2011-11490. Laboratory Animal Welfare: Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals

AGENCY:

National Institutes of Health, HHS.

ACTION:

Notice of Additional Extension of Comment Period.

SUMMARY:

NIH is further extending the period for public comments on (1) NIH's adoption of the eighth edition of the Guide for the Care and Use of Laboratory Animals (Guide) as a basis for evaluation of institutional programs receiving or proposing to receive Public Health Service (PHS) support for activities involving animals; and (2) if NIH decides to adopt the eighth edition of the Guide, NIH's proposed implementation plan, which would require that institutions complete at least one semiannual program and facility evaluation using the eighth edition of the Guide as the basis for evaluation by March 31, 2012. NIH will consider comments on (1) The adoption of the Guide and (2) the implementation plan. The notice on the proposed adoption and implementation plan for the eighth edition of the Guide was published in the Federal Register on February 24, 2011 (76 FR 10379). The comment period is extended by an additional 30 days and thus will end on May 24, 2011. Additionally, character limits on the comment form fields have been removed.

DATES:

Written comments on the adoption and implementation of the eighth edition of the Guide must be received by NIH on or before May 24, 2011, in order to be considered.

ADDRESSES:

Public comments may be entered at: http://grants.nih.gov/​grants/​olaw/​2011guidecomments/​add.htm. Character limits on the comment form fields have been removed. If the character limit previously in place prevented you from submitting your entire comment, please resubmit by the deadline in order to be considered. Comments will be made publicly available. Personally identifiable information (except organizational affiliations) will be removed prior to making comments publicly available.

FOR 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; telephone [phone].

SUPPLEMENTARY INFORMATION:

I. Background

The Guide, first published in 1963, is a widely accepted primary reference on animal care and use. Recommendations in the Guide are based on published data, scientific principles, expert opinion, and experience with methods and practices that are determined to be consistent with high quality, humane animal care and use. The eighth 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 (NAS). The NAS study process began in 2008 and followed the requirements of Section 15 of the Federal Advisory Committee Act. The NAS study process is described at the NAS Web site: http://www.nationalacademies.org/​studyprocess/​index.html.

Since 1985, the PHS Policy on Humane Care and Use of Laboratory Animals, authorized by Public Law 99-158, 42 U.S.C. 289d, and incorporated by reference at 42 CFR 52.8 and 42 CFR 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 and comply, as applicable, with the Animal Welfare Act and other Federal statutes and regulations relating to animal activities. The PHS Policy is applicable to all PHS-conducted or -supported activities (including research, research training, experimentation, biological testing, or related purposes) involving live vertebrate animals.

The eighth edition of the Guide contains substantive changes and additions from the previous edition. To gain insight from institutions on the impact of changes to the Guide on their animal care and use programs, NIH seeks comments on whether it should adopt the eighth edition of the Guide. NIH simultaneously proposes an implementation plan for the eighth edition of the Guide and seeks comments on the proposed plan.

The implementation plan proposed by NIH would require institutions to complete at least one semiannual program and facility evaluation, using the eighth edition of the Guide as the basis for evaluation, by March 31, 2012. For such an evaluation to be considered complete by NIH, it would need to include reasonable and specific plans and schedules for corrections of deficiencies where appropriate.

II. Electronic Access

The eighth edition of the Guide is available on the NIH Office of Laboratory Animal Welfare Web site at http://olaw.nih.gov.

Dated: May 4, 2011.

Francis S. Collins,

Director, National Institutes of Health.