Premarket Tobacco Product Applications and Recordkeeping Requirements

ICR 202210-0910-002

⚠️ Notice: This information collection may be outdated. More recent filings for OMB 0910-0879 can be found here:

Forms and Documents

Document Name	Status
Form FDA 4057 PMTA submission; amendments; change in ownership; supplementals; resubmissions; reporting; AE reports; waivers Form and Instruction	Modified
0879 ss follow up to emergency approval FINAL 10-11-22.docx Supporting Statement A	2022-10-11
FDA CTP Electronic Submissions (eSub) PIA 1.15.2021.pdf Supplementary Document	2021-01-15

IC Document Collections

IC ID	Document Title	Status
237744	PMTA submission; amendments; change in ownership; supplementals; resubmissions; reporting; AE reports; waivers Form and Instruction	Modified

ICR Details