Notice Number: NOT-OD-14-075
Release Date: April 7, 2014
National Institutes of Health (NIH)
The purpose of this combined notice and RFI is to notify the research community and facilities about 1) the space density characteristics of an ethologically appropriate environment applicable to requests to use captive research chimpanzees (Pan troglodytes) in research subject to consideration by the Chimpanzee Research Use Panel (CRUP), and 2) request information needed by the NIH to consider the extent to which facilities housing such chimpanzees meet the characteristics of an ethologically appropriate environment. NIH’s determination about whether a facility currently provides an ethologically appropriate environment, or has plans to provide such environments by April 7, 2019, will be used by the agency in determining whether requests to NIH to use chimpanzees in research are consistent with agency policy.
In December 2010, the NIH commissioned a study by the IOM to assess whether chimpanzees are or will be necessary for biomedical and behavioral research. 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. Among other things, the principles state that chimpanzees used in NIH-supported research must be maintained either in ethologically appropriate physical and social environments or in natural habitats. The principles also state that biomedical, comparative genomics, and behavioral research using stored samples are exempt from the IOM criteria. On December 15, 2011, the NIH announced its acceptance of the IOM recommendations with respect to the use of NIH-owned or -supported chimpanzees in research.
As one of the first steps toward implementing the recommendations, the agency issued an interim agency policy notice in the NIH Guide to Grants and Contracts (NOT-OD-12-025) on December 21, 2011 that, effective immediately, “NIH will 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” while the Agency considered and issued further policies implementing the IOM recommendations. In addition, the NIH charged the NIH Council of Councils with assembling a working group to propose advice on implementing the IOM recommendations and to consider the size and placement of the active and inactive populations of NIH-owned and -supported chimpanzees. On January 22, 2013, the Council of Councils accepted recommendations presented by its Working Group on the Use of Chimpanzees in NIH-Supported Research and provided these recommendations to the NIH. After seeking and considering public comments, the agency accepted a majority of the Council’s recommendations on June 26, 2013 (see 78 Fed. Reg. 39741 published on July 2, 2013 for a summary of the comments and the agency’s decisions and rationale).
As explained in 78 Fed. Reg. 39741 (“the FRN”) and implemented through NOT-OD-13-078, the agency established the Chimpanzee Research Use Panel (CRUP), a working group of the NIH Council of Councils, to consider whether requests to the NIH to use chimpanzees in research are consistent with the IOM principles and criteria, and to convene before the NIH makes decisions about funding or otherwise allows research involving chimpanzees. The FRN also described NIH’s acceptance of the Council’s recommendation that certain observational or non-interventional research involving chimpanzees and certain research involving chimpanzee biomaterials are exempt from the IOM criteria and, therefore, exempt from CRUP consideration. See NOT-OD-14-024 for a definition of Research Exempt from CRUP Consideration.
The agency also expressed agreement in the FRN with the IOM report that chimpanzees used in NIH-supported research must be maintained either in ethologically appropriate physical and social environments or in natural habitats and considered public comment on the 10 Council recommendations describing the characteristics of such environments. After considering public comments, the NIH accepted 9 of the 10 Council recommendations on ethologically appropriate environments. The NIH did not accept, however, the Council recommendation that research chimpanzees be housed in a minimum of 1,000 ft2 space density per individual due to lack of scientific data supporting this recommendation and expected costs of implementation. The agency stated it would review the space density requirements with respect to the promotion of species-appropriate behavior.
The NIH has completed its review of the space density needs for captive research chimpanzees and has announced its decision in NOT-OD-14-051.
For research subject to CRUP consideration, agency policy requires that captive chimpanzees are housed in ethologically appropriate environments, or in facilities with a suitable plan for providing such environments. Facilities that allow such use of captive chimpanzees are asked to provide to NIH a description of how the facility currently satisfies, or plans to satisfy by April 7, 2019, the characteristics of ethologically appropriate physical and social environments.
The characteristics of ethologically appropriate physical and social environments are discussed in detail in the NIH decision documents available at http://dpcpsi.nih.gov/council/chimpanzee_research. Although the NIH briefly summarizes the characteristics of ethologically appropriate environments within this notice, the characteristics listed below should not be interpreted in isolation from the NIH decision documents. Interested parties are strongly encouraged to review the NIH decisions as published in June 2013 and in April 2014 to gain the full context of these characteristics before responding to this notice. Characteristics of ethologically appropriate physical and social environments include:
Unless otherwise excepted below, the requirement to provide ethologically appropriate environments applies to:
Exceptions: Consistent with the IOM report, any implemented Council recommendations, including the characteristics of an ethologically appropriate environment, do not apply to chimpanzees that are retired or permanently ineligible for biomedical research. Nor do they apply to facilities conducting only research exempt from consideration by the CRUP, such as certain research using chimpanzee biospecimens or certain observational research (see NOT-OD-14-024).
Facilities that allow the use of captive chimpanzees in research subject to CRUP consideration should describe how that facility satisfies, or will satisfy within five years of this notice, the characteristics of ethologically appropriate environments.
Responses are encouraged to be submitted on institution letterhead and can include but are not limited to the following areas:
Responses should not exceed 20 pages, not including appendices. The NIH will use this information, in combination with a site visit to the facility that houses the captive chimpanzees, to assess whether the facility satisfies the ethologically appropriate characteristics or if it has a suitable plan to become ethologically appropriate.
Submitting a Response
Facilities should submit responses electronically to the Division of Program Coordination, Planning, and Strategic Initiatives at email@example.com. The deadlines for responses are June 2, 2014, October 3, 2014, and every 4 months thereafter.
Facilities are encouraged to submit responses by June 2, 2014 because, subject to the exceptions described above, NIH will not fund new research involving chimpanzees or otherwise allow new research involving chimpanzees to proceed at facilities that do not satisfy the ethologically appropriate characteristics or that lack a suitable plan.
Please direct all inquiries to firstname.lastname@example.org.
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