[Federal Register Volume 76, Number 91 (Wednesday, May 11, 2011)]
[Notices]
[Pages 27335-27336]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-11490]


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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 Additional Extension of Comment Period.

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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.

[[Page 27336]]


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 
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, 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.
[FR Doc. 2011-11490 Filed 5-10-11; 8:45 am]
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