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HHS/FDA | RIN: 0910-AG12 | Publication ID: Fall 2008 |
Title: ●Pediatric Dosing for Cough, Cold, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Proposed Amendment of Final Monograph | |
Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a monograph is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action will propose changes to the final monograph to address safety and efficacy issues associated with pediatric cough and cold products. | |
Agency: Department of Health and Human Services(HHS) | Priority: Economically Significant |
RIN Status: First time published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
Major: Yes | Unfunded Mandates: Undetermined |
CFR Citation: 21 CFR 201 21 CFR 310 21 CFR 330 to 358 | |
Legal Authority: 21 USC 331 21 USC 351 to 353 21 USC 355 21 USC 360 to 360(a) 21 USC 371 to 371(a) |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: Yes | Government Levels Affected: Local, State |
Small Entities Affected: Businesses | Federalism: Yes |
Included in the Regulatory Plan: No | |
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest. | |
RIN Data Printed in the FR: Yes | |
Related RINs: Related to 0910-AF31, Related to 0910-AF32, Related to 0910-AF33, Related to 0910-AF34 | |
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 |