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U.S. Department of Health and Human Services

For Industry

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Biosimilar User Fee Cover Sheet

The Biosimilar User Fee Cover Sheet, Form FDA 3792, is a self-generated invoice.  The form requests the minimum necessary information to determine the amount of the fee required, and to account for and track user fees.  The form provides a cross-reference of the fees submitted for a submission with the actual submission by using a unique number tracking system.  The information collected is used by FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) to initiate the administrative screening of biosimilar biological product INDs, applications, and supplements, and to account for and track user fees associated with BPD meetings. 

When should I complete the Biosimilar User Fee Cover Sheet?

  • Complete the Biosimilar User Fee Cover Sheet to pay the following fees:
    • Initial BPD
    • Reactivation
    • Application
    • Supplement requiring clinical data, other than comparative bioavailability studies, for approval
  • Include the Biosimilar User Fee Cover Sheet with your payment and with your submission to FDA.

How do I access the Biosimilar User Fee Cover Sheet?

  • Access and complete the form online at the following link:  Biosimilar User Fee Cover Sheet.  Further instructions are provided when you access the link. 
  • You need Microsoft Internet Explorer 5.5 or higher or Netscape Navigator 4.7 or higher to complete the form.
  • If a new user, you must first register your organization (if not already registered), and create a user account. 
    • You need the following information to register your organization:
      1. Employer Identification Number (EIN) – for domestic organizations only
      2. Data Universal Numbering System (DUNS) number – required for foreign organizations
      3. Contact Name
      4. Company Name
      5. Address, including City, State, Zip Code, and Country
      6. Email Address
      7. Daytime phone
    • You need the following information to create a user account, with a unique username and password:
      1. Contact Name
      2. Email Address
      3. Daytime Phone Number

 

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