Adoption and Implementation of the Guide for the Care and Use of Laboratory Animals: Eighth Edition
Update: The following update relating to this announcement has been issued:
- September 10, 2012 - See Notice NOT-OD-12-148. Guidance on Departures from the Provisions of the Guide for the Care and Use of Laboratory Animals.
- January 31, 2012 - See Notice NOT-OD-12-042. Extension of Comment Period until February 3, 2012.
Release Date: December 2, 2011
NOT-OD-11-082:
Consideration of Public Comments on Proposed Adoption and Implementation of the Guide for the Care and Use
of Laboratory Animals: Eighth Edition
NOT-OD-11-066:
Additional Extension of Comment Period on Proposed Adoption and Implementation
of the Guide for the Care
and Use of Laboratory Animals: Eighth Edition and Removal of
Character Limit for Comments
NOT-OD-11-056:
Extended Comment Period on Proposed Adoption and Implementation of the Guide for the Care and Use of
Laboratory Animals: Eighth Edition
NOT-OD-11-042:
Public Comment Period Open on Proposed Adoption and Implementation of the Guide for the Care and Use of
Laboratory Animals: Eighth Edition
NOT-OD-10-102:
Update of the Guide for
the Care and Use of Laboratory Animals
National Institutes of Health (NIH)
NIH announces that it has determined to adopt the 8th Edition of the Guide for the Care and Use of Laboratory Animals (Guide) effective January 1, 2012. This notice:
- provides the adoption and implementation plan for the 8th Edition of the Guide effective January 1, 2012;
- provides Position Statements to clarify how the Office of Laboratory Animal Welfare (OLAW) expects Assured institutions to implement the Guide and announces a comment period for the public to comment on their understanding of the Position Statements;
- announces the availability of updated resources to assist Assured institutions in implementation of the Guide; and
- announces that public comments on adoption and implementation of the 8th Edition of the Guide collected in spring 2011 and OLAW’s analysis of those comments are available on the OLAW website at https://grants.nih.gov/grants/olaw/2011guidecomments/web_listing.htm.
- A similar notice on NIH’s adoption of the 8th Edition of the Guide was published in the Federal Register (PDF).
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 OLAW, the NIH office that provides guidance and interpretation of the PHS Policy on Humane Care and Use of Laboratory Animals (Policy), 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 to 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 non-pharmaceutical-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. Links are provided for the public to submit comments on their understanding of the Position Statements for a period of 60 days until January 30, 2012. In response, OLAW may further clarify the Position Statements.
To assist Assured institutions in implementation of the 8th Edition of the Guide, OLAW has updated the following guidance resources and sample documents on its website:
- Frequently Asked Questions
- Tutorial for PHS Policy
- Annual Report to OLAW
- Animal Welfare Assurances (Domestic, Foreign and Interinstitutional)
- Semiannual Program Review and Facility Inspection Checklist
- Semiannual Report to the Institutional Official
- Animal Study Proposal
Since 1985, the PHS Policy, authorized by P.L. 99-158, 42 U.S.C. 289d, and incorporated by reference at 42 C.F.R. 52.8 and 42 C.F.R. 52a.8, has required that institutions receiving PHS support for animal activities base their animal care and use programs on the current edition of the Guide. Since 1996, programs have been based on the 7th Edition of the Guide. The 8th Edition of the Guide was published in January 2011 following a study by the Institute for Laboratory Animal Research of the National Academy of Sciences.
To gain insight from institutions on the impact of changes to the Guide on their animal care and use programs, NIH sought public comments in February 2011 on whether it should adopt the 8th Edition of the Guide and on the proposed implementation plan. The original implementation plan proposed that institutions complete at least one semiannual program and facility evaluation using the 8th Edition of the Guide by March 31, 2011.
Comments were collected via the internet through a Web link available in the Federal Register and on the OLAW website. The original comment period was extended twice and closed on May 24, 2011. In addition to the time extension, the NIH removed the original 6,000 character limit on the comment form fields. A total of 806 responses were submitted by Assured institutions, professional organizations, animal advocacy organizations, and individuals. The comments and an analysis may be viewed at https://grants.nih.gov/grants/olaw/2011guidecomments/web_listing.htm.
For questions or further information, contact:
Office of Laboratory Animal Welfare
Office of Extramural Research
National Institutes of Health
RKL1, Suite 360
6705 Rockledge Drive
Bethesda, MD 20892-7982
Phone: 301-496-7163
Fax: 301-915-9481
E-mail: [email protected]
Web: http://olaw.nih.gov/
and Human Services (HHS)
