In the House of Representatives, U. S., 
November 30, 2016. 
Resolved, That the House agree to the amendment of the 
Senate to the bill (H.R. 34) entitled ‘‘An Act to authorize 
and strengthen the tsunami detection, forecast, warning, re-
search, and mitigation program of the National Oceanic and 
Atmospheric Administration, and for other purposes.’’, with 
the following 
HOUSE AMENDMENT TO SENATE AMENDMENT: 
In lieu of the matter proposed to be added after the 
enacting clause, insert the following: 
SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the ‘‘21st 
Century Cures Act’’. 
(b) TABLE OF CONTENTS.—The table of contents for 
this Act is as follows: 
Sec. 1. Short title; table of contents. 
DIVISION A—21ST CENTURY CURES 
Sec. 1000. Short title. 
TITLE I—INNOVATION PROJECTS AND STATE RESPONSES TO 
OPIOID ABUSE 
Sec. 1001. NIH innovation projects. 
Sec. 1002. FDA innovation projects. 
Sec. 1003. Account for the state response to the opioid abuse crisis. 
Sec. 1004. Budgetary treatment. 
TITLE II—DISCOVERY 
Subtitle A—National Institutes of Health Reauthorization 
Sec. 2001. National Institutes of Health Reauthorization.
Sec. 2002. EUREKA prize competitions. 
Subtitle B—Advancing Precision Medicine 
Sec. 2011. Precision Medicine Initiative. 
Sec. 2012. Privacy protection for human research subjects. 
Sec. 2013. Protection of identifiable and sensitive information. 
Sec. 2014. Data sharing. 
Subtitle C—Supporting Young Emerging Scientists 
Sec. 2021. Investing in the next generation of researchers. 
Sec. 2022. Improvement of loan repayment program. 
Subtitle D—National Institutes of Health Planning and Administration 
Sec. 2031. National Institutes of Health strategic plan. 
Sec. 2032. Triennial reports. 
Sec. 2033. Increasing accountability at the National Institutes of Health. 
Sec. 2034. Reducing administrative burden for researchers. 
Sec. 2035. Exemption for the National Institutes of Health from the Paperwork 
Reduction Act requirements. 
Sec. 2036. High-risk, high-reward research. 
Sec. 2037. National Center for Advancing Translational Sciences. 
Sec. 2038. Collaboration and coordination to enhance research. 
Sec. 2039. Enhancing the rigor and reproducibility of scientific research. 
Sec. 2040. Improving medical rehabilitation research at the National Institutes of 
Health. 
Sec. 2041. Task force on research specific to pregnant women and lactating 
women. 
Sec. 2042. Streamlining National Institutes of Health reporting requirements. 
Sec. 2043. Reimbursement for research substances and living organisms. 
Sec. 2044. Sense of Congress on increased inclusion of underrepresented 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.
Subtitle G—Improving Scientific Expertise and Outreach at FDA 
Sec. 3071. Silvio O. Conte Senior Biomedical Research and Biomedical Product 
Assessment Service. 
Sec. 3072. Hiring authority for scientific, technical, and professional personnel. 
Sec. 3073. Establishment of Food and Drug Administration Intercenter Insti-
tutes. 
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 authoriza-
tion. 
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 Immu-
nization 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 pa-
tients. 
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 expendi-
tures under Medicaid for agents used for cosmetic purposes or 
hair growth. 
Sec. 5009. Amendment to the Prevention and Public Health Fund. 
Sec. 5010. Strategic Petroleum Reserve drawdown. 
Sec. 5011. Rescission of portion of ACA territory funding. 
Sec. 5012. Medicare coverage of home infusion therapy. 
DIVISION B—HELPING FAMILIES IN MENTAL HEALTH CRISIS 
Sec. 6000. Short title. 
TITLE VI—STRENGTHENING LEADERSHIP AND ACCOUNTABILITY 
Subtitle A—Leadership 
Sec. 6001. Assistant Secretary for Mental Health and Substance Use. 
Sec. 6002. Strengthening the leadership of the Substance Abuse and Mental 
Health Services Administration. 
Sec. 6003. Chief Medical Officer. 
Sec. 6004. Improving the quality of behavioral health programs. 
Sec. 6005. Strategic plan. 
Sec. 6006. Biennial report concerning activities and progress. 
Sec. 6007. Authorities of centers for mental health services, substance abuse 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 
PREVENTION, TREATMENT, AND RECOVERY PROGRAMS KEEP 
PACE WITH SCIENCE AND TECHNOLOGY 
Sec. 7001. Encouraging innovation and evidence-based programs. 
Sec. 7002. Promoting access to information on evidence-based programs and 
practices. 
Sec. 7003. Priority mental health needs of regional and national significance. 
Sec. 7004. Priority substance use disorder treatment needs of regional and na-
tional significance.
Sec. 7005. Priority substance use disorder prevention needs of regional and na-
tional significance. 
TITLE VIII—SUPPORTING STATE PREVENTION ACTIVITIES AND RE-
SPONSES TO MENTAL HEALTH AND SUBSTANCE USE DISORDER 
NEEDS 
Sec. 8001. Community mental health services block grant. 
Sec. 8002. Substance abuse prevention and treatment block grant. 
Sec. 8003. Additional provisions related to the block grants. 
Sec. 8004. Study of distribution of funds under the substance abuse prevention 
and treatment block grant and the community mental health 
services block grant. 
TITLE IX—PROMOTING ACCESS TO MENTAL HEALTH AND 
SUBSTANCE USE DISORDER CARE 
Subtitle A—Helping Individuals and Families 
Sec. 9001. Grants for treatment and recovery for homeless individuals. 
Sec. 9002. Grants for jail diversion programs. 
Sec. 9003. Promoting integration of primary and behavioral health care. 
Sec. 9004. Projects for assistance in transition from homelessness. 
Sec. 9005. National Suicide Prevention Lifeline Program. 
Sec. 9006. Connecting individuals and families with care. 
Sec. 9007. Strengthening community crisis response systems. 
Sec. 9008. Garrett Lee Smith Memorial Act reauthorization. 
Sec. 9009. Adult suicide prevention. 
Sec. 9010. Mental health awareness training grants. 
Sec. 9011. Sense of Congress on prioritizing American Indians and Alaska Native 
youth within suicide prevention programs. 
Sec. 9012. Evidence-based practices for older adults. 
Sec. 9013. National violent death reporting system. 
Sec. 9014. Assisted outpatient treatment. 
Sec. 9015. Assertive community treatment grant program. 
Sec. 9016. Sober truth on preventing underage drinking reauthorization. 
Sec. 9017. Center and program repeals. 
Subtitle B—Strengthening the Health Care Workforce 
Sec. 9021. Mental and behavioral health education and training grants. 
Sec. 9022. Strengthening the mental and substance use disorders workforce. 
Sec. 9023. Clarification on current eligibility for loan repayment programs. 
Sec. 9024. Minority fellowship program. 
Sec. 9025. Liability protections for health professional volunteers at community 
health centers. 
Sec. 9026. Reports. 
Subtitle C—Mental Health on Campus Improvement 
Sec. 9031. Mental health and substance use disorder services on campus. 
Sec. 9032. Interagency Working Group on College Mental Health. 
Sec. 9033. Improving mental health on college campuses. 
TITLE X—STRENGTHENING MENTAL AND SUBSTANCE USE 
DISORDER CARE FOR CHILDREN AND ADOLESCENTS 
Sec. 10001. Programs for children with a serious emotional disturbance.
Sec. 10002. Increasing access to pediatric mental health care. 
Sec. 10003. Substance use disorder treatment and early intervention services for 
children and adolescents. 
Sec. 10004. Children’s recovery from trauma. 
Sec. 10005. Screening and treatment for maternal depression. 
Sec. 10006. Infant and early childhood mental health promotion, intervention, 
and treatment. 
TITLE XI—COMPASSIONATE COMMUNICATION ON HIPAA 
Sec. 11001. Sense of Congress. 
Sec. 11002. Confidentiality of records. 
Sec. 11003. Clarification on permitted uses and disclosures of protected health 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 
benefits. 
Sec. 13005. Information and awareness on eating disorders. 
Sec. 13006. Education and training on eating disorders. 
Sec. 13007. Clarification of existing parity rules. 
TITLE XIV—MENTAL HEALTH AND SAFE COMMUNITIES 
Subtitle A—Mental Health and Safe Communities 
Sec. 14001. Law enforcement grants for crisis intervention teams, mental health 
purposes. 
Sec. 14002. Assisted outpatient treatment programs. 
Sec. 14003. Federal drug and mental health courts. 
Sec. 14004. Mental health in the judicial system. 
Sec. 14005. Forensic assertive community treatment initiatives. 
Sec. 14006. Assistance for individuals transitioning out of systems. 
Sec. 14007. Co-occurring substance abuse and mental health challenges in drug 
courts. 
Sec. 14008. Mental health training for Federal uniformed services. 
Sec. 14009. Advancing mental health as part of offender reentry.
Sec. 14010. School mental health crisis intervention teams. 
Sec. 14011. Active-shooter training for law enforcement. 
Sec. 14012. Co-occurring substance abuse and mental health challenges in 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 
assistance. 
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 simi-
lar hospital services. 
Sec. 15002. Establishing beneficiary equity in the Medicare hospital readmission 
program. 
Sec. 15003. Five-year extension of the rural community hospital demonstration 
program. 
Sec. 15004. Regulatory relief for LTCHs. 
Sec. 15005. Savings from IPPS MACRA pay-for through not applying docu-
mentation and coding adjustments. 
Sec. 15006. Extension of certain LTCH Medicare payment rules. 
Sec. 15007. Application of rules on the calculation of hospital length of stay to 
all LTCHs. 
Sec. 15008. Change in Medicare classification for certain hospitals. 
Sec. 15009. Temporary exception to the application of the Medicare LTCH site 
neutral provisions for certain spinal cord specialty hospitals. 
Sec. 15010. Temporary extension to the application of the Medicare LTCH site 
neutral provisions for certain discharges with severe wounds.
TITLE XVI—PROVISIONS RELATING TO MEDICARE PART B 
Sec. 16001. Continuing Medicare payment under HOPD prospective payment 
system for services furnished by mid-build off-campus outpatient 
departments of providers. 
Sec. 16002. Treatment of cancer hospitals in off-campus outpatient department of 
a provider policy. 
Sec. 16003. Treatment of eligible professionals in ambulatory surgical centers for 
meaningful use and MIPS. 
Sec. 16004. Continuing Access to Hospitals Act of 2016. 
Sec. 16005. Delay of implementation of Medicare fee schedule adjustments for 
wheelchair accessories and seating systems when used in con-
junction with complex rehabilitation technology (CRT) wheel-
chairs. 
Sec. 16006. Allowing physical therapists to utilize locum tenens arrangements 
under Medicare. 
Sec. 16007. Extension of the transition to new payment rates for durable medical 
equipment under the Medicare program. 
Sec. 16008. Requirements in determining adjustments using information from 
competitive bidding programs. 
TITLE XVII—OTHER MEDICARE PROVISIONS 
Sec. 17001. Delay in authority to terminate contracts for Medicare Advantage 
plans failing to achieve minimum quality ratings. 
Sec. 17002. Requirement for enrollment data reporting for Medicare. 
Sec. 17003. Updating the Welcome to Medicare package. 
Sec. 17004. No payment for items and services furnished by newly enrolled pro-
viders or suppliers within a temporary moratorium area. 
Sec. 17005. Preservation of Medicare beneficiary choice under Medicare Advan-
tage. 
Sec. 17006. Allowing end-stage renal disease beneficiaries to choose a Medicare 
Advantage plan. 
Sec. 17007. Improvements to the assignment of beneficiaries under the Medicare 
Shared Savings Program. 
TITLE XVIII—OTHER PROVISIONS 
Sec. 18001. Exception from group health plan requirements for qualified small 
employer health reimbursement arrangements. 
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 RE-
SPONSES TO OPIOID ABUSE 
SEC. 1001. NIH INNOVATION PROJECTS. 
(a) IN GENERAL.—The Director of the National Insti-
tutes of Health (referred to in this section as the ‘‘Director 
of NIH’’) shall use any funds appropriated pursuant to the 
authorization of appropriations in subsection (b)(3) to 
carry out the National Institutes of Health innovation 
projects described in subsection (b)(4) (referred to in this 
section as the ‘‘NIH Innovation Projects’’). 
(b) NATIONAL INSTITUTES OF HEALTH INNOVATION 
ACCOUNT.— 
(1) ESTABLISHMENT
OF
NIH
INNOVATION
AC-
COUNT.—There is established in the Treasury an ac-
count, to be known as the ‘‘NIH Innovation Account’’ 
(referred to in this subsection as the ‘‘Account’’), for 
purposes of carrying out the NIH Innovation Projects 
described in paragraph (4). 
(2) TRANSFER OF DIRECT SPENDING SAVINGS.— 
(A) IN GENERAL.—The following amounts 
shall be transferred to the Account from the gen-
eral 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 re-
main unavailable in the Account until such 
amounts are appropriated pursuant to para-
graph (3). 
(3) APPROPRIATIONS.— 
(A) 
AUTHORIZATION
OF
APPROPRIA-
TIONS.—For each of the fiscal years 2017 
through 2026, there is authorized to be appro-
priated from the Account to the Director of NIH, 
for the purpose of carrying out the NIH Innova-
tion Projects, an amount not to exceed the total 
amount transferred to the Account under para-
graph (2)(A), to remain available until ex-
pended. 
(B) 
OFFSETTING
FUTURE
APPROPRIA-
TIONS.—For any of fiscal years 2017 through 
2026, for any discretionary appropriation under 
the heading ‘‘NIH Innovation Account’’ provided 
to the Director of NIH pursuant to the author-
ization of appropriations under subparagraph 
(A) for the purpose of carrying out the NIH In-
novation Projects, the total amount of such ap-
propriations for the applicable fiscal year (not to 
exceed the total amount remaining in the Ac-
count) shall be subtracted from the estimate of 
discretionary budget authority and the resulting 
outlays for any estimate under the Congressional 
Budget and Impoundment Control Act of 1974 
or the Balanced Budget and Emergency Deficit 
Control Act of 1985, and the amount transferred 
to the Account shall be reduced by the same 
amount. 
(4) NIH INNOVATION PROJECTS.—NIH Innova-
tion Projects authorized to be funded under this sec-
tion shall consist of the following and, of the total
amounts authorized to be appropriated under para-
graph (3), there are authorized to be appropriated to 
each such project a total amount not to exceed the fol-
lowing, over the period of fiscal years 2017 through 
2026: 
(A) For the Precision Medicine Initiative, 
including for the advancement of a cohort of in-
dividuals 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 Ad-
vancing Innovative Neurotechnologies Initiative 
(known as the ‘‘BRAIN Initiative’’), not to ex-
ceed a total of $1,511,000,000, as follows: 
(i) For fiscal year 2017, $10,000,000. 
(ii) For fiscal year 2018, $86,000,000. 
(iii) 
For 
fiscal 
year 
2019, 
$115,000,000. 
(iv) 
For 
fiscal 
year 
2020, 
$140,000,000. 
(v) For fiscal year 2021, $100,000,000. 
(vi) 
For 
fiscal 
year 
2022, 
$152,000,000. 
(vii) 
For 
fiscal 
year 
2023, 
$450,000,000. 
(viii) 
For 
fiscal 
year 
2024, 
$172,000,000. 
(ix) For fiscal year 2025, $91,000,000. 
(x) For fiscal year 2026, $195,000,000. 
(C) To support cancer research, such as the 
development of cancer vaccines, the development 
of more sensitive diagnostic tests for cancer, 
immunotherapy and the development of com-
bination therapies, and research that has the po-
tential to transform the scientific field, that has
inherently higher risk, and that seeks to address 
major challenges related to cancer, not to exceed 
a total of $1,800,000,000, as follows: 
(i) For fiscal year 2017, $300,000,000. 
(ii) For fiscal year 2018, $300,000,000. 
(iii) 
For 
fiscal 
year 
2019, 
$400,000,000. 
(iv) 
For 
fiscal 
year 
2020, 
$195,000,000. 
(v) For fiscal year 2021, $195,000,000. 
(vi) 
For 
fiscal 
year 
2022, 
$194,000,000. 
(vii) 
For 
fiscal 
year 
2023, 
$216,000,000. 
(D) For the National Institutes of Health, 
in coordination with the Food and Drug Admin-
istration, to award grants and contracts for clin-
ical 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 available non-Federal contributions to-
ward the costs of such research in an amount not 
less than $1 for each $1 of Federal funds pro-
vided 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 Direc-
tor of NIH shall submit to the Committee on 
Health, Education, Labor, and Pensions and the 
Committee on Appropriations of the Senate and 
the Committee on Energy and Commerce and the 
Committee on Appropriations of the House of 
Representatives, a work plan including the pro-
posed allocation of funds authorized to be appro-
priated pursuant to subsection (b)(3) for each of 
fiscal years 2017 through 2026 for the NIH In-
novation 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 obli-
gated 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 prior-
ities identified in the NIH Strategic Plan 
under subsection (m) of section 402 of the 
Public Health Service Act (42 U.S.C. 282), 
as added by section 2031. 
(C) RECOMMENDATIONS.—Prior to submit-
ting the work plan under this paragraph, the Di-
rector 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 appro-
priated pursuant to the authorization of ap-
propriations 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 Oc-
tober 1 of each of fiscal years 2018 through 2027, 
the Director of NIH shall submit to the Com-
mittee on Health, Education, Labor, and Pen-
sions and the Committee on Appropriations of 
the Senate and the Committee on Energy and 
Commerce and the Committee on Appropriations 
of the House of Representatives, a report includ-
ing— 
(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 au-
thorization of appropriations under sub-
section (b)(3); and 
(iii) whether such projects are advanc-
ing the strategic research priorities identi-
fied in the NIH Strategic Plan under sub-
section (m) of section 402 of the Public 
Health Service Act (42 U.S.C. 282), as 
added by section 2031. 
(B) ADDITIONAL REPORTS.—At the request 
of the Committee on Health, Education, Labor,
and Pensions or the Committee on Appropria-
tions of the Senate, or the Committee on Energy 
and Commerce or the Committee on Appropria-
tions of the House of Representatives, the Direc-
tor 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 au-
thority 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 author-
ization 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
AC-
COUNT.—There is established in the Treasury an ac-
(A) IN GENERAL.—The following amounts 
shall be transferred to the Account from the gen-
eral 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 re-
main unavailable in the Account until such 
amounts are appropriated pursuant to para-
graph (3). 
(3) APPROPRIATIONS.— 
(A) 
AUTHORIZATION
OF
APPROPRIA-
TIONS.—In each of the fiscal years 2017 and 
2018, there is authorized to be appropriated from 
the Account to the Secretary, for the grant pro-
gram described in subsection (c), an amount not 
to exceed the total amount transferred to the Ac-
count under paragraph (2)(A), to remain avail-
able until expended. 
(B) 
OFFSETTING
FUTURE
APPROPRIA-
TIONS.—In each of fiscal years 2017 and 2018, 
for any discretionary appropriation under the 
heading ‘‘Account For the State Response to the 
Opioid Abuse Crisis’’ for the grant program de-
scribed in subsection (c), the total amount of