OMB.report

Federal forms, ICRs, and supporting documents

OMB control number

Abbreviated New Animal Drug Applications

OMB 0910-0669 ยท HHS/FDA.

OMB 0910-0669

This ICR collects information from animal drug manufacturers who seek approval of a generic copy of an approved new animal drug. The information required to be submitted as part of an abbreviated new animal drug application.

The latest form for Abbreviated New Animal Drug Applications expires 2022-10-31 and is listed under ICR 201908-0910-009.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
DocumentType
Form FDA 356v Phased Review with Administrative ANADAForm and Instruction
Form FDA 356v Abbreviated New Animal Drug ApplicationsForm and Instruction
0910-0669SupportingStatement2022 Final 9-23-22.docxSupporting Statement A
Biowaiver request: Type A medicated article, using same API/solubility approach Other-Guidance
Biowaiver request: Type A medicated article, same formulation/manufacturing process approach Other-Guidance
Biowaiver request: powder oral dosage form, using same API/solubility approach Other-Guidance
Biowaiver request: powder oral dosage form, same formulation/manufacturing process approach Other-Guidance
Phased Review with Administrative ANADA Form and Instruction
Abbreviated New Animal Drug Applications Form and Instruction

All Historical Document Collections

Historical document collections
ReferenceFilingReceivedConcludedAction
202202-0910-008 Extension without change of a currently approved collection 2022-09-27 Approved without change
201908-0910-009 Revision of a currently approved collection 2019-09-09 Approved without change
201608-0910-009 Extension without change of a currently approved collection 2016-09-07 Approved without change
201309-0910-007 Extension without change of a currently approved collection 2013-09-17 Approved without change
201004-0910-009 Existing collection in use without an OMB Control Number 2010-04-30 Approved without change

OMB Details

Abbreviated New Animal Drug Applications

Federal Enterprise Architecture: Health - Consumer Health and Safety

Information collection instruments
FormNameElectronic accessType
Form FDA 356vApplication for Approval of a New Animal Drug (Or Submission to Support New Animal Drug Approval)Fillable Fileable SignableForm and instruction

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