Premarket Tobacco Product Applications and Recordkeeping Requirements

This information collection supports Food and Drug Administration requirements for the content and format of Premarket Tobacco Applications (PMTA) Reports which are utilized for the premarket review of new tobacco products. Section 910 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 387(j)), established requirements for premarket review of new tobacco products and the implementing regulations per the PMTA final rule (86 FR 55300, October 5, 2021) that are found in 21 CFR 1114. This information collection supports requirements for the content and format of Premarket Tobacco Applications (PMTA) Reports which are utilized for the premarket review of new tobacco products. The information collection contains requirements related to the basic content and format of premarket tobacco product applications (PMTAs), the procedure by which FDA would review PMTAs, and the maintenance of records regarding the legal marketing of certain tobacco products without PMTAs. The information collection also contains requirements related to the procedures of retention of records related to the PMTA, confidentiality of application information, electronic submission of the PMTA and amendments, and postmarket reporting requirements. There are three FDA forms required for use under sections 1114.7(b) and 1114.9(a) when submitting PMTA information to the Agency. Forms FDA 4057 and 4057b are required when submitting PMTA single and bundled submissions. Form FDA 4057a is for use when firms are submitting amendments and other general correspondence. Form FDA 4057b assists industry and FDA in identifying the products that are the subject of a submission. The new CTP Portal NG application will provide web forms for PMTA applications and amendments, respectively, which will improve the submission preparation process for the tobacco industry.

The latest form for Premarket Tobacco Product Applications and Recordkeeping Requirements expires 2028-03-31 and can be found here.

Reporting: PMTA submission; amendment; unique identification for new products; validator spreadsheet; periodic reports; change in ownership; supplemental applications; resubmissions; waiver

Federal Enterprise Architecture: Health - Consumer Health and Safety

Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.