FDA User Fee Programs
The User Fee programs help the Food and Drug Administration (FDA) to fulfill its mission of protecting the public health and accelerating innovation in the industry. The Office of Financial Management (OFM) is responsible for the financial management of the user fee programs. OFM maintains an accounts receivable system used for user fee invoicing, collections, reporting, and data maintenance.
To the left are links to all of the FDA's user fee programs.
On this page:
User Fee Cover Sheets
The cover sheet creation process gathers the minimum amount of information necessary to determine whether a fee is required, to determine the amount of the fee, and to allow FDA to track payments. Industry users can click on the user fee program link directly below to create and pay for the cover sheets. Users require a user name and password to proceed once they get to the cover sheet payment pages. First-time users can register at these pages.
- ADUFA Cover Sheets
- AGDUFA Cover Sheets
- BsUFA Cover Sheets
- GDUFA Cover Sheets
- MDUFA Cover Sheets
- MDUFA Establishment Registration User Fee / FURLS Device Facility User Fee (DFUF)
- OMUFA Cover Sheets
- PDUFA Cover Sheets
User Fee Invoices
Industry users who have received FDA invoices in the mail may click on the specific user fee program link directly below to pay the invoices online. Users require a user name and password or valid access credentials to proceed once they get to the invoice payment pages. The FDA Account Management System requires first-time users to register and is currently not available for all user fee invoices. To pay invoices online for a specific user fee, click on the user fee program link. For additional information regarding payment methods for user fee programs, please refer to FDA User Fee Payment Information.
- ADUFA Invoices
- AGDUFA Invoices
- BsUFA Invoices
- Center for Tobacco Products - Civil Money Penalties (CTP- CMP)
- CQA Invoices
- Export Certificate Program Fees
- Freedom of Information Act (FOIA) Request Invoices
- GDUFA Invoices
- MDUFA Invoices
- OMUFA Invoices
- PDUFA Invoices
- Tobacco Product Fees (Quarterly Assessments Invoices)
User Fee Payment Refund and Transfer Requests
Complete Form FDA 3913 (User Fee Payment Refund Request) to request a refund of user fees paid to the FDA as directed by the Food, Drug, and Cosmetic Act (FD&C Act). Complete Form FDA 3914 (User Fee Payment Transfer Request) to request a transfer of user fees paid to the FDA as directed by the Food, Drug, and Cosmetic Act (FD&C Act). Email the completed Form FDA 3913 or Form FDA 3914 to email@example.com or to your FDA Program Manager.
For questions, please contact the User Fee Helpdesk at (301) 796-7200 or firstname.lastname@example.org.