21st Century Cures

The 21st Century Cures Act (P.L. 114-255) is landmark, bipartisan legislation that was signed into law on Dec. 13, 2016, and touches virtually all aspects of biomedical research, medical product development and the regulatory approval process. Read what FasterCures has said about 21st Century Cures over the years.

FasterCures worked closely with Congress, federal agencies and the advocacy community throughout the legislation’s journey to the president’s desk. In February 2017, we debuted the 21st Century Cures Tracker to track the implementation of the 100+ sections in Division A, which include the key provisions relevant to biomedical research and innovation. (Other divisions of the law pertain to mental health and Medicare; since those are not areas of focus for FasterCures, we will not be actively tracking them here.) Learn more about how to use the tracker with our FAQs page.

A few examples of the issues we will be tracking include the impact of changes to the National Institutes of Health’s administrative requirements for grantees, how the Food and Drug Administration implements new changes designed to enhance patient engagement and how the Department of Health and Human Services is using its new authorities to promote health information technology interoperability.

Many external factors will affect the progress of these initiatives, including policies related to hiring freezes and uncertain funding levels. This tracker is not meant to be a pass/fail report card, but rather a snapshot in time that can help explain impact and identify where progress is needed.

Please keep coming back, as we will be updating the information regularly. Use the button below to send us feedback on the value of the information we are presenting, and the usability of this new resource.

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FasterCures' 21st Century Cures Act Tracker (P.L. 114-255)

Status Section Tracked Deadlines and Requirements Update Date of Update Tags
fa fa-2x fa-long-arrow-right Sec. 1001. Beau Biden Cancer Moonshot and NIH innovation projects. Annual appropriation of funds into the NIH Innovation Account (FY17-26), and subsequent allocation to specific initiatives: PMI (FY17-26), BRAIN (FY17-26), Cancer Moonshot (FY17-23), and regenerative medicine (FY17-20).
In addition, requires NIH to submit a work plan to Congress by June 12, 2017 for the NIH Innovation Projects and to solicit input from the public prior to submitting the work plan.
Further directs NIH to submit an annual report to Congress by October 1st of each fiscal year 2018 – 2027 outlining the amount of money obligated as well as a description of the projects and how they are advancing.

10/6/2017: NIH announced the FY 2017 funded awards through the NIH Regenerative Medicine Innovation Project

9/13/2017: Work plan submitted to Congress. Further information on 21st Century Cures page of the NIH Website. The work plan and strategic plan are also available. 

3/28/2017: The Advisory Committee to the Director of NIH held a conference call to discuss the draft work plans outlined in this section. The meeting was announced in a federal register notice. It provided an overview of implementation and provided an update on work plans for each of the following: Cancer Moonshot Initiative, Regenerative Medicine, Precision Medicine Initiative, BRAIN Initiative

20171006 10/06/2017 Funding, NIH, Regenerative Medicine


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