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Agenda
Reg Review
ICR
Information Collection List
IC Title
Status
Responses
Hours
Dollars
Document Type
Form No.
Form Name
Abbreviated New Animal Drug Applications
Modified
20
3180
0
Form and Instruction
FDA 356v
Application for Approval of a New Animal Drug (Or Submission to Support New Animal Drug Approval)
Instruction
Biowaiver request: Type A medicated article, same formulation/manufacturing process approach
Modified
2
10
0
Other-Guidance
Instruction
Biowaiver request: Type A medicated article, using same API/solubility approach
Modified
5
100
0
Other-Guidance
Instruction
Biowaiver request: powder oral dosage form, same formulation/manufacturing process approach
Modified
1
5
0
Other-Guidance
Instruction
Biowaiver request: powder oral dosage form, using same API/solubility approach
Modified
5
50
0
Other-Guidance
Phased Review with Administrative ANADA
Modified
30
954
0
Form and Instruction
FDA 356v
Application for Approval of a New Animal Drug (Or Submission to Support New Animal Drug Approval)
Instruction
Total burden requested under this ICR:
63
4299
0
To view an IC, click on IC Title