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| HHS/FDA | RIN: 0910-AF44 | Publication ID: Spring 2008 |
| Title: Over-the-Counter (OTC) Drug Review--Vaginal Contraceptive 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 proposed rule addresses vaginal contraceptive drug products. | |
| Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
| 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 358; 21 USC 360; 21 USC 360a; 21 USC 360gg to 360ss; 21 USC 371; 21 USC 371a; 21 USC 374; 21 USC 379e; 42 USC 216; 42 USC 241; 42 USC 262; 42 USC 264 | |
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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 | |
| Related RINs: Split from 0910-AA01 | |
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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 |
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