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HHS/FDA RIN: 0910-AH89 Publication ID: Spring 2020 
Title: Format and Content of Reports Intended to Demonstrate Substantial Equivalence 
Abstract:

This proposed rule would establish the format and content of reports intended to demonstrate substantial equivalence (SE) in tobacco products and would 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 
EO 13771 Designation: Deregulatory 
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  07/00/2020 
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 L. Marthaler
Supervisory Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Tobacco Products, 10903 New Hampshire Avenue, Document Control Center, Building 71, Room G335,
Silver Spring, MD 20993
Phone:877 287-1373
Fax:877 287-1426
Email: ctpregulations@fda.hhs.gov