Prescription Drug User Fee Cover Sheet

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PDUFA Cover Sheet Creation: Step-by-Step Instructions
On September 30, 2022 the President signed into law the Food and Drug Administration User Fee
Reauthorization Act of 2022. This new law includes the reauthorization of the Prescription Drug User
Fee Act (PDUFA) that provides FDA with the necessary resources to maintain a predictable and
efficient review process for human drug and biologic products. The new law ensures that FDA will
continue to receive a source of stable and consistent funding during fiscal years 2023-2027 that will
allow the agency to fulfill its mission to protect and promote public health by helping to bring to
market critical new medicines for patients.
The Prescription Drug User Fee Act (PDUFA) was enacted in 1992 and renewed in 1997 (PDUFA II),
2002 (PDUFA III), 2007 (PDUFA IV), 2012 (PDUFA V), 2017 (PDUFA VI) and 2022 (PDUFA VII). It
authorizes FDA to collect fees from companies that produce certain human drug and biological
products. Since the passage of PDUFA, user fees have played an important role in expediting the
drug approval process.
For additional information, please refer to:
http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/default.htm
1) Access the User Fee Website: https://userfees.fda.gov/OA_HTML/pdufaCAcdLogin.jsp
2) Review the statement and select the “I Understand” radio button.
3) For users who have an existing user name and password, proceed to Step 4;
a) If you do not have an existing account, see the FDA User Fee Account Creation: Stepby-Step Instructions for step-by-step instructions on how to create an account. For
additional assistance, contact the User Fee Helpdesk atuserfees@fda.gov.
4) Click on the ‘Login to Enterprise ICAM’ hyperlink.

Last Updated: March 25, 2024

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PDUFA Cover Sheet Creation: Step-by-Step Instructions
5) Enter the “Username “to login to your UFS account, Click on “Next” button you are navigated to the
“Password” entry page.

6) Enter the “Password “to login to your UFS account, Click on “Next” button you are navigated to the
“Send Verification Code” screen.

7) Click “Send Code” button to receive OTP to your Registered email address. After clicking on “Send
Code button you will be navigated to Verification Code Sent Screen.

Last Updated: March 25, 2024

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PDUFA Cover Sheet Creation: Step-by-Step Instructions
8) You will receive an email with “OTP” code to your registered email address.

9) Return to “Verification Code Sent” screen and enter the “OTP” code received into your registered email
address. Click on “Submit Code” button.

Last Updated: March 25, 2024

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PDUFA Cover Sheet Creation: Step-by-Step Instructions
10) Click the “Go” button next to “PDUFA Pre-Market Cover Sheets”.

11) Select ‘Continue’ button at the bottom of the page.

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PDUFA Cover Sheet Creation: Step-by-Step Instructions
12) Scroll to the bottom of the page and select the 'Application Details'button.

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PDUFA Cover Sheet Creation: Step-by-Step Instructions
13) Make the appropriate selections and provide the requested information as applicable:
a) Select ‘CDER Submission’ or ‘CBER Submission’
b) Provide the ‘Established Name/Proper Name’, ‘Trade Name’, ‘NDA Number’, and ‘BLA
Submission Tracking Number (STN)’
c) Select the type of application requested.
d) Select ‘Yes’ or ‘No’ to the application requiring clinical data for approval question.
e) Select ‘The required clinical data are contained in the application’ or ‘The required
clinical data are submitted by reference to:’
a)
If ‘The required clinical data are submitted by reference to:’ is selected,
provide either the ‘Application Number Containing the Data’ or
‘Supplement Number Containing the Data’
f) Select ‘Yes’ or ‘No’ to the Priority Review Voucher for the treatment of tropical
diseases question
a)
If ‘Yes’, provide the Priority Review Voucher number

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PDUFA Cover Sheet Creation: Step-by-Step Instructions
14) If applicable, select the ‘Exceptions and Waivers’ button; otherwise make the appropriate
selections and click ‘Done’ to continue.

15) Click ‘Done’ to continue.

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PDUFA Cover Sheet Creation: Step-by-Step Instructions

16) After arriving at the Draft Cover Sheet page, scroll to the bottom and select the 'Next' button
to review the contact and address information.
A. Note: you may save the cover sheet by selecting the ‘Save Cover Sheet’ button. You
may return to the ‘Draft Cover Sheet’ menu to access your saved draft cover sheet.
Select the checkbox under the ‘Delete’ column and select the ‘Delete Selected
‘Draft(s)’ button to delete a draft cover sheet.

Last Updated: March 25, 2024

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PDUFA Cover Sheet Creation: Step-by-Step Instructions
17) On the ‘Checkout: Applicant Contact Information’ page, you will see the billing information for
this cover sheet. You can change the address by selecting the ‘Change’ button and follow the
instructions to update the address. Once the information has been verified and is accurate,
select ‘Next’ to proceed.

Last Updated: March 25, 2024

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PDUFA Cover Sheet Creation: Step-by-Step Instructions
18) Review and verify your information and select the 'Submit Cover Sheet to FDA' button to
obtain your Payment Identification Number (PIN).

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

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PDUFA Cover Sheet Creation: Step-by-Step Instructions
20) A unique User Fee PIN will be generated with your cover sheet upon submission. Please note
that your completed cover sheet is your invoice. To obtain an invoice copy for your records,
select on the 'Print/View Final Cover Sheet' button on the confirmation page.
Once you submit your cover sheet and obtain your PIN, you may pay online by selecting the
'Pay Now' button.
You can create and submit another PDUFA cover sheet by selecting the ‘Create Another Cover
Sheet’ button.

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: March 25, 2024