H.R. 34 (114th): 21st Century Cures Act

The text of the bill below is as of Dec 8, 2016 (Passed Congress/Enrolled Bill).

Source: GPO

I

One Hundred Fourteenth Congress of the United States of America

At the Second Session

H. R. 34

AN ACT

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

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.

Division A—21st Century Cures

Sec. 1000. Short title.

Title I—Innovation Projects and State Responses to Opioid Abuse

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.

Title II—Discovery

Subtitle A—National Institutes of Health Reauthorization

Sec. 2001. National Institutes of Health Reauthorization.

Sec. 2002. EUREKA prize competitions.

Subtitle B—Advancing precision medicine

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.

Subtitle C—Supporting young emerging scientists

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

Sec. 2022. Improvement of loan repayment program.

Subtitle D—National Institutes of Health planning and administration

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.

Subtitle E—Advancement of the National Institutes of Health research and data access

Sec. 2051. Technical updates to clinical trials database.

Sec. 2052. Compliance activities reports.

Sec. 2053. Updates to policies to improve data.

Sec. 2054. Consultation.

Subtitle F—Facilitating collaborative research

Sec. 2061. National neurological conditions surveillance system.

Sec. 2062. Tick-borne diseases.

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

Subtitle G—Promoting pediatric research

Sec. 2071. National pediatric research network.

Sec. 2072. Global pediatric clinical study network.

Title III—Development

Subtitle A—Patient-Focused Drug Development

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.

Subtitle B—Advancing new drug therapies

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.

Subtitle C—Modern Trial Design and Evidence Development

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.

Subtitle D—Patient access to therapies and information

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.

Subtitle E—Antimicrobial innovation and stewardship

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.

Subtitle F—Medical device innovations

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.

Subtitle G—Improving Scientific Expertise and Outreach at FDA

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.

Subtitle H—Medical countermeasures innovation

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.

Subtitle I—Vaccine Access, Certainty, and Innovation

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.

Subtitle J—Technical corrections

Sec. 3101. Technical corrections.

Sec. 3102. Completed studies.

Title IV—Delivery

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.

Title V—Savings

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.

Division B—Helping Families in Mental Health Crisis

Sec. 6000. Short title.

Title VI—Strengthening Leadership and Accountability

Subtitle A—Leadership

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.

Subtitle B—Oversight and accountability

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.

Subtitle C—Interdepartmental Serious Mental Illness Coordinating Committee

Sec. 6031. Interdepartmental Serious Mental Illness Coordinating Committee.

Title VII—ENSURING MENTAL AND SUBSTANCE USE DISORDERS PREVENTION, TREATMENT, AND RECOVERY PROGRAMS KEEP PACE WITH SCIENCE AND TECHNOLOGY

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.

Title VIII—SUPPORTING STATE PREVENTION ACTIVITIES AND RESPONSES TO MENTAL HEALTH AND SUBSTANCE USE DISORDER NEEDS

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.

Title IX—PROMOTING ACCESS TO MENTAL HEALTH AND SUBSTANCE USE DISORDER CARE

Subtitle A—Helping Individuals and Families

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.

Subtitle B—Strengthening the Health Care Workforce

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.

Subtitle C—Mental Health on Campus Improvement

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.

Title X—Strengthening Mental and Substance Use Disorder Care for Children and Adolescents

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.

Title XI—Compassionate communication on HIPAA

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.

Title XII—Medicaid Mental Health Coverage

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.

Title XIII—Mental Health Parity

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.

Title XIV—Mental health and safe communities

Subtitle A—Mental health and safe communities

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.

Subtitle B—Comprehensive Justice and Mental Health

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.

Division C—Increasing Choice, Access, and Quality in Health Care for Americans

Sec. 15000. Short title.

Title XV—Provisions Relating to Medicare Part A

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.

Title XVI—Provisions Relating to Medicare Part B

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.

Title XVII—Other Medicare Provisions

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.

Title XVIII—Other Provisions

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

A

21st Century Cures

1000.

Short title

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

I

Innovation Projects and State Responses to Opioid Abuse

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.

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.

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.

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.

II

Discovery

A

National Institutes of Health Reauthorization

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.

.

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).

B

Advancing precision medicine

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:

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.

.

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).

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.

.

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.

C

Supporting young emerging scientists

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:

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.

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.

D

National Institutes of Health planning and administration

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).

.

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.

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.

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).

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.

.

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;

.

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.

.

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:

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.

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.

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).

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.

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.

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.

.

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.

E

Advancement of the National Institutes of Health research and data access

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.

.

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.

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.

.

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.

F

Facilitating collaborative research

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:

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.

.

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.

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).

G

Promoting pediatric research

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.

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.

III

Development

A

Patient-Focused Drug Development

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.

.

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.

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.

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)).

B

Advancing new drug therapies

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:

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).

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:

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.

.

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.

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.

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.

.

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)).

C

Modern Trial Design and Evidence Development

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.

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:

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.

.

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.

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.

D

Patient access to therapies and information

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.

.

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:

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.

.

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.

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.

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.

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:

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).

.

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.

.

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.

E

Antimicrobial innovation and stewardship

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.

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.

.

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.

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:

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.

F

Medical device innovations

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:

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.

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)).

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.

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.

.

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.

.

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.

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.

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.

.

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.

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)..

G

Improving Scientific Expertise and Outreach at FDA

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.

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:

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.

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:

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.

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.

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.

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.

H

Medical countermeasures innovation

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)).

.

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.

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.

.

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.

.

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).

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:

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.

.

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.

.

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.

I

Vaccine Access, Certainty, and Innovation

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.”.

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.

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.

J

Technical corrections

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.

3102.

Completed studies