Animal Drug User Fee Program

OMB 0910-0540

This information collection supports FDA's Animal Drug User Fee Act program. Respondents to the collection are sponsors of applications submitted to the agency. The information is used to assess fees, as well as to grant a waiver from, or a reduction of those fees in certain circumstances.

The latest form for Animal Drug User Fee Program expires 2023-08-31 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
Animal Drug User Fees and Fee Waivers and Reductions Other-Guidance
AGDUFA Cover Sheets Other-e-Form screenshots
ADUFA Cover Sheets Other-e-form instruction screenshots

All Historical Document Collections

202308-0910-015	Extension without change of a currently approved collection	2023-08-17
202107-0910-015 Approved without change	No material or nonsubstantive change to a currently approved collection	2021-09-28
202006-0910-009 Approved without change	Revision of a currently approved collection	2020-07-13
201707-0910-004 Approved without change	Extension without change of a currently approved collection	2017-07-27
201407-0910-004 Approved without change	Revision of a currently approved collection	2014-07-08
201405-0910-025 Improperly submitted and continue	Extension without change of a currently approved collection	2014-05-29
201102-0910-002 Approved without change	Extension without change of a currently approved collection	2011-02-16
200712-0910-004 Approved without change	Extension without change of a currently approved collection	2007-12-18
200411-0910-007 Approved without change	Extension without change of a currently approved collection	2004-11-15
200403-0910-001 Approved without change	New collection (Request for a new OMB Control Number)	2004-03-12

OMB Details

Animal Drug User Fees and Fee Waivers and Reductions

Federal Enterprise Architecture: Health - Consumer Health and Safety