Information Collection Request
Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing
ICR 202301-0910-014 · OMB 0910-0458 · Received in OIRA
Forms and Documents
| Document | Type | Status | Availability |
|---|---|---|---|
 Form FDA 3486A Form FDA 3486A; Web-based Addendum |
Form | Modified | Missing upstream |
| Form FDA 3486 HCT/P deviations |
Form and Instruction | Modified | Repair queued |
| Form FDA 3486 Reporting of Product Deviations by Licensed Manufacturers, Unlicensed Registered Blood Establishments, and Transfusion Services |
Form and Instruction | Modified | Repair queued |
 0458 Deviation Reports SSA 2023.docx |
Supporting Statement A | Uploaded 2023-01-24 | Repair queued |
IC Document Collections
| IC ID | Collection | Type | Status | Form |
|---|---|---|---|---|
| 6151 |  Reporting of Biological Product Deviations by Licensed Manufacturer |
Other-IT Landing Page Screenshot | Modified | |
| 178972 | Form FDA 3486A; Web-based Addendum |
Form | Modified | |
| 178971 | HCT/P deviations |
Form and Instruction | Modified | |
| 178970 | Reporting of Product Deviations by Licensed Manufacturers, Unlicensed Registered Blood Establishments, and Transfusion Services |
Form and Instruction | Modified |
ICR Details
| Status | Received in OIRA |
|---|---|
| Agency/Subagency | HHS/FDA |
| OMB Control No | 0910-0458 |
| Type of Information Collection | Extension without change of a currently approved collection |
| Previous ICR Reference No | 201911-0910-003 |
| Agency Tracking No | CBER |
| Date Submitted to OIRA | 1969-12-31 |
| Requested Expiration Date | 1969-12-31 |