Information Collection Request
Biological Products; General records and postmarket adverse experience reporting
ICR 202403-0910-011 · OMB 0910-0308 · Received in OIRA
Forms and Documents
| Document | Type | Status | Availability |
|---|---|---|---|
 Form 3500A Biological products Reporting |
Form | Modified | Repair queued |
| Form 3500A Biological products; Recordkeeping |
Form | Modified | Repair queued |
 0308 Biologics AER including combo products SSA 2024.docx |
Supporting Statement A | Uploaded 2024-04-26 | 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 | Repair queued |
IC Document Collections
| IC ID | Collection | Type | Status | Form |
|---|---|---|---|---|
| 5877 |  Biological products Reporting |
Form | Modified | |
| 259220 | Postmarketing Safety Reporting for Combination Biological Products |
Modified | ||
| 185787 | Biological products; Recordkeeping |
Form | Modified |
ICR Details
| Status | Received in OIRA |
|---|---|
| Agency/Subagency | HHS/FDA |
| OMB Control No | 0910-0308 |
| Type of Information Collection | Extension without change of a currently approved collection |
| Previous ICR Reference No | 202303-0910-016 |
| Agency Tracking No | CBER |
| Date Submitted to OIRA | 1969-12-31 |
| Requested Expiration Date | 1969-12-31 |