Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
Recordkeeping; Premarket Tobacco Product Applications New 217 434 0
Reporting: PMTA submission; amendment; unique identification for new products; validator spreadsheet; periodic reports; change in ownership; supplemental applications; resubmissions; waiver Modified 1276 382828 0 Form and Instruction FDA 4057 Premarket Tobacco Product Application (PMTA) Submission
Form and Instruction FDA 4057a Premarket Tobacco Product Application (PMTA) Amendment and General Correspondence Submission
Form and Instruction FDA 4057b Unique Identifying Information for New Tobacco Products
Other-Validator Tool Screenshots
Form and Instruction FDA Web Form 4057 Premarket Tobacco Product Application (PMTA) Submission (FDA Web Form 4057)
Form and Instruction FDA Web Form 4057a Premarket Tobacco Product Application (PMTA) Amendment and General Correspondence Submission (FDA Web Form 4057a)
Total burden requested under this ICR: 1493 383262 0  
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