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.

10/1/2018: The Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC) submitted final recommendations for research on therapies used by pregnant and lactating women.

2/27/2018: February 26 & 27, 2018 PRCG hosted meeting with full meeting materials provided. 

11/7/2017: November 6 & 7, 2017 PRGLAC hosted the second meeting and supplied full meeting materials for public consumption. 

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

8/22/2017: On August 21 & 22, 2017, Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC) hosted it's first meeting and supplied full meeting materials for public consumption. 

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.

20181001 10/01/2018 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. 3004. Report on patient experience drug development. 6/1/2021, 6/1/2026, and 6/1/2031: Requires FDA to periodically issue a report on FDA's use of patient experience data in regulatory decision-making, in particular with respect to the review of patient experience data and information on patient-focused drug development tools as part of approved applications.

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 FDA, Patient Engagement, Regulatory Affairs, Reports
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.

10/30/2018: The FDA is seeking feedback on the surrogate endpoint table (SE table) to help determine its utility and to assist in developing future versions of the table. Comments must be submitted written or electronically by December 31, 2018.

7/25/2018: The FDA has fulfilled a requirement of Section 3011 with the publishing of the Surrogate Endpoint Table. This table is a list of "surrogate endpoints which were the basis of approval or licensure (as applicable) of a drug or a biological product" under both accelerated and traditional pathways. The endpoints can be used instead of clinical outcomes in some clinical trials, which has helped expedite drug development.

20181031 10/31/2018 FDA, Guidances, Medical Product Development, Regulatory Affairs, Reports
fa fa-2x fa-long-arrow-right Sec. 3042. Limited population pathway. Creates a new pathway for FDA to approve antibacterial and antifungal drugs based for limited populations, using a benefit-risk profile specific to that population.
6/13/2018: requires FDA to issue draft guidance describing this pathway and related processes.
At least every 2 years, FDA must report to Congress on the applications and approvals under this program.
12/31/2021: requires GAO issuance of a report on this program.

6/13/2018: FDA announced the availability for comment of draft guidance "Limited Population Pathway for Antibacterial and Antifungal Drugs"

20180613 06/13/2018 FDA, GAO, Infectious Disease, Regulatory Affairs, Reports
fa fa-2x fa-long-arrow-right Sec. 3044. Susceptibility test interpretive criteria for microorganisms; antimicrobial susceptibility testing devices. 12/13/2017: instructs FDA to establish and regularly maintain a website that lists appropriate interpretive criteria standards for antimicrobial drug susceptibility assays.
12/13/2018: requires FDA to submit a report to Congress on implementation of this provision.

12/13/2017: FDA announced the establishment of web resource, "FDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria" 

20171213 12/13/2017 FDA, Infectious Disease, Regulatory Affairs, Reports
fa fa-2x fa-long-arrow-right Sec. 3060. Clarifying medical software regulation. 12/13/2018 (and every two years thereafter): requires HHS issuance of a report on the current state of health-related software and the regulation of those products.

12/8/2017: FDA announced the release of draft guidance entitled "Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act"; Submit either electronic or written comments on the draft guidance by February 6, 2018.

12/30/2016: FDA communicated its interpretation of this policy through final guidance titled "Medical Device Accessories--Describing Accessories and Classification Pathway for New Accessory Types"

20171208 12/08/2017 FDA, Health IT, Regulatory Affairs, Reports


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