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 Unchanged 4 6750 0
Mailing of important information about drugs New 4 400 0 Other-Procedural Guidance
PART 314: Subparts E through I Unchanged 44338 395012 0 Form FDA 3938
Instruction
Subpart B - Applications Unchanged 57630 1084042 0 Form and Instruction FDA 3331a
Form FDA 2252
Instruction
Form FDA 2253
Instruction
Other-Performance Goals
Other-Legislative Authority
Other-Statutory Authority
Form FDA 356h
Instruction
Form FDA 3542a
Instruction
Form FDA 3542
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: 130305 3576450 0  
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