[Federal Register Volume 77, Number 36 (Thursday, February 23, 2012)]
[Notices]
[Pages 10760-10761]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-4269]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Request for Information (RFI): Input Into the Deliberations of 
the Council of Councils Working Group on the Use of Chimpanzees in NIH-
Supported Research

SUMMARY: The National Institutes of Health Council of Councils has 
established a working group to provide recommendations to the Council 
on: (1) Implementing the guiding principles and criteria contained 
within the Institute of Medicine report, ``Chimpanzees in Biomedical 
and Behavioral Research: Assessing the Necessity'', and (2) the size 
and placement of the research active and inactive populations of NIH-
owned or -supported chimpanzees. See http://dpcpsi.nih.gov/council/working_group.aspx for the working group's charge and roster. The NIH 
is seeking public input to inform the working group's deliberations.
    Background: The use of animals in 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 the need 
for special consideration and respect. While used very selectively and 
in limited numbers for medical 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 National Institutes of Health commissioned a 
study by the Institute of Medicine (IOM) to assess whether chimpanzees 
are or will be necessary for biomedical and behavioral research. The 
IOM issued its findings on December 15, 2011, 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 
which must all be applied to analyze current and potential future 
research using chimpanzees.
    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 also concluded, however, that the 
following areas may continue to require the use of chimpanzees: a 
limited number of ongoing studies on monoclonal antibody therapies, 
research on comparative genomics, and non-invasive 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. While the committee encouraged NIH to 
continue development of non-chimpanzee models and technologies, it 
acknowledged that new, emerging, or re-emerging diseases may present 
challenges that may require the use of chimpanzees.
    The Working Group is gathering input from various sources, 
including researchers, academic institutions, foundations, scientific 
societies, government and regulatory agencies, industry, and the 
public, to help inform the development of its recommendations to the 
Council of Councils on actions the NIH can take to implement the IOM 
recommendations and to consider the size and placement of the active 
and inactive populations of NIH-owned or -supported chimpanzees. The 
following are areas of their charge and examples of questions within 
each which might need to be considered when developing recommendations.
    <bullet> Developing a plan for implementation of the IOM's guiding 
principles and criteria.
    <bullet> Factors to consider in reviewing currently active NIH-
supported research using chimpanzees to advise on which studies 
currently meet the principles and criteria defined by the IOM report

[[Page 10761]]

and advising on the process for closing studies if any do not comply 
with the IOM recommendations. For example: Criteria to assess 
``minimally invasive'' procedures for comparative genomics and 
behavioral research and ``ethologically appropriate'' physical and 
social environments; Criteria to balance phasing out of the existing 
research without causing ``unacceptable losses to research programs'' 
or an unacceptable ``impact on the animals''.
    <bullet> Factors to consider when advising on the size and 
placement of active and inactive populations of NIH-owned or-supported 
chimpanzees as a result of implementing the IOM recommendations. For 
example: Ways to address capacity issues that would accompany an 
increase in `inactive' animals; Factors to consider in transitioning 
the animals that are newly inactive; How many and what would be the 
characteristics of animals held in reserve for future research, if any; 
The number of animals needed to maintain a viable number of research 
na[iuml]ve animals but also genetic and social stability and sufficient 
diversity for unanticipated research needs.
    <bullet> 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. For example: Factors 
to consider in determining whether other models (e.g., in vitro, other 
in vivo) would be a ``suitable model'' for answering the research 
question; Research areas where alternative model development is 
recommended; Whether NIH should have a plan to maintain a minimal 
population of federally-owned chimpanzees and input on the design of 
the plan; Circumstances under which chimpanzees should be considered as 
a model for ``a new, emerging, or reemerging disease or disorder that 
may present challenges to treatment, prevention, and/or control that 
defy non-chimpanzee models and available technologies''; 
Characteristics of the oversight committee responsible for reviewing 
future research proposals and determining whether they are consistent 
with the IOM criteria and whether they can be conducted.
    Information Requested: To ensure a thorough and comprehensive 
evaluation of the issues underlying the implementation of the IOM 
Report's guiding principles and criteria and the size and placement of 
NIH-owned or -supported animals, input is being sought from the 
biomedical research community, including:
    <bullet> Foundations
    <bullet> Scientific societies
    <bullet> Government and regulatory agencies
    <bullet> Industry
    <bullet> NIH grantee institutions, and
    <bullet> The public
    Input is sought for each of the areas identified above. For any of 
the areas identified above and any other specific areas you believe are 
worthy of consideration by the working group, please identify the 
critical issues(s) and impact(s) on institutions, scientists, and the 
mission of NIH to perform research to improve human health.
    Response to this RFI is voluntary. Responders are free to address 
any or all of the above items. Please note that the Government will not 
pay for response preparation or for the use of any information 
contained in the response. The NIH may make all responses available, 
including name of the responder. In addition, NIH will prepare and make 
available a summary of all input received which is responsive to this 
RFI.
    How To Submit a Response: All comments must be submitted 
electronically to http://grants.nih.gov/grants/guide/rfi_files/nih_chimp/add.cfm. Comments must pertain to the category for which feedback 
is requested and must conform to the word limit indicated. Responses to 
this RFI will be accepted through April 10, 2012. 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.

FOR FURTHER INFORMATION CONTACT: Specific questions about this RFI 
should be directed to the following email address: <a href="/cdn-cgi/l/email-protection#7410041704071d341b105a1a1d1c5a131b02"><span class="__cf_email__" data-cfemail="3d594d5e4d4e547d525913535455135a524b">[email protected]</span></a>.

    Dated: February 13, 2012.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2012-4269 Filed 2-22-12; 8:45 am]
BILLING CODE 4140-01-P


</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>