Notice2023-26400
Submission for OMB Review; 30-Day Comment Request; Assurance (Interinstitutional, Foreign, and Domestic) and Annual Report Office of the Director (OD)
Primary source
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Published
December 1, 2023
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 230 (Friday, December 1, 2023)</title>
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[Federal Register Volume 88, Number 230 (Friday, December 1, 2023)]
[Notices]
[Pages 83952-83953]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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
<a href="/cdn-cgi/l/email-protection#c9a6a5a8beada6a889a4a8a0a5e7a7a0a1e7aea6bf"><span class="__cf_email__" data-cfemail="47282b2630232826072a262e2b69292e2f69202831">[email protected]</span></a>. Formal requests for information collection forms
must be requested via email to <a href="/cdn-cgi/l/email-protection#5c33303d2b38333d1c313d353072323534723b332a"><span class="__cf_email__" data-cfemail="7b14171a0c1f141a3b161a121755151213551c140d">[email protected]</span></a>.
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.
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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
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