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FDA User Fee Programs

On March 27, 2020, the President signed the Over-the-Counter Monograph Safety, Innovation, and Reform Act into law. This act is intended to modernize the process by which FDA regulates over-the-counter monograph drugs. The FDA is in the process of implementing the changes set forth in the act and will update the public and this webpage as we have additional information.

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.

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.

User Fee Payment Refund and Transfer Requests

Submit an online form at https:/userfees.fda.gov/fdarefund to request refund for 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 userfees@fda.gov or to your FDA Program Manager.

For questions, please contact the User Fee Helpdesk at (301) 796-7200 or userfees@fda.gov.

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