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

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National Institutes of Health, HHS.




In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of Laboratory Animal Welfare (OLAW) in the Office of Extramural Research has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.


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

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Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, or by fax to 202-395-6974, Attention: Desk Officer for NIH.

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To submit comments in writing or request more information on the proposed collection, contact: Eileen M. Morgan, Director, Division of Assurances, Office of Laboratory Animal Welfare, NIH, call (301) 594-2289 or email your request to Formal requests for information collection forms must be requested via email to

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This proposed information collection was previously published in the Federal Register on June 17, 2019, Vol. 84, No. 116 page 28065 (84 FR 28065) 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, 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 OMB control number.

In compliance with Section 3507(a)(1)(D) of 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.

Proposed Collection Title: Assurance (Interinstitutional, Foreign, and Domestic) and Annual Report, OMB #0925-NEW, 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. The total estimated annualized burden hours are 8,140.

Estimated Annualized Burden Hours

DocumentType of respondentsNumber of respondentsNumber of responses per respondentAverage burden per response (in hours)Annual burden hours
Interinstitutional AssuranceForeign40130/6020
Interinstitutional AssuranceDomestic660130/60330
Foreign AssuranceRenewal and New601160
Domestic AssuranceRenewal2201265,720
Domestic AssuranceNew20130600
Annual ReportAll Domestic940190/601,410
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Dated: September 5, 2019.

Lawrence A. Tabak,

Principal Deputy Director, National Institutes of Health.

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[FR Doc. 2019-19652 Filed 9-10-19; 8:45 am]