Proposed Rules. Notice

Agency: National Institutes of Health, HHS
Action: Notice
Citation: FR Doc. 02-7400

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.

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 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]