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HHS/FDA RIN: 0910-AI08 Publication ID: Fall 2022 
Title: Institutional Review Boards; Cooperative Research 
Abstract:

This proposed rule would replace current FDA requirements for cooperative research such that any institution located in the United States (U.S.) participating in multisite cooperative research would 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 proposed rule would 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.

 
Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Yes  Unfunded Mandates: Private Sector 
CFR Citation: 21 CFR 56   
Legal Authority: 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   
Legal Deadline:
Action Source Description Date
NPRM  Statutory    12/13/2019 

Overall Description of Deadline: Section 3023 of the 21st Century Cures Act

Timetable:
Action Date FR Cite
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 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
David Markert
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Office of Clinical Policy, 10903 New Hampshire Avenue, WO 32, Room 5174,
Silver Spring, MD 20993
Phone:301 796-0792
Email: david.markert@fda.hhs.gov