[Federal Register Volume 76, Number 231 (Thursday, December 1, 2011)]
[Notices]
[Pages 74803-74804]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-30764]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Laboratory Animal Welfare: 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.

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SUMMARY: The National Institutes of Health (NIH) has analyzed public 
comments received regarding adoption and implementation of the 8th 
Edition of the Guide for the Care and Use of Laboratory Animals (Guide) 
and has determined to adopt the 8th Edition of the Guide. (The 
comments, received by NIH from February 24 to May 24, 2011, may be 
viewed at http://grants.nih.gov/grants/olaw/2011guidecomments/web_listing.htm.) 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 the Office of Laboratory Animal Welfare 
(OLAW), the organizational component of NIH that provides guidance and 
interpretation of the PHS Policy on Humane Care and Use of Laboratory 
Animals, 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 located at http://grants.nih.gov/grants/olaw/2011positionstatement.htm. The Position 
Statements 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 nonpharmaceutical-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. The public is invited 
to submit comments on their understanding of the Position Statements 
for a period of 60 days from December 1, 2011, to January 29, 2012. In 
response, OLAW may further clarify the Position Statements.

DATES: Written comments on the public's understanding of the Position 
Statements must be received by NIH on or before January 29, 2012, to be 
considered.

ADDRESSES: Public comments on the Position Statements may be entered at 
http://grants.nih.gov/grants/olaw/2011positionstatement.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; or telephone: 
(301) 496-7163.

SUPPLEMENTARY INFORMATION:

I. Background

    Since 1985, the PHS Policy on Humane Care and Use of Laboratory 
Animals, authorized by Public Law 99-

[[Page 74804]]

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. 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. The 8th 
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 
sought comments on whether it should adopt the 8th Edition of the Guide 
and on the proposed implementation plan. On February 24, 2011, NIH 
issued a Federal Register Notice (see http://edocket.access.gpo.gov/2011/pdf/2011-4172.pdf) requesting public comments on (1) NIH's 
adoption of the 8th Edition of the Guide as a basis for evaluating 
institutional programs receiving or proposing to receive PHS support 
for activities involving animals and (2) NIH's proposed implementation 
plan (if NIH decided to adopt the 8th Edition of the Guide). The 
original implementation plan proposed that institutions complete at 
least one semiannual program and facility evaluation using the 8th 
Edition of the Guide as the basis for evaluation by March 31, 2011.
    Comments were collected via the Internet through a Web link 
available in the Federal Register and on the OLAW Web site, where 
respondents could also access both the 7th and 8th Editions of the 
Guide. The original comment period was scheduled from February 24, 
2011, to March 24, 2011. This comment period was extended twice, on 
March 18 and April 21. Ultimately, the comment period spanned 90 days, 
closing on May 24, 2011. In addition to the time extension, the NIH 
removed the original 6,000-character limit on the comment form fields 
in the April 21 extension to maximize the opportunity for individuals 
and organizations to provide comments to NIH. 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 http://grants.nih.gov/grants/olaw/2011guidecomments/web_listing.htm.

II. Electronic Access

    The 8th Edition of the Guide is available on the OLAW Web site at 
http://olaw.nih.gov.

    Dated: November 22, 2011.
Francis S. Collins,
Director, National Institutes of Health.
[FR Doc. 2011-30764 Filed 11-30-11; 8:45 am]
BILLING CODE 4140-01-P