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HHS/FDA RIN: 0910-AH59 Publication ID: Spring 2018 
Title: Establishment Registration and Product Listing for Tobacco Products 

The proposed regulation prescribes the format, content, and procedures for establishment registration and tobacco product listings for both domestic and foreign manufacturers of tobacco products. The registration submission would include a manufacturer submitting general information about the manufacturing operation (e.g., the name of the company, location of the facility, contact telephone number) and the product listing submission would include information about the tobacco products it manufacturers. The proposed rule defines who would be required to register and list, when they would be required to register and list, how they would be required to register and list, and describes the type of listing information that manufactures would be required to submit to FDA. The proposed regulations generally would require the electronic submission of all registration and listing information. In addition, the rule would require owners or operators to maintain a historical file of labeling and advertisements.

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: Yes  Unfunded Mandates: No 
EO 13771 Designation: Regulatory 
CFR Citation: 21 CFR 1107   
Legal Authority: 21 U.S.C. 387   
Legal Deadline:  None
Action Date FR Cite
NPRM  11/00/2018 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Undetermined 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Matthew Brenner
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:877 287-1373