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HHS/FDA | RIN: 0910-AH44 | Publication ID: Fall 2016 |
Title: ●Premarket Tobacco Product Applications | |
Abstract:
This proposed rule would establish content and format requirements to ensure that premarket tobacco product applications contain sufficient information for FDA to determine whether the marketing of a new tobacco product should be authorized. Additionally, the proposed rule would set forth the basic procedures for premarket tobacco product application review and require applicants receiving marketing authorization to establish records and make postmarket reports to FDA. |
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Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
RIN Status: First time published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
Major: Undetermined | Unfunded Mandates: No |
CFR Citation: 21 CFR 1114 | |
Legal Authority: 21 U.S.C. 371 21 U.S.C. 387a 21 U.S.C. 387b 21 .U.S.C. 387i 21 U.S.C. 387j ... |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: Undetermined | Government Levels Affected: None |
Federalism: No | |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Agency Contact: Paul Hart Senior Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Tobacco Products, 10903 New Hampshire Avenue, Document Control Center, Building 71, Room G335, Silver Spring, MD 20993 Phone:301 796-3894 Email: ctpregulations@fda.hhs.gov |