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HHS/FDA RIN: 0910-AH89 Publication ID: Spring 2018 
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: Proposed Rule Stage 
Major: No  Unfunded Mandates: Undetermined 
EO 13771 Designation: Other 
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  08/00/2018 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: Yes 
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