Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
PART 314: Subparts E through I Unchanged 45045 444697 0 Form FDA 3938 Drug Master File
Subpart B - Applications Modified 66924 1234195 0 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
Form FDA 2252 Transmittal of annual drug and biologic report under 314.81
Instruction
Form FDA 2253 TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
Instruction
Other-Performance Goals
Other-Legislative Authority
Form and Instruction FDA 3542 Patent Information After Approval
Form and Instruction FDA 3542a Patent Information Prior to Approval
Other-Statutory Authority
Subpart C - Abbreviated Applications Modified 27334 2439794 0 Other-Agency Guidance
Subpart D - FDA Action on Applications Unchanged 6666 83778 0 Other-Agency Guidance
Other-Agency Guidance
Total burden requested under this ICR: 145969 4202464 0  
To view an IC, click on IC Title