Form FDA 3397 FDA 3397 User Fee Cover Sheet

Form Approved: OMB No. 0910 - 0297 Expiration Date: xxxxx xxxx xxxx See instructions for OMB Statement, below.
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? [ ] YES [ ] NO
2. NAME AND TELEPHONE NUMBER OF REPRESENTATIVE		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. ARE YOU REDEEMING A PRIORITY REVIEW VOUCHER FOR THE TREATMENT OF TROPICAL DISEASES? [ ] YES [ ] NO
PRIORITY REVIEW VOUCHER NUMBER
8. IS THIS APPLICATION COVERED BY ANY OF THE FOLLOWING USER FEE EXCLUSIONS? IF SO, CHECK THE
APPLICABLE EXCLUSION.
[ ] A LARGE VOLUME PARENTERAL DRUG PRODUCT APPROVED UNDER SECTION 505 OF THE FEDERAL FOOD,
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
9. HAS A WAIVER OF AN APPLICATION FEE BEEN GRANTED FOR THIS APPLICATION? [ ] YES [ ] NO If a waiver has been granted, include a copy of the official FDA notification with your submission.
OMB Statement:
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 Center for Biologics Evaluation and Research Office of Chief (HFA-710) 5600 Fishers Lane Rockville, MD 20857	Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research Office of Chief (HFA-710) 5600 Fishers Lane Rockville, MD 20857			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.
PRINTED NAME AND SIGNATURE OF AUTHORIZED REPRESENTATIVE	TITLE			DATE
10. USER FEE PAYMENT AMOUNT FOR THIS APPLICATION
Form FDA 3397 (03/09)