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. 2002. EUREKA prize competitions. Requires NIH director support for prize competitions to advance biomedical science and improve health outcomes for diseases that are serious and represent a significant burden in the US.
The information reporting on prize program is included in triennial report.

11/2/2017: National Institute for Aging provided RFI (NOT-AG-17-018) inviting comments and suggestions on the development of a Eureka prize for Alzheimer's disease research. The response date is December 31, 2017. 

20171102 11/02/2017 NIH, Rare Disease, Reports, Research
fa fa-2x fa-long-arrow-right Sec. 2014. Data sharing. Requires NIH grant recipients to share the data generated from NIH funded research.

NIH is addressing Data Sharing as instructed in this section through: RFIs: NOT-OD-16-133 and NOT-OD-17-015,  NIH Sharing Policies and Related Guidance on NIH-Funded Research Resources, and NIH Plan for Increasing Access to Scientific Publications and Digital Scientific Data from NIH Funded Scientific Research.

20170509 05/09/2017 Data Sharing, NIH, Research
fa fa-2x fa-long-arrow-right Sec. 2031. National Institutes of Health strategic plan. 12/13/2018: requires development and publication of the NIH Strategic Plan.

The current NIH-Wide Strategic Plan published in 2015 is available.  Revisions and updates by this section at least every six years will be provided once available.

20161213 12/13/2016 NIH, Reports, Research
fa fa-2x fa-long-arrow-right Sec. 2032. Triennial reports. Requires the development and publication by NIH of triennial reports to Congress on NIH activities.

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 NIH, Reports, Research
fa fa-2x fa-long-arrow-right Sec. 2033. Increasing accountability at the National Institutes of Health. Provides for appointment of NIH Institute and Center Directors and implementation of term limits and reappointments.
12/13/2018: requires submission of report to Congress on efforts to prevent and eliminate duplicative biomedical research.

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.

20170426 04/26/2017 NIH, Reports, Research
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.

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 FDA, GAO, HHS, NIH, Research
fa fa-2x fa-binoculars Sec. 2035. Exemption for the National Institutes of Health from the Paperwork Reduction Act requirements. Exempts voluntary information collected during NIH research from current Paperwork Reduction Act requirements. Provision in effect upon enactment.

FasterCures will periodically assess the status of implementation and impact on research activities.

20161213 12/13/2016 NIH, Research
fa fa-2x fa-long-arrow-right Sec. 2036. High-risk, high-reward research. Provides NIH "other transactions authority" to carry out high risk, high reward research.
9/30/2020: requires NIH publication of report to Congress on activities outlined in this section.

FasterCures will periodically assess this item as appropriate, specifically noting NIH use of "other transactions authority" to carry out high risk, high reward research.

20161213 12/13/2016 Funding, NIH, Research
fa fa-2x fa-binoculars Sec. 2037. National Center for Advancing Translational Sciences. Expands NCATS authority to fund clinical research and directs NCATS to include a complete list of all methods and tools it develops in its next biennial report.

FasterCures will periodically assess the status of implementation and impact on research activities.

20161213 12/13/2016 NIH, Reports, Research
fa fa-2x fa-long-arrow-right Sec. 2038. Collaboration and coordination to enhance research. 6/11/2017 (180 days): directs NIH to convene workshop of experts on pediatric and older populations to get input on appropriate age groups in research; 180 days after workshop (12/13/17) - NIH update to policies as appropriate.
12/13/2017: requires NIH to update guidelines to reflect the science regarding sex differences, and improve adherence to laws requiring inclusion of women and minorities.
12/13/2018: requires development and dissemination of appropriate measures related to reporting health information about sexual and gender minority populations.
Requires release of triennial report (as described above in section 2032) for inclusion of information regarding number of women and minorities included as research subjects.

12/1/2017: NIH released a notice (NOT-18-008) announcing the agency’s intent to revise the NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects.  

6/3/2017: On June 1st and 2nd NIH convened the “Inclusion Across the Lifespan” workshop in response to this provision. Details and summary available here.

 

20171201 12/01/2017 Diversity, NIH, Reports, Research
fa fa-2x fa-long-arrow-right Sec. 2039. Enhancing the rigor and reproducibility of scientific research. 12/13/2017: requires convening of a working group to develop and issue recommendations to enhance rigor and reproducibility of NIH research.
6/13/2018: directs NIH Director to consider recommendations and develop or update policies as appropriate.
12/13/2018: directs NIH to issue a report to Congress regarding recommendations developed and any subsequent policy changes.

The NIH has added a website resource, creating a guide for NIH grant applicants that strives to enhance reproducibility through rigor and transparency. A preliminary June 8th report (View slides or read a summary) to the full NIH Advisory Committee to the Director (ACD) will be followed up with a second meeting of the ACD Working Group in late 2017 (date TBD) and their Final Report sometime in early 2018 (date TBD).

20170609 06/09/2017 NIH, Research
fa fa-2x fa-long-arrow-right Sec. 2040. Improving medical rehabilitation research at the National Institutes of Health. Requires implementation of updates to Rehabilitation Research Plan, which must be revised and updated as appropriate, at least every five years. These updates will be reported to Congress.
Requires interagency coordination of medical rehabilitation research between NIH and other federal agencies.

The current Rehabilitation Research Plan published in 2016 is available. Revisions and updates by this section at least every five years will be provided once available.

20161213 12/13/2016 NIH, Reports, Research
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.

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.

20180227 02/27/2018 CDC, FDA, Guidances, NIH, Regulatory Affairs, Reports, Research
fa fa-2x fa-long-arrow-right Sec. 2042. Streamlining National Institutes of Health reporting requirements. 12/13/2018: directs each national research institute or national center to submit a report on the amount of research that involves cross-center collaboration

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 NIH, Research
fa fa-2x fa-check Sec. 2043. Reimbursement for research substances and living organisms. Further tracking not required. In effect upon enactment.

Complete.

20161213 12/13/2016 NIH, Research
fa fa-2x fa-long-arrow-right Sec. 2044. Sense of Congress on increased inclusion of underrepresented populations in clinical trials. Articulates a sense of Congress that National Institute on Minority Health and Health Disparities should increase representation of underrepresented populations in clinical trials.

FasterCures will periodically assess whether the National Institute on Minority Health and Health disparities is taking action to increase representation of underrepresented populations in clinical trials.

20161213 12/13/2016 Diversity, NIH, 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-binoculars 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.

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 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. 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.

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

20170717 07/17/2017 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-check Sec. 2071. National pediatric research network. Requires NIH to continue to support the National Pediatric Research Network.

Complete

20161213 12/13/2016 NIH, Research
fa fa-2x fa-long-arrow-right Sec. 2072. Global pediatric clinical study network. Encourages NIH to support a global clinical study network and engage with authorities in the European Union to establish and operationalize such a network.

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 NIH, 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.

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

20170925 09/25/2017 Clinical Trials, FDA, Health Citizenship, HHS, NIH, Research

 

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