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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
Removed
0
0
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
Removed
0
0
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
Removed
0
0
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
Removed
0
0
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
Removed
0
0
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
Removed
0
0
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
Removed
0
0
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
Removed
0
0
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
Removed
0
0
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
Removed
0
0
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
Removed
0
0
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
Removed
0
0
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
Removed
0
0
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
Removed
0
0
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
Removed
0
0
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
Removed
0
0
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
Biologics; Licensing; General Biological Products Standards; and Additional Standards
Modified
27683
439899
23314647
Form and Instruction
Form FDA 2253
TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
Form and Instruction
Form FDA 2252
TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS AND BIOLOGICS FOR HUMAN USE
Form
Form FDA 2252
TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS AND BIOLOGICS FOR HUMAN USE
Form
FDA 356h
Application to Market a New or Abbreviated New Drug or Biologic For Human Use
Notifications of suspensions
Modified
20
7
924
Form and Instruction
356h
Application to Market a New Drug or Biologic for Human Use
Total burden requested under this ICR:
27703
439906
23315571
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