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HHS/FDA RIN: 0910-AI08 Publication ID: Fall 2018 
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: Undetermined 
EO 13771 Designation: Deregulatory 
CFR Citation: 21 CFR 56   
Legal Authority: 21 U.S.C. 321    21 U.S.C. 343    21 U.S.C. 346 and 346a    21 U.S.C. 348    21 U.S.C. 350a and 350b    21 U.S.C. 351 to 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   
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  04/00/2019 
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
10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-8348
Email: bridget.foltz@fda.hhs.gov