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-check Sec. 2012. Privacy protection for human research subjects. Directs HHS to issue certificates of confidentiality to protect personal information of research participants from unauthorized disclosure.
6/11/2017: Updated policies go into effect.

9/7/2017: NIH provided a Notice of Changes to NIH Policy for Issuing Certificates of Confidentiality. The changes will be effective 10/1/2017. Further discussion can be found in this NIH blog entitled, "NIH’s Certificates of Confidentiality Policy Enhances Confidentiality of Participants Enrolled in Clinical Research Studies."

20170907 09/07/2017 HHS, Privacy, Research
fa fa-2x fa-binoculars Sec. 2013. Protection of identifiable and sensitive information. Enables HHS to exempt from disclosure, certain information that is or may be identifiable.

FasterCures will periodically assess this item as appropriate. 

20161213 12/13/2016 HHS, Privacy, 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.

3/14/2018: NIH posted a guide notice and an accompanying Federal Register Notice requesting input from the grantee community to reduce administrative burden regarding regulations related to the care and use of laboratory animals.  Dr. Lauer also posted a blog

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.

20180314 03/14/2018 FDA, GAO, HHS, NIH, 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.

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-binoculars Sec. 3015. Amendments to the Orphan Drug grants. Updates the Orphan Drug grant program to clarify that grants may be used for observational studies and other analyses to assist in the understanding of the natural history of a rare disease or condition.

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 Funding, HHS, Rare Disease
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.

2/21/2018: FDA announced it is amending its regulations on acceptance of data from clinical investigations for medical devices. FDA recognized its 21st Century Cures obligation to harmonize the differences between the HHS human subject regulations and FDA's human subject regulations. FDA will be working with others at HHS in carrying out this statutory directive, including with respect to de-identified human specimens.

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

20180221 02/21/2018 Clinical Trials, FDA, Health Citizenship, HHS, NIH, 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-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-binoculars Sec. 3074. Scientific engagement. 12/29/2017: Improves NIH and FDA scientist's ability to attend scientific conferences to promote professional development. Not later than 90 days after the end of the fiscal year, each operating division of HHS is required to prepare, and post online, an annual report on scientific meeting attendance and related travel spending for each fiscal year.

12/28/2017: FDA released 2017 Annual Reports on Conferences; including FDA Scientific Conferences with Expenses Over $30,000 and FDA-Held Conferences with Expenses Over $100,000

20171228 12/28/2017 HHS, Workforce
fa fa-2x fa-binoculars 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.

Up to date ASPR Budget and Funding is available. 

20180426 04/26/2018 Funding, HHS, Medical Countermeasures, Reports
fa fa-2x fa-check Sec. 3082. Clarifying BARDA contracting authority. Clarifies that the contracting authority for procurement of medical countermeasures using the "special reserve fund" resides within BARDA. In effect upon enactment.

For more information on BARDA visit www.MedicalCountermeasures.gov. FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 BARDA, HHS, Medical Countermeasures
fa fa-2x fa-binoculars Sec. 3083. Countermeasure budget plan. 3/14/2017, and every year thereafter: requires HHS to deliver to Congress of a coordinated 5-year budget plan for medical countermeasure development and procurement; and be made publicly available in a manner that does not compromise national security.

The Public Health Emergency Medical Countermeasures Enterprise Multiyear Budget 2016-2020 is available. As noted in the Executive Summary of the report, Completion of the FY 2018 President’s Budget as well as the passage of the Consolidated Appropriations Act, 2017, delayed the transmission of this report.

20171231 12/31/2017 HHS, Medical Countermeasures
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-check Sec. 3085. Streamlining Project BioShield procurement. Further tracking not required. In effect upon enactment.

Complete. For more information on Project BioShield.

20161213 12/13/2016 BARDA, HHS
fa fa-2x fa-check Sec. 3087. Paperwork Reduction Act waiver during a public health emergency. Waives Paperwork Reduction Act during a public health emergency.

Complete.

20161213 12/13/2016 HHS
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
fa fa-2x fa-binoculars 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.

5/10/2018: No ONC report on the Medicare and Medicaid EHR Meaningful Use Incentive program could be found on the ONC website. 

ONC provides information on its website related to Meaningful Use and MACRA. 

ONC provides information on pediatric health IT through the Health IT Playbook: 11.2 Find resources for pediatric health IT

20180510 05/10/2018 Health IT, HHS, ONC, Reports
fa fa-2x fa-binoculars Sec. 4004. Information blocking. HHS is directed, through rule-making, to determine activities that do not constitute information blocking, and therefore are not subject to penalties established by this section. (No date provided in law.)

4/8/2018: POLITICO speculated at a summer release of information blocking rule by HHS

10/31/2017: James A. Cannatti III Senior Counselor for Health Information Technology provided testimony on HHS activities before the United States Senate Committee on Health, Education, Labor, and Pensions. 

20180408 04/08/2018 Health IT, HHS, Interoperability, ONC, 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
fa fa-2x fa-long-arrow-right Sec. 4011. Medicare site-of-service price transparency. For 2018 and each year thereafter, requires HHS publishing data on a searchable Internet website related to Medicare payments made to ambulatory outpatient departments and outpatient surgical centers, and the liability of individual beneficiaries for those procedures.

7/20/2017: The Centers for Medicare and Medicaid announced their plan to establish the searchable Web site required by this section. CMS will provide details regarding the Web site will be issued through the subregulatory process and anticipates that the Web site will be made available in early CY 2018.

20170720 07/20/2017 CMS, HHS

 

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