IIB 
114TH CONGRESS 
1ST SESSION 
H. R. 6 
IN THE SENATE OF THE UNITED STATES 
JULY 13, 2015 
Received; read twice and referred to the Committee on Health, Education, 
Labor, and Pensions 
AN ACT 
To accelerate the discovery, development, and delivery of 
21st century cures, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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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 
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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 
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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. 
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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. 
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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— 
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(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 
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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— 
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(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). 
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(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-
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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.— 
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(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 
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Act or listed or designated as a trop-
ical disease under section 524 of such 
Act; and 
(IV) antibiotics; 
(iii) includes objectives for each such 
strategic focus area; and 
(iv) ensures that basic research re-
mains a priority. 
(B) UPDATES AND REVIEWS.—The Direc-
tor of the National Institutes of Health shall re-
view and, as appropriate, update the research 
strategic plan under subparagraph (A) not less 
than every 18 months. 
(e) TRANSFER AUTHORITY.—The Committee on Ap-
propriations of the Senate and the Committee on Appro-
priations of the House of Representatives may provide for 
the transfer of funds in the NIH and Cures Innovation 
Fund for the purposes specified in subsection (c). 
(f) SUPPLEMENT, NOT SUPPLANT; LIMITATIONS.— 
Funds appropriated by subsection (b)— 
(1) shall be used to supplement, not supplant, 
amounts otherwise made available to the Depart-
ment of Health and Human Services; 
(2) are subject to the requirements and limita-
tions of the most recently enacted regular or full- 
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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 
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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: 
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‘‘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 
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‘‘(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 
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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-
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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 
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‘‘(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. 
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‘‘(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.— 
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‘‘(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 
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‘‘(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— 
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(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-
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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 
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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. 
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‘‘(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-
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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 
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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 
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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 
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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. 
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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). 
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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: 
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‘‘(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— 
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‘‘(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— 
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(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-
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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— 
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(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 
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