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. 2038. Collaboration and coordination to enhance research. 6/11/2017 (180 days): directs NIH to convene workshop of experts on pediatric and older populations to get input on appropriate age groups in research; 180 days after workshop (12/13/17) - NIH update to policies as appropriate.
12/13/2017: requires NIH to update guidelines to reflect the science regarding sex differences, and improve adherence to laws requiring inclusion of women and minorities.
12/13/2018: requires development and dissemination of appropriate measures related to reporting health information about sexual and gender minority populations.
Requires release of triennial report (as described above in section 2032) for inclusion of information regarding number of women and minorities included as research subjects.

3/15/2019: NIH put out a request for comments pertaining to the "Methods and Measurement in Sexual & Gender Minority Health Research: Identifying Research Opportunities" developed by The Sexual & Gender Minority Research Office (SGMRO), to inform further revisions and content enhancement. Comments must be sent to sgmhealthresearch@od.nih.gov by April 15, 2019.

1/25/2019: The NICHD released the "2016-2018 Triennial Advisory Council Report Certifying Compliance With the NIH Policy on Inclusion Guidelines, fulfilling a requirement of this section.

1/24/2018:  “Open Mike” newsletter to the extramural community includes an article by Deputy Director for Extramural Research Dr. Mike Lauer about the age inclusion policy. 

1/9/2018: NIH posted the Age Inclusion work shop report

12/19/2017: NIH released a notice (NOT-OD-18-116) revising NIH Policy and Guidelines on the Inclusion of Children.  

12/1/2017: NIH released a notice (NOT-18-008) announcing the agency’s intent to revise the NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects.  

11/28/2017: a Guide Notice (NOT-OD-18-014) was released amending the current Inclusion of Women and Minorities policy

6/3/2017: On June 1st and 2nd NIH convened the “Inclusion Across the Lifespan” workshop in response to this provision. Details and summary available here.


20190315 03/15/2019 Diversity, NIH, Reports, Research


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