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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)
Unchanged
1
1
0
314.420
Unchanged
1038
63318
0
314.50 (a), (b), (c), (d), (e), (f), and (k)
Modified
151
290373
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
314.52
Unchanged
21
336
0
314.550
Unchanged
140
16800
0
314.60
Unchanged
2418
193440
0
314.65
Unchanged
21
42
0
314.70 and 314.71
Unchanged
2854
428100
0
314.72
Unchanged
145
290
0
314.81(b)(1) [3331]
Unchanged
4241
33928
0
314.81(b)(2) [2252]
Unchanged
10490
419600
0
314.81(b)(3)(i) [2253]
Unchanged
45464
90928
0
314.94(a) and (d)
Unchanged
1187
569760
0
314.95
Unchanged
627
10032
0
314.96
Unchanged
10676
854080
0
314.97
Unchanged
5612
448960
0
314.99(a)
Unchanged
659
1318
0
Total burden requested under this ICR:
85745
3421306
0
To view an IC, click on IC Title