0910-AH52 201904 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 proposed regulation would permit an Institutional Review Board (IRB) to waive or alter the informed consent requirements under certain conditions for minimal risk clinical investigations. This would facilitate certain minimal risk clinical investigations to support the development of new products to diagnose or treat disease and would harmonize with the HHS Common Rule waiver provision that has been adopted and successfully employed by other agencies. This proposed 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, or address unmet medical needs.

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Final Rule Stage No No Fully or Partially Exempt 21 CFR 50 21 CFR 312 21 CFR 812 21 U.S.C. 321 21 U.S.C. 343 21 U.S.C. 346 21 U.S.C. 346a 21 U.S.C. 348 21 U.S.C. 350a 21 U.S.C. 350b 21 U.S.C. 352 21 U.S.C. 353 21 U.S.C. 355 21 U.S.C. 360 21 U.S.C. 360c to 360f 21 U.S.C. 360h to 360j 21 U.S.C. 371 21 U.S.C. 379e 21 U.S.C. 381 42 U.S.C. 216 42 U.S.C. 241 42 U.S.C. 262 42 U.S.C. 263b to 263n No NPRM 11/15/2018 83 FR 57378 NPRM Comment Period Extended 12/20/2018 83 FR 65322 NPRM Comment Period End 02/13/2019 Final Rule 04/00/2020 Undetermined 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