OMB.report

Federal forms, ICRs, and supporting documents

Information Collection

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

IC 237744 under ICR 202403-0910-005 · OMB 0910-0879.

Documents and Forms
Document Name
Document Type
Form and Instruction
Other-Validator Tool Screenshots
Form and Instruction
Form and Instruction
Form and Instruction
Form and Instruction
Form and Instruction
Information Collection (IC) Details

View Information Collection (IC)

Reporting: PMTA submission; amendment; unique identification for new products; validator spreadsheet; periodic reports; change in ownership; supplemental applications; resubmissions; waiver CTP
 
No Modified
 
Mandatory
 
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

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 (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

Health Consumer Health and Safety

 

215 10
   
Private Sector Businesses or other for-profits
 
   93 %

  Requested 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 1,276 0 24 1,061 0 191
Annual IC Time Burden (Hours) 382,828 0 17 369,104 0 13,707
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.