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

Premarket Tobacco Product Applications and Recordkeeping Requirements

OMB: 0910-0879

IC ID: 237744

Information Collection (IC) Details

View Information Collection (IC)

PMTA submission; amendments; change in ownership; supplementals; resubmissions; reporting; AE reports; waivers
 
No Modified
 
Mandatory
 
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

Document Type Form No. Form Name Instrument File URL 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

Health Consumer Health and Safety

 

39 10
   
Private Sector Businesses or other for-profits
 
   99 %

  Approved Program Change Due to New Statute Program Change Due to Agency Discretion Change Due to Adjustment in Agency Estimate Change Due to Potential Violation of the PRA Previously Approved
Annual Number of Responses for this IC 191 0 0 0 0 191
Annual IC Time Burden (Hours) 13,707 0 0 -33 0 13,740
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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

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