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.

Send us your feedback and updates

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. 2022. Improvement of loan repayment program. Establishes a revised loan repayment program to support researchers in various high-need topic areas.
6/13/2018: requires the publication of GAO study on NIH efforts to attract, retain, and develop emerging scientists, including individuals from underrepresented groups.

8/10/2018: GAO published an analysis of NIH's effort to diversify the pool of biomedical investigators, focusing heavily on supporting early-career investigators and investigators from underrepresented groups and women.

20180810 08/10/2018 GAO, NIH, Reports, Workforce
fa fa-2x fa-long-arrow-right Sec. 2034. Reducing administrative burden for researchers. 12/13/2017: directs OMB to establish of the Research Policy Board.
12/13/2018: requires HHS review and revision of regulations and policies to reduce the administrative burden on researchers.
12/13/2018: requires HHS and USDA review and revision of regulations and policies for the care and use of laboratory animals to reduce administrative burden on researchers.
12/13/2018: requires submission of a Research Policy Board report to the White House and Congress containing formal recommendations on harmonization of policies to reduce administrative burden on researchers.
12/13/2020: requires publication of GAO report on the Research Policy Board's activities.

5/13/2020: The Animal and Plant Health Inspection Service amended the licensing requirements in the Animal Welfare Act to reduce regulatory burden, as mandated by the Cures Act.

8/28/2019: NIH announced the publication of a report by NIH, USDA and FDA entitled "Reducing Administrative Burden for Researchers: Animal Care and Use in Research."

3/14/2018: NIH posted a guide notice and an accompanying Federal Register Notice requesting input from the grantee community to reduce administrative burden regarding regulations related to the care and use of laboratory animals.  Dr. Lauer also posted a blog

4/26/2017: The Association of American Universities issued an open letter to OMB Director Mick Mulvaney urging the swift implementation and creation of the Research Policy Board.

2/28/2017: The Congressional Research Service issued a brief reiterating 21st Century Cures legislative mandate to OMB to create the Research Policy Board.

20200513 05/13/2020 FDA, GAO, HHS, NIH, Research
fa fa-2x fa-long-arrow-right Sec. 3071. Silvio O. Conte Senior Biomedical Research and Biomedical Product Assessment Service. 12/13/2020: requires GAO submission to Congress of a report on the effect of these amendments to HHS hiring authorities.

4/20/2020: HHS is issuing a final rule to amend regulations for the Senior Biomedical Research Service. This rule ensures consistency with amendments made to this section of the Cures Act to improve scientific expertise and outreach within the Service.

7/17/2017: FDA Commissioner Scott Gottlieb, M.D. announced a new hiring pilot, aimed at helping the agency fill hundreds of empty staff positions, including 500 just at its drug center.
5/25/2017: The hiring freeze of the administration was lifted from FDA.
3/10/2017: Read our memo, "Strengthening FDA’s Workforce: Opportunities for Action"
1/20/2017: Plans to reduce the size of the Federal workforce may adversely impact FDA.

20200420 04/20/2020 FDA, GAO, HHS, NIH, Reports, Workforce


Send us your feedback and updates