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
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
Form FDA 2252
Instruction
Form FDA 2253
Instruction
Other-Performance Goals
Other-Legislative Authority
Form and Instruction FDA 3542
Form and Instruction FDA 3542a
Other-Statutory Authority
Form FDA 356h
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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