Sec. 1. Short title; table of contents
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This Act may be cited as the . 21st Century Cures Act The table of contents for this Act is as follows: Sec. 1. Short title; table of contents. Title I—Discovery 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 Paperwork 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 eligibility 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 structured 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 developments. 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 Immunization 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 indication for a rare disease or condition. Sec. 2152. Reauthorization of rare pediatric disease priority review voucher incentive 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 concept. 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 investigational 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 Paperwork 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 transfers 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.