On February 8, FASEB submitted comments to the National Institutes of Health (NIH) Office of Laboratory Animal Welfare (OLAW) regarding the agency’s draft report by the 21st Century Cures Act, Section 2034(d) Working Group on Reducing Administrative Burden to Researchers for Animal Care and Use in Research. The report, a joint effort by the NIH, United States Department of Agriculture (USDA) and Food and Drug Administration was released on December 7, 2018. The draft addressed several concerns outlined in a previous 2017 report published by FASEB, along with the Association of Medical Colleges, Council on Governmental Relations, and National Association of Biomedical Research.
In our comments, FASEB commended many of the draft’s proposed actions including increased harmonization across agency policies. However, comments also highlighted the lack of clarity on various proposals and their implementation, and emphasized the need for consistent regulations for human subjects versus animal subject research.