PRA IC List
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Agenda
Reg Review
ICR
Information Collection List
IC Title
Status
Responses
Hours
Dollars
Document Type
Form No.
Form Name
PART 314: Subparts E through I
Modified
44338
395012
0
Form
FDA 3938
Drug Master File
Instruction
Subpart B - Applications
Modified
57630
1084042
0
Form and Instruction
FDA 3331a
NDA - Field Alert Report
Form
FDA 2252
Transmittal of annual drug and biologic report under 314.81
Instruction
Form
FDA 2253
TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
Instruction
Other-Performance Goals
Other-Legislative Authority
Other-Statutory Authority
Form
FDA 356h
Application to Market a New Drug, Abbreviated New Drug, or Biologic, for Human Use
Instruction
Form
FDA 3542a
Patent Information Submitted with an NDA, or Supplement
Instruction
Form
FDA 3542
Patent Information Submitted Upon and After Approval of an NDA or Supplement
Instruction
Subpart C - Abbreviated Applications
Modified
21744
1997542
0
Other-Agency Guidance
Subpart D - FDA Action on Applications
Modified
6279
83584
0
Other-Agency Guidance
Other-Agency Guidance
Total burden requested under this ICR:
129991
3560180
0
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