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View EO 12866 Meetings Printer-Friendly Version     Download RIN Data in XML

HHS/FDA RIN: 0910-AA01 Publication ID: Spring 2003 
Title: Over-the-Counter (OTC) Drug Review 
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. SMALL ENTITIES AFFECTED: The effects, if any, vary depending on the individual rulemaking. However, the Agency anticipates that the rules would not have a significant economic impact on a substantial number of small entities as defined by the Regulatory Flexibility Act. 
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 350 
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 360b; 21 USC 361; 21 USC 371 

Legal Deadline:  None
Action Date FR Cite
Child RIN List:
RIN Title
0910-AC65 Anorectal Products
0910-AC71 Antiemetic Products
0910-AC89 Antiperspirant Products
0910-AD31 Cough/Cold (Antihistamine) Products
0910-AD24 Cough/Cold (Antitussive) Products
0910-AD25 Cough/Cold (Combination) Products
0910-AD43 Cough/Cold (Nasal Decongestant) Products
0910-AD06 External Analgesic Products
0910-AD21 Ingrown Toenail Relief Products
0910-AD07 Internal Analgesic Products
0910-AD47 Labeling of Drug Products for OTC Human Use
0910-AD11 Nighttime Sleep Aid Products
0910-AC72 Ophthalmic Products
0910-AC98 Oral Health Care Products
0910-AC79 Pediculicide Products
0910-AD13 Salicylate (Reye's Syndrome)
0910-AC68 Sunscreen Products
0910-AD19 Vaginal Contraceptive Products
0910-AC93 Weight Control Products
0910-AC85 Laxative Drug Products
0910-AC82 Antidiarrheal Products
0910-AD33 Cough/Cold (Bronchodilator) Products
0910-AC96 Skin Protectant Products
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
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

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