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HHS/FDA | RIN: 0910-AH06 | Publication ID: Fall 2014 |
Title: Investigational Tobacco Product Applications | |
Abstract: The proposed rule would define "investigational tobacco product" and describe the procedures and requirements relating to the use of investigational tobacco products in nonclinical laboratory studies and clinical investigations. | |
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 1112 | |
Legal Authority: 21 USC 387j(g), Federal Food, Drug, and Cosmetic Act 21 USC 371 |
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 |