21st Century Cures Act – Animal Care and Use in Research

The 21^st Century Cures Act, Section 2034 (d), directed the NIH, in collaboration with USDA and FDA, to conduct a review of applicable regulations and policies for the care and use of laboratory animals and to make revisions, as appropriate, to reduce administrative burden on investigators while maintaining the integrity and credibility of research findings and protection of research animals.

Reducing Administrative Burden for Researchers: Animal Care and Use in Research

The report, Reducing Administrative Burden for Researchers: Animal Care and Use in Research (PDF), describing the recommendations of the 21^st Century Cures Act, Section 2034 (d), Working Group and decisions of the NIH, USDA, and FDA was released in August 2019 and announced in NIH Guide Notice NOT-OD-19-136 and Federal Register Notice 2019-18611.

Working Group

The agencies 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 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 researchers’ 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 recommendation to reduce the administrative burden associated with research activities with laboratory animals.

Request for Information: Input on Draft Report from Working Group on Reducing Administrative Burden to Researchers for Animal Care and Use in Research

Federal Register Notice 2018-26557 and NIH Guide Notices, NOT-OD-19-057 and NOT-OD-19-028: Request for Information was issued for a period of 90 days to solicit input on the draft report and the proposed recommendations to reduce administrative burden associated with research activities with laboratory animals. The draft report is available at Reducing Administrative Burden for Researchers: Animal Care and Use in Research (PDF). This comment period closed February 20, 2019.

Review of Applicable Regulations and Policies to Identify Inconsistent, Overlapping, and Unnecessarily Duplicative Regulations and Policies

As part of its effort, 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 21^st 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, FASEB.

Listening Sessions with Organizations and Stakeholders

The Working Group conducted listening sessions and met with organizations and stakeholder to obtain their individual perspectives.

Listening Session: January 9, 2018 

Representatives from NIH OLAW, 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 9^th. Provided here are the introductory slides (PDF) and 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 NIH OLAW, APHIS AC, and FDA joined the AAALAC International Council Meeting for a listening session on January 29^th. Provided here are the introductory slides (PDF) and a summary of the comments (PDF).

Q&A Session: March 12, 2018

Representatives from NIH OLAW, 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 12^th. Provided here are the meeting notes (PDF).

Request for Information: Animal Care and Use in Research

Federal Register Notice 2018-05173 and NIH Guide Notice NOT-OD-18-152: Request for Information was issued for a period of 90 days to solicit input on possible actions that the agencies identified to improve coordination and harmonization of regulations and policies. This comment period closed June 12, 2018.
 

Questions?

Call (301-496-7163) or e-mail (olaw@mail.nih.gov) OLAW for answers to your questions.

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From U.S. Department of Health & Human Services, https://olaw.nih.gov/21st-century-cures-act.htm