Information Collection Request

Premarket Tobacco Product Applications and Recordkeeping Requirements

ICR 202306-0910-005 · OMB 0910-0879 · Active

⚠️ Notice: This information collection may be outdated.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

Forms and Documents

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

IC Document Collections

IC ID	Collection	Type	Status	Form
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

Status	Active
Agency/Subagency	HHS/FDA
OMB Control No	0910-0879
Type of Information Collection	No material or nonsubstantive change to a currently approved collection
Previous ICR Reference No	202210-0910-002
Agency Tracking No	CTP
Date Submitted to OIRA	2023-06-21
Requested Expiration Date	1969-12-31