SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘21st Century Cures Act’’. 
(b) TABLE OF CONTENTS.—The table of contents for 
this Act is as follows: 
Sec. 1. Short title; table of contents. 
Sec. 2. NIH and Cures Innovation Fund. 
TITLE I—DISCOVERY 
Subtitle A—National Institutes of Health Funding 
Sec. 1001. National Institutes of Health reauthorization. 
Sec. 1002. Prize competitions. 
Subtitle B—National Institutes of Health Planning and Administration 
Sec. 1021. NIH research strategic plan. 
Sec. 1022. Increasing accountability at the National Institutes of Health. 
Sec. 1023. Reducing administrative burdens of researchers. 
Sec. 1024. Exemption for the National Institutes of Health from the Paper-
work Reduction Act requirements. 
Sec. 1025. NIH travel. 
Sec. 1026. Other transactions authority. 
Sec. 1027. NCATS phase IIB restriction. 
Sec. 1028. High-risk, high-reward research. 
Sec. 1029. Sense of Congress on increased inclusion of underrepresented com-
munities in clinical trials. 
Subtitle C—Supporting Young Emerging Scientists 
Sec. 1041. Improvement of loan repayment programs of the National Institutes 
of Health. 
Sec. 1042. Report. 
Subtitle D—Capstone Grant Program 
Sec. 1061. Capstone award. 
Subtitle E—Promoting Pediatric Research Through the National Institutes of 
Health 
Sec. 1081. National pediatric research network. 
Sec. 1082. Global pediatric clinical study network sense of Congress. 
Sec. 1083. Appropriate age groupings in clinical research. 
Subtitle F—Advancement of the National Institutes of Health Research and 
Data Access 
Sec. 1101. Standardization of data in Clinical Trial Registry Data Bank on eli-
gibility for clinical trials. 
Subtitle G—Facilitating Collaborative Research
Sec. 1121. Clinical trial data system. 
Sec. 1122. National neurological diseases surveillance system. 
Sec. 1123. Data on natural history of diseases. 
Sec. 1124. Accessing, sharing, and using health data for research purposes. 
Subtitle H—Council for 21st Century Cures 
Sec. 1141. Council for 21st Century Cures. 
TITLE II—DEVELOPMENT 
Subtitle A—Patient-Focused Drug Development 
Sec. 2001. Development and use of patient experience data to enhance struc-
tured risk-benefit assessment framework. 
Subtitle B—Qualification and Use of Drug Development Tools 
Sec. 2021. Qualification of drug development tools. 
Sec. 2022. Accelerated approval development plan. 
Subtitle C—FDA Advancement of Precision Medicine 
Sec. 2041. Precision medicine guidance and other programs of Food and Drug 
Administration. 
Subtitle D—Modern Trial Design and Evidence Development 
Sec. 2061. Broader application of Bayesian statistics and adaptive trial designs. 
Sec. 2062. Utilizing evidence from clinical experience. 
Sec. 2063. Streamlined data review program. 
Subtitle E—Expediting Patient Access 
Sec. 2081. Sense of Congress. 
Sec. 2082. Expanded access policy. 
Sec. 2083. Finalizing draft guidance on expanded access. 
Subtitle F—Facilitating Responsible Manufacturer Communications 
Sec. 2101. Facilitating dissemination of health care economic information. 
Sec. 2102. Facilitating responsible communication of scientific and medical de-
velopments. 
Subtitle G—Antibiotic Drug Development 
Sec. 2121. Approval of certain drugs for use in a limited population of patients. 
Sec. 2122. Susceptibility test interpretive criteria for microorganisms. 
Sec. 2123. Encouraging the development and use of DISARM drugs. 
Subtitle H—Vaccine Access, Certainty, and Innovation 
Sec. 2141. Timely review of vaccines by the Advisory Committee on Immuniza-
tion Practices. 
Sec. 2142. Review of processes and consistency of ACIP recommendations. 
Sec. 2143. Meetings between CDC and vaccine developers. 
Subtitle I—Orphan Product Extensions Now; Incentives for Certain Products 
for Limited Populations
Sec. 2151. Extension of exclusivity periods for a drug approved for a new indi-
cation for a rare disease or condition. 
Sec. 2152. Reauthorization of rare pediatric disease priority review voucher in-
centive program. 
Subtitle J—Domestic Manufacturing and Export Efficiencies 
Sec. 2161. Grants for studying the process of continuous drug manufacturing. 
Sec. 2162. Re-exportation among members of the European Economic Area. 
Subtitle K—Enhancing Combination Products Review 
Sec. 2181. Enhancing combination products review. 
Subtitle L—Priority Review for Breakthrough Devices 
Sec. 2201. Priority review for breakthrough devices. 
Subtitle M—Medical Device Regulatory Process Improvements 
Sec. 2221. Third-party quality system assessment. 
Sec. 2222. Valid scientific evidence. 
Sec. 2223. Training and oversight in least burdensome appropriate means con-
cept. 
Sec. 2224. Recognition of standards. 
Sec. 2225. Easing regulatory burden with respect to certain class I and class 
II devices. 
Sec. 2226. Advisory committee process. 
Sec. 2227. Humanitarian device exemption application. 
Sec. 2228. CLIA waiver study design guidance for in vitro diagnostics. 
Subtitle N—Sensible Oversight for Technology Which Advances Regulatory 
Efficiency 
Sec. 2241. Health software. 
Sec. 2242. Applicability and inapplicability of regulation. 
Sec. 2243. Exclusion from definition of device. 
Subtitle O—Streamlining Clinical Trials 
Sec. 2261. Protection of human subjects in research; applicability of rules. 
Sec. 2262. Use of non-local institutional review boards for review of investiga-
tional device exemptions and human device exemptions. 
Sec. 2263. Alteration or waiver of informed consent for clinical investigations. 
Subtitle P—Improving Scientific Expertise and Outreach at FDA 
Sec. 2281. Silvio O. Conte Senior Biomedical Research Service. 
Sec. 2282. Enabling FDA scientific engagement. 
Sec. 2283. Reagan-Udall Foundation for the Food and Drug Administration. 
Sec. 2284. Collection of certain voluntary information exempted from Paper-
work Reduction Act. 
Sec. 2285. Hiring authority for scientific, technical, and professional personnel. 
Subtitle Q—Exempting From Sequestration Certain User Fees 
Sec. 2301. Exempting from sequestration certain user fees of Food and Drug 
Administration.
Subtitle R—Other Provisions 
Sec. 2321. Sense of Congress. 
TITLE III—DELIVERY 
Subtitle A—Interoperability 
Sec. 3001. Ensuring interoperability of health information technology. 
Subtitle B—Telehealth 
Sec. 3021. Telehealth services under the Medicare Program. 
Subtitle C—Encouraging Continuing Medical Education for Physicians 
Sec. 3041. Exempting from manufacturer transparency reporting certain trans-
fers used for educational purposes. 
Subtitle D—Disposable Medical Technologies 
Sec. 3061. Treatment of certain items and devices. 
Subtitle E—Local Coverage Decision Reforms 
Sec. 3081. Improvements in the Medicare local coverage determination (LCD) 
process. 
Subtitle F—Medicare Pharmaceutical and Technology Ombudsman 
Sec. 3101. Medicare pharmaceutical and technology ombudsman. 
Subtitle G—Medicare Site-of-Service Price Transparency 
Sec. 3121. Medicare site-of-Service price transparency. 
Subtitle H—Medicare Part D Patient Safety and Drug Abuse Prevention 
Sec. 3141. Programs to prevent prescription drug abuse under Medicare parts 
C and D. 
TITLE IV—MEDICAID, MEDICARE, AND OTHER REFORMS 
Subtitle A—Medicaid and Medicare Reforms 
Sec. 4001. Limiting Federal Medicaid reimbursement to States for durable 
medical equipment (DME) to Medicare payment rates. 
Sec. 4002. Excluding authorized generics from calculation of average manufac-
turer price. 
Sec. 4003. Medicare payment incentive for the transition from traditional x-ray 
imaging to digital radiography and other Medicare imaging 
payment provision. 
Sec. 4004. Treatment of infusion drugs furnished through durable medical 
equipment. 
Sec. 4005. Extension and expansion of prior authorization for power mobility 
devices (PMDs) and accessories and prior authorization audit 
limitations. 
Sec. 4006. Civil monetary penalties for violations related to grants, contracts, 
and other agreements.
Subtitle B—Other Reforms 
Sec. 4041. SPR drawdown. 
Subtitle C—Miscellaneous 
Sec. 4061. Lyme disease and other tick-borne diseases. 
Sec. 4062. Outreach to historically black colleges and universities. 
SEC. 2. NIH AND CURES INNOVATION FUND. 
(a) ESTABLISHMENT.—There is hereby established in 
the Treasury of the United States a fund to be known 
as the NIH and Cures Innovation Fund. 
(b) AMOUNTS MADE AVAILABLE TO FUND.— 
(1) IN GENERAL.—There is authorized to be 
appropriated, and appropriated, to the NIH and 
Cures Innovation Fund, out of any funds in the 
Treasury 
not 
otherwise 
appropriated, 
$1,860,000,000 for each of fiscal years 2016 
through 2020. The amounts appropriated to the 
NIH and Cures Innovation Fund by the preceding 
sentence shall be in addition to any amounts other-
wise made available to the Department of Health 
and Human Services. 
(2) 
ALLOCATION
OF
AMOUNTS.—Of 
the 
amounts made available from the NIH and Cures 
Innovation Fund for a fiscal year— 
(A) $1,750,000,000 shall be for biomedical 
research of the National Institutes of Health 
under subsection (c)(1), of which—
(i) not less than $500,000,000 shall 
be for the Accelerating Advancement Pro-
gram under subsection (d)(2); 
(ii) not less than 35 percent of such 
amounts remaining after subtracting the 
allocation for the Accelerating Advance-
ment Program shall be for early stage in-
vestigators as defined in subsection (g); 
(iii) not less than 20 percent of such 
amounts remaining after subtracting the 
allocation for the Accelerating Advance-
ment Program shall be for high-risk, high- 
reward research under section 409L of the 
Public Health Service Act, as added by 
section 1028; and 
(iv) not more than 10 percent of such 
amounts (without subtracting the alloca-
tion for the Accelerating Advancement 
Program) shall be for intramural research; 
and 
(B) $110,000,000 shall be for carrying out 
the provisions listed in subsection (c)(2). 
(3) INAPPLICABILITY
OF
CERTAIN
PROVI-
SIONS.—Amounts in the NIH and Cures Innovation
Fund (including amounts made available to the Na-
tional Institutes of Health) shall not be subject to— 
(A) any transfer authority of the Secretary 
of Health and Human Services or the Director 
of the National Institutes of Health under sec-
tions 241, 402A(c), or 402A(d) of the Public 
Health Service Act (42 U.S.C. 238j, 282a(c) 
and (d)) or any other provision of law (other 
than this section); or 
(B) the Nonrecurring expenses fund under 
section 223 of division G of the Consolidated 
Appropriations Act, 2008 (42 U.S.C. 3514a). 
(c) AUTHORIZED USES.— 
(1) NIH BIOMEDICAL RESEARCH.—Amounts in 
the NIH and Cures Innovation Fund that are allo-
cated pursuant to subsection (b)(2)(A) may only be 
used for the purpose of conducting or supporting 
biomedical research (including basic, translational, 
and clinical research) through the following: 
(A) Research in which— 
(i) a principal investigator has a spe-
cific project or specific objectives; and 
(ii) funding is tied to pursuit of such 
project or objectives. 
(B) Research in which—
(i) a principal investigator has shown 
promise in biomedical research; and 
(ii) funding is not tied to a specific 
project or specific objectives. 
(C) Research to be carried out by an early 
stage investigator (as defined in subsection (g)). 
(D) Research to be carried out by a small 
business concern (as defined in section 3 of the 
Small Business Act). 
(E) The Accelerating Advancement Pro-
gram under subsection (d)(2). 
(F) Development and implementation of 
the strategic plan under subsection (d)(3). 
(2) CURES
DEVELOPMENT.—Amounts in the 
NIH and Cures Innovation Fund that are allocated 
pursuant to subsection (b)(2)(B) may only be used 
for the purpose of carrying out the following provi-
sions: 
(A) Section 229A of the Public Health 
Service Act, as added by section 1123 (relating 
to data on natural history of diseases). 
(B) Section 2001 and the amendments 
made by such section (relating to development 
and use of patient experience data to enhance 
structured risk-benefit assessment framework).
(C) Section 2021 and the amendments 
made by such section (relating to qualification 
of drug development tools). 
(D) Section 2062 and the amendments 
made by such section (relating to utilizing evi-
dence from clinical experience). 
(E) Section 2161 (relating to grants for 
studying the process of continuous drug manu-
facturing). 
(F) Section 2201 and the amendments 
made by such section (relating to priority re-
view for breakthrough devices). 
(G) Section 2221 and the amendments 
made by such section (relating to third-party 
quality system assessments). 
(H) Sections 2241, 2242, and 2243 and 
the amendments made by such sections (relat-
ing to health software). 
(I) Section 513(j) of the Federal Food, 
Drug, and Cosmetic Act, as added by section 
2223 (relating to training and oversight in least 
burdensome appropriate means concept). 
(d) NIH INNOVATION FUND.— 
(1) COORDINATION.—In conducting or sup-
porting biomedical research pursuant to funds allo-
cated pursuant to subsection (b)(2)(A), the Sec-
retary of Health and Human Services, acting 
through the Director of the National Institutes of 
Health, shall— 
(A) ensure coordination among the na-
tional research institutes, the national centers, 
and other departments, agencies, and offices of 
the Federal Government; and 
(B) minimize unnecessary duplication. 
(2) ACCELERATING ADVANCEMENT PROGRAM.— 
The Director of the National Institutes of Health 
shall establish a program, to be known as the Accel-
erating Advancement Program, under which— 
(A) the Director partners with national re-
search institutes and national centers to accom-
plish important biomedical research objectives; 
and 
(B) for every $1 made available by the Di-
rector to a national research institute or na-
tional center for a research project, the insti-
tute or center makes $1 available for such 
project from funds that are not derived from 
the NIH and Cures Innovation Fund. 
(3) STRATEGIC PLAN.—
(A) IN
GENERAL.—The Director of the 
National Institutes of Health shall ensure that 
scientifically based strategic planning is imple-
mented in support of research priorities, includ-
ing through development, use, and updating of 
a research strategic plan that— 
(i) is designed to increase the efficient 
and effective focus of biomedical research 
in a manner that leverages the best sci-
entific opportunities through a deliberative 
planning process; 
(ii) identifies areas, to be known as 
strategic focus areas, in which the re-
sources of the NIH and Cures Innovation 
Fund can contribute to the goals of ex-
panding knowledge to address, and find 
more effective treatments for, unmet med-
ical needs in the United States, including 
the areas of— 
(I) biomarkers; 
(II) precision medicine; 
(III) infectious diseases, includ-
ing pathogens listed as a qualifying 
pathogen under section 505E(f) of the 
Federal Food, Drug, and Cosmetic
year continuing appropriation Act or resolution (as 
of the date of obligation) for programs of the Na-
tional Institutes of Health or the Food and Drug 
Administration, as applicable; and 
(3) notwithstanding any transfer authority in 
any appropriation Act, shall not be used for any 
purpose other than the purposes specified in sub-
section (c). 
(g) DEFINITION.—In this subsection: 
(1) The term ‘‘early stage investigator’’ means 
an investigator who— 
(A) will be the principal investigator or the 
program director of the proposed research; 
(B) has never been awarded, or has been 
awarded only once, a substantial, competing 
grant by the National Institutes of Health for 
independent research; and 
(C) is within 10 years of having com-
pleted— 
(i) the investigator’s terminal degree; 
or 
(ii) a medical residency (or the equiva-
lent). 
(2) The terms ‘‘national center’’ and ‘‘national 
research institute’’ have the meanings given to those
terms in section 401(g) of the Public Health Service 
Act (42 U.S.C. 281(g)). 
TITLE I—DISCOVERY 
Subtitle A—National Institutes of 
Health Funding 
SEC. 1001. 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 at the end 
‘‘and’’; 
(2) in subparagraph (C), by striking at the end 
the period and inserting a semicolon; and 
(3) by adding at the end the following new sub-
paragraphs: 
‘‘(D) $31,811,000,000 for fiscal year 
2016; 
‘‘(E) $33,331,000,000 for fiscal year 2017; 
and 
‘‘(F) $34,851,000,000 for fiscal year 
2018.’’. 
SEC. 1002. PRIZE COMPETITIONS. 
Part B of title IV of the Public Health Service Act 
(42 U.S.C. 284 et seq.) is amended by adding at the end 
the following:
‘‘SEC. 
409K. 
PRIZE 
COMPETITIONS 
FOR 
IMPROVING 
HEALTH OUTCOMES AND REDUCING FED-
ERAL EXPENDITURES. 
‘‘(a) ESTABLISHMENT; GOALS.—The Director of 
NIH shall establish and implement an Innovation Prizes 
Program for one or both of the following goals: 
‘‘(1) Identifying and funding areas of bio-
medical science that could realize significant ad-
vancements through the creation of a prize competi-
tion. 
‘‘(2) Improving health outcomes, particularly 
with respect to human diseases and conditions for 
which public and private investment in research is 
disproportionately small relative to Federal Govern-
ment expenditures on prevention and treatment ac-
tivities, thereby reducing Federal expenditures on 
health programs. 
‘‘(b) DESIGN OF PRIZE COMPETITIONS.—Not later 
than 6 months after the date of enactment of this section, 
the Director of NIH shall— 
‘‘(1) design prize competitions— 
‘‘(A) to cooperate with competitors to real-
ize innovations to identify and address areas of 
biomedical science that could realize significant 
advancements through the creation of a prize 
competition; and
‘‘(B) to award one or more prizes— 
‘‘(i) if appropriate, at the beginning of 
or during the competitions, to the competi-
tors whose innovations are most promising 
or demonstrate progress; and 
‘‘(ii) at the end of the competitions, to 
the competitors whose innovations prove to 
be the best solutions; 
‘‘(2) ensure that the design of such competi-
tions— 
‘‘(A) is realistic, given the amount of funds 
to be awarded as prizes; 
‘‘(B) does not reflect any bias concerning 
the type of innovations which will prove to be 
the best solutions; and 
‘‘(C) allows any person to participate as a 
competitor without regard to the person’s place 
of incorporation, primary place of business, citi-
zenship, and residency, as applicable; and 
‘‘(3) submit to the Congress a report on the de-
sign of such competitions. 
‘‘(c) INNOVATION PRIZES ADVISORY BOARD.— 
‘‘(1) ESTABLISHMENT.—The Director of NIH 
shall establish and maintain a board, to be known as
the I-Prize Board, to advise and assist the Director 
of NIH in carrying out this section. 
‘‘(2) COMPOSITION; TERMS.— 
‘‘(A) COMPOSITION.—The I-Prize Board 
shall be composed of nine voting members as 
follows: 
‘‘(i) The Director of NIH (or the Di-
rector’s designee). 
‘‘(ii) Four members appointed by the 
Director of NIH. 
‘‘(iii) One member appointed by the 
Speaker of the House of Representatives. 
‘‘(iv) One member appointed by the 
majority leader of the Senate. 
‘‘(v) One member appointed by the 
minority leader of the House of Represent-
atives. 
‘‘(vi) One member appointed by the 
minority leader in the Senate. 
‘‘(B) INCLUSION OF CERTAIN EXPERTS.— 
The members of the I-Prize Board appointed 
under clauses (ii) through (vi) of subparagraph 
(A) shall, collectively, include medical, eco-
nomic, budgetary, innovation, or venture capital 
experts from for-profit and not-for-profit pri-
vate sector entities with experience in awarding 
prizes similar to the prizes under this section. 
‘‘(C) TERMS.—The appointed members of 
the I-Prize Board shall each be appointed for a 
term of 5 years. 
‘‘(D) APPOINTMENT
OF
INITIAL
MEM-
BERS.—The initial appointed members of the I- 
Prize Board shall be appointed not later than 
120 days after the date of enactment of this 
section. 
‘‘(3) RESPONSIBILITIES.—The I-Prize Board 
shall be responsible for advising the Director of NIH 
by— 
‘‘(A) 
identifying 
areas 
of 
biomedical 
science that could realize significant advance-
ments through the creation of a prize competi-
tion; 
‘‘(B) making recommendations on estab-
lishing the criteria for prize competitions under 
this section; 
‘‘(C) making recommendations on which 
business organizations or other entities have 
successfully met the criteria established for the 
prize competition; and
‘‘(D) gaining insight from researchers, 
health economists, academia, and industry on 
how to conduct prize competitions. 
‘‘(d) RESTRICTIONS.— 
‘‘(1) NO
FINANCIAL
CONFLICTS
OF
INTER-
EST.—Any member of the I-Prize Board, and any 
officer or employee of the National Institutes of 
Health responsible for carrying out this section, may 
not personally or substantially participate in the 
consideration or determination by the I-Prize Board 
of any matter that would directly or predictably ef-
fect any financial interest of— 
‘‘(A) the individual or a relative (as such 
term is defined in section 109(16) of the Ethics 
in Government Act of 1978) of the individual; 
or 
‘‘(B) of any business organization or other 
entity— 
‘‘(i) of which the individual is an offi-
cer or employee; 
‘‘(ii) with respect to which the indi-
vidual is negotiating for employment; or 
‘‘(iii) in which the individual has any 
other financial interest.
‘‘(2) NO AWARDS TO COMPETITORS LIKELY TO 
REAP FINANCIAL BENEFIT FROM INNOVATION.—The 
Director of NIH may not, with respect to an innova-
tion, award a prize under this section to any indi-
vidual or entity that has a vested financial interest 
in any product or procedure that is likely to be de-
veloped or marketed because of such innovation. 
‘‘(e) PROCESS
OF
AWARD.—The full monetary 
amount of any prize awarded under this section shall be 
made available to the prize winner not later than 90 days 
after the date of such award. 
‘‘(f) SIMULATION.—The Director of NIH may— 
‘‘(1) award one or more contracts— 
‘‘(A) to perform a simulation of the prize 
competitions to be conducted under this section, 
based on the designs developed under sub-
section (b); and 
‘‘(B) to use the simulation to assess the ef-
fectiveness of the design; and 
‘‘(2) not later than 4 months after awarding 
such one or more contracts, submit to the Congress 
a report on the results of the simulation and assess-
ment. 
‘‘(g) IMPLEMENTATION OF PRIZE COMPETITIONS.—
‘‘(1) IN GENERAL.—The Director of NIH may 
enter into an agreement with one or more entities 
described in section 501(c), and exempt from tax 
under section 501(a), of the Internal Revenue Code 
of 1986 to implement prize competitions based on 
the designs developed under subsection (b). 
‘‘(2) MINIMUM PERCENTAGE FOR PRIZES.—If 
the Director of NIH enters into an agreement under 
paragraph (1) to provide funds or other assistance 
(including in-kind contributions and testing or other 
technical support) to an entity to implement a prize 
competition under this section— 
‘‘(A) not more than 15 percent of such as-
sistance shall be for administration of the prize 
competition; and 
‘‘(B) not less than 85 percent of such as-
sistance shall be for activities in direct support 
of competitors such as demonstration, testing, 
education, and prize awards. 
‘‘(h) TRACKING; REPORTING.—The Director of NIH 
shall— 
‘‘(1) collect information on— 
‘‘(A) the medical efficacy of innovations 
funded through the prize competitions under 
this section; and
‘‘(B) the actual and potential effect of the 
innovations on Federal expenditures; and 
‘‘(2) not later than 1 year after the conclusion 
of the prize competitions under this section, and not 
later than the end of each of the 4 succeeding years, 
submit to the Congress a report on the information 
collected under paragraph (1). 
‘‘(i) INTELLECTUAL PROPERTY.— 
‘‘(1) PROHIBITION ON THE GOVERNMENT AC-
QUIRING
INTELLECTUAL
PROPERTY
RIGHTS.—The 
Federal Government may not gain an interest in in-
tellectual property developed by a participant in a 
prize competition under this section without the 
written consent of the participant. 
‘‘(2) LICENSES.—The Federal Government may 
negotiate a license for the use of intellectual prop-
erty developed by a participant in a prize competi-
tion under this section.’’. 
Subtitle B—National Institutes of 
Health Planning and Adminis-
tration 
SEC. 1021. NIH RESEARCH STRATEGIC PLAN. 
Section 402 of the Public Health Service Act (42 
U.S.C. 282) is amended—
(1) in subsection (b), by amending paragraph 
(5) to read as follows: 
‘‘(5) shall ensure that scientifically based stra-
tegic planning is implemented in support of research 
priorities as determined by the agencies of the Na-
tional Institutes of Health, including through devel-
opment, use, and updating of the research strategic 
plan under subsection (m);’’; and 
(2) by adding at the end the following: 
‘‘(m) RESEARCH STRATEGIC PLAN.— 
‘‘(1) FIVE-YEAR PLANS FOR BIOMEDICAL RE-
SEARCH STRATEGY.— 
‘‘(A) IN GENERAL.—For each successive 5- 
year period beginning with the period of fiscal 
years 2016 through 2020, the Director of NIH, 
in consultation with the entities described in 
subparagraph (B), shall develop and maintain a 
biomedical research strategic plan that— 
‘‘(i) is designed to increase the effi-
cient and effective focus of biomedical re-
search in a manner that leverages the best 
scientific opportunities through a delibera-
tive planning process; 
‘‘(ii) identifies areas, to be known as 
strategic focus areas, in which the re-
sources of the National Institutes of 
Health can best contribute to the goal of 
expanding knowledge on human health in 
the United States through biomedical re-
search; and 
‘‘(iii) includes objectives for each such 
strategic focus area. 
‘‘(B) ENTITIES DESCRIBED.—The entities 
described in this subparagraph are the directors 
of the national research institutes and national 
centers, researchers, patient advocacy groups, 
and industry leaders. 
‘‘(2) USE OF PLAN.—The Director of NIH and 
the directors of the national research institutes and 
national centers shall use the strategic plan— 
‘‘(A) to identify research opportunities; 
and 
‘‘(B) to develop individual strategic plans 
for the research activities of each of the na-
tional research institutes and national centers 
that— 
‘‘(i) have a common template; and 
‘‘(ii) identify strategic focus areas in 
which the resources of the national re-
search institutes and national centers can
best contribute to the goal of expanding 
knowledge on human health in the United 
States through biomedical research. 
‘‘(3) CONTENTS OF PLANS.— 
‘‘(A) STRATEGIC FOCUS AREAS.—The stra-
tegic focus areas identified pursuant to para-
graph (1)(A)(ii) shall— 
‘‘(i) be identified in a manner that— 
‘‘(I) considers the return on in-
vestment to the United States public 
through the investments of the Na-
tional Institutes of Health in bio-
medical research; and 
‘‘(II) contributes to expanding 
knowledge to improve the United 
States public’s health through bio-
medical research; and 
‘‘(ii) include overarching and trans- 
National Institutes of Health strategic 
focus areas, to be known as Mission Pri-
ority Focus Areas, which best serve the 
goals of preventing or eliminating the bur-
den of a disease or condition and scientif-
ically merit enhanced and focused research 
over the next 5 years.
‘‘(B) RARE AND PEDIATRIC DISEASES AND 
CONDITIONS.—In developing and maintaining a 
strategic plan under this subsection, the Direc-
tor of NIH shall ensure that rare and pediatric 
diseases and conditions remain a priority. 
‘‘(C) WORKFORCE.—In developing and 
maintaining a strategic plan under this sub-
section, the Director of NIH shall ensure that 
maintaining the biomedical workforce of the fu-
ture, including the participation by scientists 
from groups traditionally underrepresented in 
the scientific workforce, remains a priority. 
‘‘(4) INITIAL PLAN.—Not later than 270 days 
after the date of enactment of this subsection, the 
Director of NIH and the directors of the national re-
search institutes and national centers shall— 
‘‘(A) complete the initial strategic plan re-
quired by paragraphs (1) and (2); and 
‘‘(B) make such initial strategic plan pub-
licly available on the website of the National In-
stitutes of Health. 
‘‘(5) REVIEW; UPDATES.— 
‘‘(A) PROGRESS REVIEWS.—Not less than 
annually, the Director of NIH, in consultation 
with the directors of the national research insti-
tutes and national centers, shall conduct 
progress reviews for each strategic focus area 
identified under paragraph (1)(A)(ii). 
‘‘(B) UPDATES.—Not later than the end of 
the 5-year period covered by the initial strategic 
plan under this subsection, and every 5 years 
thereafter, the Director of NIH, in consultation 
with the directors of the national research insti-
tutes and national centers, stakeholders in the 
scientific field, advocates, and the public at 
large, shall— 
‘‘(i) conduct a review of the plan, in-
cluding each strategic focus area identified 
under paragraph (2)(B); and 
‘‘(ii) update such plan in accordance 
with this section.’’. 
SEC. 1022. INCREASING ACCOUNTABILITY AT THE NA-
TIONAL INSTITUTES OF HEALTH. 
(a) APPOINTMENT AND TERMS OF DIRECTORS OF 
NATIONAL RESEARCH INSTITUTES AND NATIONAL CEN-
TERS.—Subsection (a) of section 405 of the Public Health 
Service Act (42 U.S.C. 284) is amended to read as follows: 
‘‘(a) APPOINTMENT; TERMS.— 
‘‘(1) APPOINTMENT.—The Director of the Na-
tional Cancer Institute shall be appointed by the
President and the directors of the other national re-
search institutes, as well as the directors of the na-
tional centers, shall be appointed by the Director of 
NIH. The directors of the national research insti-
tutes, as well as national centers, shall report di-
rectly to the Director of NIH. 
‘‘(2) TERMS.— 
‘‘(A) IN GENERAL.—The term of office of 
a director of a national research institute or na-
tional center shall be 5 years. 
‘‘(B) REMOVAL.—The director of a na-
tional research institute or national center may 
be removed from office by the Director of NIH 
prior to the expiration of such director’s 5-year 
term. 
‘‘(C) REAPPOINTMENT.—At the end of the 
term of a director of a national research insti-
tute or national center, the director may be re-
appointed. There is no limit on the number of 
terms a director may serve. 
‘‘(D) VACANCIES.—If the office of a direc-
tor 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. 
‘‘(E) TRANSITIONAL PROVISION.—Each di-
rector of a national research institute or na-
tional center serving on the date of enactment 
of the 21st Century Cures Act is deemed to be 
appointed for a 5-year term under this sub-
section starting on such date of enactment.’’. 
(b) COMPENSATION
TO CONSULTANTS
OR INDI-
VIDUAL SCIENTISTS.—Section 202 of the Departments of 
Labor, Health and Human Services, and Education, and 
Related Agencies Appropriations Act, 1993 (Public Law 
102–394; 42 U.S.C. 238f note) is amended by striking 
‘‘portable structures;’’ and all that follows and inserting 
‘‘portable structures.’’. 
(c) 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 fol-
lowing: 
‘‘(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 noncompeting 
renewal of such grant, or a noncompeting administrative
supplement to such grant, the director of such national 
research institute or national center— 
‘‘(A) shall review and approve the award; and 
‘‘(B) shall take into consideration— 
‘‘(i) the mission of the national research 
institute or national center and the scientific 
priorities identified in the strategic plan under 
section 402(m); and 
‘‘(ii) whether other agencies are funding 
programs or projects to accomplish the same 
goal.’’. 
(d) IOM STUDY ON DUPLICATION IN FEDERAL BIO-
MEDICAL RESEARCH.—The Secretary of Health and 
Human Services shall enter into an arrangement with the 
Institute of Medicine of the National Academies (or, if the 
Institute declines, another appropriate entity) under which 
the Institute (or other appropriate entity) not later than 
2 years after the date of enactment of this Act will— 
(1) complete a study on the extent to which bio-
medical research conducted or supported by Federal 
agencies is duplicative; and 
(2) submit a report to the Congress on the re-
sults of such study, including recommendations on 
how to prevent such duplication.
SEC. 1023. REDUCING ADMINISTRATIVE BURDENS OF RE-
SEARCHERS. 
(a) PLAN PREPARATION AND IMPLEMENTATION OF 
MEASURES TO REDUCE ADMINISTRATIVE BURDENS.— 
The Director of the National Institutes of Health shall 
prepare a plan, including time frames, and implement 
measures to reduce the administrative burdens of re-
searchers funded by the National Institutes of Health, 
taking into account the recommendations, evaluations, 
and plans researched by the following entities: 
(1) The Scientific Management Review Board. 
(2) The National Academy of Sciences. 
(3) The 2007 and 2012 Faculty Burden Survey 
conducted by The Federal Demonstration Partner-
ship. 
(4) Relevant recommendations from the Re-
search Business Models Working Group. 
(b) REPORT.—Not later than 2 years after the date 
of enactment of this Act, the Director of the National In-
stitutes of Health shall submit to Congress a report on 
the extent to which the Director has implemented meas-
ures pursuant to subsection (a).
SEC. 1024. EXEMPTION FOR THE NATIONAL INSTITUTES OF 
HEALTH FROM THE PAPERWORK REDUCTION 
ACT REQUIREMENTS. 
Section 3518(c)(1) of title 44, United States Code, 
is amended— 
(1) in subparagraph (C), by striking ‘‘; or’’ and 
inserting a semicolon; 
(2) in subparagraph (D), by striking the period 
at the end and inserting ‘‘; or’’; and 
(3) by inserting at the end the following new 
subparagraph: 
‘‘(E) during the conduct of research by the Na-
tional Institutes of Health.’’. 
SEC. 1025. NIH TRAVEL. 
It is the sense of Congress that participation in or 
sponsorship of scientific conferences and meetings is es-
sential to the mission of the National Institutes of Health. 
SEC. 1026. OTHER TRANSACTIONS AUTHORITY. 
Section 480 of the Public Health Service Act (42 
U.S.C. 287a) is amended— 
(1) in subsection (b), by striking ‘‘the appro-
priation of funds as described in subsection (g)’’ and 
inserting ‘‘the availability of funds as described in 
subsection (f)’’; 
(2) in subsection (e)(3), by amending subpara-
graph (C) to read as follows:
‘‘(C) OTHER TRANSACTIONS AUTHORITY.— 
The Director of the Center shall have other 
transactions authority in entering into trans-
actions to fund projects in accordance with the 
terms and conditions of this section.’’; 
(3) by striking subsection (f); and 
(4) by redesignating subsection (g) as sub-
section (f). 
SEC. 1027. NCATS PHASE IIB RESTRICTION. 
Section 479 of the Public Health Service Act (42 
U.S.C. 287) is amended— 
(1) prior to making the amendments under 
paragraph (2), by striking ‘‘IIB’’ each place it ap-
pears and inserting ‘‘III’’; and 
(2) by striking ‘‘IIA’’ each place it appears and 
inserting ‘‘IIB’’. 
SEC. 1028. HIGH-RISK, HIGH-REWARD RESEARCH. 
Part B of title IV of the Public Health Service Act 
(42 U.S.C. 284 et seq.), as amended by section 1002 of 
this Act, is amended by adding at the end the following: 
‘‘SEC. 409L. HIGH-RISK, HIGH-REWARD RESEARCH PRO-
GRAM. 
‘‘The director of each national research institute 
shall, as appropriate—
‘‘(1) establish programs to conduct or support 
research projects that pursue innovative approaches 
to major contemporary challenges in biomedical re-
search that involve inherent high risk, but have the 
potential to lead to breakthroughs; and 
‘‘(2) set aside a specific percentage of funding, 
to be determined by the Director of NIH for each 
national research institute, for such projects.’’. 
SEC. 1029. SENSE OF CONGRESS ON INCREASED INCLUSION 
OF UNDERREPRESENTED COMMUNITIES IN 
CLINICAL TRIALS. 
It is the sense of Congress that the National Institute 
on Minority Health and Health Disparities (NIMHD) 
should include within its strategic plan ways to increase 
representation of underrepresented communities in clinical 
trials. 
Subtitle C—Supporting Young 
Emerging Scientists 
SEC. 1041. IMPROVEMENT OF LOAN REPAYMENT PRO-
GRAMS OF THE NATIONAL INSTITUTES OF 
HEALTH. 
(a) IN GENERAL.—Part G of title IV of the Public 
Health Service Act (42 U.S.C. 288 et seq.) is amended—
(1) by redesignating the second section 487F 
(42 U.S.C. 288–6; relating to pediatric research loan 
repayment program) as section 487G; and 
(2) by inserting after section 487G, as so redes-
ignated, the following: 
‘‘SEC. 487H. LOAN REPAYMENT PROGRAM. 
‘‘(a) IN GENERAL.—The Secretary shall establish a 
program, based on workforce and scientific needs, of en-
tering into contracts with qualified health professionals 
under which such health professionals agree to engage in 
research in consideration of the Federal Government 
agreeing to pay, for each year of engaging in such re-
search, not more than $50,000 of the principal and inter-
est of the educational loans of such health professionals. 
‘‘(b) ADJUSTMENT FOR INFLATION.—Beginning with 
respect to fiscal year 2017, the Secretary may increase 
the maximum amount specified in subsection (a) by an 
amount that is determined by the Secretary, on an annual 
basis, to reflect inflation. 
‘‘(c) LIMITATION.—The Secretary may not enter into 
a contract with a health professional pursuant to sub-
section (a) unless such professional has a substantial 
amount of educational loans relative to income. 
‘‘(d) APPLICABILITY OF CERTAIN PROVISIONS RE-
GARDING OBLIGATED SERVICE.—Except to the extent in-
consistent with this section, the provisions of sections 
338B, 338C, and 338E shall apply to the program estab-
lished under this section to the same extent and in the 
same manner as such provisions apply to the National 
Health Service Corps Loan Repayment Program estab-
lished under section 338B. 
‘‘(e) AVAILABILITY OF APPROPRIATIONS.—Amounts 
appropriated for a fiscal year for contracts under sub-
section (a) are authorized to remain available until the ex-
piration of the second fiscal year beginning after the fiscal 
year for which the amounts were appropriated.’’. 
(b) UPDATE OF OTHER LOAN REPAYMENT PRO-
GRAMS.— 
(1) Section 464z–5(a) of the Public Health 
Service Act (42 U.S.C.285t–2(a)) is amended— 
(A) by striking ‘‘$35,000’’ and inserting 
‘‘$50,000’’; and 
(B) by adding at the end the following new 
sentence: ‘‘Subsection (b) of section 487H shall 
apply with respect to the maximum amount 
specified in this subsection in the same manner 
as it applies to the maximum amount specified 
in subsection (a) of such section.’’. 
(2) Section 487A(a) of such Act (42 U.S.C. 
288–1(a)) is amended—
(A) by striking ‘‘$35,000’’ and inserting 
‘‘$50,000’’; and 
(B) by adding at the end the following new 
sentence: ‘‘Subsection (b) of section 487H shall 
apply with respect to the maximum amount 
specified in this subsection in the same manner 
as it applies to the maximum amount specified 
in subsection (a) of such section.’’. 
(3) Section 487B(a) of such Act (42 U.S.C. 
288–2(a)) is amended— 
(A) by striking ‘‘$35,000’’ and inserting 
‘‘$50,000’’; and 
(B) by adding at the end the following new 
sentence: ‘‘Subsection (b) of section 487H shall 
apply with respect to the maximum amount 
specified in this subsection in the same manner 
as it applies to the maximum amount specified 
in such subsection (a) of such section.’’. 
(4) Section 487C(a)(1) of such Act (42 U.S.C. 
288–3(a)(1)) is amended— 
(A) by striking ‘‘$35,000’’ and inserting 
‘‘$50,000’’; and 
(B) by adding at the end the following new 
sentence: ‘‘Subsection (b) of section 487H shall 
apply with respect to the maximum amount
specified in this paragraph in the same manner 
as it applies to the maximum amount specified 
in such subsection (a) of such section.’’. 
(5) Section 487E(a)(1) of such Act (42 U.S.C. 
288–5(a)(1)) is amended— 
(A) by striking ‘‘$35,000’’ and inserting 
‘‘$50,000’’; and 
(B) by adding at the end the following new 
sentence: ‘‘Subsection (b) of section 487H shall 
apply with respect to the maximum amount 
specified in this paragraph in the same manner 
as it applies to the maximum amount specified 
in such subsection (a) of such section.’’. 
(6) Section 487F(a) of such Act (42 U.S.C. 
288–5a(a)), as added by section 205 of Public Law 
106–505, is amended— 
(A) by striking ‘‘$35,000’’ and inserting 
‘‘$50,000’’; and 
(B) by adding at the end the following new 
sentence: ‘‘Subsection (b) of section 487H shall 
apply with respect to the maximum amount 
specified in this subsection in the same manner 
as it applies to the maximum amount specified 
in such subsection (a) of such section.’’.
(7) Section 487G of such Act (42 U.S.C. 288– 
6, as redesignated by subsection (a)(1)), is further 
amended— 
(A) in subsection (a)(1), by striking 
‘‘$35,000’’ and inserting ‘‘$50,000’’; and 
(B) in subsection (b), by adding at the end 
the following new sentence: ‘‘Subsection (b) of 
section 487H shall apply with respect to the 
maximum amount specified in subsection (a)(1) 
in the same manner as it applies to the max-
imum amount specified in such subsection (a) 
of such section.’’. 
SEC. 1042. REPORT. 
Not later than 18 months after the date of the enact-
ment of this Act, the Director of the National Institutes 
of Health shall submit to Congress a report on efforts of 
the National Institutes of Health to attract, retain, and 
develop emerging scientists, including underrepresented 
individuals in the sciences, such as women and other mi-
norities.
Subtitle D—Capstone Grant 
Program 
SEC. 1061. CAPSTONE AWARD. 
Part G of title IV of the Public Health Service Act 
(42 U.S.C. 288 et seq.) is amended by adding at the end 
the following: 
‘‘SEC. 490. CAPSTONE AWARD. 
‘‘(a) IN GENERAL.—The Secretary may make awards 
(each of which, hereafter in this section, referred to as 
a ‘Capstone Award’) to support outstanding scientists who 
have been funded by the National Institutes of Health. 
‘‘(b) PURPOSE.—Capstone Awards shall be made to 
facilitate the successful transition or conclusion of re-
search programs, or for other purposes, as determined by 
the Director of NIH, in consultation with the directors 
of the national research institutes and national centers. 
‘‘(c) DURATION AND AMOUNT.—The duration and 
amount of each Capstone Award shall be determined by 
the Director of NIH in consultation with the directors of 
the national research institutes and national centers. 
‘‘(d) LIMITATION.—Individuals who have received a 
Capstone Award shall not be eligible to have principle in-
vestigator status on subsequent awards from the National 
Institutes of Health.’’.
Subtitle 
E—Promoting 
Pediatric 
Research Through the National 
Institutes of Health 
SEC. 1081. 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)— 
(A) by striking ‘‘in consultation with the 
Director of the Eunice Kennedy Shriver Na-
tional Institute of Child Health and Human 
Development and in collaboration with other 
appropriate national research institutes and na-
tional centers that carry out activities involving 
pediatric research’’ and inserting ‘‘in collabora-
tion with the national research institutes and 
national centers that carry out activities involv-
ing pediatric research’’; 
(B) by striking subparagraph (B); 
(C) by striking ‘‘may be comprised of, as 
appropriate’’ and all that follows through ‘‘the 
pediatric research consortia’’ and inserting 
‘‘may be comprised of, as appropriate, the pedi-
atric research consortia’’; and 
(D) by striking ‘‘; or’’ at the end and in-
serting a period; and
(2) in paragraph (1), paragraph (2)(A), the 
first sentence of paragraph (2)(E), and paragraph 
(4), by striking ‘‘may’’ each place it appears and in-
serting ‘‘shall’’. 
SEC. 1082. GLOBAL PEDIATRIC CLINICAL STUDY NETWORK 
SENSE OF CONGRESS. 
It is the sense of Congress that— 
(1) the National Institutes of Health should en-
courage a global pediatric clinical study network 
through the allocation of grants, contracts, or coop-
erative agreements to supplement the salaries of new 
and early investigators who participate in the global 
pediatric clinical study network; 
(2) National Institutes of Health grants, con-
tracts, or cooperative agreements should be awarded, 
solely for the purpose of supplementing the salaries 
of new and early investigators, to entities that par-
ticipate in the global pediatric clinical study net-
work; 
(3) the Food and Drug Administration should 
engage the European Medicines Agency and other 
foreign regulatory entities during the formation of 
the global pediatric clinical study network to encour-
age their participation; and
(4) once a global pediatric clinical study net-
work is established and becomes operational, the 
Food and Drug Administration should continue to 
engage the European Medicines Agency and other 
foreign regulatory entities to encourage and facili-
tate their participation in the network with the goal 
of enhancing the global reach of the network. 
SEC. 1083. APPROPRIATE AGE GROUPINGS IN CLINICAL RE-
SEARCH. 
(a) 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 work-
shop of experts on pediatrics and experts on geriatrics to 
provide input on— 
(1) appropriate age groupings to be included in 
research studies involving human subjects; and 
(2) acceptable scientific justifications for ex-
cluding participants from a range of age groups 
from human subjects research studies. 
(b) GUIDELINES.—Not later than 180 days after the 
conclusion of the workshop under subsection (a), the Di-
rector of the National Institutes of Health shall publish 
guidelines—
(1) addressing the consideration of age as an 
inclusion variable in research involving human sub-
jects; and 
(2) identifying criteria for justifications for any 
age-related exclusions in such research. 
(c) PUBLIC AVAILABILITY OF FINDINGS AND CON-
CLUSIONS.—The Director of the National Institutes of 
Health shall— 
(1) make the findings and conclusions resulting 
from the workshop under subsection (a) available to 
the public on the website of the National Institutes 
of Health; and 
(2) not less than biennially, disclose to the pub-
lic on such website the number of children included 
in research that is conducted or supported by the 
National Institutes of Health, disaggregated by de-
velopmentally appropriate age group, race, and gen-
der. 
Subtitle F—Advancement of the 
National Institutes of Health Re-
search and Data Access 
SEC. 1101. STANDARDIZATION OF DATA IN CLINICAL TRIAL 
REGISTRY DATA BANK ON ELIGIBILITY FOR 
CLINICAL TRIALS. 
(a) STANDARDIZATION.—
(1) IN GENERAL.—Section 402(j) of the Public 
Health Service Act (42 U.S.C. 282(j)) is amended— 
(A) by redesignating paragraph (7) as 
paragraph (8); and 
(B) by inserting after paragraph (6) the 
following: 
‘‘(7) STANDARDIZATION.—The Director of NIH 
shall— 
‘‘(A) ensure that the registry and results 
data bank is easily used by the public; 
‘‘(B) ensure that entries in the registry 
and results data bank are easily compared; 
‘‘(C) ensure that information required to 
be submitted to the registry and results data 
bank, including recruitment information under 
paragraph (2)(A)(ii)(II), is submitted by per-
sons and posted by the Director of NIH in a 
standardized format and includes at least— 
‘‘(i) the disease or indication being 
studied; 
‘‘(ii) inclusion criteria such as age, 
gender, diagnosis or diagnoses, laboratory 
values, or imaging results; and
‘‘(iii) exclusion criteria such as spe-
cific diagnosis or diagnoses, laboratory val-
ues, or prohibited medications; and 
‘‘(D) to the extent possible, in carrying out 
this paragraph, make use of standard health 
care terminologies, such as the International 
Classification of Diseases or the Current Proce-
dural Terminology, that facilitate electronic 
matching to data in electronic health records or 
other 
relevant 
health 
information 
tech-
nologies.’’. 
(2) CONFORMING AMENDMENT.—Clause (iv) of 
section 402(j)(2)(B) of the Public Health Service 
Act (42 U.S.C. 282(j)(2)(B)) is hereby stricken. 
(b) CONSULTATION.—Not later than 90 days after 
the date of enactment of this Act, the Secretary of Health 
and Human Services shall consult with stakeholders (in-
cluding patients, researchers, physicians, industry rep-
resentatives, health information technology providers, the 
Food and Drug Administration, and standard setting or-
ganizations such as CDISC that have experience working 
with Federal agencies to standardize health data submis-
sions) to receive advice on 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 enhance-
ments to usability, functionality, and search capability) 
that are necessary to implement paragraph (7) of section 
402(j) of such Act, as added by subsection (a). 
(c) APPLICABILITY.—Not later than 18 months after 
the date of enactment of this Act, the Secretary of Health 
and Human Services shall begin implementation of para-
graph (7) of section 402(j) of the Public Health Service 
Act, as added by subsection (a). 
Subtitle G—Facilitating 
Collaborative Research 
SEC. 1121. CLINICAL TRIAL DATA SYSTEM. 
(a) 
ESTABLISHMENT.—The 
Secretary, 
acting 
through the Commissioner of Food and Drugs and the Di-
rector of the National Institutes of Health, shall enter into 
a cooperative agreement, contract, or grant for a period 
of 7 years, to be known as the Clinical Trial Data System 
Agreement, with one or more eligible entities to implement 
a pilot program with respect to all clinical trial data ob-
tained from qualified clinical trials for purposes of reg-
istered users conducting further research on such data. 
(b) APPLICATION.—Eligible entities seeking to enter 
into a cooperative agreement, contract, or grant with the 
Secretary under this section shall submit to the Secretary 
an application in such time and manner, and containing 
such information, as the Secretary may require in accord-
ance with this section. The Secretary shall not enter into 
a cooperative agreement, contract, or grant under this sec-
tion with an eligible entity unless such entity submits an 
application including the following: 
(1) A certification that the eligible entity is not 
currently and does not plan to be involved in spon-
soring, operating, or participating in a clinical trial 
nor collaborating with another entity for the pur-
poses of sponsoring, operating, or participating in a 
clinical trial. 
(2) Information demonstrating that the eligible 
entity can compile clinical trial data in standardized 
formats using terminologies and standards that have 
been developed by recognized standards developing 
organizations with input from diverse stakeholder 
groups, and information demonstrating that the eli-
gible entity can de-identify clinical trial data con-
sistent with the requirements of section 164.514 of 
title 45, Code of Federal Regulations (or successor 
regulations). 
(3) A description of the system the eligible enti-
ty will use to store and maintain such data, and in-
formation demonstrating that this system will com-
ply with applicable standards and requirements for 
ensuring the security of the clinical trial data.
(4) A certification that the eligible entity will 
allow only registered users to access and use de- 
identified clinical trial data, gathered from qualified 
clinical trials, and that the eligible entity will allow 
each registered user to access and use such data 
only after such registered user agrees in writing to 
the terms described in (e)(4)(B), and such other 
carefully controlled contractual terms as may be de-
fined by the Secretary. 
(5) Evidence demonstrating the ability of the 
eligible entity to ensure that registered users dis-
seminate the results of the research conducted in ac-
cordance with this section to interested parties to 
serve as a guide to future medical product develop-
ment or scientific research. 
(6) The plan of the eligible entity for securing 
funding for the activities it would conduct under the 
clinical trial data system agreement from govern-
mental sources and private foundations, entities, and 
individuals. 
(7) Evidence demonstrating a proven track 
record of— 
(A) being a neutral third party in working 
with medical product manufacturers, academic
institutions, and the Food and Drug Adminis-
tration; and 
(B) having the ability to protect confiden-
tial data. 
(8) An agreement that the eligible entity will 
work with the Comptroller General of the United 
States for purposes of the study and report under 
subsection (d). 
(c) EXTENSION, EXPANSION, TERMINATION.—The 
Secretary, acting through the Commissioner of Food and 
Drugs and the Director of the National Institutes of 
Health, upon the expiration of the 7-year period referred 
to in subsection (a), may extend (including permanently), 
expand, or terminate the pilot program established under 
such subsection, in whole or in part. 
(d) STUDY AND REPORT.— 
(1) IN GENERAL.—The Comptroller General of 
the United States shall conduct a study and issue a 
report to the Congress and the Secretary with re-
spect to the pilot program established under sub-
section (a), not later than 6 years after the date on 
which the pilot program is established under sub-
section (a). 
(2) STUDY.—The study under paragraph (1) 
shall—
(A) review the effectiveness of the pilot 
program established under subsection (a); and 
(B) be designed to formulate recommenda-
tions on improvements to the program. 
(3) REPORT.—The report under paragraph (1) 
shall contain at least the following information: 
(A) The new discoveries, research inquir-
ies, or clinical trials that have resulted from ac-
cessing clinical trial data under the pilot pro-
gram established under subsection (a). 
(B) The number of times scientists have 
accessed such data, disaggregated by research 
area and clinical trial phase. 
(C) An analysis of whether the program 
has helped to reduce adverse events in clinical 
trials. 
(D) An analysis of whether scientists have 
raised any concerns about the burden of having 
to share data with the system established under 
the program and, if so, a description of such 
concerns. 
(E) An analysis of privacy and data integ-
rity practices used in the program. 
(e) DEFINITIONS.—In this section:
(1) The term ‘‘eligible entity’’ means an entity 
that has experienced personnel with clinical and 
other technical expertise in the biomedical sciences 
and biomedical ethics and that is— 
(A) an institution of higher education (as 
such term is defined in section 1001 of the 
Higher Education Act of 1965 (20 U.S.C. 
1001)) or a consortium of such institutions; or 
(B) an organization described in section 
501(c)(3) of title 26 of the Internal Revenue 
Code of 1986 and exempt from tax under sec-
tion 501(a) of such title. 
(2) The term ‘‘medical product’’ means a drug 
(as defined in section 201(g) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 331(g))), a de-
vice (as defined in section 201(h) of such Act (21 
U.S.C. 331(h)), a biological product (as defined in 
section 351 of the Public Health Service Act (42 
U.S.C. 262)), or any combination thereof. 
(3) The term ‘‘qualified clinical trial’’ means a 
clinical trial sponsored solely by an agency of the 
Department of Health and Human Services with re-
spect to a medical product— 
(A) that—
(i) was approved or cleared under sec-
tion 505, 510(k), or 515, or has an exemp-
tion for investigational use in effect under 
section 505 or 520(m), of the Federal 
Food, Drug, and Cosmetic Act (42 U.S.C. 
301 et seq.); or 
(ii) was licensed under section 351 of 
the Public Health Service Act (42 U.S.C. 
262) or has an exemption for investiga-
tional use in effect under such section 351; 
or 
(B) that is an investigational product for 
which the original development was discon-
tinued and with respect to which— 
(i) no additional work to support ap-
proval, licensure, or clearance of such med-
ical product is being or is planned to be 
undertaken by the sponsor of the original 
development program, its successors, as-
signs, or collaborators; and 
(ii) the sponsor of the original inves-
tigational development program has pro-
vided its consent to the Secretary for inclu-
sion of data regarding such product in the 
system established under this section.
(4) The term ‘‘registered user’’ means a sci-
entific or medical researcher who has— 
(A) a legitimate biomedical research pur-
pose for accessing information from the clinical 
trials data system and has appropriate quali-
fications to conduct such research; and 
(B) agreed in writing not to transfer to 
any other person that is not a registered user 
de-identified clinical trial data from qualified 
clinical trials accessed through an eligible enti-
ty, use such data for reasons not specified in 
the research proposal, or seek to re-identify 
qualified clinical trial participants. 
(5) The term ‘‘Secretary’’ means the Secretary 
of Health and Human Services. 
SEC. 1122. NATIONAL NEUROLOGICAL DISEASES SURVEIL-
LANCE SYSTEM. 
Part P of title III of the Public Health Service Act 
(42 U.S.C. 280g et seq.) is amended by adding at the end 
the following: 
‘‘SEC. 399V–6 SURVEILLANCE OF NEUROLOGICAL DISEASES. 
‘‘(a) IN GENERAL.—The Secretary, acting through 
the Director of the Centers for Disease Control and Pre-
vention and in coordination with other agencies as deter-
mined appropriate by the Secretary, shall—
‘‘(1) enhance and expand infrastructure and ac-
tivities to track the epidemiology of neurological dis-
eases, including multiple sclerosis and Parkinson’s 
disease; and 
‘‘(2) incorporate information obtained through 
such activities into a statistically sound, scientifically 
credible, integrated surveillance system, to be known 
as the National Neurological Diseases Surveillance 
System. 
‘‘(b) RESEARCH.—The Secretary shall ensure that 
the National Neurological Diseases Surveillance System is 
designed in a manner that facilitates further research on 
neurological diseases. 
‘‘(c) CONTENT.—In carrying out subsection (a), the 
Secretary— 
‘‘(1) shall provide for the collection and storage 
of information on the incidence and prevalence of 
neurological diseases in the United States; 
‘‘(2) to the extent practicable, shall provide for 
the collection and storage of other available informa-
tion on neurological diseases, such as information 
concerning— 
‘‘(A) demographics and other information 
associated or possibly associated with neuro-
logical diseases, such as age, race, ethnicity, 
sex, geographic location, and family history; 
‘‘(B) risk factors associated or possibly as-
sociated with neurological diseases, including 
genetic and environmental risk factors; and 
‘‘(C) diagnosis and progression markers; 
‘‘(3) may provide for the collection and storage 
of information relevant to analysis on neurological 
diseases, such as information concerning— 
‘‘(A) the epidemiology of the diseases; 
‘‘(B) the natural history of the diseases; 
‘‘(C) the prevention of the diseases; 
‘‘(D) the detection, management, and 
treatment approaches for the diseases; and 
‘‘(E) the development of outcomes meas-
ures; and 
‘‘(4) may address issues identified during the 
consultation process under subsection (d). 
‘‘(d) CONSULTATION.—In carrying out this section, 
the Secretary shall consult with individuals with appro-
priate expertise, including— 
‘‘(1) epidemiologists with experience in disease 
surveillance or registries; 
‘‘(2) representatives of national voluntary 
health associations that—
‘‘(A) focus on neurological diseases, includ-
ing multiple sclerosis and Parkinson’s disease; 
and 
‘‘(B) have demonstrated experience in re-
search, care, or patient services; 
‘‘(3) health information technology experts or 
other information management specialists; 
‘‘(4) clinicians with expertise in neurological 
diseases; and 
‘‘(5) research scientists with experience con-
ducting translational research or utilizing surveil-
lance systems for scientific research purposes. 
‘‘(e) GRANTS.—The Secretary may award grants to, 
or enter into contracts or cooperative agreements with, 
public or private nonprofit entities to carry out activities 
under this section. 
‘‘(f) COORDINATION WITH OTHER FEDERAL, STATE, 
AND LOCAL AGENCIES.—Subject to subsection (h), the 
Secretary shall make information and analysis in the Na-
tional Neurological Diseases Surveillance System avail-
able, as appropriate— 
‘‘(1) to Federal departments and agencies, such 
as the National Institutes of Health, the Food and 
Drug Administration, the Centers for Medicare & 
Medicaid Services, the Agency for Healthcare Re-
search and Quality, the Department of Veterans Af-
fairs, and the Department of Defense; and 
‘‘(2) to State and local agencies. 
‘‘(g) PUBLIC ACCESS.—Subject to subsection (h), the 
Secretary shall make information and analysis in the Na-
tional Neurological Diseases Surveillance System avail-
able, as appropriate, to the public, including researchers. 
‘‘(h) PRIVACY.—The Secretary shall ensure that pri-
vacy and security protections applicable to the National 
Neurological Diseases Surveillance System are at least as 
stringent as the privacy and security protections under 
HIPAA privacy and security law (as defined in section 
3009(a)(2)). 
‘‘(i) REPORT.—Not later than 4 years after the date 
of the enactment of this section, the Secretary shall sub-
mit a report to the Congress concerning the implementa-
tion of this section. Such report shall include information 
on— 
‘‘(1) the development and maintenance of the 
National Neurological Diseases Surveillance System; 
‘‘(2) the type of information collected and 
stored in the System; 
‘‘(3) the use and availability of such informa-
tion, including guidelines for such use; and
‘‘(4) the use and coordination of databases that 
collect or maintain information on neurological dis-
eases. 
‘‘(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. 
‘‘(k) AUTHORIZATION
OF
APPROPRIATIONS.—To 
carry out this section, there is authorized to be appro-
priated $5,000,000 for each of fiscal years 2016 through 
2020.’’. 
SEC. 1123. DATA ON NATURAL HISTORY OF DISEASES. 
(a) SENSE OF CONGRESS.—It is the sense of the Con-
gress that studies on the natural history of diseases can 
help to facilitate and expedite the development of medical 
products for such diseases. 
(b) AUTHORITY.—Part A of title II of the Public 
Health Service Act (42 U.S.C. 202 et seq.) is amended 
by adding at the end the following: 
‘‘SEC. 229A. DATA ON NATURAL HISTORY OF DISEASES. 
‘‘(a) IN GENERAL.—The Secretary, acting through 
the Commissioner of Food and Drugs, may, for the pur-
poses described in subsection (b)—
‘‘(1) participate in public-private partnerships 
engaged in one or more activities specified in sub-
section (c); and 
‘‘(2) award grants to patient advocacy groups 
or other organizations determined appropriate by the 
Secretary. 
‘‘(b) PURPOSES
DESCRIBED.—The purposes de-
scribed in this subsection are to establish or facilitate the 
collection, maintenance, analysis, and interpretation of 
data regarding the natural history of diseases, with a par-
ticular focus on rare diseases. 
‘‘(c) ACTIVITIES
OF
PUBLIC-PRIVATE
PARTNER-
SHIPS.—The activities of public-private partnerships in 
which the Secretary may participate for purposes of this 
section include— 
‘‘(1) cooperating with other entities that spon-
sor or maintain disease registries, including disease 
registries and disease registry platforms for rare dis-
eases; 
‘‘(2) developing or enhancing a secure informa-
tion technology system that— 
‘‘(A) has the capacity to support data 
needs across a wide range of disease studies; 
‘‘(B) is easily modified as knowledge is 
gained during such studies; and
‘‘(C) is capable of handling increasing 
amounts of data as more studies are carried 
out; and 
‘‘(3) providing advice to clinical researchers, pa-
tient advocacy groups, and other entities with re-
spect to— 
‘‘(A) the design and conduct of disease 
studies; 
‘‘(B) the modification of any such ongoing 
studies; and 
‘‘(C) addressing associated patient privacy 
issues. 
‘‘(d) AVAILABILITY OF DATA ON NATURAL HISTORY 
OF DISEASES.—Data relating to the natural history of 
diseases obtained, aggregated, or otherwise maintained by 
a public-private partnership in which the Secretary par-
ticipates under subsection (a) shall be made available, con-
sistent with otherwise applicable Federal and State pri-
vacy laws, to the public (including patient advocacy 
groups, researchers, and drug developers) to help to facili-
tate and expedite medical product development programs. 
‘‘(e) 
CONFIDENTIALITY.—Notwithstanding 
sub-
section (d), nothing in this section authorizes the disclo-
sure of any information that is a trade secret or commer-
cial or financial information that is privileged or confiden-
tial and subject to section 552(b)(4) of title 5, United 
States Code, or section 1905 of title 18, United States 
Code. 
‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—There 
is authorized to be appropriated to carry out this section 
$5,000,000 for each of fiscal years 2016 through 2020.’’. 
SEC. 1124. ACCESSING, SHARING, AND USING HEALTH DATA 
FOR RESEARCH PURPOSES. 
(a) IN GENERAL.—(1) The HITECH Act (title XIII 
of division A of Public Law 111–5) is amended by adding 
at the end of subtitle D of such Act (42 U.S.C. 17921 
et seq.) the following: 
‘‘PART 4—ACCESSING, SHARING, AND USING 
HEALTH DATA FOR RESEARCH PURPOSES 
‘‘SEC. 13441. REFERENCES. 
‘‘In this part: 
‘‘(1) THE RULE.—References to ‘the Rule’ refer 
to part 160 or part 164, as appropriate, of title 45, 
Code of Federal Regulations (or any successor regu-
lation). 
‘‘(2) PART 164.—References to a specified sec-
tion of ‘part 164’, refer to such specified section of 
part 164 of title 45, Code of Federal Regulations (or 
any successor section).
‘‘SEC. 13442. DEFINING HEALTH DATA RESEARCH AS PART 
OF HEALTH CARE OPERATIONS. 
‘‘(a) IN GENERAL.—Subject to subsection (b), the 
Secretary shall revise or clarify the Rule to allow the use 
and disclosure of protected health information by a cov-
ered entity for research purposes, including studies whose 
purpose is to obtain generalizable knowledge, to be treated 
as the use and disclosure of such information for health 
care operations described in subparagraph (1) of the defi-
nition of health care operations in section 164.501 of part 
164. 
‘‘(b) MODIFICATIONS TO RULES FOR DISCLOSURES 
FOR HEALTH CARE OPERATIONS.—In applying section 
164.506 of part 164 to the disclosure of protected health 
information described in subsection (a)— 
‘‘(1) the Secretary shall revise or clarify the 
Rule so that the disclosure may be made by the cov-
ered entity to only— 
‘‘(A) another covered entity for health care 
operations (as defined in section 164.501 of 
part 164); 
‘‘(B) a business associate that has entered 
into a contract under section 164.504(e) of part 
164 with a disclosing covered entity to perform 
health care operations; or
‘‘(C) a business associate that has entered 
into a contract under section 164.504(e) of part 
164 for the purpose of data aggregation (as de-
fined in section 164.501 of part 164); and 
‘‘(2) the Secretary shall further revise or clarify 
the Rule so that the limitation specified by section 
164.506(c)(4) of part 164 does not apply to disclo-
sures that are described by subsection (a). 
‘‘(c) RULE OF CONSTRUCTION.—This section shall 
not be construed as prohibiting or restricting a use or dis-
closure of protected health information for research pur-
poses that is otherwise permitted under part 164. 
‘‘SEC. 13443. TREATING DISCLOSURES OF PROTECTED 
HEALTH INFORMATION FOR RESEARCH SIMI-
LARLY TO DISCLOSURES OF SUCH INFORMA-
TION FOR PUBLIC HEALTH PURPOSES. 
‘‘(a) REMUNERATION.—The Secretary shall revise or 
clarify the Rule so that disclosures of protected health in-
formation for research purposes are not subject to the lim-
itation 
on 
remuneration 
described 
in 
section 
164.502(a)(5)(ii)(B)(2)(ii) of part 164. 
‘‘(b) PERMITTED USES
AND DISCLOSURES.—The 
Secretary shall revise or clarify the Rule so that research 
activities, including comparative research activities, re-
lated to the quality, safety, or effectiveness of a product
or activity that is regulated by the Food and Drug Admin-
istration are included as public health activities for pur-
poses of which a covered entity may disclose protected 
health information to a person described in section 
164.512(b)(1)(iii) of part 164. 
‘‘SEC. 13444. PERMITTING REMOTE ACCESS TO PROTECTED 
HEALTH INFORMATION BY RESEARCHERS. 
‘‘The Secretary shall revise or clarify the Rule so that 
subparagraph (B) of section 164.512(i)(1)(ii) of part 164 
(prohibiting the removal of protected health information 
by a researcher) does not prohibit remote access to health 
information by a researcher so long as— 
‘‘(1) appropriate security and privacy safe-
guards are maintained by the covered entity and the 
researcher; and 
‘‘(2) the protected health information is not 
copied or otherwise retained by the researcher. 
‘‘SEC. 13445. ALLOWING ONE-TIME AUTHORIZATION OF USE 
AND DISCLOSURE OF PROTECTED HEALTH 
INFORMATION FOR RESEARCH PURPOSES. 
‘‘(a) IN GENERAL.—The Secretary shall revise or 
clarify the Rule to specify that an authorization for the 
use or disclosure of protected health information, with re-
spect to an individual, for future research purposes shall
be deemed to contain a sufficient description of the pur-
pose of the use or disclosure if the authorization— 
‘‘(1) sufficiently describes the purposes such 
that it would be reasonable for the individual to ex-
pect that the protected health information could be 
used or disclosed for such future research; 
‘‘(2) either— 
‘‘(A) states that the authorization will ex-
pire on a particular date or on the occurrence 
of a particular event; or 
‘‘(B) states that the authorization will re-
main valid unless and until it is revoked by the 
individual; and 
‘‘(3) provides instruction to the individual on 
how to revoke such authorization at any time. 
‘‘(b) REVOCATION OF AUTHORIZATION.—The Sec-
retary shall revise or clarify the Rule to specify that, if 
an individual revokes an authorization for future research 
purposes such as is described by subsection (a), the cov-
ered entity may not make any further uses or disclosures 
based on that authorization, except, as provided in para-
graph (b)(5) of section 164.508 of part 164, to the extent 
that the covered entity has taken action in reliance on the 
authorization.’’.
(2) The table of sections in section 13001(b) of such 
Act is amended by adding at the end of the items relating 
to subtitle D the following new items: 
‘‘PART 4—ACCESSING, SHARING, AND USING HEALTH DATA FOR RESEARCH 
PURPOSES 
‘‘Sec. 13441. References. 
‘‘Sec. 13442. Defining health data research as part of health care operations. 
‘‘Sec. 13443. Treating disclosures of protected health information for research 
similarly to disclosures of such information for public health 
purposes. 
‘‘Sec. 13444. Permitting remote access to protected health information by re-
searchers. 
‘‘Sec. 13445. Allowing one-time authorization of use and disclosure of protected 
health information for research purposes.’’. 
(b) REVISION OF REGULATIONS.—Not later than 12 
months after the date of the enactment of this Act, the 
Secretary of Health and Human Services shall revise and 
clarify the provisions of title 45, Code of Federal Regula-
tions, for consistency with part 4 of subtitle D of the 
HITECH Act, as added by subsection (a). 
Subtitle H—Council for 21st 
Century Cures 
SEC. 1141. COUNCIL FOR 21ST CENTURY CURES. 
Title II of the Public Health Service Act (42 U.S.C. 
202 et seq.) is amended by adding at the end the fol-
lowing: 
‘‘PART E—COUNCIL FOR 21ST CENTURY CURES 
‘‘SEC. 281. ESTABLISHMENT. 
‘‘A nonprofit corporation to be known as the Council 
for 21st Century Cures (referred to in this part as the 
‘Council’) shall be established in accordance with this sec-
tion. The Council shall be a public-private partnership 
headed by an Executive Director (referred to in this part 
as the ‘Executive Director’), appointed by the members 
of the Board of Directors. The Council shall not be an 
agency or instrumentality of the United States Govern-
ment. 
‘‘SEC. 281A. PURPOSE. 
‘‘The purpose of the Council is to accelerate the dis-
covery, development, and delivery in the United States of 
innovative cures, treatments, and preventive measures for 
patients. 
‘‘SEC. 281B. DUTIES. 
‘‘For the purpose described in section 281A, the 
Council shall— 
‘‘(1) foster collaboration and coordination 
among the entities that comprise the Council, includ-
ing academia, government agencies, industry, health 
care payors and providers, patient advocates, and 
others engaged in the cycle of discovery, develop-
ment, and delivery of life-saving and health-enhanc-
ing innovative interventions; 
‘‘(2) undertake communication and dissemina-
tion activities; 
‘‘(3) publish information on the activities fund-
ed under section 281D;
‘‘(4) establish a strategic agenda for accel-
erating the discovery, development, and delivery in 
the United States of innovative cures, treatments, 
and preventive measures for patients; 
‘‘(5) identify gaps and opportunities within and 
across the discovery, development, and delivery cycle; 
‘‘(6) develop and propose recommendations 
based on the gaps and opportunities so identified; 
‘‘(7) facilitate the interoperability of the compo-
nents of the discovery, development, and delivery 
cycle; 
‘‘(8) propose recommendations that will facili-
tate precompetitive collaboration; 
‘‘(9) identify opportunities to work with, but 
not duplicate the efforts of, nonprofit organizations 
and other public-private partnerships; and 
‘‘(10) identify opportunities for collaboration 
with organizations operating outside of the United 
States, such as the Innovative Medicines Initiative of 
the European Union. 
‘‘SEC. 281C. ORGANIZATION; ADMINISTRATION. 
‘‘(a) BOARD OF DIRECTORS.— 
‘‘(1) ESTABLISHMENT.— 
‘‘(A) IN
GENERAL.—The Council shall 
have a Board of Directors (in this part referred
to as the ‘Board of Directors’), which shall be 
composed of the ex officio members under sub-
paragraph (B) and the appointed members 
under subparagraph (C). All members of the 
Board shall be voting members. 
‘‘(B) EX OFFICIO MEMBERS.—The ex offi-
cio members of the Board shall be the following 
individuals or their designees: 
‘‘(i) The Director of the National In-
stitutes of Health. 
‘‘(ii) The Commissioner of Food and 
Drugs. 
‘‘(iii) The Administrator of the Cen-
ters for Medicare & Medicaid Services. 
‘‘(iv) The heads of five other Federal 
agencies deemed by the Secretary to be en-
gaged in biomedical research and develop-
ment. 
‘‘(C) APPOINTED
MEMBERS.—The ap-
pointed members of the Board shall consist of 
17 individuals, of whom— 
‘‘(i) eight shall be appointed by the 
Comptroller General of the United States 
from a list of nominations submitted by 
leading trade associations—
‘‘(I) four of whom shall be rep-
resentatives of the biopharmaceutical 
industry; 
‘‘(II) two of whom shall be rep-
resentatives of the medical device in-
dustry; and 
‘‘(III) two of whom shall be rep-
resentatives of the information and 
digital technology industry; and 
‘‘(ii) nine shall be appointed by the 
Comptroller General of the United States, 
after soliciting nominations— 
‘‘(I) two of whom shall be rep-
resentatives of academic researchers; 
‘‘(II) three of whom shall be rep-
resentatives of patients; 
‘‘(III) two of whom shall be rep-
resentatives of health care providers; 
and 
‘‘(IV) two of whom shall be rep-
resentatives of health care plans and 
insurers. 
‘‘(D) CHAIR.—The Chair of the Board 
shall be selected by the members of the Board
by majority vote from among the members of 
the Board. 
‘‘(2) TERMS AND VACANCIES.— 
‘‘(A) IN GENERAL.—The term of office of 
each member of the Board appointed under 
paragraph (1)(C) shall be 5 years. 
‘‘(B) VACANCY.—Any vacancy in the mem-
bership of the Board— 
‘‘(i) shall not affect the power of the 
remaining members to execute the duties 
of the Board; and 
‘‘(ii) shall be filled by appointment by 
the appointed members described in para-
graph (1)(C) by majority vote. 
‘‘(C) PARTIAL TERM.—If a member of the 
Board does not serve the full term applicable 
under subparagraph (A), the individual ap-
pointed under subparagraph (B) to fill the re-
sulting vacancy shall be appointed for the re-
mainder of the term of the predecessor of the 
individual. 
‘‘(3) RESPONSIBILITIES.—Not later than 90 
days after the date on which the Council is incor-
porated and its Board of Directors is fully con-
stituted, the Board of Directors shall establish by-
laws and policies for the Council that— 
‘‘(A) are published in the Federal Register 
and available for public comment; 
‘‘(B) establish policies for the selection 
and, as applicable, appointment of— 
‘‘(i) the officers, employees, agents, 
and contractors of the Council; and 
‘‘(ii) the members of any committees 
of the Council; 
‘‘(C) establish policies, including ethical 
standards, for the conduct of programs and 
other activities under section 281D; and 
‘‘(D) establish specific duties of the Execu-
tive Director. 
‘‘(4) MEETINGS.— 
‘‘(A) IN GENERAL.—The Board of Direc-
tors shall— 
‘‘(i) meet on a quarterly basis; and 
‘‘(ii) submit to Congress, and make 
publicly available, the minutes of such 
meetings. 
‘‘(B) AGENDA.—The Board of Directors 
shall, not later than 3 months after the incorpo-
ration of the Council—
‘‘(i) issue an agenda (in this part re-
ferred to as the ‘agenda’) outlining how 
the Council will achieve the purpose de-
scribed in section 281A; and 
‘‘(ii) annually thereafter, in consulta-
tion with the Executive Director, review 
and update such agenda. 
‘‘(b) APPOINTMENT
AND
INCORPORATION.—Not 
later than 6 months after the date of enactment of the 
21st Century Cures Act— 
‘‘(1) the Comptroller General of the United 
States shall appoint the appointed members of the 
Board of Directors under subsection (a)(1)(C); and 
‘‘(2) the ex officio members of the Board of Di-
rectors under subsection (a)(1)(B) shall serve as 
incorporators and shall take whatever actions are 
necessary to incorporate the Council. 
‘‘(c) NONPROFIT STATUS.—In carrying out this part, 
the Board of Directors shall establish such policies and 
bylaws, and the Executive Director shall carry out such 
activities, as may be necessary to ensure that the Council 
maintains status as an organization that— 
‘‘(1) is described in subsection (c)(3) of section 
501 of the Internal Revenue Code of 1986; and