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. 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.

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.

20170717 07/17/2017 FDA, GAO, HHS, NIH, Reports, Workforce
fa fa-2x fa-long-arrow-right Sec. 3072. Hiring authority for scientific, technical, and professional personnel. 6/13/2018: requires FDA submission to Congress of a report on workforce needs and planning.
1/1/2022: requires GAO issuance of a report on FDA progress to recruit and retain staff.

7/13/2018: FDA provided a "21st Century Cures" report on their progress in recruiting and retaining staff.  The agency's current workforce needs were outlined, as were their efforts in recruiting and retaining staff.

11/15/2017: FDA provided an "Initial Assessment of FDA Hiring and Retention – A Path Forward"

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.

20180713 07/13/2018 FDA, GAO, Reports, Workforce
fa fa-2x fa-binoculars Sec. 3074. Scientific engagement. 12/29/2017: Improves NIH and FDA scientist's ability to attend scientific conferences to promote professional development. Not later than 90 days after the end of the fiscal year, each operating division of HHS is required to prepare, and post online, an annual report on scientific meeting attendance and related travel spending for each fiscal year.

12/28/2017: FDA released 2017 Annual Reports on Conferences; including FDA Scientific Conferences with Expenses Over $30,000 and FDA-Held Conferences with Expenses Over $100,000

20171228 12/28/2017 HHS, Workforce

 

Send us your feedback and updates