Animal Drug User Fee Cover Sheet
The Animal Drug User Fee Cover Sheet is required for your Animal Drug Application Submission.
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 online an Animal Drug User Fee Cover Sheet and submit
it electronically. See browser requirements below Your
company can register on-line and create users electronically. To accomplish
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 your companyís Tax identification number (EIN)
Once this process is complete, you may begin filling out the Animal Drug User Fee Cover Sheet. Once
you have identified you and your companyís organization number the system
will populate with the information you or your company provided in the registration
process. Then there is a series of questions based on the type of the application
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
a form will appear 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.
- Mail payment and cover sheet to
Food and Drug Administration
P.O. Box 953877
St. Louis, MO 63195-3877
(Note: In no case should payment be submitted with the application.)
- If you prefer to send a check by 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: This address is for courier delivery only. Contact the US
Bank at 314-418-4821 if you have any questions concerning courier delivery.)
- 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. 0910-0539
Form FDA 3546 (06/08)
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; and
- Are unsure what type of application to file.
Please Contact:
FDA User Fee Information Desk
Phone: 301-827-9539
E-mail: userfees@fda.gov
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, and a person is not required to respond
to a collection of information, unless it displays a currently valid OMB control
number.
