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HHS/FDA RIN: 0910-AI07 Publication ID: Fall 2021 
Title: Protection of Human Subjects and Institutional Review Boards 
Abstract:

This proposed rule would harmonize, to the extent practicable and consistent with other statutory provisions, certain provisions of FDA’s regulations on human subject protection and institutional review boards with the revised "Federal Policy for the Protection of Human Subjects” (the revised Common Rule (45 CFR 46, subpart A)). The rule also proposes minor amendments to related regulatory provisions.

 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: Undetermined 
CFR Citation: 21 CFR 50    21 CFR 56    21 CFR 812   
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  03/00/2022 
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:
Carol Drew
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Office of Good Clinical Practice, WO 32, Room 5105, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-3505
Email: carol.drew@fda.hhs.gov