Information Collection Request
Biological Products; General records and postmarket adverse experience reporting
ICR 202303-0910-016 · OMB 0910-0308 · Active
⚠️ Notice: This information collection may be outdated. More recent filings for OMB 0910-0308 can be found here:
Forms and Documents
| Document | Type | Status | Availability |
|---|---|---|---|
 Form 3500A Biological products Reporting |
Form | Unchanged | Repair queued |
| Form 3500A Biological products Reporting |
Form | Unchanged | Missing upstream |
| Form 3500A Biological products; Recordkeeping |
Form | Unchanged | Available |
| Form 3500A Biological products; Recordkeeping |
Form | Unchanged | Repair queued |
 83-C for 0308 to add Combo Product AER disclosure MARCH 2023.docx |
Justification for No Material/Nonsubstantive Change | Uploaded 2023-03-20 | Available |
| 83-C for 0308 to add Combo Product AER disclosure MARCH 2023.docx |
Justification for No Material/Nonsubstantive Change | Uploaded 2023-03-20 | Repair queued |
| 0308 BLAs VAERS SSA 2021 EXT.docx |
Supporting Statement A | Uploaded 2021-03-14 | Available |
| 0308 BLAs VAERS SSA 2021 EXT.docx |
Supporting Statement A | Uploaded 2021-03-14 | Repair queued |
IC Document Collections
| IC ID | Collection | Type | Status | Form |
|---|---|---|---|---|
| 5877 |  Biological products Reporting |
Form | Unchanged | |
| 5877 | Biological products Reporting |
Form | Unchanged | |
| 259220 | Postmarketing Safety Reporting for Combination Products |
New | ||
| 185787 | Biological products; Recordkeeping |
Form | Unchanged | |
| 185787 | Biological products; Recordkeeping |
Form | Unchanged |
ICR Details
| Status | Active |
|---|---|
| Agency/Subagency | HHS/FDA |
| OMB Control No | 0910-0308 |
| Type of Information Collection | No material or nonsubstantive change to a currently approved collection |
| Previous ICR Reference No | 202102-0910-007 |
| Agency Tracking No | CBER |
| Date Submitted to OIRA | 2023-03-20 |
| Requested Expiration Date | 1969-12-31 |