I 
114TH CONGRESS 
1ST SESSION 
H. R. 6 
To accelerate the discovery, development, and delivery of 21st century cures, 
and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 19, 2015 
Mr. UPTON (for himself, Ms. DEGETTE, Mr. PITTS, Mr. PALLONE, and Mr. 
GENE GREEN of Texas) introduced the following bill; which was referred 
to the Committee on Energy and Commerce, and in addition to the Com-
mittee on Ways and Means, for a period to be subsequently determined 
by the Speaker, in each case for consideration of such provisions as fall 
within the jurisdiction of the committee concerned 
A BILL 
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, 
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. 
TITLE I—DISCOVERY 
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Subtitle A—National Institutes of Health Funding 
Sec. 1001. National Institutes of Health reauthorization. 
Sec. 1002. NIH Innovation Fund. 
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. 
Subtitle C—Supporting Young Emerging Scientists 
Sec. 1041. Improvement of loan repayment programs of 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 National Institutes of Health Research and Data 
Access 
Sec. 1101. Sharing of data generated through NIH-funded research. 
Sec. 1102. 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 
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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 new antimicrobial 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. 
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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. 
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 
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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 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 ‘‘; and’’; 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.’’. 
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