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HHS/FDA | RIN: 0910-AF43 | Publication ID: Spring 2011 |
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. The first action finalizes sunscreen labeling and testing requirements for both ultraviolet B and ultraviolet A radiation protection. The second action addresses other safety and effectiveness issues for OTC sunscreen drug products. The third action addresses active ingredients reviewed under Time and Extent Applications. The fourth action addresses the safety of sunscreen products. The last action addresses combination products containing sunscreen and insect repellent ingredients. | |
Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule 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 331 21 USC 351 to 353 21 USC 355 21 USC 360 21 USC 371 |
Legal Deadline:
None |
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Timetable:
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Additional Information: The proposed rule is economically significant and a major rule (reviewed under 0910-ZA39). The final rule is not economically significant nor a major rule. | |
Regulatory Flexibility Analysis Required: Yes | Government Levels Affected: Local, State |
Small Entities Affected: Businesses | Federalism: No |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: Yes | |
Related RINs: Split from 0910-AA01 | |
Agency Contact: David Eng Regulatory Project Manager Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research, WO 22, Room 5487, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone:301 796-2773 Fax:301 796-9899 Email: david.eng@fda.hhs.gov |