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. 2002. EUREKA prize competitions. Requires NIH director support for prize competitions to advance biomedical science and improve health outcomes for diseases that are serious and represent a significant burden in the US.
The information reporting on prize program is included in triennial report.

9/11/2018: National Institute for Aging announced its Alzheimer's prize challenge in an effort to improve care navigation as well as dementia care coordination.

11/2/2017: National Institute for Aging provided RFI (NOT-AG-17-018) inviting comments and suggestions on the development of a Eureka prize for Alzheimer's disease research. The response date is December 31, 2017. 

20180911 09/11/2018 NIH, Rare Disease, Reports, Research
fa fa-2x fa-check Sec. 3012. Targeted drugs for rare diseases. Permits FDA to allow the sponsor of a drug or biologic application for a genetically targeted drug or variant protein targeted drug to rely on data for the same or similar technology from previously approved applications developed by the same sponsor.


20161213 12/13/2016 FDA, Rare Disease, Regulatory Affairs
fa fa-2x fa-binoculars Sec. 3013. Reauthorization of program to encourage treatments for rare pediatric diseases. Reauthorizes the pediatric rare disease priority review voucher program until 2020.

7/30/2019: FDA announced the availability of a draft guidance entitled "Rare Pediatric Disease Priority Review Vouchers," providing information on the rare pediatric disease priority review voucher program. Comments on the draft guidance may be submitted electronically by September 30, 2019.

12/7/2017: FDA announced the availability of draft guidance entitled "Pediatric Rare Diseases-A Collaborative Approach for Drug Development Using Gaucher Disease as a Model"

20190730 07/30/2019 FDA, Medical Product Development, Rare Disease, Regulatory Affairs
fa fa-2x fa-long-arrow-right Sec. 3014. GAO study of priority review voucher programs. 12/31/2020: requires GAO to issue report evaluating the three Priority Review Voucher (PRV) programs: Neglected Tropical Disease, Rare Pediatric Disease, and Medical Countermeasure.

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 FDA, GAO, Medical Countermeasures, Medical Product Development, Rare Disease, Regulatory Affairs
fa fa-2x fa-check Sec. 3015. Amendments to the Orphan Drug grants. Updates the Orphan Drug grant program to clarify that grants may be used for observational studies and other analyses to assist in the understanding of the natural history of a rare disease or condition.

10/8/2019: FDA announced that it has awarded 12 grants through the Orphan Products Clinical Trials Grants Program over the next four years.

Section 5 of the Orphan Drug Act was amended upon enactment of the 21st Century Cures Act.

20191008 10/08/2019 Funding, HHS, Rare Disease


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