OMB.report

Federal forms, ICRs, and supporting documents

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 is listed under ICR 202512-0910-001.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
DocumentType
Form 356V Application for Approval of a New Animal Drug (or Submission to Support New Animal Drug Approval)Form and Instruction
Form 356V New Animal Drug Application SubmissionsForm and Instruction
83C 0032 to add 0669 ANDA activity.docxJustification for No Material/Nonsubstantive Change
83C 0032 to add 0669 ANDA activity.docx Justification for No Material/Nonsubstantive Change
0032 NADAs ANADAs and Vet Master Files SSA 2025 REV to include 0669.docxSupporting Statement A
0032 NADAs and Vet Master Files SSA 2025 Ext.docxSupporting Statement A
New Animal Drug Application Submissions Form and Instruction
New Animal Drug Application Submissions Form and Instruction
New Animal Drug Application Submissions Other-Agency Guidance
Biowaiver requests Other-Agency Guidance
Abbreviated New Animal Drug Application Submissions Other-Agency Guidance

All Historical Document Collections

Historical document collections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

OMB Details

New Animal Drug Application Submissions

Federal Enterprise Architecture: Health - Consumer Health and Safety

Information collection instruments
FormNameElectronic accessType
Form 356VApplication for Approval of a New Animal Drug (or Submission to Support New Animal Drug Approval)Fillable FileableForm and instruction

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