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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