BsUFA Fee Schedule and Payment Instructions

Fee schedule for fiscal year 2013

Fee Category	Fee Rates for FY 2013
Initial BPD	$195,880
Annual BPD	$195,880
Reactivation	$391,760
Biosimilar Biological Product Applications
Requiring clinical data	$1,958,800*
Not requiring clinical data	$979,400*
Biosimilar Biological Product Supplement requiring clinical data	$979,400
Biosimilar Biological Product Establishment	$526,500
Biosimilar Biological Product	$98,380

* Under section 744H(a)(2)(A) of the FD&C Act, if a sponsor that submits a biosimilar biological product application has previously paid initial BPD, annual BPD, or reactivation fees for the product that is the subject of the application, the fee for the application is reduced by the cumulative amount of these previously paid fees.

Payment instructions

• For initial BPD, reactivation, application, and supplement fees, first complete a Biosimilar User Fee Cover Sheet, and generate a user fee identification (ID) number. 
• Include the Biosimilar User Fee Cover Sheet with your payment and with your submission to FDA.
  • Payment must be made in U.S. currency by electronic check (ACH), wire transfer, check, bank draft, or U.S. postal money order. 

By electronic check (ACH)

• FDA has partnered with the U.S. Department of the Treasury to utilize Pay.gov, a Web-based payment application, for online electronic payment. 
• The Pay.gov feature is available on the FDA Web site after completing the Biosimilar User Fee Cover Sheet, and generating the user fee ID number.

By wire transfer

• Please reference your unique user fee ID number, generated after submitting the Biosimilar User Fee Cover Sheet, when completing your transfer. 
• The originating financial institution may assess an additional fee for wire transfer payments.  Please ask your financial institution about this fee and include it with your payment to ensure that your fee is fully paid. 
• The account information is as follows: 
  
  New York Federal Reserve Bank
  U.S. Department of Treasury
  TREAS NYC
  33 Liberty Street
  New York, NY 10045
  Acct. No.:  75060099
  Routing No.:  021030004
  SWIFT:  FRNYUS33
  Beneficiary:  FDA, 1350 Piccard Dr., Rockville, MD, 20850

By check, bank draft, or postal money order

• Please include the user fee ID number, generated after submitting the Biosimilar User Fee Cover Sheet on your check, bank draft, or postal money order, and make payable to the order of the Food and Drug Administration. 
• Include a copy of the Biosimilar User Fee Cover Sheet with your payment.
• Mail payment to: 
  
  Food and Drug Administration
  P.O. Box 979108
  St. Louis, MO 63197-9000
  
  Note:  In no case should payment be included with the review submission
  
   
• If checks are to be sent by a courier requiring a street address, deliver the checks to:
  
  U.S. Bank
  Attention: Government Lockbox 979108
  1005 Convention Plaza
  St. Louis, MO 63101. 
  Note:  This U.S. Bank address is for courier delivery only. 

• FDA issues invoices for annual BPD, establishment, and product fees.  Invoices include payment instructions.