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HHS/FDA | RIN: 0910-AH06 | Publication ID: Fall 2013 |
Title: ●Investigational Tobacco Product Applications and General Information Regarding Submission of Information to Support Legal Marketing | |
Abstract: The investigational tobacco product application regulation would codify procedures and requirements relating to the use of investigational tobacco products in nonclinical and clinical studies. Both the Agency and industry are seeking more certainty regarding the conditions under which FDA will, under section 910(g) of the FD&C Act, exempt tobacco products intended for investigational use from the tobacco product provisions in Chapter IX of the FD&C Act. The investigational tobacco product application regulation would describe the information that must be included in an investigational tobacco product application and how the Agency will act on these applications. The general information regulations would codify procedures relating generally to the submission of information to support the legal marketing and/or investigational use of tobacco products, including the submission of information to tobacco product master files. | |
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: No | Unfunded Mandates: No |
CFR Citation: 21 CFR 1112 21 CFR 1114 | |
Legal Authority: 21 USC 387j(g), Federal Food, Drug, and Cosmetic Act |
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 | |
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest. | |
RIN Data Printed in the FR: No | |
Agency Contact: Gail L. Schmerfeld Senior Regulatory Counsel Department of Health and Human Services Food and Drug Administration HFV-100, Center for Tobacco Products, Document Control Center, Building 71, Room G335, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone:877 287-1373 Fax:301 595-1426 Email: ctpregulations@fda.hhs.gov |