Information Collection Request
Export Certificates for FDA Regulated Products
ICR 202303-0910-018 · OMB 0910-0498 · Active
⚠️ Notice: This information collection may be outdated. More recent filings for OMB 0910-0498 can be found here:
Forms and Documents
| Document | Type | Status | Availability |
|---|---|---|---|
 Form FDA 3613 CBER Export Certificate (FDA 3613, 3613b, 3613c) |
Form and Instruction | Unchanged | Available |
| Form FDA 3613 CBER Export Certificate (FDA 3613, 3613b, 3613c) |
Form and Instruction | Unchanged | Repair queued |
| Form FDA 3613 CVM Export Certificate (FDA 3613, 3613b) |
Form and Instruction | Unchanged | Available |
| Form FDA 3613 CVM Export Certificate (FDA 3613, 3613b) |
Form and Instruction | Unchanged | Repair queued |
| Form FDA 3613 CDRH Export Certificate (FDA 3613, 3613a, 3613c) |
Form and Instruction | Modified | Available |
| Form FDA 3613 CDRH Export Certificate (FDA 3613, 3613a, 3613c) |
Form and Instruction | Modified | Repair queued |
 21 USC 381 Exports under FFDCA.pdf |
Supplementary Document | Uploaded 2023-03-25 | Available |
| 21 USC 381 Exports under FFDCA.pdf |
Supplementary Document | Uploaded 2023-03-25 | Repair queued |
 0498 Export Certs 83-C for 3613g MARCH 2023.docx |
Justification for No Material/Nonsubstantive Change | Uploaded 2023-03-25 | Available |
| 0498 Export Certs 83-C for 3613g MARCH 2023.docx |
Justification for No Material/Nonsubstantive Change | Uploaded 2023-03-25 | Repair queued |
| 0498 Export Certs SSA REV 2021.docx |
Supporting Statement A | Uploaded 2021-03-03 | Available |
| 0498 Export Certs SSA REV 2021.docx |
Supporting Statement A | Uploaded 2021-03-03 | Repair queued |
IC Document Collections
| IC ID | Collection | Type | Status | Form |
|---|---|---|---|---|
| 6208 |  CBER Export Certificate (FDA 3613, 3613b, 3613c) |
Form and Instruction | Unchanged | |
| 6208 | CBER Export Certificate (FDA 3613, 3613b, 3613c) |
Form and Instruction | Unchanged | |
| 217014 | CDER Export Certificate (FDA 3613f) |
Other-Screenshots of electronic submission of API Drug | Unchanged | |
| 188597 | CVM Export Certificate (FDA 3613, 3613b) |
Form and Instruction | Unchanged | |
| 188597 | CVM Export Certificate (FDA 3613, 3613b) |
Form and Instruction | Unchanged | |
| 188596 | CDRH Export Certificate (FDA 3613, 3613a, 3613c) |
Form and Instruction | Modified | |
| 188596 | CDRH Export Certificate (FDA 3613, 3613a, 3613c) |
Form and Instruction | Modified |
ICR Details
| Status | Active |
|---|---|
| Agency/Subagency | HHS/FDA |
| OMB Control No | 0910-0498 |
| Type of Information Collection | No material or nonsubstantive change to a currently approved collection |
| Previous ICR Reference No | 202208-0910-015 |
| Agency Tracking No | OC |
| Date Submitted to OIRA | 2023-03-27 |
| Requested Expiration Date | 1969-12-31 |