Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
(RULE) Other postmarketing reports; submission of each individual consumer affected by a failure in implementation of an ACNU Unchanged 150 6000 0
(RULE) Requirements for failures in implementation of an ACNU Unchanged 150 1200 0
(RULE) Submission of separate application for nonprescription drug product with an ACNU Unchanged 6 1920 0
Diagnostic Radiopharmaceuticals New 4 6750 0
PART 314: Subparts E through I Unchanged 44338 395012 0 Form FDA 3938 Drug Master File
Instruction
Subpart B - Applications Modified 57630 1084042 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
Other-Statutory Authority
Form FDA 356h Application to Market a New Drug, Abbreviated New Drug, or Biologic, for Human Use
Instruction
Form FDA 3542a Patent Information Submitted with an NDA, or Supplement
Instruction
Form FDA 3542 Patent Information Submitted Upon and After Approval of an NDA or Supplement
Instruction
Subpart C - Abbreviated Applications Unchanged 21744 1997542 0 Other-Agency Guidance
Subpart D - FDA Action on Applications Unchanged 6279 83584 0 Other-Agency Guidance
Other-Agency Guidance
Total burden requested under this ICR: 130301 3576050 0  
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