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HHS/FDA RIN: 0910-AI08 Publication ID: Spring 2019 
Title: Institutional Review Boards; Cooperative Research 

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: Undetermined 
EO 13771 Designation: Deregulatory 
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    21 U.S.C. 360e - 360j    21 U.S.C. 360hh - 360pp    21 U.S.C 360rr - 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

Action Date FR Cite
NPRM  08/00/2019 
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:
Bridget Foltz
Health Scientist Policy Analyst
Department of Health and Human Services
Food and Drug Administration
Office of Good Clinical Practice, 10903 New Hampshire Avenue, WO 32, Room 5174,
Silver Spring, MD 20993
Phone:301 796-8348