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. 3041. Antimicrobial resistance monitoring. 12/13/2017, and annually thereafter: requires FDA and CDC to issue reports addressing national trends in antimicrobial use and resistance to those drugs.

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 CDC, FDA, HHS, Infectious Disease, Reports
fa fa-2x fa-long-arrow-right Sec. 3042. Limited population pathway. Creates a new pathway for FDA to approve antibacterial and antifungal drugs based for limited populations, using a benefit-risk profile specific to that population.
6/13/2018: requires FDA to issue draft guidance describing this pathway and related processes.
At least every 2 years, FDA must report to Congress on the applications and approvals under this program.
12/31/2021: requires GAO issuance of a report on this program.

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 FDA, GAO, Infectious Disease, Regulatory Affairs, Reports
fa fa-2x fa-long-arrow-right Sec. 3044. Susceptibility test interpretive criteria for microorganisms; antimicrobial susceptibility testing devices. 12/13/2017: instructs FDA to establish and regularly maintain a website that lists appropriate interpretive criteria standards for antimicrobial drug susceptibility assays.
12/13/2018: requires FDA to submit a report to Congress on implementation of this provision.


FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 FDA, Infectious Disease, Regulatory Affairs, Reports
fa fa-2x fa-long-arrow-right Sec. 3092. Review of processes and consistency of Advisory Committee on Immunization Practices recommendations. 6/13/2018: requires CDC submission to Congress of a report on decision-making processes used by the Advisory Committee on Immunization Practices and opportunities for improvement.

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 CDC, Infectious Disease, Reports
fa fa-2x fa-long-arrow-right Sec. 3093. Encouraging vaccine innovation. 12/13/2017: requires HHS to submit a report to Congress on promoting innovation in infectious disease vaccine development.

The National Vaccine Advisory Committee 2017 meeting on June 6 and June 7 with include an update on the the Secretary of the Department of Health and Human Services' report on vaccine innovation required by this section and other themes related to encouraging vaccine innovation. Information on the final meeting agenda will be posted prior to the meeting on the NVAC website.

20170417 04/17/2017 BARDA, CDC, FDA, HHS, Infectious Disease, NIH, Reports, Vaccines

 

Send us your feedback and updates