Premarket Tobacco Product Applications and Recordkeeping Requirements

OMB 0910-0879

Latest Forms, Documents, and Supporting Material

Document Name
Form FDA 4057 Reporting: PMTA submission; amendment; unique identification for new products; validator spreadsheet; periodic reports; change in ownership; supplemental applications; resubmissions; waiver Form and Instruction
Change Request OMB Memo September 2023.docx Justification for No Material/Nonsubstantive Change
0910-0879_SSA_2024._Final 11-21-24.docx Supporting Statement A
0910-0879 OMB Change Request Memo 6.2023.docx Justification for No Material/Nonsubstantive Change
FDA CTP Electronic Submissions (eSub) PIA 1.15.2021.pdf Supplementary Document
Recordkeeping; Premarket Tobacco Product Applications
Reporting: PMTA submission; amendment; unique identification for new products; validator spreadsheet; periodic reports; change in ownership; supplemental applications; resubmissions; waiver Form and Instruction