OMB control number

New Animal Drug Applications; Abbreviated New Animal Drug Applications; and Veterinary Master Files

OMB 0910-0032 · HHS/FDA.

OMB 0910-0032

FDA is requesting to include abbreviated new animal drug application information collection activity into the collection for efficiency of agency operations and because activities are conducted under related statutory authorities.

The latest form for New Animal Drug Applications; Abbreviated New Animal Drug Applications; and Veterinary Master Files expires 2028-09-30 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
Form 356V New Animal Drug Application Submissions Form and Instruction
83C 0032 to add 0669 ANDA activity.docx Justification for No Material/Nonsubstantive Change
0032 NADAs and Vet Master Files SSA 2025 Ext.docx Supporting Statement A
New Animal Drug Application Submissions Form and Instruction
Biowaiver requests Other-Agency Guidance
Abbreviated New Animal Drug Application Submissions Other-Agency Guidance

All Historical Document Collections

202512-0910-001	No material or nonsubstantive change to a currently approved collection	2025-12-01
202411-0910-008	Extension without change of a currently approved collection	2025-07-31
202206-0910-006 Approved without change	Extension without change of a currently approved collection	2022-06-29
201905-0910-005 Approved without change	Extension without change of a currently approved collection	2019-06-26
201605-0910-014 Approved without change	Extension without change of a currently approved collection	2016-06-03
201305-0910-003 Approved without change	Extension without change of a currently approved collection	2013-05-15
201104-0910-011 Approved without change	Extension without change of a currently approved collection	2011-04-28
200803-0910-001 Approved without change	Revision of a currently approved collection	2008-03-04
200411-0910-002 Approved without change	Extension without change of a currently approved collection	2004-11-01
200104-0910-004 Approved without change	Extension without change of a currently approved collection	2001-04-26
199805-0910-008 Approved without change	Reinstatement with change of a previously approved collection	1998-05-29
199401-0910-001 Approved without change	Reinstatement with change of a previously approved collection	1994-01-07
199303-0910-005 Approved with change	No material or nonsubstantive change to a currently approved collection	1993-03-04
199210-0910-007 Approved without change	Revision of a currently approved collection	1992-10-19
199106-0910-001 Approved without change	Reinstatement with change of a previously approved collection	1991-06-17
198905-0910-006 Approved with change	No material or nonsubstantive change to a currently approved collection	1989-05-03
198801-0910-001 Approved without change	Reinstatement with change of a previously approved collection	1988-01-04
198611-0910-002 Approved with change	No material or nonsubstantive change to a currently approved collection	1986-11-20
198603-0910-003 Approved without change	Revision of a currently approved collection	1986-03-19
198510-0910-003 Approved without change	Revision of a currently approved collection	1985-10-30
198507-0910-003 Approved without change	Reinstatement with change of a previously approved collection	1985-07-08
197911-0910-010 Approved with change	No material or nonsubstantive change to a currently approved collection	1979-11-20
197904-0910-001 Approved without change	Extension without change of a currently approved collection	1979-04-02
197711-0910-007 Approved with change	No material or nonsubstantive change to a currently approved collection	1977-11-18
197708-0910-005 Approved without change	Revision of a currently approved collection	1977-08-31

OMB Details

New Animal Drug Application Submissions

Federal Enterprise Architecture: Health - Consumer Health and Safety

Form 356V

Application for Approval of a New Animal Drug (or Submission to Support New Animal Drug Approval)

Fillable Fileable

Form and instruction

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