OTC User Fee Program

General Drug Labeling Provisions and OTC Monograph Drug User Fee Submissions

OMB: 0910-0340

IC ID: 244708

Information Collection (IC) Details

View Information Collection (IC)

OTC User Fee Program
 
No Unchanged
 
Required to Obtain or Retain Benefits
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form FDA 5009 OVER-THE-COUNTER MONOGRAPH USER FEE COVER SHEET Draft OTC Coversheet Form FDA 5009 Dec 2020.docx Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

1 0
   
Private Sector Businesses or other for-profits
 
   100 %

  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 0 0 0 0 1
Annual IC Time Burden (Hours) 575 0 0 0 0 575
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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