Information Collection Request
Adverse Experience/Events with Approved New Animal Drugs
ICR 202306-0910-009 · OMB 0910-0284 · Received in OIRA
⚠️ Notice: This information collection may be outdated. More recent filings for OMB 0910-0284 can be found here:
Forms and Documents
| Document | Type | Status | Availability |
|---|---|---|---|
 Form FDA 1932 Animal Drug Adverse Event Information Collection Activities |
Form and Instruction | Modified | Repair queued |
| Form 2301 Drug experience reports; advertisements and promotional labeling; distributor statements |
Form and Instruction | Removed | Repair queued |
| Form 1932a Voluntary adverse event reporting |
Form and Instruction | Removed | Repair queued |
 0284 CVM AER SSA 2023 REV.docx |
Supporting Statement A | Uploaded 2023-06-30 | Repair queued |
IC Document Collections
| IC ID | Collection | Type | Status | Form |
|---|---|---|---|---|
| 37624 |  Animal Drug Adverse Event Information Collection Activities |
Form and Instruction | Modified | |
| 239296 | One time recordkeeping resulting from implementation of new requirements (New SOPs and training) |
Removed | ||
| 239295 | Request for waiver from electronic reporting requirement |
Removed | ||
| 230017 | Medicated feed reports |
Removed | ||
| 197284 | Recordkeeping requirements under 510.301 and 514.80 |
Modified | ||
| 197280 | Drug experience reports; advertisements and promotional labeling; distributor statements |
Form and Instruction | Removed | |
| 197279 | Voluntary adverse event reporting |
Form and Instruction | Removed |
ICR Details
| Status | Received in OIRA |
|---|---|
| Agency/Subagency | HHS/FDA |
| OMB Control No | 0910-0284 |
| Type of Information Collection | Extension without change of a currently approved collection |
| Previous ICR Reference No | 202001-0910-009 |
| Agency Tracking No | CVM |
| Date Submitted to OIRA | 1969-12-31 |
| Requested Expiration Date | 1969-12-31 |