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HHS/FDA RIN: 0910-AG12 Publication ID: 2012 
Title: Over-the-Counter (OTC) Drug Review--Pediatric Dosing for Cough/Cold 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 will propose changes to the final monograph to address safety and efficacy issues associated with pediatric cough and cold 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 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  06/00/2013   
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Local, State 
Small Entities Affected: Businesses  Federalism: Yes 
Included in the Regulatory Plan: No 
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.
RIN Data Printed in the FR: Yes 
Related RINs: Related to 0910-AF31, Related to 0910-AF32, Related to 0910-AF33, Related to 0910-AF34 
Agency Contact:
Mary Chung
Regulatory Health Project Manager
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, WO 22, Room 5488, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-0260
Fax:301 796-9899
Email: mary.chung@fda.hhs.gov

 
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