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HHS/FDA RIN: 0910-AF69 Publication ID: Spring 2015 
Title: Over-the-Counter (OTC) Drug Review--Topical Antimicrobial Drug Products 
Abstract:

The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective, and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses antimicrobial agents in healthcare antiseptic products.

 
Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Yes  Unfunded Mandates: Private Sector 
CFR Citation: 21 CFR 201    21 CFR 310    21 CFR 330 to 358   
Legal Authority: 21 U.S.C. 321p    21 U.S.C. 331    21 U.S.C. 351 to 353    21 U.S.C. 355    21 U.S.C. 360    21 U.S.C. 371   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM (Healthcare)  06/17/1994  59 FR 31402   
Comment Period End  12/15/1995    
NPRM (Consumer Hand Wash Products)  12/17/2013  78 FR 76443   
NPRM (Healthcare Antiseptic)  05/01/2015  80 FR 25166   
NPRM Comment Period End  10/28/2015 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Local, State 
Small Entities Affected: Businesses  Federalism: Yes 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: Yes 
Agency Contact:
Janice Adams-King
Regulatory Project Manager
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, WO 22, Room 5416, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-3713
Email: janice.adams-king@fda.hhs.gov