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HHS/FDA RIN: 0910-AH45 Publication ID: Fall 2016 
Title: ●Record-keeping Requirements for Certain Submissions to FDA  
Abstract:

The Food and Drug Administration is proposing regulations to establish recordkeeping requirements for certain submissions to FDA. This regulation would establish recordkeeping requirements for premarket tobacco product applications, modified risk tobacco product applications, requests for exemption from substantial equivalence, and abbreviated reports. This regulation would also establish recordkeeping requirements for 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: No 
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 to 387k   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  07/00/2017 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
Small Entities Affected: Businesses  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 51, Room 5198,
Silver Spring, MD 20993
Phone:301 796-4040
Email: darin.achilles@fda.hhs.gov

Bryant Godfrey
Senior Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Ave., ,
Silver Spring, MD 20993
Phone:877 287-1373
Email: ctpregulations@fda.hhs.gov