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HHS/FDA RIN: 0910-AH40 Publication ID: Spring 2018 
Title: Safety and Effectiveness of Healthcare Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use  

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: Completed Actions 
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 to 360f    21 U.S.C. 360j    21 U.S.C. 360hh to 360ss    21 U.S.C. 371    21 U.S.C. 374 to 375    21 U.S.C. 379e    42 U.S.C. 241    42 U.S.C. 262    ...   
Legal Deadline:
Action Source Description Date
Final  Judicial    01/15/2018 
Action Date FR Cite
NPRM  05/01/2015  80 FR 25166   
NPRM Comment Period End  10/28/2015 
Final Action  12/20/2017  82 FR 60474   
Final Action Effective  12/20/2018 
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:
Michelle Jackson
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-0923