Release Date: December 21, 1999
NOTICE: OD-00-007
National Institutes of Health
This notice provides guidance to Public Health Service (PHS) awardee institutions and Institutional Animal Care and Use Committees (IACUCs) on existing ways to reduce the burden of provisions of the PHS Policy on Humane Care and Use of Laboratory Animals (PHS Policy).
In its report on the FY 1998 budget, the House Committee on Appropriations requested that NIH undertake an effort to streamline Federal regulations that govern the conduct of extramural scientific research while continuing to provide the intended protections. The initial focus comprised five areas, one of which was animal care and use. The report–A NIH Initiative to Reduce Regulatory Burden - Identification of Issues and Potential Solutions–available on the OER WWW site at: http://grants.nih.gov/grants/policy/regulatoryburden/index.htm was completed in March, 1999. After public comment on the report, NIH developed a Regulatory Burden Three-month Plan, available on the OER www site at: http://grants.nih.gov/grants/policy/regulatoryburden/regburd3monthplan_09_1999.htm .
The NIH plan identified several activities that could be readily pursued without the need for additional legislation or rulemaking. Two of the activities called for the Division of Animal Welfare, Office for Protection from Research Risks (OPRR), OER, to issue guidance to institutions concerning currently available options to reduce regulatory burden. The guidance is as follows:
The PHS Policy requires that institutions notify OPRR at least once every 12 months of any change in the institution’s program, any changes in the IACUC membership, and the dates that the IACUC conducted its semiannual evaluations of the program and facilities. Institutions that are covered by the USDA animal welfare regulations are required to submit APHIS Form 7023, Annual Report of Research Facility, by December 1 of every year, providing assurances concerning professional standards governing care and consideration of alternatives, and data regarding animals used in research. Institutions that are accredited by the Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALAC) must submit an annual report to AAALAC providing a program and facility update. Significant burden reduction could result from gathering similar reporting data over the same time period. In fact, beginning in 1998 AAALAC modified its annual reporting requirements to allow accredited programs to employ the USDA-specified reporting period and animal use data.
The PHS Policy reporting requirement does not specify the time of year that an institution must report. In most cases, by default, institutions report to OPRR on the anniversary of the approval of the institution’s Animal Welfare Assurance.
If institutions wish to change the date that they report to OPRR in order to synchronize the date with other annual reporting requirements, institutions may submit a report at any time before the end of any given 12 month cycle, essentially resetting the clock with regard to their annual reporting requirement under the PHS Policy. Subsequent reports would be due 12 months later.
The PHS Policy requires IACUCs to review at least once every six months the institution’s program for humane care and use of animals, and inspect at least once every six months all of the institution’s animal facilities. The IACUC is also responsible for preparing reports of the IACUC evaluations and submitting the reports to the Institutional Official (PHS Policy IV.B.1.-3.). The Guide for the Care and Use of Laboratory Animals (Guide) is to be used by the IACUC as a basis for evaluating the program and facilities.
The PHS Policy further provides that the IACUC may, at its discretion, determine the best means of conducting an evaluation of the institution’s programs and facilities. The IACUC may invite ad hoc consultants to assist in conducing the evaluation. However, the IACUC remains responsible for the evaluation and report. (PHS Policy, footnote 7.)
The provision to utilize ad hoc consultants may be invoked by IACUCs to make use of either of the two AAALAC assessment programs (Program Status Evaluation or Accreditation), or the pre-assessment preparation activities, to meet the requirements for an IACUC semiannual program evaluation and subsequent report.
To utilize one of these AAALAC- related activities as a semiannual evaluation, the IACUC must ensure that the following provisions of the PHS Policy and USDA animal welfare regulations, as applicable, are met:
For institutions covered by USDA animal welfare regulations:
the report must comply with §2.31(c) of USDA regulations;
at least two IACUC members must participate in the evaluation;
no IACUC member wishing to participate in any evaluation may be excluded;
the report must be signed by a majority of the IACUC members; and
the report must include any minority reviews.
The Animal Care unit of the USDA Animal and Plant Health Inspection Service and AAALAC have reviewed and concur with the guidance provided in this notice.
For questions or further information, contact:
Office of the Director
Office of Extramural Research
Office for Protection from Research Risks
Division of Animal Welfare
6100 Executive Blvd., Suite 3B01
Rockville, Maryland 20892-7507
telephone: (301) 496-7163
fax: (301) 402-2803
e-mail: carol_wigglesworth@nih.gov
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The Animal Welfare Information Center
U.S. Department of Agriculture
Agricultural Research Service
National Agricultural Library
10301 Baltimore Ave.
Beltsville, MD 20705-2351
Phone: (301) 504-6212
FAX: (301) 504-7125
Contact us: http://www.nal.usda.gov/awic/contact.php
