Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
PART 314: Subparts E through I Unchanged 1253 89708 0
Subpart B - Applications Modified 71706 2644204 0 Form 2252 Transmittal of Annual Report for Drug and Biologics for Human Use
Form 2253 Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use
Form 356 Application to Market a New or Abbreviated New Drug or Biologic for Human Use
Form and Instruction FDA 3331a NDA - Field Alert Report
Subpart C - Abbreviated Applications Unchanged 22217 1902374 0
Subpart D - FDA Action on Applications Unchanged 151 750 0
Total burden requested under this ICR: 95327 4637036 0  
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