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HHS/FDA RIN: 0910-AG96 Publication ID: Fall 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. 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  07/00/2015 
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
Director of Policy, Office of Dietary Supplement Programs
Department of Health and Human Services
Food and Drug Administration
Humans Foods Program,
College Park, MD 20705
Phone:240 620-9744
Fax:301 595-1426
Email: gerie.voss@fda.hhs.gov