Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
Biologics; Licensing; General Biological Products Standards; and Additional Standards Modified 67117 813017 0 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
Other-Agency Guidance
Form FDA 356h Application to Market a New Drug or Abbreviated New Drug or Biologic for Human Use
Instruction
Form FDA 3988 Transmittal of PMR/PMC Submissions for Drugs and Biological Products
Instruction
Form FDA 3989 PMR/PMC Annual Status Report for Drugs and Biological Products
Instruction
Form FDA 3674 Certification of Compliance
Instruction
Notifications of suspensions Unchanged 20 7 924 Form and Instruction 356h Application to Market a New Drug or Biologic for Human Use
Total burden requested under this ICR: 67137 813024 924  
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