Form 3397 Prescription Drug User Fee Cover Sheet

Form Approved: OMB No. 0910 - 0297 Expiration Date: Xxxxxxxxxx xx, 2016. 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 FDA's website:
http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm119184.htm.
1. APPLICANT'S NAME AND ADDRESS

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

2. NAME AND TELEPHONE NUMBER OF REPRESENTATIVE

5. DOES THIS APPLICATION REQUIRE CLINICAL DATA
FOR APPROVAL?
[ ] 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:

6. USER FEE I.D. NUMBER

3. PRODUCT NAME

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)(F) 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.
Privacy Act Notice: This notice is provided pursuant to the Privacy Act of 1974, 5 U.S.C. 552a. The collection of this information is authorized by 21 U.S.C. 371, 379, 379e, 379h,
379h-1, 379j, 379j-12, 379j-21, 387s, and 393(d)(2); 42 U.S.C. 263b(r)(1); 5 U.S.C. 301 and 552; and 42 U.S.C. 3101. FDA will use the information to assess, collect and process
user fee payments, and, facilitate debt collection under the Debt Collection Improvement Act. FDA may disclose information to courts and the Department of Justice in the context
of litigation and requests for legal advice; to other Federal agencies in response to subpoenas issued by such agencies; to HHS and FDA employees and contractors to perform user
fee services; to the National Archives and Records Administration and General Services Administration for records management inspections; to the Department of Homeland
Security and other Federal agencies and contractors in order to respond to system breaches; to banks in order to process payment made by credit card; to Dun and Bradstreet to
validate submitter contact information, and to other entities as permitted under the Debt Collection Improvement Act. Furnishing the requested information is mandatory. Failure to
supply the information could prevent FDA from processing user fee payments. Additional detail regarding FDA’s use of information is available online:
http://www.fda.gov/RegulatoryInformation/FOI/PrivacyAct/default.htm.

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 Information Management (HFA-710)
1350 Piccard Drive, 4th Floor
Rockville, MD 20850

Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research
Office of Information Management (HFA710)
1350 Piccard Drive, 4th Floor
Rockville, MD 20850

PRINTED NAME AND SIGNATURE OF AUTHORIZED
REPRESENTATIVE

9. USER FEE PAYMENT AMOUNT FOR THIS APPLICATION
Form FDA 3397 (03/2012)

TITLE

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

INSTRUCTIONS FOR COMPLETING PRESCRIPTION DRUG USER FEE COVER
SHEET
FORM FDA 3397
Form FDA 3397 is to be completed for and submitted with each new drug or biologic product original
application or supplemental application submitted to the Agency,unless specifically exempted below. Form
FDA 3397 should be placed in the first volume of the application with the application (FORM FDA 356(h)) form.
Form FDA 3397 is to be completed on-line at https://userfees.fda.gov/OA_HTML/pdufaCAcdLogin.jsp. If you
need assistance in completing the form call 301-796-7200 or email: [email protected].
NOTE: Form FDA 3397 need not be submitted for:
CDER
505(j) applications
Supplements to 505(j) applications
351(k) applications
CBER
Any supplement that does not require clinical data for approval.
Applications and supplements for:

*
*
*
*
*
*

ITEM
NO.
1-2.
3.
4.

5.

6.
7.

8.

9.

Products for further manufacturing use only
Whole blood or blood components for transfusion
Bovine blood product for topical application licensed before September 1, 1992
A crude allergenic extract product
An in vitro diagnostic biological product licensed under Section 351 of the PHS Act
351(k) applications

INSTRUCTIONS
Self-explanatory
PRODUCT NAME: Include generic or proper name and trade name, as applicable.
BLA STN / NDA NUMBER - FOR AN ORIGINAL BIOLOGIC LICENSE APPLICATION (BLA) - Indicate the
6-digit BLA number (Submission Tracking Number (STN)) if pre-assigned, otherwise leave blank. For A
SUPPLEMENT enter the BLA STN.
FOR DRUG PRODUCTS:
Indicate the new drug application (NDA) number. NDA numbers can be obtained by completing the
information at
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm114027.htm.
CLINICAL DATA: The definition of 'clinical data' for the assessment of user fees is found in FDA's Guidance
for Industry: Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User
Fees. FDA's guidance on the definition of clinical data can be found on FDA's web site:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM079320.pdf.
USER FEE I.D. NUMBER: Please include the ID number (generated when completing Form FDA 3397) on
the application payment check.
PRIORITY REVIEW VOUCHER:
If you are redeeming a priority review voucher awarded to a sponsor of a tropical disease product application
(see section 524 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)), please include the priority review
voucher number assigned when the voucher was initially granted. See FDA´s Guidance for Industry: Tropical
Disease Priority Review Vouchers for further information. FDA´s guidance can be found on FDA´s web site:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM080599.pdf
EXCLUSIONS:
The application is for an orphan drug product. Under section 736(a) (1) (F) of the FD&C Act, a human drug
application is not subject to an application fee if the proposed product is for a rare disease or condition
designated under section 526 of the FD&C Act (orphan drug designation) AND the application does not
include an indication that is not so designated. A supplement is not subject to an application fee if it proposes
to include a new indication for a rare disease or condition, and the drug has been designated pursuant to
section 526 for a rare disease or condition with regard to the indication proposed in the supplement. A copy of
the FDA letter granting orphan designation should be included with the BLA/NDA submission.
WAIVER: Complete this section only if a waiver of user fees, including the small business waiver, has been
granted for this application. A copy of the official FDA notification that the waiver has been granted must be
provided with the BLA/NDA submission.

Form FDA 3397 (03/2012)(BACK)