[Federal Register Volume 78, Number 24 (Tuesday, February 5, 2013)]
[Notices]
[Pages 8154-8155]
From the Federal Register Online via the Government Printing 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 dpcpsi@od.nih.gov.

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