[Federal Register Volume 78, Number 24 (Tuesday, February 5, 2013)]
[Notices]
[Pages 8154-8155]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-02507]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Request for Comment: Input on Recommendations from the Council of
Councils Working Group on Use of Chimpanzees in NIH-Supported Research
SUMMARY: The National Institutes of Health (NIH) Council of Councils
received and adopted the recommendations and Report of the NIH Council
of Councils Working Group on the Use of Chimpanzees in NIH-Supported
Research on January 22, 2013. The report is posted on the NIH Web site
at http://dpcpsi.nih.gov/council/working_group_message.aspx. The
agency will consider the recommendations contained in the report as the
agency formulates policy. The NIH also announces the opening of a
Request for Comment (RFC) period to collect input on the
recommendations from interested parties. Comments will be accepted
until Saturday, March 23, 2013, via the comment database at http://grants.nih.gov/grants/rfi/rfi.cfm?ID=31. In the interim, NIH will
continue to apply its policy on Research Involving Chimpanzees (see
NOT-OD-12-025; http://grants.nih.gov/grants/guide/notice-files/NOT-OD-12-025.html.)
DATES: Responses to this RFC will be accepted through 11:59 p.m. EST
Saturday, March 23, 2013.
ADDRESSES: All comments should be submitted electronically to http://grants.nih.gov/grants/rfi/rfi.cfm?ID=31.
FOR FURTHER INFORMATION CONTACT: The Division of Program Coordination,
Planning, and Strategic Initiatives, Office of the Director, National
Institutes of Health at [email protected].
SUPPLEMENTARY INFORMATION: The use of animals in biomedical and
behavioral research has enabled scientists to identify new ways to
treat illness, extend life, and improve health and well-being.
Chimpanzees are our closest relatives in the animal kingdom, providing
exceptional insights into human biology and requiring special
consideration and respect. While used very selectively and in limited
numbers for biomedical research, chimpanzees have served an important
role in advancing human health in the past. However, new methods and
technologies developed by the biomedical community have provided
alternatives to the use of chimpanzees in several areas of research.
In December 2010, the NIH commissioned a study by the Institute of
Medicine (IOM) to assess whether chimpanzees are or will be necessary
for NIH-funded biomedical and behavioral research. A year later on
December 15, 2011, the IOM issued its findings, with a primary
recommendation that the use of chimpanzees in research be guided by a
set of principles and criteria. The committee proposed three principles
to analyze current and potential future research using chimpanzees:
[[Page 8155]]
1. That the knowledge gained must be necessary to advance the
public's health;
2. There must be no other research model by which the knowledge
could be obtained, and the research cannot be ethically performed on
human subjects; and
3. The animals used in the proposed research must be maintained
either in ethologically appropriate physical and social environments
(i.e., as would occur in their natural environment) or in natural
habitats.
Based on its deliberations, the IOM committee concluded that
``while the chimpanzee has been a valuable animal model in past
research, most current use of chimpanzees for biomedical research is
unnecessary.'' The committee generated case studies of predominant
areas of chimpanzee research exemplifying the committee's vision for
applying the criteria it developed. The case studies concluded that the
following areas of the research they assessed may continue to require
the use of chimpanzees: some ongoing research on monoclonal antibody
therapies, research on comparative genomics, and important studies of
social and behavioral factors that affect the development, prevention,
or treatment of disease. The committee was unable to reach consensus on
the necessity of the chimpanzee for the development of prophylactic
hepatitis C virus vaccine. It also acknowledged that new, emerging, or
re-emerging diseases may present challenges that may require the use of
chimpanzees. To assist the NIH in considering future requests to use
chimpanzees in research, the IOM committee provided the set of
principles and criteria as a framework to guide NIH's assessment.
In December 2011, NIH accepted the IOM Recommendations (http://www.nih.gov/news/health/dec2011/od-15.htm) contained in the report
Chimpanzees in Biomedical and Behavioral Research: Assessing the
Necessity and issued interim policy in notice NOT-OD-12-025, which
indicated that NIH would not fund any new or other competing projects
(renewal and revisions) for research involving chimpanzees and will not
allow any new projects to go forward with NIH-owned or -supported
chimpanzees. However, currently funded research was allowed to
continue. The policy remains in effect until NIH considers and issues
policy implementing the IOM recommendations.
NIH assembled a working group of the NIH Council of Councils on
February 1, 2012, to provide advice on implementation of the IOM
recommendations and to consider the size and placement of the active
and inactive populations of NIH-owned or -supported chimpanzees. The
Working Group was charged with (1) Developing a plan for implementation
of the IOM's guiding principles and criteria; (2) Analyzing currently
active NIH-supported research using chimpanzees to advise on which
studies currently meet the principles and criteria defined by the IOM
report and to advise on the process for closing studies if any do not
comply with the IOM recommendations; (3) Advising on the size and
placement of active and inactive populations of NIH-owned or -supported
chimpanzees that may need to be considered as a result of implementing
the IOM recommendations; and (4) Developing a review process for
considering whether potential future use of the chimpanzee in NIH-
supported research is scientifically necessary and consistent with the
IOM principles.
The Working Group's efforts culminated in the report containing 28
recommendations to NIH. In developing its recommendations, the Working
Group considered public comments received in response to a previous
Request for Information (http://dpcpsi.nih.gov/council/working_group.aspx#Summary), considered the scientific use of chimpanzees in
currently funded research, obtained advice from external experts, and
visited several facilities that house and care for chimpanzees. The
Working Group submitted its recommendations and the report to the NIH
Council of Councils in open session on January 22, 2013, and the
Council of Councils adopted the report. The report is available at
http://dpcpsi.nih.gov/council/working_group_message.aspx.
Comments Requested: The NIH is seeking input on the recommendations
from the Council of Councils from the public and the biomedical
research community, including foundations, scientific societies,
government and regulatory agencies, industry, and NIH grantee
institutions. Input is sought for each of the report's recommendations.
Response to this RFC is voluntary. Responders are free to address any
or all of the recommendations.
Please note that the government will not pay for response
preparation or for the use of any information contained in the
comments. The NIH may make all comments available, including name of
the responder. In addition, NIH may prepare and make available a
summary of all input received that is responsive to this RFC.
How to Submit a Response: All comments should be submitted
electronically to http://grants.nih.gov/grants/rfi/rfi.cfm?ID=31.
Comments should pertain to the specific recommendation for which
feedback is requested and should conform to the word limit indicated.
You will see an electronic confirmation acknowledging receipt of your
response, but will not receive individualized feedback on any
suggestions. No basis for claims against the U.S. government shall
arise as a result of a response to this request for information or from
the government's use of such information.
Dated: January 28, 2013.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2013-02507 Filed 2-4-13; 8:45 am]
BILLING CODE 4140-01-P