0297-PDUFA CoverSheetInstructions

PDUFA User Fee Cover Sheet

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PDUFA User Fee Cover Sheet
Under sections 735 and 736 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379g and 379h), FDA has the authority to assess and collect user fees for
certain drug and biologics license applications and supplements. Under this
authority, pharmaceutical companies pay fees for certain new human drug
applications, biologics applications, and supplements submitted to the agency
for review. Because the submission of user fees concurrently with applications
and supplements is required, review of an application by FDA cannot begin until
the fee has been submitted. Form FDA 3397, the PDUFA user fee cover sheet, is
designed to provide the minimum necessary information to determine whether a fee
is required for review of an application, to determine the amount of the fee
required, and to help FDA track payments.
The form provides a cross-reference of the fee submitted for an application with
the actual application by using a unique number tracking system to assign the
user fee payment identification number. The information collected is used by
FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics
Evaluation and Research (CBER) to initiate the administrative screening of new
drug applications, biologics license applications, and supplemental
applications.
How to Fill Out the PDUFA User Fee Cover Sheet On-line:
FDA offers you the ability to complete a PDUFA User Fee Cover Sheet on-line and
submit it electronically. To fill out the form online, you need Microsoft
Internet Explorer 5.5 or higher or Netscape Navigator 4.7 or higher. To view
instructions for checking and updating your browser, please go to:
www.fda.gov/cber/browser.htm.
Read the instructions below and then go to the PDUFA User Fee Coversheet to fill
out the form.
1. You will register on-line by providing the following information:
Employer Identification Number (EIN)
Contact Name
Company Name
Address, City, State, Zip Code, Country
Daytime Telephone
Facsimile Number
E-mail
Dun & Bradstreet Number (DUNS)
2. Fill out the PDUFA User Fee Cover Sheet. Please answer a series of questions
regarding the type of application being submitted for FDA's review. You will
have the opportunity to view the cover sheet in draft form before submitting it
to FDA. You have not submitted your cover sheet until you receive a user fee
payment identification number.
3. When you are done, click the SUBMIT button to complete the cover sheet
submission process. A form will appear with an electronically generated user fee
payment identification number that is located in the upper right-hand corner,
beginning with the letters PD. This number will assist FDA in tracking your
payment and submission for the review process. Please print a copy for your
files to send with your payment and for your submission to CDER and CBER.
Submitting Payment
Please send a printed copy of the completed PDUFA User Fee Cover Sheet along
with a check, bank draft, or U.S. Postal money order made payable to the Food
and Drug Administration for the fee amount due. Remember to include the user fee
payment identification number, beginning with "PD", the BLA/NDA number, and the
FDA P.O. Box on the enclosed check.
Mail payment and copy of PDUFA user fee cover sheet to:
Food and Drug Administration
P.O. Box 360909
Mellon Client Service Center -- Room 670
500 Ross Street
Pittsburgh, PA 15251-6909
Note: In no case should payment be submitted with the application.
If checks are to be sent by a courier that requires a street address, the
courier can deliver the checks to:
Food and Drug Administration (360909)
Mellon Client Service Center - Room 670
500 Ross Street
Pittsburgh, PA 15262-0001
Note: This address is for courier delivery only.
If You Have Problems:
If you are unsure whether or not you need to file an application with FDA or are
unsure what type of application to file:
Contact: Bev Friedman or Mike Jones at 301-594-2041
FDA Center for Drug Evaluation and Research
Contact: Carla Vincent at 301-827-3503
FDA Center for Biologics Evaluation and Research
If you need technical assistance with your cover sheet or are unsure how to
proceed.
Contact: FDA User Fee Financial Support Team at (301) 827-9539 or
[email protected].
PDUFA User Fee Cover Sheet
OMB No. 0910-0297
Form FDA 3397 (12/06)

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