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HHS/FDA RIN: 0910-AF34 Publication ID: Fall 2007 
Title: Over-the-Counter (OTC) Drug Review--Cough/Cold (Nasal Decongestant) 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 the ingredient phenylpropanolamine. 
Agency: Department of Health and Human Services(HHS)  Priority: Routine and Frequent 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final 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; 21 USC 360a; 21 USC 371; 21 USC 371a 
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM (Amendment) (Sinusitis Claim)  08/02/2004  69 FR 46119 
NPRM (Phenylephrine Bitartrate)  11/02/2004  69 FR 63482 
NPRM (Phenylpropanolamine)  12/22/2005  70 FR 75988 
Final Action (Amendment) (Sinusitis Claim)  10/31/2005  70 FR 58974 
Final Action (Phenylephrine Bitartrate)  08/01/2006  71 FR 83358 
Final Action (Phenylpropanolamine)  12/00/2008   
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 
Related RINs: Split from 0910-AA01 
Agency Contact:
Walter J. Ellenberg
Regulatory Project Management Officer
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:301 796-2090
Fax:301 796-9899
Email: walter.ellenberg@fda.hhs.gov

 
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