Adverse Experience/Events with Approved New Animal Drugs
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 2023-07-31 and can be found here.
Document Name |
|---|
Form and Instruction |
Form and Instruction |
Form and Instruction |
Supporting Statement A |
Form FDA 1932 Animal Drug Adverse Event Information Collection Activities
0284 CVM AER SSA 2023 REV.docx
Animal Drug Adverse Event Information Collection Activities Mandatory adverse event reporting
Federal Enterprise Architecture: Health - Consumer Health and Safety
| Form FDA 1932 | Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report | Fillable Fileable | Form and instruction |
Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.
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