Antimicrobial Animal Drug Distribution Reports and Recordkeeping

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.

Latest Forms, Documents, and Supporting Material

Document Name
Form FDA 3744 New animal drug sponsors w/inactive applications; electronic submissions Form and Instruction
Form FDA 3744 New animal drug sponsors w/inactive applications; paper submissions Form and Instruction
Form FDA 3744 New animal drug sponsors w/active applications; electronic submissions Form and Instruction
Form FDA 3744 New animal drug sponsors w/active applications; paper submissions Form and Instruction
0659 CVM Antimicrobial Reports and Records SSA 2022 Ext.docx Supporting Statement A
Recordkeeping under 21 USC 360b(l)(3)(C)
New animal drug sponsors w/inactive applications; electronic submissions Form and Instruction
New animal drug sponsors w/inactive applications; paper submissions Form and Instruction
New animal drug sponsors w/active applications; electronic submissions Form and Instruction
New animal drug sponsors w/active applications; paper submissions Form and Instruction

All Historical Document Collections

202205-0910-009 Approved without change	Extension without change of a currently approved collection	2022-05-25
201904-0910-009 Approved without change	Extension without change of a currently approved collection	2019-05-09
201605-0910-004 Approved without change	Revision of a currently approved collection	2016-05-12
201304-0910-007 Approved with change	Revision of a currently approved collection	2013-04-25
201302-0910-001 Improperly submitted and continue	Revision of a currently approved collection	2013-02-04
201002-0910-005 Approved with change	New collection (Request for a new OMB Control Number)	2010-02-26

OMB Details

New animal drug sponsors w/active applications; paper submissions

Federal Enterprise Architecture: Health - Consumer Health and Safety

Form FDA 3744

Antimicrobial Animal Drug Distribution Report

Fillable Fileable

Form and instruction

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