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HHS/FDA RIN: 0910-AI07 Publication ID: Spring 2019 
Title: Part 50 Protection of Human Subjects and Part 56 Institutional Review Boards 
Abstract:

This proposed rule would harmonize, to the extent practicable and consistent with other statutory provisions, several sections certain provisions of FDA’s regulations on human subject protection and institutional review boards with the recently 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: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Deregulatory 
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    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. 371    21 U.S.C. 379e    21 U.S.C. 360rr to 360ss    42 U.S.C. 262    21 U.S.C. 350b   
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  09/00/2019 
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:
Carol Drew
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Tobacco Products, Document Control Center, Building 71, Room G335, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-6563
Email: carol.drew@fda.hhs.gov