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HHS/FDA | RIN: 0910-AF43 | Publication ID: Spring 2004 |
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. | |
Agency: Department of Health and Human Services(HHS) | Priority: Routine and Frequent |
RIN Status: First time 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 21USC 371a 21 USC 331 21 USC 360 21 USC 360b 21 USC 361 21 USC 371 |
Legal Deadline:
None |
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Timetable:
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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 |