0910-AH52 202304 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations

This regulation would permit an Institutional Review Board (IRB) to waive or alter certain informed consent elements or to waive the requirement to obtain informed consent under limited conditions, for certain minimal risk clinical investigations. This would facilitate certain minimal risk clinical investigations to support the development of new products to diagnose or treat diseases or conditions and would harmonize, to the extent practicable and consistent with statutory provisions, with the HHS Common Rule waiver provision that has been adopted and successfully employed by other agencies. This regulation is intended to aid patient access to new products by facilitating investigators’ ability to conduct studies that may contribute substantially to the development of products to diagnose or treat diseases or conditions, including products that may address unmet medical needs.

]]> Other Significant Previously Published in The Unified Agenda Final Rule Stage No No 21 CFR 50 21 CFR 312 21 CFR 812 21 U.S.C. 355(i)(4) 21 U.S.C. 360j(g)(3) 21 U.S.C. 371(a) No NPRM 11/15/2018 83 FR 57378 NPRM Comment Period Extended 12/20/2018 83 FR 65322 NPRM Comment Period End 01/14/2019 NPRM Comment Period Extended End 02/13/2019 NPRM Comment Period Reopened 02/25/2019 84 FR 5968 NPRM Comment Period Reopened End 03/07/2019 Final Rule 11/00/2023 No No None No No No No Lauren Milner Regulatory Policy Advisor 0910 Food and Drug Administration FDA 301 796-5114 lauren.milner@fda.hhs.gov Office of Clinical Policy, 10903 New Hampshire Avenue, WO 32, Room 5103, Silver Spring MD 20993-0002