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HHS/FDA RIN: 0910-AI07 Publication ID: Fall 2022 
Title: Protection of Human Subjects and Institutional Review Boards 

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 part 46, subpart A)). The rule also proposes minor amendments to related regulatory provisions.

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: No 
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

Action Date FR Cite
NPRM  09/28/2022  87 FR 58733   
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:
Sheila Brown
Health Policy Analyst
Department of Health and Human Services
Food and Drug Administration
Office of Clinical Policy, 10903 New Hampshire Avenue, WO 32, Room 5109,
Silver Spring, MD 20993
Phone:301 796-6563