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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

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 Extension of Public Comment Period.

SUMMARY:

The National Institutes of Health (NIH) is 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 30 days and thus will end on April 24, 2011.

DATES:

Written comments on the adoption and implementation of the eighth edition of the

Guide

must be received by NIH on or before April 24, 2011 in order to be considered.

ADDRESSES:

Public comments may be entered at:

http://grants.nih.gov/grants/olaw/2011guidecomments/add.htm.

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, NIH, RKL1, Suite 360, 6705 Rockledge Drive, Bethesda, MD 20892-7982; telephone 301-496-7163.

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 or 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: March 23, 2011.

Francis S. Collins,

Director, National Institutes of Health.

[FR Doc. 2011-7316 Filed 3-28-11; 8:45 am]

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