PMTA submission; amendments; change in ownership; supplementals; resubmissions; reporting; AE reports; waivers

Premarket Tobacco Product Applications and Recordkeeping Requirements

OMB: 0910-0879

IC ID: 237744

Documents and Forms

Document Name Document Type
Form FDA 4057 PMTA submission; amendments; change in ownership; supplementals; resubmissions; reporting; AE reports; waivers Form and Instruction
FDA 4057 Premarket Tobacco Product Application (PMTA) Submission FDA-Form-4057_Sept 23.pdf Form and Instruction
FDA 4057a Premarket Tobacco Product Application Amendment and General Correspondence Submission FDA 4057a.pdf Form and Instruction
FDA 4057b Unique Identifying Information for New Tobacco Products Form FDA 4057b Product Grouping_v3.0_Sept_23.xlsm Form and Instruction
Sep_23 Validator Tool Screenshots.docx Other-Validator Tool Screenshots