Records and Reports Concerning Experience with Approved New Animal Drugs

OMB 0910-0284

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 Records and Reports Concerning Experience with Approved New Animal Drugs expires 2023-07-31 and can be found here.

OMB Details

Mandatory adverse event reporting

Federal Enterprise Architecture: Health - Consumer Health and Safety

Form FDA 1932Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect ReportFillable FileableForm and instruction

Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.


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