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Feb2019

Last week, PRIM&R submitted comments in response to a request for information (RFI) on a draft report issued by the federal Working Group on Reducing Administrative Burden to Researchers for Animal Care and Use in Research. The Working Group was convened in response to the 21st Century Cures Act, which required the National Institutes of Health (NIH) to work with the US Department of Agriculture (USDA) and the Food and Drug Administration to review their regulations and policies on the care and use of laboratory animals to address how the government could reduce administrative burden that researchers face while maintaining the integrity of research results and protecting the welfare of research animals.

The draft report was a response to comments the NIH received after issuing a March 2018 RFI on how best to improve the coordination of regulations and policies with respect to research with laboratory animals. As we noted on the blog in May 2018, PRIM&R submitted comments in response to the earlier RFI, encouraging the NIH and its sister agencies, in the spirit of the mandate of Cures Section 2034(d), to be open to the wide range of recommendations that the regulated community has put forth to achieve the goals of reducing burden while protecting animal welfare and the integrity of science.

In our comments on the report, we applaud the agencies for responding to the full range of comments submitted by the animal research community in response to the March RFI.  We believe the animal research community will appreciate proposed changes such as enhancing flexibility around scheduled IACUC inspections, harmonizing annual reporting expectations, streamlining technologies to facilitate report submissions, and agency coordination for training. 

In our comments, we also acknowledge that several recommendations made in response to the original RFI, including some of PRIM&R’s, would require statutory changes beyond the purview of the NIH and the USDA; nevertheless, we express hope that the Working Group will include these suggestions—especially, amending the law to allow all vertebrate species to be brought under one harmonized regulatory framework—in any reports they plan to share with Congress, which is in the position to rewrite the law. In our comments on the original RFI on this topic, we note that a consolidated oversight system covering all vertebrate species would result in greater respect and buy-in from the community than the current system, which has a patchwork of bureaucratically intensive regulations that do not necessarily translate to better animal welfare.

With respect to changes that the NIH and USDA themselves have the power to implement, we point out that very few of the proposals have definitive timelines attached, including a re-evaluation of USDA Policy #12 regarding the consideration of alternatives. We look forward to the agencies implementing a process for following up on their proposed changes to keep the research oversight community informed about how their proposals will be solidified.

Comments on the draft report are due February 20, 2019, and we encourage you to consider submitting your own comments. The community is welcome to cite PRIM&R’s comments or borrow any of the points we make if that would be useful to you in crafting your own comments. Please let us know in the comment section below if you take this approach and also what you think of the report in general! You can submit comments to the NIH via this form: (note there’s a 2700 word limit cap): https://grants.nih.gov/grants/rfi/rfi.cfm?ID=83.

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