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HHS/FDA RIN: 0910-AH40 Publication ID: Spring 2017 
Title: Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use (Healthcare Antiseptic) 
Abstract:

This rulemaking addresses whether FDA considers certain active ingredients in over the counter (OTC) consumer antiseptic hand wash and health care antiseptic products to be generally recognized as safe and effective.  If FDA determines that the ingredient is not generally recognized as safe and effective, a manufacturer will not be able to market the product unless it submits and receives approval of a new drug application. 

 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 310    21 CFR 333   
Legal Authority: 21 U.S.C. 321    21 U.S.C. 331    21 U.S.C. 351 to 353    21 U.S.C. 355    21 U.S.C. 360 to 361    21 U.S.C. 371    21 U.S.C. 374 to 375    21 U.S.C. 379    42 U.S.C. 216    42 U.S.C. 241    42 U.S.C. 262   
Legal Deadline:
Action Source Description Date
Final  Statutory    09/15/2016 
Timetable:
Action Date FR Cite
NPRM  12/17/2013  78 FR 764444   
NPRM Comment Period End  06/16/2014 
Final Action  01/00/2018 
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:
Pranvera Ikonomi
Biologist
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:240 402-0272
Email:  pranvera.ikonomi@fda.hhs.gov