OMB control number
Adverse Experience/Events with Approved New Animal Drugs
OMB 0910-0284 · HHS/FDA.
OMB 0910-0284
This information collection supports FDA regulations regarding records and reports concerning experience with approved new animal drugs. Respondents to the collection are animal drug manufacturers with approved new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), or conditionally approved new animal drug applications (CNADAs), as well as licensed commercial feed mills and licensed mixer-feeders. The reporting and recordkeeping elements implement public health protection provisions provided for in the Federal Food, Drug and Cosmetic.
The latest form for Adverse Experience/Events with Approved New Animal Drugs expires 2026-08-31 and is listed under ICR 202306-0910-009.
Latest Forms, Documents, and Supporting Material
Form FDA 1932a VETERINARY ADVERSE DRUG REACTION, LACK OF EFFECTIVENESS, PRODUCT DEFECT REPORT (VOLUNTARY)
0910-0284 Supporting Statement 05_2026.docx
Animal Drug Adverse Event Information Collection ActivitiesAll Historical Document Collections
OMB Details
Animal Drug Adverse Event Information Collection Activities
Federal Enterprise Architecture: Health - Consumer Health and Safety
| Form | Name | Electronic access | Type |
|---|---|---|---|
| Form FDA 2301 | TRANSMITTAL OF PERIODIC REPORTS AND PROMOTIONAL MATERIAL FOR NEW ANIMAL DRUGS | Fillable Fileable | Form and instruction |
| Form FDA 1932 | VETERINARY ADVERSE DRUG REACTION, LACK OF EFFECTIVENESS, PRODUCT DEFECT REPORT | Fillable Fileable | Form and instruction |
| Form FDA 1932a | VETERINARY ADVERSE DRUG REACTION, LACK OF EFFECTIVENESS, OR PRODUCT DEFECT REPORT (voluntary reporting) | Fillable Fileable | Form and instruction |
Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.