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-check Sec. 2051. Technical updates to clinical trials database. Provides technical updates to clinical trials database. In effect upon enactment.


20161213 12/13/2016 Clinical Trials, Research
fa fa-2x fa-long-arrow-right Sec. 2052. Compliance activities reports. 12/13/2018: requires issuance of a Report On Activities To Encourage Compliance describing education and outreach, guidance, enforcement, and other activities undertaken to encourage compliance with section 402(j) of the Public Health Service Act (42 U.S.C. 282(j)).
Not later than 2 years after the final compliance date under the final rule implementing section 402(j) of the Public Health Service Act, and every 2 years thereafter for the next 4 years, issuance of a Report on Clinical Trials

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 Clinical Trials, FDA, NIH, Reports, Research
fa fa-2x fa-check Sec. 2053. Updates to policies to improve data. Updates policies to ensure reporting of data from valid analyses for certain clinical trials. Revised policies go into effect for all grant awards received 1 year after enactment.

11/28/2017: a Guide Notice (NOT-OD-18-014) was released notifying the research community that recipients conducting applicable NIH-defined Phase III clinical trials ensure results of valid analysis are submitted to Clinicaltrials.gov.

20171128 11/28/2017 Clinical Trials, Data Sharing, NIH, Research
fa fa-2x fa-long-arrow-right Sec. 2054. Consultation. 3/13/2017 (90 days): requires HHS to consult with relevant Federal agencies, including the Food and Drug Administration, the Office of the National Coordinator for Health Information Technology, and the National Institutes of Health, as well as other stakeholders (including patients, researchers, physicians, industry representatives, and developers of health information technology) to receive recommendations with respect to enhancements to the clinical trial registry data bank under section 402(j) of the Public Health Service Act (42 U.S.C. 282(j)), including with respect to usability, functionality, and search capability.

6/1/2017: NLM rolled out the first in a series of changes to ClinicalTrials.gov
3/16/2017: in a letter responding to several organizations who expressed interest in ensuring the requirements of this provision be fulfilled, the Director of the NIH highlighted a new partnership between NIH and technical experts at 18F to make enhancements to ClinicalTrials.gov.
2/28/2017: the Secretary of HHS delegated the authority to fulfill the requirements of this Section to the NIH.
2/1/2017: a new beta version of ClinicalTrials.gov was released and is available here."

20170601 06/01/2017 Clinical Trials, Data Sharing, FDA, NIH, ONC, Research
fa fa-2x fa-long-arrow-right Sec. 3021. Novel clinical trial designs. 6/13/2018: directs FDA to host a public meeting to discuss the incorporation of complex adaptive and other novel trial designs into clinical protocols and new drug applications.

12/13/2019: requires FDA to issue draft guidance addressing the use of complex adaptive and other novel trial design in the development of new drugs or biologicals; within 1 year after the public comment period closes, FDA finalization of such guidance.

9/30/2018: FDA initiated a pilot program to help drug developers use complex innovative trial designs, an element of the most recent PDUFA agreement.

8/29/2018: FDA launched a pilot program, the "Complex Innovative Designs Pilot Meeting Program," which provides drug and biologic companies the opportunities to discuss the use of novel complex innovative trial designs (CID) with agency staff for their clinical development programs.

3/20/2018: FDA held a public meeting entitled, "Promoting the Use of Complex Innovative Designs in Clinical Trials" with meeting materials and information now available on the FDA website. 

20180930 09/30/2018 Clinical Trials, FDA, Guidances, Medical Product Development, Regulatory Affairs
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
fa fa-2x fa-binoculars Sec. 3024. Informed consent waiver or alteration for clinical investigations. Gives FDA the flexibility to waive or alter informed consent requirements for clinical trials with minimal risk.

12/20/2018: FDA is extending the comment period for the amendment proposed on November 15, 2018. Comments must be submitted by February 13, 2019.

11/15/2018: FDA is proposing an amendment to allow for an exception from the requirement to obtain informed consent for clinical investigations that pose no more than minimal risk to human subjects. Public comments on this proposed rule are requested and must be submitted by January 14, 2019.

7/24/2017: FDA announced its intent to revise its informed consent regulations to add a waiver or alteration for minimal risk clinical investigations, under appropriate human subject protection safeguards, to the two existing exceptions from informed consent. FDA also issued guidance, informing sponsors, investigators, and IRBs on FDA's approach to such investigations in the interim until the final regulations are issued.

20181220 12/20/2018 Clinical Trials, FDA, Research


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