Full SE 905(j)(1)(A)(i) and 910(a) Bundled

Substantial Equivalence Applications for Tobacco Products

OMB: 0910-0673

IC ID: 221153

Documents and Forms
Information Collection (IC) Details

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Full SE 905(j)(1)(A)(i) and 910(a) Bundled CTP
 
No Modified
 
Mandatory
 
21 CFR 1107.18

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Guidance Guidance SE of a New Tobacco Product - Responses to FAQs (Ed 2).pdf Yes Yes Printable Only

Health Consumer Health and Safety

 

456 0
   
Private Sector Businesses or other for-profits
 
   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 456 0 206 0 0 250
Annual IC Time Burden (Hours) 41,040 0 18,540 0 0 22,500
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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