The Generic Drug User Fee Amendments of 2012 authorizes FDA to assess and collect user fees for human generic drug applications, certain application supplements, and related manufacturers. Form FDA 3794, also known as the Generic Drug User Fee Cover Sheet or GDUFA Cover Sheet, is designed to collect the minimum necessary information to determine the total applicable user fee required and to help FDA track the user fee payments. Furthermore, FDA’s review of a generic drug submission cannot begin until all relevant user fee obligations have been satisfied.
FDA issues clarifications for completing the GDUFA Cover Sheet by fee type. Please refer to the appropriate link below to obtain the clarification information. FDA will continue to make updates to these links as it identifies further information that will assist the generic drug industry in completing cover sheets.
When is the GDUFA Cover Sheet required?
The GDUFA Cover Sheet is required for each of the following human generic drug user fees:
- Abbreviated new drug application (ANDA) or applicable amendment;
- Prior approval supplement (PAS) or applicable amendment;
- Type II active pharmaceutical ingredient (API) drug master file (DMF) that is referenced on or after October 1, 2012, in a generic drug submission to the FDA and for which the DMF fee has not already been paid;
- Generic drug facility which is identified or intended to be identified in at least one generic drug submission that is pending or approved to produce a finished dosage form (FDF) of a human generic drug or an API contained in a human generic drug; and
- Backlog ANDA which is pending on October 1, 2012, and that has not received a tentative approval prior to that date.
Note: A cover sheet is not required for all ANDA and PAS amendments. It is only applicable to an amendment that is adding API manufacturing information other than by reference to a Type II DMF which is subject to the Section 744B(a)(3)(F) fee under GDUFA.
How to fill out a GDUFA Cover Sheet?
Read the instructions below and then go to Create GDUFA Cover Sheet to fill out the form.
A GDUFA Cover Sheet will be completed online using FDA’s User Fee System which requires the use of Microsoft Internet Explorer 7.0 or higher.
- Access the User Fee System at Create GDUFA Cover Sheet.
- Register your organization by providing information about your organization.
- Create a user account for your organization and provide contact information.
- Create a cover sheet by answering a series of questions and making appropriate selections.
- Submit the cover sheet to complete the process and determine the user fee amount owed. Upon submission, a User Fee Payment I.D. Number (PIN), which begins with the letters “GD”, is generated. The PIN must be referenced in your payment submission.
Additional instructions for the User Fee System and the process to create a GDUFA Cover Sheet can be located under the Frequently Asked Questions (FAQs) within the User Fee System. For detailed instructions to complete the GDUFA Cover Sheet, please access Form FDA 3794 - Instructions.
Note: A signed copy of a completed GDUFA Cover Sheet must be included in the following submissions to the FDA: ANDA or PAS submission (placed in the first volume with Form FDA 356h) and Type II API DMF submission.
What information is needed to complete a GDUFA Cover Sheet?
* GDUFA requires applicants to pay the Section 744B(a)(3)(F) fee if the application includes API manufacturing information other than by reference to a Type II DMF.
Type II API DMF
How are payments submitted?
A payment may be submitted by Pay.gov (electronic payment), check, bank draft, U.S. postal money order, or wire transfer. For all payment options, the payment must be made in U.S. currency drawn on a U.S. financial institution. FDA recommends that user fee payments be made in a timely manner to meet the required payment due date or to be received prior to an application submission. For application submissions, it is recommended that you send manual payments to the bank 4-5 business days before the application submission arrives at FDA so that there is no delay in starting the review of your application submission. Please follow the instructions below for your selected payment option:
Pay.gov is a web-based payment application that allows electronic payments to be made directly from your bank account. A payment can be initiated after submitting your cover sheet by clicking the “Pay Now”button and following the on-screen instructions to make payment. To pay later, log into your GDUFA User Fee account and access your cover sheet history page by clicking on the “Previous Cover Sheets” icon at the top of the page. Click the “Pay Now”link next to the User Fee Payment I.D. Number (PIN) you need to pay for.
Check, Bank Draft, or U.S. Postal Money Order
Payment must be made payable to the Food and Drug Administration and make reference to the User Fee Payment I.D. Number (PIN). The payment and a copy of your signed cover sheet must be mailed to one of the addresses shown below.
Contact your financial institution and provide the following information:
Note: Financial institutions may charge a wire transfer fee between $15 and $35. Please inquire about the wire transfer fee and include the additional amount with your user fee payment to ensure that your user fee is fully paid and to avoid making additional payments.
How to get help?
For technical assistance with the User Fee System or GDUFA Cover Sheet, please contact the User Fee Helpdesk at 301-796-7200 or firstname.lastname@example.org.
For assistance in understanding when a GDUFA Cover Sheet is required, please contact FDA’s Division of Drug Information at 866-405-5367 or 301-796-6707 or AskGDUFA@fda.hhs.gov.
Useful Links for GDUFA Cover Sheet and Payments: