For Industry

BsUFA Contacts

For technical assistance with accessing and completing the Biosimilar User Fee Cover Sheet  

For questions about BsUFA fee requirements, waivers, or refunds  

  • Center for Drug Evaluation and Research (CDER) 
    Contact Donal Parks or Beena Alex
    By phone:  301-796-7900 
    By e-mailCDER-OM-Collections-Biosimilars@fda.hhs.gov
    By mail:  Attention:  Donal Parks or Beena Alex
    Food and Drug Administration
    10001 New Hampshire Avenue
    Silver Spring, MD 20993  
  • Center for Biologics Evaluation and Research (CBER)
    Contact Carla Vincent
    By phone: 301-827-3503
    By email: carla.vincent@fda.hhs.gov
    By mail:  Attention:  Carla Vincent           
    Center for Biologics Evaluation and Research 
    Food and Drug Administration
    11400 Rockville Pike
    Rockwall Building, Room 383
    Rockville, MD 20852  

For more information about the Federal Register notice of biosimilar user fee rates  

  • Contact David Miller
    By phone: 301-796-7103
    By mail: David Miller
    Office of Financial Management (HFA-100)
    Food and Drug Administration
    1350 Picard Drive, P150, room 210J
    Rockville, MD 20850  

For information about biosimilar product development

See Information for Industry (Biosimilars)

Page Last Updated: 08/08/2014
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