Regulatory Counsel

0910-AI08 202504 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Institutional Review Boards; Cooperative Research

This rule will replace current FDA requirements for cooperative research such that any institution located in the United States (U.S.) participating in multisite cooperative research will need to rely on approval by a single Institutional Review Board (IRB) for that portion of the research that is conducted in the U.S., with some exceptions. This rule will also establish an IRB recordkeeping requirement for research that takes place at an institution in which IRB oversight is conducted by an IRB that is not operated by the institution.

]]> Economically Significant Previously Published in The Unified Agenda Final Rule Stage Yes Private Sector Deregulatory 21 CFR 56 21 U.S.C. 343 21 U.S.C. 346 21 U.S.C. 348 21 U.S.C. 350a and 350b 21 U.S.C. 353 21 U.S.C. 355 21 U.S.C. 360 21 U.S.C. 360c to 360e 21 U.S.C. 360j 21 U.S.C. 360hh to 360pp 21 U.S.C. 360rr to 360ss 21 U.S.C. 371 21 U.S.C. 379e 42 U.S.C. 262 Statutory NPRM 12/13/2019 Section 3023 of the 21st Century Cures Act No NPRM 09/28/2022 87 FR 58752 NPRM Comment Period End 11/28/2022 NPRM Comment Period Extended 11/14/2022 87 FR 68118 NPRM Comment Period Extended End 12/28/2022 Final Rule 01/00/2026 Undetermined None No No No No Darin Achilles Regulatory Counsel 0910 Food and Drug Administration FDA 301 796-4040 darin.achilles@fda.hhs.gov Office of Clinical Policy, 10903 New Hampshire Avenue, WO 32, Room 5103, Silver Spring MD 20993