Antimicrobial Animal Drug Distribution Reports and Recordkeeping

OMB 0910-0659

OMB 0910-0659

This information collection requires that sponsors of each new animal drug that contains an antimicrobial agent submit an annual report to FDA on the amount of each antimicrobial active ingredient in the drug that is sold or distributed for use in food-producing animals, including information on any distributor-labeled product. Its purpose is to ensure that the FDA has the necessary information to examine safety concerns related to the use of antibiotics in food-producing animals.

The latest form for Antimicrobial Animal Drug Distribution Reports and Recordkeeping expires 2022-06-30 and can be found here.

OMB Details

New animal drug sponsors w/active applications; paper submissions

Federal Enterprise Architecture: Health - Consumer Health and Safety

Form FDA 3744Antimicrobial Animal Drug Distribution ReportFillable FileableForm and instruction

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

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