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  
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