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. 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-long-arrow-right Sec. 3081. Medical countermeasure guidelines. 3/1/2017 (and each year thereafter in which there is less that $1.5 billion available for procurement of medical countermeasures): requires HHS to deliver a report to Congress describing the impact this may have on national security needs.

No public information on this provision is available on the website of the HHS Assistant Secretary for Preparedness and Response. FasterCures is reaching out to HHS and Congressional stakeholders to determine if there is any information on this report to Congress that can be made available to the public

20170314 03/14/2017 Funding, HHS, Medical Countermeasures, Reports
fa fa-2x fa-binoculars Sec. 3082. Clarifying BARDA contracting authority. Clarifies that the contracting authority for procurement of medical countermeasures using the "special reserve fund" resides within BARDA. In effect upon enactment.

For more information on BARDA visit www.MedicalCountermeasures.gov. FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 BARDA, HHS, Medical Countermeasures
fa fa-2x fa-long-arrow-right Sec. 3083. Countermeasure budget plan. 3/14/2017, and every year thereafter: requires HHS to deliver to Congress of a coordinated 5-year budget plan for medical countermeasure development and procurement; and be made publicly available in a manner that does not compromise national security.

A new 5-year budget plan is not publicly available on the website of the HHS Assistant Secretary for Preparedness and Response (ASPR). ASPR’s FY17 “Budget in Brief” document is available, but is likely out of date. FasterCures is reaching out to HHS and Congressional stakeholders to determine if there is any information that can be made available to the public.

20170314 03/14/2017 HHS, Medical Countermeasures
fa fa-2x fa-long-arrow-right Sec. 3084. Medical countermeasures innovation. 12/13/2020: requires GAO publication of a review of medical countermeasure innovation program established by this provision. The program will sunset on 9/30/2022.

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 BARDA, GAO, HHS, Medical Countermeasures, Medical Product Development, Reports
fa fa-2x fa-long-arrow-right Sec. 3086. Encouraging treatments for agents that present a national security threat. Establishes a Priority Review Voucher program at FDA to incentivize the development of medical countermeasures; sunsets 10/1/2023.


10/2/2017: Fee rate announced for using a material threat medical countermeasures priority review voucher for fiscal year (FY) 2018. 

4/28/2017: For more information on FDA Priority Voucher Programs please review this RAPS article entitled "Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers." As noted in the articled, to date no product has been awarded a priority review voucher under the medical counter measures program. For more information on FDA's Medical Countermeasures work relating to 21st Century Cures.

FasterCures will periodically assess this item as appropriate. For more information on FDA's Medical Countermeasures work relating to 21st Century Cures.

20171002 10/02/2017 FDA, Medical Countermeasures, Regulatory Affairs
fa fa-2x fa-check Sec. 3088. Clarifying Food and Drug Administration emergency use authorization. Clarifies Food and Drug Administration emergency use authorization.

Complete. For more information on FDA's Medical Countermeasures work relating to 21st Century Cures.

20161213 12/13/2016 FDA, Medical Countermeasures, Regulatory Affairs

 

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