[Federal Register Volume 88, Number 230 (Friday, December 1, 2023)]
[Notices]
[Pages 83952-83953]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-26400]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-Day Comment Request; Assurance 
(Interinstitutional, Foreign, and Domestic) and Annual Report Office of 
the Director (OD)

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the 
National Institutes of Health (NIH) has submitted to the Office of 
Management and Budget (OMB) a request for review and approval of the 
information collection listed below.

DATES: Comments regarding this information collection are best assured 
of having their full effect if received within 30 days of the date of 
this publication.

ADDRESSES: Written comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: To submit comments in writing or 
request more information on the proposed collection, contact: Jane J. 
Na, Director, Division of Assurances, Office of Laboratory Animal 
Welfare, NIH, call (301) 496-7163 or email your request to 
[email protected]. Formal requests for information collection forms 
must be requested via email to [email protected].

SUPPLEMENTARY INFORMATION: This proposed information collection was 
previously published in the Federal Register on December 15, 2022, Vol. 
87, No. 240 page 76631-76632 (87 FR 76631) and allowed 60 days for 
public comment. No public comments were received. The purpose of this 
notice is to allow an additional 30 days for public comment.
    The Office of the Director (OD), National Institutes of Health 
(NIH), may not conduct or sponsor, and the respondent is not required 
to respond to, an information collection that has been extended, 
revised, or implemented on or after October 1, 1995, unless it displays 
a currently valid Office of Management and Budget (OMB) control number.

[[Page 83953]]

    In compliance with section 3507(a)(1)(D) of the Paperwork Reduction 
Act of 1995, NIH has submitted to OMB a request for review and approval 
of the information collection listed below.
    Proposed Collection Title: Assurance (Interinstitutional, Foreign, 
and Domestic) and Annual Report, OMB #0925-0765, expiration date 11/30/
2022, Reinstatement with Change, Office of the Director (OD), National 
Institutes of Health (NIH).
    Need and Use of Information Collection: The NIH Office of 
Laboratory Welfare (OLAW) is responsible for the implementation, 
general administration, and interpretation of the Public Health Service 
(PHS) Policy on Humane Care and Use of Laboratory Animals (Policy) as 
codified in 42 CFR 52.8. The PHS Policy implements the Health Research 
Extension Act (HREA) of 1985 (Pub. L. 99-158 as codified in 42 U.S.C. 
289d). The PHS Policy requires entities that conduct research involving 
vertebrate animals using PHS funds to have an Institutional Animal Care 
and Use Committee (IACUC), provide assurance that requirements of the 
Policy are met, and submit an annual report. Institutions in foreign 
countries comply with the PHS Policy or provide evidence that 
acceptable standards for the humane care and use of the animals in PHS-
conducted or -supported activities will be met. An institution's animal 
care and use program is described in the Animal Welfare Assurance 
(Assurance) document and sets forth institutional compliance with PHS 
Policy. The purpose of the Assurance (Interinstitutional, Foreign, and 
Domestic) and Annual Report is to provide OLAW with documentation to 
satisfy the requirements of the HREA, illustrate institutional 
adherence to PHS Policy, and enable OLAW to carry out its mission to 
ensure the humane care and use of animals in PHS-supported research, 
testing, and training, thereby contributing to the quality of PHS-
supported activities.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 9,219.

                                        Estimated Annualized Burden Hours
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                                                                                       Average
                                       Type of          Number of       Number of     burden per   Total annual
           Form name                 respondents       respondents    responses per    response    burden hours
                                                                       respondent     (in hours)
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Domestic Assurance.............  Renewal and New...             235               1           30           7,050
Domestic Annual Report.........  All Domestic......             890               1        90/60           1,335
Foreign Assurance..............  Renewal and New...              67               1        90/60             101
Foreign Annual Report..........  All Foreign.......             335               1            1             335
Interinstitutional Assurance     Foreign...........              46               1        30/60              23
 for Foreign Performance Site
 or Interinstitutional
 Assurance Triad for Foreign
 Performance Site.
Interinstitutional Assurance     Domestic..........             750               1        30/60             375
 for Domestic Performance Site
 or Interinstitutional
 Assurance Triad for Domestic
 Performance Site.
                                                    ------------------------------------------------------------
    Total......................  ..................           2,323               6  ...........           9,219
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    Dated: November 22, 2023.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2023-26400 Filed 11-30-23; 8:45 am]
BILLING CODE 4140-01-P