Overview and Technical Walk-through. Kim Karakorn and David Miller Division of User Fees Office of Financial Management Office of the Commissioner

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1 Overview and Technical Walk-through Kim Karakorn and David Miller Division of User Fees Office of Financial Management Office of the Commissioner

2 Division of User Fees The Division of User Fees (DUF) is part of the FDA s Office of Financial Management (OFM). The Division is responsible for the financial management of the User Fee programs including collections, accounting, reporting, and analysis. The Division develops and maintains an accounts receivable system used for user fee invoicing, collections, reporting, and data maintenance. The User Fee programs include fees for the following: Animal Drug User Fee Act (ADUFA) Animal Generic Drug User Fee Act (AGDUFA) Biosimilar User Fee Act (BsUFA) Color Certification (CERTS) Exports Certificate (Exports) Generic Drug User Fee Amendments (GDUFA) Medical Device User Fee Amendments (MDUFA) Mammography Quality Standards Act (MQSA) Prescription Drug User Fee Act (PDUFA) Family Smoking Prevention and Tobacco Control Act (Tobacco) Food Safety Modernization Act (FSMA) Freedom of Information Act Fees 2

3 Overview of the User Fee System FDA s User Fee System (UFS) is a user-friendly government-to-business, Webbased customer registration and payment system, based on Oracle Federal Financials. UFS provides FDA with an effective mechanism to automate, standardize and streamline the billing, collection and recording of fees. Over 42,000 users 20,000 cover sheets Fiscal Year Submitted Cover Sheets , ,358 3

4 GDUFA Cover Sheet Process Overview The high level process for submitting a Generic Drug User Fee Cover Sheet is: 1. Register in the User Fee System by creating a secure user account 2. Submit a Generic Drug User Fee Cover Sheet electronically 3. Submit a payment for the Generic Drug User Fee Cover Sheet 1. Register in the User Fee System 2. Submit a Generic Drug User Fee Cover Sheet 3. Submit a payment for the Generic Drug User Fee Cover Sheet 4

5 Access the User Fee Website Navigate to the User Fee website from the FDA website. Select the I understand radio button to proceed. 5

6 Register in the User Fee System Click on the New User? Please register link to register. Note: Existing customers should use their login information to sign into the system. 6

7 Register in the User Fee System There are various search options (including a paid cover sheet number, invoice number, address, organization number, employer identification number, or DUNS) to see if your organization already exists in the User Fee System. In this scenario, we assume you are a new organization. Select the radio button next to I am a new FDA User Fee Organization and click the Go button. 7

8 Register in the User Fee System Enter your business name, DUNS number, country, city and state and click the Go button to perform a search for your DUNS number in the Dun & Bradstreet (D&B) database. 8

9 Register in the User Fee System If the search in the D&B database did not return any matches for your organization, click the Select button next to I am a new Organization to continue. 9

10 Register in the User Fee System Select whether the organization is a U.S. or foreign organization and enter the required business information (organization name, Federal Employer Identification Number (EIN) and address). Click the Submit button to continue. Note: For foreign organizations, a DUNS number is required for registration. Also, the EIN is masked except for the last four digits. 10

11 Register in the User Fee System Enter the required user information (name, , daytime phone number, user name and password). Click the Submit button to continue. 11

12 User Fee Website Homepage After creating an account, you will be logged into the User Fee System where you can select from various user fee cover sheets. Also, on the bottom of the page are links to the Federal Register notices for each user fee. 12

13 Submit a Generic Drug User Fee Cover Sheet The Generic Drug User Fee Cover Sheet Homepage has instructions for submitting a cover sheet (FDA form 3794). Also on the left menu, there are websites that you can refer to for additional information. 13

14 Submit a Generic Drug User Fee Cover Sheet Below the cover sheet instructions, you ll find an Applications Details button. Click on the Application Details button to begin the process for submitting a Generic Drug User Fee Cover Sheet. 14

15 Submit a Generic Drug User Fee Cover Sheet You will answer a set of questions to determine the user fee amount that needs to be paid. To initiate the cover sheet process, select the appropriate cover sheet fee type. Click the Next button to continue. Note: When a cover sheet type is selected, the other application types are de-selected as indicated with the red x. 15

16 Submit a Generic Drug User Fee Cover Sheet Enter or confirm the applicant s name and address. Please note that there are Help prompts throughout the Generic Drug User Fee Cover Sheet submission process. Click on the Help link for guidance on answering the associated question. Click on the Next button to continue. 16

17 Submit a Generic Drug User Fee Cover Sheet The name, telephone number and address will pre-populate based on your registration. Enter the applicant s representative or U.S. agent information. Click the Next button to continue. 17

18 Submit a Generic Drug User Fee Cover Sheet Answer the questions regarding the application and provide the application number and established name of the product. Click the Next button to continue. 18

19 Submit a Generic Drug User Fee Cover Sheet Answer the question and click the Finish button to proceed. 19

20 Submit a Generic Drug User Fee Cover Sheet On the Draft Cover Sheet page, you will see the price for your cover sheet. This price is determined by the selections made during the cover sheet creation process. On this page, you have the option to modify, delete, save, or continue with the cover sheet process. Click the Next button to continue. 20

21 Submit a Generic Drug User Fee Cover Sheet On this page, you can click the Change button to update your billing address. You can also save the cover sheet or click Next to continue with the submission process. 21

22 Submit a Generic Drug User Fee Cover Sheet On the Checkout: Review and Submit Draft Cover Sheet page, you can view and print the draft cover sheet, update the contact information or submit the cover sheet electronically to FDA. Click the Submit Cover Sheet to FDA to submit the cover sheet and receive a Payment Identification Number (PIN). 22

23 Submit a Generic Drug User Fee Cover Sheet After submitting the cover sheet, a confirmation page will display with the Payment Identification Number (PIN). Click the Print/View Final Coversheet button to view and print the final cover sheet. 23

24 Submit a Generic Drug User Fee Cover Sheet A new window will open displaying the Generic Drug User Fee Cover Sheet. Use the scroll bar to drag the bar down to view the entire form. Please note the location of the Payment Identification Number (PIN) under the User Fee Payment Information section. 24

25 Submit a Generic Drug User Fee Cover Sheet At the bottom of the cover sheet window is a Print Cover sheet button to print the form and a Close button to close it. Click the Print Cover sheet button, enter your print options in the print window and click the Print button to print the form. Click the Close button to close the cover sheet window. 25

26 Submit a Generic Drug User Fee Cover Sheet Once a cover sheet is submitted, a Pay Now button will appear at the bottom of the page. Click the Pay Now button to submit an electronic payment through Pay.gov (a web-based payment application for online secure electronic payments). 26

27 Submit a Payment for the Generic Drug User Fee Payment methods include online, checks by mail and via wire transfer. Online payment: Pay.gov provides customers the option to submit online payment via Automated Clearing House (ACH) electronic check (echeck). After submitting your cover sheet click the Pay Now button and follow 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 PIN number you need to pay for. Confirmation of payment made by electronic check can be received in as little as 48 hours. Check payments by mail: If you prefer to pay via check, please write your PIN on the check and mail the check and a copy of the cover sheet to one of the addresses shown below. FDA will not be able to process your payment correctly without your GDUFA cover sheet PIN. Note: In no case should payment be submitted with the application. Food and Drug Administration P.O. Box St. Louis, MO Check payments delivered by a courier service: U.S. Bank ATTN: Government Lockbox Convention Plaza St. Louis, MO Note: This address is for courier delivery only. If you have any questions concerning courier delivery, contact the U.S. Bank at (314)

28 Submit a Payment for the Generic Drug User Fee Wire transfer payment: If you prefer to send your payment via wire transfer, please include your GDUFA cover sheet PIN with your wire transfer and send it to the address show below. FDA will not be able to process your payment correctly without your GDUFA cover sheet PIN. Note: Wire Transfers to the Department of the Treasury are distinct from online ACH payments via Pay.gov. New York Federal Reserve Bank U.S. Department of Treasury TREAS NYC 33 Liberty Street New York, NY10045 FDA Deposit Account Number: U.S. Department of Treasury Routing/Transit number: SWIFT Number: FRNYUS33 Beneficiary: FDA 1350 Piccard Drive, Suite 200A Rockville, MD20850 If needed for accounting purposes, FDA's tax identification number is

29 Customer Support The following resources are available to assist you with the registration, cover sheet and payment processes: Frequently Asked Questions (FAQs) - The FAQ icon in the User Fee System provides detailed instructions for account creation, account maintenance, cover sheet creation, payment options and contacts. User Guides Step-by-step instructions on how to register in the User Fee System and create/submit a GDUFA facility fee cover sheet can be found under Useful Links on the GDUFA User Fee System login page. Help Prompts Help prompts can be found throughout the cover sheet submission process to guide and assist you in answering the associated question. User Fee Help Desk Contact the User Fee Help Desk by phone at or at userfees@fda.gov. 29