[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]
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