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Animal Drug User Fee Cover Sheet

The Animal Drug User Fee cover sheet is required for submission of your New Animal Drug Application. By completing this cover sheet, you will be assigned a unique Payment Identification Number that distinguishes your fee payment and submission.

Getting Started:

• FDA offers you the ability to complete an Animal Drug User Fee cover sheet online and submit it electronically. See browser requirements below. Your company can register online and create users electronically. To complete the registration process, FDA/CVM asks you to provide information about your company such as:
• Contact Name, Company Name, Address, City, State, Zip Code, Country
  Telephone, Fax, E-Mail and company’s federal Employer Identification Number (EIN)
• Once this process is complete, you may begin filling out the Animal Drug User Fee cover sheet. There is a series of questions based on the type of the application that you are submitting for review to the FDA Center for Veterinary Medicine. When you have completed answering the questions and you SUBMIT your cover sheet, you will be able to view/print a form with an electronically generated Payment Identification Number. This is located in the upper right hand corner beginning with the letters "AD." This is the link that FDA will use to track your payment and your submission to begin the review process.
• Include a printed copy of the completed cover sheet with a check made payable to the Food and Drug Administration. Remember that the Payment Identification Number must be written on the check.

Payment Submission Information:

• Mail your check and one copy of the FDA ADUFA cover sheet to:
• The Food and Drug Administration
  P.O. Box 953877
  St. Louis, MO 63195-3877
• (Note: Please do not send your application to this address, only your payment.)
• Send a check by a courier. The courier may deliver the check and cover sheet to:
• US Bank
  Attn: Government Lockbox 953877
  1005 Convention Plaza
  St. Louis, MO 63101
• (Note: Please do not send your application to this address, only your payment. This address is for courier delivery only. Contact US Bank at 314-418-4821 if you have any questions concerning courier delivery.)
• If paying by wire transfer, you may send your payment using the following information.You are responsible for any administrative costs associated with the processing of a wire transfer. Contact your bank or financial institution regarding additional fees. Please note that the review of your application can not begin until full payment is received. Also include your user fee payment identification number from your user fee cover sheet when you send payment by wire transfer. Please ensure that the fee that your bank will charge for the wire transfer is added to your fee payment.
  
• US Department of Treasury
  TREAS NYC
  33 Liberty Street
  New York, NY 10045
  FDA Deposit Account Number: 75060099
  US Department of Treasury routing/transit number: 021030004
  SWIFT Number: FRNYUS33
  
• Pay.gov can be used to submit secure online payments for cover sheets to the FDA. Payments can be made through the Automated Clearing House (ACH) method, which can come directly from your bank account or an eCheck.  The FDA has partnered with the US Department of the Treasury to use Pay.gov, a web-based payment application, for online electronic payment. The Treasury has compiled a comprehensive list of Pay.gov FAQs which can be accessed at https://www.pay.gov/paygov/faqs.html.

Application Submission Information

• Mail application and include a copy of the completed cover sheet to:
• Food and Drug Administration
  Center for Veterinary Medicine
  Document Control Unit (HFV-199)
  7500 Standish Place
  Rockville, MD 20855

Create ADUFA User Fee Cover Sheet

OMB No. 0910-0538
Form FDA 3546 (03/08)

How to Get Help if You:

• Already submitted an application and/or payment and forgot your Payment Identification Number
• Are unable to use the online system
• Are unsure whether or not you need to file an application with FDA
• Are unsure what type of application to file.

Please Contact:

FDA User Fee Information Desk
Phone: 301-827-9539
E-mail: userfees@fda.gov

System Requirements
To fill out the form online, you need Microsoft Internet Explorer 5.5 or higher or Netscape Navigator 4.7 or higher.

Public Reporting Burden

Public reporting burden for this collection of information is estimated to average 20 minutes per response, including time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to:

Department of Health and Human Services
Food and Drug Administration
Center for Veterinary Medicine
7519 Standish Place
Rockville, MD 20855

An agency may not conduct or sponsor a collection of information, and a person is not required to respond to a collection of information, unless it displays a currently valid OMB control number.

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