Information Collection Request
Tobacco Health Document Submission
ICR 202303-0910-012 · OMB 0910-0654 · Active
⚠️ Notice: This information collection may be outdated. More recent filings for OMB 0910-0654 can be found here:
Forms and Documents
| Document | Type | Status | Availability |
|---|---|---|---|
 Form FDA 3743 Tobacco Health Document Submission |
Form and Instruction | Unchanged | Available |
| Form FDA 3743 Tobacco Health Document Submission |
Form and Instruction | Unchanged | Repair queued |
 OMB Change Request Memo 0654 3.23.docx |
Justification for No Material/Nonsubstantive Change | Uploaded 2023-03-15 | Available |
| OMB Change Request Memo 0654 3.23.docx |
Justification for No Material/Nonsubstantive Change | Uploaded 2023-03-15 | Repair queued |
| 0654SupportingStatementFinal 08-03-22.docx |
Supporting Statement A | Uploaded 2022-08-03 | Available |
| 0654SupportingStatementFinal 08-03-22.docx |
Supporting Statement A | Uploaded 2022-08-03 | Repair queued |
IC Document Collections
| IC ID | Collection | Type | Status | Form |
|---|---|---|---|---|
| 254991 |  Health Document Submission Requirements for Tobacco Products; Guidance for Industry |
Other-Guidance: Health Document Submission Requirements for Toba | Modified | |
| 191698 | Tobacco Health Document Submission |
Form and Instruction | Unchanged | |
| 191698 | Tobacco Health Document Submission |
Form and Instruction | Unchanged |
ICR Details
| Status | Active |
|---|---|
| Agency/Subagency | HHS/FDA |
| OMB Control No | 0910-0654 |
| Type of Information Collection | No material or nonsubstantive change to a currently approved collection |
| Previous ICR Reference No | 202201-0910-006 |
| Agency Tracking No | CTP |
| Date Submitted to OIRA | 2023-03-23 |
| Requested Expiration Date | 1969-12-31 |