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HHS/FDA RIN: 0910-AI07 Publication ID: Spring 2018 
Title: ●Part 50 Protection of Human Subjects and Part 56 Institutional Review Boards 

This direct final rule will amend several sections of FDA’s regulations for the Protection of Human Subjects and Institutional Review Boards to harmonize with the recently revised final HHS Common Rule (42 CFR 46, subpart A).  This rule adds definitions, conforms wording, and makes minor editorial changes to FDA regulations to harmonize with the Common Rule. The rule also makes minor technical amendments unrelated to the harmonization efforts.

Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Other 
CFR Citation: 21 CFR 50    21 CFR 56   
Legal Authority: 21 U.S.C. 321    21 U.S.C. 343    21 U.S.C. 346    21 U.S.C. 346a    21 U.S.C. 348    21 U.S.C. 350a to 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. 360hh to 360ss    21 U.S.C. 371    21 U.S.C. 379e    21 U.S.C. 381    42 U.S.C. 216    42 U.S.C. 262   
Legal Deadline:
Action Source Description Date
Final  Statutory  Direct Final Rule, Part 50 and Part 56  12/13/2019 
Action Date FR Cite
Direct Final Rule  12/00/2018 
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