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INFORMATION FOR

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In this section: For Industry
 * FDA User Fee Programs
   
    * Accredited Third-Party Certification Program User Fees
    * Animal Drug User Fee Act (ADUFA)
    * Animal Generic Drug User Fee Act (AGDUFA)
    * Biosimilar User Fee Amendments
    * Color Additive Certification Fees
    * Export Certificate Fees
    * Freedom of Information Act Fees (FOIA)
    * Generic Drug User Fee Amendments
    * Human Drug Compounding Outsourcing Facility Fees
    * Mammography Facility Fees (MQSA)
    * Medical Device User Fee Amendments (MDUFA)
    * Over-The-Counter Monograph Drug User Fee Program (OMUFA)
    * Prescription Drug User Fee Amendments
    * Voluntary Qualified Importer Program User Fees

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 3. FDA User Fee Programs

 1. For Industry


FDA USER FEE PROGRAMS

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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:

 * Cover Sheets
 * Invoices
 * User Fee Payment Refund and Transfer Requests


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
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.


RESOURCES FOR YOU

 * User Fee Financial Reports
 * User Fee Performance Reports
 * User Fee Five-Year Financial Plans




   CONTENT CURRENT AS OF:
   
   04/07/2021

 * 

 * FDA User Fee Programs
   
    * Accredited Third-Party Certification Program User Fees
    * Animal Drug User Fee Act (ADUFA)
    * Animal Generic Drug User Fee Act (AGDUFA)
    * Biosimilar User Fee Amendments
    * Color Additive Certification Fees
    * Export Certificate Fees
    * Freedom of Information Act Fees (FOIA)
    * Generic Drug User Fee Amendments
    * Human Drug Compounding Outsourcing Facility Fees
    * Mammography Facility Fees (MQSA)
    * Medical Device User Fee Amendments (MDUFA)
    * Over-The-Counter Monograph Drug User Fee Program (OMUFA)
    * Prescription Drug User Fee Amendments
    * Voluntary Qualified Importer Program User Fees




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