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HHS/FDA | RIN: 0910-AF95 | Publication ID: Spring 2009 |
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: Long-Term Actions |
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 to 360a 21 USC 371 to 371a |
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 | |
RIN Data Printed in the FR: Yes | |
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 |