[Federal Register Volume 84, Number 176 (Wednesday, September 11, 2019)]
[Notices]
[Pages 47966-47967]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-19652]


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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 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.

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.

[[Page 47967]]


ADDRESSES: 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, 
[email protected] or by fax to 202-395-6974, Attention: Desk 
Officer for NIH.

FOR FURTHER INFORMATION CONTACT: 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 
[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 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
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                                                                     Number of    Average burden
           Document                  Type of         Number of     responses per   per response    Annual burden
                                   respondents      respondents     respondent      (in hours)         hours
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Interinstitutional Assurance..  Foreign.........              40               1           30/60              20
Interinstitutional Assurance..  Domestic........             660               1           30/60             330
Foreign Assurance.............  Renewal and New.              60               1               1              60
Domestic Assurance............  Renewal.........             220               1              26           5,720
Domestic Assurance............  New.............              20               1              30             600
Annual Report.................  All Domestic....             940               1           90/60           1,410
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    Total.....................  ................           1,940  ..............  ..............           8,140
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    Dated: September 5, 2019.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2019-19652 Filed 9-10-19; 8:45 am]
BILLING CODE 4140-01-P