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HHS/FDA | RIN: 0910-AH06 | Publication ID: Fall 2019 |
Title: Investigational Tobacco Product Applications | |
Abstract:
The proposed rule would define an investigational tobacco product (ITP) and describe the procedures and requirements relating to the use of investigational tobacco products in a clinical investigation, including the procedures and requirements for the submission to, and review by, FDA of an ITP application. The proposed rule will also set forth responsibilities of those involved with the investigation along with reporting and recordkeeping requirements. |
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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 |
EO 13771 Designation: Regulatory | |
CFR Citation: 21 CFR 1112 | |
Legal Authority: 21 U.S.C. 387j(g), Federal Food, Drug, and Cosmetic Act 21 U.S.C. 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: Annette L. Marthaler Deputy Director 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:877 287-1373 Email: ctpregulations@fda.hhs.gov |