Rules and Regulations. Notice

Agency: Office of the Secretary, HHS
Action: Notice
Citation: FR Doc. 2025-09000 · Document Identifier: OS-0990-0481

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 June 20, 2025.

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/OASH Consultation Process, Institutional Review Board (IRB) Records. Type of Collection: Reinstatement without changes. OMB No. 0990-0481. Abstract: The Office of the Assistant Secretary for Health (OASH), Office for Human Research Protections (OHRP) is requesting reinstatement of the Office of Management and Budget (OMB) information collection request, OMB No. 0990-0481, For OASH/HHS Consultation Process, Institutional Review Board (IRB) Records, with no changes, for a three-year period. The previous information collection was approved by OMB on February 14, 2022, and expired on February 28, 2025. 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.g., 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. Likely Respondents: IRBs. Annualized Burden Hour Table 45 CFR part 46—HHS Consultation process provision Respondent type Number of respondents Number of respondents Average burden per response (in hours) Total burden hours subpart B, § 46. 207 IRBs 3 1 1 3 subpart C, § 46.306(a)(2) (iii) and (iv) IRBs 3 1 1 3 subpart D, § 46.407 IRBs 4 1 1 4 Total 10 Susan R. Little, Department Information Collection Clearance Officer, Paperwork Reduction Act Program, Department of Health and Human Services. [FR Doc. 2025-09000 Filed 5-19-25; 8:45 am]