Laboratory Animal Welfare: Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals
Health and Human Services Department, National Institutes of Health
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This is a regulatory record from Health and Human Services Department, National Institutes of Health — a rule, proposed rule, or notice. Regulations carry the force of law once final, and often invite public comment before that point.
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Key Details
- Posted Date
- Response Deadline
- NAICS Code
- 541715
- Source
- Federal Register
- Contract Type
- regulation
Description
The National Institutes of Health (NIH) has analyzed public comments received regarding adoption and implementation of the 8th Edition of the Guide for the Care and Use of Laboratory Animals (Guide) and has determined to adopt the 8th Edition of the Guide. (The comments, received by NIH from February 24 to May 24, 2011, may be viewed at http://grants.nih.gov/grants/olaw/2011guidecomments/web-- listing.htm.) In NIH's judgment, the 8th Edition of the Guide empowers continued advancement in the humane care and use of vertebrate animals in research, research training, and biological testing. Effective January 1, 2012, institutions that receive Public Health Service (PHS) support for animal activities must base their animal care and use programs on the 8th Edition of the Guide and must complete at least one semiannual program review and facilities inspection using the 8th Edition of the Guide as the basis for evaluation by December 31, 2012. It is not required that all necessary changes be completed by December 31, 2012, but rather that an evaluation must be conducted and a plan and schedule for implementation of the standards in the 8th Edition of the Guide must be developed by December 31, 2012. Institutions must verify to the Office of Laboratory Animal Welfare (OLAW), the organizational component of NIH that provides guidance and interpretation of the PHS Policy on Humane Care and Use of Laboratory Animals, that they have met the required schedule. This will be done through the Annual Report to OLAW covering the 2012 reporting period due January 31, 2013. In addition, institutions must document the implementation of the 8th Edition of the Guide in their next Animal Welfare Assurance renewal. OLAW has developed Position Statements located at http:// grants.nih.gov/grants/olaw/2011positionstatement.htm. The Position Statements clarify the ways in which NIH expects Assured institutions to implement the 8th Edition of the Guide by addressing the following concerns: cost of implementing the 8th Edition of the Guide; animal housing specifications; use of nonpharmaceutical-grade compounds; food and fluid restrictions; multiple surgical procedures; and application of the 8th Edition of the Guide to agricultural animals used in biomedical research. In addition, there is a summary of OLAW's position on performance standards and practice standards. The public is invited to submit comments on their understanding of the Position Statements for a period of 60 days from December 1, 2011, to January 29, 2012. In response, OLAW may further clarify the Position Statements.
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