Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
PMTA submission; amendments; change in ownership; supplementals; resubmissions; reporting; AE reports; waivers Modified 117 13740 0 Form and Instruction Form FDA 4057
Form and Instruction Form FDA 4057a
Form and Instruction Form FDA 4057b
Form and Instruction FDA 4057b
Form and Instruction FDA 4057b
Total burden requested under this ICR: 117 13740 0  
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