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HHS/FDA RIN: 0910-AF95 Publication ID: Spring 2011 
Title: Over-the-Counter (OTC) Drug Review-Certain Category II Active Ingredients 
Abstract: The Food and Drug Administration (FDA) is proposing that certain ingredients in over-the-counter (OTC) drug products are not generally recognized as safe and effective or are misbranded. FDA issued this proposed rule because we did not receive any data and information on these ingredients in response to our request on December 31, 2003 (68 FR 75585). This rule will finalize the 2008 proposed rule. 
Agency: Department of Health and Human Services(HHS)  Priority: Routine and Frequent 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
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 371   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  06/19/2008  73 FR 34895   
NPRM Comment Period End  09/17/2008    
Withdrawn  03/11/2011    
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:
David Eng
Regulatory Project Manager
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, WO 22, Room 5487, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-2773
Fax:301 796-9899
Email: david.eng@fda.hhs.gov