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

This rulemaking addresses whether FDA considers certain active ingredients in over the counter (OTC) healthcare antiseptic hand wash and healthcare 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 
EO 13771 Designation: Regulatory 
CFR Citation: 21 CFR 310   
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. 360b-360f    21 U.S.C. 371    21 U.S.C. 374 to 375    21 U.S.C. 379e    21 U.S.C. 360j    42 U.S.C. 241    42 U.S.C. 262    21 U.S.Cl. 360hh-360ss    ...   
Legal Deadline:
Action Source Description Date
Final  Judicial    01/15/2018 
Timetable:
Action Date FR Cite
NPRM  05/01/2015  80 FR 25166   
NPRM Comment Period End  10/28/2015 
Final Action  01/00/2018 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Federal, State 
Small Entities Affected: Businesses  Federalism: Yes 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: Yes 
Agency Contact:
Michelle Jackson
Microbiologist
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-0923
Email: michelle.jackon@fda.hhs.gov