FDA 3794 GDUFA Cover Sheet (e-form screenshot)

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GDUFA Facility Fee Cover Sheet Creation Process: Step-by-Step Instructions
Any person that owns a facility that is identified or intended to be identified in at least one generic drug
submission that is pending or approved to produce one or more generic drug FDFs and/or APIs is required to
pay facility fees. For additional information, please refer to:
http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/ucm319566.htm
** Please note that domestic (based in the U.S. and its territories) facilities will have a different fee
than foreign facilities. For more information regarding the facility fee rates, please refer to the Federal
Register
1. Access the User Fee website: https://userfees.fda.gov/OA_HTML/gdufaCAcdLogin.jsp
2. Review the statement and select the “I Understand” radio button.
3. For users who have an existing user account, proceed to Step 4.
a. If you do not have an existing account, please see the FDA User Fee Account Creation Process
guide. If you do not have this document for reference, please email the User Fee Help Desk
at userfees@fda.gov and request it.
4. Enter a valid User Name and Password.
5. Click the “Login” button.

Note: There are Help prompts throughout the cover sheet process. When you click on a Help link, a new window will
open with helpful hints and tips to guide you through answering the questions.

Last Updated: August 26, 2020

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GDUFA Facility Fee Cover Sheet Creation Process: Step-by-Step Instructions
6. Click the “Go” button next to “Generic Drug User Fee”.

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GDUFA Facility Fee Cover Sheet Creation Process: Step-by-Step Instructions
7. Scroll to the bottom of the page and select the 'Application Details' button.

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GDUFA Facility Fee Cover Sheet Creation Process: Step-by-Step Instructions
8. Select the “Facility Fee” checkbox then click the “Next” button.

Note: By clicking on Help above, system will provide more info on what to enter.

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GDUFA Facility Fee Cover Sheet Creation Process: Step-by-Step Instructions
9. Enter or confirm the facility owner’s name and address. Enter all required fields that are notated
with an asterisk (e.g., Facility Owner’s Name, Country, and Address). Click the “Next” button to
continue.

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GDUFA Facility Fee Cover Sheet Creation Process: Step-by-Step Instructions
10. Enter or confirm the facility owner’s representative or U.S. agent information. Enter all required
fields (e.g., First Name, Last Name, Job Title, Telephone Number, and Email Address). Click the
“Next” button to continue.

11. Select whether the facility is located in the United States, its territories or possessions.
Enter the physical address of the facility for which the facility fee is being paid. Enter all required
fields (e.g., Facility Name, Country, FEI Number, Facility DUNS Number, and Address). Click the
“Next” button.

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GDUFA Facility Fee Cover Sheet Creation Process: Step-by-Step Instructions
12. Indicate what the facility produces for the manufacture of human drugs (API and/or FDF). Check all
options that apply. Answer the corresponding Positron Emission Tomography (PET) question for API
and/or FDF if applicable.
Next, answer the question regarding whether or not the facility produces human drugs other than
human generic drugs. Click the “Next” button to continue.
Note: For clarification on this question, please contact the GDUFA Policy Team at
AskGDUFA@fda.hhs.gov.

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GDUFA Facility Fee Cover Sheet Creation Process: Step-by-Step Instructions
13. On the Draft Cover Sheet page, verify the amount owed for the cover sheet. You have four
options on this page:
a) Click the “Next” button to continue.
b) You can click the “Modify Application Details” button to make changes to the
draft cover sheet. To view the draft cover sheet, click on the “GENERIC
DRUG USER FEE COVER SHEET” link.
c) If you do not save or submit your cover sheet, it will be available for 30 days
in the “Draft Cover Sheet” menu.
d) You can save the cover sheet by clicking on the “Save Cover Sheet” button.
In this scenario, click the “Next” button to continue.
**Please note that the cover sheet amount in this example is based upon options
chosen and for demonstration purposes only. The amount calculated during your
cover sheet creation process may be different than the amount stated in the
example.

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GDUFA Facility Fee Cover Sheet Creation Process: Step-by-Step Instructions
14. Confirm the Bill To information and click the “Next” button to proceed.
Note: If you would like to change the billing information, click the “Change” button to create a
new address.

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GDUFA Facility Fee Cover Sheet Creation Process: Step-by-Step Instructions
15. Confirm the details of your cover sheet on the Checkout: Review and Submit Draft Cover
Sheet page. Click the “Submit Cover Sheet to FDA” button to electronically submit your
GDUFA cover sheet.

16. After reading the message, select ‘Submit Cover Sheet to FDA’.

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GDUFA Facility Fee Cover Sheet Creation Process: Step-by-Step Instructions
17. A confirmation of your cover sheet submission and a Payment Identification Number appears.
On this page, you may:
a) Click the “Print/View Final Cover Sheet” button to view and/or print the cover sheet.
b) Click the “Pay Now” button to make an online payment.
c) Click the “Create Another Cover Sheet” button to create another cover sheet. Refer to
steps 6 through 15.

Note: Your cover sheet is your invoice. To view and/or print your cover sheet at any time,
select the “Previous Cover Sheets” menu at the top of the page. From this menu, click on
the Payment Identification Number under the search results and a new window will open.
Scroll down to the bottom of the window and click on the link to print the cover sheet.

Note: You can submit payment online by credit card or Automated Clearing House (ACH) electronic
check (eCheck), by paper check or by wire/bank transfer. There is a credit card payment limit of
$24,999.99. Any payment above the limit will need to be paid using another payment method. The
preferred payment method is online. If you prefer to pay via check or wire transfer, please write the
PIN on the check or include the PIN with your wire transfer payment. FDA will not be able to process
your payment correctly without your PIN.
If you have any further questions about the cover sheet creation process, please contact the User Fee
Helpdesk at userfees@fda.gov.

Last Updated: August 26, 2020