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. 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. 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.

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 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 the Tick-Borne Disease Working Group and launched the group's website.

20180605 06/05/2018 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

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. 3041. Antimicrobial resistance monitoring. 12/13/2017, and annually thereafter: requires FDA and CDC to issue reports addressing national trends in antimicrobial use and resistance to those drugs.

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 CDC, FDA, HHS, Infectious Disease, Reports
fa fa-2x fa-check Sec. 3091. Predictable review timelines of vaccines by the Advisory Committee on Immunization Practices. Provides predictable review timelines of vaccines by the Advisory Committee on Immunization Practices.

For more information on the Advisory Committee on Immunization Practices. 

20161213 12/13/2016 CDC, Infectious Disease, Vaccines
fa fa-2x fa-binoculars Sec. 3092. Review of processes and consistency of Advisory Committee on Immunization Practices recommendations. 6/13/2018: requires CDC submission to Congress of a report on decision-making processes used by the Advisory Committee on Immunization Practices and opportunities for improvement.

2/22/2018: ACIP adopted an Evidence to Recommendation framework to support ACIP decision making.

20180222 02/22/2018 CDC, Infectious Disease, Reports
fa fa-2x fa-check Sec. 3093. Encouraging vaccine innovation. 12/13/2017: requires HHS to submit a report to Congress on promoting innovation in infectious disease vaccine development.

4/4/2018: HHS is seeking comment on a proposed amendment to the National Vaccine Injury Compensation Program (VICP) Vaccine Injury Table to include vaccines recommended by the Centers for Disease Control and Prevention (CDC) for routine administration in pregnant women.

2/8/2018: The National Vaccine Advisory Committee held a public meeting on February 7 & 8, 2018. Sessions consisted of presentations on vaccine innovation, including the current status of adjuvants in vaccines, universal influenza, and an overview on the Secretary of the Department of Health and Human Services' Report to Congress on Vaccine Innovation in response to the 21st Century Cures Act. Recording available here

6/8/2017: The National Vaccine Advisory Committee 2017 meeting on June 6 and June 7 with include an update on the the Secretary of the Department of Health and Human Services' report on vaccine innovation required by this section and other themes related to encouraging vaccine innovation. Information on the final meeting agenda will be posted prior to the meeting on the NVAC website.

20180404 04/04/2018 BARDA, CDC, FDA, HHS, Infectious Disease, NIH, Reports, Vaccines

 

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