[Federal Register Volume 67, Number 152 (Wednesday, August 7, 2002)]
[Pages 51289-51290]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-19867]



National Institutes of Health

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

AGENCY: National Institutes of Health, DHHS.

ACTION: Amended Policy Statement.


SUMMARY: The NIH is changing 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.

DATES: This change in PHS Policy is effective as of September 1, 2002 
(i.e., for all applications submitted for the May-June 2003 Advisory 
Council dates).

[[Page 51290]]

FOR FURTHER INFORMATION CONTACT: Anthony Demsey, Ph.D., Senior Advisor 
for Policy, Office of Extramural Research, National Institutes of 
Health, 301-496-5127, email: [email protected].

SUPPLEMENTARY INFORMATION: In the March 28, 2002, Federal Register (67 
FR 14956), the NIH proposed to change the PHS Policy to allow 
institutions to provide IACUC approval for competing applications 
subsequent to peer review but prior to award. This change would modify 
the PHS Policy, applicable to all PHS-conducted or -supported 
activities involving live, vertebrate animals, which currently provides 
institutions with a PHS-approved Animal Welfare Assurance the option of 
submitting verification of IACUC approval for competing applications 
(1) at the time of submission, or (2) subsequent to submission but 
within 60 days from the receipt date and in any case prior to peer 
review. Now, with this change in the PHS Policy, IACUC verification is 
no longer required to be submitted prior to NIH peer review, but 
instead is simply required prior to award. This process, already 
adopted as of May 1, 2000, for Institutional Review Board approval of 
applications involving human subjects, is often referred to as ``just-
in-time.'' The purpose of the change is to enhance the flexibility of 
institutions and reduce the burden on applicants and IACUCs, allowing 
resources to be focused on substantive review of applications likely to 
be funded. The change, however, permits funding components to require 
verification of IACUC approval at an earlier date if necessary.
    Over 200 comments from the research community and institutional 
officials were received in response to the March 28, 2002, Federal 
Register solicitation for public comment on the proposed change. The 
comments were overwhelmingly in favor of the change; some included 
suggestions for NIH in its implementation of the change. Consequently, 
NIH emphasizes the following principles and expectations:
     The fundamental PHS Policy requirement that no award may 
be made without an approved Assurance and without verification of IACUC 
approval remains in effect. This change only affects the timing of the 
submission of the verification of that review.
     This change is intended to permit flexibility and 
discretion on the part of the institution. It is not a requirement that 
IACUC approval be deferred. Institutional officials retain the 
discretion to require IACUC approval prior to peer review in certain 
circumstances of their choosing if they so desire.
     Under no circumstances may an IACUC be pressured to 
approve a protocol or be overruled on its decision to withhold 
approval. NIH peer review groups will continue to address the adequacy 
of animal usage and protections in their review of an application and 
will continue to raise concerns about animal welfare issues. However, 
in no way is peer review intended to supersede or serve as a 
replacement for IACUC approval. An institution that elects to use IACUC 
just-in-time bears the responsibility for supporting the role of the 
     It remains incumbent upon investigators to be totally 
forthcoming and timely in conveying to their IACUCs any modifications 
related to project scope and animal usage that may result from the NIH 
review and award process. Should an institution find that one of its 
investigators disregards his/her responsibilities, the institution may, 
for example, determine that all animal protocols from that investigator 
be subject to IACUC approval before it will permit submission of an 
application from that investigator.
     The existing PHS Policy requirement that modifications 
required by the IACUC be submitted to the NIH with the verification of 
IACUC approval remains in effect, and it remains the responsibility of 
institutions to communicate any IACUC-imposed changes to NIH staff.
     The NIH understands its responsibility to ensure that 
institutions are given adequate notice to allow for timely IACUC review 
prior to award and will take appropriate internal measures to fulfill 
its responsibility to establish timely feedback.
    For the reasons stated above, the NIH amends the PHS Policy on 
Humane Care and Use of Laboratory Animals as set forth below:
    Amend the second sentence of Section IV.D.2. of the PHS Policy to 
delete the words ``a time not to exceed 60 days after the receipt 
deadline date'' and replace them with the words ``any time prior to 
award unless specifically required earlier by the funding component'' 
so that the sentence states: ``For competing applications or proposals 
only, such verification may be filed at any time prior to award unless 
specifically required earlier by the funding component.''
    The NIH will modify the NIH Grants Policy Statement and 
instructions for the 398 Grant Application Form accordingly.

    Dated: July 29, 2002.
Elias A. Zerhouni,
Director, National Institutes or Health.
[FR Doc. 02-19867 Filed 8-6-02; 8:45 am]