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HHS/FDA RIN: 0910-AG96 Publication ID: Spring 2013 
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: First time 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  06/00/2014   
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, 9200 Corporate Boulevard,
Rockville, MD 20850
Phone:877 287-1373
Fax:240 276-4193
Email: gerie.voss@fda.hhs.gov

 
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