count, to be known as the ‘‘FDA Innovation Account’’ 
(referred to in this subsection as the ‘‘Account’’), for 
purposes of carrying out the activities described in 
paragraph (4). 
(2) TRANSFER OF DIRECT SPENDING SAVINGS.— 
(A) IN GENERAL.—For each of fiscal years 
2017 through 2025, the following amounts shall 
be transferred to the Account from the general 
fund of the Treasury: 
(i) For fiscal year 2017, $20,000,000. 
(ii) For fiscal year 2018, $60,000,000. 
(iii) For fiscal year 2019, $70,000,000. 
(iv) For fiscal year 2020, $75,000,000. 
(v) For fiscal year 2021, $70,000,000. 
(vi) For fiscal year 2022, $50,000,000. 
(vii) For fiscal year 2023, $50,000,000. 
(viii) 
For 
fiscal 
year 
2024, 
$50,000,000. 
(ix) For fiscal year 2025, $55,000,000. 
(B) AMOUNTS
DEPOSITED.—Any amounts 
transferred under subparagraph (A) shall 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 2025, there is authorized to be appro-
priated from the Account to the Commissioner, 
for the purpose of carrying out the activities de-
scribed in paragraph (5), an amount not to ex-
ceed the total amount transferred to the Account 
under paragraph (2)(A), to remain available 
until expended. 
(B) 
OFFSETTING
FUTURE
APPROPRIA-
TIONS.—For any of fiscal years 2017 through 
2025, for any discretionary appropriation under 
the heading ‘‘FDA Innovation Account’’ provided 
to the Commissioner pursuant to the authoriza-
tion of appropriations under subparagraph (A) 
for the purpose of carrying out the projects ac-
tivities described in paragraph (4), the total 
amount of such appropriations in the applicable 
fiscal year (not to exceed the total amount re-
maining 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 re-
duced 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 amend-
ments made by such subtitles) of title III of this Act 
and section 1014 of the Federal Food, Drug, and Cos-
metic 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 Com-
missioner 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 appropriated pursuant 
to the authorization of appropriations under 
subsection (b)(3) for each of fiscal years 2017 
through 2025 and the contents described in sub-
paragraph (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 activity described in subsection (b)(4); 
and 
(iii) a description and justification of 
each such project activity. 
(C) RECOMMENDATIONS.—Prior to submit-
ting the work plan under this paragraph, the 
Commissioner shall seek recommendations from 
the Science Board to the Food and Drug Admin-
istration, on the proposed allocation of funds ap-
propriated pursuant to the authorization of ap-
propriations under subsection (b)(3) for each of 
fiscal years 2017 through 2025 and on the con-
tents of the proposed work plan. 
(2) REPORTS.— 
(A) ANNUAL REPORTS.—Not later than Oc-
tober 1 of each of fiscal years 2018 through 2026, 
the Commissioner shall submit to the Committee 
on Health, Education, Labor, and Pensions and 
the Committee on Appropriations of the Senate 
and the Committee on Energy and Commerce
and the Committee on Appropriations of the 
House of Representatives, a report including— 
(i) the amount of money obligated or 
expended in the prior fiscal year for each 
activity described in subsection (b)(4); 
(ii) a description of all such activities 
using funds provided pursuant to the au-
thorization of appropriations under sub-
section (b)(3); and 
(iii) how the activities are advancing 
public health. 
(B) ADDITIONAL REPORTS.—At the request 
of the Committee on Health, Education, Labor, 
and Pensions or the Committee on Appropria-
tions of the Senate, or the Committee on Energy 
and Commerce or the Committee on Appropria-
tions of the House of Representatives, the Com-
missioner shall provide an update in the form of 
testimony and any additional reports to the re-
spective congressional committee regarding the 
allocation of funding under this section or the 
description of the activities undertaken with such 
funding. 
(d) LIMITATIONS.—Notwithstanding any transfer au-
thority authorized by this Act or any appropriations Act,
any funds made available pursuant to the authorization of 
appropriations in subsection (b)(3) shall not be used for 
any purpose other than an activity described in subsection 
(b)(4). 
(e) SUNSET.—This section shall expire on September 
30, 2025. 
SEC. 1003. ACCOUNT FOR THE STATE RESPONSE TO THE 
OPIOID ABUSE CRISIS. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services (referred to in this section as the ‘‘Sec-
retary’’) shall use any funds appropriated pursuant to the 
authorization of appropriations under subsection (b) to 
carry out the grant program described in subsection (c) for 
purposes of addressing the opioid abuse crisis within the 
States. 
(b) ACCOUNT FOR THE STATE RESPONSE TO THE 
OPIOID ABUSE CRISIS.— 
(1) ESTABLISHMENT.—There is established in 
the Treasury an account, to be known as the ‘‘Account 
For the State Response to the Opioid Abuse Crisis’’ 
(referred to in this subsection as the ‘‘Account’’), to 
carry out the opioid grant program described in sub-
section (c). 
(2) TRANSFER OF DIRECT SPENDING SAVINGS.—
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 rel-
ative to other States. 
(2) OPIOID GRANTS.—Grants awarded to a State 
under this subsection shall be used for carrying out 
activities that supplement activities pertaining to 
opioids undertaken by the State agency responsible 
for administering the substance abuse prevention and
treatment block grant under subpart II of part B of 
title XIX of the Public Health Service Act (42 U.S.C. 
300x–21 et seq.), which may include public health-re-
lated activities such as the following: 
(A) Improving State prescription drug 
monitoring programs. 
(B) Implementing prevention activities, and 
evaluating such activities to identify effective 
strategies to prevent opioid abuse. 
(C) Training for health care practitioners, 
such as best practices for prescribing opioids, 
pain management, recognizing potential cases of 
substance abuse, referral of patients to treatment 
programs, and overdose prevention. 
(D) Supporting access to health care serv-
ices, including those services provided by Feder-
ally certified opioid treatment programs or other 
appropriate health care providers to treat sub-
stance use disorders. 
(E) Other public health-related activities, as 
the State determines appropriate, related to ad-
dressing the opioid abuse crisis within the State. 
(d) ACCOUNTABILITY AND OVERSIGHT.—A State re-
ceiving a grant under subsection (c) shall include in a re-
port 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 re-
ceived by the State under such subsection for the pre-
ceding 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 pursu-
ant to the authorization of appropriations under subsection 
(b)— 
(1) notwithstanding any transfer authority in 
any appropriations Act, shall not be used for any 
purpose other than the grant program in subsection 
(c); and 
(2) shall be subject to the same requirements as 
substance abuse prevention and treatment programs 
under titles V and XIX of the Public Health Service 
Act (42 U.S.C. 290aa et seq., 300w et seq.). 
(f) SUNSET.—This section shall expire on September 
30, 2026. 
SEC. 1004. BUDGETARY TREATMENT. 
(a) STATUTORY PAYGO SCORECARDS.—The budgetary 
effects of division A of this Act shall not be entered on either
PAYGO scorecard maintained pursuant to section 4(d) of 
the Statutory Pay-As-You-Go Act of 2010. 
(b) SENATE PAYGO SCORECARDS.—The budgetary ef-
fects of division A of this Act shall not be entered on any 
PAYGO scorecard maintained for purposes of section 201 
of S. Con. Res. 21 (110th Congress). 
(c) RESERVATION OF SAVINGS.—None of the funds in 
the NIH Innovation Account, the FDA Innovation Account, 
or the Account For the State Response to the Opioid Abuse 
Crisis established by this title shall be made available except 
to the extent provided in advance in appropriations Acts, 
and legislation or an Act that rescinds or reduces amounts 
in such accounts shall not be estimated as a reduction in 
direct spending under the Congressional Budget and Im-
poundment Control Act of 1974 or the Balanced Budget and 
Emergency Deficit Control Act of 1985. 
TITLE II—DISCOVERY 
Subtitle A—National Institutes of 
Health Reauthorization 
SEC. 2001. NATIONAL INSTITUTES OF HEALTH REAUTHOR-
IZATION. 
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 sub-
paragraphs: 
‘‘(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 preven-
tion and treatment activities with respect to such
diseases and conditions, such that Federal ex-
penditures on health programs would be reduced; 
(B) that are serious and represent a signifi-
cant disease burden in the United States; or 
(C) for which there is potential for signifi-
cant return on investment to the United States. 
(b) TRACKING; REPORTING.—The Director of the Na-
tional Institutes of Health shall— 
(1) collect information on— 
(A) the effect of innovations funded through 
the prize competitions under this section in ad-
vancing biomedical science or improving health 
outcomes pursuant to subsection (a); and 
(B) the effect of the innovations on Federal 
expenditures; and 
(2) include the information collected under para-
graph (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:
‘‘SEC. 498E. PRECISION MEDICINE INITIATIVE. 
‘‘(a) IN GENERAL.—The Secretary is encouraged to es-
tablish and carry out an initiative, to be known as the ‘Pre-
cision Medicine Initiative’ (in this section referred to as 
the ‘Initiative’), to augment efforts to address disease pre-
vention, 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 mo-
lecular basis of disease; 
‘‘(4) collecting information voluntarily provided 
by a diverse cohort of individuals that can be used to 
better understand health and disease; and 
‘‘(5) other activities to advance the goals of the 
Initiative, as the Secretary determines appropriate. 
‘‘(c) AUTHORITY OF THE SECRETARY.—In carrying 
out this section, the Secretary may— 
‘‘(1) coordinate with the Secretary of Energy, 
private industry, and others, as the Secretary deter-
mines appropriate, to identify and address the ad-
vanced supercomputing and other advanced tech-
nology needs for the Initiative; 
‘‘(2) develop and utilize public-private partner-
ships; 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 In-
stitutes of Health, the Food and Drug Administra-
tion, 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 re-
search, including the protection of participant pri-
vacy; 
‘‘(3) implement policies and mechanisms for ap-
propriate secure data sharing across systems that in-
clude 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 deter-
minants of health that contribute to health dispari-
ties;
‘‘(5) ensure that only authorized individuals 
may access controlled or sensitive, identifiable biologi-
cal material and associated information collected or 
stored in connection with the Initiative; and 
‘‘(6) on the appropriate Internet website of the 
Department of Health and Human Services, identify 
any entities with access to such information and pro-
vide 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 infor-
mation to which the entity has access. 
‘‘(e) REPORT.—Not later than 1 year after the date 
of enactment of the 21st Century Cures Act, the Secretary 
shall submit a report on the relevant data access policies 
and procedures to the Committee on Health, Education, 
Labor, and Pensions of the Senate and the Committee on 
Energy and Commerce of the House of Representatives. 
Such report shall include steps the Secretary has taken to 
consult with experts or other heads of departments or agen-
cies 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, behav-
ioral, clinical, or other research, in which identifiable, sen-
sitive information is collected (including research on mental 
health and research on the use and effect of alcohol and 
other psychoactive drugs), the Secretary, in coordination 
with other agencies, as applicable— 
‘‘(i) shall issue to such person a certificate of 
confidentiality to protect the privacy of individuals 
who are the subjects of such research if the research 
is funded wholly or in part by the Federal Govern-
ment; and 
‘‘(ii) may, upon application by a person engaged 
in research, issue to such person a certificate of con-
fidentiality 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 per-
son 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 pur-
poses 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, ex-
cluding 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 per-
tains; or 
‘‘(iv) made for the purposes of other scientific re-
search that is in compliance with applicable Federal 
regulations governing the protection of human sub-
jects in research. 
‘‘(D) Any person to whom a certificate is issued under 
subparagraph (A) to protect the privacy of an individual 
described in such subparagraph shall not, in any Federal, 
State, or local civil, criminal, administrative, legislative, 
or other proceeding, disclose or provide the name of such 
individual or any such information, document, or biospeci-
men that contains identifiable, sensitive information about
the individual and that was created or compiled for pur-
poses of the research, except in the circumstance described 
in subparagraph (C)(iii). 
‘‘(E) Identifiable, sensitive information protected 
under subparagraph (A), and all copies thereof, shall be im-
mune from the legal process, and shall not, without the con-
sent of the individual to whom the information pertains, 
be admissible as evidence or used for any purpose in any 
action, suit, or other judicial, legislative, or administrative 
proceeding. 
‘‘(F) Identifiable, sensitive information collected by a 
person to whom a certificate has been issued under subpara-
graph (A), and all copies thereof, shall be subject to the pro-
tections 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 de-
partments 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