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HHS/FDA | RIN: 0910-AG01 | Publication ID: Spring 2007 |
Title: ●Over-the-Counter (OTC) Drug Review--Multiple Drug Products | |
Abstract: Amendments to the Federal Food, Drug, and Cosmetic Act (the act) necessitate several changes to the citations used in Food and Drug Administration (FDA) regulations regarding the prescription-exemption procedure and the list of new drugs that are exempted from the prescription-dispensing requirements. These changes are editorial, pertaining only to citations, and do not constitute a change in FDA regulation. | |
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: Completed 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 21 USC 360a 21 USC 371 21 USC 371a |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: No | Government Levels Affected: Local, State |
Small Entities Affected: No | Federalism: Yes |
Included in the Regulatory Plan: No | |
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 |