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Reporting; Tobacco Substantial Equivalence Report Amendment and General Correspondence Report (Form FDA 3965a)

IC 245288 under ICR 202402-0910-004 · OMB 0910-0673.

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Document Name
Document Type
Form and Instruction
Form and Instruction
Form and Instruction
Information Collection (IC) Details

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Reporting; Tobacco Substantial Equivalence Report Amendment and General Correspondence Report (Form FDA 3965a) CTP
 
No Modified
 
Mandatory
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form and Instruction Form FDA 3965a Tobacco Substantial Equivalence Report Amendment and General Correspondence Submission FDA_Form_3965a (2024).pdf Yes Yes Fillable Fileable Signable
Form and Instruction FDA Web Form 3965a Tobacco Substantial Equivalence Report Amendment Final Wireframes for FDA Web Form 3965a (SE Amendment) (2024).pdf Yes Yes Fillable Fileable Signable

Health Public Health Monitoring

 

628 0
   
Private Sector Businesses or other for-profits
 
   83 %

  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 628 0 0 0 0 628
Annual IC Time Burden (Hours) 100 0 0 0 0 100
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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