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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
18
2862
0
Form and Instruction
FDA 356v
Application for Approval of a New Animal Drug (Or Submission to Support New Animal Drug Approval)
Biowaiver request: Type A medicated article, same formulation/manufacturing process approach
New
2
10
0
Other-guidance
Biowaiver request: Type A medicated article, using same API/solubility approach
New
10
200
0
Other-guidance
Biowaiver request: powder oral dosage form, same formulation/manufacturing process approach
New
1
5
0
Other-guidance
Biowaiver request: powder oral dosage form, using same API/solubility approach
New
5
50
0
Other-guidance
Phased Review with Administrative ANADA
Modified
15
477
0
Form and Instruction
FDA 356v
Application for Approval of a New Animal Drug (Or Submission to Support New Animal Drug Approval)
Total burden requested under this ICR:
51
3604
0
To view an IC, click on IC Title