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
Unchanged
1253
89708
0
Subpart B - Applications
Modified
71706
2644204
0
Form
2252
Transmittal of Annual Report for Drug and Biologics for Human Use
Form
2253
Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use
Form
356
Application to Market a New or Abbreviated New Drug or Biologic for Human Use
Form and Instruction
FDA 3331a
NDA - Field Alert Report
Subpart C - Abbreviated Applications
Unchanged
22217
1902374
0
Subpart D - FDA Action on Applications
Unchanged
151
750
0
Total burden requested under this ICR:
95327
4637036
0
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