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.
FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 NIH, Rare Disease, Reports, Research
fa fa-2x fa-long-arrow-right Sec. 2011. Precision Medicine Initiative. 12/13/2017: requires HHS submission of a report on the relevant data access policies and procedures to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives. The report should include steps the HHS has taken to consult with experts or other heads of departments or agencies of the Federal Government in the development of such policies. FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 Data Sharing, Reports
fa fa-2x fa-long-arrow-right Sec. 2021. Investing in the next generation of researchers. Establishes the "Next Generations of Researchers Initiative" in the NIH Office of the Director.
Requires submission of a report to Congress on any actions taken in response to the NAS comprehensive study on young researchers.

8/31/2017: NIH Office of Extramural Research posted the Policy Supporting the Next Generation Researchers Initiative

7/8/2017: NIH Principal Deputy Director Dr. Larry Tabak presented the "Next Generation Researchers Initiative". More detail on the initiative can be found on its website and in this blog post by Dr. Michael Lauer, NIH Deputy Director for Extramural Research

20170831 08/31/2017 NIH, Reports
fa fa-2x fa-long-arrow-right Sec. 2022. Improvement of loan repayment program. Establishes a revised loan repayment program to support researchers in various high-need topic areas.
6/13/2018: requires the publication of GAO study on NIH efforts to attract, retain, and develop emerging scientists, including individuals from underrepresented groups.
FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 GAO, NIH, Reports, Workforce
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. FasterCures will periodically assess this item as appropriate. 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-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.

One June 1 & 2, 2017 NIH convened the “Inclusion Across the Lifespan” workshop in response to this provision. Details and summary available here.

20170603 06/03/2017 Diversity, NIH, Reports, 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.

April 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 

March 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.

January 18, 2017, The Secretary of HHS delegated authority to the NIH to establish this task force.

20170418 04/18/2017 CDC, FDA, Guidances, NIH, Regulatory Affairs, Reports, 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-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.

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-long-arrow-right Sec. 3004. Report on patient experience drug development. 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.
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. 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-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.
FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 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.


FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 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.

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

20161213 12/13/2016 FDA, Health IT, Regulatory Affairs, Reports
fa fa-2x fa-long-arrow-right Sec. 3071. Silvio O. Conte Senior Biomedical Research and Biomedical Product Assessment Service. 12/13/2020: requires GAO submission to Congress of a report on the effect of these amendments to HHS hiring authorities.

7/17/2017: FDA Commissioner Scott Gottlieb, M.D. announced a new hiring pilot, aimed at helping the agency fill hundreds of empty staff positions, including 500 just at its drug center.
5/25/2017: The hiring freeze of the administration was lifted from FDA.
3/10/2017: Read our memo, "Strengthening FDA’s Workforce: Opportunities for Action"
1/20/2017: Plans to reduce the size of the Federal workforce may adversely impact FDA.

20170717 07/17/2017 FDA, GAO, HHS, NIH, Reports, Workforce
fa fa-2x fa-long-arrow-right Sec. 3072. Hiring authority for scientific, technical, and professional personnel. 6/13/2018: requires FDA submission to Congress of a report on workforce needs and planning.
1/1/2022: requires GAO issuance of a report on FDA progress to recruit and retain staff.

7/17/2017: FDA Commissioner Scott Gottlieb, M.D. announced a new hiring pilot, aimed at helping the agency fill hundreds of empty staff positions, including 500 just at its drug center. 
5/25/2017: The hiring freeze of the administration was lifted from FDA.
3/10/2017: Read our memo, "Strengthening FDA’s Workforce: Opportunities for Action" 
1/20/2017: Plans to reduce the size of the Federal workforce may adversely impact FDA.

20170717 07/17/2017 FDA, GAO, Reports, Workforce
fa fa-2x fa-long-arrow-right Sec. 3081. Medical countermeasure guidelines. 3/1/2017 (and each year thereafter in which there is less that $1.5 billion available for procurement of medical countermeasures): requires HHS to deliver a report to Congress describing the impact this may have on national security needs.

No public information on this provision is available on the website of the HHS Assistant Secretary for Preparedness and Response. FasterCures is reaching out to HHS and Congressional stakeholders to determine if there is any information on this report to Congress that can be made available to the public

20170314 03/14/2017 Funding, HHS, Medical Countermeasures, Reports
fa fa-2x fa-long-arrow-right Sec. 3084. Medical countermeasures innovation. 12/13/2020: requires GAO publication of a review of medical countermeasure innovation program established by this provision. The program will sunset on 9/30/2022.
FasterCures will periodically assess this item as appropriate. 20161213 12/13/2016 BARDA, GAO, HHS, Medical Countermeasures, Medical Product Development, Reports
fa fa-2x fa-long-arrow-right 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.

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 CDC, Infectious Disease, Reports
fa fa-2x fa-long-arrow-right Sec. 3093. Encouraging vaccine innovation. 12/13/2017: requires HHS to submit a report to Congress on promoting innovation in infectious disease vaccine development.

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.

20170417 04/17/2017 BARDA, CDC, FDA, HHS, Infectious Disease, NIH, Reports, Vaccines
fa fa-2x fa-long-arrow-right Sec. 4001. Assisting doctors and hospitals in improving quality of care for patients. 6/13/2017: requires ONC issuance of a report on the Medicare and Medicaid EHR Meaningful Use Incentive program.
6/13/2017: requires the Secretary of HHS to submit to the HIT Advisory Committee of the Office of the National Coordinator for Health Information Technology, a report concerning attestation statistics for the Medicare and Medicaid Meaningful Use Incentive Program.
6/13/2018: requires ONC issuance of recommendation for a voluntary certification program for health IT use in pediatric settings.
12/13/2018: requires ONC adoption of certification criteria for a voluntary certification program for health IT use in pediatric settings.
12/13/2018: requires HHS issuance of a strategy and recommendations for improving patient care and reducing the administrative burden of electronic health record use by medical professionals.

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 Health IT, HHS, ONC, Reports
fa fa-2x fa-long-arrow-right Sec. 4005. Leveraging electronic health records to improve patient care. 12/13/2020: requires HHS submission to Congress, a report concerning best practices of patient safety organizations to improve the integration of health information technology into clinical practice.

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 Health IT, ONC, Reports
fa fa-2x fa-long-arrow-right Sec. 4007. GAO study on patient matching. 12/13/2017: requires GAO issue a study on matching patient identities to their health information - and protection of their privacy - by electronic health records and other health IT products.

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 GAO, Health IT, ONC, Reports
fa fa-2x fa-long-arrow-right Sec. 4008. GAO study on patient access to health information. 6/13/2018: requires GAO submission of a report to Congress on the findings of the study conducted 

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 GAO, Health IT, Reports

 

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