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Agenda
Reg Review
ICR
Information Collection List
IC Title
Status
Responses
Hours
Dollars
Document Type
Form No.
Form Name
601.12(a)(5) - Changes to an Approved Application
Unchanged
13106
13106
0
Form and Instruction
356h
Application to Market a New Drug or Biologic for Human Use
Form and Instruction
Form FDA 2253
TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
601.12(b)(1)/(b)(3)/(e) - Changes to an Approved Application
Unchanged
600
48000
0
Form and Instruction
356h
Application to Market a New Drug or Biologic for Human Use
Form and Instruction
Form FDA 2253
TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
601.12(c)(1) and (c)(3) - Changes to an Approved Application
Unchanged
574
28700
0
Form and Instruction
356h
Application to Market a New Drug or Biologic for Human Use
Form and Instruction
Form FDA 2253
TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
601.12(c)(5) - Changes to an Approved Application
Unchanged
8
400
0
Form and Instruction
Form FDA 2253
TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
Form and Instruction
356h
Application to Market a New Drug or Biologic for Human Use
601.12(d)(1)/(d)(3)/(f)(3) - Changes to an Application
Unchanged
822
19728
0
Form and Instruction
356h
Application to Market a New Drug or Biologic for Human Use
Form and Instruction
Form FDA 2253
TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
601.12(f)(1) - Changes to an Approved Application
Unchanged
139
5560
0
Form and Instruction
356h
Application to Market a New Drug or Biologic for Human Use
Form and Instruction
Form FDA 2253
TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
601.12(f)(2) - Changes to an Approved Application
Unchanged
109
2180
0
Form and Instruction
356h
Application to Market a New Drug or Biologic for Human Use
Form and Instruction
Form FDA 2253
TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
601.12(f)(4)/601.45 - Changes to an Approved Application
Unchanged
11676
116760
0
Form and Instruction
356h
Application to Market a New Drug or Biologic for Human Use
Form and Instruction
Form FDA 2253
TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
601.2(a) - Applications for Biologics Licenses; procedures for filing and 610.60 through 610.65 - Container Label
Unchanged
38
32680
0
Form and Instruction
356h
Application to Market a New Drug or Biologic for Human Use
Form and Instruction
Form FDA 2253
TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
601.27(b) - Pediatric Studies - Deferred Submission
Unchanged
330
7920
0
Form and Instruction
356h
Application to Market a New Drug or Biologic for Human Use
Form and Instruction
Form FDA 2253
TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
601.27(c) - Pediatric Studies
Unchanged
13
104
0
Form and Instruction
356h
Application to Market a New Drug or Biologic for Human Use
Form and Instruction
Form FDA 2253
TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
601.5(a) - Revocation of License
Unchanged
9
3
0
Form and Instruction
Form FDA 2253
TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
Form and Instruction
356h
Application to Market a New Drug or Biologic for Human Use
601.6(a) - Suspension of License
Unchanged
1
1
0
Form and Instruction
356h
Application to Market a New Drug or Biologic for Human Use
Form and Instruction
Form FDA 2253
TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
601.70(b) and (d)/601.28 - Annual Progress Reports of Postmarketing Studies and Annual reports of postmarketing pediatric studies
Unchanged
139
3336
0
Form and Instruction
356h
Application to Market a New Drug or Biologic for Human Use
Form and Instruction
Form FDA 2253
TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
610.15(d) - Constituent Materials
Unchanged
1
1
0
Form and Instruction
356h
Application to Market a New Drug or Biologic for Human Use
Form and Instruction
Form FDA 2253
TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
680.1(b)(3)(iv) - Allergenic Products
Unchanged
1
2
0
Form and Instruction
356h
Application to Market a New Drug or Biologic for Human Use
Form and Instruction
Form FDA 2253
TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
680.1(c) - Allergenic Products
Unchanged
9
18
0
Form and Instruction
356h
Application to Market a New Drug or Biologic for Human Use
Form and Instruction
Form FDA 2253
TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
Amendments/Resubmissions
Unchanged
2777
55540
0
Form and Instruction
356h
Application to Market a New Drug or Biologic for Human Use
Total burden requested under this ICR:
30352
334039
0
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