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HHS/FDA RIN: 0910-AF95 Publication ID: Spring 2008 
Title: Status of Certain Additional Over-the-Counter Drug 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 is issuing 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 proposed rule is part of FDA’s ongoing review of OTC drug products. 
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    21 USC 360a    21 USC 371    21 USC 371a   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  06/00/2008    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Local, State 
Small Entities Affected: No  Federalism: Yes 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
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