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                    the following: the agency or agencies that issued and signed a document
the number of the CFR title and the number of each part
                      the document amends, proposes to amend, or is directly
                      related to
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 Department of Health and Human Services [Document Identifier: OS-0990-New]
 AGENCY: Office of the Secretary, HHS.
 ACTION: Notice.
 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 
                        *Sherrette.Funn@hhs.gov*
                         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: 
                        *Sherrette.Funn@hhs.gov,*
                         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).
                    ( print page 40861) Annualized Burden Hour Table
45 CFR part 46—HHS consultation process provision
Number of 
                             respondents
Number of 
                             responses per  
                             respondents
Average 
                             burden per  
                             response
Total burden hoursSubpart B, § 46.207
3
1
1
3Subpart C, § 46.306 (iii) and (iv)
3
1
1
3Subpart D, § 46.407
4
1
1
4Total



10
 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