f6098d8b__and_Use_of_Laboratory_Animals__Comments
[ID] 418 [Entry Date] 04/22/2011 at 12:18:33 PM [Affiliation] Organization [Organization Name] Johns Hopkins University [Organization City and State] Baltimore, MD [Comments] 
Comment 1: The Johns Hopkins University appreciates the opportunity to offer comments on the 8th edition of the Guide for the Care and Use of Laboratory Animals. We applaud the efforts of the ILAR revision committee that has expanded and updated the previous edition of The Guide. Although the 8th edition contains useful new information (e.g., on the care of aquatic species), it otherwise represents a significant departure from the 7th edition in ways that impose unjustified new constraints on research design, new paperwork burdens, and new costs (for both equipment and personnel) on institutions receiving federal funds for research. We believe these significant changes come without a concomitant increase in animal welfare and will therefore diminish the quality of essential biomedical research. Johns Hopkins University therefore supports the position of the National Association for Biomedical Research (NABR) in its letter to Francis Collins urging that the NIH not adopt the new Guide until and unless concerns regarding new regulatory burdens are addressed through evaluation of the 8th edition of the Guide as a "significant guidance document under the Office of Management and Budget's Bulletin No. 07-02, "Final Bulletin for Agency Good Guidance Practices." Comment 2: The Johns Hopkins University concurs with NABR that the 2011 Guide represents a significant "guidance document," as defined by the Office of Management and Budget (OMB), which "may reasonably be anticipated to lead to an annual effect on the economy of $100 million or more. . . ." Therefore, setting a date by which PHS-Assured institutions must comply with the new Guide prior to an OMB analysis of its financial impact on those institutions and on the National Institutes of Health itself is premature.
Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals