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. 2041. Task force on research specific to pregnant women and lactating women. 3/13/2017 (90 days): requires establishment of a "Task Force on Research Specific to Pregnant Women and Lactating Women;" 18 months after establishment of task force (by 6/13/18 ) -- requires Task Force submission of a report to Congress.

12/13/2018: requires HHS to update regulations and guidance, as appropriate, regarding the inclusion of pregnant women and lactating women in clinical research.

10/2/2017: An updated notice was published for the meeting of the Task Force on November 6-7, 2017

4/18/2017: the Federal Register published a meeting notice for the Task Force which will be August 21 & 22, 2017 and a second meeting will be November 6-7, 2017 

3/21/2017: the NIH formally announced the establishment of the task force within the Eunice Kennedy Shriver National Institute of Child Health and Human Development. NICHD has reported to us that it is now in the process of compiling the slate of nominees to serve on the taskforce for the Secretary’s consideration.

1/18/2017: The Secretary of HHS delegated authority to the NIH to establish this task force.

20171002 10/02/2017 CDC, FDA, Guidances, NIH, Regulatory Affairs, 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

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 CDC, Data Sharing, FDA, Guidances, HHS, NIH, Regulatory Affairs, Reports, Research
fa fa-2x fa-long-arrow-right Sec. 3002. Patient-focused drug development guidance. 6/11/2017 (180 days): instructs FDA to develop a plan to issue draft and final versions of guidance documents regarding the collection of patient experience data, and the use of such data in drug development.
6/13/2018: requires FDA to issue a draft version of at least one such guidance identified in plan and within 18 months from close of public comment period, issue a final/ revised guidance.
12/13/2021: requires FDA to issued patient experience guidance documents

9/8/2017: CDER announced a public workshop entitled “CDER Rare Diseases Public Workshop: Strategies, Tools, and Best Practices for Effective Advocacy in Rare Diseases Drug Development.” This public workshop builds upon previous CDER patient advocacy public workshops and is primarily for the rare disease community to help them effectively understand what FDA needs to enhance drug development. 

6/9/2017: FDA released the “Plan for Issuance of Patient‐Focused Drug Development Guidance” in accordance with this provision.

20170908 09/08/2017 FDA, Guidances, Patient Engagement, Regulatory Affairs
fa fa-2x fa-long-arrow-right Sec. 3011. Qualification of drug development tools. 12/13/2018: instructs FDA to convene a public meeting to solicit input on a new qualification process for biomarkers and other drug development tools.
12/13/2018: requires FDA to publish taxonomy on drug development tools for public comment. 1 year after close of comment period taxonomy must be finanlized.
12/13/2019: directs FDA to issue draft guidance on this qualification process.
12/13/2021: directs FDA to release a report which describes the use of, and success of, this new qualification process.

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 FDA, Guidances, Medical Product Development, Regulatory Affairs, Reports
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.

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 Clinical Trials, FDA, Guidances, Medical Product Development, Regulatory Affairs
fa fa-2x fa-long-arrow-right Sec. 3022. Real world evidence. 12/13/2018: requires FDA to develop and begin to implement, a framework to evaluate the use of real world evidence to help support the approval a new indication for a for a previously approved drug, or to support post-approval study requirements.

12/13/2021: requires FDA to issue draft guidance based on implementation and use of RWE framework which describes circumstances where RWE may be relied upon and appropriate standards and methodologies for collection and analysis of RWE; by 18 months after the above comment period closes finalization of guidance.

7/31/2017: FDA announced  a public workshop, "A Framework for Regulatory Use of Real-World Evidence” convened by the the Duke-Robert J. Margolis, MD, Center for Health Policy at Duke University and supported by a cooperative agreement with FDA. The purpose of the public workshop is to bring the stakeholder community together to discuss a variety of topics related to the use of real-world data (RWD) and real-world evidence (RWE) in drug development and regulatory decision making.

20161213 12/13/2016 FDA, Guidances, Medical Product Development, Regulatory Affairs
fa fa-2x fa-long-arrow-right Sec. 3036. Standards for regenerative medicine and regenerative advanced therapies. 12/13/2017: instructs HHS to review regulations and guidance relevant to regenerative advanced therapies; and, through a public process, update such regulations and guidance as the Secretary determines appropriate.

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 FDA, Guidances, Regenerative Medicine, Regulatory Affairs
fa fa-2x fa-long-arrow-right Sec. 3038. Combination product innovation. Contains a number of elements designed to improve the regulation and review of combination products, including issuing guidance by 12/13/2020 that describes the process for managing pre-submission interactions, best practices for ensuring that feedback represents FDA's best advice, and information on meetings between the sponsor and FDA.

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 FDA, Guidances, Regulatory Affairs
fa fa-2x fa-long-arrow-right Sec. 3052. Humanitarian device exemption. 6/13/2018: requires FDA to issue a guidance document define "probable benefit" in the context of the humanitarian device exemption.

6/7/2017: FDA rule notice in the Federal Register: section 3052 of the 21st Century Cures Act amended section 520(m) of the FD&C Act to allow for HDE approval for devices that, among other things, treat or diagnose a disease or condition that affects “not more than 8,000” individuals in the United States; this threshold had been “fewer than 4,000” individuals in the United States (amending 21 U.S.C. 360j(m), passim). This final rule amends part 814 (21 CFR part 814) in several places to accurately reflect the threshold recently enacted into law.

20170607 06/07/2017 FDA, Guidances, Medical Devices, Regulatory Affairs
fa fa-2x fa-long-arrow-right Sec. 3053. Recognition of standards. Instructs FDA to review and update its guidance on submission and evaluation of independent standards for medical device review.

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 FDA, Guidances, Medical Devices, Regulatory Affairs
fa fa-2x fa-long-arrow-right Sec. 3057. CLIA waiver improvements. 12/13/2017: instructs CMS to issue draft guidance on CLIA waiver improvements, and issuance of final guidance within one year after comment period closes.

Additional information on the Clinical Laboratory Improvement Amendments (CLIA) can be found on the CMS website.

20161213 12/13/2016 CMS, FDA, Guidances, Medical Devices, Regulatory Affairs
fa fa-2x fa-long-arrow-right Sec. 4006. Empowering patients and improving patient access to their electronic health information. Requires HHS issuance of guidance to health information exchanges on best practices to ensure that patient data is private, secure, accurate, and able to be shared when appropriate.

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 Guidances, Health IT, HHS, Interoperability, ONC

 

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