Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
Other postmarketing reports; submission of each individual consumer affected by a failure in implementation of an ACNU New 150 6000 0
PART 314: Subparts E through I Unchanged 45045 444697 0 Form FDA 3938 Drug Master File
Requirements for failures in implementation of an ACNU New 150 1200 0
Submission of separate application for nonprescription drug product with an ACNU New 6 1920 0
Subpart B - Applications Unchanged 66924 1234195 0 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
Form FDA 356h Application to Market a New Drug, Abbreviated New Drug, or Biologic, for Human Use
Instruction
Subpart C - Abbreviated Applications Unchanged 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: 146275 4211584 0  
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