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HHS/FDA RIN: 0910-AG96 Publication ID: Fall 2016 
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)    21 U.S.C. 371    21 U.S.C. 374    21 U.S.C. 387b    21 U.S.C 387c    21 U.S.C. 387i   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  11/00/2016 
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 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