[Federal Register Volume 87, Number 240 (Thursday, December 15, 2022)]
[Notices]
[Pages 76631-76632]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-27240]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-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 requirement of the Paperwork Reduction
Act of 1995 to provide opportunity for public comment on proposed data
collection projects, the Office of Laboratory Animal Welfare (OLAW) in
the Office of Extramural Research will publish periodic summaries of
proposed projects to be submitted to the Office of Management and
Budget (OMB) for review and approval.
DATES: Comments regarding this information collection are best assured
of having their full effect if received within 60 days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data
collection plans and instruments, submit comments in writing, or
request more information on the proposed project, 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 additional plans and instruments must be requested
in writing.
SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires written comments and/or suggestions from
the public and affected agencies are invited to address one or more of
the following points: (1) Whether the proposed collection of
information is necessary for the proper performance of the function of
the agency, including whether the information will have practical
utility; (2) The accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) Ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) Ways
to minimize the burden of the collection of information on those who
are to respond, including the use of appropriate automated, electronic,
mechanical, or other technological collection techniques or other forms
of information technology.
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 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. 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.
[[Page 76632]]
Estimated Annualized Burden Hours
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Number of Average burden
Document Type of respondents Number of responses per per response Annual burden
respondents respondent (in hours) hours
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Interinstitutional Assurance for Foreign Site Foreign.................................. 46 1 30/60 23
or Interinstitutional Assurance Triad for
Foreign Site.
Interinstitutional Assurance for Domestic Domestic................................. 750 1 30/60 375
Site or Interinstitutional Assurance Triad
for Domestic Site.
Foreign Assurance............................ Renewal and New.......................... 67 1 90/60 101
Foreign Annual Report to OLAW................ All Foreign.............................. 335 1 1 335
Domestic Assurance........................... Renewal.................................. 215 1 30 6,450
Domestic Assurance........................... New...................................... 20 1 30 600
Domestic Annual Report to OLAW............... All Domestic............................. 890 1 90/60 1,335
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Total.................................... ......................................... .............. 2,323 .............. 9,219
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Dated: December 9, 2022.
Tara A. Schwetz,
Acting Principal Deputy Director, National Institutes of Health.
[FR Doc. 2022-27240 Filed 12-14-22; 8:45 am]
BILLING CODE 4140-01-P