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HHS/FDA RIN: 0910-AG96 Publication ID: Spring 2014 
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 and compliance with the FD&C Act (sections 905(j) and 910(a) of the FD&C Act). 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 USC 387e(j)    21 USC 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  02/00/2015 
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:
Gerie Voss
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Tobacco Products, Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave.,
Silver Spring, MD 20993
Phone:877 287-1373
Fax:301 595-1426
Email: ctpregulations@fda.hhs.gov