PMTA submission; amendments; change in ownership; supplementals; resubmissions; reporting; AE reports; waivers

Premarket Tobacco Product Applications and Recordkeeping Requirements

Documents and Forms

Document Name Document Type
Form FDA 4057 PMTA submission; amendments; change in ownership; supplementals; resubmissions; reporting; AE reports; waivers Form and Instruction
Sep_23 Validator Tool Screenshots.docx Other-Validator Tool Screenshots
Sep_23 Validator Tool Screenshots.docx Other-Validator Tool Screenshots
FDA 4057 Premarket Tobacco Product Application (PMTA) Submission FDA-Form-4057_Sept 23.pdf Form and Instruction
FDA 4057 Premarket Tobacco Product Application (PMTA) Submission FDA-Form-4057_Sept 23.pdf Form and Instruction
FDA 4057a Premarket Tobacco Product Application Amendment and Gene FDA 4057a.pdf Form and Instruction
FDA 4057a Premarket Tobacco Product Application Amendment and Gene FDA 4057a.pdf Form and Instruction
FDA 4057b Unique Identifying Information for New Tobacco Products Form FDA 4057b Product Grouping_v3.0_Sept_23.xlsm Form and Instruction
FDA 4057b Unique Identifying Information for New Tobacco Products Form FDA 4057b Product Grouping_v3.0_Sept_23.xlsm Form and Instruction

Information Collection (IC) Details

IC Title:	PMTA submission; amendments; change in ownership; supplementals; resubmissions; reporting; AE reports; waivers	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 1114.15 21 CFR 1107.3 21 CFR 1107.3 21 CFR 1114.5 21 CFR 1114.9 21 CFR 1114.13 21 CFR 1100.204 21 CFR 1114.17 21 CFR 1114.41 21 CFR 1114.45 21 CFR 1114.49

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_Sept 23.pdf	Yes	Yes	Fillable Fileable Signable
Form and Instruction	FDA 4057a	Premarket Tobacco Product Application Amendment and General Correspondence Submission	FDA 4057a.pdf	Yes	Yes	Fillable Fileable Signable
Form and Instruction	FDA 4057b	Unique Identifying Information for New Tobacco Products	Form FDA 4057b Product Grouping_v3.0_Sept_23.xlsm	Yes	Yes	Fillable Fileable
Other-Validator Tool Screenshots			Sep_23 Validator Tool Screenshots.docx	Yes	Yes	Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 39	Number of Respondents for Small Entity: 10

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

Percentage of Respondents Reporting Electronically: 99 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	191	0	191
Annual IC Time Burden (Hours)	13,707	-33	13,740
Annual IC Cost Burden (Dollars)	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.