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HHS/FDA RIN: 0910-AH74 Publication ID: Fall 2017 
Title: ●Record Keeping Requirements Related to Tobacco Product Applications 

The Food and Drug Administration is proposing regulations to establish recordkeeping and record inspection 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: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: Undetermined 
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
Action Date FR Cite
NPRM  08/00/2018 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Undetermined 
Federalism: Undetermined 
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
Center for Tobacco Products, 10903 New Hampshire Avenue, Document Control Center, Building 71, Room G335,
Silver Spring, MD 20993
Phone:877 287-1373
Fax:301 595-1426