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U.S. Department of Health and Human Services

For Industry

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User Fees

The User Fee program allows FDA to fulfill its mission of protecting the public health and accelerating innovation in the industry.  The fees collected are used to support the surveillance of human and animal drugs, medical and mammography devices, color additives, exports, and tobacco products.  The Division of User Fees is responsible for the overall management of the program.  The team develops and maintains an accounts receivable system used for user fee invoicing and collections, reporting, and data maintenance.

 

The different user fees are:
  • Animal Drug User Fee Act (ADUFA)
  • Animal Generic Drug User Fee Act (AGDUFA)
  • Biosimilar User Fee Act (BsUFA)
  • Color Certification (CERTS)
  • Exports Certificate (Exports)
  • Family Smoking Prevention and Tobacco Control Act (Tobacco)
  • Food Safety Modernization Act (FSMA)
  • Freedom of Information Act Fees
  • Generic Drug User Fee Act (GDUFA)
  • Mammography Quality Standards Act (MQSA)
  • Medical Device User Fee and Modernization Act (MDUFMA)
  • Prescription Drug User Fee Act (PDUFA)
  • Tobacco Product Fees

 

More information on each fee can be found through the links at the left.  

For more information about fees for Freedom of Information Act (FOIA) requests, see the Freedom of Information Act Fees page.

 

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