[Federal Register Volume 76, Number 37 (Thursday, February 24, 2011)]
[Notices]
[Pages 10379-10380]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-4172]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

SUMMARY: The National Institutes of Health (NIH) requests 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.

DATES: Written comments on the adoption and implementation of the 
eighth edition of the Guide must be received by NIH within 30 days of 
the date of publication of this notice 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, National Institutes of Health, 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

[[Page 10380]]

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: February 16, 2011.
Francis S. Collins,
Director, National Institutes of Health.
[FR Doc. 2011-4172 Filed 2-23-11; 8:45 am]
BILLING CODE 4140-01-P