[Federal Register Volume 77, Number 36 (Thursday, February 23, 2012)]
[Notices]
[Pages 10760-10761]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-4269]
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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.
Developing a plan for implementation of the IOM's guiding
principles and criteria.
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''.
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.
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:
Foundations
Scientific societies
Government and regulatory agencies
Industry
NIH grantee institutions, and
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: dpcpsi@od.nih.gov.
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