Premarket Tobacco Product Applications and Recordkeeping Requirements

ICR 202306-0910-005

OMB: 0910-0879

Federal Form Document

⚠️ Notice: This information collection may be outdated.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

2023-09-08 - No material or nonsubstantive change to a currently approved collection

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
Form FDA 4057 PMTA submission; amendments; change in ownership; supplementals; resubmissions; reporting; AE reports; waivers Form and Instruction	Modified
0910-0879 OMB Change Request Memo 6.2023.docx Justification for No Material/Nonsubstantive Change	2023-06-21
0910-0879 OMB Change Request Memo 6.2023.docx Justification for No Material/Nonsubstantive Change	2023-06-21
0910-0879 SSA AMENDED FINAL 6.2023.docx Supporting Statement A	2023-06-21
0910-0879 SSA AMENDED FINAL 6.2023.docx Supporting Statement A	2023-06-21
FDA CTP Electronic Submissions (eSub) PIA 1.15.2021.pdf Supplementary Document	2021-01-15
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
237744	PMTA submission; amendments; change in ownership; supplementals; resubmissions; reporting; AE reports; waivers Form and Instruction	Modified

ICR Details

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