Tobacco Substantial Equivalence Report Submission

Reports Intended to Demonstrate the Substantial Equivalence of a New Tobacco Product

OMB: 0910-0673

IC ID: 245286

Documents and Forms
Information Collection (IC) Details

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Tobacco Substantial Equivalence Report Submission
 
No New
 
Mandatory
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form and Instruction FDA 3965 Tobacco Substantial Equivalence Report Submission FDA 3965.pdf Yes Yes Fillable Fileable

Health Public Health Monitoring

 

1,570 0
   
Private Sector Businesses or other for-profits
 
   85 %

  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 1,570 0 1,570 0 0 0
Annual IC Time Burden (Hours) 1,178 0 1,178 0 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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