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HHS/FDA RIN: 0910-AG96 Publication ID: Fall 2015 
Title: Format and Content of Reports Intended to Demonstrate Substantial Equivalence 
Abstract: This regulation would establish the format and content of reports intended to demonstrate substantial equivalence. This regulation also 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: No 
CFR Citation: 21 CFR 1107   
Legal Authority: 21 U.S.C. 387e(j)    21 U.S.C. 387j(a)    secs 905(j) and 910(a) of the Federal Food, Drug, and Cosmetic Act   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  07/00/2016 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: Yes 
Agency Contact:
Annette L. Marthaler
Deputy Director
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
Email: ctpregulations@fda.hhs.gov