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HHS/FDA RIN: 0910-AF40 Publication ID: Spring 2014 
Title: Over-the-Counter (OTC) Drug Review--Oral Health Care 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. The NPRM will address the safety of oral health care products containing benzocaine. 
Agency: Department of Health and Human Services(HHS)  Priority: Routine and Frequent 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 201    21 CFR 310    21 CFR 330 to 358   
Legal Authority: 21 USC 321p    21 USC 331    21 USC 351 to 353    21 USC 355    21 USC 360 to 360a    21 USC 371 to 371a   
Legal Deadline:  None
Timetable:
Action Date FR Cite
ANPRM (Plaque Gingivitis)  05/29/2003  68 FR 32232   
ANPRM Comment Period End  08/27/2003    
NPRM (Benzocaine Labeling)  12/00/2014 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Local, State 
Federalism: Yes 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Related RINs: Split from 0910-AA01 
Agency Contact:
Janice Adams-King
Regulatory Health 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
Fax:301 796-9899
Email: janice.adams-king@fda.hhs.gov