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⚠️ Notice: This information collection may be outdated.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 | Available |
| Form FDA 4057 PMTA submission; amendments; change in ownership; supplementals; resubmissions; reporting; AE reports; waivers |
Form and Instruction | Modified | Missing upstream |
 0910-0879 OMB Change Request Memo 6.2023.docx |
Justification for No Material/Nonsubstantive Change | Uploaded 2023-06-21 | Available |
| 0910-0879 OMB Change Request Memo 6.2023.docx |
Justification for No Material/Nonsubstantive Change | Uploaded 2023-06-21 | Missing upstream |
| 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 | Repair queued |
 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 | Missing upstream |
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 |