f6098d8b__and_Use_of_Laboratory_Animals__Comments
[ID] 348 [Entry Date] 04/21/2011 at 02:41:20 PM [Affiliation] Self [Comments] 
Comment 1: Re: NIH's Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals My comments regarding the National Institutes of Health's solicitation of comments concerning the Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals (Guide) that appeared in the Federal Register on February 24, 2011 (76 Federal Register 10379 – 80) are as follows: (1) The 2011 Guide contains many recommendations that will, in effect, function like regulations, rather than the "guidelines" for the care and use of research animals authorized by the Health Research Extension Act of 1985 (2) There is insufficient scientific evidence for some revisions reflected in the new Guide; (3) The additional provisions of the 2011 Guide will have a significant economic impact on PHS-assured institutions such as my home institution, The University of Arizona. I ask that NIH not adopt the new Guide until the above concerns are addressed. I suggest that the 2011 Guide be reviewed for consistency with the Office of Management and Budget's (OMB) Bulletin No. 07-02: Final Bulletin for Agency Good Guidance Practices, specifically the definitions, standards, notice and public comment provisions regarding "significant guidance document[s]", "economically significant guidance document[s]" and "regulatory action" (72 Federal Register 3432-40). In view of the Guide's general applicability, scope, depth, complexity, and effect of setting NIH policies regarding the humane care and use of laboratory animals in PHS supported activities, it is reasonable to assume that NIH's adoption of the 2011 Guide would qualify the Guide as a "guidance document" as defined by OMB. To follow all the Guide's provisions in order to qualify for NIH awards, the more than 1,100 PHS-assured institutions will likely spend a minimum of $100 million annually. I believe changes in the guide will significantly increase the cost of research at our insitution, which will impact our ability to continue biomedical research goals, which relate directly to human health and welfare. I believe it is imperative for the animal research community to have a meaningful opportunity to comment on the substance of the new Guide and its financial consequences so that NIH can formulate an appropriate, well-informed implementation plan. Thank you. Comment 2: I believe you need to delay your plan by one year, given the signficant issues that remain before implementation and the difficulty research facilities will have in fully evaluating and complying with this extensive document.
Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals