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HHS/FDA RIN: 0910-AF43 Publication ID: Spring 2005 
Title: Over-the-Counter (OTC) Drug Review--Sunscreen 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. One action addresses formulation, labeling, and testing requirements for both ultraviolet B (UVB) and ultraviolet A (UVA) radiation protection, and the other action addresses combination products containing sunscreen and insect repellent ingredients. 
Agency: Department of Health and Human Services(HHS)  Priority: Routine and Frequent 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Prerule 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 351 to 353; 21 USC 355; 21 USC 360a; 21 USC 371a; 21 USC 331; 21 USC 360; 21 USC 371 
Legal Deadline:  None
Timetable:
Action Date FR Cite
ANPRM (Sunscreen and Insect Repellent)  10/00/2005   
NPRM (UVA/UVB)  12/00/2005   
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
Related RINs: Split from 0910-AA01 
Agency Contact:
Gerald M. Rachanow
Regulatory Counsel, Division of Over-the-Counter Drug Products
Department of Health and Human Services
Food and Drug Administration
HFD-560, Center for Drug Evaluation and Research (HFD-560), 5600 Fishers Lane,
Rockville, MD 20857
Phone:301 827-2241
Fax:301 827-2315
Email: gerald.rachanow@fda.hhs.gov

 
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