Form 3397 Prescription Drug User Fee Coversheet

Form Approved: OMB No. 0910 - 0297 Expiration Date: December 31, 2006 See instructions for OMB Statement.
DEPARTMENT OF HEALTH AND HUMAN
SERVICES
FOOD AND DRUG ADMINISTRATION

PRESCRIPTION DRUG USER FEE
COVERSHEET

A completed form must be signed and accompany each new drug or biologic product application and each new supplement. See
exceptions on the reverse side. If payment is sent by U.S. mail or courier, please include a copy of this completed form with payment.
Payment instructions and fee rates can be found on CDER's website: http://www.fda.gov/cder/pdufa/default.htm
1. APPLICANT'S NAME AND ADDRESS

4. BLA SUBMISSION TRACKING NUMBER (STN) / NDA
NUMBER

5. DOES THIS APPLICATION REQUIRE CLINICAL DATA
FOR APPROVAL?

2. TELEPHONE NUMBER

[ ] YES [ ] NO
IF YOUR RESPONSE IS "NO" AND THIS IS FOR A
SUPPLEMENT, STOP HERE AND SIGN THIS FORM.
IF RESPONSE IS "YES", CHECK THE APPROPRIATE
RESPONSE BELOW:
[ ] THE REQUIRED CLINICAL DATA ARE CONTAINED IN
THE APPLICATION
[ ] THE REQUIRED CLINICAL DATA ARE SUBMITTED BY
REFERENCE TO:

3. PRODUCT NAME

6. USER FEE I.D. NUMBER

7. IS THIS APPLICATION COVERED BY ANY OF THE FOLLOWING USER FEE EXCLUSIONS? IF SO, CHECK THE
APPLICABLE EXCLUSION.
[ ] A LARGE VOLUME PARENTERAL DRUG PRODUCT
[ ] A 505(b)(2) APPLICATION THAT DOES NOT REQUIRE A
APPROVED UNDER SECTION 505 OF THE FEDERAL FOOD, FEE
DRUG, AND COSMETIC ACT BEFORE 9/1/92 (Self Explanatory)
[ ] THE APPLICATION QUALIFIES FOR THE ORPHAN
EXCEPTION UNDER SECTION 736(a)(1)(E) of the Federal
Food,Drug, and Cosmetic Act

[ ] THE APPLICATION IS SUBMITTED BY A STATE OR
FEDERAL GOVERNMENT ENTITY FOR A DRUG THAT IS NOT
DISTRIBUTED COMMERCIALLY

8. HAS A WAIVER OF AN APPLICATION FEE BEEN GRANTED FOR THIS APPLICATION? [ ] YES [] NO
Public reporting burden for this collection of information is estimated to average 30 minutes per response, including the 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
CBER, HFM-99
1401 Rockville Pike
Rockville, MD 20852-1448

Food and Drug Administration
CDER, HFD-94
12420 Parklawn Drive, Room 3046
Rockville, MD 20852

SIGNATURE OF AUTHORIZED COMPANY REPRESENTATIVE TITLE

9. USER FEE PAYMENT AMOUNT FOR THIS APPLICATION
Form FDA 3397 (12/03)

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.
DATE