Agency Information Collection Request; 60-Day Public Comment Request

<NOTICE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <DEPDOC>[Document Identifier: OS-0990-0481]</DEPDOC> <SUBJECT>Agency Information Collection Request; 60-Day Public Comment Request</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Office of the Secretary, HHS. <HD SOURCE="HED">ACTION:</HD> Notice. <SUM> <HD SOURCE="HED">SUMMARY:</HD> 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. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> Comments on the ICR must be received on or before March 7, 2025. </DATES> <HD SOURCE="HED">ADDRESSES:</HD> Submit your comments to <E T="03">Sherrette.Funn@hhs.gov</E> or by calling (202) 264-0041 and <E T="03">PRA@HHS.GOV</E> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> When submitting comments or requesting information, please include the document identifier 0990-0481-60D and project title for reference, to Sherrette A. Funn, email: <E T="03">Sherrette.Funn@hhs.gov, PRA@HHS.GOV</E> or call (202) 264-0041 the Reports Clearance Officer. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> 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. <E T="03">Title of the Collection:</E> For HHS/OASH Consultation Process, Institutional Review Board (IRB) Records. <E T="03">Type of Collection:</E> Renewal, 3-year extension without change. <E T="03">OMB No.:</E> 0990-0481 <E T="03">Abstract:</E> The Office of the Assistant Secretary for Health (OASH), Office for Human Research Protections (OHRP) is requesting a 3-year extension without change to the currently approved information collection request, For OASH/HHS Consultation Process, Institutional Review Board (IRB) Records, OMB No. 0990-0481. The purpose of the collection is for OHRP to receive IRB records when an IRB or an institution requests an HHS consultation process for proposed research that is not otherwise approvable by an IRB involving, respectively: (1) pregnant women, human fetuses and neonates; (2) prisoners; or, (3) children, as subjects. The information that must be submitted to OHRP by an IRB or institution includes the research protocol, consent form, parental permission and child assent forms (if relevant), and other relevant IRB records ( <E T="03">e.g.,</E> IRB minutes). 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 meeting other procedural requirements. <E T="03">Likely Respondents:</E> IRBs. <GPOTABLE COLS="06" OPTS="L2,i1" CDEF="s40,xs54,12,12,12,12"> <TTITLE>Annualized Burden Hour Table</TTITLE> <CHED H="1">45 CFR part 46—HHS consultation process provision</CHED> <CHED H="1">Respondent type</CHED> <ENT I="01">subpart B, § 46. 207</ENT> <ENT>IRBs</ENT> <ENT I="01">subpart C, § 46.306 (iii) and (iv)</ENT> <ENT>IRBs</ENT> <ENT I="01">subpart D, § 46.407</ENT> <ENT>IRBs</ENT> <NAME>Vivianna P. Cowl,</NAME> Paperwork Reduction Act Reports Clearance Officer, Health and Human Services, Office of the Secretary. </SIG> </SUPLINF> <FRDOC>[FR Doc. 2024-31615 Filed 1-3-25; 8:45 am]</FRDOC> </NOTICE>