Information Collection Request
Applications for FDA Approval to Market a New Drug
ICR 202402-0910-003 · OMB 0910-0001 · Received in OIRA
⚠️ Notice: This information collection may be outdated. More recent filings for OMB 0910-0001 can be found here:
Forms and Documents
| Document | Type | Status | Availability |
|---|---|---|---|
 Form FDA 3331a Subpart B - Applications |
Form and Instruction | Modified | Repair queued |
| Form FDA 3938 PART 314: Subparts E through I |
Form | Modified | Repair queued |
 0001 NDAs SSA 2024 REV.docx |
Supporting Statement A | Uploaded 2024-03-06 | Available |
| 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 |
|---|---|---|---|---|
| 5662 |  Subpart B - Applications |
Form and Instruction | Modified | |
| 184605 | PART 314: Subparts E through I |
Form | Modified | |
| 184601 | Subpart D - FDA Action on Applications |
Other-Agency Guidance | Modified | |
| 184600 | Subpart C - Abbreviated Applications |
Other-Agency Guidance | Modified |
ICR Details
| Status | Received in OIRA |
|---|---|
| Agency/Subagency | HHS/FDA |
| OMB Control No | 0910-0001 |
| Type of Information Collection | Revision of a currently approved collection |
| Previous ICR Reference No | 202209-0910-003 |
| Agency Tracking No | CDER |
| Date Submitted to OIRA | 1969-12-31 |
| Requested Expiration Date | 1969-12-31 |