Information Collection Request
Biologics License Applications; Procedures & Requirements
ICR 202302-0910-011 · OMB 0910-0338 · Received in OIRA
⚠️ Notice: This information collection may be outdated. More recent filings for OMB 0910-0338 can be found here:
Forms and Documents
| Document | Type | Status | Availability |
|---|---|---|---|
 Form Form FDA 2253 Biologics; Licensing; General Biological Products Standards; and Additional Standards |
Form and Instruction | Modified | Available |
| Form 356h Notifications of suspensions |
Form and Instruction | Unchanged | Repair queued |
 0338 BLAs Supporting Statement 2023 REV.docx |
Supporting Statement A | Uploaded 2023-02-26 | Repair queued |
| 0014 and 0338 PDUFA Forms Change Request Sept 2022.docx |
Justification for No Material/Nonsubstantive Change | Uploaded 2022-09-01 | Repair queued |
IC Document Collections
| IC ID | Collection | Type | Status | Form |
|---|---|---|---|---|
| 5935 |  Biologics; Licensing; General Biological Products Standards; and Additional Standards |
Form and Instruction | Modified | |
| 209328 | Notifications of suspensions |
Form and Instruction | Unchanged |
ICR Details
| Status | Received in OIRA |
|---|---|
| Agency/Subagency | HHS/FDA |
| OMB Control No | 0910-0338 |
| Type of Information Collection | Revision of a currently approved collection |
| Previous ICR Reference No | 202209-0910-002 |
| Agency Tracking No | CBER |
| Date Submitted to OIRA | 1969-12-31 |
| Requested Expiration Date | 1969-12-31 |