[Federal Register Volume 84, Number 116 (Monday, June 17, 2019)]
[Notices]
[Page 28065]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12734]


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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, 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. The purpose of this notice is to allow 60 days 
for public comment.

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 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: 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-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
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............           1,940  ..............           8,140
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    Dated: June 11, 2019.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2019-12734 Filed 6-14-19; 8:45 am]
 BILLING CODE 4140-01-P