BsUFA Contacts

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

• Call 301-796-7200 or email userfees@fda.gov

For questions about BsUFA fee requirements, waivers, or refunds
 

• Center for Drug Evaluation and Research (CDER) 
  Contact Donal Parks or Sherly Abraham
  By phone:  301-796-7900 
  By e-mail:  CDER-OM-Collections-Biosimilars@fda.hhs.gov
  By mail:  Attention:  Donal Parks or Sherly Abraham
  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)