OFFICE OF EXTRAMURAL RESEARCH GUIDANCE REGARDING ADMINISTRATIVE IACUC ISSUES AND 
EFFORTS TO REDUCE REGULATORY BURDEN

Release Date:  February 12, 2001

NOTICE:  NOT-OD-01-017

Update: The following update relating to this announcement has been issued:

March 18, 2011 - See Notice NOT-OD-11-053 Guidance to Reduce Regulatory Burden for IACUC Administration Regarding Alternate Members and Approval Dates. July 14, 2010 - See Notice NOT-OD-10-114 Update on Applicability of the Shelf Life Extension Program (SLEP). National Institutes of Health This notice provides guidance to Public Health Service (PHS) awardee institutions and Institutional Animal Care and Use Committees (IACUCs) concerning the following two administrative IACUC issues: use of alternate IACUC members and IACUC protocol and programmatic review at collaborating institutions. It further provides an example of an existing drug shelf life extension program that may be utilized to extend the expiration date of certain pharmaceuticals in an animal care and use program. A renewed Memorandum of Understanding (MOU) among USDA, FDA and NIH is also announced. BACKGROUND The Office of Laboratory Animal Welfare (OLAW), NIH, and the USDA Animal and Plant Health Inspection Service have continued to work with the NIH Advisory Working Group on Regulatory Burden established in January, 2000, to assist and advise the NIH on issues and recommendations presented in the report "NIH Initiative to Reduce Regulatory Burden." As a result of ongoing discussions about administrative issues dealing with the ways that IACUCs function and efforts by IACUCs to conduct business more efficiently, OLAW is issuing the following guidance. The purpose of the guidance is to ensure that IACUCs policies and procedures are in accordance with the PHS Policy on Humane Care and Use of Laboratory Animals and, as applicable, the USDA animal welfare regulations (AWRs). The USDA Animal and Plant Health Inspection Service (APHIS) has reviewed and concurs with the guidance provided in this notice. USE OF ALTERNATE IACUC MEMBERS Although PHS Policy and the USDA AWRs are silent on the use of alternate IACUC members, OLAW and APHIS agree that alternates may be utilized if the following provisions are met: o Alternates must be appointed by the chief executive officer (CEO) of the entity for which the committee is established, or by the official to whom the CEO has specifically delegated, in writing, authority to appoint IACUC members. Alternates should be listed on the IACUC rosters submitted to OLAW with Assurances and annual reports. o There must be a specific one-to-one designation of IACUC members and alternates. This is necessary to ensure that a committee is properly constituted, even when alternates are serving. For example, an alternate for a non-affiliated IACUC member would need to also meet the non-affiliated member requirements. Use of a pool of alternates would not be consistent with this requirement. o An IACUC member and his/her alternate may not contribute to a quorum at the same time or act in an official IACUC member capacity at the same time. An alternate may only contribute to a quorum and function as an IACUC member if the regular member for whom they serve as alternate is unavailable. o Alternates should receive IACUC training or orientation similar or identical to what is provided regular IACUC members. o Alternate members would be expected to "vote their conscience" as opposed to representing the position of the regular member for whom they serve. o Alternate members may be permitted to attend IACUC meetings and participate in other IACUC activities even when the regular member is present, at the discretion of the institution, although as stated above they may not contribute to the formation of a quorum or vote unless the member for whom they substitute is not available. NO REQUIREMENT FOR DUPLICATE REVIEW There are many circumstances that involve partnerships between collaborating institutions or relationships between institutional animal care programs. OLAW and APHIS agree that review of a research project or evaluation of a program or facility by more than one recognized IACUC is not a federal requirement. It is imperative that institutions define their respective responsibilities. PHS Policy requires that all awardees and performance sites hold an approved Animal Welfare Assurance. OLAW negotiates Interinstitutional Agreement Assurances of Compliance when an awardee institution without an animal care and use program or IACUC will rely on the program of an Assured institution. Assured institutions also have the option to amend their Assurance to cover nonassured performance sites, which effectively subjugates the performance site to the Assured institution and makes the Assured institution responsible for the performance site. If both institutions have full PHS Assurances, they may exercise discretion in determining which IACUC reviews research protocols and under which institutional program the research will be performed. It is recommended that if an IACUC defers protocol review to another IACUC, then documentation of the review should be maintained by both committees. Similarly, an IACUC would want to know about any significant questions or issues raised during a semiannual program inspection by another IACUC of a facility housing a research activity for which that IACUC bears some responsibility or exposure. DOD SHELF LIFE EXTENSION PROGRAM (SLEP) The Department of Defense Shelf Life Extension Program (SLEP), on the internet at http://www.jrcab.army.mil/fda/page1.html, was developed to defer drug replacement costs of date sensitive military reserve stock by extending the useful life of pharmaceutical products. The program involves the identification of candidate items by DOD Service representatives to a Joint Readiness Clinical Advisory Board, which submits products to the FDA. The FDA requires submission of samples and evaluates candidate materials using original manufacturer's test data to establish a protocol for testing. The testing conducted by the FDA is comprehensive and scientifically sound, and FDA bases expiration date extensions on conservative estimates of the useful life of the product as substantiated by the test results. The FDA grants the extensions as specified by lot number, expiration date, and manufacturer that have been stored under appropriate conditions. Institutional animal care and use programs, although ineligible to submit candidates for testing, may access the database of items tested and expiration date extensions. Identified pharmaceutical products (specified by lot number) used in animal care and use programs that have new expiration dates need not be replaced until after the new expiration date. Both OLAW and USDA will recognize the validity of the new expiration dates assigned through the SLEP program. MEMORANDUM OF UNDERSTANDING In January, 2001, USDA, FDA and NIH renewed a Memorandum of Understanding (MOU) Concerning Laboratory Animal Welfare. Since 1995 the three agencies have operated under an MOU that provides for enhanced communication and allows common concerns of the agencies to be managed in a consistent and coherent manner in spite of differing statutory or regulatory mandates. The MOU is perhaps most effective in serving to ensure that the differing approaches of the agencies are harmonized without unnecessarily increasing regulatory burden. Renewal of the MOU signals a willingness to continue the long-standing cooperation that has been of mutual benefit to the agencies while fostering proper animal care and welfare. The new MOU is posted at: http://grants.nih.gov/grants/olaw/references/finalmou.htm. INQUIRIES For questions or further information, contact: Carol Wigglesworth Senior Policy Analyst Office of Laboratory Animal Welfare Office of Extramural Research 6705 Rockledge Drive RKL 1, Suite 1050, MSC 7982 Bethesda, Maryland 20892-7982 Telephone: (301) 402-5913 FAX: (301) 402-2803 carol_wigglesworth@nih.gov


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