H. R. 34 
One Hundred Fourteenth Congress 
of the 
United States of America 
AT THE SECOND SESSION 
Begun and held at the City of Washington on Monday, 
the fourth day of January, two thousand and sixteen 
An Act 
To accelerate the discovery, development, and delivery of 21st century cures, and 
for other purposes. 
Be it enacted by the Senate and House of Representatives of 
the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the ‘‘21st Century 
Cures Act’’. 
(b) TABLE OF CONTENTS.—The table of contents for this Act 
is as follows: 
Sec. 1. Short title; table of contents. 
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 Re-
duction 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.
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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 popu-
lations 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 thera-
pies. 
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.
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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 As-
sessment 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 Immuni-
zation 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.
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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 pre-
vention, 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 PRE-
VENTION, 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 prac-
tices. 
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 na-
tional 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.
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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 in-
formation. 
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 sub-
stance use disorder benefits. 
Sec. 13004. GAO study on parity in mental health and substance use disorder ben-
efits. 
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.
H. R. 34—6 
Sec. 14012. Co-occurring substance abuse and mental health challenges in residen-
tial substance abuse treatment programs. 
Sec. 14013. Mental health and drug treatment alternatives to incarceration pro-
grams. 
Sec. 14014. National criminal justice and mental health training and technical as-
sistance. 
Sec. 14015. Improving Department of Justice data collection on mental illness in-
volved 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 au-
thority. 
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 pro-
gram. 
Sec. 15004. Regulatory relief for LTCHs. 
Sec. 15005. Savings from IPPS MACRA pay-for through not applying documenta-
tion 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 neu-
tral provisions for certain spinal cord specialty hospitals. 
Sec. 15010. Temporary extension to the application of the Medicare LTCH site neu-
tral provisions for certain discharges with severe wounds. 
TITLE XVI—PROVISIONS RELATING TO MEDICARE PART B 
Sec. 16001. Continuing Medicare payment under HOPD prospective payment sys-
tem for services furnished by mid-build off-campus outpatient depart-
ments 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 com-
petitive 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.
H. R. 34—7 
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 pro-
viders 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 Ad-
vantage 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 em-
ployer health reimbursement arrangements. 
DIVISION A—21ST CENTURY CURES 
SEC. 1000. SHORT TITLE. 
This Division may be cited as the ‘‘21st Century Cures Act’’. 
TITLE I—INNOVATION PROJECTS AND 
STATE RESPONSES TO OPIOID ABUSE 
SEC. 1001. BEAU BIDEN CANCER MOONSHOT AND NIH INNOVATION 
PROJECTS. 
(a) IN GENERAL.—The Director of the National Institutes of 
Health (referred to in this section as the ‘‘Director of NIH’’) shall 
use any funds appropriated pursuant to the authorization of appro-
priations 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 Innova-
tion 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
H. R. 34—8 
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 trans-
ferred 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 appro-
priation under the heading ‘‘NIH Innovation Account’’ pro-
vided 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 discre-
tionary budget authority and the resulting outlays for any 
estimate under the Congressional Budget and Impound-
ment 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 appro-
priated under paragraph (3), there are authorized to be appro-
priated 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 Innova-
tive 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 develop-
ment of cancer vaccines, the development of more sensitive
H. R. 34—9 
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 coordina-
tion 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 con-
tracts shall be contingent upon the recipient making avail-
able 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 Rep-
resentatives, a work plan including the proposed allocation 
of funds authorized to be appropriated pursuant to sub-
section (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.
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(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 Rep-
resentatives, 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 appropria-
tions under subsection (b)(3); and 
(iii) whether such projects are advancing the stra-
tegic 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 Com-
mittee on Health, Education, Labor, and Pensions or the 
Committee on Appropriations of the Senate, or the Com-
mittee on Energy and Commerce or the Committee on 
Appropriations of the House of Representatives, the 
Director of NIH shall provide an update in the form of 
testimony and any additional reports to the respective 
congressional committee regarding the allocation of funding 
under this section or the description of the NIH Innovation 
Projects. 
(d) LIMITATIONS.—Notwithstanding any transfer authority 
authorized by this Act or any appropriations Act, any funds made 
available pursuant to the authorization of appropriations under 
subsection (b)(3) may not be used for any purpose other than 
a NIH Innovation Project. 
(e) SUNSET.—This section shall expire on September 30, 2026. 
SEC. 1002. FDA INNOVATION PROJECTS. 
(a) IN
GENERAL.—The Commissioner of Food and Drugs 
(referred to in this section as the ‘‘Commissioner’’) shall use any 
funds appropriated pursuant to the authorization of appropriations 
under subsection (b)(3) to carry out the activities described in 
subsection (b)(4). 
(b) FDA INNOVATION ACCOUNT.— 
(1) ESTABLISHMENT OF FDA INNOVATION ACCOUNT.—There 
is established in the Treasury an account, to be known as 
the ‘‘FDA Innovation Account’’ (referred to in this subsection 
as the ‘‘Account’’), for purposes of carrying out the activities 
described in paragraph (4). 
(2) TRANSFER OF DIRECT SPENDING SAVINGS.—
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(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 appro-
priation under the heading ‘‘FDA Innovation Account’’ pro-
vided to the Commissioner pursuant to the authorization 
of appropriations under subparagraph (A) for the purpose 
of carrying out the projects activities described in para-
graph (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 Rep-
resentatives, 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).
H. R. 34—12 
(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 appropria-
tions 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 Rep-
resentatives, 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 appropria-
tions under subsection (b)(3); and 
(iii) how the activities are advancing public health. 
(B) ADDITIONAL REPORTS.—At the request of the Com-
mittee on Health, Education, Labor, and Pensions or the 
Committee on Appropriations of the Senate, or the Com-
mittee on Energy and Commerce or the Committee on 
Appropriations of the House of Representatives, the 
Commissioner shall provide an update in the form of testi-
mony and any additional reports to the respective congres-
sional 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 sub-
section (b)(3) shall not be used for any purpose other than an 
activity described in subsection (b)(4). 
(e) SUNSET.—This section shall expire on September 30, 2025. 
SEC. 1003. ACCOUNT FOR THE STATE RESPONSE TO THE OPIOID ABUSE 
CRISIS. 
(a) IN GENERAL.—The Secretary of Health and Human Services 
(referred to in this section as the ‘‘Secretary’’) shall use any funds 
appropriated pursuant to the authorization of appropriations under 
subsection (b) to carry out the grant program described in subsection 
(c) for purposes of addressing the opioid abuse crisis within the 
States.
H. R. 34—13 
(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 appropria-
tion 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 pref-
erence 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 supple-
ment 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 activi-
ties such as the following: 
(A) Improving State prescription drug monitoring pro-
grams.
H. R. 34—14 
(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, recog-
nizing 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 treat-
ment 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 appro-
priations Act, shall not be used for any purpose other than 
the grant program in subsection (c); and 
(2) shall be subject to the same requirements as substance 
abuse prevention and treatment programs under titles V and 
XIX of the Public Health Service Act (42 U.S.C. 290aa et 
seq., 300w et seq.). 
(f) SUNSET.—This section shall expire on September 30, 2026. 
SEC. 1004. BUDGETARY TREATMENT. 
(a) STATUTORY PAYGO SCORECARDS.—The budgetary effects of 
division A of this Act shall not be entered on either PAYGO score-
card maintained pursuant to section 4(d) of the Statutory Pay- 
As-You-Go Act of 2010. 
(b) SENATE PAYGO SCORECARDS.—The budgetary effects of divi-
sion 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.
H. R. 34—15 
TITLE II—DISCOVERY 
Subtitle A—National Institutes of Health 
Reauthorization 
SEC. 2001. NATIONAL INSTITUTES OF HEALTH REAUTHORIZATION. 
Section 402A(a)(1) of the Public Health Service Act (42 U.S.C. 
282a(a)(1)) is amended— 
(1) in subparagraph (B), by striking ‘‘and’’ at the end; 
(2) in subparagraph (C), by striking the period at the 
end and inserting a semicolon; and 
(3) by adding at the end the following new subparagraphs: 
‘‘(D) $34,851,000,000 for fiscal year 2018; 
‘‘(E) $35,585,871,000 for fiscal year 2019; and 
‘‘(F) $36,472,442,775 for fiscal year 2020.’’. 
SEC. 2002. EUREKA PRIZE COMPETITIONS. 
(a) IN GENERAL.—Pursuant to the authorities and processes 
established under section 24 of the Stevenson-Wydler Technology 
Innovation Act of 1980 (15 U.S.C. 3719), the Director of the National 
Institutes of Health shall support prize competitions for one or 
both of the following goals: 
(1) Identifying and funding areas of biomedical science 
that could realize significant advancements through a prize 
competition. 
(2) Improving health outcomes, particularly with respect 
to human diseases and conditions— 
(A) for which public and private investment in research 
is disproportionately small relative to Federal Government 
expenditures on prevention and treatment activities with 
respect to such diseases and conditions, such that Federal 
expenditures on health programs would be reduced; 
(B) that are serious and represent a significant disease 
burden in the United States; or 
(C) for which there is potential for significant return 
on investment to the United States. 
(b) TRACKING; REPORTING.—The Director of the National 
Institutes of Health shall— 
(1) collect information on— 
(A) the effect of innovations funded through the prize 
competitions under this section in advancing biomedical 
science or improving health outcomes pursuant to sub-
section (a); and 
(B) the effect of the innovations on Federal expendi-
tures; 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). 
Subtitle B—Advancing Precision Medicine 
SEC. 2011. PRECISION MEDICINE INITIATIVE. 
Part H of title IV of the Public Health Service Act (42 U.S.C. 
289 et seq.) is amended by adding at the end the following:
H. R. 34—16 
‘‘SEC. 498E. PRECISION MEDICINE INITIATIVE. 
‘‘(a) IN GENERAL.—The Secretary is encouraged to establish 
and carry out an initiative, to be known as the ‘Precision Medicine 
Initiative’ (in this section referred to as the ‘Initiative’), to augment 
efforts to address disease prevention, diagnosis, and treatment. 
‘‘(b) COMPONENTS.—The Initiative described under subsection 
(a) may include— 
‘‘(1) developing a network of scientists to assist in carrying 
out the purposes of the Initiative; 
‘‘(2) developing new approaches for addressing scientific, 
medical, public health, and regulatory science issues; 
‘‘(3) applying genomic technologies, such as whole genomic 
sequencing, to provide data on the molecular basis of disease; 
‘‘(4) collecting information voluntarily provided by a diverse 
cohort of individuals that can be used to better understand 
health and disease; and 
‘‘(5) other activities to advance the goals of the Initiative, 
as the Secretary determines appropriate. 
‘‘(c) AUTHORITY OF THE SECRETARY.—In carrying out this sec-
tion, 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 con-
tribute to health disparities; 
‘‘(5) ensure that only authorized individuals may access 
controlled or sensitive, identifiable biological material and asso-
ciated 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 descrip-
tion 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
H. R. 34—17 
on the relevant data access policies and procedures to the Com-
mittee on Health, Education, Labor, and Pensions of the Senate 
and the Committee on Energy and Commerce of the House of 
Representatives. Such report shall include steps the Secretary has 
taken to consult with experts or other heads of departments or 
agencies of the Federal Government in the development of such 
policies.’’. 
SEC. 2012. PRIVACY PROTECTION FOR HUMAN RESEARCH SUBJECTS. 
(a) IN GENERAL.—Subsection (d) of section 301 of the Public 
Health Service Act (42 U.S.C. 241) is amended to read as follows: 
‘‘(d)(1)(A) If a person is engaged in biomedical, behavioral, 
clinical, or other research, in which identifiable, sensitive informa-
tion 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 gov-
erning the protection of human subjects in research. 
‘‘(D) Any person to whom a certificate is issued under subpara-
graph (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 subpara-
graph (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
H. R. 34—18 
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 informa-
tion 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 deter-
mined 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 enact-
ment of this Act, all persons engaged in research and authorized 
by the Secretary of Health and Human Services to protect informa-
tion under section 301(d) of the Public Health Service Act (42 
U.S.C. 241(d)) prior to the date of enactment of this Act shall 
be subject to the requirements of such section (as amended by 
this Act). 
SEC. 2013. PROTECTION OF IDENTIFIABLE AND SENSITIVE INFORMA-
TION. 
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 indi-
vidual. 
‘‘(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.
H. R. 34—19 
‘‘(3) Nothing in this subsection shall be construed to limit 
a research participant’s access to information about such participant 
collected during the participant’s participation in the research.’’. 
SEC. 2014. DATA SHARING. 
(a) IN GENERAL.—Section 402(b) of the Public Health Service 
Act (42 U.S.C. 282(b)) is amended— 
(1) in paragraph (23), by striking ‘‘and’’ at the end; 
(2) in paragraph (24), by striking the period and inserting 
‘‘; and’’; and 
(3) by inserting after paragraph (24) the following: 
‘‘(25) may require recipients of National Institutes of Health 
awards to share scientific data, to the extent feasible, generated 
from such National Institutes of Health awards in a manner 
that is consistent with all applicable Federal laws and regula-
tions, 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 Serv-
ices 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. 
Subtitle C—Supporting Young Emerging 
Scientists 
SEC. 2021. INVESTING IN THE NEXT GENERATION OF RESEARCHERS. 
(a) IN GENERAL.—Part A of title IV of the Public Health Service 
Act (42 U.S.C. 281 et seq.) is amended by adding at the end 
the following: 
‘‘SEC. 404M. NEXT GENERATION OF RESEARCHERS. 
‘‘(a) NEXT GENERATION
OF RESEARCHERS INITIATIVE.—There 
shall be established within the Office of the Director of the National 
Institutes of Health, the Next Generation of Researchers Initiative 
(referred to in this section as the ‘Initiative’), through which the 
Director shall coordinate all policies and programs within the 
National Institutes of Health that are focused on promoting and 
providing opportunities for new researchers and earlier research 
independence. 
‘‘(b) ACTIVITIES.—The Director of the National Institutes of 
Health, through the Initiative shall— 
‘‘(1) promote policies and programs within the National 
Institutes of Health that are focused on improving opportunities 
for new researchers and promoting earlier research independ-
ence, including existing policies and programs, as appropriate;
H. R. 34—20 
‘‘(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 Acad-
emies of Sciences, Engineering, and Medicine as part of the com-
prehensive 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 Appro-
priations Act, 2016. 
SEC. 2022. IMPROVEMENT OF LOAN REPAYMENT PROGRAM. 
(a) INTRAMURAL LOAN REPAYMENT PROGRAM.—Section 487A 
of the Public Health Service Act (42 U.S.C. 288–1) is amended— 
(1) by amending the section heading to read as follows: 
‘‘INTRAMURAL LOAN REPAYMENT PROGRAM’’; 
(2) in subsection (a)— 
(A) by striking ‘‘The Secretary shall carry out a pro-
gram’’ 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 sub-
section (a), the Director of the National Institutes of Health— 
‘‘(A) shall continue to focus on— 
‘‘(i) general research;
H. R. 34—21 
‘‘(ii) research on acquired immune deficiency syn-
drome; and 
‘‘(iii) clinical research conducted by appropriately 
qualified health professional who are from disadvan-
taged 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 pursu-
ant 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 appro-
priate 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 sub-
section (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
H. R. 34—22 
‘‘(v) clinical research conducted by appropriately 
qualified health professional who are from disadvan-
taged 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 pursu-
ant to guidelines issued by the Director).’’; 
(5) in subsection (d) (as so redesignated), by striking ‘‘The 
provisions’’ and inserting ‘‘APPLICABILITY OF CERTAIN PROVI-
SIONS 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 repay-
ment 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. 
Subtitle D—National Institutes of Health 
Planning and Administration 
SEC. 2031. NATIONAL INSTITUTES OF HEALTH STRATEGIC PLAN. 
(a) STRATEGIC PLAN.—Section 402 of the Public Health Service 
Act (42 U.S.C. 282) is amended— 
(1) in subsection (b)(5), by inserting before the semicolon 
the following: ‘‘, and through the development, implementation,
H. R. 34—23 
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 commit-
tees 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 sci-
entific 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 treat-
ment, 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 pro-
posed 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 sub-
section. Such plans developed by and updated by the national 
research institutes and national centers shall have a common 
template.
H. R. 34—24 
‘‘(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 there-
after,’’ 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 cen-
ters take into account women and minorities and are 
focused on reducing health disparities. 
‘‘(B) STRATEGIC PLANS.—Any strategic plan issued by 
a national institute or national center shall include details 
on the objectives described in subparagraph (A).’’. 
SEC. 2032. TRIENNIAL REPORTS. 
Section 403 of the Public Health Service Act (42 U.S.C. 283) 
is amended— 
(1) in the section heading, by striking ‘‘BIENNIAL’’ and 
inserting ‘‘TRIENNIAL’’ ; and 
(2) in subsection (a)— 
(A) in the matter preceding paragraph (1), by striking 
‘‘biennial’’ and inserting ‘‘triennial’’; 
(B) by amending paragraph (3) to read as follows: 
‘‘(3) A description of intra-National Institutes of Health 
activities, including— 
‘‘(A) identification of the percentage of funds made 
available by each national research institute and national 
center with respect to each applicable fiscal year for con-
ducting 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 ‘‘demo-
graphic variables, including biological and social vari-
ables 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
H. R. 34—25 
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 subpara-
graph (B); and 
(v) in subparagraph (B), as redesignated by clause 
(iv), by striking ‘‘Recommendations’’ and inserting ‘‘rec-
ommendations’’. 
SEC. 
2033. 
INCREASING 
ACCOUNTABILITY 
AT 
THE 
NATIONAL 
INSTITUTES OF HEALTH. 
(a) APPOINTMENT
AND TERMS
OF DIRECTORS
OF NATIONAL 
RESEARCH INSTITUTES AND NATIONAL CENTERS.—Subsection (a) of 
section 405 of the Public Health Service Act (42 U.S.C. 284) is 
amended to read as follows: 
‘‘(a) APPOINTMENT.— 
‘‘(1) IN
GENERAL.—The Director of the National Cancer 
Institute shall be appointed by the President, and the Directors 
of the other national research institutes and national centers 
shall be appointed by the Secretary, acting through the Director 
of National Institutes of Health. Each Director of a national 
research institute or national center shall report directly to 
the Director of National Institutes of Health. 
‘‘(2) APPOINTMENT.— 
‘‘(A) TERM.—A Director of a national research institute 
or national center who is appointed by the Secretary, acting 
through the Director of National Institutes of Health, shall 
be appointed for 5 years. 
‘‘(B) REAPPOINTMENT.—At the end of the term of a 
Director of a national research institute or national center, 
the Director may be reappointed in accordance with stand-
ards 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
H. R. 34—26 
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 sub-
section 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 re-
appointments 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 deter-
mines relevant. 
‘‘(3) NONAPPLICATION OF CERTAIN PROVISION.—The restric-
tions contained in section 202 of the Departments of Labor, 
Health and Human Services, and Education, and Related Agen-
cies 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 bio-
medical research that is not necessary for scientific purposes. Such 
report shall— 
(1) describe the procedures in place to identify such duplica-
tive research, including procedures for monitoring research 
applications and funded research awards to prevent unneces-
sary duplication; 
(2) describe the steps taken to improve the procedures 
described in paragraph (1), in response to relevant recommenda-
tions made by the Comptroller General of the United States;
H. R. 34—27 
(3) describe how the Secretary operationally distinguishes 
necessary and appropriate scientific replication from unneces-
sary duplication; and 
(4) provide examples of instances where the Secretary has 
identified unnecessarily duplicative research and the steps 
taken to eliminate the unnecessary duplication. 
SEC. 2034. REDUCING ADMINISTRATIVE BURDEN FOR RESEARCHERS. 
(a) PLAN PREPARATION AND IMPLEMENTATION OF MEASURES TO 
REDUCE ADMINISTRATIVE BURDENS.— 
(1) IN GENERAL.—Not later than 2 years after the date 
of enactment of this Act, the Secretary of Health and Human 
Services (referred to in this section as the ‘‘Secretary’’) shall— 
(A) lead a review by research funding agencies of all 
regulations and policies related to the disclosure of financial 
conflicts of interest, including the minimum threshold for 
reporting financial conflicts of interest; 
(B) make revisions, as appropriate, to harmonize 
existing policies and reduce administrative burden on 
researchers while maintaining the integrity and credibility 
of research findings and protections of human participants; 
and 
(C) confer with the Office of the Inspector General 
about the activities of such office related to financial con-
flicts of interest involving research funding agencies. 
(2) CONSIDERATIONS.—In updating policies under para-
graph (1)(B), the Secretary shall consider— 
(A) modifying the timelines for the reporting of finan-
cial 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 modi-
fication of the definition of the term ‘‘investigator’’ for pur-
poses of the regulations and policies described in subpara-
graphs (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 sub-
recipients 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 meas-
ures may include, as appropriate— 
(1) an exemption from subrecipient monitoring require-
ments, upon request from the primary awardees, provided 
that— 
(A) the subrecipient is subject to Federal audit require-
ments pursuant to the Uniform Guidance of the Office 
of Management and Budget; 
(B) the primary awardee conducts, pursuant to guid-
ance of the National Institutes of Health, a pre-award
H. R. 34—28 
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 appro-
priate, 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 inconsist-
encies, overlap, or duplication among such regulations and poli-
cies; 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 require-
ments 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 Manage-
ment 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.—
H. R. 34—29 
(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 Tech-
nology Policy. 
(iii) The Secretary of Health and Human Services. 
(iv) The Director of the National Science Founda-
tion. 
(v) The secretaries and directors of other depart-
ments 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 com-
prised of not less than 9 and not more than 12 representa-
tives of academic research institutions, other private, non-
profit 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 sci-
entific 
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 harmoni-
zation 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 regula-
tions 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 prac-
tices; and 
(E) conducting ongoing assessment and evaluation of 
regulatory burden, including development of metrics, peri-
odic measurement, and identification of process improve-
ments and policy changes. 
(4) EXPERT SUBCOMMITTEES.—The Board may form tem-
porary 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.
H. R. 34—30 
(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 Manage-
ment and Budget, the Director of the Office of Science and 
Technology Policy, the heads of relevant Federal departments 
and agencies, the Committee on Health, Education, Labor, and 
Pensions of the Senate, and the Committee on Energy and 
Commerce of the House of Representatives containing formal 
recommendations 
on 
the 
conceptualization, 
development, 
harmonization, and reconsideration of scientific research policy, 
including the regulatory benefits and burdens. 
(6) SUNSET.—The Board shall terminate on September 30, 
2021. 
(7) GAO REPORT.—Not later than 4 years after the date 
of enactment of this Act, the Comptroller General of the United 
States shall conduct an independent evaluation of the activities 
carried out by the Board pursuant to this subsection and submit 
to the appropriate committees of Congress a report regarding 
the results of the independent evaluation. Such report shall 
review and assess the Board’s activities with respect to the 
responsibilities described in paragraph (3). 
SEC. 2035. EXEMPTION FOR THE NATIONAL INSTITUTES OF HEALTH 
FROM THE PAPERWORK REDUCTION ACT REQUIRE-
MENTS. 
Section 301 of the Public Health Service Act (42 U.S.C. 241), 
as amended by section 2013, is further amended by adding at 
the end the following: 
‘‘(g) Subchapter I of chapter 35 of title 44, United States Code, 
shall not apply to the voluntary collection of information during 
the conduct of research by the National Institutes of Health.’’. 
SEC. 2036. HIGH-RISK, HIGH-REWARD RESEARCH. 
(a) IN GENERAL.—Section 402 of the Public Health Service 
Act (42 U.S.C. 282), as amended by section 2031, is further amended 
by adding at the end the following: 
‘‘(n) UNIQUE RESEARCH INITIATIVES.— 
‘‘(1) IN GENERAL.—The Director of NIH may approve, after 
consideration of a proposal under paragraph (2)(A), requests 
by the national research institutes and centers, or program 
officers within the Office of the Director to engage in trans-
actions 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—
H. R. 34—31 
‘‘(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 sub-
paragraphs (D) through (M), respectively; and 
(2) by inserting after subparagraph (B), the following: 
‘‘(C) shall, as appropriate, conduct and support research 
that has the potential to transform the scientific field, has 
inherently higher risk, and that seeks to address major current 
challenges;’’. 
SEC. 2037. NATIONAL CENTER FOR ADVANCING TRANSLATIONAL 
SCIENCES. 
(a) IN GENERAL.—Section 479(b) of the Public Health Service 
Act (42 U.S.C. 287(b)) is amended— 
(1) in paragraph (1), by striking ‘‘phase IIA’’ and inserting 
‘‘phase IIB’’; and 
(2) in paragraph (2)— 
(A) in the matter preceding subparagraph (A), by 
striking ‘‘phase IIB’’ and inserting ‘‘phase III’’; 
(B) in subparagraph (A), by striking ‘‘phase IIB’’ and 
inserting ‘‘phase III’’; 
(C) in subparagraph (B), by striking ‘‘phase IIA’’ and 
inserting ‘‘phase IIB’’; and 
(D) in subparagraph (C), by striking ‘‘phase IIB’’ and 
inserting ‘‘phase III’’. 
(b) INCREASED
TRANSPARENCY.—Section 479 of the Public 
Health Service Act (42 U.S.C. 287) is amended— 
(1) in subsection (c)— 
(A) in paragraph (4)(D), by striking ‘‘and’’ at the end; 
(B) in paragraph (5), by striking the period and 
inserting a semicolon; and 
(C) by adding at the end the following: 
‘‘(6) the methods and tools, if any, that have been developed 
since the last biennial report was prepared; and 
‘‘(7) the methods and tools, if any, that have been developed 
and are being utilized by the Food and Drug Administration 
to support medical product reviews.’’; and
H. R. 34—32 
(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 informa-
tion that is a trade secret, or other privileged or confidential 
information subject to section 552(b)(4) of title 5, United States 
Code, or section 1905 of title 18, United States Code.’’. 
SEC. 2038. COLLABORATION AND COORDINATION TO ENHANCE 
RESEARCH. 
(a) 
RESEARCH
PRIORITIES; 
COLLABORATIVE
RESEARCH 
PROJECTS.—Section 402(b) of the Public Health Service Act (42 
U.S.C. 282(b)) is amended— 
(1) by amending paragraph (4) to read as follows: 
‘‘(4) shall assemble accurate data to be used to assess 
research priorities, including— 
‘‘(A) information to better evaluate scientific oppor-
tunity, 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 pedi-
atric subgroups; and 
‘‘(IV) other demographic variables as the 
Director of the National Institutes of Health deter-
mines appropriate; 
‘‘(ii) is disaggregated by research area, condition, 
and disease categories; and 
‘‘(iii) is to be made publicly available on the Inter-
net 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 subpara-
graph (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 deter-
minants of health that contribute to health dispari-
ties;’’.
H. R. 34—33 
(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-eth-
nicity studies. 
‘‘(C) For the applicable reporting period, the number 
of projects of clinical research that include women and 
members of minority groups and that— 
‘‘(i) have been completed during such reporting 
period; and 
‘‘(ii) are being carried out during such reporting 
period and have not been completed. 
‘‘(D) The number of studies completed during the 
applicable reporting period for which reporting has been 
submitted in accordance with subsection (c)(2)(A).’’. 
(c) COORDINATION.—Section 486(c)(2) of the Public Health 
Service Act (42 U.S.C. 287d(c)(2)) is amended by striking ‘‘designees’’ 
and inserting ‘‘senior-level staff designees’’. 
(d) IN GENERAL.—Part A of title IV of the Public Health Service 
Act (42 U.S.C. 281 et seq.), as amended by section 2021, is further 
amended by adding at the end the following: 
‘‘SEC. 404N. POPULATION FOCUSED RESEARCH. 
‘‘The Director of the National Institutes of Health shall, as 
appropriate, encourage efforts to improve research related to the 
health of sexual and gender minority populations, including by— 
‘‘(1) facilitating increased participation of sexual and gender 
minority populations in clinical research supported by the 
National Institutes of Health, and reporting on such participa-
tion, 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 appro-
priate—
H. R. 34—34 
(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 ‘‘INTER-
AGENCY’’ 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 aca-
demic 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
H. R. 34—35 
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 accord-
ance 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 sec-
tion 492B of the Public Health Service Act (42 U.S.C. 
289a–2), including the reporting requirements under sub-
section (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 out-
comes 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—
H. R. 34—36 
(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 tri-
ennial report under section 403 of the Public Health Service 
Act (42 U.S.C. 283) (as amended by section 2032) are 
made available to the public on the Internet website of 
the National Institutes of Health. 
SEC. 2039. ENHANCING THE RIGOR AND REPRODUCIBILITY OF SCI-
ENTIFIC 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 recommenda-
tions 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 deter-
minants of health that contribute to health disparities; 
(B) the circumstances under which summary informa-
tion regarding biological, social, and other factors that con-
tribute 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 dispari-
ties; 
(3) applicable levels of rigor in statistical methods, method-
ology, and analysis; 
(4) data and information sharing in accordance with 
applicable privacy laws and regulations; and 
(5) any other matter the working group determines rel-
evant. 
(c) POLICIES.—Not later than 18 months after the date of enact-
ment of this Act, the Director of the National Institutes of Health 
shall consider the recommendations developed by the working group
H. R. 34—37 
and issued by the Advisory Committee under subsection (a) and 
develop or update policies as appropriate. 
(d) REPORT.—Not later than 2 years after the date of enactment 
of this Act, the Director of the National Institutes of Health shall 
issue a report to the Secretary of Health and Human Services, 
the Committee on Health, Education, Labor, and Pensions of the 
Senate, and the Committee on Energy and Commerce of the House 
of Representatives regarding recommendations developed under 
subsection (a) and any subsequent policy changes implemented, 
to enhance rigor and reproducibility in scientific research funded 
by the National Institutes of Health. 
(e) CONFIDENTIALITY.—Nothing in this section authorizes the 
Secretary of Health and Human Services to disclose any information 
that is a trade secret, or other privileged or confidential information, 
described in section 552(b)(4) of title 5, United States Code, or 
section 1905 of title 18, United States Code. 
SEC. 2040. IMPROVING MEDICAL REHABILITATION RESEARCH AT THE 
NATIONAL INSTITUTES OF HEALTH. 
(a) IN GENERAL.—Section 452 of the Public Health Service 
Act (42 U.S.C. 285g–4) is amended— 
(1) in subsection (b), by striking ‘‘conduct and support’’ 
and inserting ‘‘conduct, support, and coordination’’; 
(2) in subsection (c)(1)(C), by striking ‘‘of the Center’’ and 
inserting ‘‘within the Center’’; 
(3) in subsection (d)— 
(A) by striking ‘‘(d)(1) In consultation’’ and all that 
follows through the end of paragraph (1) and inserting 
the following: 
‘‘(d)(1) The Director of the Center, in consultation with the 
Director of the Institute, the coordinating committee established 
under subsection (e), and the advisory board established under 
subsection (f), shall develop a comprehensive plan (referred to in 
this section as the ‘Research Plan’) for the conduct, support, and 
coordination of medical rehabilitation research.’’; 
(B) in paragraph (2)— 
(i) in subparagraph (A), by striking ‘‘; and’’ and 
inserting a semicolon; 
(ii) in subparagraph (B), by striking the period 
and inserting ‘‘; and’’; and 
(iii) by adding at the end the following: 
‘‘(C) include goals and objectives for conducting, supporting, 
and coordinating medical rehabilitation research, consistent 
with the purpose described in subsection (b).’’; 
(C) by striking paragraph (4) and inserting the fol-
lowing: 
‘‘(4) The Director of the Center, in consultation with the Director 
of the Institute, the coordinating committee established under sub-
section (e), and the advisory board established under subsection 
(f), shall revise and update the Research Plan periodically, as appro-
priate, 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:
H. R. 34—38 
‘‘(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 rehabilita-
tion 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 rehabilita-
tion 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 rehabilita-
tion research’ means the science of mechanisms and interventions 
that prevent, improve, restore, or replace lost, underdeveloped, or 
deteriorating function.’’. 
(b) CONFORMING
AMENDMENT.—Section 3 of the National 
Institutes of Health Amendments of 1990 (42 U.S.C. 285g–4 note) 
is amended— 
(1) in subsection (a), by striking ‘‘IN GENERAL.—’’; and 
(2) by striking subsection (b). 
SEC. 2041. TASK FORCE ON RESEARCH SPECIFIC TO PREGNANT 
WOMEN AND LACTATING WOMEN. 
(a) TASK FORCE ON RESEARCH SPECIFIC TO PREGNANT WOMEN 
AND LACTATING WOMEN.— 
(1) ESTABLISHMENT.—Not later than 90 days after the date 
of enactment of this Act, the Secretary of Health and Human 
Services (referred to in this section as the ‘‘Secretary’’) shall 
establish a task force, in accordance with the Federal Advisory 
Committee Act (5 U.S.C. App.), to be known as the ‘‘Task
H. R. 34—39 
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 guid-
ance 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 com-
posed 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 appro-
priate 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, lac-
tating 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 oper-
ation 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 appro-
priate 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 appro-
priate, to fulfill its duties under paragraph (2).
H. R. 34—40 
(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 preg-
nant women and lactating women in clinical research. 
(C) Effective communication strategies with health care 
providers and the public on information relevant to preg-
nant 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 lac-
tating 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 LAC-
TATING WOMEN IN RESEARCH.— 
(1) IN GENERAL.—Not later than 2 years after the date 
of enactment of this Act, the Secretary, considering any rec-
ommendations 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 appro-
priate, 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 individ-
uals reviewing grant proposals for excluding pregnant women 
or lactating women as a study population requiring additional 
protections from participating in human subject research.
H. R. 34—41 
SEC. 
2042. 
STREAMLINING 
NATIONAL 
INSTITUTES 
OF 
HEALTH 
REPORTING REQUIREMENTS. 
(a) 
TRANS-NATIONAL
INSTITUTES
OF
HEALTH
RESEARCH 
REPORTING.—Section 402A(c)(2) of the Public Health Service Act 
(42 U.S.C. 282a(c)(2)) is amended— 
(1) by amending subparagraph (B) to read as follows: 
‘‘(B) REPORTING.—Not later than 2 years after the date 
of enactment of 21st Century Cures Act, the head of each 
national research institute or national center shall submit 
to the Director of the National Institutes of Health a report, 
to be included in the triennial report under section 403, 
on the amount made available by the institute or center 
for conducting or supporting research that involves 
collaboration between the institute or center and 1 or more 
other national research institutes or national centers.’’; and 
(2) in subparagraphs (D) and (E) by striking ‘‘(B)(i)’’ each 
place it appears and inserting ‘‘(B)’’. 
(b) FRAUD AND ABUSE REPORTING.—Section 403B of the Public 
Health Service Act (42 U.S.C. 283a–1) is amended— 
(1) by striking subsection (b); 
(2) by redesignating subsection (c) as subsection (b); and 
(3) in subsection (b) (as so redesignated), by striking ‘‘sub-
sections (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’’.
H. R. 34—42 
SEC. 2043. REIMBURSEMENT FOR RESEARCH SUBSTANCES AND LIVING 
ORGANISMS. 
Section 301 of the Public Health Service Act (42 U.S.C. 241), 
as amended by section 2035, is further amended— 
(1) in the flush matter at the end of subsection (a)— 
(A) by redesignating such matter as subsection (h)(1); 
and 
(B) by moving such matter so as to appear at the 
end of such section; and 
(2) in subsection (h) (as so redesignated), by adding at 
the end the following: 
‘‘(2) Where research substances and living organisms are made 
available under paragraph (1) through contractors, the Secretary 
may direct such contractors to collect payments on behalf of the 
Secretary for the costs incurred to make available such substances 
and organisms and to forward amounts so collected to the Secretary, 
in the time and manner specified by the Secretary. 
‘‘(3) Amounts collected under paragraph (2) shall be credited 
to the appropriations accounts that incurred the costs to make 
available the research substances and living organisms involved, 
and shall remain available until expended for carrying out activities 
under such accounts.’’. 
SEC. 2044. SENSE OF CONGRESS ON INCREASED INCLUSION OF UNDER-
REPRESENTED 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 underrep-
resented 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. 
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 clin-
ical trial for a product that is a combination of drug, 
device, or biological product shall be considered—
H. R. 34—43 
‘‘(I) an applicable drug clinical trial, if the 
Secretary determines under section 503(g) of the 
Federal Food, Drug, and Cosmetic Act that the 
primary mode of action of such product is that 
of a drug or biological product; or 
‘‘(II) an applicable device clinical trial, if the 
Secretary determines under such section that the 
primary mode of action of such product is that 
of a device.’’. 
SEC. 2052. COMPLIANCE ACTIVITIES REPORTS. 
(a) DEFINITIONS.—In this section: 
(1) APPLICABLE CLINICAL TRIAL.—The term ‘‘applicable clin-
ical 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 reg-
istered 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 edu-
cate 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 para-
graph (1)(C), the Secretary shall include in subsequent reports
H. R. 34—44 
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 registra-
tion and results submission requirements. 
SEC. 2053. UPDATES TO POLICIES TO IMPROVE DATA. 
Section 492B(c) of the Public Health Service Act (42 U.S.C. 
289a–2(c)) is amended— 
(1) by striking ‘‘In the case’’ and inserting the following: 
‘‘(1) IN GENERAL.—In the case’’; and 
(2) by adding at the end the following: 
‘‘(2) REPORTING REQUIREMENTS.—For any new and com-
peting project of clinical research subject to the requirements 
under this section that receives a grant award 1 year after 
the date of enactment of the 21st Century Cures Act, or any 
date thereafter, for which a valid analysis is provided under 
paragraph (1)— 
‘‘(A) and which is an applicable clinical trial as defined 
in section 402(j), the entity conducting such clinical 
research shall submit the results of such valid analysis 
to the clinical trial registry data bank expanded under 
section 402(j)(3), and the Director of the National Institutes 
of Health shall, as appropriate, consider whether such 
entity has complied with the reporting requirement 
described in this subparagraph in awarding any future 
grant to such entity, including pursuant to section 
402(j)(5)(A)(ii) when applicable; and 
‘‘(B) the Director of the National Institutes of Health 
shall encourage the reporting of the results of such valid 
analysis described in paragraph (1) through any additional 
means determined appropriate by the Director.’’. 
SEC. 2054. CONSULTATION. 
Not later than 90 days after the date of enactment of this 
Act, the Secretary of Health and Human Services shall consult 
with relevant Federal agencies, including the Food and Drug 
Administration, the Office of the National Coordinator for Health 
Information Technology, and the National Institutes of Health, 
as well as other stakeholders (including patients, researchers, physi-
cians, industry representatives, and developers of health informa-
tion 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. 
Subtitle F—Facilitating Collaborative 
Research 
SEC. 2061. NATIONAL NEUROLOGICAL CONDITIONS SURVEILLANCE 
SYSTEM. 
Part P of title III of the Public Health Service Act (42 U.S.C. 
280g et seq.) is amended by inserting after section 399S the fol-
lowing:
H. R. 34—45 
‘‘SEC. 399S–1. SURVEILLANCE OF NEUROLOGICAL DISEASES. 
‘‘(a) IN GENERAL.—The Secretary, acting through the Director 
of the Centers for Disease Control and Prevention and in coordina-
tion 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 activi-
ties into an integrated surveillance system, which may consist 
of or include a registry, to be known as the National Neuro-
logical 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 informa-
tion 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 dis-
eases, 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 neuro-
logical 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 informa-
tion 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 associa-
tions that— 
‘‘(A) focus on neurological diseases; and 
‘‘(B) have demonstrated experience in research, care, 
or patient services; 
‘‘(3) health information technology experts or other informa-
tion management specialists; 
‘‘(4) clinicians with expertise in neurological diseases; and 
‘‘(5) 
research 
scientists 
with 
experience 
conducting 
translational research or utilizing surveillance systems for sci-
entific research purposes.
H. R. 34—46 
‘‘(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 Neuro-
logical Conditions Surveillance System available, as appro-
priate— 
‘‘(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 prac-
ticable. 
‘‘(g) PUBLIC ACCESS.—Subject to subsection (h), the Secretary 
shall ensure that information and analysis in the National Neuro-
logical 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 informa-
tion collected pursuant to this section and epidemiological anal-
yses, 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 popu-
lation of individuals with neurological disease and have dem-
onstrated experience in neurological disease research, care, and 
patient services.
H. R. 34—47 
‘‘(k) AUTHORIZATION
OF APPROPRIATIONS.—To carry out this 
section, there is authorized to be appropriated $5,000,000 for each 
of fiscal years 2018 through 2022.’’. 
SEC. 2062. TICK-BORNE DISEASES. 
(a) IN GENERAL.—The Secretary of Health and Human Services 
(referred to in this section as ‘‘the Secretary’’) shall continue to 
conduct or support epidemiological, basic, translational, and clinical 
research related to vector-borne diseases, including tick-borne dis-
eases. 
(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 inter-
agency 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 dis-
eases; 
(ii) advances made pursuant to such research; 
(iii) Federal activities related to tick-borne dis-
eases, 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 nongovern-
mental entities, including organizations representing 
patients, health care providers, researchers, and industry 
regarding scientific advances, research questions, surveil-
lance activities, and emerging strains in species of patho-
genic organisms.
H. R. 34—48 
(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, con-
sisting of one or more representatives of each of the fol-
lowing: 
(i) The Office of the Assistant Secretary for Health. 
(ii) The Food and Drug Administration. 
(iii) The Centers for Disease Control and Preven-
tion. 
(iv) The National Institutes of Health. 
(v) Such other agencies and offices of the Depart-
ment of Health and Human Services as the Secretary 
determines appropriate. 
(B) NON–FEDERAL PUBLIC MEMBERS.—Seven non–Fed-
eral public members, consisting of representatives of the 
following categories: 
(i) Physicians and other medical providers with 
experience in diagnosing and treating tick-borne dis-
eases. 
(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 deter-
mined by the Secretary to be beneficial to the func-
tioning of the Working Group. 
(4) MEETINGS.—The Working Group shall meet not less 
than twice each year. 
(5) REPORTING.—Not later than 2 years after the date 
of enactment of this Act, and every 2 years thereafter until 
termination of the Working Group pursuant to paragraph (7), 
the Working Group shall— 
(A) submit a report on its activities under paragraph 
(2)(A) and any recommendations under paragraph (2)(B) 
to the Secretary, the Committee on Energy and Commerce 
of the House of Representatives, and the Committee on 
Health, Education, Labor, and Pensions of the Senate; and 
(B) make such report publicly available on the Internet 
website of the Department of Health and Human Services. 
(6) APPLICABILITY OF FACA.—The Working Group shall be 
treated as an advisory committee subject to the Federal 
Advisory Committee Act (5 U.S.C. App.). 
(7) SUNSET.—The Working Group under this section shall 
terminate 6 years after the date of enactment of this Act. 
SEC. 2063. ACCESSING, SHARING, AND USING HEALTH DATA FOR 
RESEARCH PURPOSES. 
(a) GUIDANCE RELATED TO REMOTE ACCESS.—Not later than 
1 year after the date of enactment of this Act, the Secretary of 
Health and Human Services (referred to in this section as the 
‘‘Secretary’’) shall issue guidance clarifying that subparagraph (B) 
of section 164.512(i)(1)(ii) of part 164 of the Rule (prohibiting the 
removal of protected health information by a researcher) does not 
prohibit remote access to health information by a researcher for 
such purposes as described in section 164.512(i)(1)(ii) of part 164 
of the Rule so long as—
H. R. 34—49 
(1) at a minimum, security and privacy safeguards, con-
sistent 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 other-
wise 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 indi-
vidual has the right to revoke such authorization. 
(3) REVOCATION OF AUTHORIZATION.—Clarification of appro-
priate 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 pro-
tected 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 represent-
atives 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 deter-
mines appropriate.
H. R. 34—50 
(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 pur-
poses, 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 individ-
ual’s protected health information will be used or dis-
closed for such research; 
(ii) opportunities for individuals to set preferences 
on the manner in which their protected health informa-
tion is used in research; 
(iii) opportunities for patients to revoke authoriza-
tion; 
(iv) notification to individuals of a breach in pri-
vacy; 
(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 pro-
tected health information; and 
(B) consider, at a minimum— 
(i) expectations and preferences on how an individ-
ual’s protected health information is shared and used; 
(ii) issues related to specific subgroups of people, 
such as children, incarcerated individuals, and individ-
uals 
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-disclo-
sure 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, Edu-
cation, 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:
H. R. 34—51 
(1) THE RULE.—References to ‘‘the Rule’’ refer to part 160 
or part 164, as appropriate, of title 45, Code of Federal Regula-
tions (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). 
Subtitle G—Promoting Pediatric Research 
SEC. 2071. NATIONAL PEDIATRIC RESEARCH NETWORK. 
Section 409D(d) of the Public Health Service Act (42 U.S.C. 
284h(d)) is amended— 
(1) in paragraph (1), by striking ‘‘in consultation with the 
Director of the Eunice Kennedy Shriver National Institute of 
Child Health and Human Development and in collaboration 
with other appropriate national research institutes and national 
centers that carry out activities involving pediatric research, 
may provide for the establishment of’’ and inserting ‘‘in 
collaboration with the national research institutes and national 
centers that carry out activities involving pediatric research, 
shall support’’; and 
(2) in paragraph (2)(A) and the first sentence of paragraph 
(2)(E), by striking ‘‘may’’ each place such term appears and 
inserting ‘‘shall’’. 
SEC. 2072. GLOBAL PEDIATRIC CLINICAL STUDY NETWORK. 
It is the sense of Congress that— 
(1) the National Institutes of Health should encourage a 
global pediatric clinical study network by providing grants, 
contracts, or cooperative agreements to support new and early 
stage investigators who participate in the global pediatric clin-
ical 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 authori-
ties; and 
(3) once a global pediatric clinical study network is estab-
lished and becomes operational, the Secretary should continue 
to encourage and facilitate the participation of clinical inves-
tigators 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. 
TITLE III—DEVELOPMENT 
Subtitle A—Patient-Focused Drug 
Development 
SEC. 3001. PATIENT EXPERIENCE DATA. 
Section 569C of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360bbb–8c) is amended—
H. R. 34—52 
(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 subpara-
graphs (A) and (B), respectively, and moving such subpara-
graphs 2 ems to the right; and 
(C) by striking ‘‘The Secretary’’ and inserting the fol-
lowing: 
‘‘(1) IN GENERAL.—The Secretary’’; 
(2) by redesignating subsections (b) through (e) as para-
graphs (2) through (5), respectively, and moving such para-
graphs 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 organiza-
tions, disease research foundations, researchers, and drug 
manufacturers); and 
‘‘(2) are intended to provide information about patients’ 
experiences with a disease or condition, including— 
‘‘(A) the impact of such disease or condition, or a related 
therapy, on patients’ lives; and 
‘‘(B) patient preferences with respect to treatment of 
such disease or condition.’’. 
SEC. 3002. PATIENT-FOCUSED DRUG DEVELOPMENT GUIDANCE. 
(a) PUBLICATION OF GUIDANCE DOCUMENTS.—Not later than 
180 days after the date of enactment of this Act, the Secretary 
of Health and Human Services (referred to in this section as the 
‘‘Secretary’’), acting through the Commissioner of Food and Drugs, 
shall develop a plan to issue draft and final versions of one or 
more guidance documents, over a period of 5 years, regarding 
the collection of patient experience data, and the use of such data 
and related information in drug development. Not later than 18 
months after the date of enactment of this Act, the Secretary 
shall issue a draft version of at least one such guidance document. 
Not later than 18 months after the public comment period on 
the draft guidance ends, the Secretary shall issue a revised draft 
guidance or final guidance.
H. R. 34—53 
(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 sub-
section (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 through-
out the drug development process and methodological consider-
ations 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 regu-
latory decisionmaking; 
(5) how a person seeking to develop and submit proposed 
draft guidance relating to patient experience data for consider-
ation by the Secretary may submit such proposed draft guidance 
to the Secretary; 
(6) the format and content required for submissions under 
this section to the Secretary, including with respect to the 
information described in paragraph (1); 
(7) how the Secretary intends to respond to submissions 
of information described in paragraph (1), if applicable, 
including any timeframe for response when such submission 
is not part of a regulatory application or other submission 
that has an associated timeframe for response; and 
(8) how the Secretary, if appropriate, anticipates using 
relevant patient experience data and related information, 
including with respect to the structured risk-benefit assessment 
framework described in section 505(d) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(d)), to inform regulatory 
decisionmaking. 
SEC. 3003. STREAMLINING PATIENT INPUT. 
Chapter 35 of title 44, United States Code, shall not apply 
to the collection of information to which a response is voluntary, 
that is initiated by the Secretary under section 569C of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–8c) (as amended 
by section 3001) or section 3002. 
SEC. 3004. REPORT ON PATIENT EXPERIENCE DRUG DEVELOPMENT. 
Not later than June 1 of 2021, 2026, and 2031, the Secretary 
of Health and Human Services, acting through the Commissioner 
of Food and Drugs, shall prepare and publish on the Internet 
website of the Food and Drug Administration a report assessing 
the use of patient experience data in regulatory decisionmaking, 
in particular with respect to the review of patient experience data 
and information on patient-focused drug development tools as part
H. R. 34—54 
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)). 
Subtitle B—Advancing New Drug 
Therapies 
SEC. 3011. QUALIFICATION OF DRUG DEVELOPMENT TOOLS. 
(a) IN GENERAL.—Chapter V of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after 
section 506F the following new section: 
‘‘SEC. 507. QUALIFICATION OF DRUG DEVELOPMENT TOOLS. 
‘‘(a) PROCESS FOR QUALIFICATION.— 
‘‘(1) IN GENERAL.—The Secretary shall establish a process 
for the qualification of drug development tools for a proposed 
context of use under which— 
‘‘(A)(i) a requestor initiates such process by submitting 
a letter of intent to the Secretary; and 
‘‘(ii) the Secretary accepts or declines to accept such 
letter of intent; 
‘‘(B)(i) if the Secretary accepts the letter of intent, 
a requestor submits a qualification plan to the Secretary; 
and 
‘‘(ii) the Secretary accepts or declines to accept the 
qualification plan; and 
‘‘(C)(i) if the Secretary accepts the qualification plan, 
the requestor submits to the Secretary a full qualification 
package; 
‘‘(ii) the Secretary determines whether to accept such 
qualification package for review; and 
‘‘(iii) if the Secretary accepts such qualification package 
for review, the Secretary conducts such review in accord-
ance 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 para-
graph as ‘qualification submissions’). 
‘‘(B) ACCEPTANCE FACTORS; NONACCEPTANCE.—The Sec-
retary shall determine whether to accept a qualification 
submission based on factors which may include the sci-
entific merit of the qualification submission. A determina-
tion 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
H. R. 34—55 
development tool and the availability or lack of alter-
native treatments for such disease or condition; and 
‘‘(ii) the identification, by the Secretary or by bio-
medical research consortia and other expert stake-
holders, of such a drug development tool and its pro-
posed context of use as a public health priority. 
‘‘(D) ENGAGEMENT OF EXTERNAL EXPERTS.—The Sec-
retary may, for purposes of the review of qualification 
submissions, through the use of cooperative agreements, 
grants, or other appropriate mechanisms, consult with bio-
medical research consortia and may consider the rec-
ommendations 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 para-
graph (3). 
‘‘(3) REVIEW OF FULL QUALIFICATION PACKAGE.—The Sec-
retary shall— 
‘‘(A) conduct a comprehensive review of a full qualifica-
tion 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 para-
graph (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 pro-
posed 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.—
H. R. 34—56 
‘‘(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 Administra-
tion the following: 
‘‘(A) Information with respect to each qualification 
submission under the qualification process under sub-
section (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 uti-
lized in the development of a qualification plan or 
the review of a full qualification package; and 
‘‘(iv) submissions from requestors under the quali-
fication 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 sub-
section (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 con-
strued 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’—
H. R. 34—57 
‘‘(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 ‘bio-
medical 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, clin-
ical 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 develop-
ment 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 regu-
latory 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 ‘quali-
fied’ 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, radio-
graphic 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.—
H. R. 34—58 
(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 appro-
priate 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 Sec-
retary’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 qualifica-
tion 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 sub-
section (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 quali-
fication process under section 507 of the Federal Food, Drug, 
and Cosmetic Act, as added by subsection (a).