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HHS/FDA RIN: 0910-AH89 Publication ID: Spring 2021 
Title: Format and Content of Reports Intended to Demonstrate Substantial Equivalence 
Abstract:

This final rule will establish the format and content of reports intended to demonstrate substantial equivalence (SE) in tobacco products and will provide information as to how the Agency will review and act on these submissions.

 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 1107   
Legal Authority: 21 U.S.C. 371    21 U.S.C. 374    21 U.S.C. 387    42 U.S.C. 4332   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  04/02/2019  84 FR 12740   
NPRM Comment Period End  07/17/2019 
Final Rule  05/00/2021 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Annette Marthaler
Senior Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Office of Combination Products, 10903 New Hampshire Avenue, WO32, Room 5129,
Silver Spring, MD 20993
Phone:240 753-3043
Email: annette.marthaler@fda.hhs.gov