[Federal Register Volume 67, Number 60 (Thursday, March 28, 2002)]
[Notices]
[Pages 14956-14957]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-7400]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Laboratory Animal Welfare: Proposed Change in PHS Policy on 
Humane Care and Use of Laboratory Animals

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The NIH is proposing to change the PHS Policy on Humane Care 
and Use of Laboratory Animals (PHS Policy) to permit institutions with 
PHS Animal Welfare Assurances to submit verification of Institutional 
Animal Care and Use Committee (IACUC) approval for competing 
applications subsequent to peer review but prior to award. Current PHS 
Policy, applicable to all PHS-conducted or supported activities 
involving live, vertebrate animals, provides institutions with a PHS 
approval Animal Welfare Assurance the option of submitting IACUC 
approval for competing application subsequent to the submission of the 
application of proposal, but within 60 days from the receipt date. NIH 
grants policy mandates that applications lacking IACUC approval are 
considered incomplete; thus IACUC approval is presently required prior 
to initial NIH peer review.

DATES: Comments must be submitted on or before May 28, 2002.

ADDRESSES: Comments may be submitted to Anthony Demsey, Ph.D., Senior 
Advisor for Policy, Office of Extramural Research, National Institutes 
of Health, Building 1, Room 154, Bethesda, Maryland 20892. All comments 
received will be available for inspection weekdays (Federal holidays 
excepted) between the hours of 9:00 a.m. and 4:30 p.m. at this address.

SUPPLEMENTARY INFORMATION: The NIH is proposing to revise the 
requirement that IACUC verification be submitted prior to NIH peer 
review. This revision would permit Assured institutions to submit IACUC 
verification for competing application subsequent to peer review but 
prior to award. This concept is often referred to as ``just-in-time.'' 
The proposed change would enhance the flexibility of institutions and 
reduce the burden on applicants and IACUCs, allowing resources to be 
focused on substantive review of proposals likely to be funded.
    On May 1, 2000, the NIH announced that IRB approval would no longer 
be required prior to NIH peer review of an application that involves 
human subjects. Because of the different bases for these policies, the 
NIH did not extend this permission to IACUC approval at that time. 
However, the NIH is now inviting comments from the community on 
proceeding with a revision of the Humane Care and Use of Laboratory 
Animals to permit IACUC approval for competing applications to be 
submitted subsequent to peer review but prior to award. If such a 
change were adopted it would be optional (i.e., as a matter of 
institutional policy institutions could require IACUC review and 
approval prior to submission of applications or prior to NIH peer

[[Page 14957]]

review). The current requirement that modifications required by the 
IACUC must be submitted to NIH with the verification of IACUC approval 
would remain in effect.
    Public comment on this proposed revision is encouraged.

    Dated: March 19, 2002.
Ruth Kirschstein,
Acting Director, National Institutes of Health.
[FR Doc. 02-7400 Filed 3-27-02; 8:45 am]
BILLING CODE 4140-01-M