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
314.101(a)
Removed
0
0
0
314.52
Removed
0
0
0
314.550
Removed
0
0
0
314.60
Removed
0
0
0
314.65
Removed
0
0
0
314.70 and 314.71
Removed
0
0
0
314.72
Removed
0
0
0
314.81(b)(1) [3331]
Removed
0
0
0
314.81(b)(2) [2252]
Removed
0
0
0
314.81(b)(3)(i) [2253]
Removed
0
0
0
314.95
Removed
0
0
0
314.97
Removed
0
0
0
314.99(a)
Removed
0
0
0
PART 314: Subparts E through I
Modified
1253
89708
0
Subpart B - Applications
Modified
69553
2641415
0
Form and Instruction
3331
NDA-Field Alert Report
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
Subpart C - Abbreviated Applications
Modified
22217
1902374
0
Subpart D - FDA Action on Applications
Modified
151
750
0
Total burden requested under this ICR:
93174
4634247
0
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