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Parent RIN:   0910-AA01
HHS/FDA	RIN: 0910-AD25	Publication ID: Spring 2003

Title: Cough/Cold (Combination) 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. 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

Timetable: Action Date FR Cite Final Action  12/23/2002  67 FR 78158    NPRM (Amendment)  02/00/2004

Regulatory Flexibility Analysis Required: Yes	Government Levels Affected: None
Small Entities Affected: Businesses	Federalism: No
Included in the Regulatory Plan: No
Agency Contact: