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. 1001. Beau Biden Cancer Moonshot and NIH innovation projects. Annual appropriation of funds into the NIH Innovation Account (FY17-26), and subsequent allocation to specific initiatives: PMI (FY17-26), BRAIN (FY17-26), Cancer Moonshot (FY17-23), and regenerative medicine (FY17-20).
In addition, requires NIH to submit a work plan to Congress by June 12, 2017 for the NIH Innovation Projects and to solicit input from the public prior to submitting the work plan.
Further directs NIH to submit an annual report to Congress by October 1st of each fiscal year 2018 – 2027 outlining the amount of money obligated as well as a description of the projects and how they are advancing.

10/6/2017: NIH announced the FY 2017 funded awards through the NIH Regenerative Medicine Innovation Project

9/13/2017: Work plan submitted to Congress. Further information on 21st Century Cures page of the NIH Website. The work plan and strategic plan are also available. 

3/28/2017: the Advisory Committee to the Director of NIH held a conference call to discuss the draft work plans outlined in this section. The meeting was announced in a federal register notice. It provided an overview of implementation and provided an update on work plans for each of the following: Cancer Moonshot Initiative, Regenerative Medicine, Precision Medicine Initiative, BRAIN Initiative

20171006 10/06/2017 Funding, NIH, Regenerative Medicine
fa fa-2x fa-long-arrow-right Sec. 1002. FDA innovation projects. Annual appropriation of funds into the FDA Innovation Account (FY17-25)
6/11/2017 - Requires submission of a work plan for the FDA Innovation Fund

7/7/2017: FDA Commissioner Scott Gottlieb, M.D. announced that the agency had submitted its final work plan to Congress.
5/9/2017: The FDA Science Board held a meeting to review the proposal.
5/5/2017: The FDA released its plan outlining proposed uses of innovation funds.

20170707 07/07/2017 FDA, Funding, Regulatory Affairs
fa fa-2x fa-long-arrow-right Sec. 1003. Account for the state response to the opioid abuse crisis. Annual appropriations into the “Account for the State Response to the Opioid Abuse Crisis” (FY17-18)

6/9/2017: Nora D. Volkow, M.D. Director of the National Institute on Drug Abuse presented on NIH’s Efforts to Reduce the Opioid Epidemic at the June 8-9 meeting of the The Advisory Committee to the Director of NIH [Day 1: Agenda, Webcast, Day 2: Agenda, Webcast].

20170609 06/09/2017 Funding
fa fa-2x fa-check Sec. 1004. Budgetary treatment. Provision in effect upon enactment. Further tracking not required.

Complete.

20161213 12/13/2016 FDA, Funding, NIH
fa fa-2x fa-long-arrow-right Sec. 2061. National neurological conditions surveillance system. Directs CDC to establish integrated surveillance system to be called the "National Neurological Conditions Surveillance System".
Authorizes appropriation of funds to support the system: $5M per year (FY18-22).
12/13/2017: requires CDC submission of a report to Congress "regarding aggregate information collected" by the system. This report will be made public and will be updated biennially.
12/13/2020: requires HHS submission of a report to congress describing implementation of this system.

7/17/2017: Appropriations for FY18 are still pending. The National MS Society has issued a brief in support of the $5M appropriations to CDC for the establishment of the surveillance system as directed in this section.

20170717 07/17/2017 CDC, Funding, Reports
fa fa-2x fa-long-arrow-right Sec. 2001. National Institutes of Health Reauthorization. Reauthorizes NIH funding for 2018, 2019, and 2020.

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 Funding, NIH
fa fa-2x fa-long-arrow-right Sec. 2036. High-risk, high-reward research. Provides NIH "other transactions authority" to carry out high risk, high reward research.
9/30/2020: requires NIH publication of report to Congress on activities outlined in this section.

FasterCures will periodically assess this item as appropriate, specifically noting NIH use of "other transactions authority" to carry out high risk, high reward research.

20161213 12/13/2016 Funding, NIH, Research
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. 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.

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 Funding, HHS, Rare Disease
fa fa-2x fa-check Sec. 3016. Grants for studying continuous drug manufacturing. Allows the FDA to issue grants to further the study of continuous manufacturing for drugs.

Complete.

20161213 12/13/2016 FDA, Funding, Medical Product Development

 

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