H.R. 6: The 21st Century Cures Act (CRS Report for Congress)
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| Release Date |
Revised Aug. 10, 2015 |
| Report Number |
R44071 |
| Report Type |
Report |
| Authors |
Judith A. Johnson, Susan Thaul, Erin Bagalman, Matthew B. Barry, Cliff Binder, Jim Hahn, Elayne J. Heisler, Suzanne M. Kirchhoff, Sarah A. Lister, Paulette C. Morgan, Robert Pirog, C. Stephen Redhead, Bernice Reyes-Akinbileje, Amanda K. Sarata, Jennifer |
| Source Agency |
Congressional Research Service |
| Older Revisions |
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Summary:
On July 10, 2015, the House passed H.R. 6, the 21st Century Cures Act, on a vote of 344 to 77. Eight amendments were offered; five were approved by voice vote, two failed by recorded vote, and one was withdrawn. The House Energy and Commerce Committee, on May 21, 2015, unanimously ordered to be reported H.R. 6 and the House Committee on Rules published a committee print of the bill on July 2, 2015. On July 7, 2015, H.R. 6 was reported by the Committee on Energy and Commerce (H.Rept. 114-190), and the House Committee on Ways and Means was discharged from further consideration of the bill.
The bill would reauthorize the National Institutes of Health (NIH) through FY2018 and provide other funding to the agency through FY2020. In addition, the bill would promote and encourage more strategic planning for research conducted by NIH; change loan support for young, emerging scientists; promote pediatric research; and encourage more collaborative research activities. The bill also focuses on changes to the Food and Drug Administration's (FDA's) regulatory procedures for drugs and devices by requiring the issuance of more guidance and increasing regulatory flexibility in areas such as precision (or personalized) medicine, types of data that could serve as evidence of safety and effectiveness, antibiotic drug development, orphan drugs, and medical devices. The bill proposes additional funding for the FDA to support some of its efforts in certain specified areas.
H.R. 6 consists of four separate titles. Title I focuses on discovery-related issues and is concentrated on matters related to the NIH, including developing strategic plans, cultivating young scientists, and promoting more collaboration among NIH researchers, grant recipients, and institutions. Title II targets the development of new and more innovative drugs and medical devices and the regulatory processes in place to consider these products. Title III includes provisions related to the delivery of health care, including interoperability of electronic health information technology and the treatment of disposable medical technologies. Title IV includes Medicare and Medicaid changes being proposed to offset the costs of the NIH- and FDA-related changes in Titles I, II, and III. These proposed offsets include changes in prior authorization procedures for power mobility devices under Medicare, as well as a proposed drawdown in the nation's strategic petroleum reserve.
This report provides a brief summary of each provision of H.R. 6 as passed by the House on July 10, 2015. Each summary includes a brief description of current law and an explanation of how the bill would change current law. A list of the abbreviations used throughout this report appears in Appendix B.
