(Full SE) Reports Demonstrating Substantial Equivalence for Tobacco Products (Sections 905(j) and 910(a))

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

OMB: 0910-0673

IC ID: 195793

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(Full SE) Reports Demonstrating Substantial Equivalence for Tobacco Products (Sections 905(j) and 910(a))
 
No Modified
 
Voluntary
 
21 CFR 1107.18

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Instruction Section 905j Reports Demo Substantial Equivalence Guidance Document .pdf No   Printable Only

Health Consumer Health and Safety

 

683 126
   
Individuals or Households
 
   99 %

  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 683 0 0 0 0 683
Annual IC Time Burden (Hours) 204,900 0 0 0 0 204,900
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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