OFFICE OF EXTRAMURAL RESEARCH GUIDANCE REGARDING REDUCTION OF REGULATORY BURDEN 
IN LABORATORY ANIMAL WELFARE

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).

BACKGROUND

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 ANIH 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:

SYNCHRONIZATION OF REPORTING PERIODS

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 Aresetting the clock@ with regard to their annual reporting 
  requirement under the PHS Policy.  Subsequent reports would be due 12 
  months later.

UTILIZATION OF AAALAC ACTIVITIES AS SEMIANNUAL PROGRAM EVALUATION

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 AThe 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:

o   The IACUC report of the program review must comply with section IV.B.3. of 
the PHS Policy which requires that the report contain certain information 
regarding the institution's adherence to the Guide, including a plan and 
schedule for correcting each deficiency identified in the report.
o   The report must be endorsed by the IACUC as an official IACUC report, and 
submitted by the IACUC to the Institutional Official. 

For institutions covered by USDA animal welfare regulations:

o  the report must comply with '2.31(c) of USDA regulations;
o  at least two IACUC members must participate in the evaluation;
o  no IACUC member wishing to participate in any evaluation may be excluded;
o  the report must be signed by a majority of the IACUC members; and
o  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.

INQUIRIES

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
carol_wigglesworth@nih.gov


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