21st Century Cures Act
The 21st Century Cures Act, passed overwhelmingly in both the U.S. House of Representatives and Senate with strong bipartisan support, was signed into law on December 13, 2016. It aims to accelerate research to improve human health, and to that end, it mandates that federal agencies reduce the administrative burden on investigators, allowing them to focus on conducting the research.
Regarding research with animals, Section 2034(d) of the law mandated that the NIH, USDA, and FDA review policies and procedures and identify steps to reduce administrative burden on investigators. It also mandated that any actions in response to the 21st Century Cures Act must maintain the integrity and credibility of research findings and the protection of research animals.
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Policies and Laws
Public Law 114-255 Section 2034(d) ANIMAL CARE AND USE IN RESEARCH - Not later than 2 years after the date of enactment of this Act, the Director of National Institutes of Health, in collaboration with the Secretary of Agriculture and the Commissioner of Food and Drugs, shall complete a review of applicable regulations and policies for the care and use of laboratory animals and make revisions, as appropriate, to reduce administrative burden on investigators while maintaining the integrity and credibility of research findings and protection of research animals. In carrying out this effort, the Director of the National Institutes of Health shall seek the input of experts, as appropriate. The Director of the National Institutes of Health shall -
(1) identify ways to ensure such regulations and policies are not inconsistent, overlapping, or unnecessarily duplicative, including with respect to inspection and review requirements by Federal agencies and accrediting associations;
(2) take steps to eliminate or reduce identified inconsistencies, overlap, or duplication among such regulations and policies; and
(3) take other actions, as appropriate, to improve the coordination of regulations and policies with respect to research with laboratory animals.
Federal Register Notice 2019-18611 - Laboratory Animal Welfare: Report on Reducing Administrative Burden for Researchers: Animal Care and Use in Research
Federal Register Notice 2018-26557 - Laboratory Animal Welfare: Draft Report on Recommendations to Reduce Administrative Burden on Researchers.
|NOT-OD-19-136||Report on Reducing Administrative Burden for Researchers: Animal Care and Use in Research||August 28, 2019|
|NOT-OD-19-057||Extension of Comment Period on Draft Report: Reducing Administrative Burden to Researchers for Animal Care and Use in Research||January 10, 2019|
|NOT-OD-19-028||Request for Information (RFI): Input on Draft Report from Working Group on Reducing Administrative Burden to Researchers for Animal Care and Use in Research||December 7, 2018|
The NIH, FDA, and USDA convened a Working Group of federal subject matter experts that carried out a review and prepared a draft report of its recommendations as directed by the 21st Century Cures Act. To identify inconsistent, overlapping, and unnecessarily duplicative regulations and policies, the Working Group:
- reviewed published reports, communications, and surveys highlighting the regulations and policies that contribute to investigators' administrative burden;
- conducted listening sessions and met with organizations and stakeholders; and
- issued a Request for Information on possible actions and analyzed stakeholder responses.
These efforts are described in more detail below.
Following this research and analysis, the Working Group sought input through a Request for Information on the draft report and proposed recommendations to reduce the administrative burden associated with research activities with laboratory animals.
Review of Applicable Regulations and Policies to Identify Inconsistent, Overlapping, and Unnecessarily Duplicative Regulations and Policies
The Working Group reviewed numerous reports and surveys that have been published over the last several years addressing the topic of administrative and investigator burden.
The following documents were reviewed:
- Rebuttal to Federation of American Societies for Experimental Biology’s Reforming Animal Research Regulations (PDF) 2018, People for the Ethical Treatment of Animals.
- Animal Welfare Regulations Must Not Be Compromised to Comply with the Goals of the 21st Century Cures Act (PDF) 2018, Humane Society of the United States and Humane Society Legislative Fund.
- Reforming Animal Research Regulations: Workshop Recommendations to Reduce Regulatory Burden (PDF) 2017, Report of an April 17, 2017 workshop organized by Federation of American Societies for Experimental Biology, Association of American Medical Colleges, and the Council on Governmental Relations, with assistance from National Association for Biomedical Research.
- Revising the Requirements for Prompt Reporting under PHS Policy IV.F.3. (PDF) 2017, National Association for Biomedical Research.
- Optimizing the Nation’s Investment in Academic Research: A New Regulatory Framework for the 21st Century (PDF) 2016, National Academies.
- Reducing Investigators’ Administrative Workload for Federally Funded Research (PDF) 2014, National Science Board, National Science Foundation.
- 2012 Faculty Workload Survey Research Report (PDF) 2014, Federal Demonstration Partnership.
- Findings of the FASEB Survey on Administrative Burden (PDF) 2013, Federation of American Societies for Experimental Biology.
The Working Group conducted listening sessions and met with organizations and stakeholders to obtain their individual perspectives.
Listening Session: January 9, 2018
Representatives from the NIH OLAW, USDA APHIS AC, and FDA held a public listening session at the Hyatt Regency Capitol Hill, Washington, DC, immediately following the Federal Demonstration Partnership (FDP) sessions on January 9th. Provided here are the introductory slides (PDF) and a list of registered speakers with their written comments if provided.
Speakers and Comments
- Ellen Paul, Ornithological Council – Comments (PDF)
- Norman Peterson, MedImmune
- Sue Leary, Alternatives Research & Development Foundation and the American Anti-Vivisection Society
- Alka Chandna, People for the Ethical Treatment of Animals – Comments (PDF)
- Jennifer Ball, Humane Society of the United States – Comments (PDF)
- Cathy Liss, Animal Welfare Institute – Comments (PDF)
- Ryan Merkley, Physicians Committee for Responsible Medicine – Comments (PDF)
- J.R. Haywood, Michigan State University – Comments (PDF)
- Molly Greene, Michigan State University – Comments (PDF)
- Stuart Leland, Princeton University and American College of Laboratory Animal Medicine – Comments (PDF)
Listening Session: January 29, 2018
Representatives from the NIH OLAW, USDA APHIS AC, and FDA joined the AAALAC International Council Meeting for a listening session on January 29th. Provided here are the introductory slides (PDF) and a summary of the comments (PDF).
Q&A Session: March 12, 2018
Representatives from the NIH OLAW, USDA APHIS AC, and FDA met with the Animal Welfare Institute, Humane Society Legislative Fund, Physicians Committee for Responsible Medicine, and Humane Society of the United States for a Q&A session on March 12th. Provided here are the meeting notes (PDF).
|Webinar Link||Webinar Date|
|21st Century Cures Act: Update on Implementation||March 11, 2021|
|21st Century Cures Act: Next Steps||December 5, 2019|
|Report - Reducing Administrative Burden for Researchers: Animal Care and Use in Research||August 2019|