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HHS/FDA RIN: 0910-AF45 Publication ID: Spring 2018 
Title: Over-the-Counter (OTC) Drug Review--Weight Control 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 final action finalizes the 2005 proposed rule for weight control products containing phenylpropanolamine.

 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Long-Term Actions 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Regulatory 
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 (Phenylpropanolamine)  12/22/2005  70 FR 75988   
NPRM Comment Period End  03/22/2006    
NPRM (Benzocaine)  03/09/2011  76 FR 12916   
NPRM Comment Period End  06/07/2011    
Final Action (Phenylpropanolamine)  To Be Determined 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Local, State 
Small Entities Affected: Businesses  Federalism: Undetermined 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: Yes 
Related RINs: Split from 0910-AA01 
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