[Federal Register Volume 87, Number 3 (Wednesday, January 5, 2022)]
[Notices]
[Pages 462-463]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-28566]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Document Identifier: OS-0990-new]


Agency Information Collection Request. 30-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 February 4, 
2022.

ADDRESSES: Written comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: Sherrette Funn, [email protected] 
or (202) 795-7714. When submitting comments or requesting information, 
please include the document identifier 0990-New-30D and project title 
for reference.

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: For HHS/OHRP Consultation Process, 
Institutional Review Board Records.
    Type of Collection: New OMB No. 0990-XXXX.
    Abstract: 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: IRBs.

                                          Table--Annualized Burden Hour
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                                                                     Number of    Average burden
    45 CFR part 46--HHS consultation process         Number of     responses per   per response    Total burden
                    provision                       respondents     respondent      (in hours)         hours
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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
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[[Page 463]]

 
    Total.......................................  ..............  ..............  ..............              10
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Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance Officer, Office of the 
Secretary.
[FR Doc. 2021-28566 Filed 1-4-22; 8:45 am]
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