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.

Send us your feedback and updates

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. 1001. Beau Biden Cancer Moonshot and NIH innovation projects. Annual appropriation of funds into the NIH Innovation Account (FY17-26), and subsequent allocation to specific initiatives: PMI (FY17-26), BRAIN (FY17-26), Cancer Moonshot (FY17-23), and regenerative medicine (FY17-20).
In addition, requires NIH to submit a work plan to Congress by June 12, 2017 for the NIH Innovation Projects and to solicit input from the public prior to submitting the work plan.
Further directs NIH to submit an annual report to Congress by October 1st of each fiscal year 2018 – 2027 outlining the amount of money obligated as well as a description of the projects and how they are advancing.

10/6/2017: NIH announced the FY 2017 funded awards through the NIH Regenerative Medicine Innovation Project

9/13/2017: Work plan submitted to Congress. Further information on 21st Century Cures page of the NIH Website. The work plan and strategic plan are also available. 

3/28/2017: the Advisory Committee to the Director of NIH held a conference call to discuss the draft work plans outlined in this section. The meeting was announced in a federal register notice. It provided an overview of implementation and provided an update on work plans for each of the following: Cancer Moonshot Initiative, Regenerative Medicine, Precision Medicine Initiative, BRAIN Initiative

20171006 10/06/2017 Funding, NIH, Regenerative Medicine
fa fa-2x fa-check Sec. 1002. FDA innovation projects. Annual appropriation of funds into the FDA Innovation Account (FY17-25)
6/11/2017 - Requires submission of a work plan for the FDA Innovation Fund

7/7/2017: FDA Commissioner Scott Gottlieb, M.D. announced that the agency had submitted its final work plan to Congress.
5/9/2017: The FDA Science Board held a meeting to review the proposal.
5/5/2017: The FDA released its plan outlining proposed uses of innovation funds.

20170707 07/07/2017 FDA, Funding, Regulatory Affairs
fa fa-2x fa-long-arrow-right Sec. 1003. Account for the state response to the opioid abuse crisis. Annual appropriations into the “Account for the State Response to the Opioid Abuse Crisis” (FY17-18)

10/16/2018: The Substance Abuse and Mental Health Services Administration (SAMHSA) requests commentary on the mid-year and end-year performance reports for the Opioid STR program.

8/10/2018: The Substance Abuse and Mental Health Services Administration (SAMHSA) is seeking OMB approval for a new data collection package that will help SAMHSA effectively manage the Opioid STR program.

6/9/2017: Nora D. Volkow, M.D. Director of the National Institute on Drug Abuse presented on NIH’s Efforts to Reduce the Opioid Epidemic at the June 8-9 meeting of the The Advisory Committee to the Director of NIH [Day 1: Agenda, Webcast, Day 2: Agenda, Webcast].

20181016 10/16/2018 Funding
fa fa-2x fa-check Sec. 1004. Budgetary treatment. Provision in effect upon enactment. Further tracking not required.

Complete.

20161213 12/13/2016 FDA, Funding, NIH
fa fa-2x fa-long-arrow-right Sec. 2001. National Institutes of Health Reauthorization. Reauthorizes NIH funding for 2018, 2019, and 2020.

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 Funding, NIH
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.

9/11/2018: National Institute for Aging announced its Alzheimer's prize challenge in an effort to improve care navigation as well as dementia care coordination.

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. 

20180911 09/11/2018 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.

5/6/2018: NIH launched the All of Us Research Program, a study aimed to advance the science of precision medicine by involving 1 million participants living in the United States.

20180508 05/08/2018 Data Sharing, Reports
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. In effect upon enactment.

Complete.

20161213 12/13/2016 HHS, Privacy, 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.

10/10/2018: The National Institutes of Health (NIH) issued a Request for Information (RFI) on proposed key provisions to inform future NIH policies for data management and sharing. Comments may be submitted here until December 10, 2018.

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.

20181011 10/11/2018 Data Sharing, NIH, Research
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.

12/15/17:  NIH Principal Deputy Director Dr. Larry Tabak provided an update on the Next Generation Researchers Initiative on day 2 of the December 14-15 Meeting of the Advisory Committee to the Director.  

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

20171215 12/15/2017 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.

8/10/2018: GAO published an analysis of NIH's effort to diversify the pool of biomedical investigators, focusing heavily on supporting early-career investigators and investigators from underrepresented groups and women.

20180810 08/10/2018 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.

9/13/2018: NIH held a presentation entitled "The 2018 NICHD Strategic Planning Process," detailing the purpose of strategic planning, the role of the advisory council, and the process itself.

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.

20160915 09/15/2016 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.
12/13/2019: First triennial report to Congress due.

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.

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 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.

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-check 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.

Complete.

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.

10/2/2018: The NIH has awarded 89 grants to highly innovative scientists as part of the High-Risk, High-Reward Research Program.

20181002 10/02/2018 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.

5/9/2018: NCATS published a notice in the NIH Guide informing the research community of the NCATS policy regarding support of phase III clinical trial activities for a rare disease or condition. 

20180509 05/09/2018 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.

1/24/2018:  “Open Mike” newsletter to the extramural community includes an article by Deputy Director for Extramural Research Dr. Mike Lauer about the age inclusion policy. 

1/9/2018: NIH posted the Age Inclusion work shop report

12/19/2017: NIH released a notice (NOT-OD-18-116) revising NIH Policy and Guidelines on the Inclusion of Children.  

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.  

11/28/2017: a Guide Notice (NOT-OD-18-014) was released amending the current Inclusion of Women and Minorities policy

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.

 

20180124 01/24/2018 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) and followed up with a second meeting of the ACD Working Group on December 14, 2017 (see agenda or view webcast). Final recommendations were presented at the June 14, 2018 ACD Meeting (view slides or view webcast) 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.

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. 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

12/29/2017: The NIH submitted a report on cross-center collaborations for Fiscal Year 2017 entitled, "Report on NIH Collaborations with Other HHS Agencies for Fiscal Year 2017."

20171229 12/29/2017 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-check Sec. 2051. Technical updates to clinical trials database. Provides technical updates to clinical trials database. In effect upon enactment.

Complete.

20161213 12/13/2016 Clinical Trials, 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-check 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.

11/28/2017: a Guide Notice (NOT-OD-18-014) was released notifying the research community that recipients conducting applicable NIH-defined Phase III clinical trials ensure results of valid analysis are submitted to Clinicaltrials.gov.

20171128 11/28/2017 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. 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.

11/16/2018: HHS announced that it is seeking nominations for non-federal individuals who represent diverse scientific disciplines and views who are interested in being considered for appointment to the Working Group. Nominations must be sent to tickbornedisease@hhs.gov on December 14, 2018, by 5:00 p.m. EST.

11/6/2018: The Working Group announced a meeting on December 3, 2018, from 1:00 p.m. to 4:00 p.m. Eastern Time that will focus on the release of the 2018 Report to Congress, recognize the contributors to the Report, and address next steps and the transition to a new Working Group for the 2020 Report to Congress.

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

20181116 11/16/2018 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

12/13/2017: HHS issued a guidance entitled "21st Century Cures Act Guidance: Remote Access to PHI for activities Preparatory to Research." The issuance of this guidance signifies the completion of two of the requirements of this section.

20180105 01/05/2018 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. 3001. Patient experience data. Requires FDA to include a statement regarding any patient experience data that was used at the time a drug is approved.

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 FDA, Patient Engagement, Regulatory Affairs
fa fa-2x fa-long-arrow-right Sec. 3002. Patient-focused drug development guidance. 6/11/2017 (180 days): instructs FDA to develop a plan to issue draft and final versions of guidance documents regarding the collection of patient experience data, and the use of such data in drug development.
6/13/2018: requires FDA to issue a draft version of at least one such guidance identified in plan and within 18 months from close of public comment period, issue a final/ revised guidance.
12/13/2021: requires FDA to issued patient experience guidance documents

6/13/2018: FDA announced draft guidance entitled “Patient-Focused Drug Development: Collecting Comprehensive and Representative Input," available for comment.

3/19/2018: FDA held a public workshop "Patient-Focused Drug Development: Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data"

10/27/2017: FDA announced a public workshop on "Patient-Focused Drug Development: Guidance 1 – Collecting Comprehensive and Representative Input" to take place 12/18/2017; registration will close on 12/10/2017. Meeting materials: Discussion Document , Attachment to Discussion Document: Appendices , Attachment to Discussion Document: Draft Standardized Nomenclature and Terminologies for the Series of FDA PFDD Guidances (Glossary)

6/7/2017: FDA released their "Plan for Issuance of Patient-Focused Drug Development Guidance," completing one of the deliverables of this section.

9/8/2017: CDER announced a public workshop entitled “CDER Rare Diseases Public Workshop: Strategies, Tools, and Best Practices for Effective Advocacy in Rare Diseases Drug Development.” This public workshop builds upon previous CDER patient advocacy public workshops and is primarily for the rare disease community to help them effectively understand what FDA needs to enhance drug development. 

6/9/2017: FDA released the “Plan for Issuance of Patient‐Focused Drug Development Guidance” in accordance with this provision.

20180613 06/13/2018 FDA, Guidances, Patient Engagement, Regulatory Affairs
fa fa-2x fa-check Sec. 3003. Streamlining patient input. Exempts FDA from going through the Paperwork Reduction Act clearance process when requesting information from patients regarding their disease or treatments.

Complete.

20161213 12/13/2016 FDA, Patient Engagement
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.

12/12/2018: The FDA announced a draft guidance on considerations to address when developing a biomarker, entitled "Biomarker Qualification: Evidentiary Framework." Public commentary on the guidance is requested and may be submitted written or electronically by February 11, 2019.

11/13/2018: The FDA announced a public meeting titled "Drug Development Tool Process under the 21st Century Cures Act and PDUFA VI" that will provide an opportunity for public input regarding the drug development tools qualification pathway for animal models, biomarkers, and clinical outcome assessments. Public commentary is requested and may be submitted written or electronically through the public docket until January 31, 2019.

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.

20181212 12/12/2018 FDA, Guidances, Medical Product Development, Regulatory Affairs, Reports
fa fa-2x fa-binoculars Sec. 3012. Targeted drugs for rare diseases. Permits FDA to allow the sponsor of a drug or biologic application for a genetically targeted drug or variant protein targeted drug to rely on data for the same or similar technology from previously approved applications developed by the same sponsor.

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 FDA, Rare Disease, Regulatory Affairs
fa fa-2x fa-check Sec. 3013. Reauthorization of program to encourage treatments for rare pediatric diseases. Reauthorizes the pediatric rare disease priority review voucher program until 2020.

12/7/2017: FDA announced the availability of draft guidance entitled "Pediatric Rare Diseases-A Collaborative Approach for Drug Development Using Gaucher Disease as a Model"

20171207 12/07/2017 FDA, Medical Product Development, Rare Disease, Regulatory Affairs
fa fa-2x fa-long-arrow-right Sec. 3014. GAO study of priority review voucher programs. 12/31/2020: requires GAO to issue report evaluating the three Priority Review Voucher (PRV) programs: Neglected Tropical Disease, Rare Pediatric Disease, and Medical Countermeasure.

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 FDA, GAO, Medical Countermeasures, Medical Product Development, Rare Disease, Regulatory Affairs
fa fa-2x fa-check 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.

Section 5 of the Orphan Drug Act was amended upon enactment of the 21st Century Cures Act.

20161213 12/13/2016 Funding, HHS, Rare Disease
fa fa-2x fa-check Sec. 3016. Grants for studying continuous drug manufacturing. Allows the FDA to issue grants to further the study of continuous manufacturing for drugs.

Complete.

20161213 12/13/2016 FDA, Funding, Medical Product Development
fa fa-2x fa-long-arrow-right Sec. 3021. Novel clinical trial designs. 6/13/2018: directs FDA to host a public meeting to discuss the incorporation of complex adaptive and other novel trial designs into clinical protocols and new drug applications.

12/13/2019: requires FDA to issue draft guidance addressing the use of complex adaptive and other novel trial design in the development of new drugs or biologicals; within 1 year after the public comment period closes, FDA finalization of such guidance.

3/20/2018: FDA held a public meeting entitled, "Promoting the Use of Complex Innovative Designs in Clinical Trials" with meeting materials and information now available on the FDA website. 

20180320 03/20/2018 Clinical Trials, FDA, Guidances, Medical Product Development, Regulatory Affairs
fa fa-2x fa-long-arrow-right Sec. 3022. Real world evidence. 12/13/2018: requires FDA to develop and begin to implement a framework to evaluate the use of real-world evidence to help support the approval a new indication for a previously approved drug, or to support post-approval study requirements.

12/13/2021: requires FDA to issue draft guidance based on implementation and use of RWE framework which describes circumstances where RWE may be relied upon and appropriate standards and methodologies for collection and analysis of RWE; by 18 months after the above comment period closes finalization of guidance.

12/6/2018: FDA released a new strategic framework for their real-world evidence program, fulfilling a requirement for this section.

11/6/2018: FDA launched the MyStudies App to collect real-world evidence from patients' mobile devices to help inform regulatory decisions around medical products.

7/31/2017: FDA announced a public workshop, "A Framework for Regulatory Use of Real-World Evidence” convened by the Duke-Robert J. Margolis, MD, Center for Health Policy at Duke University and supported by a cooperative agreement with FDA. The purpose of the public workshop is to bring the stakeholder community together to discuss a variety of topics related to the use of real-world data (RWD) and real-world evidence (RWE) in drug development and regulatory decision making.

20181206 12/06/2018 FDA, Guidances, Medical Product Development, Regulatory Affairs
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.

10/15/2018: FDA released a guidance document entitled "Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations," whose purpose is to clarify the impact and progress of certain provisions of the 2018 Common Rule requirements on FDA-regulated clinical investigations.

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

20181020 10/20/2018 Clinical Trials, FDA, Health Citizenship, HHS, NIH, Research
fa fa-2x fa-binoculars Sec. 3024. Informed consent waiver or alteration for clinical investigations. Gives FDA the flexibility to waive or alter informed consent requirements for clinical trials with minimal risk.

11/15/2018: FDA is proposing an amendment to allow for an exception from the requirement to obtain informed consent for clinical investigations that pose no more than minimal risk to human subjects. Public comments on this proposed rule are requested and must be submitted by January 14, 2019.

7/24/2017: FDA announced its intent to revise its informed consent regulations to add a waiver or alteration for minimal risk clinical investigations, under appropriate human subject protection safeguards, to the two existing exceptions from informed consent. FDA also issued guidance, informing sponsors, investigators, and IRBs on FDA's approach to such investigations in the interim until the final regulations are issued.

20181119 11/19/2018 Clinical Trials, FDA, Research
fa fa-2x fa-check Sec. 3031. Summary level review. Permits FDA to rely upon qualified data summaries to support the approval of a supplemental application for a new indication of an already approved drug.

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

20161213 12/13/2016 -
fa fa-2x fa-binoculars Sec. 3032. Expanded access policy. 2/11/2017: Requires manufacturers with one or more investigational drugs for treatment of serious disease or conditions, to have publically accessible expanded access policies for these investigational drugs (60 days after enactment, or upon initiation of Phase 2/3 study).

This requirement to post compassionate use policies may explain a two-fold increase between September 2016 and March 2017, in the number of companies with posted policies as reported by Avalere Health. Full report available here.

20170327 03/27/2017 -
fa fa-2x fa-binoculars Sec. 3033. Accelerated approval for regenerative advanced therapies. Authorizes FDA to designate certain products as Regenerative Medicine Advanced Therapies, making them eligible for increased and earlier interactions with FDA.

FDA has articulated the eligibility criteria for a drug to receive RMAT designation and the process to submit a request. For more, please see this March 21, 2017 FDA voice blog post.

CBER Director reflects on how RMAT designation will speed approval at the May 2017, Food & Drug Law Institute Annual Conference. (See more here

 

20170508 05/08/2017 Regenerative Medicine
fa fa-2x fa-long-arrow-right Sec. 3034. Guidance regarding devices used in the recovery, isolation, or delivery of regenerative advanced therapies. 12/13/2017: requires issuance of draft guidance clarifying how, in the context of regenerative advanced therapies, the Secretary will evaluate devices used in the recovery, isolation, or delivery of regenerative advanced therapies.

11/17/2017: FDA announces the availability of the draft guidance entitled “Evaluation of Devices Used with Regenerative Medicine Advanced Therapies; Draft Guidance for Industry.

20171117 11/17/2017 Regenerative Medicine
fa fa-2x fa-long-arrow-right Sec. 3035. Report on regenerative advanced therapies. 3/1/2017 (and every year thereafter): requires HHS to submit a report to Congress on the number and type of applications for regenerative advanced therapies.

4/5/2018: CBER reported to Congress on the number and type of applications for regenerative advanced therapies.

20180405 04/05/2018 FDA, Regenerative Medicine, Regulatory Affairs
fa fa-2x fa-long-arrow-right Sec. 3036. Standards for regenerative medicine and regenerative advanced therapies. 12/13/2017: instructs HHS to review regulations and guidance relevant to regenerative advanced therapies; and, through a public process, update such regulations and guidance as the Secretary determines appropriate.

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 FDA, Guidances, Regenerative Medicine, Regulatory Affairs
fa fa-2x fa-binoculars Sec. 3037. Health care economic information. Clarifies the scope of permissible manufacturer communications regarding health care economic information to certain entities.

6/13/2018: FDA announced the availability for comment of guidance entitled, "Drug and Device Manufacturer Communications With Payors, Formulary Committees"

20180613 06/13/2018 FDA
fa fa-2x fa-long-arrow-right Sec. 3038. Combination product innovation. Contains a number of elements designed to improve the regulation and review of combination products, including issuing guidance by 12/13/2020 that describes the process for managing pre-submission interactions, best practices for ensuring that feedback represents FDA's best advice, and information on meetings between the sponsor and FDA.

6/13/2018: FDA announced the availability for comment of a list of alternative or streamlined mechanisms for complying with the current good manufacturing practice (CGMP) requirements for combination products. 

20180613 06/13/2018 FDA, Guidances, Regulatory Affairs
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.

10/4/2017: The CDC released a report on national trends in antimicrobial use and resistance entitled "2017 Antibiotic Use in the United States: Progress and Opportunities."

20171010 10/10/2017 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.

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-check Sec. 3043. Prescribing authority. Clarifies that nothing in this section restricts the authority of healthcare providers to prescribe antimicrobial drugs or products. In effect upon enactment.
Complete. 20161213 12/13/2016 FDA, Infectious Disease
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. 3051. Breakthrough devices. 12/13/2017: requires FDA to issue guidance on the implementation of the medical device review pathway established by this provision.
1/1/2019: requires FDA to issue a report to Congress on the new medical device review pathway and opportunities for improvement.

9/6/2018: FDA announced a revision to section V of the FD&C Act, created by section 3051 of the 21st Century Cures act, which states that "Congress codified and expanded this program to include devices reviewed through a 510(k) notification."

10/25/2017: FDA announced the availability of draft guidance entitled “Breakthrough Devices Program; Draft Guidance for Industry and Food and Drug Administration Staff.”

20180906 09/06/2018 FDA, Medical Devices, Regulatory Affairs
fa fa-2x fa-long-arrow-right Sec. 3052. Humanitarian device exemption. 6/13/2018: requires FDA to issue a guidance document define "probable benefit" in the context of the humanitarian device exemption.

6/13/2018: FDA issued draft guidance on Humanitarian Device Exemption (HDE) Program

6/7/2017: FDA rule notice in the Federal Register: section 3052 of the 21st Century Cures Act amended section 520(m) of the FD&C Act to allow for HDE approval for devices that, among other things, treat or diagnose a disease or condition that affects “not more than 8,000” individuals in the United States; this threshold had been “fewer than 4,000” individuals in the United States (amending 21 U.S.C. 360j(m), passim). This final rule amends part 814 (21 CFR part 814) in several places to accurately reflect the threshold recently enacted into law.

20180613 06/13/2018 FDA, Guidances, Medical Devices, Regulatory Affairs
fa fa-2x fa-long-arrow-right Sec. 3053. Recognition of standards. Instructs FDA to review and update its guidance on submission and evaluation of independent standards for medical device review.

9/22/2017: FDA noted on its tracker of 21CC deliverables that, "provided training to FDA employees who review premarket submissions for devices on use of recognized standards for purposes of meeting a premarket submission requirement or other applicable requirement."

9/14/2018: FDA announced the availability of a draft guidance titled "Recognition and Withdrawal of Voluntary Consensus Standards" which updates published guidance topics covered in section 3053.

20180914 09/14/2018 FDA, Guidances, Medical Devices, Regulatory Affairs
fa fa-2x fa-long-arrow-right Sec. 3054. Certain class I and class II devices. 3/13/2017 (and every 5 years thereafter), instructs FDA to publish in the Federal Register a notice that contains Class II devices exempt from reporting requirements due to low risk; followed by 60 day public comment period. Final list published 7/11/2017.
4/12/2017 (and every 5 years thereafter): instructs FDA to provide a list of Class I devices exempt from reporting requirements due to low risk.

3/14/2018: FDA announced it's granting a petition requesting exemption from premarket notification requirements for over-the-counter (OTC) denture repair kits (Product Code EBO). 

11/17/2017: FDA announced it received a petition requesting an exemption from the premarket notification requirements for over-the-counter (OTC) denture repair kits and is receiving comments. 

11/7/2017: FDA published an order to exempt autosomal recessive carrier screening gene mutation detection systems from the premarket notification requirements, subject to certain limitations. 

4/13/2017: FDA issued a notice in the Federal Register identifying a list of class I devices that are now exempt from premarket notification requirements, subjects to certain eliminations. FDA's action will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulation.

3/14/2017: FDA issued a notice in the Federal Register identifying more than 1,000 medical class II devices it is proposing to exempt or partially exempt from the premarket review process. A 60-day comment period is now open, after which FDA may narrow or expand this list.

20180314 03/14/2018 FDA, Medical Devices, Regulatory Affairs
fa fa-2x fa-long-arrow-right Sec. 3055. Classification panels. Requires FDA to provide an annual opportunity for stakeholders to provide recommendations for individuals with appropriate expertise to fill voting member positions on medical device classification panels

6/23/2017: FDA is requesting nominations for voting members to serve on the Device Good Manufacturing Practice Advisory Committee and device panels of the Medical Devices Advisory Committee in the Center for Devices and Radiological Health.

20170623 06/23/2017 FDA, Medical Devices, Regulatory Affairs
fa fa-2x fa-check Sec. 3056. Institutional review board flexibility. Removes the requirement that a sponsor of medical device trial use a local institutional review board. In effect upon enactment.

6/7/2017: On June 7, 2017 FDA rule notice in the Federal Register: “section 3056 of the 21st Century Cures Act amended section 520 of the FD&C Act to remove the requirement for institutional review committees, i.e., IRBs, for devices to be “local”, (amending 21 U.S.C. 360j, passim). This final rule amends 21 CFR 814.124(a), “IRB approval”, to remove the term “local” and related language in order to accurately reflect the requirements recently enacted into law.”

20170607 06/07/2017 FDA, Medical Devices, Regulatory Affairs
fa fa-2x fa-long-arrow-right Sec. 3057. CLIA waiver improvements. 12/13/2017: instructs CMS to issue draft guidance on CLIA waiver improvements, and issuance of final guidance within one year after comment period closes.

11/29/2018: FDA announced the availability of the draft guidance entitled "Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications for Manufacturers of In Vitro Diagnostic Devices." Comments on the draft guidance must be submitted written or electronically by 2/27/2019.

11/29/2017: FDA announced the availability of the draft guidance entitled “Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices.” Comments on the draft guidance must be submitted by 1/29/2018.

20181129 11/29/2018 CMS, FDA, Guidances, Medical Devices, Regulatory Affairs
fa fa-2x fa-long-arrow-right Sec. 3058. Least burdensome device review. 6/13/2018: requires FDA to conduct an audit on training and use of least burdensome requirements during review of medical devices.

6/13/2018: FDA published the "Report to Congress: Least Burdensome Training Audit"

20180613 06/13/2018 FDA, Medical Devices, Regulatory Affairs
fa fa-2x fa-check Sec. 3059. Cleaning instructions and validation data requirement. 6/11/2017: requires HHS to identify and publish of a list of reusable medical devices that require additional instruction on, and validation of, proper cleaning and disinfection procedures.

10/25/2017: FDA issued final guidance on "Deciding When to Submit a 510(k) for a Change to an Existing Device"

6/9/2017: On June 9, 2017 FDA published such a list in the Federal Register. This list becomes effective on August 8, 2017.

20170609 06/09/2017 FDA, Medical Devices, Regulatory Affairs
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.

12/13/2018: FDA released a report entitled "Report on Non-Device Software Functions: Impact to Health and Best Practices," fulfilling their requirement to issue a report on the current state of health-related software and their regulations.

12/8/2017: FDA announced the release of a 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"

20181213 12/13/2018 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.

7/13/2018: FDA provided a "21st Century Cures" report on their progress in recruiting and retaining staff.  The agency's current workforce needs were outlined, as were their efforts in recruiting and retaining staff.

11/15/2017: FDA provided an "Initial Assessment of FDA Hiring and Retention – A Path Forward"

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.

20180713 07/13/2018 FDA, GAO, Reports, Workforce
fa fa-2x fa-check Sec. 3073. Establishment of Food and Drug Administration Intercenter Institutes. 12/13/2017: requires FDA establishment of at least one Intercenter Institute.

1/19/2017: Commissioner Califf announced the formation of the Oncology Center of Excellence and named Richard Pazdur as its director.  The FDA allocated $3.6 million of existing agency funds to establish the OCE. However, a drafting error in sec. 1001(b)(3)(A) may prevent FDA from receiving an additional $75 million to fund the OCE. (Read more here and here).

20170119 01/19/2017 FDA, Regulatory Affairs
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-check Sec. 3075. Drug surveillance. Makes targeted edits to FDA Drug Surveillance program to allow FDA to focus on risk.

10/6/2017: FDA provided the final “Postmarket Drug and Biologic Safety Evaluations” posting 

7/21/2017: FDA provided Information FDA Considers During Postmarket Safety Evaluations

FDA has a website of information on Postmarket Drug and Biologic Safety Evaluations

20171006 10/06/2017 FDA
fa fa-2x fa-check Sec. 3076. Reagan-Udall Foundation for the Food and Drug Administration. Makes key updates to Reagan-Udall Foundation.

For more information on the Reagan-Udall Foundation

20161213 12/13/2016 FDA
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. 3086. Encouraging treatments for agents that present a national security threat. Establishes a Priority Review Voucher program at FDA to incentivize the development of medical countermeasures; sunsets 10/1/2023.


1/17/2018: FDA issued draft guidance for industry entitled “Material Threat Medical Countermeasure Priority Review Vouchers" and it is available for comment. 

10/2/2017: Fee rate announced for using a material threat medical countermeasures priority review voucher for fiscal year (FY) 2018. 

4/28/2017: For more information on FDA Priority Voucher Programs please review this RAPS article entitled "Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers." As noted in the articled, to date no product has been awarded a priority review voucher under the medical counter measures program. 

 

For more information on FDA's Medical Countermeasures work relating to 21st Century Cures.

 

20180117 01/17/2018 FDA, Medical Countermeasures, Regulatory Affairs
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. 3088. Clarifying Food and Drug Administration emergency use authorization. Clarifies Food and Drug Administration emergency use authorization.

Complete. For more information on FDA's Medical Countermeasures work relating to 21st Century Cures.

20161213 12/13/2016 FDA, Medical Countermeasures, Regulatory Affairs
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
fa fa-2x fa-check Sec. 3101. Technical corrections. Further tracking not required. In effect upon enactment.

Complete.

20161213 12/13/2016 FDA
fa fa-2x fa-check Sec. 3102. Completed studies. Strikes studies from the law that have been completed.

Complete.

20161213 12/13/2016 FDA
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.

11/28/2018: HHS released a draft "Strategy on Reducing Regulatory and Administrative Burden Relating to the Use of Health IT and EHRs." Comments are requested and may be submitted electronically until 1/28/2019.

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

20181129 11/29/2018 Health IT, HHS, ONC, Reports
fa fa-2x fa-binoculars Sec. 4002. Transparent reporting on usability, security, and functionality. 12/13/2017: requires ONC promulgation of a rule updating the health IT certification program to include new requirements for interoperability.
12/13/2017: requires HHS awarding of grants, contracts, or agreements to independent entities on a competitive basis to support the convening of stakeholders as described in subsection (a)(2), collect the information required to be reported in accordance with the criteria established as described subsection (a)(3), and develop and implement a process in accordance with paragraph (5) and report such information to the Secretary.

8/24/2018: ONC requests public input regarding the EHR Reporting Program to help inform subsequent discussions among stakeholders and future work toward the development of reporting criteria. ONC provided background on the topic here.

1/12/2018: HHS announced forthcoming rule Health Information Technology: Interoperability and Certification Enhancements (RIN: 0955-AA01) which would, "update the Health IT Certification Program to support voluntary attestation to the adoption of the Trusted Exchange Framework and Common Agreement (TEFCA)

8/16/2017: ONC hosted a two-day technical interoperability forum with standards and technology industry stakeholders reduce information blocking, and enhancing the usability, accessibility, and privacy and security of health IT. ONC provided meeting materials for public consumption

20180824 08/24/2018 Health IT, Interoperability, ONC, Regulatory Affairs
fa fa-2x fa-long-arrow-right Sec. 4003. Interoperability. 6/13/2017: requires ONC to convene appropriate public and private stakeholders to develop or support a trusted exchange framework for trust policies and practices and for a common agreement for exchange between health information networks.
6/13/2018: requires ONC publication of health IT trusted exchange framework and common agreement.
6/13/2019: requires ONC publication of health IT networks that have adopted the trusted exchange framework common agreement. To be updated annually thereafter.
6/13/2019: requires HHS, directly or through a partnership with a private entity, to establish a provider digital contact information index to provide digital contact information for health professionals and health facilities.
The section established the Health IT Advisory Committee (HITAC). Requires the committee no later than 30 days after the date on which first meets to establish and publish a schedule for assessing relevant health IT issues. The schedule will be updated annually. (HITAC consolidates the pre-existing HIT Policy Committee and the HIT Standards Committee.)

3/8/2018: HITAC published its schedule for the assessment of policy recommendations.

1/5/2018: ONC released the draft Trusted Exchange Framework for public comment.

12/22/2017: ONC provided the 2018 meeting dates for the Health Information Technology Advisory Committee (HITAC). 

12/1/2017: As part of the ONC Annual Meeting the agency convened the third and final meeting in the trusted exchange series

9/29/2017: ONC hosted a webinar as the second meeting in the series on trusted exchange framework and common agreement. 

7/24/2017: ONC convened the first in a series of meetings to support work on the trusted exchange framework and common agreement provisions.
7/24/2017: HHS announced it is seeking applications for two members of the HITAC; one of whom shall be appointed to be a public health official representative. A third representative will be appointed by the Secretary to represent HHS. To submit an application.
3/8/2017: The Government and Accountability Office (GAO) is accepting nominations for the HITAC. GAO is responsible for 14 of the 25 seats
The remaining 8 members will be appointed by Congressional leaders with the majority and minority leaders of the Senate, and the speaker and minority leader of the House of Representatives each appointing 2 members respectively.

20180308 03/08/2018 Health IT, Interoperability, ONC
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.)

12/11/2018: The Subcommittee on Health held a hearing entitled "Implementing the 21st Century Cures Act: An Update from the Office of the National Coordinator" which included a discussion on information blocking.

7/31/2018: The Centers for Medicare and Medicaid Services posed a question pertaining to the reduction of information blocking if CMS were to propose a new CoP/CfC/RfP standard to require electronic exchange of medically necessary information.

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. 

20181211 12/11/2018 Health IT, HHS, Interoperability, ONC, Regulatory Affairs
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. 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. 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-check 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 

5/15/2018: GAO published GAO-18-386: Report to Congressional Committees. Full report available here

20180515 05/15/2018 GAO, Health IT, Reports
fa fa-2x fa-long-arrow-right Sec. 4009. Improving Medicare local coverage determinations. 6/13/2017: requires Medicare Administrative Contractors (MACs) to publish a summary of evidence it considered when developing a local coverage determination (LCD).

FasterCures will periodically assess this item as appropriate.

20161213 12/13/2016 CMS
fa fa-2x fa-check Sec. 4010. Medicare pharmaceutical and technology ombudsman. 12/13/2017: requires HHS to establish a pharmaceutical and technology ombudsman.

2/12/2018: CMS announced James Bailey is currently serving as the new Medicare Pharmaceutical and Technology Ombudsman. 

20180212 02/12/2018 CMS, Health IT
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.

7/31/2018: The Centers for Medicare and Medicaid announced that they will make available a website that provides comparison information between the OPPS and ASC payment and copayment rates.

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.

20180731 07/31/2018 CMS, HHS
fa fa-2x fa-check Sec. 4012. Telehealth services in Medicare. 12/13/2017: requires CMS to provide information to Congress on use of telehealth services by Medicare.

2/15/2018: Medicare published updated Medicare Learning Network (MLN) Booklet on Telehealth Services

2/9/2018: Congress passes the Bipartisan Budget Act including landmark support for telemedicine in Medicare. Specific sections on the topic: Sec. 50323. Increasing convenience for Medicare Advantage enrollees through telehealth.Sec. 50324. Providing accountable care organizations the ability to expand the use of telehealth., and; Sec. 50325. Expanding the use of telehealth for individuals with stroke.

11/15/2017: The Congressional Research Service published a report, "Telehealth Services Proposed for Medicare Part B Reimbursements, 2018: Fact Sheet"

6/15/2017: MedPac issued the June 2017 Report to the Congress: Medicare and the Health Care Delivery System. It includes some reference to telehealth.

Other resources relating to CMS telehealth services include:

20180215 02/15/2018 CMS, Health IT
fa fa-2x fa-check Sec. 5001. Savings in the Medicare Improvement Fund. Further tracking not required.

Complete.

20161213 12/13/2016 CMS
fa fa-2x fa-check Sec. 5002. Medicaid reimbursement to States for durable medical equipment. Further tracking not required.

Complete.

20161213 12/13/2016 CMS
fa fa-2x fa-check Sec. 5003. Penalties for violations of grants, contracts, and other agreements. Further tracking not required.

Further tracking not required. In effect upon enactment.

20161213 12/13/2016 CMS
fa fa-2x fa-check Sec. 5004. Reducing overpayments of infusion drugs. Changes the payment methodology for DME infusion drugs.

7/21/2017: CMS provided detail on how it would implement the changes in payment methodology for DME infusion drugs required by this section.

20170721 07/21/2017 CMS
fa fa-2x fa-binoculars Sec. 5005. Increasing oversight of termination of Medicaid providers. FasterCures will periodically assess this item as appropriate.

FasterCures will periodically assess this item as appropriate. 

20161213 12/13/2016 CMS
fa fa-2x fa-binoculars Sec. 5006. Requiring publication of fee-for-service provider directory. FasterCures will periodically assess this item as appropriate.

Fee-for-service Provider Directory available here

20170101 01/01/2017 CMS
fa fa-2x fa-check Sec. 5007. Fairness in Medicaid supplemental needs trusts. Further tracking not required.

Complete.

20161213 12/13/2016 CMS
fa fa-2x fa-check Sec. 5008. Eliminating Federal financial participation with respect to expenditures under Medicaid for agents used for cosmetic purposes or hair growth. Further tracking not required.

Complete.

20161213 12/13/2016 CMS
fa fa-2x fa-check Sec. 5009. Amendment to the Prevention and Public Health Fund. Further tracking not required.

Complete.

20161213 12/13/2016 -
fa fa-2x fa-check Sec. 5010. Strategic Petroleum Reserve drawdown. Further tracking not required.

Complete.

20161213 12/13/2016 -
fa fa-2x fa-check Sec. 5011. Rescission of portion of ACA territory funding. Further tracking not required.

Complete.

20161213 12/13/2016 -
fa fa-2x fa-check Sec. 5012. Medicare coverage of home infusion therapy. Further tracking not required.

Complete.

20161213 12/13/2016 CMS

 

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