42 U.S.C. 283) (as amended by section 2032) includes information on actions undertaken by the National Institutes of Health to carry out subsection (a) with respect to tick-borne diseases.

(c) Tick-borne diseases working group.—

(1) ESTABLISHMENT.—The Secretary shall establish a working group, to be known as the Tick-Borne Disease Working Group (referred to in this section as the “Working Group”), comprised of representatives of appropriate Federal agencies and other non-Federal entities, to provide expertise and to review all efforts within the Department of Health and Human Services related to all tick-borne diseases, to help ensure interagency coordination and minimize overlap, and to examine research priorities.

(2) RESPONSIBILITIES.—The working group shall—

(A) not later than 2 years after the date of enactment of this Act, develop or update a summary of—

(i) ongoing tick-borne disease research, including research related to causes, prevention, treatment, surveillance, diagnosis, diagnostics, duration of illness, and intervention for individuals with tick-borne diseases;

(ii) advances made pursuant to such research;

(iii) Federal activities related to tick-borne diseases, including—

(I) epidemiological activities related to tick-borne diseases; and

(II) basic, clinical, and translational tick-borne disease research related to the pathogenesis, prevention, diagnosis, and treatment of tick-borne diseases;

(iv) gaps in tick-borne disease research described in clause (iii)(II);

(v) the Working Group’s meetings required under paragraph (4); and

(vi) the comments received by the Working Group;

(B) make recommendations to the Secretary regarding any appropriate changes or improvements to such activities and research; and

(C) solicit input from States, localities, and nongovernmental entities, including organizations representing patients, health care providers, researchers, and industry regarding scientific advances, research questions, surveillance activities, and emerging strains in species of pathogenic organisms.

(3) MEMBERSHIP.—The members of the working group shall represent a diversity of scientific disciplines and views and shall be composed of the following members:

(A) FEDERAL MEMBERS.—Seven Federal members, consisting of one or more representatives of each of the following:

(i) The Office of the Assistant Secretary for Health.

(ii) The Food and Drug Administration.

(iii) The Centers for Disease Control and Prevention.

(iv) The National Institutes of Health.

(v) Such other agencies and offices of the Department of Health and Human Services as the Secretary determines appropriate.

(B) NON–FEDERAL PUBLIC MEMBERS.—Seven non–Federal public members, consisting of representatives of the following categories:

(i) Physicians and other medical providers with experience in diagnosing and treating tick-borne diseases.

(ii) Scientists or researchers with expertise.

(iii) Patients and their family members.

(iv) Nonprofit organizations that advocate for patients with respect to tick-borne diseases.

(v) Other individuals whose expertise is determined by the Secretary to be beneficial to the functioning of the Working Group.

(4) MEETINGS.—The Working Group shall meet not less than twice each year.

(5) REPORTING.—Not later than 2 years after the date of enactment of this Act, and every 2 years thereafter until termination of the Working Group pursuant to paragraph (7), the Working Group shall—

(A) submit a report on its activities under paragraph (2)(A) and any recommendations under paragraph (2)(B) 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; and

(B) make such report publicly available on the Internet website of the Department of Health and Human Services.

(6) APPLICABILITY OF FACA.—The Working Group shall be treated as an advisory committee subject to the Federal Advisory Committee Act (5 U.S.C. App.).

(7) SUNSET.—The Working Group under this section shall terminate 6 years after the date of enactment of this Act.

SEC. 2063. Accessing, sharing, and using health data for research purposes.

(a) Guidance related to Remote Access.—Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the “Secretary”) shall issue guidance clarifying that subparagraph (B) of section 164.512(i)(1)(ii) of part 164 of the Rule (prohibiting the removal of protected health information by a researcher) does not prohibit remote access to health information by a researcher for such purposes as described in section 164.512(i)(1)(ii) of part 164 of the Rule so long as—

(1) at a minimum, security and privacy safeguards, consistent with the requirements of the Rule, are maintained by the covered entity and the researcher; and

(2) the protected health information is not copied or otherwise retained by the researcher.

(b) Guidance related to Streamlining Authorization.—Not later than 1 year after the date of enactment of this Act, the Secretary shall issue guidance on the following:

(1) AUTHORIZATION FOR USE AND DISCLOSURE OF HEALTH INFORMATION.—Clarification of the circumstances under which the authorization for the use or disclosure of protected health information, with respect to an individual, for future research purposes contains a sufficient description of the purpose of the use or disclosure, such as if the authorization—

(A) sufficiently describes the purposes such that it would be reasonable for the individual to expect that the protected health information could be used or disclosed for such future research;

(B) either—

(i) states that the authorization will expire on a particular date or on the occurrence of a particular event; or

(ii) states that the authorization will remain valid unless and until it is revoked by the individual; and

(C) provides instruction to the individual on how to revoke such authorization at any time.

(2) REMINDER OF THE RIGHT TO REVOKE.—Clarification of the circumstances under which it is appropriate to provide an individual with an annual notice or reminder that the individual has the right to revoke such authorization.

(3) REVOCATION OF AUTHORIZATION.—Clarification of appropriate mechanisms by which an individual may revoke an authorization for future research purposes, such as described in paragraph (1)(C).

(c) Working group on protected health information for research.—

(1) ESTABLISHMENT.—Not later than 1 year after the date of enactment of this Act, the Secretary shall convene a working group to study and report on the uses and disclosures of protected health information for research purposes, under the Health Insurance Portability and Accountability Act of 1996 (Public Law 104–191).

(2) MEMBERS.—The working group shall include representatives of—

(A) relevant Federal agencies, including the National Institutes of Health, the Centers for Disease Control and Prevention, the Food and Drug Administration, and the Office for Civil Rights;

(B) the research community;

(C) patients;

(D) experts in civil rights, such as privacy rights;

(E) developers of health information technology;

(F) experts in data privacy and security;

(G) health care providers;

(H) bioethicists; and

(I) other experts and entities, as the Secretary determines appropriate.

(3) REPORT.—Not later than 1 year after the date on which the working group is convened under paragraph (1), the working group shall conduct a review and submit a report to the Secretary containing recommendations on whether the uses and disclosures of protected health information for research purposes should be modified to allow protected health information to be available, as appropriate, for research purposes, including studies to obtain generalizable knowledge, while protecting individuals’ privacy rights. In conducting the review and making recommendations, the working group shall—

(A) address, at a minimum—

(i) the appropriate manner and timing of authorization, including whether additional notification to the individual should be required when the individual’s protected health information will be used or disclosed for such research;

(ii) opportunities for individuals to set preferences on the manner in which their protected health information is used in research;

(iii) opportunities for patients to revoke authorization;

(iv) notification to individuals of a breach in privacy;

(v) existing gaps in statute, regulation, or policy related to protecting the privacy of individuals, and

(vi) existing barriers to research related to the current restrictions on the uses and disclosures of protected health information; and

(B) consider, at a minimum—

(i) expectations and preferences on how an individual’s protected health information is shared and used;

(ii) issues related to specific subgroups of people, such as children, incarcerated individuals, and individuals with a cognitive or intellectual disability impacting capacity to consent;

(iii) relevant Federal and State laws;

(iv) models of facilitating data access and levels of data access, including data segmentation, where applicable;

(v) potential impacts of disclosure and non-disclosure of protected health information on access to health care services; and

(vi) the potential uses of such data.

(4) REPORT SUBMISSION.—The Secretary shall submit the report under paragraph (3) 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 shall post such report on the appropriate Internet website of the Department of Health and Human Services.

(5) TERMINATION.—The working group convened under paragraph (1) shall terminate the day after the report under paragraph (3) is submitted to Congress and made public in accordance with paragraph (4).

(d) Definitions.—In this section:

(1) THE RULE.—References to “the Rule” refer to part 160 or part 164, as appropriate, of title 45, Code of Federal Regulations (or any successor regulation).

(2) PART 164.—References to a specified section of “part 164”, refer to such specified section of part 164 of title 45, Code of Federal Regulations (or any successor section).

SEC. 2071. National pediatric research network.

Section 409D(d) of the Public Health Service Act (42 U.S.C. 284h(d)) is amended—

(1) in paragraph (1), by striking “in consultation with the Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development and in collaboration with other appropriate national research institutes and national centers that carry out activities involving pediatric research, may provide for the establishment of” and inserting “in collaboration with the national research institutes and national centers that carry out activities involving pediatric research, shall support”; and

(2) in paragraph (2)(A) and the first sentence of paragraph (2)(E), by striking “may” each place such term appears and inserting “shall”.

SEC. 2072. Global pediatric clinical study network.

It is the sense of Congress that—

(1) the National Institutes of Health should encourage a global pediatric clinical study network by providing grants, contracts, or cooperative agreements to support new and early stage investigators who participate in the global pediatric clinical study network;

(2) the Secretary of Health and Human Services (referred to in this section as the “Secretary”) should engage with clinical investigators and appropriate authorities outside of the United States, including authorities in the European Union, during the formation of the global pediatric clinical study network to encourage the participation of such investigator and authorities; and

(3) once a global pediatric clinical study network is established and becomes operational, the Secretary should continue to encourage and facilitate the participation of clinical investigators and appropriate authorities outside of the United States, including in the European Union, to participate in the network with the goal of enhancing the global reach of the network.

SEC. 3001. Patient experience data.

Section 569C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–8c) is amended—

(1) in subsection (a)—

(A) in the subsection heading, by striking “In general” and inserting “Patient Engagement in Drugs and Devices”;

(B) by redesignating paragraphs (1) and (2) as subparagraphs (A) and (B), respectively, and moving such subparagraphs 2 ems to the right; and

(C) by striking “The Secretary” and inserting the following:

“(1) IN GENERAL.—The Secretary”;

(2) by redesignating subsections (b) through (e) as paragraphs (2) through (5), respectively, and moving such paragraphs 2 ems to the right; and

(3) by adding at the end the following:

“(b) Statement of patient experience.—

“(1) IN GENERAL.—Following the approval of an application that was submitted under section 505(b) of this Act or section 351(a) of the Public Health Service Act at least 180 days after the date of enactment of the 21st Century Cures Act, the Secretary shall make public a brief statement regarding the patient experience data and related information, if any, submitted and reviewed as part of such application.

“(2) DATA AND INFORMATION.—The data and information referred to in paragraph (1) are—

“(A) patient experience data;

“(B) information on patient-focused drug development tools; and

“(C) other relevant information, as determined by the Secretary.

“(c) Patient experience data.—For purposes of this section, the term ‘patient experience data’ includes data that—

“(1) are collected by any persons (including patients, family members and caregivers of patients, patient advocacy organizations, disease research foundations, researchers, and drug manufacturers); and

“(2) are intended to provide information about patients’ experiences with a disease or condition, including—

“(A) the impact of such disease or condition, or a related therapy, on patients’ lives; and

“(B) patient preferences with respect to treatment of such disease or condition.”.

SEC. 3002. Patient-focused drug development guidance.

(a) Publication of guidance documents.—Not later than 180 days after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the “Secretary”), acting through the Commissioner of Food and Drugs, shall develop a plan to issue draft and final versions of one or more guidance documents, over a period of 5 years, regarding the collection of patient experience data, and the use of such data and related information in drug development. Not later than 18 months after the date of enactment of this Act, the Secretary shall issue a draft version of at least one such guidance document. Not later than 18 months after the public comment period on the draft guidance ends, the Secretary shall issue a revised draft guidance or final guidance.

(b) Patient experience data.—For purposes of this section, the term “patient experience data” has the meaning given such term in section 569C of the Federal Food, Drug, and Cosmetic Act (as added by section 3001).

(c) Contents.—The guidance documents described in subsection (a) shall address—

(1) methodological approaches that a person seeking to collect patient experience data for submission to, and proposed use by, the Secretary in regulatory decisionmaking may use, that are relevant and objective and ensure that such data are accurate and representative of the intended population, including methods to collect meaningful patient input throughout the drug development process and methodological considerations for data collection, reporting, management, and analysis;

(2) methodological approaches that may be used to develop and identify what is most important to patients with respect to burden of disease, burden of treatment, and the benefits and risks in the management of the patient’s disease;

(3) approaches to identifying and developing methods to measure impacts to patients that will help facilitate collection of patient experience data in clinical trials;

(4) methodologies, standards, and technologies to collect and analyze clinical outcome assessments for purposes of regulatory decisionmaking;

(5) how a person seeking to develop and submit proposed draft guidance relating to patient experience data for consideration by the Secretary may submit such proposed draft guidance to the Secretary;

(6) the format and content required for submissions under this section to the Secretary, including with respect to the information described in paragraph (1);

(7) how the Secretary intends to respond to submissions of information described in paragraph (1), if applicable, including any timeframe for response when such submission is not part of a regulatory application or other submission that has an associated timeframe for response; and

(8) how the Secretary, if appropriate, anticipates using relevant patient experience data and related information, including with respect to the structured risk-benefit assessment framework described in section 505(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(d)), to inform regulatory decisionmaking.

SEC. 3003. Streamlining patient input.

Chapter 35 of title 44, United States Code, shall not apply to the collection of information to which a response is voluntary, that is initiated by the Secretary under section 569C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–8c) (as amended by section 3001) or section 3002.

SEC. 3004. Report on patient experience drug development.

Not later than June 1 of 2021, 2026, and 2031, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall prepare and publish on the Internet website of the Food and Drug Administration a report assessing the use of patient experience data in regulatory decisionmaking, in particular with respect to the review of patient experience data and information on patient-focused drug development tools as part of applications approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(c)) or section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)).

SEC. 3011. Qualification of drug development tools.

(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 506F the following new section:

“SEC. 507. Qualification of drug development tools.

“(a) Process for qualification.—

“(1) IN GENERAL.—The Secretary shall establish a process for the qualification of drug development tools for a proposed context of use under which—

“(A)(i) a requestor initiates such process by submitting a letter of intent to the Secretary; and

“(ii) the Secretary accepts or declines to accept such letter of intent;

“(B)(i) if the Secretary accepts the letter of intent, a requestor submits a qualification plan to the Secretary; and

“(ii) the Secretary accepts or declines to accept the qualification plan; and

“(C)(i) if the Secretary accepts the qualification plan, the requestor submits to the Secretary a full qualification package;

“(ii) the Secretary determines whether to accept such qualification package for review; and

“(iii) if the Secretary accepts such qualification package for review, the Secretary conducts such review in accordance with this section.

“(2) ACCEPTANCE AND REVIEW OF SUBMISSIONS.—

“(A) IN GENERAL.—Subparagraphs (B), (C), and (D) shall apply with respect to the treatment of a letter of intent, a qualification plan, or a full qualification package submitted under paragraph (1) (referred to in this paragraph as ‘qualification submissions’).

“(B) ACCEPTANCE FACTORS; NONACCEPTANCE.—The Secretary shall determine whether to accept a qualification submission based on factors which may include the scientific merit of the qualification submission. A determination not to accept a submission under paragraph (1) shall not be construed as a final determination by the Secretary under this section regarding the qualification of a drug development tool for its proposed context of use.

“(C) PRIORITIZATION OF QUALIFICATION REVIEW.—The Secretary may prioritize the review of a full qualification package submitted under paragraph (1) with respect to a drug development tool, based on factors determined appropriate by the Secretary, including—

“(i) as applicable, the severity, rarity, or prevalence of the disease or condition targeted by the drug development tool and the availability or lack of alternative treatments for such disease or condition; and

“(ii) the identification, by the Secretary or by biomedical research consortia and other expert stakeholders, of such a drug development tool and its proposed context of use as a public health priority.

“(D) ENGAGEMENT OF EXTERNAL EXPERTS.—The Secretary may, for purposes of the review of qualification submissions, through the use of cooperative agreements, grants, or other appropriate mechanisms, consult with biomedical research consortia and may consider the recommendations of such consortia with respect to the review of any qualification plan submitted under paragraph (1) or the review of any full qualification package under paragraph (3).

“(3) REVIEW OF FULL QUALIFICATION PACKAGE.—The Secretary shall—

“(A) conduct a comprehensive review of a full qualification package accepted under paragraph (1)(C); and

“(B) determine whether the drug development tool at issue is qualified for its proposed context of use.

“(4) QUALIFICATION.—The Secretary shall determine whether a drug development tool is qualified for a proposed context of use based on the scientific merit of a full qualification package reviewed under paragraph (3).

“(b) Effect of qualification.—

“(1) IN GENERAL.—A drug development tool determined to be qualified under subsection (a)(4) for a proposed context of use specified by the requestor may be used by any person in such context of use for the purposes described in paragraph (2).

“(2) USE OF A DRUG DEVELOPMENT TOOL.—Subject to paragraph (3), a drug development tool qualified under this section may be used for—

“(A) supporting or obtaining approval or licensure (as applicable) of a drug or biological product (including in accordance with section 506(c)) under section 505 of this Act or section 351 of the Public Health Service Act; or

“(B) supporting the investigational use of a drug or biological product under section 505(i) of this Act or section 351(a)(3) of the Public Health Service Act.

“(3) RESCISSION OR MODIFICATION.—

“(A) IN GENERAL.—The Secretary may rescind or modify a determination under this section to qualify a drug development tool if the Secretary determines that the drug development tool is not appropriate for the proposed context of use specified by the requestor. Such a determination may be based on new information that calls into question the basis for such qualification.

“(B) MEETING FOR REVIEW.—If the Secretary rescinds or modifies under subparagraph (A) a determination to qualify a drug development tool, the requestor involved shall, on request, be granted a meeting with the Secretary to discuss the basis of the Secretary’s decision to rescind or modify the determination before the effective date of the rescission or modification.

“(c) Transparency.—

“(1) IN GENERAL.—Subject to paragraph (3), the Secretary shall make publicly available, and update on at least a biannual basis, on the Internet website of the Food and Drug Administration the following:

“(A) Information with respect to each qualification submission under the qualification process under subsection (a), including—

“(i) the stage of the review process applicable to the submission;

“(ii) the date of the most recent change in stage status;

“(iii) whether external scientific experts were utilized in the development of a qualification plan or the review of a full qualification package; and

“(iv) submissions from requestors under the qualification process under subsection (a), including any data and evidence contained in such submissions, and any updates to such submissions.

“(B) The Secretary’s formal written determinations in response to such qualification submissions.

“(C) Any rescissions or modifications under subsection (b)(3) of a determination to qualify a drug development tool.

“(D) Summary reviews that document conclusions and recommendations for determinations to qualify drug development tools under subsection (a).

“(E) A comprehensive list of—

“(i) all drug development tools qualified under subsection (a); and

“(ii) all surrogate endpoints which were the basis of approval or licensure (as applicable) of a drug or biological product (including in accordance with section 506(c)) under section 505 of this Act or section 351 of the Public Health Service Act.

“(2) RELATION TO TRADE SECRETS ACT.—Information made publicly available by the Secretary under paragraph (1) shall be considered a disclosure authorized by law for purposes of section 1905 of title 18, United States Code.

“(3) APPLICABILITY.—Nothing in this section shall be construed as authorizing the Secretary to disclose any information contained in an application submitted under section 505 of this Act or section 351 of the Public Health Service Act that is confidential commercial or trade secret information subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code.

“(d) Rule of construction.—Nothing in this section shall be construed—

“(1) to alter the standards of evidence under subsection (c) or (d) of section 505, including the substantial evidence standard in such subsection (d), or under section 351 of the Public Health Service Act (as applicable); or

“(2) to limit the authority of the Secretary to approve or license products under this Act or the Public Health Service Act, as applicable (as in effect before the date of the enactment of the 21st Century Cures Act).

“(e) Definitions.—In this section:

“(1) BIOMARKER.—The term ‘biomarker’—

“(A) means a characteristic (such as a physiologic, pathologic, or anatomic characteristic or measurement) that is objectively measured and evaluated as an indicator of normal biologic processes, pathologic processes, or biological responses to a therapeutic intervention; and

“(B) includes a surrogate endpoint.

“(2) BIOMEDICAL RESEARCH CONSORTIA.—The term ‘biomedical research consortia’ means collaborative groups that may take the form of public-private partnerships and may include government agencies, institutions of higher education (as defined in section 101(a) of the Higher Education Act of 1965), patient advocacy groups, industry representatives, clinical and scientific experts, and other relevant entities and individuals.

“(3) CLINICAL OUTCOME ASSESSMENT.—The term ‘clinical outcome assessment’ means—

“(A) a measurement of a patient’s symptoms, overall mental state, or the effects of a disease or condition on how the patient functions; and

“(B) includes a patient-reported outcome.

“(4) CONTEXT OF USE.—The term ‘context of use’ means, with respect to a drug development tool, the circumstances under which the drug development tool is to be used in drug development and regulatory review.

“(5) DRUG DEVELOPMENT TOOL.—The term ‘drug development tool’ includes—

“(A) a biomarker;

“(B) a clinical outcome assessment; and

“(C) any other method, material, or measure that the Secretary determines aids drug development and regulatory review for purposes of this section.

“(6) PATIENT-REPORTED OUTCOME.—The term ‘patient-reported outcome’ means a measurement based on a report from a patient regarding the status of the patient’s health condition without amendment or interpretation of the patient’s report by a clinician or any other person.

“(7) QUALIFICATION.—The terms ‘qualification’ and ‘qualified’ mean a determination by the Secretary that a drug development tool and its proposed context of use can be relied upon to have a specific interpretation and application in drug development and regulatory review under this Act.

“(8) REQUESTOR.—The term ‘requestor’ means an entity or entities, including a drug sponsor or a biomedical research consortia, seeking to qualify a drug development tool for a proposed context of use under this section.

“(9) SURROGATE ENDPOINT.—The term ‘surrogate endpoint’ means a marker, such as a laboratory measurement, radiographic image, physical sign, or other measure, that is not itself a direct measurement of clinical benefit, and—

“(A) is known to predict clinical benefit and could be used to support traditional approval of a drug or biological product; or

“(B) is reasonably likely to predict clinical benefit and could be used to support the accelerated approval of a drug or biological product in accordance with section 506(c).”.

(b) Guidance.—

(1) IN GENERAL.—The Secretary of Health and Human Services (referred to in this section as the “Secretary”) shall, in consultation with biomedical research consortia (as defined in subsection (e) of section 507 of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)) and other interested parties through a collaborative public process, issue guidance to implement such section 507 that—

(A) provides a conceptual framework describing appropriate standards and scientific approaches to support the development of biomarkers delineated under the taxonomy established under paragraph (3);

(B) with respect to the qualification process under such section 507—

(i) describes the requirements that entities seeking to qualify a drug development tool under such section shall observe when engaging in such process;

(ii) outlines reasonable timeframes for the Secretary’s review of letters, qualification plans, or full qualification packages submitted under such process; and

(iii) establishes a process by which such entities or the Secretary may consult with biomedical research consortia and other individuals and entities with expert knowledge and insights that may assist the Secretary in the review of qualification plans and full qualification submissions under such section; and

(C) includes such other information as the Secretary determines appropriate.

(2) TIMING.—Not later than 3 years after the date of the enactment of this Act, the Secretary shall issue draft guidance under paragraph (1) on the implementation of section 507 of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)). The Secretary shall issue final guidance on the implementation of such section not later than 6 months after the date on which the comment period for the draft guidance closes.

(3) TAXONOMY.—

(A) IN GENERAL.—For purposes of informing guidance under this subsection, the Secretary shall, in consultation with biomedical research consortia and other interested parties through a collaborative public process, establish a taxonomy for the classification of biomarkers (and related scientific concepts) for use in drug development.

(B) PUBLIC AVAILABILITY.—Not later than 2 years after the date of the enactment of this Act, the Secretary shall make such taxonomy publicly available in draft form for public comment. The Secretary shall finalize the taxonomy not later than 1 year after the close of the public comment period.

(c) Meeting and report.—

(1) MEETING.—Not later than 2 years after the date of the enactment of this Act, the Secretary shall convene a public meeting to describe and solicit public input regarding the qualification process under section 507 of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a).

(2) REPORT.—Not later than 5 years after the date of the enactment of this Act, the Secretary shall make publicly available on the Internet website of the Food and Drug Administration a report. Such report shall include, with respect to the qualification process under section 507 of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), information on—

(A) the number of requests submitted, as a letter of intent, for qualification of a drug development tool (as defined in subsection (e) of such section 507);

(B) the number of such requests accepted and determined to be eligible for submission of a qualification plan or full qualification package (as such terms are defined in subsection (e) of such section 507), respectively;

(C) the number of such requests for which external scientific experts were utilized in the development of a qualification plan or review of a full qualification package;

(D) the number of qualification plans and full qualification packages, respectively, submitted to the Secretary; and

(E) the drug development tools qualified through such qualification process, specified by type of tool, such as a biomarker or clinical outcome assessment (as such terms are defined in subsection (e) of such section 507).

SEC. 3012. Targeted drugs for rare diseases.

Subchapter B of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360aa et seq.) is amended by inserting after section 529 the following:

“SEC. 529A. Targeted drugs for rare diseases.

“(a) Purpose.—The purpose of this section, through the approach provided for in subsection (b), is to—

“(1) facilitate the development, review, and approval of genetically targeted drugs and variant protein targeted drugs to address an unmet medical need in one or more patient subgroups, including subgroups of patients with different mutations of a gene, with respect to rare diseases or conditions that are serious or life-threatening; and

“(2) maximize the use of scientific tools or methods, including surrogate endpoints and other biomarkers, for such purposes.

“(b) Leveraging of data from previously approved drug application or applications.—The Secretary may, consistent with applicable standards for approval under this Act or section 351(a) of the Public Health Service Act, allow the sponsor of an application under section 505(b)(1) of this Act or section 351(a) of the Public Health Service Act for a genetically targeted drug or a variant protein targeted drug to rely upon data and information—

“(1) previously developed by the same sponsor (or another sponsor that has provided the sponsor with a contractual right of reference to such data and information); and

“(2) submitted by a sponsor described in paragraph (1) in support of one or more previously approved applications that were submitted under section 505(b)(1) of this Act or section 351(a) of the Public Health Service Act,

for a drug that incorporates or utilizes the same or similar genetically targeted technology as the drug or drugs that are the subject of an application or applications described in paragraph (2) or for a variant protein targeted drug that is the same or incorporates or utilizes the same variant protein targeted drug, as the drug or drugs that are the subject of an application or applications described in paragraph (2).

“(c) Definitions.—For purposes of this section—

“(1) the term ‘genetically targeted drug’ means a drug that—

“(A) is the subject of an application under section 505(b)(1) of this Act or section 351(a) of the Public Health Service Act for the treatment of a rare disease or condition (as such term is defined in section 526) that is serious or life-threatening;

“(B) may result in the modulation (including suppression, up-regulation, or activation) of the function of a gene or its associated gene product; and

“(C) incorporates or utilizes a genetically targeted technology;

“(2) the term ‘genetically targeted technology’ means a technology comprising non-replicating nucleic acid or analogous compounds with a common or similar chemistry that is intended to treat one or more patient subgroups, including subgroups of patients with different mutations of a gene, with the same disease or condition, including a disease or condition due to other variants in the same gene; and

“(3) the term ‘variant protein targeted drug’ means a drug that—

“(A) is the subject of an application under section 505(b)(1) of this Act or section 351(a) of the Public Health Service Act for the treatment of a rare disease or condition (as such term is defined in section 526) that is serious or life-threatening;

“(B) modulates the function of a product of a mutated gene where such mutation is responsible in whole or in part for a given disease or condition; and

“(C) is intended to treat one or more patient subgroups, including subgroups of patients with different mutations of a gene, with the same disease or condition.

“(d) Rule of construction.—Nothing in this section shall be construed to—

“(1) alter the authority of the Secretary to approve drugs pursuant to this Act or section 351 of the Public Health Service Act (as authorized prior to the date of enactment of the 21st Century Cures Act), including the standards of evidence, and applicable conditions, for approval under such applicable Act; or

“(2) confer any new rights, beyond those authorized under this Act or the Public Health Service Act prior to enactment of this section, with respect to the permissibility of a sponsor referencing information contained in another application submitted under section 505(b)(1) of this Act or section 351(a) of the Public Health Service Act.”.

SEC. 3013. Reauthorization of program to encourage treatments for rare pediatric diseases.

(a) In General.—Section 529(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ff(b)) is amended by striking paragraph (5) and inserting the following:

“(5) TERMINATION OF AUTHORITY.—The Secretary may not award any priority review vouchers under paragraph (1) after September 30, 2020, unless the rare pediatric disease product application—

“(A) is for a drug that, not later than September 30, 2020, is designated under subsection (d) as a drug for a rare pediatric disease; and

“(B) is, not later than September 30, 2022, approved under section 505(b)(1) of this Act or section 351(a) of the Public Health Service Act.”.

(b) Report.—The Advancing Hope Act of 2016 (Public Law 114–229) is amended by striking section 3.

SEC. 3014. GAO study of priority review voucher programs.

(a) Study.—The Comptroller General of the United States (referred to in this section as the “Comptroller General”) shall conduct a study addressing the effectiveness and overall impact of the following priority review voucher programs, including any such programs amended or established by this Act:

(1) The neglected tropical disease priority review voucher program under section 524 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360n).

(2) The rare pediatric disease priority review voucher program under section 529 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ff).

(3) The medical countermeasure priority review voucher program under section 565A of the Federal Food, Drug, and Cosmetic Act, as added by section 3086.

(b) Issuance of report.—Not later than January 31, 2020, the Comptroller General shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report containing the results of the study under subsection (a).

(c) Contents of reports.—The report submitted under subsection (b) shall address—

(1) for each drug for which a priority review voucher has been awarded as of initiation of the study—

(A) the indications for which the drug is approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(c)), pursuant to an application under section 505(b)(1) of such Act, or licensed under section 351(a) of the Public Health Service Act (42 U.S.C. 262(a));

(B) whether, and to what extent, the voucher impacted the sponsor’s decision to develop the drug; and

(C) whether, and to what extent, the approval or licensure of the drug, as applicable and appropriate—

(i) addressed a global unmet need related to the treatment or prevention of a neglected tropical disease, including whether the sponsor of a drug coordinated with international development organizations;

(ii) addressed an unmet need related to the treatment of a rare pediatric disease; or

(iii) affected the Nation’s preparedness against a chemical, biological, radiological, or nuclear threat, including naturally occurring threats;

(2) for each drug for which a priority review voucher has been used—

(A) the indications for which such drug is approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(c)), pursuant to an application under section 505(b)(1) of such Act, or licensed under section 351(a) of the Public Health Service Act (42 U.S.C. 262);

(B) the value of the voucher, if transferred; and

(C) the length of time between the date on which the voucher was awarded and the date on which the voucher was used; and

(3) an analysis of the priority review voucher programs described in subsection (a), including—

(A) the resources used by the Food and Drug Administration in reviewing drugs for which vouchers were used, including the effect of the programs on the Food and Drug Administration’s review of drugs for which priority review vouchers were not awarded or used;

(B) whether any improvements to such programs are necessary to appropriately target incentives for the development of drugs that would likely not otherwise be developed, or developed in as timely a manner, and, as applicable and appropriate—

(i) address global unmet needs related to the treatment or prevention of neglected tropical diseases, including in countries in which neglected tropical diseases are endemic; or

(ii) address unmet needs related to the treatment of rare pediatric diseases; and

(C) whether the sunset of the rare pediatric disease program and medical countermeasure program has had an impact on the program, including any potential unintended consequences.

(d) Protection of national security.—The Comptroller General shall conduct the study and issue reports under this section in a manner that does not compromise national security.

SEC. 3015. Amendments to the Orphan Drug grants.

Section 5 of the Orphan Drug Act (21 U.S.C. 360ee) is amended—

(1) in subsection (a), by striking paragraph (1) and inserting the following: “(1) defraying the costs of developing drugs for rare diseases or conditions, including qualified testing expenses, ”; and

(2) in subsection (b)(1)—

(A) in subparagraph (A)(ii), by striking “and” after the semicolon;

(B) in subparagraph (B), by striking the period and inserting “; and”; and

(C) by adding at the end the following:

“(C) prospectively planned and designed observational studies and other analyses conducted to assist in the understanding of the natural history of a rare disease or condition and in the development of a therapy, including studies and analyses to—

“(i) develop or validate a drug development tool related to a rare disease or condition; or

“(ii) understand the full spectrum of the disease manifestations, including describing genotypic and phenotypic variability and identifying and defining distinct subpopulations affected by a rare disease or condition.”.

SEC. 3016. Grants for studying continuous drug manufacturing.

(a) In general.—The Secretary of Health and Human Services may award grants to institutions of higher education and nonprofit organizations for the purpose of studying and recommending improvements to the process of continuous manufacturing of drugs and biological products and similar innovative monitoring and control techniques.

(b) Definitions.—In this section—

(1) the term “drug” has the meaning given such term in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321);

(2) the term “biological product” has the meaning given such term in section 351(i) of the Public Health Service Act (42 U.S.C. 262(i)); and

(3) the term “institution of higher education” has the meaning given such term in section 101(a) of the Higher Education Act of 1965 (20 U.S.C. 1001(a)).

SEC. 3021. Novel clinical trial designs.

(a) Proposals for use of novel clinical trial designs for drugs and biological products.—For purposes of assisting sponsors in incorporating complex adaptive and other novel trial designs into proposed clinical protocols and applications for new drugs under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) and biological products under section 351 of the Public Health Service Act (42 U.S.C. 262), the Secretary of Health and Human Services (referred to in this section as the “Secretary”) shall conduct a public meeting and issue guidance in accordance with subsection (b).

(b) Guidance addressing use of novel clinical trial designs.—

(1) IN GENERAL.—The Secretary, acting through the Commissioner of Food and Drugs, shall update or issue guidance addressing the use of complex adaptive and other novel trial design in the development and regulatory review and approval or licensure for drugs and biological products.

(2) CONTENTS.—The guidance under paragraph (1) shall address—

(A) the use of complex adaptive and other novel trial designs, including how such clinical trials proposed or submitted help to satisfy the substantial evidence standard under section 505(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(d));

(B) how sponsors may obtain feedback from the Secretary on technical issues related to modeling and simulations prior to—

(i) completion of such modeling or simulations; or

(ii) the submission of resulting information to the Secretary;

(C) the types of quantitative and qualitative information that should be submitted for review; and

(D) recommended analysis methodologies.

(3) PUBLIC MEETING.—Prior to updating or issuing the guidance required by paragraph (1), the Secretary shall consult with stakeholders, including representatives of regulated industry, academia, patient advocacy organizations, consumer groups, and disease research foundations, through a public meeting to be held not later than 18 months after the date of enactment of this Act.

(4) TIMING.—The Secretary shall update or issue a draft version of the guidance required by paragraph (1) not later than 18 months after the date of the public meeting required by paragraph (3) and finalize such guidance not later than 1 year after the date on which the public comment period for the draft guidance closes.

SEC. 3022. Real world evidence.

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

“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 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 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. 3023. Protection of human research subjects.

(a) In general.—In order to simplify and facilitate compliance by researchers with applicable regulations for the protection of human subjects in research, the Secretary of Health and Human Services (referred to in this section as the “Secretary”) shall, to the extent practicable and consistent with other statutory provisions, harmonize differences between the HHS Human Subject Regulations and the FDA Human Subject Regulations in accordance with subsection (b).

(b) Avoiding regulatory duplication and unnecessary delays.—The Secretary shall, as appropriate—

(1) make such modifications to the provisions of the HHS Human Subject Regulations, the FDA Human Subject Regulations, and the vulnerable populations rules as may be necessary—

(A) to reduce regulatory duplication and unnecessary delays;

(B) to modernize such provisions in the context of multisite and cooperative research projects; and

(C) to protect vulnerable populations, incorporate local considerations, and support community engagement through mechanisms such as consultation with local researchers and human research protection programs, in a manner consistent with subparagraph (B); and

(2) ensure that human subject research that is subject to the HHS Human Subject Regulations and to the FDA Human Subject Regulations may—

(A) use joint or shared review;

(B) rely upon the review of—

(i) an independent institutional review board; or

(ii) an institutional review board of an entity other than the sponsor of the research; or

(C) use similar arrangements to avoid duplication of effort.

(c) Consultation.—In harmonizing or modifying regulations or guidance under this section, the Secretary shall consult with stakeholders (including researchers, academic organizations, hospitals, institutional research boards, pharmaceutical, biotechnology, and medical device developers, clinical research organizations, patient groups, and others).

(d) Timing.—The Secretary shall complete the harmonization described in subsection (a) not later than 3 years after the date of enactment of this Act.

(e) Progress report.—Not later than 2 years after the date of enactment of this Act, the Secretary shall submit to Congress a report on the progress made toward completing such harmonization.

(f) Definitions.—

(1) HUMAN SUBJECT REGULATIONS.—In this section:

(A) FDA HUMAN SUBJECT REGULATIONS.—The term “FDA Human Subject Regulations” means the provisions of parts 50, 56, 312, and 812 of title 21, Code of Federal Regulations (or any successor regulations).

(B) HHS HUMAN SUBJECT REGULATIONS.—The term “HHS Human Subject Regulations” means the provisions of subpart A of part 46 of title 45, Code of Federal Regulations (or any successor regulations).

(C) VULNERABLE POPULATION RULES.—The term “vulnerable population rules” means—

(i) except in the case of research described in clause (ii), the provisions of subparts B through D of part 46, Code of Federal Regulations (or any successor regulations); and

(ii) in the case of research that is subject to FDA Human Subject Regulations, the provisions applicable to vulnerable populations under part 56 of title 21, Code of Federal Regulations (or any successor regulations) and subpart D of part 50 of such title 21 (or any successor regulations).

(2) INSTITUTIONAL REVIEW BOARD DEFINED.—In this section, the term “institutional review board” has the meaning that applies to the term “institutional review board” under the HHS Human Subject Regulations.

SEC. 3024. Informed consent waiver or alteration for clinical investigations.

(a) Devices.—Section 520(g)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(g)(3)) is amended—

(1) in subparagraph (D), by striking “except where subject to such conditions as the Secretary may prescribe, the investigator” and inserting the following: “except where, subject to such conditions as the Secretary may prescribe—

“(i) the proposed clinical testing poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of the human subject; or

“(ii) the investigator”; and

(2) in the matter following subparagraph (D), by striking “subparagraph (D)” and inserting “subparagraph (D)(ii)”.

(b) Drugs.—Section 505(i)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)(4)) is amended by striking “except where it is not feasible or it is contrary to the best interests of such human beings” and inserting “except where it is not feasible, it is contrary to the best interests of such human beings, or the proposed clinical testing poses no more than minimal risk to such human beings and includes appropriate safeguards as prescribed to protect the rights, safety, and welfare of such human beings”.

SEC. 3031. Summary level review.

(a) FFDCA.—Section 505(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(c)) is amended by adding at the end the following:

“(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.”.

(b) PHSA.—Section 351(a)(2) of the Public Health Service Act (42 U.S.C. 262(a)(2)) is amended by adding at the end the following:

“(E)(i) 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 this subsection, if such supplemental application complies with the requirements of subparagraph (B) of section 505(c)(5) of the Federal Food, Drug, and Cosmetic Act.

“(ii) In this subparagraph, the terms ‘qualified indication’ and ‘qualified data summary’ have the meanings given such terms in section 505(c)(5) of the Federal Food, Drug, and Cosmetic Act.”.

SEC. 3032. Expanded access policy.

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

“SEC. 561A. Expanded access policy required for investigational drugs.

“(a) In general.—The manufacturer or distributor of one or more investigational drugs for the diagnosis, monitoring, or treatment of one or more serious diseases or conditions shall make available the policy of the manufacturer or distributor on evaluating and responding to requests submitted under section 561(b) for provision of such a drug.

“(b) Public availability of expanded access policy.—The policies under subsection (a) shall be made public and readily available, such as by posting such policies on a publicly available Internet website. Such policies may be generally applicable to all investigational drugs of such manufacturer or distributor.

“(c) Content of policy.—A policy described in subsection (a) shall include—

“(1) contact information for the manufacturer or distributor to facilitate communication about requests described in subsection (a);

“(2) procedures for making such requests;

“(3) the general criteria the manufacturer or distributor will use to evaluate such requests for individual patients, and for responses to such requests;

“(4) the length of time the manufacturer or distributor anticipates will be necessary to acknowledge receipt of such requests; and

“(5) a hyperlink or other reference to the clinical trial record containing information about the expanded access for such drug that is required under section 402(j)(2)(A)(ii)(II)(gg) of the Public Health Service Act.

“(d) No guarantee of access.—The posting of policies by manufacturers and distributors under subsection (a) shall not serve as a guarantee of access to any specific investigational drug by any individual patient.

“(e) Revised policy.—Nothing in this section shall prevent a manufacturer or distributor from revising a policy required under this section at any time.

“(f) Application.—This section shall apply to a manufacturer or distributor with respect to an investigational drug beginning on the later of—

“(1) the date that is 60 calendar days after the date of enactment of the 21st Century Cures Act; or

“(2) the first initiation of a phase 2 or phase 3 study (as such terms are defined in section 312.21(b) and (c) of title 21, Code of Federal Regulations (or any successor regulations)) with respect to such investigational drug.”.

SEC. 3033. Accelerated approval for regenerative advanced therapies.

(a) In general.—Section 506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356) is amended—

(1) by transferring subsection (e) (relating to construction) so that it appears before subsection (f) (relating to awareness efforts); and

(2) by adding at the end the following:

“(g) Regenerative advanced therapy.—

“(1) IN GENERAL.—The Secretary, at the request of the sponsor of a drug, shall facilitate an efficient development program for, and expedite review of, such drug if the drug qualifies as a regenerative advanced therapy under the criteria described in paragraph (2).

“(2) CRITERIA.—A drug is eligible for designation as a regenerative advanced therapy under this subsection if—

“(A) the drug is a regenerative medicine therapy (as defined in paragraph (8));

“(B) the drug is intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition; and

“(C) preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for such a disease or condition.

“(3) REQUEST FOR DESIGNATION.—The sponsor of a drug may request the Secretary to designate the drug as a regenerative advanced therapy concurrently with, or at any time after, submission of an application for the investigation of the drug under section 505(i) of this Act or section 351(a)(3) of the Public Health Service Act.

“(4) DESIGNATION.—Not later than 60 calendar days after the receipt of a request under paragraph (3), the Secretary shall determine whether the drug that is the subject of the request meets the criteria described in paragraph (2). If the Secretary determines that the drug meets the criteria, the Secretary shall designate the drug as a regenerative advanced therapy and shall take such actions as are appropriate under paragraph (1). If the Secretary determines that a drug does not meet the criteria for such designation, the Secretary shall include with the determination a written description of the rationale for such determination.

“(5) ACTIONS.—The sponsor of a regenerative advanced therapy shall be eligible for the actions to expedite development and review of such therapy under subsection (a)(3)(B), including early interactions to discuss any potential surrogate or intermediate endpoint to be used to support the accelerated approval of an application for the product under subsection (c).

“(6) ACCESS TO EXPEDITED APPROVAL PATHWAYS.—An application for a regenerative advanced therapy under section 505(b)(1) of this Act or section 351(a) of the Public Health Service Act may be—

“(A) eligible for priority review, 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(b) of the Prescription Drug User Fee Amendments of 2012; and

“(B) eligible for accelerated approval under subsection (c), as agreed upon pursuant to subsection (a)(3)(B), through, as appropriate—

“(i) surrogate or intermediate endpoints reasonably likely to predict long-term clinical benefit; or

“(ii) reliance upon data obtained from a meaningful number of sites, including through expansion to additional sites, as appropriate.

“(7) POSTAPPROVAL REQUIREMENTS.—The sponsor of a regenerative advanced therapy that is granted accelerated approval and is subject to the postapproval requirements under subsection (c) may, as appropriate, fulfill such requirements, as the Secretary may require, through—

“(A) the submission of clinical evidence, clinical studies, patient registries, or other sources of real world evidence, such as electronic health records;

“(B) the collection of larger confirmatory data sets, as agreed upon pursuant to subsection (a)(3)(B); or

“(C) postapproval monitoring of all patients treated with such therapy prior to approval of the therapy.

“(8) DEFINITION.—For purposes of this section, the term ‘regenerative medicine therapy’ includes cell therapy, therapeutic tissue engineering products, human cell and tissue products, and combination products using any such therapies or products, except for those regulated solely under section 361 of the Public Health Service Act and part 1271 of title 21, Code of Federal Regulations.”.

(b) Rule of construction.—Nothing in this section and the amendments made by this section shall be construed to alter the authority of the Secretary of Health and Human Services—

(1) to approve drugs pursuant to the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) and section 351 of the Public Health Service Act (42 U.S.C. 262) as authorized prior to the date of enactment of the 21st Century Cures Act, including the standards of evidence, and applicable conditions, for approval under such Acts; or

(2) to alter the authority of the Secretary to require postapproval studies pursuant to such Acts, as authorized prior to the date of enactment of the 21st Century Cures Act.

(c) Conforming amendment.—Section 506(e)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356(e)(1)) is amended by inserting “and the 21st Century Cures Act” after “Food and Drug Administration Safety and Innovation Act”.

SEC. 3034. Guidance regarding devices used in the recovery, isolation, or delivery of regenerative advanced therapies.

(a) Draft guidance.—Not later than 1 year after the date of enactment of the 21st Century Cures Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall issue draft guidance clarifying how, in the context of regenerative advanced therapies, the Secretary will evaluate devices used in the recovery, isolation, or delivery of regenerative advanced therapies. In doing so, the Secretary shall specifically address—

(1) how the Food and Drug Administration intends to simplify and streamline regulatory requirements for combination device and cell or tissue products;

(2) what, if any, intended uses or specific attributes would result in a device used with a regenerative therapy product to be classified as a class III device;

(3) when the Food and Drug Administration considers it is necessary, if ever, for the intended use of a device to be limited to a specific intended use with only one particular type of cell; and

(4) application of the least burdensome approach to demonstrate how a device may be used with more than one cell type.

(b) Final guidance.—Not later than 12 months after the close of the period for public comment on the draft guidance under subsection (a), the Secretary of Health and Human Services shall finalize such guidance.

SEC. 3035. Report on regenerative advanced therapies.

(a) Report to Congress.—Before March 1 of each calendar year, the Secretary of Health and Human Services shall, with respect to the previous calendar year, 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 on—

(1) the number and type of applications for approval of regenerative advanced therapies filed, approved or licensed as applicable, withdrawn, or denied; and

(2) how many of such applications or therapies, as applicable, were granted accelerated approval or priority review.

(b) Regenerative Advanced Therapy.—In this section, the term “regenerative advanced therapy” has the meaning given such term in section 506(g) of the Federal Food, Drug, and Cosmetic Act, as added by section 3033 of this Act.

SEC. 3036. Standards for regenerative medicine and regenerative advanced therapies.

Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after section 506F the following:

“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 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. 3037. Health care economic information.

Section 502(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(a)) is amended—

(1) by striking “(a) If its” and inserting “(a)(1) If its”;

(2) by striking “a formulary committee, or other similar entity, in the course of the committee or the entity carrying out its responsibilities for the selection of drugs for managed care or other similar organizations” and inserting “a payor, formulary committee, or other similar entity with knowledge and expertise in the area of health care economic analysis, carrying out its responsibilities for the selection of drugs for coverage or reimbursement”;

(3) by striking “directly relates” and inserting “relates”;

(4) by striking “and is based on competent and reliable scientific evidence. The requirements set forth in section 505(a) or in section 351(a) of the Public Health Service Act shall not apply to health care economic information provided to such a committee or entity in accordance with this paragraph” and inserting “, is based on competent and reliable scientific evidence, and includes, where applicable, a conspicuous and prominent statement describing any material differences between the health care economic information and the labeling approved for the drug under section 505 or under section 351 of the Public Health Service Act. The requirements set forth in section 505(a) or in subsections (a) and (k) of section 351 of the Public Health Service Act shall not apply to health care economic information provided to such a payor, committee, or entity in accordance with this paragraph”; and

(5) by striking “In this paragraph, the term” and all that follows and inserting the following:

“(2)(A) For purposes of this paragraph, the term ‘health care economic information’ means any analysis (including the clinical data, inputs, clinical or other assumptions, methods, results, and other components underlying or comprising the analysis) that identifies, measures, or describes the economic consequences, which may be based on the separate or aggregated clinical consequences of the represented health outcomes, of the use of a drug. Such analysis may be comparative to the use of another drug, to another health care intervention, or to no intervention.

“(B) Such term does not include any analysis that relates only to an indication that is not approved under section 505 or under section 351 of the Public Health Service Act for such drug.”.

SEC. 3038. Combination product innovation.

(a) In general.—Section 503(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(g)) is amended—

(1) by striking paragraph (3);

(2) by redesignating paragraph (2) as paragraph (7);

(3) by redesignating paragraphs (4) and (5) as paragraphs (8) and (9), respectively;

(4) by striking “(g)(1)” and all that follows through the end of paragraph (1) and inserting the following:

“(g)(1)(A) The Secretary shall, in accordance with this subsection, assign a primary agency center to regulate products that constitute a combination of a drug, device, or biological product.

“(B) The Secretary shall conduct the premarket review of any combination product under a single application, whenever appropriate.

“(C) For purposes of this subsection, the term ‘primary mode of action’ means the single mode of action of a combination product expected to make the greatest contribution to the overall intended therapeutic effects of the combination product.

“(D) The Secretary shall determine the primary mode of action of the combination product. If the Secretary determines that the primary mode of action is that of—

“(i) a drug (other than a biological product), the agency center charged with premarket review of drugs shall have primary jurisdiction;

“(ii) a device, the agency center charged with premarket review of devices shall have primary jurisdiction; or

“(iii) a biological product, the agency center charged with premarket review of biological products shall have primary jurisdiction.

“(E) In determining the primary mode of action of a combination product, the Secretary shall not determine that the primary mode of action is that of a drug or biological product solely because the combination product has any chemical action within or on the human body.

“(F) If a sponsor of a combination product disagrees with the determination under subparagraph (D)—

“(i) such sponsor may request, and the Secretary shall provide, a substantive rationale to such sponsor that references scientific evidence provided by the sponsor and any other scientific evidence relied upon by the Secretary to support such determination; and

“(ii)(I) the sponsor of the combination product may propose one or more studies (which may be nonclinical, clinical, or both) to establish the relevance, if any, of the chemical action in achieving the primary mode of action of such product;

“(II) if the sponsor proposes any such studies, the Secretary and the sponsor of such product shall collaborate and seek to reach agreement, within a reasonable time of such proposal, not to exceed 90 calendar days, on the design of such studies; and

“(III) if an agreement is reached under subclause (II) and the sponsor conducts one or more of such studies, the Secretary shall consider the data resulting from any such study when reevaluating the determination of the primary mode of action of such product, and unless and until such reevaluation has occurred and the Secretary issues a new determination, the determination of the Secretary under subparagraph (D) shall remain in effect.

“(2)(A)(i) To establish clarity and certainty for the sponsor, the sponsor of a combination product may request a meeting on such combination product. If the Secretary concludes that a determination of the primary mode of action pursuant to paragraph (1)(D) is necessary, the sponsor may request such meeting only after the Secretary makes such determination. If the sponsor submits a written meeting request, the Secretary shall, not later than 75 calendar days after receiving such request, meet with the sponsor of such combination product.

“(ii) A meeting under clause (i) may—

“(I) address the standards and requirements for market approval or clearance of the combination product;

“(II) address other issues relevant to such combination product, such as requirements related to postmarket modification of such combination product and good manufacturing practices applicable to such combination product; and

“(III) identify elements under subclauses (I) and (II) that may be more appropriate for discussion and agreement with the Secretary at a later date given that scientific or other information is not available, or agreement is otherwise not feasible regarding such elements, at the time a request for such meeting is made.

“(iii) Any agreement under this subparagraph shall be in writing and made part of the administrative record by the Secretary.

“(iv) Any such agreement shall remain in effect, except—

“(I) upon the written agreement of the Secretary and the sponsor or applicant; or

“(II) pursuant to a decision by the director of the reviewing division of the primary agency center, or a person more senior than such director, in consultation with consulting centers and the Office, as appropriate, that an issue essential to determining whether the standard for market clearance or other applicable standard under this Act or the Public Health Service Act applicable to the combination product has been identified since the agreement was reached, or that deviating from the agreement is otherwise justifiable based on scientific evidence, for public health reasons.

“(3) For purposes of conducting the premarket review of a combination product that contains an approved constituent part described in paragraph (4), the Secretary may require that the sponsor of such combination product submit to the Secretary only data or information that the Secretary determines is necessary to meet the standard for clearance or approval, as applicable, under this Act or the Public Health Service Act, including any incremental risks and benefits posed by such combination product, using a risk-based approach and taking into account any prior finding of safety and effectiveness or substantial equivalence for the approved constituent part relied upon by the applicant in accordance with paragraph (5).

“(4) For purposes of paragraph (3), an approved constituent part is—

“(A) a drug constituent part of a combination product being reviewed in a single application or request under section 515, 510(k), or 513(f)(2) (submitted in accordance with paragraph (5)), that is an approved drug, provided such application or request complies with paragraph (5);

“(B) a device constituent part approved under section 515 that is referenced by the sponsor and that is available for use by the Secretary under section 520(h)(4); or

“(C) any constituent part that was previously approved, cleared, or classified under section 505, 510(k), 513(f)(2), or 515 of this Act for which the sponsor has a right of reference or any constituent part that is a nonprescription drug, as defined in section 760(a)(2).

“(5)(A) If an application is submitted under section 515 or 510(k) or a request is submitted under section 513(f)(2), consistent with any determination made under paragraph (1)(D), for a combination product containing as a constituent part an approved drug—

“(i) the application or request shall include the certification or statement described in section 505(b)(2); and

“(ii) the applicant or requester shall provide notice as described in section 505(b)(3).

“(B) For purposes of this paragraph and paragraph (4), the term ‘approved drug’ means an active ingredient—

“(i) that was in an application previously approved under section 505(c);

“(ii) where such application is relied upon by the applicant submitting the application or request described in subparagraph (A);

“(iii) for which full reports of investigations that have been made to show whether such drug is safe for use and whether such drug is effective in use were not conducted by or for the applicant submitting the application or request described in subparagraph (A); and

“(iv) for which the applicant submitting the application or request described in subparagraph (A) has not obtained a right of reference or use from the person by or for whom the investigations described in clause (iii) were conducted.

“(C) The following provisions shall apply with respect to an application or request described in subparagraph (A) to the same extent and in the same manner as if such application or request were an application described in section 505(b)(2) that referenced the approved drug:

“(i) Subparagraphs (A), (B), (C), and (D) of section 505(c)(3).

“(ii) Clauses (ii), (iii), and (iv) of section 505(c)(3)(E).

“(iii) Subsections (b) and (c) of section 505A.

“(iv) Section 505E(a).

“(v) Section 527(a).

“(D) Notwithstanding any other provision of this subsection, an application or request for classification for a combination product described in subparagraph (A) shall be considered an application submitted under section 505(b)(2) for purposes of section 271(e)(2)(A) of title 35, United States Code.

“(6) Nothing in this subsection shall be construed as prohibiting a sponsor from submitting separate applications for the constituent parts of a combination product, unless the Secretary determines that a single application is necessary.”;

(5) in paragraph (8) (as redesignated by paragraph (3))—

(A) in subparagraph (C)—

(i) by amending clause (i) to read as follows:

“(i) In carrying out this subsection, the Office shall help to ensure timely and effective premarket review that involves more than one agency center by coordinating such reviews, overseeing the timeliness of such reviews, and overseeing the alignment of feedback regarding such reviews.”;

(ii) in clause (ii), by inserting “and alignment” after “the timeliness” each place it appears; and

(iii) by adding at the end the following new clauses:

“(iii) The Office shall ensure that, with respect to a combination product, a designated person or persons in the primary agency center is the primary point or points of contact for the sponsor of such combination product. The Office shall also coordinate communications to and from any consulting center involved in such premarket review, if requested by such primary agency center or any such consulting center. Agency communications and commitments, to the extent consistent with other provisions of law and the requirements of all affected agency centers, from the primary agency center shall be considered as communication from the Secretary on behalf of all agency centers involved in the review.

“(iv) The Office shall, with respect to the premarket review of a combination product—

“(I) ensure that any meeting between the Secretary and the sponsor of such product is attended by each agency center involved in the review, as appropriate;

“(II) ensure that each consulting agency center has completed its premarket review and provided the results of such review to the primary agency center in a timely manner; and

“(III) ensure that each consulting center follows the guidance described in clause (vi) and advises, as appropriate, on other relevant regulations, guidances, and policies.

“(v) In seeking agency action with respect to a combination product, the sponsor of such product—

“(I) shall identify the product as a combination product; and

“(II) may request in writing the participation of representatives of the Office in meetings related to such combination product, or to have the Office otherwise engage on such regulatory matters concerning the combination product.

“(vi) Not later than 4 years after the date of enactment of the 21st Century Cures Act, and after a public comment period of not less than 60 calendar days, the Secretary shall issue a final guidance that describes—

“(I) the structured process for managing pre-submission interactions with sponsors developing combination products;

“(II) the best practices for ensuring that the feedback in such pre-submission interactions represents the Agency’s best advice based on the information provided during such pre-submission interactions;

“(III) the information that is required to be submitted with a meeting request under paragraph (2), how such meetings relate to other types of meetings in the Food and Drug Administration, and the form and content of any agreement reached through a meeting under such paragraph (2);”; and

(B) in subparagraph (G)—

(i) in the matter preceding clause (i), by inserting “(except with respect to clause (iv), beginning not later than one year after the date of the enactment of the 21st Century Cures Act)” after “enactment of this paragraph”;

(ii) in clause (ii), by striking “and” at the end;

(iii) in clause (iii), by striking the period at the end and inserting “; and”; and

(iv) by adding at the end the following new clause:

“(iv) identifying the percentage of combination products for which a dispute resolution, with respect to premarket review, was requested by the combination product’s sponsor.”; and

(6) in paragraph (9) (as redesignated by paragraph (3))—

(A) in subparagraph (C)—

(i) in clause (i), by striking the comma at the end and inserting a semicolon;

(ii) in clause (ii), by striking “, and” at the end and inserting a semicolon;

(iii) in clause (iii), by striking the period at the end and inserting “; and”; and

(iv) by adding at the end the following:

“(iv) de novo classification under section 513(a)(1).”; and

(B) by adding at the end the following:

“(D) The terms ‘premarket review’ and ‘reviews’ include all activities of the Food and Drug Administration conducted prior to approval or clearance of an application, notification, or request for classification submitted under section 505, 510(k), 513(f)(2), 515, or 520 of this Act or under section 351 of the Public Health Service Act, including with respect to investigational use of the product.”.

(b) Information for approval of combination products.—Section 520(h)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(h)(4)) is amended—

(1) in subparagraph (A), by striking “Any information” and inserting “Subject to subparagraph (C), any information”; and

(2) by adding at the end the following new subparagraph:

“(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).”.

(c) Variations From CGMP Streamlined Approach.—Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this subsection as the “Secretary”) shall identify types of combination products and manufacturing processes with respect to which the Secretary proposes that good manufacturing processes may be adopted that vary from the requirements set forth in section 4.4 of title 21, Code of Federal Regulations (or any successor regulations) or that the Secretary proposes can satisfy the requirements in section 4.4 through alternative or streamlined mechanisms. The Secretary shall identify such types, variations from such requirements, and such mechanisms, in a proposed list published in the Federal Register. After a public comment period regarding the appropriate good manufacturing practices for such types, the Secretary shall publish a final list in the Federal Register, notwithstanding section 553 of title 5, United States Code. The Secretary shall evaluate such types, variations, and mechanisms using a risk-based approach. The Secretary shall periodically review such final list.

SEC. 3041. Antimicrobial resistance monitoring.

(a) In general.—Section 319E of the Public Health Service Act (42 U.S.C. 247d–5) is amended—

(1) by redesignating subsections (f) and (g) as subsections (l) and (m), respectively; and

(2) by inserting after subsection (e), the following:

“(f) Monitoring at Federal health care facilities.—The Secretary shall encourage reporting on aggregate antimicrobial drug use and antimicrobial resistance to antimicrobial drugs and the implementation of antimicrobial stewardship programs by health care facilities of the Department of Defense, the Department of Veterans Affairs, and the Indian Health Service and shall provide technical assistance to the Secretary of Defense and the Secretary of Veterans Affairs, as appropriate and upon request.

“(g) Report on antimicrobial resistance in humans and use of antimicrobial drugs.—Not later than 1 year after the date of enactment of the 21st Century Cures Act, and annually thereafter, the Secretary shall prepare and make publicly available data and information concerning—

“(1) aggregate national and regional trends of antimicrobial resistance in humans to antimicrobial drugs, including such drugs approved under section 506(h) of the Federal Food, Drug, and Cosmetic Act;

“(2) antimicrobial stewardship, which may include summaries of State efforts to address antimicrobial resistance in humans to antimicrobial drugs and antimicrobial stewardship; and

“(3) coordination between the Director of the Centers for Disease Control and Prevention and the Commissioner of Food and Drugs with respect to the monitoring of—

“(A) any applicable resistance under paragraph (1); and

“(B) drugs approved under section 506(h) of the Federal Food, Drug, and Cosmetic Act.

“(h) Information related to antimicrobial stewardship programs.—The Secretary shall, as appropriate, disseminate guidance, educational materials, or other appropriate materials related to the development and implementation of evidence-based antimicrobial stewardship programs or practices at health care facilities, such as nursing homes and other long-term care facilities, ambulatory surgical centers, dialysis centers, outpatient clinics, and hospitals, including community and rural hospitals.

“(i) Supporting state-Based activities To combat antimicrobial resistance.—The Secretary shall continue to work with State and local public health departments on statewide or regional programs related to antimicrobial resistance. Such efforts may include activities to related to—

“(1) identifying patterns of bacterial and fungal resistance in humans to antimicrobial drugs;

“(2) preventing the spread of bacterial and fungal infections that are resistant to antimicrobial drugs; and

“(3) promoting antimicrobial stewardship.

“(j) Antimicrobial Resistance and Stewardship activities.—

“(1) IN GENERAL.—For the purposes of supporting stewardship activities, examining changes in antimicrobial resistance, and evaluating the effectiveness of section 506(h) of the Federal Food, Drug, and Cosmetic Act, the Secretary shall—

“(A) provide a mechanism for facilities to report data related to their antimicrobial stewardship activities (including analyzing the outcomes of such activities); and

“(B) evaluate—

“(i) antimicrobial resistance data using a standardized approach; and

“(ii) trends in the utilization of drugs approved under such section 506(h) with respect to patient populations.

“(2) USE OF SYSTEMS.—The Secretary shall use available systems, including the National Healthcare Safety Network or other systems identified by the Secretary, to fulfill the requirements or conduct activities under this section.

“(k) Antimicrobial.—For purposes of subsections (f) through (j), the term ‘antimicrobial’ includes any antibacterial or antifungal drugs, and may include drugs that eliminate or inhibit the growth of other microorganisms, as appropriate.”.

(b) Availability of data.—The Secretary shall make the data collected pursuant to this subsection public. Nothing in this subsection shall be construed as authorizing the Secretary to disclose any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code.

SEC. 3042. Limited population pathway.

Section 506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356), as amended by section 3033, is further amended by adding at the end the following:

“(h) Limited population pathway for antibacterial and antifungal drugs.—

“(1) IN GENERAL.—The Secretary may approve an antibacterial or antifungal drug, alone or in combination with one or more other drugs, as a limited population drug pursuant to this subsection only if—

“(A) the drug is intended to treat a serious or life-threatening infection in a limited population of patients with unmet needs;

“(B) the standards for approval under section 505(c) and (d), or the standards for licensure under section 351 of the Public Health Service Act, as applicable, are met; and

“(C) the Secretary receives a written request from the sponsor to approve the drug as a limited population drug pursuant to this subsection.

“(2) BENEFIT-RISK CONSIDERATION.—The Secretary’s determination of safety and effectiveness of an antibacterial or antifungal drug shall reflect the benefit-risk profile of such drug in the intended limited population, taking into account the severity, rarity, or prevalence of the infection the drug is intended to treat and the availability or lack of alternative treatment in such limited population. Such drug may be approved under this subsection notwithstanding a lack of evidence to fully establish a favorable benefit-risk profile in a population that is broader than the intended limited population.

“(3) ADDITIONAL REQUIREMENTS.—A drug approved under this subsection shall be subject to the following requirements, in addition to any other applicable requirements of this Act:

“(A) LABELING.—To indicate that the safety and effectiveness of a drug approved under this subsection has been demonstrated only with respect to a limited population—

“(i) all labeling and advertising of an antibacterial or antifungal drug approved under this subsection shall contain the statement ‘Limited Population’ in a prominent manner and adjacent to, and not more prominent than—

“(I) the proprietary name of such drug, if any; or

“(II) if there is no proprietary name, the established name of the drug, if any, as defined in section 503(e)(3), or, in the case of a drug that is a biological product, the proper name, as defined by regulation; and

“(ii) the prescribing information for the drug required by section 201.57 of title 21, Code of Federal Regulations (or any successor regulation) shall also include the following statement: ‘This drug is indicated for use in a limited and specific population of patients.’.

“(B) PROMOTIONAL MATERIAL.—The sponsor of an antibacterial or antifungal drug subject to this subsection shall submit to the Secretary copies of all promotional materials related to such drug at least 30 calendar days prior to dissemination of the materials.

“(4) OTHER PROGRAMS.—A sponsor of a drug that seeks approval of a drug under this subsection may also seek designation or approval, as applicable, of such drug under other applicable sections or subsections of this Act or the Public Health Service Act.

“(5) GUIDANCE.—Not later than 18 months after the date of enactment of the 21st Century Cures Act, the Secretary shall issue draft guidance describing criteria, processes, and other general considerations for demonstrating the safety and effectiveness of limited population antibacterial and antifungal drugs. The Secretary shall publish final guidance within 18 months of the close of the public comment period on such draft guidance. The Secretary may approve antibacterial and antifungal drugs under this subsection prior to issuing guidance under this paragraph.

“(6) ADVICE.—The Secretary shall provide prompt advice to the sponsor of a drug for which the sponsor seeks approval under this subsection to enable the sponsor to plan a development program to obtain the necessary data for such approval, and to conduct any additional studies that would be required to gain approval of such drug for use in a broader population.

“(7) TERMINATION OF LIMITATIONS.—If, after approval of a drug under this subsection, the Secretary approves a broader indication for such drug under section 505(b) or section 351(a) of the Public Health Service Act, the Secretary may remove any postmarketing conditions, including requirements with respect to labeling and review of promotional materials under paragraph (3), applicable to the approval of the drug under this subsection.

“(8) RULES OF CONSTRUCTION.—Nothing in this subsection shall be construed to alter the authority of the Secretary to approve drugs pursuant to this Act or section 351 of the Public Health Service Act, including the standards of evidence and applicable conditions for approval under such Acts, the standards of approval of a drug under such Acts, or to alter the authority of the Secretary to monitor drugs pursuant to such Acts.

“(9) REPORTING AND ACCOUNTABILITY.—

“(A) BIENNIAL REPORTING.—The Secretary shall report to Congress not less often than once every 2 years on the number of requests for approval, and the number of approvals, of an antibacterial or antifungal drug under this subsection.

“(B) GAO REPORT.—Not later than December 2021, the Comptroller General of the United States shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor and Pensions of the Senate a report on the coordination of activities required under section 319E of the Public Health Service Act. Such report shall include a review of such activities, and the extent to which the use of the pathway established under this subsection has streamlined premarket approval for antibacterial or antifungal drugs for limited populations, if such pathway has functioned as intended, if such pathway has helped provide for safe and effective treatment for patients, if such premarket approval would be appropriate for other categories of drugs, and if the authorities under this subsection have affected antibacterial or antifungal resistance.”.

SEC. 3043. Prescribing authority.

Nothing in this subtitle, or an amendment made by this subtitle, shall be construed to restrict the prescribing of antimicrobial drugs or other products, including drugs approved under subsection (h) of section 506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356) (as added by section 3042), by health care professionals, or to limit the practice of health care.

SEC. 3044. Susceptibility test interpretive criteria for microorganisms; antimicrobial susceptibility testing devices.

(a) In general.—Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after section 511 the following:

“SEC. 511A. Susceptibility test interpretive criteria for microorganisms.

“(a) Purpose; Identification of criteria.—

“(1) PURPOSE.—The purpose of this section is to clarify the Secretary’s authority to—

“(A) efficiently update susceptibility test interpretive criteria for antimicrobial drugs when necessary for public health, due to, among other things, the constant evolution of microorganisms that leads to the development of resistance to drugs that have been effective in decreasing morbidity and mortality for patients, which warrants unique management of antimicrobial drugs that is inappropriate for most other drugs in order to delay or prevent the development of further resistance to existing therapies;

“(B) provide for public notice of the availability of recognized interpretive criteria and interpretive criteria standards; and

“(C) clear under section 510(k), classify under section 513(f)(2), or approve under section 515, antimicrobial susceptibility testing devices utilizing updated, recognized susceptibility test interpretive criteria to characterize the in vitro susceptibility of particular bacteria, fungi, or other microorganisms, as applicable, to antimicrobial drugs.

“(2) IDENTIFICATION OF CRITERIA.—The Secretary shall identify appropriate susceptibility test interpretive criteria with respect to antimicrobial drugs—

“(A) if such criteria are available on the date of approval of the drug under section 505 of this Act or licensure of the drug under section 351 of the Public Health Service Act (as applicable), upon such approval or licensure; or

“(B) if such criteria are unavailable on such date, on the date on which such criteria are available for such drug.

“(3) BASES FOR INITIAL IDENTIFICATION.—The Secretary shall identify appropriate susceptibility test interpretive criteria under paragraph (2), based on the Secretary’s review of, to the extent available and relevant—

“(A) preclinical and clinical data, including pharmacokinetic, pharmacodynamic, and epidemiological data;

“(B) the relationship of susceptibility test interpretive criteria to morbidity and mortality associated with the disease or condition for which such drug is used; and

“(C) such other evidence and information as the Secretary considers appropriate.

“(b) Susceptibility test Interpretive Criteria Website.—

“(1) IN GENERAL.—Not later than 1 year after the date of the enactment of the 21st Century Cures Act, the Secretary shall establish, and maintain thereafter, on the website of the Food and Drug Administration, a dedicated website that contains a list of any appropriate new or updated susceptibility test interpretive criteria standards and interpretive criteria in accordance with paragraph (2) (referred to in this section as the ‘Interpretive Criteria Website’).

“(2) LISTING OF SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA STANDARDS AND INTERPRETIVE CRITERIA.—

“(A) IN GENERAL.—The list described in paragraph (1) shall consist of any new or updated susceptibility test interpretive criteria standards that are—

“(i) established by a nationally or internationally recognized standard development organization that—

“(I) establishes and maintains procedures to address potential conflicts of interest and ensure transparent decisionmaking;

“(II) holds open meetings to ensure that there is an opportunity for public input by interested parties, and establishes and maintains processes to ensure that such input is considered in decisionmaking; and

“(III) permits its standards to be made publicly available, through the National Library of Medicine or another similar source acceptable to the Secretary; and

“(ii) recognized in whole, or in part, by the Secretary under subsection (c).

“(B) OTHER LIST.—The Interpretive Criteria Website shall, in addition to the list described in subparagraph (A), include a list of interpretive criteria, if any, that the Secretary has determined to be appropriate with respect to legally marketed antimicrobial drugs, where—

“(i) the Secretary does not recognize, in whole or in part, an interpretive criteria standard described under subparagraph (A) otherwise applicable to such a drug;

“(ii) the Secretary withdraws under subsection (c)(1)(A) recognition of a standard, in whole or in part, otherwise applicable to such a drug;

“(iii) the Secretary approves an application under section 505 of this Act or section 351 of the Public Health Service Act, as applicable, with respect to marketing of such a drug for which there are no relevant interpretive criteria included in a standard recognized by the Secretary under subsection (c); or

“(iv) because the characteristics of such a drug differ from other drugs with the same active ingredient, the interpretive criteria with respect to such drug—

“(I) differ from otherwise applicable interpretive criteria included in a standard listed under subparagraph (A) or interpretive criteria otherwise listed under this subparagraph; and

“(II) are determined by the Secretary to be appropriate for the drug.

“(C) REQUIRED STATEMENTS.—The Interpretive Criteria Website shall include statements conveying—

“(i) that the website provides information about the in vitro susceptibility of bacteria, fungi, or other microorganisms, as applicable to a certain drug (or drugs);

“(ii) that—

“(I) the safety and efficacy of such drugs in treating clinical infections due to such bacteria, fungi, or other microorganisms, as applicable, may or may not have been established in adequate and well-controlled clinical trials in order for the susceptibility information described in clause (i) to be included on the website; and

“(II) the clinical significance of such susceptibility information in such instances is unknown;

“(iii) that the approved product labeling for specific drugs provides the uses for which the Secretary has approved the product; and

“(iv) any other information that the Secretary determines appropriate to adequately convey the meaning of the data supporting the recognition or listing of susceptibility test interpretive criteria standards or susceptibility test interpretive criteria included on the website.

“(3) NOTICE.—Not later than the date on which the Interpretive Criteria Website is established, the Secretary shall publish a notice of that establishment in the Federal Register.

“(4) INAPPLICABILITY OF MISBRANDING PROVISION.—The inclusion in the approved labeling of an antimicrobial drug of a reference or hyperlink to the Interpretive Criteria Website, in and of itself, shall not cause the drug to be misbranded in violation of section 502.

“(5) TRADE SECRETS AND CONFIDENTIAL INFORMATION.—Nothing in this section shall be construed as authorizing the Secretary to disclose any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5, United States Code.

“(c) Recognition of susceptibility test interpretive criteria.—

“(1) EVALUATION AND PUBLICATION.—

“(A) IN GENERAL.—Beginning on the date of the establishment of the Interpretive Criteria Website, and at least every 6 months thereafter, the Secretary shall—

“(i) evaluate any appropriate new or updated susceptibility test interpretive criteria standards established by a nationally or internationally recognized standard development organization described in subsection (b)(2)(A)(i); and

“(ii) publish on the public website of the Food and Drug Administration a notice

“(I) withdrawing recognition of any different susceptibility test interpretive criteria standard, in whole or in part;

“(II) recognizing the new or updated standards;

“(III) recognizing one or more parts of the new or updated interpretive criteria specified in such a standard and declining to recognize the remainder of such standard; and

“(IV) making any necessary updates to the lists under subsection (b)(2).

“(B) UPON APPROVAL OF A DRUG.—Upon the approval of an initial or supplemental application for an antimicrobial drug under section 505 of this Act or section 351 of the Public Health Service Act, as applicable, where such approval is based on susceptibility test interpretive criteria which differ from those contained in a standard recognized, or from those otherwise listed, by the Secretary pursuant to this subsection, or for which there are no relevant interpretive criteria standards recognized, or interpretive criteria otherwise listed, by the Secretary pursuant to this subsection, the Secretary shall update the lists under subparagraphs (A) and (B) of subsection (b)(2) to include the susceptibility test interpretive criteria upon which such approval was based.

“(2) BASES FOR UPDATING INTERPRETIVE CRITERIA STANDARDS.—In evaluating new or updated susceptibility test interpretive criteria standards under paragraph (1)(A), the Secretary may consider—

“(A) the Secretary’s determination that such a standard is not applicable to a particular drug because the characteristics of the drug differ from other drugs with the same active ingredient;

“(B) information provided by interested third parties, including public comment on the annual compilation of notices published under paragraph (3);

“(C) any bases used to identify susceptibility test interpretive criteria under subsection (a)(2); and

“(D) such other information or factors as the Secretary determines appropriate.

“(3) ANNUAL COMPILATION OF NOTICES.—Each year, the Secretary shall compile the notices published under paragraph (1)(A) and publish such compilation in the Federal Register and provide for public comment. If the Secretary receives comments, the Secretary shall review such comments and, if the Secretary determines appropriate, update pursuant to this subsection susceptibility test interpretive criteria standards or criteria—

“(A) recognized by the Secretary under this subsection; or

“(B) otherwise listed on the Interpretive Criteria Website under subsection (b)(2).

“(4) RELATION TO SECTION 514(c).—Any susceptibility test interpretive standard recognized under this subsection or any criteria otherwise listed under subsection (b)(2)(B) shall be deemed to be recognized as a standard by the Secretary under section 514(c)(1).

“(5) VOLUNTARY USE OF INTERPRETIVE CRITERIA.—Nothing in this section prohibits a person from seeking approval or clearance of a drug or device, or changes to the drug or the device, on the basis of susceptibility test interpretive criteria which differ from those contained in a standard recognized, or from those otherwise listed, by the Secretary pursuant to subsection (b)(2).

“(d) Antimicrobial drug labeling.—

“(1) DRUGS MARKETED PRIOR TO ESTABLISHMENT OF INTERPRETIVE CRITERIA WEBSITE.—

“(A) IN GENERAL.—With respect to an antimicrobial drug lawfully introduced or delivered for introduction into interstate commerce for commercial distribution before the establishment of the Interpretive Criteria Website, a holder of an approved application under section 505 of this Act or section 351 of the Public Health Service Act, as applicable, for each such drug, not later than 1 year after establishment of the Interpretive Criteria Website described in subsection (b)(1), shall remove susceptibility test interpretive criteria, if any, and related information from the approved drug labeling and replace it with a reference to the Interpretive Criteria Website.

“(B) LABELING CHANGES.—The labeling changes required by this section shall be considered a minor change under section 314.70 of title 21, Code of Federal Regulations (or any successor regulations) that may be implemented through documentation in the next applicable annual report.

“(2) DRUGS MARKETED SUBSEQUENT TO ESTABLISHMENT OF INTERPRETIVE CRITERIA WEBSITE.—With respect to antimicrobial drugs approved on or after the date of the establishment of the Interpretive Criteria Website described in subsection (b)(1), the labeling for such a drug shall include, in lieu of susceptibility test interpretive criteria and related information, a reference to such Website.

“(e) Special condition for marketing of antimicrobial susceptibility testing devices.—

“(1) IN GENERAL.—Notwithstanding sections 501, 502, 505, 510, 513, and 515, if the conditions specified in paragraph (2) are met (in addition to other applicable provisions under this chapter) with respect to an antimicrobial susceptibility testing device described in subsection (f)(1), the Secretary may authorize the marketing of such device for a use described in such subsection.

“(2) CONDITIONS APPLICABLE TO ANTIMICROBIAL SUSCEPTIBILITY TESTING DEVICES.—The conditions specified in this paragraph are the following:

“(A) The device is used to make a determination of susceptibility using susceptibility test interpretive criteria that are—

“(i) included in a standard recognized by the Secretary under subsection (c); or

“(ii) otherwise listed on the Interpretive Criteria Website under subsection (b)(2).

“(B) The labeling of such device includes statements conveying—

“(i) that the device provides information about the in vitro susceptibility of bacteria, fungi, or other microorganisms, as applicable to antimicrobial drugs;

“(ii) that—

“(I) the safety and efficacy of such drugs in treating clinical infections due to such bacteria, fungi, or other microorganisms, as applicable, may or may not have been established in adequate and well-controlled clinical trials in order for the device to report the susceptibility of such bacteria, fungi, or other microorganisms, as applicable, to such drugs; and

“(II) the clinical significance of such susceptibility information in those instances is unknown;

“(iii) that the approved labeling for drugs tested using such a device provides the uses for which the Secretary has approved such drugs; and

“(iv) any other information the Secretary determines appropriate to adequately convey the meaning of the data supporting the recognition or listing of susceptibility test interpretive criteria standards or susceptibility test interpretive criteria described in subparagraph (A).

“(C) The antimicrobial susceptibility testing device meets all other requirements to be cleared under section 510(k), classified under section 513(f)(2), or approved under section 515.

“(f) Definitions.—In this section:

“(1) The term ‘antimicrobial susceptibility testing device’ means a device that utilizes susceptibility test interpretive criteria to determine and report the in vitro susceptibility of certain microorganisms to a drug (or drugs).

“(2) The term ‘qualified infectious disease product’ means a qualified infectious disease product designated under section 505E(d).

“(3) The term ‘susceptibility test interpretive criteria’ means—

“(A) one or more specific numerical values which characterize the susceptibility of bacteria or other microorganisms to the drug tested; and

“(B) related categorizations of such susceptibility, including categorization of the drug as susceptible, intermediate, resistant, or such other term as the Secretary determines appropriate.

“(4)(A) The term ‘antimicrobial drug’ means, subject to subparagraph (B), a systemic antibacterial or antifungal drug that—

“(i) is intended for human use in the treatment of a disease or condition caused by a bacterium or fungus;

“(ii) may include a qualified infectious disease product designated under section 505E(d); and

“(iii) is subject to section 503(b)(1).

“(B) If provided by the Secretary through regulations, such term may include—

“(i) drugs other than systemic antibacterial and antifungal drugs; and

“(ii) biological products (as such term is defined in section 351 of the Public Health Service Act) to the extent such products exhibit antimicrobial activity.

“(5) The term ‘interpretive criteria standard’ means a compilation of susceptibility test interpretive criteria developed by a standard development organization that meets the criteria set forth in subsection (b)(2)(A)(i).

“(g) Rule of construction.—Nothing in this section shall be construed to—

“(1) alter the standards of evidence under subsection (c) or (d) of section 505 (including the substantial evidence standard under section 505(d)) or under section 351 of the Public Health Service Act (as applicable); or

“(2) with respect to clearing devices under section 510(k), classifying devices under section 513(f)(2), or approving devices under section 515—

“(A) apply with respect to any drug, device, or biological product, in any context other than an antimicrobial drug and an antimicrobial susceptibility testing device that uses susceptibility test interpretive criteria to characterize and report the susceptibility of certain bacteria, fungi, or other microorganisms, as applicable, to such drug to reflect patient morbidity and mortality in accordance with this section; or

“(B) unless specifically stated, have any effect on authorities provided under other sections of this Act, including any regulations issued under such sections.”.

(b) Conforming amendments.—

(1) REPEAL OF PRIOR RELATED AUTHORITY.—Section 1111 of the Food and Drug Administration Amendments Act of 2007 (42 U.S.C. 247d–5a), relating to identification of clinically susceptible concentrations of antimicrobials, is repealed.

(2) ADDITION TO CATEGORIES OF MISBRANDED DRUGS.—Section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amended by adding at the end the following:

“(dd) If it is an antimicrobial drug, as defined in section 511A(f), and its labeling fails to conform with the requirements under section 511A(d).”.

(3) RECOGNITION OF INTERPRETIVE CRITERIA STANDARD AS DEVICE STANDARD.—Section 514(c)(1)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360d(c)(1)(A)) is amended by inserting after “the Secretary shall, by publication in the Federal Register” the following: “(or, with respect to a susceptibility test interpretive criteria standard under section 511A, by posting on the Interpretive Criteria Website in accordance with such section)”.

(c) Report to congress.—Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on the progress made in implementing section 511A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360a), as added by subsection (a).

(d) Requests for updates to Interpretive Criteria Website.—Chapter 35 of title 44, United States Code, shall not apply to the collection of information from interested parties regarding updating the lists established under section 511A(b) of the Federal Food, Drug, and Cosmetic Act and posted on the Interpretive Criteria Website established under section 511A(c) of such Act.

SEC. 3051. Breakthrough devices.

(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 515B, as added by section 3034(b), the following:

“SEC. 515C. 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.

“(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.”.

(b) Documentation and review of significant decisions.—Section 517A(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360g–1(a)(1)) is amended by inserting “a request for designation under section 515C,” after “application under section 515,”.

(c) Termination of previous program.—

(1) IN GENERAL.—Section 515(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(d)) is amended—

(A) by striking paragraph (5); and

(B) by redesignating paragraph (6) as paragraph (5).

(2) CONFORMING AMENDMENT.—Section 737(5) of the Federal Food, Drug, and Cosmetics Act (21 U.S.C. 379i(5)) is amended by striking “515(d)(6)” and inserting “515(d)(5)”.

(d) Report.—On January 1, 2019, the Secretary of Health and Human Services shall issue 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) on the program under section 515C of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), in bringing safe and effective devices included in such program to patients as soon as possible; and

(2) that includes recommendations, if any, to strengthen the program to better meet patient device needs in a manner as timely as possible.

SEC. 3052. Humanitarian device exemption.

(a) In general.—Section 520(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j) is amended—

(1) in paragraph (1) by striking “fewer than 4,000” and inserting “not more than 8,000”;

(2) in paragraph (2)(A) by striking “fewer than 4,000” and inserting “not more than 8,000”; and

(3) in paragraph (6)(A)(ii), by striking “4,000” and inserting “8,000”.

(b) Guidance document on probable benefit.—Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall publish a draft guidance that defines the criteria for establishing “probable benefit” as that term is used in section 520(m)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)(2)(C)).

SEC. 3053. Recognition of standards.

(a) In general.—Section 514(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360d(c)) is amended—

(1) in paragraph (1), by inserting after subparagraph (B) the following new subparagraphs:

“(C)(i) Any person may submit a request for recognition under subparagraph (A) of all or part of an appropriate standard established by a nationally or internationally recognized standard organization.

“(ii) Not later than 60 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.”; and

(2) by adding at the end the following:

“(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.”.

(b) Guidance.—The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall review and update, if necessary, previously published guidance and standard operating procedures identifying the principles for recognizing standards, and for withdrawing the recognition of standards, under section 514(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360d(c)), taking into account the experience with and reliance on a standard by foreign regulatory authorities and the device industry, and whether recognition of a standard will promote harmonization among regulatory authorities in the regulation of devices.

SEC. 3054. Certain class I and class II devices.

(a) Class i devices.—Section 510(l) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(l)) is amended—

(1) by striking “A report under subsection (k)” and inserting “(1) A report under subsection (k)”; and

(2) by adding at the end the following new paragraph:

“(2) Not later than 120 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.”.

(b) Class II devices.—Section 510(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(m)) is amended—

(1) by striking “(m)(1)” and all that follows through “by the Secretary.” and inserting the following:

“(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).”; and

(2) in paragraph (2)—

(A) by striking “1 day after the date of publication of a list under this subsection,” and inserting “1 calendar day after the date of publication of the final list under paragraph (1)(B),”; and

(B) by striking “30-day period” and inserting “60-calendar-day period”; and

(C) by adding at the end the following new paragraph:

“(3) Upon the publication of the final list under paragraph (1)(B)—

“(A) each type of class II device so listed shall be exempt from the requirement for a report under subsection (k); and

“(B) the classification regulation applicable to each such type of device shall be deemed amended to incorporate such exemption.”.

SEC. 3055. Classification panels.

(a) Classification panels.—Paragraph (5) of section 513(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(b)) is amended—

(1) by striking “(5)” and inserting “(5)(A)”; and

(2) by adding at the end the following:

“(B) When a device is specifically the subject of review by a classification panel, the Secretary shall—

“(i) ensure that adequate expertise is represented on the classification panel to assess—

“(I) the disease or condition which the device is intended to cure, treat, mitigate, prevent, or diagnose; and

“(II) the technology of the device; and

“(ii) 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 to provide recommendations for individuals with appropriate expertise to fill voting member positions on classification panels.”.

(b) Panel review process.—Section 513(b)(6) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(b)(6)) is amended—

(1) in subparagraph (A)(iii), by inserting before the period at the end “, including, 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”; and

(2) by striking subparagraph (B) and inserting the following new subparagraph:

“(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.”.

SEC. 3056. Institutional review board flexibility.

Section 520 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j) is amended—

(1) in subsection (g)(3)—

(A) in subparagraph (A)(i)—

(i) by striking “local”; and

(ii) by striking “which has been”; and

(B) in subparagraph (B), by striking “a local institutional” and inserting “an institutional”; and

(2) in subsection (m)(4)—

(A) by striking subparagraph (A) and inserting the following:

“(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) in subparagraph (B), by striking “a local institutional” and inserting “an institutional”; and

(C) in the matter following subparagraph (B), by striking “local”.

SEC. 3057. CLIA waiver improvements.

(a) Draft revised guidance.—Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall publish a draft guidance that—

(1) revises “Section V. Demonstrating Insignificant Risk of an Erroneous Result – Accuracy” of the guidance entitled “Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices” and dated January 30, 2008; and

(2) includes the appropriate use of comparable performance between a waived user and a moderately complex laboratory user to demonstrate accuracy.

(b) Final revised guidance.—The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall finalize the draft guidance published under subsection (a) not later than 1 year after the comment period for such draft guidance closes.

SEC. 3058. Least burdensome device review.

(a) In general.—Section 513 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c) is amended by adding at the end the following:

“(j) Training and oversight 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.”.

(b) Premarket applications.—Section 515(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(c)) is amended by adding at the end the following:

“(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.”.

(c) Rationale for significant decisions regarding devices.—Section 517A(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360g–1(a)) is amended by adding at the end the following:

“(3) APPLICATION OF LEAST BURDENSOME REQUIREMENTS.—The substantive summary required under this subsection shall include a brief statement regarding how the least burdensome requirements were considered and applied consistent with section 513(i)(1)(D), section 513(a)(3)(D), and section 515(c)(5), as applicable.”.

SEC. 3059. Cleaning instructions and validation data requirement.

(a) In general.—Section 510 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360) is amended by adding at the end the following:

“(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.”.

(b) Device modifications.—The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall issue final guidance regarding when a premarket notification under section 510(k) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(k)) is required to be submitted for a modification or change to a legally marketed device. Such final guidance shall be issued not later than 1 year after the date on which the comment period closes for the draft guidance on such subject.

SEC. 3060. Clarifying medical software regulation.

(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:

“(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).”.

(b) Reports.—The Secretary of Health and Human Services (referred to in this subsection as the “Secretary”), after consultation with agencies and offices of the Department of Health and Human Services involved in health information technology, shall publish a report, not later than 2 years after the date of enactment of this Act and every 2 years thereafter, that—

(1) includes input from outside experts, such as representatives of patients, consumers, health care providers, startup companies, health plans or other third-party payers, venture capital investors, information technology vendors, health information technology vendors, small businesses, purchasers, employers, and other stakeholders with relevant expertise, as determined by the Secretary;

(2) examines information available to the Secretary on any risks and benefits to health associated with software functions described in section 520(o)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j) (as amended by subsection (a)); and

(3) summarizes findings regarding the impact of such software functions on patient safety, including best practices to promote safety, education, and competency related to such functions.

(c) Classification of accessories.—Section 513(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(b)) is amended by adding at the end the following:

“(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.”.

(d) Conforming amendment.—Section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h)) is amended by adding at the end the following: “The term ‘device’ does not include software functions excluded pursuant to section 520(o).”.

SEC. 3071. Silvio O. Conte Senior Biomedical Research and Biomedical Product Assessment Service.

(a) Hiring and retention authority.—Section 228 of the Public Health Service Act (42 U.S.C. 237) is amended—

(1) in the section heading, by inserting “and Biomedical Product Assessment” after “Research”;

(2) in subsection (a)—

(A) in paragraph (1), by striking “Silvio O. Conte Senior Biomedical Research Service, not to exceed 500 members” and inserting “Silvio O. Conte Senior Biomedical Research and Biomedical Product Assessment Service (in this section referred to as the ‘Service’), not to exceed 2,000 members, the purpose of which is to recruit and retain outstanding and qualified scientific and technical experts in the fields of biomedical research, clinical research evaluation, and biomedical product assessment”;

(B) by amending paragraph (2) to read as follows:

“(2) The authority established in paragraph (1) may not be construed to require the Secretary to reduce the number of employees serving under any other employment system in order to offset the number of members serving in the Service.”; and

(C) by adding at the end the following:

“(3) The Secretary shall assign experts under this section to agencies within the Department of Health and Human Services taking into account the need for the expertise of such expert.”;

(3) in subsection (b)—

(A) in the matter preceding paragraph (1), by striking “or clinical research evaluation” and inserting “, clinical research evaluation, or biomedical product assessment”; and

(B) in paragraph (1), by inserting “or a doctoral or master's level degree in engineering, bioinformatics, or a related or emerging field,” after the comma;

(4) in subsection (d)(2), by striking “and shall not exceed the rate payable for level I of the Executive Schedule unless approved by the President under section 5377(d)(2) of title 5, United States Code” and inserting “and shall not exceed the amount of annual compensation (excluding expenses) specified in section 102 of title 3, United States Code”;

(5) by striking subsection (e); and

(6) by redesignating subsections (f) and (g) as subsections (e) and (f), respectively.

(b) GAO study.—

(1) IN GENERAL.—The Comptroller General of the United States shall conduct a study of the effectiveness of the amendments to section 228 of the Public Health Service Act (42 U.S.C. 237) made by subsection (a) and the impact of such amendments, if any, on all agencies or departments of the Department of Health and Human Services, and, not later than 4 years after the date of enactment of this Act, shall submit a report based on such study to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives.

(2) CONTENT OF STUDY AND REPORT.—The study and report under paragraph (1) shall include an examination of the extent to which recruitment and retention of outstanding and qualified scientific, medical, or technical experts in the fields of biomedical research, clinical research evaluation, and biomedical product assessment have improved or otherwise have been affected by the amendments to section 228 of the Public Health Service Act (42 U.S.C. 237) made by subsection (a), including by determining, during the period between the date of enactment of this Act and the completion of the study—

(A) the total number of members recruited and retained under the Senior Biomedical Research and Biomedical Product Assessment Service under such section 228, and the effect of increasing the number of members eligible for such Service;

(B) the number of members of such Senior Biomedical Research and Biomedical Product Assessment Service hired with a doctoral level degree in biomedicine or a related field, and the number of such members hired with a doctoral or master's level degree in engineering, bioinformatics, or a related or emerging field; and

(C) the number of Senior Biomedical Research and Biomedical Product Assessment Service members that have been hired by each agency or department of the Department of Health and Human Services, and how such Department assigns such members to each agency or department.

SEC. 3072. Hiring authority for scientific, technical, and professional personnel.

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

“SEC. 714A. Hiring authority for scientific, technical, and professional personnel.

“(a) In general.—The Secretary may, notwithstanding title 5, United States Code, governing appointments in the competitive service, appoint outstanding and qualified candidates to scientific, technical, or professional positions that support the development, review, and regulation of medical products. Such positions shall be within the competitive service.

“(b) Compensation.—

“(1) IN GENERAL.—Notwithstanding any other provision of law, including any requirement with respect to General Schedule pay rates under subchapter III of chapter 53 of title 5, United States Code, and consistent with the requirements of paragraph (2), the Commissioner of Food and Drugs may determine and set—

“(A) the annual rate of pay of any individual appointed under subsection (a); and

“(B) for purposes of retaining qualified employees, the annual rate of pay for any qualified scientific, technical, or professional personnel appointed to a position described in subsection (a) before the date of enactment of the 21st Century Cures Act.

“(2) LIMITATION.—The annual rate of pay established pursuant to paragraph (1) may not exceed the amount of annual compensation (excluding expenses) specified in section 102 of title 3, United States Code.

“(3) PUBLIC AVAILABILITY.—The annual rate of pay provided to an individual in accordance with this section shall be publicly available information.

“(c) Rule of construction.—The authorities under this section shall not be construed to affect the authority provided under section 714.

“(d) Report on workforce planning.—

“(1) IN GENERAL.—Not later than 18 months after the date of enactment of the 21st Century Cures Act, the Secretary shall submit a report on workforce planning to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives that examines the extent to which the Food and Drug Administration has a critical need for qualified individuals for scientific, technical, or professional positions, including—

“(A) an analysis of the workforce needs at the Food and Drug Administration and the Secretary’s strategic plan for addressing such needs, including through use of the authority under this section; and

“(B) a recruitment and retention plan for hiring qualified scientific, technical, and professional candidates, which may include the use of—

“(i) recruitment through nongovernmental recruitment or placement agencies;

“(ii) recruitment through academic institutions;

“(iii) recruitment or hiring bonuses, if applicable;

“(iv) recruitment using targeted direct hiring authorities; and

“(v) retention of qualified scientific, technical, and professional employees using the authority under this section, or other applicable authorities of the Secretary.

“(2) RECOMMENDATIONS.—The report under paragraph (1) may include the recommendations of the Commissioner of Food and Drugs that would help the Food and Drug Administration to better recruit and retain qualified individuals for scientific, technical, or professional positions at the agency.”.

(b) GAO study and report.—

(1) IN GENERAL.—The Comptroller General of the United States shall conduct a study of the ability of the Food and Drug Administration to hire, train, and retain qualified scientific, technical, and professional staff, not including contractors, necessary to fulfill the mission of the Food and Drug Administration to protect and promote public health. Not later than January 1, 2022, the Comptroller General shall submit a report on such study to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives.

(2) CONTENTS OF STUDY.—The Comptroller General shall include in the study and report under paragraph (1)—

(A) information about the progress of the Food and Drug Administration in recruiting and retaining qualified scientific, technical, and professional staff outstanding in the field of biomedical research, clinical research evaluation, and biomedical product assessment;

(B) the extent to which critical staffing needs exist at the Food and Drug Administration, and barriers to hiring, training, and retaining qualified staff, if any;

(C) an examination of the recruitment and retention strategies of the Food and Drug Administration, including examining any strategic workforce plan, focused on improving scientific, technical, and professional staff recruitment and retention; and

(D) recommendations for potential improvements that would address staffing needs of the Food and Drug Administration.

SEC. 3073. Establishment of Food and Drug Administration Intercenter Institutes.

(a) In general.—Chapter X of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 391 et seq.) is amended by adding at the end the following:

“SEC. 1014. Food and Drug Administration Intercenter Institutes.

“(a) In general.—The Secretary shall establish one or more Intercenter Institutes within the Food and Drug Administration (referred to in this section as an ‘Institute’) for a major disease area or areas. With respect to the major disease area of focus of an Institute, such Institute shall develop and implement processes for coordination of activities, as applicable to such major disease area or areas, among the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health (for the purposes of this section, referred to as the ‘Centers’). Such activities may include—

“(1) coordination of staff from the Centers with diverse product expertise in the diagnosis, cure, mitigation, treatment, or prevention of the specific diseases relevant to the major disease area of focus of the Institute;

“(2) streamlining, where appropriate, the review of medical products to diagnose, cure, mitigate, treat, or prevent the specific diseases relevant to the major disease area of focus of the Institute, applying relevant standards under sections 505, 510(k), 513(f)(2), and 515 of this Act and section 351 of the Public Health Service Act, and other applicable authorities;

“(3) promotion of scientific programs within the Centers related to the major disease area of focus of the Institute;

“(4) development of programs and enhancement of strategies to recruit, train, and provide continuing education opportunities for the personnel of the Centers with expertise related to the major disease area of focus of the Institute;

“(5) enhancement of the interactions of the Centers with patients, sponsors, and the external biomedical community regarding the major disease area of focus of the Institute; and

“(6) facilitation of the collaborative relationships of the Centers with other agencies within the Department of Health and Human Services regarding the major disease area of focus of the Institute.

“(b) Public process.—The Secretary shall provide a period for public comment during the time that each Institute is being implemented.

“(c) Timing.—The Secretary shall establish at least one Institute under subsection (a) before the date that is 1 year after the date of enactment of the 21st Century Cures Act.

“(d) Termination of institutes.—The Secretary may terminate any Institute established pursuant to this section if the Secretary determines such Institute is no longer benefitting the public health. Not less than 60 days prior to so terminating an Institute, the Secretary shall provide public notice, including the rationale for such termination.”.

(b) Technical amendments.—Chapter X of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 391 et seq.) is amended—

(1) by redesignating section 1012 as section 1013; and

(2) by redesignating the second section 1011 (with respect to improving the training of State, local, territorial, and tribal food safety officials), as added by section 209(a) of the FDA Food Safety Modernization Act (Public Law 111–353), as section 1012.

SEC. 3074. Scientific engagement.

(a) In general.—Scientific meetings that are attended by scientific or medical personnel, or other professionals, of the Department of Health and Human Services for whom attendance at such meeting is directly related to their professional duties and the mission of the Department—

(1) shall not be considered conferences for the purposes of complying with Federal reporting requirements contained in annual appropriations Acts or in this section; and

(2) shall not be considered conferences for purposes of a restriction contained in an annual appropriations Act, based on Office of Management and Budget Memorandum M-12-12 or any other regulation restricting travel to such meeting.

(b) Limitation.—Nothing in this section shall be construed to exempt travel for scientific meetings from Federal regulations relating to travel.

(c) Reports.—Not later than 90 days after the end of the fiscal year, each operating division of the Department of Health and Human Services shall prepare, and post on an Internet website of the operating division, an annual report on scientific meeting attendance and related travel spending for each fiscal year. Such report shall include—

(1) general information concerning the scientific meeting activities involved;

(2) information concerning the total amount expended for such meetings;

(3) a description of all such meetings that were attended by scientific or medical personnel, or other professionals, of each such operating division where the total amount expended by the operating division associated with each such meeting were in excess of $30,000, including—

(A) the total amount of meeting expenses incurred by the operating division for such meeting;

(B) the location of such meeting;

(C) the date of such meeting;

(D) a brief explanation on how such meeting advanced the mission of the operating division; and

(E) the total number of individuals whose travel expenses or other scientific meeting expenses were paid by the operating division; and

(4) with respect to any such meeting where the total expenses to the operating division exceeded $150,000, a description of the exceptional circumstances that necessitated the expenditure of such amounts.

SEC. 3075. Drug surveillance.

(a) New drugs.—Section 505(k)(5) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(k)(5)), as amended by section 2074, is further amended—

(1) in subparagraph (A), by striking “, bi-weekly screening” and inserting “screenings”;

(2) in subparagraph (B), as redesignated by section 2074(1)(C), by striking the period at the end and inserting “; and”; and

(3) by adding at the end the following:

“(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.”.

(b) FAERS revision.—Section 505(r)(2)(D) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(r)(2)(D)) is amended by striking “, by 18 months” and all that follows through the semicolon at the end of the subparagraph and inserting “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;”.

(c) Risk evaluation and mitigation strategies.—Section 505–1(f)(5) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1(f)(5)) is amended—

(1) in the matter preceding subparagraph (A), by inserting “or other advisory committee” after “(or successor committee)”; and

(2) in subparagraph (B), by striking “at least annually,” and inserting “periodically”.

SEC. 3076. Reagan-Udall Foundation for the Food and Drug Administration.

(a) Board of Directors.—

(1) COMPOSITION AND SIZE.—Section 770(d)(1)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379dd(d)(1)(C)) is amended—

(A) by redesignating clause (ii) as clause (iii);

(B) by inserting after clause (i) the following:

“(ii) ADDITIONAL MEMBERS.—The Board, through amendments to the bylaws of the Foundation, may provide that the number of voting members of the Board shall be a number (to be specified in such amendment) greater than 14. Any Board positions that are established by any such amendment shall be appointed (by majority vote) by the individuals who, as of the date of such amendment, are voting members of the Board and persons so appointed may represent any of the categories specified in subclauses (I) through (V) of clause (i), so long as no more than 30 percent of the total voting members of the Board (including members whose positions are established by such amendment) are representatives of the general pharmaceutical, device, food, cosmetic, and biotechnology industries.”; and

(C) in clause (iii)(I), as redesignated by subparagraph (A), by striking “The ex officio members shall ensure” and inserting “The ex officio members, acting pursuant to clause (i), and the Board, acting pursuant to clause (ii), shall ensure”.

(2) FEDERAL EMPLOYEES ALLOWED TO SERVE ON BOARD.—Clause (iii)(II) of section 770(d)(1)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379dd(d)(1)(C)), as redesignated by paragraph (1)(A), is amended by adding at the end the following: “For purposes of this section, the term ‘employee of the Federal Government’ does not include a special Government employee, as that term is defined in section 202(a) of title 18, United States Code.”.

(3) STAGGERED TERMS.—Subparagraph (A) of section 770(d)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379dd(d)(3)) is amended to read as follows:

“(A) TERM.—The term of office of each member of the Board appointed under paragraph (1)(C)(i), and the term of office of any member of the Board whose position is established pursuant to paragraph (1)(C)(ii), shall be 4 years, except that—

“(i) the terms of offices for the members of the Board initially appointed under paragraph (1)(C)(i) shall expire on a staggered basis as determined by the ex officio members; and

“(ii) the terms of office for the persons initially appointed to positions established pursuant to paragraph (1)(C)(ii) may be made to expire on a staggered basis, as determined by the individuals who, as of the date of the amendment establishing such positions, are members of the Board.”.

(b) Executive Director compensation.—Section 770(g)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379dd(g)(2)) is amended by striking “but shall not be greater than the compensation of the Commissioner”.

(c) Separation of Funds.—Section 770(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379dd(m)) is amended by striking “are held in separate accounts from funds received from entities under subsection (i)” and inserting “are managed as individual programmatic funds under subsection (i), according to best accounting practices”.

SEC. 3081. Medical countermeasure guidelines.

Section 319F–2 of the Public Health Service Act (42 U.S.C. 247d–6b) is amended—

(1) in subsection (a), by adding at the end the following:

“(3) UTILIZATION GUIDELINES.—The Secretary shall ensure timely and accurate recommended utilization guidelines for qualified countermeasures (as defined in section 319F–1), qualified pandemic and epidemic products (as defined in section 319F–3), and security countermeasures (as defined in subsection (c)), including for such products in the stockpile.”; and

(2) in subsection (g)—

(A) by amending paragraph (4) to read as follows:

“(4) REPORT ON SECURITY COUNTERMEASURE PROCUREMENT.—Not later than March 1 of each year in which the Secretary determines that the amount of funds available for procurement of security countermeasures is less than $1,500,000,000, the Secretary shall submit to the Committee on Appropriations and the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Appropriations and the Committee on Energy and Commerce of the House of Representatives a report detailing the amount of such funds available for procurement and the impact such amount of funding will have—

“(A) in meeting the security countermeasure needs identified under this section; and

“(B) on the annual Public Health Emergency Medical Countermeasures Enterprise and Strategy Implementation Plan (pursuant to section 2811(d)).”.

SEC. 3082. Clarifying BARDA contracting authority.

(a) In general.—Section 319F–2(g) of the Public Health Service Act (42 U.S.C. 247d–6b(g)) is amended by adding at the end the following:

“(5) CLARIFICATION ON CONTRACTING AUTHORITY.—The Secretary, acting through the Director of the Biomedical Advanced Research and Development Authority, shall carry out the programs funded by the special reserve fund (for the procurement of security countermeasures under subsection (c) and for carrying out section 319L), including the execution of procurement contracts, grants, and cooperative agreements pursuant to this section and section 319L.”.

(b) BARDA contracting authority.—Section 319L(c)(3) of the Public Health Service Act (42 U.S.C. 247d–7c) is amended by inserting “, including the execution of procurement contracts, grants, and cooperative agreements pursuant to this section” before the period.

SEC. 3083. Countermeasure budget plan.

Section 2811(b)(7) of the Public Health Service Act (42 U.S.C. 300hh–10(b)(7)) is amended—

(1) in the matter preceding subparagraph (A), by striking the first sentence and inserting “Develop, and update not later than March 1 of each year, a coordinated 5-year budget plan based on the medical countermeasure priorities described in subsection (d), including with respect to chemical, biological, radiological, and nuclear agent or agents that may present a threat to the Nation, including such agents that are novel or emerging infectious diseases, and the corresponding efforts to develop qualified countermeasures (as defined in section 319F–1), security countermeasures (as defined in section 319F–2), and qualified pandemic or epidemic products (as defined in section 319F–3) for each such threat.”;

(2) in subparagraph (C), by striking “; and” and inserting a semicolon;

(3) in subparagraph (D), by striking “to the appropriate committees of Congress upon request.” and inserting “, not later than March 15 of each year, to the Committee on Appropriations and the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Appropriations and the Committee on Energy and Commerce of the House of Representatives; and”; and

(4) by adding at the end the following:

    “(E) not later than March 15 of each year, be made publicly available in a manner that does not compromise national security.”.

SEC. 3084. Medical countermeasures innovation.

Section 319L(c)(4) of the Public Health Service Act (42 U.S.C. 247d–7e(c)(4)) is amended by adding at the end the following:

“(E) MEDICAL COUNTERMEASURES INNOVATION PARTNER.—

“(i) IN GENERAL.—To support the purposes described in paragraph (2), the Secretary, acting through the Director of BARDA, may enter into an agreement (including through the use of grants, contracts, cooperative agreements, or other transactions as described in paragraph (5)) with an independent, nonprofit entity to—

“(I) foster and accelerate the development and innovation of medical countermeasures and technologies that may assist advanced research and the development of qualified countermeasures and qualified pandemic or epidemic products, including through the use of strategic venture capital practices and methods;

“(II) promote the development of new and promising technologies that address urgent medical countermeasure needs, as identified by the Secretary;

“(III) address unmet public health needs that are directly related to medical countermeasure requirements, such as novel antimicrobials for multidrug resistant organisms and multiuse platform technologies for diagnostics, prophylaxis, vaccines, and therapeutics; and

“(IV) provide expert consultation and advice to foster viable medical countermeasure innovators, including helping qualified countermeasure innovators navigate unique industry challenges with respect to developing chemical, biological, radiological, and nuclear countermeasure products.

“(ii) ELIGIBILITY.—

“(I) IN GENERAL.—To be eligible to enter into an agreement under clause (i) an entity shall—

“(aa) be an independent, nonprofit entity;

“(bb) have a demonstrated record of being able to create linkages between innovators and investors and leverage such partnerships and resources for the purpose of addressing identified strategic needs of the Federal Government;

“(cc) have experience in promoting novel technology innovation;

“(dd) be problem-driven and solution-focused based on the needs, requirements, and problems identified by the Secretary under clause (iv);

“(ee) demonstrate the ability, or the potential ability, to promote the development of medical countermeasure products;

“(ff) demonstrate expertise, or the capacity to develop or acquire expertise, related to technical and regulatory considerations with respect to medical countermeasures; and

“(gg) not be within the Department of Health and Human Services.

“(II) PARTNERING EXPERIENCE.—In selecting an entity with which to enter into an agreement under clause (i), the Secretary shall place a high value on the demonstrated experience of the entity in partnering with the Federal Government to meet identified strategic needs.

“(iii) NOT AGENCY.—An entity that enters into an agreement under clause (i) shall not be deemed to be a Federal agency for any purpose, including for any purpose under title 5, United States Code.

“(iv) DIRECTION.—Pursuant to an agreement entered into under this subparagraph, the Secretary, acting through the Director of BARDA, shall provide direction to the entity that enters into an agreement under clause (i). As part of this agreement the Director of BARDA shall—

“(I) communicate the medical countermeasure needs, requirements, and problems to be addressed by the entity under the agreement;

“(II) develop a description of work to be performed by the entity under the agreement;

“(III) provide technical feedback and appropriate oversight over work carried out by the entity under the agreement, including subsequent development and partnerships consistent with the needs and requirements set forth in this subparagraph;

“(IV) ensure fair consideration of products developed under the agreement in order to maintain competition to the maximum practical extent, as applicable and appropriate under applicable provisions of this section; and

“(V) ensure, as a condition of the agreement that the entity—

“(aa) has in place a comprehensive set of policies that demonstrate a commitment to transparency and accountability;

“(bb) protects against conflicts of interest through a comprehensive set of policies that address potential conflicts of interest, ethics, disclosure, and reporting requirements;

“(cc) provides monthly accounting on the use of funds provided under such agreement; and

“(dd) provides on a quarterly basis, reports regarding the progress made toward meeting the identified needs set forth in the agreement.

“(v) SUPPLEMENT NOT SUPPLANT.—Activities carried out under this subparagraph shall supplement, and not supplant, other activities carried out under this section.

“(vi) NO ESTABLISHMENT OF ENTITY.—To prevent unnecessary duplication and target resources effectively, nothing in this subparagraph shall be construed to authorize the Secretary to establish within the Department of Health and Human Services an entity for the purposes of carrying out this subparagraph.

“(vii) TRANSPARENCY AND OVERSIGHT.—Upon request, the Secretary shall provide to Congress the information provided to the Secretary under clause (iv)(V)(dd).

“(viii) INDEPENDENT EVALUATION.—Not later than 4 years after the date of enactment of the 21st Century Cures Act, the Comptroller General of the United States shall conduct an independent evaluation, and submit to the Secretary and the appropriate committees of Congress a report, concerning the activities conducted under this subparagraph. Such report shall include recommendations with respect to any agreement or activities carried out pursuant to this subparagraph.

“(ix) SUNSET.—This subparagraph shall have no force or effect after September 30, 2022.”.

SEC. 3085. Streamlining Project BioShield procurement.

Section 319F–2(c) of the Public Health Service Act (42 U.S.C. 247d–6b(c)) is amended—

(1) in paragraph (4)(A)(ii), by striking “make a recommendation under paragraph (6) that the special reserve fund as defined in subsection (h) be made available for the procurement of such countermeasure” and inserting “and subject to the availability of appropriations, make available the special reserve fund as defined in subsection (h) for procurement of such countermeasure, as applicable”;

(2) in paragraph (6)—

(A) by striking subparagraphs (A), (B), and (E);

(B) by redesignating subparagraphs (C) and (D) as subparagraphs (A) and (B), respectively;

(C) by amending subparagraph (A), as so redesignated, to read as follows:

“(A) NOTICE TO APPROPRIATE CONGRESSIONAL COMMITTEES.—The Secretary shall notify the Committee on Appropriations and the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Appropriations and the Committee on Energy and Commerce of the House of Representatives of each decision to make available the special reserve fund as defined in subsection (h) for procurement of a security countermeasure, including, where available, the number of, the nature of, and other information concerning potential suppliers of such countermeasure, and whether other potential suppliers of the same or similar countermeasures were considered and rejected for procurement under this section and the reasons for each such rejection.”; and

(D) in the heading, by striking “Recommendation for president's approval” and inserting “Recommendations for procurement”; and

(3) in paragraph (7)—

(A) by striking subparagraphs (A) and (B) and inserting the following:

“(A) PAYMENTS FROM SPECIAL RESERVE FUND.—The special reserve fund as defined in subsection (h) shall be available for payments made by the Secretary to a vendor for procurement of a security countermeasure in accordance with the provisions of this paragraph.”; and

(B) by redesignating subparagraph (C) as subparagraph (B).

SEC. 3086. Encouraging treatments for agents that present a national security threat.

Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.) is amended by inserting after section 565 the following:

“SEC. 565A. Priority review to encourage treatments for agents that present national security threats.

“(a) Definitions.—In this section:

“(1) HUMAN DRUG APPLICATION.—The term ‘human drug application’ has the meaning given such term in section 735(1).

“(2) PRIORITY REVIEW.—The term ‘priority review’, with respect to a human drug application, 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 in the Food and Drug Administration and goals identified in the letters described in section 101(b) of the Food and Drug Administration Safety and Innovation Act.

“(3) PRIORITY REVIEW VOUCHER.—The term ‘priority review voucher’ means a voucher issued by the Secretary to the sponsor of a material threat medical countermeasure 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(a) of the Public Health Service Act after the date of approval of the material threat medical countermeasure application.

“(4) MATERIAL THREAT MEDICAL COUNTERMEASURE APPLICATION.—The term ‘material threat medical countermeasure application’ means an application that—

“(A) is a human drug application for a drug intended for use—

“(i) to prevent, or treat harm from a biological, chemical, radiological, or nuclear agent identified as a material threat under section 319F–2(c)(2)(A)(ii) of the Public Health Service Act; or

“(ii) to mitigate, prevent, or treat harm from a condition that may result in adverse health consequences or death and may be caused by administering a drug, or biological product against such agent; and

“(B) the Secretary determines eligible for priority review;

“(C) is approved after the date of enactment of the 21st Century Cures Act; and

“(D) 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(a) 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 material threat medical countermeasure application upon approval by the Secretary of such material threat medical countermeasure application.

“(2) TRANSFERABILITY.—The sponsor of a material threat medical countermeasure application 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(a) of the Public Health Service Act will be submitted after the date of the approval of the material threat medical countermeasure application. There is no limit on the number of times a priority review voucher may be transferred before such voucher is used.

“(3) NOTIFICATION.—

“(A) IN GENERAL.—The sponsor of a human drug application shall notify the Secretary not later than 90 calendar 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.

“(B) TRANSFER AFTER NOTICE.—The sponsor of a human drug application that provides notification of the intent of such sponsor to use the voucher for the human drug application under subparagraph (A) may transfer the voucher after such notification is provided, if such sponsor has not yet submitted the human drug application described in the notification.

“(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, 2016, 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(a) 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

“(6) shall not be collected for any fiscal year except to the extent provided in advance in appropriation Acts.

“(d) Notice of Issuance of Voucher and Approval of Products Under Voucher.—The Secretary shall publish a notice in the Federal Register and on the Internet website of the Food and Drug Administration not later than 30 calendar days after the occurrence of each of the following:

“(1) The Secretary issues a priority review voucher under this section.

“(2) The Secretary approves a drug pursuant to an application submitted under section 505(b) of this Act or section 351(a) of the Public Health Service Act for which the sponsor of the application used a priority review voucher issued under this section.

“(e) Eligibility for other programs.—Nothing in this section precludes a sponsor who seeks a priority review voucher under this section from participating in any other incentive program, including under this Act, except that no sponsor of a material threat medical countermeasure application may receive more than one priority review voucher issued under any section of this Act with respect to such drug.

“(f) Relation to other provisions.—The provisions of this section shall supplement, not supplant, any other provisions of this Act or the Public Health Service Act that encourage the development of medical countermeasures.

“(g) Sunset.—The Secretary may not award any priority review vouchers under subsection (b) after October 1, 2023.”.

SEC. 3087. Paperwork Reduction Act waiver during a public health emergency.

Section 319 of the Public Health Service Act (42 U.S.C. 247d) is amended by adding at the end the following:

“(f) Determination with respect to paperwork reduction act waiver during a public health emergency.—

“(1) DETERMINATION.—If the Secretary determines, after consultation with such public health officials as may be necessary, that—

“(A)(i) the criteria set forth for a public health emergency under paragraph (1) or (2) of subsection (a) has been met; or

“(ii) a disease or disorder, including a novel and emerging public health threat, is significantly likely to become a public health emergency; and

“(B) the circumstances of such public health emergency, or potential for such significantly likely public health emergency, including the specific preparation for and response to such public health emergency or threat, necessitate a waiver from the requirements of subchapter I of chapter 35 of title 44, United States Code (commonly referred to as the Paperwork Reduction Act),

then the requirements of such subchapter I with respect to voluntary collection of information shall not be applicable during the immediate investigation of, and response to, such public health emergency during the period of such public health emergency or the period of time necessary to determine if a disease or disorder, including a novel and emerging public health threat, will become a public health emergency as provided for in this paragraph. The requirements of such subchapter I with respect to voluntary collection of information shall not be applicable during the immediate postresponse review regarding such public health emergency if such immediate postresponse review does not exceed a reasonable length of time.

“(2) TRANSPARENCY.—If the Secretary determines that a waiver is necessary under paragraph (1), the Secretary shall promptly post on the Internet website of the Department of Health and Human Services a brief justification for such waiver, the anticipated period of time such waiver will be in effect, and the agencies and offices within the Department of Health and Human Services to which such waiver shall apply, and update such information posted on the Internet website of the Department of Health and Human Services, as applicable.

“(3) EFFECTIVENESS OF WAIVER.—Any waiver under this subsection shall take effect on the date on which the Secretary posts information on the Internet website as provided for in this subsection.

“(4) TERMINATION OF WAIVER.—Upon determining that the circumstances necessitating a waiver under paragraph (1) no longer exist, the Secretary shall promptly update the Internet website of the Department of Health and Human Services to reflect the termination of such waiver.

“(5) LIMITATIONS.—

“(A) PERIOD OF WAIVER.—The period of a waiver under paragraph (1) shall not exceed the period of time for the related public health emergency, including a public health emergency declared pursuant to subsection (a), and any immediate postresponse review regarding the public health emergency consistent with the requirements of this subsection.

“(B) SUBSEQUENT COMPLIANCE.—An initiative subject to a waiver under paragraph (1) that is ongoing after the date on which the waiver expires, shall be subject to the requirements of subchapter I of chapter 35 of title 44, United States Code, and the Secretary shall ensure that compliance with such requirements occurs in as timely a manner as possible based on the applicable circumstances, but not to exceed 30 calendar days after the expiration of the applicable waiver.”.

SEC. 3088. Clarifying Food and Drug Administration emergency use authorization.

(a) Authorization for medical products for use in emergencies.—Section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3) is amended—

(1) in subsection (a)(2)—

(A) in subparagraph (A)—

(i) by striking “or 515” and inserting “512, or 515”; and

(ii) by inserting “or conditionally approved under section 571 of this Act” after “Public Health Service Act”; and

(B) in subparagraph (B), by inserting “conditionally approved under section 571,” after “approved,” each place the term appears;

(2) in subsection (b)(4), by striking the second comma after “determination”;

(3) in subsection (e)(3)(B), by striking “section 503(b)” and inserting “subsection (b) or (f) of section 503 or under section 504”;

(4) in subsection (f)(2)—

(A) by inserting “, or an animal to which,” after “to a patient to whom”; and

(B) by inserting “or by the veterinarian caring for such animal, as applicable” after “attending physician”;

(5) in subsection (g)(1), by inserting “conditional approval under section 571,” after “approval,”;

(6) in subsection (h)(1), by striking “or section 520(g)”and inserting “512(j), or 520(g)”; and

(7) in subsection (k), by striking “section 520(g),”and inserting “512(j), or 520(g)”.

(b) New animal drugs.—Section 512(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(a)(1)) is amended—

(1) in subparagraph (B), by striking “or” at the end;

(2) in subparagraph (C), by striking the period and inserting “; or”; and

(3) by inserting after subparagraph (C) the following:

“(D) there is in effect an authorization pursuant to section 564 with respect to such use or intended use of such drug, and such drug, its labeling, and such use conform to any conditions of such authorization.”.

(c) Emergency use of medical products.—Section 564A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3a) is amended—

(1) in subsection (a)(1)(A), by inserting “, conditionally approved under section 571,” after “chapter”; and

(2) in subsection (d), by striking “sections 503(b) and 520(e)” and inserting “subsections (b) and (f) of section 503, section 504, and section 520(e)”.

(d) Products Held for Emergency Use.—Section 564B(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3b(2)) is amended—

(1) in subparagraph (A)—

(A) by inserting “or conditionally approved under section 571 of this Act” after “Public Health Service Act”; and

(B) by striking “or 515” and inserting “512, or 515”; and

(2) in subparagraph (B), by striking “or 520” and inserting “512, or 520”.

SEC. 3091. Predictable review timelines of vaccines by the Advisory Committee on Immunization Practices.

(a) Consideration of new vaccines.—Upon the licensure of any vaccine or any new indication for a vaccine, the Advisory Committee on Immunization Practices (in this section referred to as the “Advisory Committee”) shall, as appropriate, consider the use of the vaccine at its next regularly scheduled meeting.

(b) Additional information.—If the Advisory Committee does not make a recommendation with respect to the use of a vaccine at the Advisory Committee’s first regularly scheduled meeting after the licensure of the vaccine or any new indication for the vaccine, the Advisory Committee shall provide an update on the status of such committee's review.

(c) Consideration for breakthrough therapies and for potential use during public health emergency.—The Advisory Committee shall make recommendations with respect to the use of certain vaccines in a timely manner, as appropriate, including vaccines that—

(1) are designated as a breakthrough therapy under section 506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356) and licensed under section 351 of the Public Health Service Act (42 U.S.C. 262); or

(2) could be used in a public health emergency.

(d) Definition.—In this section, the terms “Advisory Committee on Immunization Practices” and “Advisory Committee” mean the Advisory Committee on Immunization Practices established by the Secretary pursuant to section 222 of the Public Health Service Act (42 U.S.C. 217a), acting through the Director of the Centers for Disease Control and Prevention.”.

SEC. 3092. Review of processes and consistency of Advisory Committee on Immunization Practices recommendations.

(a) Review.—The Director of the Centers for Disease Control and Prevention shall conduct a review of the processes used by the Advisory Committee on Immunization Practices in formulating and issuing recommendations pertaining to vaccines, including with respect to consistency.

(b) Considerations.—The review under subsection (a) shall include an assessment of—

(1) the criteria used to evaluate new and existing vaccines, including the identification of any areas for which flexibility in evaluating such criteria is necessary and the reason for such flexibility;

(2) the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach to the review and analysis of scientific and economic data, including the scientific basis for such approach; and

(3) the extent to which the processes used by the work groups of the Advisory Committee on Immunization Practices are consistent among such groups, including the identification of reasons for any variation.

(c) Stakeholders.—In carrying out the review under subsection (a), the Director of the Centers for Disease Control and Prevention shall solicit input from vaccine stakeholders.

(d) Report.—Not later than 18 months after the date of enactment of this Act, the Director of the Centers for Disease Control and Prevention shall submit to the appropriate committees of the Congress, and make publicly available, a report on the results of the review under subsection (a), including any recommendations on improving the consistency of the processes described in such subsection.

(e) Definition.—In this section, the term “Advisory Committee on Immunization Practices” means the Advisory Committee on Immunization Practices established by the Secretary of Health and Human Services pursuant to section 222 of the Public Health Service Act (42 U.S.C. 217a), acting through the Director of the Centers for Disease Control and Prevention.

SEC. 3093. Encouraging vaccine innovation.

(a) Vaccine meetings.—The Director of the Centers for Disease Control and Prevention shall ensure that appropriate staff within the relevant centers and divisions of the Office of Infectious Diseases, and others, as appropriate, coordinate with respect to the public health needs, epidemiology, and program planning and implementation considerations related to immunization, including with regard to meetings with stakeholders related to such topics.

(b) Report on vaccine innovation.—

(1) IN GENERAL.—Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the “Secretary”), in collaboration with appropriate agencies or offices within the Department of Health and Human Services, including the National Institutes of Health, the Centers for Disease Control and Prevention, the Food and Drug Administration, and the Biomedical Advanced Research and Development Authority, shall submit 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 post publicly on the Internet website of the Department of Health and Human Services, a report on ways to promote innovation in the development of vaccines that minimize the burden of infectious disease.

(2) CONTENTS.—The report described in paragraph (1) shall review the current status of vaccine development and, as appropriate—

(A) consider the optimal process to determine which vaccines would be beneficial to public health and how information on such vaccines is disseminated to key stakeholders;

(B) examine and identify whether obstacles exist that inhibit the development of beneficial vaccines; and

(C) make recommendations about how best to remove any obstacles identified under subparagraph (B) in order to promote and incentivize vaccine innovation and development.

(3) CONSULTATION.—In preparing the report under this subsection, the Secretary may consult with—

(A) representatives of relevant Federal agencies and departments, including the Department of Defense and the Department of Veterans Affairs;

(B) academic researchers;

(C) developers and manufacturers of vaccines;

(D) medical and public health practitioners;

(E) representatives of patient, policy, and advocacy organizations; and

(F) representatives of other entities, as the Secretary determines appropriate.

(c) Updates related to maternal immunization.—

(1) ADDITIONAL VACCINES.—Section 2114(e) of the Public Health Service Act (42 U.S.C. 300aa–14(e)) is amended by adding at the end the following:

“(3) VACCINES RECOMMENDED FOR USE IN PREGNANT WOMEN.—The Secretary shall revise the Vaccine Injury Table included in subsection (a), through the process described in subsection (c), to include vaccines recommended by the Centers for Disease Control and Prevention for routine administration in pregnant women and the information described in subparagraphs (B) and (C) of paragraph (2) with respect to such vaccines.”.

(2) PETITION CONTENT.—Section 2111 of the Public Health Service Act (42 U.S.C. 300aa–11) is amended by adding at the end the following:

“(f) Maternal immunization.—

“(1) IN GENERAL.—Notwithstanding any other provision of law, for purposes of this subtitle, both a woman who received a covered vaccine while pregnant and any child who was in utero at the time such woman received the vaccine shall be considered persons to whom the covered vaccine was administered and persons who received the covered vaccine.

“(2) DEFINITION.—As used in this subsection, the term ‘child’ shall have the meaning given that term by subsections (a) and (b) of section 8 of title 1, United States Code, except that, for purposes of this subsection, such section 8 shall be applied as if the term ‘include’ in subsection (a) of such section were replaced with the term ‘mean”.’.”.

(3) PETITIONERS.—Section 2111(b)(2) of the Public Health Service Act (42 U.S.C. 300aa–11(b)(2)) is amended by adding “A covered vaccine administered to a pregnant woman shall constitute more than one administration, one to the mother and one to each child (as such term is defined in subsection (f)(2)) who was in utero at the time such woman was administered the vaccine.” at the end.

SEC. 3101. Technical corrections.

(a) FFDCA.—

(1) REFERENCES.—Except as otherwise expressly provided, whenever in this subsection an amendment is expressed in terms of an amendment to a section or other provision, the reference shall be considered to be made to that section or other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).

(2) AMENDMENTS.—

(A) PROHIBITED ACTS.—Section 301(r) (21 U.S.C. 331(r)) is amended by inserting “, drug,” after “device” each place the term appears.

(B) NEW DRUGS.—Section 505 (21 U.S.C. 355) is amended—

(i) in subsection (d), in the last sentence, by striking “premarket approval” and inserting “marketing approval”; and

(ii) in subsection (q)(5)(A), by striking “subsection (b)(2) or (j) of the Act or 351(k)” and inserting “subsection (b)(2) or (j) of this section or section 351(k)”.

(C) RISK EVALUATION AND MITIGATION STRATEGIES.—Section 505–1(h)(21 U.S.C. 355–1(h)) is amended—

(i) in paragraph (2)(A)(iii)—

(I) in the clause heading, by striking “label” and inserting “labeling”;

(II) by striking “label” each place the term appears and inserting “labeling”; and

(III) by striking “sponsor” and inserting “responsible person”; and

(ii) in paragraph (8), by striking “and (7).” and inserting “and (7)”.

(D) PEDIATRIC STUDY PLANS.—Section 505B (21 U.S.C. 355c) is amended—

(i) in subsection (e)—

(I) in paragraph (2)—

(aa) in subparagraph (A), by inserting “study” after “initial pediatric” each place the term appears; and

(bb) in subparagraph (B), in the subparagraph heading, by striking “initial plan” and inserting “initial pediatric study plan”;

(II) in paragraph (5), in the paragraph heading, by inserting “agreed initial pediatric study” before “plan”; and

(III) in paragraph (6), by striking “agreed initial pediatric plan” and inserting “agreed initial pediatric study plan”; and

(ii) in subsection (f)(1), by inserting “and any significant amendments to such plans,” after “agreed initial pediatric study plans,”.

(E) DISCONTINUANCE OR INTERRUPTION IN THE PRODUCTION OF LIVE-SAVING DRUGS.—Section 506C (21 U.S.C. 356c) is amended—

(i) in subsection (c), by striking “discontinuation” and inserting “discontinuance”; and

(ii) in subsection (g)(1), by striking “section 505(j) that could help” and inserting “section 505(j), that could help”.

(F) ANNUAL REPORTING ON DRUG SHORTAGES.—Section 506C–1(a) (21 U.S.C. 331(a)) is amended, in the matter before paragraph (1)—

(i) by striking “Not later than the end of calendar year 2013, and not later than the end of each calendar year thereafter,” and inserting “Not later than March 31 of each calendar year, ”; and

(ii) by inserting “, with respect to the preceding calendar year,” after “a report”.

(G) DRUG SHORTAGE LIST.—Section 506E(b)(3)(E) (21 U.S.C. 356e(b)(3)(E)) is amended by striking “discontinuation” and inserting “discontinuance”.

(H) INSPECTIONS OF ESTABLISHMENTS.—Section 510(h) (21 U.S.C. 360(h)) is amended—

(i) in paragraph (4), in the matter preceding subparagraph (A), by striking “establishing the risk-based scheduled” and inserting “establishing a risk-based schedule”; and

(ii) in paragraph (6)—

(I) in subparagraph (A), by striking “fiscal” and inserting “calendar” each place the term appears; and

(II) in subparagraph (B), by striking “an active ingredient of a drug, a finished drug product, or an excipient of a drug” and inserting “an active ingredient of a drug or a finished drug product”.

(I) CLASSIFICATION OF DEVICES INTENDED FOR HUMAN USE.—Section 513(f)(2)(A) (21 U.S.C. 360c(f)(2)(A)) is amended—

(i) in clause (i), by striking “within 30 days”; and

(ii) in clause (iv), by striking “low-moderate” and inserting “low to moderate”.

(J) PREMARKET APPROVAL.—Section 515(a)(1) (21 U.S.C. 360e(a)(1)) is amended by striking “subject to a an order” and inserting “subject to an order”.

(K) PROGRAM TO IMPROVE THE DEVICE RECALL SYSTEM.—Section 518A (21 U.S.C. 360h–1) is amended—

(i) by striking subsection (c); and

(ii) by redesignating subsection (d) as subsection (c).

(L) UNIQUE DEVICE IDENTIFIER.—Section 519(f) (21 U.S.C. 360i(f)) is amended by striking “and life sustaining” and inserting “or life sustaining”.

(M) PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR TROPICAL DISEASES.—Section 524(c)(4)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360n(c)(4)(A)) is amended by striking “Services Act” and inserting “Service Act”.

(N) PRIORITY REVIEW FOR QUALIFIED INFECTIOUS DISEASE PRODUCTS.—Section 524A (21 U.S.C. 360n–1) is amended—

(i) by striking “If the Secretary” and inserting the following:

“(a) In General.—If the Secretary”;

(ii) by striking “any” and inserting “the first”; and

(iii) by adding at the end the following:

“(b) Construction.—Nothing in this section shall prohibit the Secretary from giving priority review to a human drug application or efficacy supplement submitted for approval under section 505(b) that otherwise meets the criteria for the Secretary to grant priority review.”.

(O) CONSULTATION WITH EXTERNAL EXPERTS ON RARE DISEASES, TARGETED THERAPIES, AND GENETIC TARGETING OF TREATMENTS.—Section 569(a)(2)(A) (21 U.S.C. 360bbb–8(a)(2)(A)) is amended, in the first sentence, by striking “subsection (c)” and inserting “subsection (b)”.

(P) OPTIMIZING GLOBAL CLINICAL TRIALS.—Section 569A(c) (21 U.S.C. 360bbb–8a(c)) is amended by inserting “or under the Public Health Service Act” after “this Act”.

(Q) USE OF CLINICAL INVESTIGATION DATA FROM OUTSIDE THE UNITED STATES.—Section 569B (21 U.S.C. 360bbb–8b) is amended by striking “drug or device” and inserting “drug, biological product, or device” each place the term appears.

(R) MEDICAL GASES DEFINITIONS.—Section 575(1)(H) (21 U.S.C. 360ddd(1)(H)) is amended—

(i) by inserting “for a new drug” after “any period of exclusivity”; and

(ii) by inserting “or any period of exclusivity for a new animal drug under section 512(c)(2)(F),” after “section 505A,”.

(S) REGULATION OF MEDICAL GASES.—Section 576(a) (21 U.S.C. 360ddd–1(a)) is amended—

(i) in the matter preceding subparagraph (A) of paragraph (1), by inserting “who seeks to initially introduce or deliver for introduction a designated medical gas into interstate commerce” after “any person”; and

(ii) in paragraph (3)—

(I) in subparagraph (A)—

(aa) in clause (i)(VIII), by inserting “for a new drug” after “any period of exclusivity”; and

(bb) in clause (ii), in the matter preceding subclause (I), by inserting “the” before “final use”; and

(II) in subparagraph (B)—

(aa) in clause (i), by inserting “for a new drug” after “any period of exclusivity”; and

(bb) in clause (ii), by inserting a comma after “drug product”.

(T) INAPPLICABILITY OF DRUG FEES TO DESIGNATED MEDICAL GASES.—Section 577 (21 U.S.C. 360ddd–2) is amended by inserting “or 740(a)” after “section 736(a)”.

(U) CONFLICTS OF INTEREST.—Section 712(e)(1)(B) (21 U.S.C. 379d–1(e)(1)(B)) is amended by striking “services” and inserting “service”.

(V) AUTHORITY TO ASSESS AND USE BIOSIMILAR BIOLOGICAL PRODUCT FEES.—Section 744H(a) (21 U.S.C. 379j–52(a)) is amended—

(i) in paragraph (1)(A)(v), by striking “Biosimilars User Fee Act of 2012” and inserting “Biosimilar User Fee Act of 2012”; and

(ii) in paragraph (2)(B), by striking “Biosimilars User Fee Act of 2012” and inserting “Biosimilar User Fee Act of 2012”.

(W) REGISTRATION OF COMMERCIAL IMPORTERS.—

(i) AMENDMENT.—Section 801(s)(2) (21 U.S.C. 381(s)(2)) is amended by adding at the end the following:

“(D) EFFECTIVE DATE.—In establishing the effective date of the regulations under subparagraph (A), the Secretary shall, in consultation with the Secretary of Homeland Security acting through U.S. Customs and Border Protection, as determined appropriate by the Secretary of Health and Human Services, provide a reasonable period of time for an importer of a drug to comply with good importer practices, taking into account differences among importers and types of imports, including based on the level of risk posed by the imported product.”.

(ii) CONFORMING AMENDMENT.—Section 714 of the Food and Drug Administration Safety and Innovation Act (Public Law 112–144; 126 Stat. 1074) is amended by striking subsection (d).

(X) RECOGNITION OF FOREIGN GOVERNMENT INSPECTIONS.—Section 809(a)(2) (21 U.S.C. 384e(a)(2)) is amended by striking “conduction” and inserting “conducting”.

(b) FDASIA.—

(1) FINDINGS RELATING TO DRUG APPROVAL.—Section 901(a)(1)(A) of the Food and Drug Administration Safety and Innovation Act (Public Law 112–144; 21 U.S.C. 356 note) is amended by striking “serious and life-threatening diseases” and inserting “serious or life-threatening diseases”.

(2) REPORTING OF INCLUSION OF DEMOGRAPHIC SUBGROUPS.—Section 907 of the Food and Drug Administration Safety and Innovation Act (Public Law 112–144; 126 Stat. 1092, 1093) is amended—

(A) in the section heading, by striking “Biologics” in the heading and inserting “Biological Products”; and

(B) in subsection (a)(2)(B), by striking “applications for new drug applications” and inserting “new drug applications”.

(3) COMBATING PRESCRIPTION DRUG ABUSE.—Section 1122 of the Food and Drug Administration Safety and Innovation Act (Public Law 112–144; 126 Stat. 1112, 1113) is amended—

(A) in subsection (a)(2), by striking “dependance” and inserting “dependence”; and

(B) in subsection (c), by striking “promulgate” and inserting “issue”.

SEC. 3102. Completed studies.

The Federal Food, Drug, and Cosmetic Act is amended—

(1) in section 505(k)(5) (21 U.S.C. 355(k)(5))—

(A) in subparagraph (A), by inserting “and” after the semicolon;

(B) by striking subparagraph (B); and

(C) by redesignating subparagraph (C) as subparagraph (B);

(2) in section 505A (21 U.S.C. 355a), by striking subsection (p);

(3) in section 505B (21 U.S.C. 355c)—

(A) by striking subsection (l); and

(B) by redesignating subsection (m) as subsection (l); and

(4) in section 523 (21 U.S.C. 360m), by striking subsection (d).

SEC. 4001. Assisting doctors and hospitals in improving quality of care for patients.

(a) In general.—The Health Information Technology for Economic and Clinical Health Act (title XIII of division A of Public Law 111–5) is amended—

(1) by adding at the end of part 1 of subtitle A the following:

“SEC. 13103. Assisting doctors and hospitals in improving quality of care for patients.

“(a) Reduction in burdens goal.—The Secretary of Health and Human Services (referred to in this section as the ‘Secretary’), in consultation with providers of health services, health care suppliers of services, health care payers, health professional societies, health information technology developers, health care quality organizations, health care accreditation organizations, public health entities, States, and other appropriate entities, shall, in accordance with subsection (b)—

“(1) establish a goal with respect to the reduction of regulatory or administrative burdens (such as documentation requirements) relating to the use of electronic health records;

“(2) develop a strategy for meeting the goal established under paragraph (1); and

“(3) develop recommendations for meeting the goal established under paragraph (1).

“(b) Strategy and recommendations.—

“(1) IN GENERAL.—To achieve the goal established under subsection (a)(1), the Secretary, in consultation with the entities described in such subsection, shall, not later than 1 year after the date of enactment of the 21st Century Cures Act, develop a strategy and recommendations to meet the goal in accordance with this subsection.

“(2) STRATEGY.—The strategy developed under paragraph (1) shall address the regulatory and administrative burdens (such as documentation requirements) relating to the use of electronic health records. Such strategy shall include broad public comment and shall prioritize—

“(A)(i) incentives for meaningful use of certified EHR technology for eligible professionals and hospitals under sections 1848(a)(7) and 1886(b)(3)(B)(ix), respectively, of the Social Security Act (42 U.S.C. 1395w–4(a)(7), 1395ww(b)(3)(B)(ix));

“(ii) the program for making payments under section 1903(a)(3)(F) of the Social Security Act (42 U.S.C. 1396b(a)(3)(F)) to encourage the adoption and use of certified EHR technology by Medicaid providers;

“(iii) the Merit-based Incentive Payment System under section 1848(q) of the Social Security Act (42 U.S.C. 1395w–4(q));

“(iv) alternative payment models (as defined in section 1833(z)(3)(C) of the Social Security Act (42 U.S.C. 1395l(z)(3)(C));

“(v) the Hospital Value-Based Purchasing Program under section 1886(o) of the Social Security Act (42 U.S.C. 1395ww(o)); and

“(vi) other value-based payment programs, as the Secretary determines appropriate;

“(B) health information technology certification;

“(C) standards and implementation specifications, as appropriate;

“(D) activities that provide individuals access to their electronic health information;

“(E) activities related to protecting the privacy of electronic health information;

“(F) activities related to protecting the security of electronic health information;

“(G) activities related to facilitating health and clinical research;

“(H) activities related to public health;

“(I) activities related to aligning and simplifying quality measures across Federal programs and other payers;

“(J) activities related to reporting clinical data for administrative purposes; and

“(K) other areas, as the Secretary determines appropriate.

“(3) RECOMMENDATIONS.—The recommendations developed under paragraph (1) shall address—

“(A) actions that improve the clinical documentation experience;

“(B) actions that improve patient care;

“(C) actions to be taken by the Secretary and by other entities; and

“(D) other areas, as the Secretary determines appropriate, to reduce the reporting burden required of health care providers.

“(4) FACA.—The Federal Advisory Committee Act (5 U.S.C. App.) shall not apply to the development of the goal, strategies, or recommendations described in this section.

“(c) Application of certain regulatory requirements.—A physician (as defined in section 1861(r)(1) of the Social Security Act), to the extent consistent with applicable State law, may delegate electronic medical record documentation requirements specified in regulations promulgated by the Centers for Medicare & Medicaid Services to a person performing a scribe function who is not such physician if such physician has signed and verified the documentation.”; and

(2) in the table of contents in section 13001(b), by inserting after the item relating to section 13102 the following:


“13103. Assisting doctors and hospitals in improving the quality and care for patients.”.

(b) Certification of health information technology for medical specialties and sites of service.—Section 3001(c)(5) of the Public Health Service Act (42 U.S.C. 300jj–11(c)(5)) is amended by adding at the end the following:

“(C) HEALTH INFORMATION TECHNOLOGY FOR MEDICAL SPECIALTIES AND SITES OF SERVICE.—

“(i) IN GENERAL.—The National Coordinator shall encourage, keep, or recognize, through existing authorities, the voluntary certification of health information technology under the program developed under subparagraph (A) for use in medical specialties and sites of service for which no such technology is available or where more technological advancement or integration is needed.

“(ii) SPECIFIC MEDICAL SPECIALTIES.—The Secretary shall accept public comment on specific medical specialties and sites of service, in addition to those described in clause (i), for the purpose of selecting additional specialties and sites of service as necessary.

“(iii) HEALTH INFORMATION TECHNOLOGY FOR PEDIATRICS.—Not later than 18 months after the date of enactment of the 21st Century Cures Act, the Secretary, in consultation with relevant stakeholders, shall make recommendations for the voluntary certification of health information technology for use by pediatric health providers to support the health care of children. Not later than 2 years after the date of enactment of the 21st Century Cures Act, the Secretary shall adopt certification criteria under section 3004 to support the voluntary certification of health information technology for use by pediatric health providers to support the health care of children.”.

(c) Meaningful use statistics.—

(1) IN GENERAL.—Not later than 6 months after the date of enactment of this Act, the Secretary of Health and Human Services shall submit to the HIT Advisory Committee of the Office of the National Coordinator for Health Information Technology, a report concerning attestation statistics for the Medicare and Medicaid EHR Meaningful Use Incentive programs to assist in informing standards adoption and related practices. Such statistics shall include attestation information delineated by State, including, to the extent practicable, the number of providers who did not meet the minimum criteria necessary to attest for the Medicare and Medicaid EHR Meaningful Use Incentive programs for a calendar year, and shall be made publicly available on the Internet website of the Secretary on at least a quarterly basis.

(2) AUTHORITY TO ALTER FORMAT.—The Secretary of Health and Human Services may alter the format of the reports on the attestation of eligible health care professionals following the first performance year of the Merit-based Incentive Payment System to account for changes arising from the implementation of such payment system.

SEC. 4002. Transparent reporting on usability, security, and functionality.

(a) Enhancements to certification.—Section 3001(c)(5) of the Public Health Service Act (42 U.S.C. 300jj–11), as amended by section 4001(b), is further amended by adding at the end the following:

“(D) CONDITIONS OF CERTIFICATION.—Not later than 1 year after the date of enactment of the 21st Century Cures Act, the Secretary, through notice and comment rulemaking, shall require, as a condition of certification and maintenance of certification for programs maintained or recognized under this paragraph, consistent with other conditions and requirements under this title, that the health information technology developer or entity—

“(i) does not take any action that constitutes information blocking as defined in section 3022(a);

“(ii) provides assurances satisfactory to the Secretary that such developer or entity, unless for legitimate purposes specified by the Secretary, will not take any action described in clause (i) or any other action that may inhibit the appropriate exchange, access, and use of electronic health information;

“(iii) does not prohibit or restrict communication regarding—

“(I) the usability of the health information technology;

“(II) the interoperability of the health information technology;

“(III) the security of the health information technology;

“(IV) relevant information regarding users’ experiences when using the health information technology;

“(V) the business practices of developers of health information technology related to exchanging electronic health information; and

“(VI) the manner in which a user of the health information technology has used such technology;

“(iv) has published application programming interfaces and allows health information from such technology to be accessed, exchanged, and used without special effort through the use of application programming interfaces or successor technology or standards, as provided for under applicable law, including providing access to all data elements of a patient’s electronic health record to the extent permissible under applicable privacy laws;

“(v) has successfully tested the real world use of the technology for interoperability (as defined in section 3000) in the type of setting in which such technology would be marketed;

“(vi) provides to the Secretary an attestation that the developer or entity—

“(I) has not engaged in any of the conduct described in clause (i);

“(II) has provided assurances satisfactory to the Secretary in accordance with clause (ii);

“(III) does not prohibit or restrict communication as described in clause (iii);

“(IV) has published information in accordance with clause (iv);

“(V) ensures that its technology allows for health information to be exchanged, accessed, and used, in the manner described in clause (iv); and

“(VI) has undertaken real world testing as described in clause (v); and

“(vii) submits reporting criteria in accordance with section 3009A(b).”.

“(E) COMPLIANCE WITH CONDITIONS OF CERTIFICATION.—The Secretary may encourage compliance with the conditions of certification described in subparagraph (D) and take action to discourage noncompliance, as appropriate.”.

(b) EHR significant hardship exception.—

(1) APPLICATION TO ELIGIBLE PROFESSIONALS.—

(A) IN CASE OF DECERTIFICATION.—Section 1848(a)(7)(B) of the Social Security Act (42 U.S.C. 1395w–4(a)(7)(B)) is amended by inserting after the first sentence the following new sentence: “The Secretary shall exempt an eligible professional from the application of the payment adjustment under subparagraph (A) with respect to a year, subject to annual renewal, if the Secretary determines that compliance with the requirement for being a meaningful EHR user is not possible because the certified EHR technology used by such professional has been decertified under a program kept or recognized pursuant to section 3001(c)(5) of the Public Health Service Act.”.

(B) CONTINUED APPLICATION UNDER MIPS.—Section 1848(o)(2)(D) of the Social Security Act (42 U.S.C. 1395w–4(o)(2)(D)) is amended by adding at the end the following new sentence: “The provisions of subparagraphs (B) and (D) of subsection (a)(7), shall apply to assessments of MIPS eligible professionals under subsection (q) with respect to the performance category described in subsection (q)(2)(A)(iv) in an appropriate manner which may be similar to the manner in which such provisions apply with respect to payment adjustments made under subsection (a)(7)(A).”.

(2) APPLICATION TO ELIGIBLE HOSPITALS.—Section 1886(b)(3)(B)(ix)(II) of the Social Security Act (42 U.S.C. 1395ww(b)(3)(B)(ix)(II)) is amended by inserting after the first sentence the following new sentence: “The Secretary shall exempt an eligible hospital from the application of the payment adjustment under subclause (I) with respect to a fiscal year, subject to annual renewal, if the Secretary determines that compliance with the requirement for being a meaningful EHR user is not possible because the certified EHR technology used by such hospital is decertified under a program kept or recognized pursuant to section 3001(c)(5) of the Public Health Service Act.”.

(c) Electronic health record reporting program.—Subtitle A of title XXX of the Public Health Service Act (42 U.S.C. 300jj–11 et seq.) is amended by adding at the end the following:

“SEC. 3009A. Electronic health record reporting program.

“(a) Reporting criteria.—

“(1) CONVENING OF STAKEHOLDERS.—Not later than 1 year after the date of enactment of the 21st Century Cures Act, the Secretary shall convene stakeholders, as described in paragraph (2), for the purpose of developing the reporting criteria in accordance with paragraph (3).

“(2) DEVELOPMENT OF REPORTING CRITERIA.—The reporting criteria under this subsection shall be developed through a public, transparent process that reflects input from relevant stakeholders, including—

“(A) health care providers, including primary care and specialty care health care professionals;

“(B) hospitals and hospital systems;

“(C) health information technology developers;

“(D) patients, consumers, and their advocates;

“(E) data sharing networks, such as health information exchanges;

“(F) authorized certification bodies and testing laboratories;

“(G) security experts;

“(H) relevant manufacturers of medical devices;

“(I) experts in health information technology market economics;

“(J) public and private entities engaged in the evaluation of health information technology performance;

“(K) quality organizations, including the consensus based entity described in section 1890 of the Social Security Act;

“(L) experts in human factors engineering and the measurement of user-centered design; and

“(M) other entities or individuals, as the Secretary determines appropriate.

“(3) CONSIDERATIONS FOR REPORTING CRITERIA.—The reporting criteria developed under this subsection—

“(A) shall include measures that reflect categories including—

“(i) security;

“(ii) usability and user-centered design;

“(iii) interoperability;

“(iv) conformance to certification testing; and

“(v) other categories, as appropriate to measure the performance of electronic health record technology;

“(B) may include categories such as—

“(i) enabling the user to order and view the results of laboratory tests, imaging tests, and other diagnostic tests;

“(ii) submitting, editing, and retrieving data from registries such as clinician-led clinical data registries;

“(iii) accessing and exchanging information and data from and through health information exchanges;

“(iv) accessing and exchanging information and data from medical devices;

“(v) accessing and exchanging information and data held by Federal, State, and local agencies and other applicable entities useful to a health care provider or other applicable user in the furtherance of patient care;

“(vi) accessing and exchanging information from other health care providers or applicable users;

“(vii) accessing and exchanging patient generated information;

“(viii) providing the patient or an authorized designee with a complete copy of their health information from an electronic record in a computable format;

“(ix) providing accurate patient information for the correct patient, including exchanging such information, and avoiding the duplication of patients records; and

“(x) other categories regarding performance, accessibility, as the Secretary determines appropriate; and

“(C) shall be designed to ensure that small and startup health information technology developers are not unduly disadvantaged by the reporting criteria.

“(4) MODIFICATIONS.—After the reporting criteria have been developed under paragraph (3), the Secretary may convene stakeholders and conduct a public comment period for the purpose of modifying the reporting criteria developed under such paragraph.

“(b) Participation.—As a condition of maintaining certification under section 3001(c)(5)(D), a developer of certified electronic health records shall submit to an appropriate recipient of a grant, contract, or agreement under subsection (c)(1) responses to the criteria developed under subsection (a), with respect to all certified technology offered by such developer.

“(c) Reporting program.—

“(1) IN GENERAL.—Not later than 1 year after the date of enactment of the 21st Century Cures Act, the Secretary shall award grants, contracts, or agreements to independent entities on a competitive basis to support the convening of stakeholders as described in subsection (a)(2), collect the information required to be reported in accordance with the criteria established as described subsection (a)(3), and develop and implement a process in accordance with paragraph (5) and report such information to the Secretary.

“(2) APPLICATIONS.—An independent entity that seeks a grant, contract, or agreement under this subsection shall submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary may reasonably require, including a description of—

“(A) the proposed method for reviewing and summarizing information gathered based on reporting criteria established under subsection (a);

“(B) if applicable, the intended focus on a specific subset of certified electronic health record technology users, such as health care providers, including primary care, specialty care, and care provided in rural settings; hospitals and hospital systems; and patients, consumers, and patients and consumer advocates;

“(C) the plan for widely distributing reports described in paragraph (6);

“(D) the period for which the grant, contract, or agreement is requested, which may be up to 2 years; and

“(E) the budget for reporting program participation, and whether the eligible independent entity intends to continue participation after the period of the grant, contract, or agreement.

“(3) CONSIDERATIONS FOR INDEPENDENT ENTITIES.—In awarding grants, contracts, and agreements under paragraph (1), the Secretary shall give priority to independent entities with appropriate expertise in health information technology usability, interoperability, and security (especially entities with such expertise in electronic health records) with respect to—

“(A) health care providers, including primary care, specialty care, and care provided in rural settings;

“(B) hospitals and hospital systems; and

“(C) patients, consumers, and patient and consumer advocates.

“(4) LIMITATIONS.—

“(A) ASSESSMENT AND REDETERMINATION.—Not later than 4 years after the date of enactment of the 21st Century Cures Act and every 2 years thereafter, the Secretary, in consultation with stakeholders, shall—

“(i) assess performance of the recipients of the grants, contracts, and agreements under paragraph (1) based on quality and usability of reports described in paragraph (6); and

“(ii) re-determine grants, contracts, and agreements as necessary.

“(B) PROHIBITIONS ON PARTICIPATION.—The Secretary may not award a grant, contract, or cooperative agreement under paragraph (1) to—

“(i) a proprietor of certified health information technology or a business affiliate of such a proprietor;

“(ii) a developer of certified health information technology; or

“(iii) a State or local government agency.

“(5) FEEDBACK.—Based on reporting criteria established under subsection (a), the recipients of grants, contracts, and agreements under paragraph (1) shall develop and implement a process to collect and verify confidential feedback on such criteria from—

“(A) health care providers, patients, and other users of certified electronic health record technology; and

“(B) developers of certified electronic health record technology.

“(6) REPORTS.—

“(A) DEVELOPMENT OF REPORTS.—Each recipient of a grant, contract, or agreement under paragraph (1) shall report on the information reported to such recipient pursuant to subsection (a) and the user feedback collected under paragraph (5) by preparing summary reports and detailed reports of such information.

“(B) DISTRIBUTION OF REPORTS.—Each recipient of a grant, contract, or agreement under paragraph (1) shall submit the reports prepared under subparagraph (A) to the Secretary for public distribution in accordance with subsection (d).

“(d) Publication.—The Secretary shall distribute widely, as appropriate, and publish, on the Internet website of the Office of the National Coordinator—

“(1) the reporting criteria developed under subsection (a); and

“(2) the summary and detailed reports under subsection (c)(6).

“(e) Review.—Each recipient of a grant, contract, or agreement under paragraph (1) shall develop and implement a process through which participating electronic health record technology developers may review and recommend changes to the reports created under subsection (c)(6) for products developed by such developer prior to the publication of such report under subsection (d).

“(f) Additional resources.—The Secretary may provide additional resources on the Internet website of the Office of the National Coordinator to better inform consumers of health information technology. Such reports may be carried out through partnerships with private organizations with appropriate expertise.”.

(d) Authorization of Appropriations.—There is authorized to be appropriated $15,000,000 for purposes of carrying out subparagraph (D) of section 3001(c)(5) of the Public Health Service Act (42 U.S.C. 300jj–11) (as added by subsection (a)) and section 3009A of the Public Health Service Act (as added by subsection (b)), including for purposes of administering any contracts, grants, or agreements, to remain available until expended.

SEC. 4003. Interoperability.

(a) Definition.—Section 3000 of the Public Health Service Act (42 U.S.C. 300jj) is amended—

(1) by redesignating paragraphs (10) through (14), as paragraphs (11) through (15), respectively; and

(2) by inserting after paragraph (9) the following:

“(10) INTEROPERABILITY.—The term ‘interoperability’, with respect to health information technology, means such health information technology that—

“(A) enables the secure exchange of electronic health information with, and use of electronic health information from, other health information technology without special effort on the part of the user;

“(B) allows for complete access, exchange, and use of all electronically accessible health information for authorized use under applicable State or Federal law; and

“(C) does not constitute information blocking as defined in section 3022(a).”.

(b) Support for interoperable network exchange.—Section 3001(c) of the Public Health Service Act (42 U.S.C. 300jj–11(c)) is amended by adding at the end the following:

“(9) SUPPORT FOR INTEROPERABLE NETWORKS EXCHANGE.—

“(A) IN GENERAL.—The National Coordinator shall, in collaboration with the National Institute of Standards and Technology and other relevant agencies within the Department of Health and Human Services, for the purpose of ensuring full network-to-network exchange of health information, convene public-private and public-public partnerships to build consensus and develop or support a trusted exchange framework, including a common agreement among health information networks nationally. Such convention may occur at a frequency determined appropriate by the Secretary.

“(B) ESTABLISHING A TRUSTED EXCHANGE FRAMEWORK.—

“(i) IN GENERAL.—Not later than 6 months after the date of enactment of the 21st Century Cures Act, the National Coordinator shall convene appropriate public and private stakeholders to develop or support a trusted exchange framework for trust policies and practices and for a common agreement for exchange between health information networks. The common agreement may include—

“(I) a common method for authenticating trusted health information network participants;

“(II) a common set of rules for trusted exchange;

“(III) organizational and operational policies to enable the exchange of health information among networks, including minimum conditions for such exchange to occur; and

“(IV) a process for filing and adjudicating noncompliance with the terms of the common agreement.

“(ii) TECHNICAL ASSISTANCE.—The National Coordinator, in collaboration with the National Institute of Standards and Technology, shall provide technical assistance on how to implement the trusted exchange framework and common agreement under this paragraph.

“(iii) PILOT TESTING.—The National Coordinator, in consultation with the National Institute of Standards and Technology, shall provide for the pilot testing of the trusted exchange framework and common agreement established or supported under this subsection (as authorized under section 13201 of the Health Information Technology for Economic and Clinical Health Act). The National Coordinator, in consultation with the National Institute of Standards and Technology, may delegate pilot testing activities under this clause to independent entities with appropriate expertise.

“(C) PUBLICATION OF A TRUSTED EXCHANGE FRAMEWORK AND COMMON AGREEMENT.—Not later than 1 year after convening stakeholders under subparagraph (A), the National Coordinator shall publish on its public Internet website, and in the Federal register, the trusted exchange framework and common agreement developed or supported under subparagraph (B). Such trusted exchange framework and common agreement shall be published in a manner that protects proprietary and security information, including trade secrets and any other protected intellectual property.

“(D) DIRECTORY OF PARTICIPATING HEALTH INFORMATION NETWORKS.—

“(i) IN GENERAL.—Not later than 2 years after convening stakeholders under subparagraph (A), and annually thereafter, the National Coordinator shall publish on its public Internet website a list of the health information networks that have adopted the common agreement and are capable of trusted exchange pursuant to the common agreement developed or supported under paragraph (B).

“(ii) PROCESS.—The Secretary shall, through notice and comment rulemaking, establish a process for health information networks that voluntarily elect to adopt the trusted exchange framework and common agreement to attest to such adoption of the framework and agreement.

“(E) APPLICATION OF THE TRUSTED EXCHANGE FRAMEWORK AND COMMON AGREEMENT.—As appropriate, Federal agencies contracting or entering into agreements with health information exchange networks may require that as each such network upgrades health information technology or trust and operational practices, such network may adopt, where available, the trusted exchange framework and common agreement published under subparagraph (C).

“(F) RULE OF CONSTRUCTION.—

“(i) GENERAL ADOPTION.—Nothing in this paragraph shall be construed to require a health information network to adopt the trusted exchange framework or common agreement.

“(ii) ADOPTION WHEN EXCHANGE OF INFORMATION IS WITHIN NETWORK.—Nothing in this paragraph shall be construed to require a health information network to adopt the trusted exchange framework or common agreement for the exchange of electronic health information between participants of the same network.

“(iii) EXISTING FRAMEWORKS AND AGREEMENTS.—The trusted exchange framework and common agreement published under subparagraph (C) shall take into account existing trusted exchange frameworks and agreements used by health information networks to avoid the disruption of existing exchanges between participants of health information networks.

“(iv) APPLICATION BY FEDERAL AGENCIES.—Notwithstanding clauses (i), (ii), and (iii), Federal agencies may require the adoption of the trusted exchange framework and common agreement published under subparagraph (C) for health information exchanges contracting with or entering into agreements pursuant to subparagraph (E).

“(v) CONSIDERATION OF ONGOING WORK.—In carrying out this paragraph, the Secretary shall ensure the consideration of activities carried out by public and private organizations related to exchange between health information exchanges to avoid duplication of efforts.”.

(c) Provider digital contact information index.—

(1) IN GENERAL.—Not later than 3 years after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this subsection as the “Secretary”) shall, directly or through a partnership with a private entity, establish a provider digital contact information index to provide digital contact information for health professionals and health facilities.

(2) USE OF EXISTING INDEX.—In establishing the initial index under paragraph (1), the Secretary may utilize an existing provider directory to make such digital contact information available.

(3) CONTACT INFORMATION.—An index established under this subsection shall ensure that contact information is available at the individual health care provider level and at the health facility or practice level.

(4) RULE OF CONSTRUCTION.—

(A) IN GENERAL.—The purpose of this subsection is to encourage the exchange of electronic health information by providing the most useful, reliable, and comprehensive index of providers possible. In furthering such purpose, the Secretary shall include all health professionals and health facilities applicable to provide a useful, reliable, and comprehensive index for use in the exchange of health information.

(B) LIMITATION.—In no case shall exclusion from the index of providers be used as a measure to achieve objectives other the objectives described in subparagraph (A).

(d) Standards development organizations.—Section 3004 of the Public Health Service Act (42 U.S.C. 300jj–14) is amended by adding at the end the following:

“(c) Deference to standards development organizations.—In adopting and implementing standards under this section, the Secretary shall give deference to standards published by standards development organizations and voluntary consensus-based standards bodies.”.

(e) Health Information Technology advisory committee.—

(1) IN GENERAL.—Title XXX of the Public Health Service Act (42 U.S.C. 300jj et seq.) is amended by striking sections 3002 (42 U.S.C. 300jj–12) and 3003 (42 U.S.C. 300jj–13) and inserting the following:

“SEC. 3002. Health information technology advisory committee.

“(a) Establishment.—There is established a Health Information Technology Advisory Committee (referred to in this section as the ‘HIT Advisory Committee’) to recommend to the National Coordinator, consistent with the implementation of the strategic plan described in section 3001(c)(3), policies, and, for purposes of adoption under section 3004, standards, implementation specifications, and certification criteria, relating to the implementation of a health information technology infrastructure, nationally and locally, that advances the electronic access, exchange, and use of health information. Such Committee shall serve to unify the roles of, and replace, the HIT Policy Committee and the HIT Standards Committee, as in existence before the date of the enactment of the 21st Century Cures Act.

“(b) Duties.—

“(1) RECOMMENDATIONS ON POLICY FRAMEWORK TO ADVANCE AN INTEROPERABLE HEALTH INFORMATION TECHNOLOGY INFRASTRUCTURE.—

“(A) IN GENERAL.—The HIT Advisory Committee shall recommend to the National Coordinator a policy framework for adoption by the Secretary consistent with the strategic plan under section 3001(c)(3) for advancing the target areas described in this subsection. Such policy framework shall seek to prioritize achieving advancements in the target areas specified in subparagraph (B) of paragraph (2) and may, to the extent consistent with this section, incorporate policy recommendations made by the HIT Policy Committee, as in existence before the date of the enactment of the 21st Century Cures Act.

“(B) UPDATES.—The HIT Advisory Committee shall propose updates to such recommendations to the policy framework and make new recommendations, as appropriate.

“(2) GENERAL DUTIES AND TARGET AREAS.—

“(A) IN GENERAL.—The HIT Advisory Committee shall recommend to the National Coordinator for purposes of adoption under section 3004, standards, implementation specifications, and certification criteria and an order of priority for the development, harmonization, and recognition of such standards, specifications, and certification criteria. Such recommendations shall include recommended standards, architectures, and software schemes for access to electronic individually identifiable health information across disparate systems including user vetting, authentication, privilege management, and access control.

“(B) PRIORITY TARGET AREAS.—For purposes of this section, the HIT Advisory Committee shall make recommendations under subparagraph (A) with respect to at least each of the following target areas:

“(i) Achieving a health information technology infrastructure, nationally and locally, that allows for the electronic access, exchange, and use of health information, including through technology that provides accurate patient information for the correct patient, including exchanging such information, and avoids the duplication of patient records.

“(ii) The promotion and protection of privacy and security of health information in health information technology, including technologies that allow for an accounting of disclosures and protections against disclosures of individually identifiable health information made by a covered entity for purposes of treatment, payment, and health care operations (as such terms are defined for purposes of the regulation promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996), including for the segmentation and protection from disclosure of specific and sensitive individually identifiable health information with the goal of minimizing the reluctance of patients to seek care.

“(iii) The facilitation of secure access by an individual to such individual’s protected health information and access to such information by a family member, caregiver, or guardian acting on behalf of a patient, including due to age-related and other disability, cognitive impairment, or dementia.

“(iv) Subject to subparagraph (D), any other target area that the HIT Advisory Committee identifies as an appropriate target area to be considered under this subparagraph.

“(C) ADDITIONAL TARGET AREAS.—For purposes of this section, the HIT Advisory Committee may make recommendations under subparagraph (A), in addition to areas described in subparagraph (B), with respect to any of the following areas:

“(i) The use of health information technology to improve the quality of health care, such as by promoting the coordination of health care and improving continuity of health care among health care providers, reducing medical errors, improving population health, reducing chronic disease, and advancing research and education.

“(ii) The use of technologies that address the needs of children and other vulnerable populations.

“(iii) The use of electronic systems to ensure the comprehensive collection of patient demographic data, including at a minimum, race, ethnicity, primary language, and gender information.

“(iv) The use of self-service, telemedicine, home health care, and remote monitoring technologies.

“(v) The use of technologies that meet the needs of diverse populations.

“(vi) The use of technologies that support—

“(I) data for use in quality and public reporting programs;

“(II) public health; or

“(III) drug safety.

“(vii) The use of technologies that allow individually identifiable health information to be rendered unusable, unreadable, or indecipherable to unauthorized individuals when such information is transmitted in a health information network or transported outside of the secure facilities or systems where the disclosing covered entity is responsible for security conditions.

“(viii) The use of a certified health information technology for each individual in the United States.

“(D) AUTHORITY FOR TEMPORARY ADDITIONAL PRIORITY TARGET AREAS.—For purposes of subparagraph (B)(iv), the HIT Advisory Committee may identify an area to be considered for purposes of recommendations under this subsection as a target area described in subparagraph (B) if—

“(i) the area is so identified for purposes of responding to new circumstances that have arisen in the health information technology community that affect the interoperability, privacy, or security of health information, or affect patient safety; and

“(ii) at least 30 days prior to treating such area as if it were a target area described in subparagraph (B), the National Coordinator provides adequate notice to Congress of the intent to treat such area as so described.

“(E) FOCUS OF COMMITTEE WORK.—It is the sense of Congress that the HIT Advisory Committee shall focus its work on the priority areas described in subparagraph (B) before proceeding to other work under subparagraph (C).

“(3) RULES RELATING TO RECOMMENDATIONS FOR STANDARDS, IMPLEMENTATION SPECIFICATIONS, AND CERTIFICATION CRITERIA.—

“(A) IN GENERAL.—The HIT Advisory Committee shall recommend to the National Coordinator standards, implementation specifications, and certification criteria described in subsection (a), which may include standards, implementation specifications, and certification criteria that have been developed, harmonized, or recognized by the HIT Advisory Committee or predecessor committee. The HIT Advisory Committee shall update such recommendations and make new recommendations as appropriate, including in response to a notification sent under section 3004(a)(2)(B). Such recommendations shall be consistent with the latest recommendations made by the Committee.

“(B) HARMONIZATION.—The HIT Advisory Committee may recognize harmonized or updated standards from an entity or entities for the purpose of harmonizing or updating standards and implementation specifications in order to achieve uniform and consistent implementation of the standards and implementation specification.

“(C) PILOT TESTING OF STANDARDS AND IMPLEMENTATION SPECIFICATIONS.—In the development, harmonization, or recognition of standards and implementation specifications, the HIT Advisory Committee for purposes of recommendations under paragraph (2)(B), shall, as appropriate, provide for the testing of such standards and specifications by the National Institute for Standards and Technology under section 13201(a) of the Health Information Technology for Economic and Clinical Health Act.

“(D) CONSISTENCY.—The standards, implementation specifications, and certification criteria recommended under paragraph (2)(B) shall be consistent with the standards for information transactions and data elements adopted pursuant to section 1173 of the Social Security Act.

“(E) SPECIAL RULE RELATED TO INTEROPERABILITY.—Any recommendation made by the HIT Advisory Committee after the date of the enactment of this subparagraph with respect to interoperability of health information technology shall be consistent with interoperability as described in section 3000.

“(4) FORUM.—The HIT Advisory Committee shall serve as a forum for the participation of a broad range of stakeholders with specific expertise in policies, including technical expertise, relating to the matters described in paragraphs (1), (2), and (3) to provide input on the development, harmonization, and recognition of standards, implementation specifications, and certification criteria necessary for the development and adoption of health information technology infrastructure nationally and locally that allows for the electronic access, exchange, and use of health information.

“(5) SCHEDULE.—Not later than 30 days after the date on which the HIT Advisory Committee first meets, such HIT Advisory Committee shall develop a schedule for the assessment of policy recommendations developed under paragraph (1). The HIT Advisory Committee shall update such schedule annually. The Secretary shall publish such schedule in the Federal Register.

“(6) PUBLIC INPUT.—The HIT Advisory Committee shall conduct open public meetings and develop a process to allow for public comment on the schedule described in paragraph (5) and recommendations described in this subsection. Under such process comments shall be submitted in a timely manner after the date of publication of a recommendation under this subsection.

“(c) Measured progress in advancing priority areas.—

“(1) IN GENERAL.—For purposes of this section, the National Coordinator, in collaboration with the Secretary, shall establish, and update as appropriate, objectives and benchmarks for advancing and measuring the advancement of the priority target areas described in subsection (b)(2)(B).

“(2) ANNUAL PROGRESS REPORTS ON ADVANCING INTEROPERABILITY.—

“(A) IN GENERAL.—The HIT Advisory Committee, in consultation with the National Coordinator, shall annually submit to the Secretary and Congress a report on the progress made during the preceding fiscal year in—

“(i) achieving a health information technology infrastructure, nationally and locally, that allows for the electronic access, exchange, and use of health information; and

“(ii) meeting the objectives and benchmarks described in paragraph (1).

“(B) CONTENT.—Each such report shall include, for a fiscal year—

“(i) a description of the work conducted by the HIT Advisory Committee during the preceding fiscal year with respect to the areas described in subsection (b)(2)(B);

“(ii) an assessment of the status of the infrastructure described in subparagraph (A), including the extent to which electronic health information is appropriately and readily available to enhance the access, exchange, and the use of electronic health information between users and across technology offered by different developers;

“(iii) the extent to which advancements have been achieved with respect to areas described in subsection (b)(2)(B);

“(iv) an analysis identifying existing gaps in policies and resources for—

“(I) achieving the objectives and benchmarks established under paragraph (1); and

“(II) furthering interoperability throughout the health information technology infrastructure;

“(v) recommendations for addressing the gaps identified in clause (iii); and

“(vi) a description of additional initiatives as the HIT Advisory Committee and National Coordinator determine appropriate.

“(3) SIGNIFICANT ADVANCEMENT DETERMINATION.—The Secretary shall periodically, based on the reports submitted under this subsection, review the target areas described in subsection (b)(2)(B), and, based on the objectives and benchmarks established under paragraph (1), the Secretary shall determine if significant advancement has been achieved with respect to such an area. Such determination shall be taken into consideration by the HIT Advisory Committee when determining to what extent the Committee makes recommendations for an area other than an area described in subsection (b)(2)(B).

“(d) Membership and operations.—

“(1) IN GENERAL.—The National Coordinator shall take a leading position in the establishment and operations of the HIT Advisory Committee.

“(2) MEMBERSHIP.—The membership of the HIT Advisory Committee shall—

“(A) include at least 25 members, of which—

“(i) no fewer than 2 members are advocates for patients or consumers of health information technology;

“(ii) 3 members are appointed by the Secretary, 1 of whom shall be appointed to represent the Department of Health and Human Services and 1 of whom shall be a public health official;

“(iii) 2 members are appointed by the majority leader of the Senate;

“(iv) 2 members are appointed by the minority leader of the Senate;

“(v) 2 members are appointed by the Speaker of the House of Representatives;

“(vi) 2 members are appointed by the minority leader of the House of Representatives; and

“(vii) such other members are appointed by the Comptroller General of the United States; and

“(B) at least reflect providers, ancillary health care workers, consumers, purchasers, health plans, health information technology developers, researchers, patients, relevant Federal agencies, and individuals with technical expertise on health care quality, system functions, privacy, security, and on the electronic exchange and use of health information, including the use standards for such activity.

“(3) PARTICIPATION.—The members of the HIT Advisory Committee shall represent a balance among various sectors of the health care system so that no single sector unduly influences the recommendations of the Committee.

“(4) TERMS.—

“(A) IN GENERAL.—The terms of the members of the HIT Advisory Committee shall be for 3 years, except that the Secretary shall designate staggered terms of the members first appointed.

“(B) VACANCIES.—Any member appointed to fill a vacancy in the membership of the HIT Advisory Committee that occurs prior to the expiration of the term for which the member’s predecessor was appointed shall be appointed only for the remainder of that term. A member may serve after the expiration of that member’s term until a successor has been appointed. A vacancy in the HIT Advisory Committee shall be filled in the manner in which the original appointment was made.

“(C) LIMITS.—Members of the HIT Advisory Committee shall be limited to two 3-year terms, for a total of not to exceed 6 years of service on the Committee.

“(5) OUTSIDE INVOLVEMENT.—The HIT Advisory Committee shall ensure an opportunity for the participation in activities of the Committee of outside advisors, including individuals with expertise in the development of policies and standards for the electronic exchange and use of health information, including in the areas of health information privacy and security.

“(6) QUORUM.—A majority of the members of the HIT Advisory Committee shall constitute a quorum for purposes of voting, but a lesser number of members may meet and hold hearings.

“(7) CONSIDERATION.—The National Coordinator shall ensure that the relevant and available recommendations and comments from the National Committee on Vital and Health Statistics are considered in the development of policies.

“(8) ASSISTANCE.—For the purposes of carrying out this section, the Secretary may provide or ensure that financial assistance is provided by the HIT Advisory Committee to defray in whole or in part any membership fees or dues charged by such Committee to those consumer advocacy groups and not-for-profit entities that work in the public interest as a party of their mission.

“(e) Application of FACA.—The Federal Advisory Committee Act (5 U.S.C. App.), other than section 14 of such Act, shall apply to the HIT Advisory Committee.

“(f) Publication.—The Secretary shall provide for publication in the Federal Register and the posting on the Internet website of the Office of the National Coordinator for Health Information Technology of all policy recommendations made by the HIT Advisory Committee under this section.”.

(2) TECHNICAL AND CONFORMING AMENDMENTS.—Title XXX of the Public Health Service Act (42 U.S.C. 300jj et seq.) is amended—

(A) by striking—

(i) “HIT Policy Committee” and “HIT Standards Committee” each place that such terms appear (other than within the term “HIT Policy Committee and the HIT Standards Committee” or within the term “HIT Policy Committee or the HIT Standards Committee”) and inserting “HIT Advisory Committee”;

(ii) “HIT Policy Committee and the HIT Standards Committee” each place that such term appears and inserting “HIT Advisory Committee”; and

(iii) “HIT Policy Committee or the HIT Standards Committee” each place that such term appears and inserting “HIT Advisory Committee”;

(B) in section 3000 (42 U.S.C. 300jj)—

(i) by striking paragraphs (7) and (8) and redesignating paragraphs (9) through (14) as paragraphs (8) through (13), respectively; and

(ii) by inserting after paragraph (6) the following paragraph:

“(7) HIT ADVISORY COMMITTEE.—The term ‘HIT Advisory Committee’ means such Committee established under section 3002(a).”;

(C) in section 3001(c) (42 U.S.C. 300jj–11(c))—

(i) in paragraph (1)(A), by striking “under section 3003” and inserting “under section 3002”;

(ii) in paragraph (2), by striking subparagraph (B) and inserting the following:

“(B) HIT ADVISORY COMMITTEE.—The National Coordinator shall be a leading member in the establishment and operations of the HIT Advisory Committee and shall serve as a liaison between that Committee and the Federal Government.”;

(D) in section 3004(b)(3) (42 U.S.C. 300jj–14(b)(3)), by striking “3003(b)(2)” and inserting “3002(b)(4)”;

(E) in section 3007(b) (42 U.S.C. 300jj–17(b)), by striking “3003(a)” and inserting “3002(a)(2)”; and

(F) in section 3008 (42 U.S.C. 300jj–18)—

(i) in subsection (b), by striking “or 3003”; and

(ii) in subsection (c), by striking “3003(b)(1)(A)” and inserting “3002(b)(2)”.

(3) TRANSITION TO THE HIT ADVISORY COMMITTEE.—The Secretary of Health and Human Services shall provide for an orderly and timely transition to the HIT Advisory Committee established under amendments made by this section.

(f) Priorities for Adoption of Standards, Implementation Specifications, and Certification criteria.—Title XXX of the Public Health Service Act (42 U.S.C. 300jj et seq.), as amended by subsection (e), is further amended by inserting after section 3002 the following:

“SEC. 3003. Setting priorities for standards adoption.

“(a) Identifying priorities.—

“(1) IN GENERAL.—Not later than 6 months after the date on which the HIT Advisory Committee first meets, the National Coordinator shall periodically convene the HIT Advisory Committee to—

“(A) identify priority uses of health information technology, focusing on priorities—

“(i) arising from the implementation of the incentive programs for the meaningful use of certified EHR technology, the Merit-based Incentive Payment System, Alternative Payment Models, the Hospital Value-Based Purchasing Program, and any other value-based payment program determined appropriate by the Secretary;

“(ii) related to the quality of patient care;

“(iii) related to public health;

“(iv) related to clinical research;

“(v) related to the privacy and security of electronic health information;

“(vi) related to innovation in the field of health information technology;

“(vii) related to patient safety;

“(viii) related to the usability of health information technology;

“(ix) related to individuals’ access to electronic health information; and

“(x) other priorities determined appropriate by the Secretary;

“(B) identify existing standards and implementation specifications that support the use and exchange of electronic health information needed to meet the priorities identified in subparagraph (A); and

“(C) publish a report summarizing the findings of the analysis conducted under subparagraphs (A) and (B) and make appropriate recommendations.

“(2) PRIORITIZATION.—In identifying such standards and implementation specifications under paragraph (1)(B), the HIT Advisory Committee shall prioritize standards and implementation specifications developed by consensus-based standards development organizations.

“(3) GUIDELINES FOR REVIEW OF EXISTING STANDARDS AND SPECIFICATIONS.—In consultation with the consensus-based entity described in section 1890 of the Social Security Act and other appropriate Federal agencies, the analysis of existing standards under paragraph (1)(B) shall include an evaluation of the need for a core set of common data elements and associated value sets to enhance the ability of certified health information technology to capture, use, and exchange structured electronic health information.

“(b) Review of adopted standards.—

“(1) IN GENERAL.—Beginning 5 years after the date of enactment of the 21st Century Cures Act and every 3 years thereafter, the National Coordinator shall convene stakeholders to review the existing set of adopted standards and implementation specifications and make recommendations with respect to whether to—

“(A) maintain the use of such standards and implementation specifications; or

“(B) phase out such standards and implementation specifications.

“(2) PRIORITIES.—The HIT Advisory Committee, in collaboration with the National Institute for Standards and Technology, shall annually and through the use of public input, review and publish priorities for the use of health information technology, standards, and implementation specifications to support those priorities.

“(c) Rule of construction.—Nothing in this section shall be construed to prevent the use or adoption of novel standards that improve upon the existing health information technology infrastructure and facilitate the secure exchange of health information.”.

SEC. 4004. Information blocking.

Subtitle C of title XXX of the Public Health Service Act (42 U.S.C. 300jj–51 et seq.) is amended by adding at the end the following:

“SEC. 3022. Information blocking.

“(a) Definition.—

“(1) IN GENERAL.—In this section, the term ‘information blocking’ means a practice that—

“(A) except as required by law or specified by the Secretary pursuant to rulemaking under paragraph (3), is likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information; and

“(B)(i) if conducted by a health information technology developer, exchange, or network, such developer, exchange, or network knows, or should know, that such practice is likely to interfere with, prevent, or materially discourage the access, exchange, or use of electronic health information; or

“(ii) if conducted by a health care provider, such provider knows that such practice is unreasonable and is likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information.

“(2) PRACTICES DESCRIBED.—The information blocking practices described in paragraph (1) may include—

“(A) practices that restrict authorized access, exchange, or use under applicable State or Federal law of such information for treatment and other permitted purposes under such applicable law, including transitions between certified health information technologies;

“(B) implementing health information technology in nonstandard ways that are likely to substantially increase the complexity or burden of accessing, exchanging, or using electronic health information; and

“(C) implementing health information technology in ways that are likely to—

“(i) restrict the access, exchange, or use of electronic health information with respect to exporting complete information sets or in transitioning between health information technology systems; or

“(ii) lead to fraud, waste, or abuse, or impede innovations and advancements in health information access, exchange, and use, including care delivery enabled by health information technology.

“(3) RULEMAKING.—The Secretary, through rulemaking, shall identify reasonable and necessary activities that do not constitute information blocking for purposes of paragraph (1).

“(4) NO ENFORCEMENT BEFORE EXCEPTION IDENTIFIED.—The term ‘information blocking’ does not include any practice or conduct occurring prior to the date that is 30 days after the date of enactment of the 21st Century Cures Act.

“(5) CONSULTATION.—The Secretary may consult with the Federal Trade Commission in promulgating regulations under this subsection, to the extent that such regulations define practices that are necessary to promote competition and consumer welfare.

“(6) APPLICATION.—The term ‘information blocking’, with respect to an individual or entity, shall not include an act or practice other than an act or practice committed by such individual or entity.

“(7) CLARIFICATION.—In carrying out this section, the Secretary shall ensure that health care providers are not penalized for the failure of developers of health information technology or other entities offering health information technology to such providers to ensure that such technology meets the requirements to be certified under this title.

“(b) Inspector general authority.—

“(1) IN GENERAL.—The inspector general of the Department of Health and Human Services (referred to in this section as the ‘Inspector General’) may investigate any claim that—

“(A) a health information technology developer of certified health information technology or other entity offering certified health information technology—

“(i) submitted a false attestation under section 3001(c)(5)(D)(vii); or

“(ii) engaged in information blocking;

“(B) a health care provider engaged in information blocking; or

“(C) a health information exchange or network engaged in information blocking.

“(2) PENALTIES.—

“(A) DEVELOPERS, NETWORKS, AND EXCHANGES.—Any individual or entity described in subparagraph (A) or (C) of paragraph (1) that the Inspector General, following an investigation conducted under this subsection, determines to have committed information blocking shall be subject to a civil monetary penalty determined by the Secretary for all such violations identified through such investigation, which may not exceed $1,000,000 per violation. Such determination shall take into account factors such as the nature and extent of the information blocking and harm resulting from such information blocking, including, where applicable, the number of patients affected, the number of providers affected, and the number of days the information blocking persisted.

“(B) PROVIDERS.—Any individual or entity described in subparagraph (B) of paragraph (1) determined by the Inspector General to have committed information blocking shall be referred to the appropriate agency to be subject to appropriate disincentives using authorities under applicable Federal law, as the Secretary sets forth through notice and comment rulemaking.

“(C) PROCEDURE.—The provisions of section 1128A of the Social Security Act (other than subsections (a) and (b) of such section) shall apply to a civil money penalty applied under this paragraph in the same manner as such provisions apply to a civil money penalty or proceeding under such section 1128A(a).

“(D) RECOVERED PENALTY FUNDS.—The amounts recovered under this paragraph shall be allocated as follows:

“(i) ANNUAL OPERATING EXPENSES.—Each year following the establishment of the authority under this subsection, the Office of the Inspector General shall provide to the Secretary an estimate of the costs to carry out investigations under this section. Such estimate may include reasonable reserves to account for variance in annual amounts recovered under this paragraph. There is authorized to be appropriated for purposes of carrying out this section an amount equal to the amount specified in such estimate for the fiscal year.

“(ii) APPLICATION TO OTHER PROGRAMS.—The amounts recovered under this paragraph and remaining after amounts are made available under clause (i) shall be transferred to the Federal Hospital Insurance Trust Fund under section 1817 of the Social Security Act and the Federal Supplementary Medical Insurance Trust Fund under section 1841 of such Act, in such proportion as the Secretary determines appropriate.

“(E) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to the Office of the Inspector General to carry out this section $10,000,000, to remain available until expended.

“(3) RESOLUTION OF CLAIMS.—

“(A) IN GENERAL.—The Office of the Inspector General, if such Office determines that a consultation regarding the health privacy and security rules promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. 1320d–2 note) will resolve an information blocking claim, may refer such instances of information blocking to the Office for Civil Rights of the Department of Health and Human Services for resolution.

“(B) LIMITATION ON LIABILITY.—If a health care provider or health information technology developer makes information available based on a good faith reliance on consultations with the Office for Civil Rights of the Department of Health and Human Services pursuant to a referral under subparagraph (A), with respect to such information, the health care provider or developer shall not be liable for such disclosure or disclosures made pursuant to subparagraph (A).

“(c) Identifying barriers To exchange of certified health information technology.—

“(1) TRUSTED EXCHANGE DEFINED.—In this section, the term ‘trusted exchange’ with respect to certified electronic health records means that the certified electronic health record technology has the technical capability to enable secure health information exchange between users and multiple certified electronic health record technology systems.

“(2) GUIDANCE.—The National Coordinator, in consultation with the Office for Civil Rights of the Department of Health and Human Services, shall issue guidance on common legal, governance, and security barriers that prevent the trusted exchange of electronic health information.

“(3) REFERRAL.—The National Coordinator and the Office for Civil Rights of the Department of Health and Human Services may refer to the Inspector General instances or patterns of refusal to exchange health information with an individual or entity using certified electronic health record technology that is technically capable of trusted exchange and under conditions when exchange is legally permissible.

“(d) Additional provisions.—

“(1) INFORMATION SHARING PROVISIONS.—The National Coordinator may serve as a technical consultant to the Inspector General and the Federal Trade Commission for purposes of carrying out this section. The National Coordinator may, notwithstanding any other provision of law, share information related to claims or investigations under subsection (b) with the Federal Trade Commission for purposes of such investigations and shall share information with the Inspector General, as required by law.

“(2) PROTECTION FROM DISCLOSURE OF INFORMATION.—Any information that is received by the National Coordinator in connection with a claim or suggestion of possible information blocking and that could reasonably be expected to facilitate identification of the source of the information—

“(A) shall not be disclosed by the National Coordinator except as may be necessary to carry out the purpose of this section;

“(B) shall be exempt from mandatory disclosure under section 552 of title 5, United States Code, as provided by subsection (b)(3) of such section; and

“(C) may be used by the Inspector General or Federal Trade Commission for reporting purposes to the extent that such information could not reasonably be expected to facilitate identification of the source of such information.

“(3) STANDARDIZED PROCESS.—

“(A) IN GENERAL.—The National Coordinator shall implement a standardized process for the public to submit reports on claims of—

“(i) health information technology products or developers of such products (or other entities offering such products to health care providers) not being interoperable or resulting in information blocking;

“(ii) actions described in subsection (b)(1) that result in information blocking as described in subsection (a); and

“(iii) any other act described in subsection (a).

“(B) COLLECTION OF INFORMATION.—The standardized process implemented under subparagraph (A) shall provide for the collection of such information as the originating institution, location, type of transaction, system and version, timestamp, terminating institution, locations, system and version, failure notice, and other related information.

“(4) NONDUPLICATION OF PENALTY STRUCTURES.—In carrying out this subsection, the Secretary shall, to the extent possible, ensure that penalties do not duplicate penalty structures that would otherwise apply with respect to information blocking and the type of individual or entity involved as of the day before the date of the enactment of this section.”.

SEC. 4005. Leveraging electronic health records to improve patient care.

(a) Requirement relating to registries.—

(1) IN GENERAL.—To be certified in accordance with title XXX of the Public Health Service Act (42 U.S.C. 300jj et seq.), electronic health records shall be capable of transmitting to, and where applicable, receiving and accepting data from, registries in accordance with standards recognized by the Office of the National Coordinator for Health Information Technology, including clinician-led clinical data registries, that are also certified to be technically capable of receiving and accepting from, and where applicable, transmitting data to certified electronic health record technology in accordance with such standards.

(2) RULE OF CONSTRUCTION.—Nothing in this subsection shall be construed to require the certification of registries beyond the technical capability to exchange data in accordance with applicable recognized standards.

(b) Definition.—For purposes of this Act, the term “clinician-led clinical data registry” means a clinical data repository—

(1) that is established and operated by a clinician-led or controlled, tax-exempt (pursuant to section 501(c) of the Internal Revenue Code of 1986), professional society or other similar clinician-led or -controlled organization, or such organization’s controlled affiliate, devoted to the care of a population defined by a particular disease, condition, exposure or therapy;

(2) that is designed to collect detailed, standardized data on an ongoing basis for medical procedures, services, or therapies for particular diseases, conditions, or exposures;

(3) that provides feedback to participants who submit reports to the repository;

(4) that meets standards for data quality including—

(A) systematically collecting clinical and other health care data, using standardized data elements and having procedures in place to verify the completeness and validity of those data; and

(B) being subject to regular data checks or audits to verify completeness and validity; and

(5) that provides ongoing participant training and support.

(c) Treatment of health information technology developers with respect to patient safety organizations.—

(1) IN GENERAL.—In applying part C of title IX of the Public Health Service Act (42 U.S.C. 299b–21 et seq.), a health information technology developer shall be treated as a provider (as defined in section 921 of such Act) for purposes of reporting and conducting patient safety activities concerning improving clinical care through the use of health information technology that could result in improved patient safety, health care quality, or health care outcomes.

(2) REPORT.—Not later than 4 years after the date of enactment of this Act, the Secretary of Health and Human Services shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report concerning best practices and current trends voluntarily provided, without identifying individual providers or disclosing or using protected health information or individually identifiable information, by patient safety organizations to improve the integration of health information technology into clinical practice.

SEC. 4006. Empowering patients and improving patient access to their electronic health information.

(a) Use of health information exchanges for patient access.—Section 3009 of the Public Health Service Act (42 U.S.C. 300jj–19) is amended by adding at the end the following:

“(c) Promoting patient access to electronic health information through health information exchanges .—

“(1) IN GENERAL.—The Secretary shall use existing authorities to encourage partnerships between health information exchange organizations and networks and health care providers, health plans, and other appropriate entities with the goal of offering patients access to their electronic health information in a single, longitudinal format that is easy to understand, secure, and may be updated automatically.

“(2) EDUCATION OF PROVIDERS.—The Secretary, in coordination with the Office for Civil Rights of the Department of Health and Human Services, shall—

“(A) educate health care providers on ways of leveraging the capabilities of health information exchanges (or other relevant platforms) to provide patients with access to their electronic health information;

“(B) clarify misunderstandings by health care providers about using health information exchanges (or other relevant platforms) for patient access to electronic health information; and

“(C) to the extent practicable, educate providers about health information exchanges (or other relevant platforms) that employ some or all of the capabilities described in paragraph (1).

“(3) REQUIREMENTS.—In carrying out paragraph (1), the Secretary, in coordination with the Office for Civil Rights, shall issue guidance to health information exchanges related to best practices to ensure that the electronic health information provided to patients is—

“(A) private and secure;

“(B) accurate;

“(C) verifiable; and

“(D) where a patient’s authorization to exchange information is required by law, easily exchanged pursuant to such authorization.

“(4) RULE OF CONSTRUCTION.—Nothing in this subsection shall be construed to preempt State laws applicable to patient consent for the access of information through a health information exchange (or other relevant platform) that provide protections to patients that are greater than the protections otherwise provided for under applicable Federal law.

“(d) Efforts To promote access to health information.—The National Coordinator and the Office for Civil Rights of the Department of Health and Human Services shall jointly promote patient access to health information in a manner that would ensure that such information is available in a form convenient for the patient, in a reasonable manner, without burdening the health care provider involved.

“(e) Accessibility of patient records.—

“(1) ACCESSIBILITY AND UPDATING OF INFORMATION.—

“(A) IN GENERAL.—The Secretary, in consultation with the National Coordinator, shall promote policies that ensure that a patient’s electronic health information is accessible to that patient and the patient's designees, in a manner that facilitates communication with the patient’s health care providers and other individuals, including researchers, consistent with such patient’s consent.

“(B) UPDATING EDUCATION ON ACCESSING AND EXCHANGING PERSONAL HEALTH INFORMATION.—To promote awareness that an individual has a right of access to inspect, obtain a copy of, and transmit to a third party a copy of such individual's protected health information pursuant to the Health Information Portability and Accountability Act, Privacy Rule (subpart E of part 164 of title 45, Code of Federal Regulations), the Director of the Office for Civil Rights, in consultation with the National Coordinator, shall assist individuals and health care providers in understanding a patient’s rights to access and protect personal health information under the Health Insurance Portability and Accountability Act of 1996 (Public Law 104–191), including providing best practices for requesting personal health information in a computable format, including using patient portals or third-party applications and common cases when a provider is permitted to exchange and provide access to health information.”.

“(2) CERTIFYING USABILITY FOR PATIENTS.—In carrying out certification programs under section 3001(c)(5), the National Coordinator may require that—

“(A) the certification criteria support—

“(i) patient access to their electronic health information, including in a single longitudinal format that is easy to understand, secure, and may be updated automatically;

“(ii) the patient's ability to electronically communicate patient-reported information (such as family history and medical history); and

“(iii) patient access to their personal electronic health information for research at the option of the patient; and

“(B) the HIT Advisory Committee develop and prioritize standards, implementation specifications, and certification criteria required to help support patient access to electronic health information, patient usability, and support for technologies that offer patients access to their electronic health information in a single, longitudinal format that is easy to understand, secure, and may be updated automatically.”.

(b) Access to information in an electronic format.—Section 13405(e) of the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. 17935) is amended—

(1) in paragraph (1), by striking “and” at the end;

(2) by redesignating paragraph (2) as paragraph (3); and

(3) by inserting after paragraph (1), the following:

“(2) if the individual makes a request to a business associate for access to, or a copy of, protected health information about the individual, or if an individual makes a request to a business associate to grant such access to, or transmit such copy directly to, a person or entity designated by the individual, a business associate may provide the individual with such access or copy, which may be in an electronic form, or grant or transmit such access or copy to such person or entity designated by the individual; and”.

SEC. 4007. GAO study on patient matching.

(a) In general.—Not later than 1 year after the date of enactment of this Act, the Comptroller General of the United States shall conduct a study to—

(1) review the policies and activities of the Office of the National Coordinator for Health Information Technology and other relevant stakeholders, which may include standards development organizations, experts in the technical aspects of health information technology, health information technology developers, providers of health services, health care suppliers, health care payers, health care quality organizations, States, health information technology policy experts, and other appropriate entities, to ensure appropriate patient matching to protect patient privacy and security with respect to electronic health records and the exchange of electronic health information; and

(2) survey ongoing efforts related to the policies and activities described in paragraph (1) and the effectiveness of such efforts occurring in the private sector.

(b) Areas of concentration.—In conducting the study under subsection (a), the Comptroller General shall—

(1) evaluate current methods used in certified electronic health records for patient matching based on performance related to factors such as—

(A) the privacy of patient information;

(B) the security of patient information;

(C) improving matching rates;

(D) reducing matching errors; and

(E) reducing duplicate records; and

(2) determine whether the Office of the National Coordinator for Health Information Technology could improve patient matching by taking steps including—

(A) defining additional data elements to assist in patient data matching;

(B) agreeing on a required minimum set of elements that need to be collected and exchanged;

(C) requiring electronic health records to have the ability to make certain fields required and use specific standards; and

(D) other options recommended by the relevant stakeholders consulted pursuant to subsection (a).

(c) Report.—Not later than 2 years after the date of enactment of this Act, the Comptroller General shall submit to the appropriate committees of Congress a report concerning the findings of the study conducted under subsection (a).

SEC. 4008. GAO study on patient access to health information.

(a) Study.—

(1) IN GENERAL.—The Comptroller General of the United States (referred to in this section as the “Comptroller General”) shall build on prior Government Accountability Office studies and other literature review and conduct a study to review patient access to their own protected health information, including barriers to such patient access and complications or difficulties providers experience in providing access to patients. In conducting such study, the Comptroller General shall consider the increase in adoption of health information technology and the increasing prevalence of protected health information that is maintained electronically.

(2) AREAS OF CONCENTRATION.—In conducting the review under paragraph (1), the Comptroller General shall consider—

(A) instances when covered entities charge individuals, including patients, third parties, and health care providers, for record requests, including records that are requested in an electronic format;

(B) examples of the amounts and types of fees charged to individuals for record requests, including instances when the record is requested to be transmitted to a third party;

(C) the extent to which covered entities are unable to provide the access requested by individuals in the form and format requested by the individual, including examples of such instances;

(D) instances in which third parties may request protected health information through patients’ individual right of access, including instances where such requests may be used to circumvent appropriate fees that may be charged to third parties;

(E) opportunities that permit covered entities to charge appropriate fees to third parties for patient records while providing patients with access to their protected health information at low or no cost;

(F) the ability of providers to distinguish between requests originating from an individual that require limitation to a cost-based fee and requests originating from third parties that may not be limited to cost-based fees; and

(G) other circumstances that may inhibit the ability of providers to provide patients with access to their records, and the ability of patients to gain access to their records.

(b) Report.—Not later than 18 months after the date of enactment of this Act, the Comptroller General shall submit a report to Congress on the findings of the study conducted under subsection (a).

SEC. 4009. Improving Medicare local coverage determinations.

(a) In general.—Section 1862(l)(5) of the Social Security Act (42 U.S.C. 1395y(l)(5)) is amended by adding at the end the following new subparagraph:

“(D) LOCAL COVERAGE DETERMINATIONS.—The Secretary shall require each Medicare administrative contractor that develops a local coverage determination to make available on the Internet website of such contractor and on the Medicare Internet website, at least 45 days before the effective date of such determination, the following information:

“(i) Such determination in its entirety.

“(ii) Where and when the proposed determination was first made public.

“(iii) Hyperlinks to the proposed determination and a response to comments submitted to the contractor with respect to such proposed determination.

“(iv) A summary of evidence that was considered by the contractor during the development of such determination and a list of the sources of such evidence.

“(v) An explanation of the rationale that supports such determination.”.

(b) Effective date.—The amendment made by subsection (a) shall apply with respect to local coverage determinations that are proposed or revised on or after the date that is 180 days after the date of enactment of this Act.

SEC. 4010. Medicare pharmaceutical and technology ombudsman.

Section 1808 of the Social Security Act (42 U.S.C. 1395b–9) is amended by adding at the end the following new subsection:

“(d) Pharmaceutical and technology ombudsman.—

“(1) IN GENERAL.—Not later than 12 months after the date of enactment of this paragraph, the Secretary shall provide for a pharmaceutical and technology ombudsman within the Centers for Medicare & Medicaid Services who shall receive and respond to complaints, grievances, and requests that—

“(A) are from entities that manufacture pharmaceutical, biotechnology, medical device, or diagnostic products that are covered or for which coverage is being sought under this title; and

“(B) are with respect to coverage, coding, or payment under this title for such products.

“(2) APPLICATION.—The second sentence of subsection (c)(2) shall apply to the ombudsman under subparagraph (A) in the same manner as such sentence applies to the Medicare Beneficiary Ombudsman under subsection (c).”.

SEC. 4011. Medicare site-of-service price transparency.

Section 1834 of the Social Security Act (42 U.S.C. 1395m) is amended by adding at the end the following new subsection:

“(t) Site-of-Service price transparency.—

“(1) IN GENERAL.—In order to facilitate price transparency with respect to items and services for which payment may be made either to a hospital outpatient department or to an ambulatory surgical center under this title, the Secretary shall, for 2018 and each year thereafter, make available to the public via a searchable Internet website, with respect to an appropriate number of such items and services—

“(A) the estimated payment amount for the item or service under the outpatient department fee schedule under subsection (t) of section 1833 and the ambulatory surgical center payment system under subsection (i) of such section; and

“(B) the estimated amount of beneficiary liability applicable to the item or service.

“(2) CALCULATION OF ESTIMATED BENEFICIARY LIABILITY.—For purposes of paragraph (1)(B), the estimated amount of beneficiary liability, with respect to an item or service, is the amount for such item or service for which an individual who does not have coverage under a Medicare supplemental policy certified under section 1882 or any other supplemental insurance coverage is responsible.

“(3) IMPLEMENTATION.—In carrying out this subsection, the Secretary—

“(A) shall include in the notice described in section 1804(a) a notification of the availability of the estimated amounts made available under paragraph (1); and

“(B) may utilize mechanisms in existence on the date of enactment of this subsection, such as the portion of the Internet website of the Centers for Medicare & Medicaid Services on which information comparing physician performance is posted (commonly referred to as the Physician Compare Internet website), to make available such estimated amounts under such paragraph.

“(4) FUNDING.—For purposes of implementing this subsection, the Secretary shall provide for the transfer, from the Federal Supplementary Medical Insurance Trust Fund under section 1841 to the Centers for Medicare & Medicaid Services Program Management Account, of $6,000,000 for fiscal year 2017, to remain available until expended.”.

SEC. 4012. Telehealth services in Medicare.

(a) Provision of information by Centers for Medicare & Medicaid Services.—Not later than 1 year after the date of enactment of this Act, the Administrator of the Centers for Medicare & Medicaid Services shall provide to the committees of jurisdiction of the House of Representatives and the Senate information on the following:

(1) The populations of Medicare beneficiaries, such as those who are dually eligible for the Medicare program under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) and the Medicaid program under title XIX of such Act (42 U.S.C. 1396 et seq.) and those with chronic conditions, whose care may be improved most in terms of quality and efficiency by the expansion, in a manner that meets or exceeds the existing in-person standard of care under the Medicare program under such title XVIII, of telehealth services under section 1834(m)(4) of such Act (42 U.S.C. 1395m(m)(4)).

(2) Activities by the Center for Medicare and Medicaid Innovation which examine the use of telehealth services in models, projects, or initiatives funded through section 1115A of such Act (42 U.S.C. 1315a).

(3) The types of high-volume services (and related diagnoses) under such title XVIII which might be suitable to be furnished using telehealth.

(4) Barriers that might prevent the expansion of telehealth services under section 1834(m)(4) of the Social Security Act (42 U.S.C. 1395m(m)(4)) beyond such services that are in effect as of the date of enactment of this Act.

(b) Provision of information by MedPAC.—Not later than March 15, 2018, the Medicare Payment Advisory Commission established under section 1805 of the Social Security Act (42 U.S.C. 1395b–6) shall, using quantitative and qualitative research methods, provide information to the committees of jurisdiction of the House of Representatives and the Senate that identifies—

(1) the telehealth services for which payment can be made, as of the date of enactment of this Act, under the fee-for-service program under parts A and B of title XVIII of such Act;

(2) the telehealth services for which payment can be made, as of such date, under private health insurance plans; and

(3) with respect to services identified under paragraph (2) but not under paragraph (1), ways in which payment for such services might be incorporated into such fee-for-service program (including any recommendations for ways to accomplish this incorporation).

(c) Sense of Congress.—It is the sense of Congress that—

(1) eligible originating sites should be expanded beyond those originating sites described in section 1834(m)(4)(C) of the Social Security Act (42 U.S.C. 1395m(m)(4)(C)); and

(2) any expansion of telehealth services under the Medicare program under title XVIII of such Act should—

(A) recognize that telemedicine is the delivery of safe, effective, quality health care services, by a health care provider, using technology as the mode of care delivery;

(B) meet or exceed the conditions of coverage and payment with respect to the Medicare program if the service was furnished in person, including standards of care, unless specifically addressed in subsequent legislation; and

(C) involve clinically appropriate means to furnish such services.

SEC. 5001. Savings in the Medicare Improvement Fund.

Section 1898(b)(1) of the Social Security Act (42 U.S.C. 1395iii(b)(1)), as amended by section 704(h) of the Comprehensive Addiction and Recovery Act of 2016, is amended by striking “$140,000,000” and inserting “$270,000,000”.

SEC. 5002. Medicaid reimbursement to States for durable medical equipment.

Section 1903(i)(27) of the Social Security Act (42 U.S.C. 1396b(i)(27)) is amended by striking “January 1, 2019” and inserting “January 1, 2018”.

SEC. 5003. Penalties for violations of grants, contracts, and other agreements.

(a) In general.—Section 1128A of the Social Security Act (42 U.S.C. 1320a–7a) is amended by adding at the end the following new subsections:

“(o) Any person (including an organization, agency, or other entity, but excluding a program beneficiary, as defined in subsection (q)(4)) that, with respect to a grant, contract, or other agreement for which the Secretary provides funding—

“(1) knowingly presents or causes to be presented a specified claim (as defined in subsection (r)) under such grant, contract, or other agreement that the person knows or should know is false or fraudulent;

“(2) knowingly makes, uses, or causes to be made or used any false statement, omission, or misrepresentation of a material fact in any application, proposal, bid, progress report, or other document that is required to be submitted in order to directly or indirectly receive or retain funds provided in whole or in part by such Secretary pursuant to such grant, contract, or other agreement;

“(3) knowingly makes, uses, or causes to be made or used, a false record or statement material to a false or fraudulent specified claim under such grant, contract, or other agreement;

“(4) knowingly makes, uses, or causes to be made or used, a false record or statement material to an obligation (as defined in subsection (s)) to pay or transmit funds or property to such Secretary with respect to such grant, contract, or other agreement, or knowingly conceals or knowingly and improperly avoids or decreases an obligation to pay or transmit funds or property to such Secretary with respect to such grant, contract, or other agreement; or

“(5) fails to grant timely access, upon reasonable request (as defined by such Secretary in regulations), to the Inspector General of the Department, for the purpose of audits, investigations, evaluations, or other statutory functions of such Inspector General in matters involving such grants, contracts, or other agreements;

shall be subject, in addition to any other penalties that may be prescribed by law, to a civil money penalty in cases under paragraph (1), of not more than $10,000 for each specified claim; in cases under paragraph (2), not more than $50,000 for each false statement, omission, or misrepresentation of a material fact; in cases under paragraph (3), not more than $50,000 for each false record or statement; in cases under paragraph (4), not more than $50,000 for each false record or statement or $10,000 for each day that the person knowingly conceals or knowingly and improperly avoids or decreases an obligation to pay; or in cases under paragraph (5), not more than $15,000 for each day of the failure described in such paragraph. In addition, in cases under paragraphs (1) and (3), such a person shall be subject to an assessment of not more than 3 times the amount claimed in the specified claim described in such paragraph in lieu of damages sustained by the United States or a specified State agency because of such specified claim, and in cases under paragraphs (2) and (4), such a person shall be subject to an assessment of not more than 3 times the total amount of the funds described in paragraph (2) or (4), respectively (or, in the case of an obligation to transmit property to the Secretary described in paragraph (4), of the value of the property described in such paragraph) in lieu of damages sustained by the United States or a specified State agency because of such case. In addition, the Secretary may make a determination in the same proceeding to exclude the person from participation in the Federal health care programs (as defined in section 1128B(f)(1)) and to direct the appropriate State agency to exclude the person from participation in any State health care program.

“(p) The provisions of subsections (c), (d), (g), and (h) shall apply to a civil money penalty or assessment under subsection (o) in the same manner as such provisions apply to a penalty, assessment, or proceeding under subsection (a). In applying subsection (d), each reference to a claim under such subsection shall be treated as including a reference to a specified claim (as defined in subsection (r)).

“(q) For purposes of this subsection and subsections (o) and (p):

“(1) The term ‘Department’ means the Department of Health and Human Services.

“(2) The term ‘material’ means having a natural tendency to influence, or be capable of influencing, the payment or receipt of money or property.

“(3) The term ‘other agreement’ includes a cooperative agreement, scholarship, fellowship, loan, subsidy, payment for a specified use, donation agreement, award, or subaward (regardless of whether one or more of the persons entering into the agreement is a contractor or subcontractor).

“(4) The term ‘program beneficiary’ means, in the case of a grant, contract, or other agreement designed to accomplish the objective of awarding or otherwise furnishing benefits or assistance to individuals and for which the Secretary provides funding, an individual who applies for, or who receives, such benefits or assistance from such grant, contract, or other agreement. Such term does not include, with respect to such grant, contract, or other agreement, an officer, employee, or agent of a person or entity that receives such grant or that enters into such contract or other agreement.

“(5) The term ‘recipient’ includes a subrecipient or subcontractor.

“(6) The term ‘specified State agency’ means an agency of a State government established or designated to administer or supervise the administration of a grant, contract, or other agreement funded in whole or in part by the Secretary.

“(r) For purposes of this section, the term ‘specified claim’ means any application, request, or demand under a grant, contract, or other agreement for money or property, whether or not the United States or a specified State agency has title to the money or property, that is not a claim (as defined in subsection (i)(2)) and that—

“(1) is presented or caused to be presented to an officer, employee, or agent of the Department or agency thereof, or of any specified State agency; or

“(2) is made to a contractor, grantee, or any other recipient if the money or property is to be spent or used on the Department’s behalf or to advance a Department program or interest, and if the Department—

“(A) provides or has provided any portion of the money or property requested or demanded; or

“(B) will reimburse such contractor, grantee, or other recipient for any portion of the money or property which is requested or demanded.

“(s) For purposes of subsection (o), the term ‘obligation’ means an established duty, whether or not fixed, arising from an express or implied contractual, grantor-grantee, or licensor-licensee relationship, for a fee-based or similar relationship, from statute or regulation, or from the retention of any overpayment.”.

(b) Conforming amendments.—Section 1128A of the Social Security Act (42 U.S.C. 1320a–7a) is amended—

(1) in subsection (e), by inserting “or specified claim” after “claim” in the first sentence; and

(2) in subsection (f)—

(A) in the matter preceding paragraph (1)—

(i) by inserting “or specified claim (as defined in subsection (r))” after “district where the claim”; and

(ii) by inserting “(or, with respect to a person described in subsection (o), the person)” after “claimant”; and

(B) in the matter following paragraph (4), by inserting “(or, in the case of a penalty or assessment under subsection (o), by a specified State agency (as defined in subsection (q)(6)),” after “or a State agency”.

SEC. 5004. Reducing overpayments of infusion drugs.

(a) Treatment of infusion drugs furnished through durable medical equipment.—Section 1842(o)(1) of the Social Security Act (42 U.S.C. 1395u(o)(1)) is amended—

(1) in subparagraph (C), by inserting “(and including a drug or biological described in subparagraph (D)(i) furnished on or after January 1, 2017)” after “2005”; and

(2) in subparagraph (D)—

(A) by striking “infusion drugs” and inserting “infusion drugs or biologicals” each place it appears; and

(B) in clause (i)—

(i) by striking “2004” and inserting “2004, and before January 1, 2017”; and

(ii) by striking “for such drug”.

(b) Noninclusion of DME infusion drugs under DME competitive acquisition programs.—

(1) IN GENERAL.—Section 1847(a)(2)(A) of the Social Security Act (42 U.S.C. 1395w–3(a)(2)(A)) is amended—

(A) by striking “and excluding” and inserting “, excluding”; and

(B) by inserting before the period at the end the following: “, and excluding drugs and biologicals described in section 1842(o)(1)(D)”.

(2) CONFORMING AMENDMENT.—Section 1842(o)(1)(D)(ii) of the Social Security Act (42 U.S.C. 1395u(o)(1)(D)(ii)) is amended by striking “2007” and inserting “2007, and before the date of the enactment of the 21st Century Cures Act.”.

SEC. 5005. Increasing oversight of termination of Medicaid providers.

(a) Increased oversight and reporting.—

(1) STATE REPORTING REQUIREMENTS.—Section 1902(kk) of the Social Security Act (42 U.S.C. 1396a(kk)) is amended—

(A) by redesignating paragraph (8) as paragraph (9); and

(B) by inserting after paragraph (7) the following new paragraph:

“(8) PROVIDER TERMINATIONS.—

“(A) IN GENERAL.—Beginning on July 1, 2018, in the case of a notification under subsection (a)(41) with respect to a termination for a reason specified in section 455.101 of title 42, Code of Federal Regulations (as in effect on November 1, 2015) or for any other reason specified by the Secretary, of the participation of a provider of services or any other person under the State plan (or under a waiver of the plan), the State, not later than 30 days after the effective date of such termination, submits to the Secretary with respect to any such provider or person, as appropriate—

“(i) the name of such provider or person;

“(ii) the provider type of such provider or person;

“(iii) the specialty of such provider’s or person’s practice;

“(iv) the date of birth, Social Security number, national provider identifier (if applicable), Federal taxpayer identification number, and the State license or certification number of such provider or person (if applicable);

“(v) the reason for the termination;

“(vi) a copy of the notice of termination sent to the provider or person;

“(vii) the date on which such termination is effective, as specified in the notice; and

“(viii) any other information required by the Secretary.

“(B) EFFECTIVE DATE DEFINED.—For purposes of this paragraph, the term ‘effective date’ means, with respect to a termination described in subparagraph (A), the later of—

“(i) the date on which such termination is effective, as specified in the notice of such termination; or

“(ii) the date on which all appeal rights applicable to such termination have been exhausted or the timeline for any such appeal has expired.”.

(2) CONTRACT REQUIREMENT FOR MANAGED CARE ENTITIES.—Section 1932(d) of the Social Security Act (42 U.S.C. 1396u–2(d)) is amended by adding at the end the following new paragraph:

“(5) CONTRACT REQUIREMENT FOR MANAGED CARE ENTITIES.—With respect to any contract with a managed care entity under section 1903(m) or 1905(t)(3) (as applicable), no later than July 1, 2018, such contract shall include a provision that providers of services or persons terminated (as described in section 1902(kk)(8)) from participation under this title, title XVIII, or title XXI shall be terminated from participating under this title as a provider in any network of such entity that serves individuals eligible to receive medical assistance under this title.”.

(3) TERMINATION NOTIFICATION DATABASE.—Section 1902 of the Social Security Act (42 U.S.C. 1396a) is amended by adding at the end the following new subsection:

“(ll) Termination notification database.—In the case of a provider of services or any other person whose participation under this title or title XXI is terminated (as described in subsection (kk)(8)), the Secretary shall, not later than 30 days after the date on which the Secretary is notified of such termination under subsection (a)(41) (as applicable), review such termination and, if the Secretary determines appropriate, include such termination in any database or similar system developed pursuant to section 6401(b)(2) of the Patient Protection and Affordable Care Act (42 U.S.C. 1395cc note; Public Law 111–148).”.

(4) NO FEDERAL FUNDS FOR ITEMS AND SERVICES FURNISHED BY TERMINATED PROVIDERS.—Section 1903 of the Social Security Act (42 U.S.C. 1396b) is amended—

(A) in subsection (i)(2)—

(i) in subparagraph (A), by striking the comma at the end and inserting a semicolon;

(ii) in subparagraph (B), by striking “or” at the end; and

(iii) by adding at the end the following new subparagraph:

“(D) beginning on July 1, 2018, under the plan by any provider of services or person whose participation in the State plan is terminated (as described in section 1902(kk)(8)) after the date that is 60 days after the date on which such termination is included in the database or other system under section 1902(ll); or”; and

(B) in subsection (m), by inserting after paragraph (2) the following new paragraph:

“(3) No payment shall be made under this title to a State with respect to expenditures incurred by the State for payment for services provided by a managed care entity (as defined under section 1932(a)(1)) under the State plan under this title (or under a waiver of the plan) unless the State—

“(A) beginning on July 1, 2018, has a contract with such entity that complies with the requirement specified in section 1932(d)(5); and

“(B) beginning on January 1, 2018, complies with the requirement specified in section 1932(d)(6)(A).”.

(5) DEVELOPMENT OF UNIFORM TERMINOLOGY FOR REASONS FOR PROVIDER TERMINATION.—Not later than July 1, 2017, the Secretary of Health and Human Services shall, in consultation with the heads of State agencies administering State Medicaid plans (or waivers of such plans), issue regulations establishing uniform terminology to be used with respect to specifying reasons under subparagraph (A)(v) of paragraph (8) of section 1902(kk) of the Social Security Act (42 U.S.C. 1396a(kk)), as added by paragraph (1), for the termination (as described in such paragraph (8)) of the participation of certain providers in the Medicaid program under title XIX of such Act or the Children’s Health Insurance Program under title XXI of such Act.

(6) CONFORMING AMENDMENT.—Section 1902(a)(41) of the Social Security Act (42 U.S.C. 1396a(a)(41)) is amended by striking “provide that whenever” and inserting “provide, in accordance with subsection (kk)(8) (as applicable), that whenever”.

(b) Increasing availability of Medicaid provider information.—

(1) FFS PROVIDER ENROLLMENT.—Section 1902(a) of the Social Security Act (42 U.S.C. 1396a(a)) is amended by inserting after paragraph (77) the following new paragraph:

“(78) provide that, not later than January 1, 2017, in the case of a State that pursuant to its State plan or waiver of the plan for medical assistance pays for medical assistance on a fee-for-service basis, the State shall require each provider furnishing items and services to, or ordering, prescribing, referring, or certifying eligibility for, services for individuals eligible to receive medical assistance under such plan to enroll with the State agency and provide to the State agency the provider’s identifying information, including the name, specialty, date of birth, Social Security number, national provider identifier (if applicable), Federal taxpayer identification number, and the State license or certification number of the provider (if applicable);”.

(2) MANAGED CARE PROVIDER ENROLLMENT.—Section 1932(d) of the Social Security Act (42 U.S.C. 1396u–2(d)), as amended by subsection (a)(2), is amended by adding at the end the following new paragraph:

“(6) ENROLLMENT OF PARTICIPATING PROVIDERS.—

“(A) IN GENERAL.—Beginning not later than January 1, 2018, a State shall require that, in order to participate as a provider in the network of a managed care entity that provides services to, or orders, prescribes, refers, or certifies eligibility for services for, individuals who are eligible for medical assistance under the State plan under this title (or under a waiver of the plan) and who are enrolled with the entity, the provider is enrolled consistent with section 1902(kk) with the State agency administering the State plan under this title. Such enrollment shall include providing to the State agency the provider’s identifying information, including the name, specialty, date of birth, Social Security number, national provider identifier, Federal taxpayer identification number, and the State license or certification number of the provider.

“(B) RULE OF CONSTRUCTION.—Nothing in subparagraph (A) shall be construed as requiring a provider described in such subparagraph to provide services to individuals who are not enrolled with a managed care entity under this title.”.

(c) Coordination with CHIP.—

(1) IN GENERAL.—Section 2107(e)(1) of the Social Security Act (42 U.S.C. 1397gg(e)(1)) is amended—

(A) by redesignating subparagraphs (B), (C), (D), (E), (F), (G), (H), (I), (J), (K), (L), (M), (N), and (O) as subparagraphs (D), (E), (F), (G), (H), (I), (J), (K), (M), (N), (O), (P), (Q), and (R), respectively;

(B) by inserting after subparagraph (A) the following new subparagraphs:

“(B) Section 1902(a)(39) (relating to termination of participation of certain providers).

“(C) Section 1902(a)(78) (relating to enrollment of providers participating in State plans providing medical assistance on a fee-for-service basis).”;

(C) by inserting after subparagraph (K) (as redesignated by subparagraph (A)) the following new subparagraph:

“(L) Section 1903(m)(3) (relating to limitation on payment with respect to managed care).”; and

(D) in subparagraph (P) (as redesignated by subparagraph (A)), by striking “(a)(2)(C) and (h)” and inserting “(a)(2)(C) (relating to Indian enrollment), (d)(5) (relating to contract requirement for managed care entities), (d)(6) (relating to enrollment of providers participating with a managed care entity), and (h) (relating to special rules with respect to Indian enrollees, Indian health care providers, and Indian managed care entities)”.

(2) EXCLUDING FROM MEDICAID PROVIDERS EXCLUDED FROM CHIP.—Section 1902(a)(39) of the Social Security Act (42 U.S.C. 1396a(a)(39)) is amended by striking “title XVIII or any other State plan under this title” and inserting “title XVIII, any other State plan under this title (or waiver of the plan), or any State child health plan under title XXI (or waiver of the plan) and such termination is included by the Secretary in any database or similar system developed pursuant to section 6401(b)(2) of the Patient Protection and Affordable Care Act”.

(d) Rule of construction.—Nothing in this section shall be construed as changing or limiting the appeal rights of providers or the process for appeals of States under the Social Security Act.

(e) OIG report.—Not later than March 31, 2020, the Inspector General of the Department of Health and Human Services shall submit to Congress a report on the implementation of the amendments made by this section. Such report shall include the following:

(1) An assessment of the extent to which providers who are included under subsection (ll) of section 1902 of the Social Security Act (42 U.S.C. 1396a) (as added by subsection (a)(3)) in the database or similar system referred to in such subsection are terminated (as described in paragraph (8) of subsection (kk) of such section, as added by subsection (a)(1)) from participation in all State plans under title XIX of such Act (or waivers of such plans).

(2) Information on the amount of Federal financial participation paid to States under section 1903 of such Act in violation of the limitation on such payment specified in subparagraph (D) of subsection (i)(2) of such section and paragraph (3) of subsection (m) of such section, as added by subsection (a)(4).

(3) An assessment of the extent to which contracts with managed care entities under title XIX of such Act comply with the requirement specified in paragraph (5) of section 1932(d) of such Act, as added by subsection (a)(2).

(4) An assessment of the extent to which providers have been enrolled under section 1902(a)(78) or 1932(d)(6)(A) of such Act (42 U.S.C. 1396a(a)(78), 1396u–2(d)(6)(A)) with State agencies administering State plans under title XIX of such Act (or waivers of such plans).

SEC. 5006. Requiring publication of fee-for-service provider directory.

(a) In general.—Section 1902(a) of the Social Security Act (42 U.S.C. 1396a(a)) is amended—

(1) in paragraph (81), by striking “and” at the end;

(2) in paragraph (82), by striking the period at the end and inserting “; and”; and

(3) by inserting after paragraph (82) the following new paragraph:

“(83) provide that, not later than January 1, 2017, in the case of a State plan (or waiver of the plan) that provides medical assistance on a fee-for-service basis or through a primary care case-management system described in section 1915(b)(1) (other than a primary care case management entity (as defined by the Secretary)), the State shall publish (and update on at least an annual basis) on the public website of the State agency administering the State plan, a directory of the physicians described in subsection (mm) and, at State option, other providers described in such subsection that—

“(A) includes—

“(i) with respect to each such physician or provider—

“(I) the name of the physician or provider;

“(II) the specialty of the physician or provider;

“(III) the address at which the physician or provider provides services; and

“(IV) the telephone number of the physician or provider; and

“(ii) with respect to any such physician or provider participating in such a primary care case-management system, information regarding—

“(I) whether the physician or provider is accepting as new patients individuals who receive medical assistance under this title; and

“(II) the physician’s or provider’s cultural and linguistic capabilities, including the languages spoken by the physician or provider or by the skilled medical interpreter providing interpretation services at the physician’s or provider’s office; and

“(B) may include, at State option, with respect to each such physician or provider—

“(i) the Internet website of such physician or provider; or

“(ii) whether the physician or provider is accepting as new patients individuals who receive medical assistance under this title.”.

(b) Directory physician or provider described.—Section 1902 of the Social Security Act (42 U.S.C. 1396a), as amended by section 5005(a)(3), is further amended by adding at the end the following new subsection:

“(mm) Directory physician or provider described.—A physician or provider described in this subsection is—

“(1) in the case of a physician or provider of a provider type for which the State agency, as a condition on receiving payment for items and services furnished by the physician or provider to individuals eligible to receive medical assistance under the State plan, requires the enrollment of the physician or provider with the State agency, a physician or a provider that—

“(A) is enrolled with the agency as of the date on which the directory is published or updated (as applicable) under subsection (a)(83); and

“(B) received payment under the State plan in the 12-month period preceding such date; and

“(2) in the case of a physician or provider of a provider type for which the State agency does not require such enrollment, a physician or provider that received payment under the State plan (or a waiver of the plan) in the 12-month period preceding the date on which the directory is published or updated (as applicable) under subsection (a)(83).”.

(c) Rule of construction.—

(1) IN GENERAL.—The amendment made by subsection (a) shall not be construed to apply in the case of a State (as defined for purposes of title XIX of the Social Security Act) in which all the individuals enrolled in the State plan under such title (or under a waiver of such plan), other than individuals described in paragraph (2), are enrolled with a medicaid managed care organization (as defined in section 1903(m)(1)(A) of such Act (42 U.S.C. 1396b(m)(1)(A))), including prepaid inpatient health plans and prepaid ambulatory health plans (as defined by the Secretary of Health and Human Services).

(2) INDIVIDUALS DESCRIBED.—An individual described in this paragraph is an individual who is an Indian (as defined in section 4 of the Indian Health Care Improvement Act (25 U.S.C. 1603)) or an Alaska Native.

(d) Exception for State legislation.—In the case of a State plan under title XIX of the Social Security Act (42 U.S.C. 1396 et seq.), which the Secretary of Health and Human Services determines requires State legislation in order for the respective plan to meet one or more additional requirements imposed by amendments made by this section, the respective plan shall not be regarded as failing to comply with the requirements of such title solely on the basis of its failure to meet such an additional requirement before the first day of the first calendar quarter beginning after the close of the first regular session of the State legislature that begins after the date of enactment of this Act. For purposes of the previous sentence, in the case of a State that has a 2-year legislative session, each year of the session shall be considered to be a separate regular session of the State legislature.

SEC. 5007. Fairness in Medicaid supplemental needs trusts.

(a) In general.—Section 1917(d)(4)(A) of the Social Security Act (42 U.S.C. 1396p(d)(4)(A)) is amended by inserting “the individual,” after “for the benefit of such individual by”.

(b) Effective date.—The amendment made by subsection (a) shall apply to trusts established on or after the date of the enactment of this Act.

SEC. 5008. Eliminating Federal financial participation with respect to expenditures under Medicaid for agents used for cosmetic purposes or hair growth.

(a) In general.—Section 1903(i)(21) of the Social Security Act (42 U.S.C. 1396b(i)(21)) is amended by inserting “section 1927(d)(2)(C) (relating to drugs when used for cosmetic purposes or hair growth), except where medically necessary, and” after “drugs described in”.

(b) Effective date.—The amendment made by subsection (a) shall apply with respect to calendar quarters beginning on or after the date of the enactment of this Act.

SEC. 5009. Amendment to the Prevention and Public Health Fund.

Section 4002(b) of the Patient Protection and Affordable Care Act (42 U.S.C. 300u–11(b)) is amended—

(1) in paragraph (3), by striking “$1,250,000,000” and inserting “$900,000,000”;

(2) in paragraph (4), by striking “$1,500,000,000” and inserting “$1,000,000,000”; and

(3) by striking paragraph (5) and inserting the following:

“(5) for fiscal year 2022, $1,500,000,000;

“(6) for fiscal year 2023, $1,000,000,000;

“(7) for fiscal year 2024, $1,700,000,000; and

“(8) for fiscal year 2025 and each fiscal year thereafter, $2,000,000,000.”.

SEC. 5010. Strategic Petroleum Reserve drawdown.

(a) Drawdown and Sale.—

(1) IN GENERAL.—Notwithstanding section 161 of the Energy Policy and Conservation Act (42 U.S.C. 6241), except as provided in subsections (b) and (c), the Secretary of Energy shall drawdown and sell from the Strategic Petroleum Reserve—

(A) 10,000,000 barrels of crude oil during fiscal year 2017;

(B) 9,000,000 barrels of crude oil during fiscal year 2018; and

(C) 6,000,000 barrels of crude oil during fiscal year 2019.

(2) DEPOSIT OF AMOUNTS RECEIVED FROM SALE.—Amounts received from a sale under paragraph (1) shall be deposited in the general fund of the Treasury during the fiscal year in which the sale occurs.

(b) Emergency Protection.—The Secretary shall not draw down and sell crude oil under this section in quantities that would limit the authority to sell petroleum products under section 161(h) of the Energy Policy and Conservation Act (42 U.S.C. 6241(h)) in the full quantity authorized by that subsection.

(c) Strategic Petroleum drawdown limitations.—Subparagraphs (C) and (D) of section 161(h)(2) of the Energy Policy and Conservation Act (42 U.S.C. 6241(h)(2)(C) and (D)) are both amended by striking “500,000,000” and inserting “450,000,000”.

SEC. 5011. Rescission of portion of ACA territory funding.

Of the unobligated amounts available under section 1323(c)(1) of the Patient Protection and Affordable Care Act (42 U.S.C. 18043(c)(1)), $464,000,000 is rescinded immediately upon the date of the enactment of this Act.

SEC. 5012. Medicare coverage of home infusion therapy.

(a) In general.—Section 1861 of the Social Security Act (42 U.S.C. 1395x) is amended—

(1) in subsection (s)(2)—

(A) by striking “and” at the end of subparagraph (EE);

(B) by inserting “and” at the end of subparagraph (FF); and

(C) by inserting at the end the following new subparagraph:

“(GG) home infusion therapy (as defined in subsection (iii)(1));”; and

(2) by adding at the end the following new subsection:

“(iii) Home Infusion Therapy.—(1) The term ‘home infusion therapy’ means the items and services described in paragraph (2) furnished by a qualified home infusion therapy supplier (as defined in paragraph (3)(D)) which are furnished in the individual’s home (as defined in paragraph (3)(B)) to an individual—

“(A) who is under the care of an applicable provider (as defined in paragraph (3)(A)); and

“(B) with respect to whom a plan prescribing the type, amount, and duration of infusion therapy services that are to be furnished such individual has been established by a physician (as defined in subsection (r)(1)) and is periodically reviewed by a physician (as so defined) in coordination with the furnishing of home infusion drugs (as defined in paragraph (3)(C)) under part B.

“(2) The items and services described in this paragraph are the following:

“(A) Professional services, including nursing services, furnished in accordance with the plan.

“(B) Training and education (not otherwise paid for as durable medical equipment (as defined in subsection (n)), remote monitoring, and monitoring services for the provision of home infusion therapy and home infusion drugs furnished by a qualified home infusion therapy supplier.

“(3) For purposes of this subsection:

“(A) The term ‘applicable provider’ means—

“(i) a physician;

“(ii) a nurse practitioner; and

“(iii) a physician assistant.

“(B) The term ‘home’ means a place of residence used as the home of an individual (as defined for purposes of subsection (n)).

“(C) The term ‘home infusion drug’ means a parenteral drug or biological administered intravenously, or subcutaneously for an administration period of 15 minutes or more, in the home of an individual through a pump that is an item of durable medical equipment (as defined in subsection (n)). Such term does not include the following:

“(i) Insulin pump systems.

“(ii) A self-administered drug or biological on a self-administered drug exclusion list.

“(D)(i) The term ‘qualified home infusion therapy supplier’ means a pharmacy, physician, or other provider of services or supplier licensed by the State in which the pharmacy, physician, or provider or services or supplier furnishes items or services and that—

“(I) furnishes infusion therapy to individuals with acute or chronic conditions requiring administration of home infusion drugs;

“(II) ensures the safe and effective provision and administration of home infusion therapy on a 7-day-a-week, 24-hour-a-day basis;

“(III) is accredited by an organization designated by the Secretary pursuant to section 1834(u)(5); and

“(IV) meets such other requirements as the Secretary determines appropriate, taking into account the standards of care for home infusion therapy established by Medicare Advantage plans under part C and in the private sector.

“(ii) A qualified home infusion therapy supplier may subcontract with a pharmacy, physician, provider of services, or supplier to meet the requirements of this subparagraph.”.

(b) Payment and related requirements for home infusion therapy.—Section 1834 of the Social Security Act (42 U.S.C. 1395m), as amended by section 4011, is further amended by adding at the end the following new subsection:

“(u) Payment and related requirements for home infusion therapy.—

“(1) PAYMENT.—

“(A) SINGLE PAYMENT.—

“(i) IN GENERAL.—Subject to clause (iii) and subparagraphs (B) and (C), the Secretary shall implement a payment system under which a single payment is made under this title to a qualified home infusion therapy supplier for items and services described in subparagraphs (A) and (B) of section 1861(iii)(2)) furnished by a qualified home infusion therapy supplier (as defined in section 1861(iii)(3)(D)) in coordination with the furnishing of home infusion drugs (as defined in section 1861(iii)(3)(C)) under this part.

“(ii) UNIT OF SINGLE PAYMENT.—A unit of single payment under the payment system implemented under this subparagraph is for each infusion drug administration calendar day in the individual’s home. The Secretary shall, as appropriate, establish single payment amounts for types of infusion therapy, including to take into account variation in utilization of nursing services by therapy type.

“(iii) LIMITATION.—The single payment amount determined under this subparagraph after application of subparagraph (B) and paragraph (3) shall not exceed the amount determined under the fee schedule under section 1848 for infusion therapy services furnished in a calendar day if furnished in a physician office setting, except such single payment shall not reflect more than 5 hours of infusion for a particular therapy in a calendar day.

“(B) REQUIRED ADJUSTMENTS.—The Secretary shall adjust the single payment amount determined under subparagraph (A) for home infusion therapy services under section 1861(iii)(1) to reflect other factors such as—

“(i) a geographic wage index and other costs that may vary by region; and

“(ii) patient acuity and complexity of drug administration.

“(C) DISCRETIONARY ADJUSTMENTS.—

“(i) IN GENERAL.—Subject to clause (ii), the Secretary may adjust the single payment amount determined under subparagraph (A) (after application of subparagraph (B)) to reflect outlier situations and other factors as the Secretary determines appropriate.

“(ii) REQUIREMENT OF BUDGET NEUTRALITY.—Any adjustment under this subparagraph shall be made in a budget neutral manner.

“(2) CONSIDERATIONS.—In developing the payment system under this subsection, the Secretary may consider the costs of furnishing infusion therapy in the home, consult with home infusion therapy suppliers, consider payment amounts for similar items and services under this part and part A, and consider payment amounts established by Medicare Advantage plans under part C and in the private insurance market for home infusion therapy (including average per treatment day payment amounts by type of home infusion therapy).

“(3) ANNUAL UPDATES.—

“(A) IN GENERAL.—Subject to subparagraph (B), the Secretary shall update the single payment amount under this subsection from year to year beginning in 2022 by increasing the single payment amount from the prior year by the percentage increase in the Consumer Price Index for all urban consumers (United States city average) for the 12-month period ending with June of the preceding year.

“(B) ADJUSTMENT.—For each year, the Secretary shall reduce the percentage increase described in subparagraph (A) by the productivity adjustment described in section 1886(b)(3)(B)(xi)(II). The application of the preceding sentence may result in a percentage being less than 0.0 for a year, and may result in payment being less than such payment rates for the preceding year.

“(4) AUTHORITY TO APPLY PRIOR AUTHORIZATION.—The Secretary may, as determined appropriate by the Secretary, apply prior authorization for home infusion therapy services under section 1861(iii)(1).

“(5) ACCREDITATION OF QUALIFIED HOME INFUSION THERAPY SUPPLIERS.—

“(A) FACTORS FOR DESIGNATION OF ACCREDITATION ORGANIZATIONS.—The Secretary shall consider the following factors in designating accreditation organizations under subparagraph (B) and in reviewing and modifying the list of accreditation organizations designated pursuant to subparagraph (C):

“(i) The ability of the organization to conduct timely reviews of accreditation applications.

“(ii) The ability of the organization to take into account the capacities of suppliers located in a rural area (as defined in section 1886(d)(2)(D)).

“(iii) Whether the organization has established reasonable fees to be charged to suppliers applying for accreditation.

“(iv) Such other factors as the Secretary determines appropriate.

“(B) DESIGNATION.—Not later than January 1, 2021, the Secretary shall designate organizations to accredit suppliers furnishing home infusion therapy. The list of accreditation organizations so designated may be modified pursuant to subparagraph (C).

“(C) REVIEW AND MODIFICATION OF LIST OF ACCREDITATION ORGANIZATIONS.—

“(i) IN GENERAL.—The Secretary shall review the list of accreditation organizations designated under subparagraph (B) taking into account the factors under subparagraph (A). Taking into account the results of such review, the Secretary may, by regulation, modify the list of accreditation organizations designated under subparagraph (B).

“(ii) SPECIAL RULE FOR ACCREDITATIONS DONE PRIOR TO REMOVAL FROM LIST OF DESIGNATED ACCREDITATION ORGANIZATIONS.—In the case where the Secretary removes an organization from the list of accreditation organizations designated under subparagraph (B), any supplier that is accredited by the organization during the period beginning on the date on which the organization is designated as an accreditation organization under subparagraph (B) and ending on the date on which the organization is removed from such list shall be considered to have been accredited by an organization designated by the Secretary under subparagraph (B) for the remaining period such accreditation is in effect.

“(D) RULE FOR ACCREDITATIONS MADE PRIOR TO DESIGNATION.—In the case of a supplier that is accredited before January 1, 2021, by an accreditation organization designated by the Secretary under subparagraph (B) as of January 1, 2019, such supplier shall be considered to have been accredited by an organization designated by the Secretary under such paragraph as of January 1, 2023, for the remaining period such accreditation is in effect.

“(6) NOTIFICATION OF INFUSION THERAPY OPTIONS AVAILABLE PRIOR TO FURNISHING HOME INFUSION THERAPY.—Prior to the furnishing of home infusion therapy to an individual, the physician who establishes the plan described in section 1861(iii)(1) for the individual shall provide notification (in a form, manner, and frequency determined appropriate by the Secretary) of the options available (such as home, physician’s office, hospital outpatient department) for the furnishing of infusion therapy under this part.”.

(c) Conforming amendments.—

(1) PAYMENT REFERENCE.—Section 1833(a)(1) of the Social Security Act (42 U.S.C. 1395l(a)(1)) is amended—

(A) by striking “and” before “(AA)”; and

(B) by inserting before the semicolon at the end the following: “, and (BB) with respect to home infusion therapy, the amount paid shall be an amount equal to 80 percent of the lesser of the actual charge for the services or the amount determined under section 1834(u)”.

(2) DIRECT PAYMENT.—The first sentence of section 1842(b)(6) of the Social Security Act (42 U.S.C. 1395u(b)(6)) is amended—

(A) by striking “and” before “(H)”; and

(B) by inserting before the period at the end the following: “, and (I) in the case of home infusion therapy, payment shall be made to the qualified home infusion therapy supplier”.

(3) EXCLUSION FROM HOME HEALTH SERVICES.—Section 1861(m) of the Social Security Act (42 U.S.C. 1395x(m)) is amended, in the first sentence, by inserting the following before the period at the end: “and home infusion therapy (as defined in subsection (iii)(i))”.

(d) Effective date.—The amendments made by this section shall apply to items and services furnished on or after January 1, 2021.

SEC. 6000. Short title.

This division may be cited as the “Helping Families in Mental Health Crisis Reform Act of 2016”.

SEC. 6001. Assistant Secretary for Mental Health and Substance Use.

(a) Assistant Secretary.—Section 501(c) of the Public Health Service Act (42 U.S.C. 290aa(c)) is amended to read as follows:

“(c) Assistant secretary and deputy assistant secretary.—

“(1) ASSISTANT SECRETARY.—The Administration shall be headed by an official to be known as the Assistant Secretary for Mental Health and Substance Use (hereinafter in this title referred to as the ‘Assistant Secretary’) who shall be appointed by the President, by and with the advice and consent of the Senate.

“(2) DEPUTY ASSISTANT SECRETARY.—The Assistant Secretary, with the approval of the Secretary, may appoint a Deputy Assistant Secretary and may employ and prescribe the functions of such officers and employees, including attorneys, as are necessary to administer the activities to be carried out through the Administration.”.

(b) Transfer of authorities.—The Secretary of Health and Human Services shall delegate to the Assistant Secretary for Mental Health and Substance Use all duties and authorities that—

(1) as of the day before the date of enactment of this Act, were vested in the Administrator of the Substance Abuse and Mental Health Services Administration; and

(2) are not terminated by this Act.

(c) Conforming amendments.—Title V of the Public Health Service Act (42 U.S.C. 290aa et seq.), as amended by the previous provisions of this section, is further amended—

(1) by striking “Administrator of the Substance Abuse and Mental Health Services Administration” each place it appears and inserting “Assistant Secretary for Mental Health and Substance Use”; and

(2) by striking “Administrator” or “Administrator” each place it appears (including in any headings) and inserting “Assistant Secretary” or “Assistant Secretary”, respectively, except where the term “Administrator” appears—

(A) in each of subsections (e) and (f) of section 501 of such Act (42 U.S.C. 290aa), including the headings of such subsections, within the term “Associate Administrator”;

(B) in section 507(b)(6) of such Act (42 U.S.C. 290bb(b)(6)), within the term “Administrator of the Health Resources and Services Administration”;

(C) in section 507(b)(6) of such Act (42 U.S.C. 290bb(b)(6)), within the term “Administrator of the Centers for Medicare & Medicaid Services”;

(D) in section 519B(c)(1)(B) of such Act (42 U.S.C. 290bb–25b(c)(1)(B)), within the term “Administrator of the National Highway Traffic Safety Administration”; or

(E) in each of sections 519B(c)(1)(B), 520C(a), and 520D(a) of such Act (42 U.S.C. 290bb–25b(c)(1)(B), 290bb–34(a), 290bb–35(a)), within the term “Administrator of the Office of Juvenile Justice and Delinquency Prevention”.

(d) References.—After executing subsections (a), (b), and (c), any reference in statute, regulation, or guidance to the Administrator of the Substance Abuse and Mental Health Services Administration shall be construed to be a reference to the Assistant Secretary for Mental Health and Substance Use.

SEC. 6002. Strengthening the leadership of the Substance Abuse and Mental Health Services Administration.

Section 501 of the Public Health Service Act (42 U.S.C. 290aa), as amended by section 6001, is further amended—

(1) in subsection (b)—

(A) in the subsection heading, by striking “Agencies” and inserting “Centers”; and

(B) in the matter preceding paragraph (1), by striking “entities” and inserting “Centers”;

(2) in subsection (d)—

(A) in paragraph (1)—

(i) by striking “agencies” each place the term appears and inserting “Centers”; and

(ii) by striking “such agency” and inserting “such Center”;

(B) in paragraph (2)—

(i) by striking “agencies” and inserting “Centers”;

(ii) by striking “with respect to substance abuse” and inserting “with respect to substance use disorders”; and

(iii) by striking “and individuals who are substance abusers” and inserting “and individuals with substance use disorders”;

(C) in paragraph (5), by striking “substance abuse” and inserting “substance use disorder”;

(D) in paragraph (6)—

(i) by striking “the Centers for Disease Control” and inserting “the Centers for Disease Control and Prevention,”;

(ii) by striking “Administration develop” and inserting “Administration, develop”;

(iii) by striking “HIV or tuberculosis among substance abusers and individuals with mental illness” and inserting “HIV, hepatitis, tuberculosis, and other communicable diseases among individuals with mental or substance use disorders,”; and

(iv) by striking “illnesses” at the end and inserting “diseases or disorders”;

(E) in paragraph (7), by striking “abuse utilizing anti-addiction medications, including methadone” and inserting “use disorders, including services that utilize drugs or devices approved or cleared by the Food and Drug Administration for the treatment of substance use disorders”;

(F) in paragraph (8)—

(i) by striking “Agency for Health Care Policy Research” and inserting “Agency for Healthcare Research and Quality”; and

(ii) by striking “treatment and prevention” and inserting “prevention and treatment”;

(G) in paragraph (9)—

(i) by inserting “and maintenance” after “development”;

(ii) by striking “Agency for Health Care Policy Research” and inserting “Agency for Healthcare Research and Quality”; and

(iii) by striking “treatment and prevention services” and inserting “prevention, treatment, and recovery support services and are appropriately incorporated into programs carried out by the Administration”;

(H) in paragraph (10), by striking “abuse” and inserting “use disorder”;

(I) by striking paragraph (11) and inserting the following:

“(11) work with relevant agencies of the Department of Health and Human Services on integrating mental health promotion and substance use disorder prevention with general health promotion and disease prevention and integrating mental and substance use disorders treatment services with physical health treatment services;”;

(J) in paragraph (13)—

(i) in the matter preceding subparagraph (A), by striking “this title, assure that” and inserting “this title or part B of title XIX, or grant programs otherwise funded by the Administration”;

(ii) in subparagraph (A)—

(I) by inserting “require that” before “all grants”; and

(II) by striking “and” at the end;

(iii) by redesignating subparagraph (B) as subparagraph (C);

(iv) by inserting after subparagraph (A) the following:

“(B) ensure that the director of each Center of the Administration consistently documents the application of criteria when awarding grants and the ongoing oversight of grantees after such grants are awarded;”;

(v) in subparagraph (C), as so redesignated—

(I) by inserting “require that” before “all grants”; and

(II) in clause (ii), by inserting “and” after the semicolon at the end; and

(vi) by adding at the end the following:

“(D) inform a State when any funds are awarded through such a grant to any entity within such State;”;

(K) in paragraph (16), by striking “abuse and mental health information” and inserting “use disorder information, including evidence-based and promising best practices for prevention, treatment, and recovery support services for individuals with mental and substance use disorders,”;

(L) in paragraph (17)—

(i) by striking “substance abuse” and inserting “substance use disorder”; and

(ii) by striking “and” at the end;

(M) in paragraph (18), by striking the period and inserting a semicolon; and

(N) by adding at the end the following:

“(19) consult with State, local, and tribal governments, nongovernmental entities, and individuals with mental illness, particularly adults with a serious mental illness, children with a serious emotional disturbance, and the family members of such adults and children, with respect to improving community-based and other mental health services;

“(20) collaborate with the Secretary of Defense and the Secretary of Veterans Affairs to improve the provision of mental and substance use disorder services provided by the Department of Defense and the Department of Veterans Affairs to members of the Armed Forces, veterans, and the family members of such members and veterans, including through the provision of services using the telehealth capabilities of the Department of Defense and the Department of Veterans Affairs;

“(21) collaborate with the heads of relevant Federal agencies and departments, States, communities, and nongovernmental experts to improve mental and substance use disorders services for chronically homeless individuals, including by designing strategies to provide such services in supportive housing;

“(22) work with States and other stakeholders to develop and support activities to recruit and retain a workforce addressing mental and substance use disorders;

“(23) collaborate with the Attorney General and representatives of the criminal justice system to improve mental and substance use disorders services for individuals who have been arrested or incarcerated;

“(24) after providing an opportunity for public input, set standards for grant programs under this title for mental and substance use disorders services and prevention programs, which standards may address—

“(A) the capacity of the grantee to implement the award;

“(B) requirements for the description of the program implementation approach;

“(C) the extent to which the grant plan submitted by the grantee as part of its application must explain how the grantee will reach the population of focus and provide a statement of need, which may include information on how the grantee will increase access to services and a description of measurable objectives for improving outcomes;

“(D) the extent to which the grantee must collect and report on required performance measures; and

“(E) the extent to which the grantee is proposing to use evidence-based practices; and

“(25) advance, through existing programs, the use of performance metrics, including those based on the recommendations on performance metrics from the Assistant Secretary for Planning and Evaluation under section 6021(d) of the Helping Families in Mental Health Crisis Reform Act of 2016.”; and

(3) in subsection (m), by adding at the end the following:

“(4) EMERGENCY RESPONSE.—Amounts made available for carrying out this subsection shall remain available through the end of the fiscal year following the fiscal year for which such amounts are appropriated.”.

SEC. 6003. Chief Medical Officer.

Section 501 of the Public Health Service Act (42 U.S.C. 290aa), as amended by sections 6001 and 6002, is further amended—

(1) by redesignating subsections (g) through (j) and subsections (k) through (o) as subsections (h) through (k) and subsections (m) through (q), respectively;

(2) in subsection (e)(3)(C), by striking “subsection (k)” and inserting “subsection (m)”;

(3) in subsection (f)(2)(C)(iii), by striking “subsection (k)” and inserting “subsection (m)”; and

(4) by inserting after subsection (f) the following:

“(g) Chief medical officer.—

“(1) IN GENERAL.—The Assistant Secretary, with the approval of the Secretary, shall appoint a Chief Medical Officer to serve within the Administration.

“(2) ELIGIBLE CANDIDATES.—