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 191 13740 0 Form and Instruction FDA 4057
Form and Instruction FDA 4057a
Form and Instruction FDA 4057b
Total burden requested under this ICR: 191 13740 0  
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