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Ellen Paul

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

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COMMENTS ON THE DRAFT REPORT, DESCRIBED BELOW, ARE SOUGHT. COMMENTS MUST BE SUBMITTED ELECTRONICALLY BY 2 FEB 2019.

The draft report on Reducing Administrative Burden for Researchers: Animal Care and Use in Research by the 21st Century Cures Act Working Group is officially available: https://olaw.nih.gov/sites/default/files/21CCA_draft_report.pdf.

The 2016 21st Century Cures Act (21CCA) directed the National Institutes of Health (NIH), in collaboration with the United States Department of Agriculture (USDA) and the Food and Drug Administration (FDA), to review 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. The Act instructs NIH to: (1) seek the input of experts, if appropriate; (2) identify ways to ensure applicable regulations and policies are not inconsistent, overlapping, or unnecessarily duplicative; (3) take steps to eliminate or reduce identified inconsistencies, overlap, or duplication among such regulations and policies; and (4) take other actions, as appropriate, to improve the coordination of regulations and policies with respect to research with laboratory animals.

NIH, USDA, and FDA convened a Working Group of federal subject matter experts that carried out a review and prepared a report of its recommendations as directed in the 21CCA.

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 (Section 1, page 2); conducted listening sessions and met with organizations and stakeholders (Section 2, page 3); and issued a Request for Information (RFI) and analyzed stakeholder responses (Section 3, page 4). Appendix 1. Analysis of Key Findings from the Reports, Communications, and Surveys presents a condensed description of the key findings from the eight reports, communications, and surveys; the Working Group’s analysis; and proposed actions. Appendix 2. Analysis of Responses to the Request for Information presents a summary of the public responses received for the eleven RFI topics, the Working Group’s analysis, and proposed actions.

The Working Group identified the following areas in which there is opportunity to reduce administrative burden: semiannual inspections by Institutional Animal Care and Use Committees (IACUC), animal activities (protocol) review, and institutional reporting. Recommended steps to reduce duplicative regulations and policies are provided on page 5.

The Working Group identified the following areas in which there is opportunity to improve coordination: guidance on federal standards, agency harmonization, and training and resources.

 

 

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