[Federal Register Volume 86, Number 143 (Thursday, July 29, 2021)]
[Notices]
[Pages 40860-40861]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16159]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Document Identifier: OS-0990-New]


Agency Information Collection Request; 60-Day Public Comment 
Request

AGENCY: Office of the Secretary, HHS.

ACTION: Notice.

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SUMMARY: In compliance with the requirement of the Paperwork Reduction 
Act of 1995, the Office of the Secretary (OS), Department of Health and 
Human Services, is publishing the following summary of a proposed 
collection for public comment.

DATES: Comments on the ICR must be received on or before September 27, 
2021.

ADDRESSES: Submit your comments to <a href="/cdn-cgi/l/email-protection#02516a677070677676672c44776c6c426a6a712c656d74"><span class="__cf_email__" data-cfemail="b8ebd0ddcacaddccccdd96fecdd6d6f8d0d0cb96dfd7ce">[email protected]</span></a> or by calling 
(202) 795-7714.

FOR FURTHER INFORMATION CONTACT: When submitting comments or requesting 
information, please include the document identifier 0990-New-60D and 
project title for reference, to Sherrette A. Funn, email: 
<a href="/cdn-cgi/l/email-protection#207348455252455454450e66554e4e604848530e474f56"><span class="__cf_email__" data-cfemail="0a59626f78786f7e7e6f244c7f64644a626279246d657c">[email protected]</span></a>, or call (202) 795-7714 the Reports Clearance 
Officer.

SUPPLEMENTARY INFORMATION: Interested persons are invited to send 
comments regarding this burden estimate or any other aspect of this 
collection of information, including any of the following subjects: (1) 
The necessity and utility of the proposed information collection for 
the proper performance of the agency's functions; (2) the accuracy of 
the estimated burden; (3) ways to enhance the quality, utility, and 
clarity of the information to be collected; and (4) the use of 
automated collection techniques or other forms of information 
technology to minimize the information collection burden.
    Title of the Collection: Institutional Review Board (IRB) Records 
for HHS/OASH Consultation Process.
    Type of Collection: New.
    OMB No.: OS-0990-New.
    Abstract: The Office of the Assistant Secretary for Health, Office 
for Human Research Protections is requesting a new approval from the 
Office of Management and Budget of the Office for Human Research 
Protections (OHRP) requirement that Institutional Review Board records 
be submitted when an IRB or its institution request an HHS consultation 
process, for proposed research involving, respectively: (1) Pregnant 
women, human fetuses and neonates; (2) prisoners; or, (3) children, as 
subjects that are not otherwise approval by an IRB. The Office of the 
Assistant Secretary for Health, on behalf of the Secretary of HHS, may 
determine that such research can be conducted or supported by HHS after 
consulting with experts and allowing for public review of, and comment 
on, the proposed research.
    Likely Respondents: Institutional Review Boards (IRBs).

[[Page 40861]]



                                          Annualized Burden Hour Table
----------------------------------------------------------------------------------------------------------------
                                                                     Number of        Average
    45 CFR part 46--HHS consultation process         Number of     responses per    burden per     Total burden
                    provision                       respondents     respondents      response          hours
----------------------------------------------------------------------------------------------------------------
Subpart B, Sec.   46.207........................               3               1               1               3
Subpart C, Sec.   46.306 (iii) and (iv).........               3               1               1               3
Subpart D, Sec.   46.407........................               4               1               1               4
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............              10
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Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance Officer, Office of the 
Secretary.
[FR Doc. 2021-16159 Filed 7-28-21; 8:45 am]
BILLING CODE 4150-36-P


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