For Industry

BsUFA Payment Instructions

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, 8455 Colesville Road, COLE-14-14253, Silver Spring, MD 20993-0002

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.

 

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Page Last Updated: 08/04/2016
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