[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                             Number of    Average burden
                   Document                               Type of respondents                Number of     responses per   per response    Annual burden
                                                                                            respondents     respondent      (in hours)         hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
                                                                                         ---------------------------------------------------------------
    Total....................................  .........................................  ..............           2,323  ..............           9,219
--------------------------------------------------------------------------------------------------------------------------------------------------------


    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