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HHS/FDA

RIN: 0910-AH74

Publication ID: Spring 2018

Title: Record Keeping Requirements Related to Tobacco Product Applications
Abstract: The Food and Drug Administration is proposing regulations to establish recordkeeping requirements for persons who submit certain tobacco product submissions to FDA, such as premarket tobacco product applications, modified risk tobacco product applications, requests for exemption from substantial equivalence, and abbreviated reports. The manufacturer would be required to maintain all records necessary to support the application or submission. This regulation would also establish recordkeeping requirements for persons who commercially market tobacco products that were commercially marketed (other than exclusively in test markets) in the United States as of February 15, 2007.
Agency: Department of Health and Human Services(HHS)	Priority: Other Significant
RIN Status: Previously published in the Unified Agenda	Agenda Stage of Rulemaking: Completed Actions
Major: No	Unfunded Mandates: No
EO 13771 Designation: Regulatory
CFR Citation: 21 CFR 1100 21 CFR 1107
Legal Authority: 21 U.S.C. 371 21 U.S.C. 374 21 U.S.C. 387i 21 U.S.C. 387j 21 U.S.C. 387k

Legal Deadline: None

Timetable:

Action	Date	FR Cite
Withdrawn	02/14/2018

Regulatory Flexibility Analysis Required: No	Government Levels Affected: None
Small Entities Affected: No	Federalism: No
Included in the Regulatory Plan: No
RIN Data Printed in the FR: No
Agency Contact: Darin Achilles Regulatory Counsel Department of Health and Human Services Food and Drug Administration Office of Clinical Policy, 10903 New Hampshire Avenue, WO 32, Room 5103, Silver Spring, MD 20993 Phone:301 796-4040 Email: darin.achilles@fda.hhs.gov