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 Premarket Tobacco Product Application (PMTA) Submission
Form and Instruction Form FDA 4057a Premarket Tobacco Product Application Amendment and General Correspondence Submission
Form and Instruction Form FDA 4057b Unique Identifying Information for New Tobacco Products
Form and Instruction FDA 4057b Premarket Tobacco Product Application Grouping Submission
Form and Instruction FDA 4057b Premarket Tobacco Product Application Grouping Submission (detailed changes)
Total burden requested under this ICR: 117 13740 0  
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