NIH Seeking Public Comments on Ways to Reduce PI Administrative Burden
Although you are likely familiar with the 21st Century Cures Act (Cures Act), a major healthcare research and reform bill passed in December 2016, you may not know that the Act holds important implications for the future state of animal care and use in biomedical research, most notably the reform of existing animal research regulations.
As required by Section 2034(d) of the Cures Act, the National Institutes of Health (NIH) Office of Laboratory Animal Welfare (OLAW) is currently seeking public comments on how the coordination of regulations and policies governing the use of laboratory animals in research can be improved.
This public comment period is part of a larger coordinated effort between OLAW, the U.S. Department of Agriculture Animal and Plant Health Inspection Service (APHIS), and the U.S. Food and Drug Administration (FDA) to “reduce administrative burden on investigators while maintaining the integrity and credibility of research findings and protection of research animals.”
To complement these national reform efforts, Bill Greer, Assistant Vice President for Research – Animal Program Compliance Oversight and the Director of the Animal Care & Use Office, has partnered with OLAW and the IACUC Administrators Association to create a new Institutional Animal Care
& Use Committee (IACUC) protocol application template form.
The new application template is focused on reducing administrative and regulatory burden, and limiting the type and amount of information requested to only what is necessary to address the regulatory charge of the IACUC.
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Public comments regarding the following are due
to the NIH by 11:59 PM EST on Tuesday, June 12: Proposed actions that the agencies have identified to improve
coordination and harmonization of regulations and policies. Tools and resources that are or would be helpful for reducing burden on investigators. All comments must be submitted electronically via the NIH’s website.
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See Federal Register Notice 2018-05173 (PDF) and NIH Guide Notice NOT-OD-18-152 for more information. Existing comments and meeting notes from previous public listening sessions held on this topic by OLAW, APHIS, the FDA, and AAALAC are also available for review on the OLAW website.
We hope you’ll consider lending your voice to this important national discussion; your insight is essential in shaping the direction of animal care and use in research at the national level, and at the University of Michigan.