Skip to main content
An official website of the United States government
The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.
Search:
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
Modified
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
Modified
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
Modified
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
Modified
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
Modified
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
Modified
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
Modified
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
Modified
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
Modified
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
601.26(f) - Additional Studies and Labeling
Removed
0
0
0
Form and Instruction
356h
Application to Market a New Drug or Biologic for Human Use
Form and Instruction
2567
Transmittal of Labels and Circulars
601.27(b) - Pediatric Studies - Deferred Submission
Modified
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
Modified
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
Modified
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
Modified
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
601.6(a) - Suspension of License
Removed
0
0
0
Form and Instruction
356h
Application to Market a New Drug or Biologic for Human Use
601.70(b) and (d)/601.28 - Annual Progress Reports of Postmarketing Studies and Annual reports of postmarketing pediatric studies
Modified
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
Modified
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
Modified
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
Modified
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
Modified
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
To view an IC, click on IC Title