Reporting: PMTA submission; amendment; unique identification for new products; validator spreadsheet; periodic reports; change in ownership; supplemental applications; resubmissions; waiver

Premarket Tobacco Product Applications and Recordkeeping Requirements

Documents and Forms

Document Name Document Type
Form FDA 4057 Reporting: PMTA submission; amendment; unique identification for new products; validator spreadsheet; periodic reports; change in ownership; supplemental applications; resubmissions; waiver Form and Instruction
0879_Validation Tool 2.0_Screenshots (2024).pdf Other-Validator Tool Screenshots
FDA 4057 Premarket Tobacco Product Application (PMTA) Submission FDA_Form_4057 (2024).pdf Form and Instruction
FDA 4057a Premarket Tobacco Product Application (PMTA) Amendment a FDA_Form_4057a (2024).pdf Form and Instruction
FDA 4057b Unique Identifying Information for New Tobacco Products FDA 4057b ProductGrouping_v3.1_10-2024.xlsm Form and Instruction
FDA Web Form 4057 Premarket Tobacco Product Application (PMTA) Submission Final Wireframes for FDA Web Form 4057 (PMTA) (2024).pdf Form and Instruction
FDA Web Form 4057a Premarket Tobacco Product Application (PMTA) Amendment a Final Wireframes for FDA Web Form 4057a (PMTA Amendment) (2024).pdf Form and Instruction

Information Collection (IC) Details

IC Title:	Reporting: PMTA submission; amendment; unique identification for new products; validator spreadsheet; periodic reports; change in ownership; supplemental applications; resubmissions; waiver	Agency IC Tracking Number:	CTP

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 1114.5 21 CFR 1114.9 21 CFR 1114.13 21 CFR 1114.17 21 CFR 1114.41 21 CFR 1114.45 21 CFR 1114.49 21 CFR 1114.15

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	FDA 4057	Premarket Tobacco Product Application (PMTA) Submission	FDA_Form_4057 (2024).pdf	Yes	Yes	Fillable Fileable Signable
Form and Instruction	FDA 4057a	Premarket Tobacco Product Application (PMTA) Amendment and General Correspondence Submission	FDA_Form_4057a (2024).pdf	Yes	Yes	Fillable Fileable Signable
Form and Instruction	FDA 4057b	Unique Identifying Information for New Tobacco Products	FDA 4057b ProductGrouping_v3.1_10-2024.xlsm	Yes	Yes	Fillable Fileable
Other-Validator Tool Screenshots			0879_Validation Tool 2.0_Screenshots (2024).pdf	Yes	Yes	Printable Only
Form and Instruction	FDA Web Form 4057	Premarket Tobacco Product Application (PMTA) Submission (FDA Web Form 4057)	Final Wireframes for FDA Web Form 4057 (PMTA) (2024).pdf	Yes	Yes	Fillable Fileable Signable
Form and Instruction	FDA Web Form 4057a	Premarket Tobacco Product Application (PMTA) Amendment and General Correspondence Submission (FDA Web Form 4057a)	Final Wireframes for FDA Web Form 4057a (PMTA Amendment) (2024).pdf	Yes	Yes	Fillable Fileable Signable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 215	Number of Respondents for Small Entity: 10

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 93 %

	Requested	Program Change Due to Agency Discretion	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	1,276	24	1,061	191
Annual IC Time Burden (Hours)	382,828	17	369,104	13,707
Annual IC Cost Burden (Dollars)	0	0	0	0

Documents for IC

Title	Document	Date Uploaded
No associated records found

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.