For Industry
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, and exports. 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)
- Prescription Drug User Fee Act (PDUFA)
- Medical Device User Fee Act (MDUFMA)
- Exports Certificate (Exports)
- Color Certification (CERTS)
- Mammography Quality Standards Act (MQSA)
More information on each fee can be found through the links at the left.
The Division of User Fees also manages billing and collections for Freedom of Information Act (FOIA) requests. See the Division of Freedom of Information page for more information.
As part of the Office of Financial Management, the Division of User Fees:
- Negotiates with FDA centers and the Office of Regulatory Affairs on spending plans related to user fee triggers
- Liaises with industry customers to address their questions or concerns regarding the User Fee program
- Participates in the budget formulation process for the User Fee program
- Reviews and analyzes potential impacts of legislative or administrative proposals on existing and new user fees
- Produces annual legislatively-mandated financial reports for Congress for PDUFA, MDUFMA, ADUFA, and AGDUFA
Working in conjunction with the Division of Budget Execution and Control, the Division of User Fees:
- Develops allocation and spending plans including rent, other activities, central and program accounts related to all user fees
- Prepares the spending plans for the program, including the PDUFA five-year plan
- Prepares cost reporting to ensure statutory triggers are met