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. 2034. Reducing administrative burden for researchers. 12/13/2017: directs OMB to establish of the Research Policy Board.
12/13/2018: requires HHS review and revision of regulations and policies to reduce the administrative burden on researchers.
12/13/2018: requires HHS and USDA review and revision of regulations and policies for the care and use of laboratory animals to reduce administrative burden on researchers.
12/13/2018: requires submission of a Research Policy Board report to the White House and Congress containing formal recommendations on harmonization of policies to reduce administrative burden on researchers.
12/13/2020: requires publication of GAO report on the Research Policy Board's activities.

3/14/2018: NIH posted a guide notice and an accompanying Federal Register Notice requesting input from the grantee community to reduce administrative burden regarding regulations related to the care and use of laboratory animals.  Dr. Lauer also posted a blog

4/26/2017: The Association of American Universities issued an open letter to OMB Director Mick Mulvaney urging the swift implementation and creation of the Research Policy Board.

2/28/2017: The Congressional Research Service issued a brief reiterating 21st Century Cures legislative mandate to OMB to create the Research Policy Board.

20180314 03/14/2018 FDA, GAO, HHS, NIH, Research
fa fa-2x fa-long-arrow-right Sec. 2062. Tick-borne diseases. Requires HHS to establish the "Tick-Borne Disease Working Group." (And subsequent sun-setting of the working group 6 years after enactment of the act.)

12/13/2018 (and every 2 years thereafter): delivery of a summary of tick-born disease research, treatment, and epidemiological studies.

11/16/2018: HHS announced that it is seeking nominations for non-federal individuals who represent diverse scientific disciplines and views who are interested in being considered for appointment to the Working Group. Nominations must be sent to tickbornedisease@hhs.gov on December 14, 2018, by 5:00 p.m. EST.

11/6/2018: The Working Group announced a meeting on December 3, 2018, from 1:00 p.m. to 4:00 p.m. Eastern Time that will focus on the release of the 2018 Report to Congress, recognize the contributors to the Report, and address next steps and the transition to a new Working Group for the 2020 Report to Congress.

6/5/2018: The Working Group announced a meeting on June 21, 2018, from 9:30 a.m. to 6:00 p.m. that will focus on subcommittee findings and will review and provide input on the content of the five chapters that will be submitted into the Working Group Congressional Report.

4/9/2018: The Working Group announced a meeting on May 10, 2018, from 8:30 a.m. to 6:30 p.m. that will focus on the findings and basis for the draft reports from the work of the six Subcommittee Working Groups that were established on December 12, 2017. 

2/12/2018: The Working Group held a public meeting on February 12, 2018

12/13/2017: The Working Group held a public meeting on December 11 & 12, 2017

7/17/2017: HHS announced the establishment of the Tick-Borne Disease Working Group and launched the group's website.

20181116 11/16/2018 CDC, FDA, HHS, NIH, Reports, Research
fa fa-2x fa-long-arrow-right Sec. 2063. Accessing, sharing, and using health data for research purposes. 12/13/2017: requires HHS issuance of guidance clarifying that remote access of health data by researchers (under appropriate circumstances) is not forbidden by regulation.
12/13/2017: requires HHS issuance of guidance clarifying requirements for the authorized disclosure of protected health information for research.
12/13/2017: requires HHS establishment of a "Working Group on Protected Health Information for Research" to study and, within 1 year of establishment, report on whether the uses and disclosures of protected health information for research purposes should be modified.
12/13/2017: requires submission of a report to the HHS Secretary

12/13/2017: HHS issued a guidance entitled "21st Century Cures Act Guidance: Remote Access to PHI for activities Preparatory to Research." The issuance of this guidance signifies the completion of two of the requirements of this section.

20180105 01/05/2018 CDC, Data Sharing, FDA, Guidances, HHS, NIH, Regulatory Affairs, Reports, Research
fa fa-2x fa-long-arrow-right Sec. 3023. Protection of human research subjects. 12/13/2018: requires HHS to submit a report to Congress describing progress being made to harmonize differences between the human subject regulations under the Common Rule and the Federal Food Drug and Cosmetic Act.

12/13/2019: requires harmonization of these rules is to be completed.

10/15/2018: FDA released a guidance document entitled "Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations," whose purpose is to clarify the impact and progress of certain provisions of the 2018 Common Rule requirements on FDA-regulated clinical investigations.

2/21/2018: FDA announced it is amending its regulations on acceptance of data from clinical investigations for medical devices. FDA recognized its 21st Century Cures obligation to harmonize the differences between the HHS human subject regulations and FDA's human subject regulations. FDA will be working with others at HHS in carrying out this statutory directive, including with respect to de-identified human specimens.

9/25/2017: FDA issued guidance entitled, "Minutes of Institutional Review Board (IRB) Meetings - Guidance for Institutions and IRBs" consistent with the goal of rule harmonization set forth in this section of 21st Century Cures. Further context for this guidance was laid out in the Federal Register Notice

20181020 10/20/2018 Clinical Trials, FDA, Health Citizenship, HHS, NIH, Research

 

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