Form FDA 3792 Form FDA 3792 Biosimilar User Fee Cover Sheet

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Form Approved: OMB No. 0910 - 0718 Expiration Date: August 31, 2015. See instructions for OMB Statement, below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION

APPLICANT'S NAME AND ADDRESS
FDA TEST COMPANY

BIOSIMILAR USER FEE COVER
SHEET

WHAT SUBMISSION DOES THIS COVER SHEET
REFERENCE?
PRE-IND AND/OR IND NUMBER(S): 123456
[ ] INITIAL BPD
[ ] REACTIVATION

NAME, TELEPHONE NUMBER, AND E-MAIL OF
REPRESENTATIVE

SUBMISSION TRACKING NUMBER (STN):
[ ] 351(k) APPLICATION
[ ] 351(k) SUPPLEMENT
REQUIRING CLINICAL DATA

PRODUCT NAME(S)

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)
8455 Colesville Road, COLE-14-14253
Silver Spring, MD 20993-0002

Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research
Office of Information Management (HFA710)
8455 Colesville Road, COLE-14-14253
Silver Spring, MD 20993-0002

PRINTED NAME AND SIGNATURE OF AUTHORIZED
REPRESENTATIVE

USER FEE I.D. NUMBER
USER FEE PAYMENT AMOUNT FOR THIS SUBMISSION
Form FDA 3792 (08/12)

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

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INSTRUCTIONS FOR COMPLETING BIOSIMILAR USER FEE COVER SHEET
FORM FDA 3792
Complete this form for:
 a biosimilar biological product development (BPD) meeting;
 an investigational new drug application (IND) intended to support a biologics license application submitted under
section 351(k) of the Public Health Service Act ("351(k) application");
 a 351(k) application; or
 a 351(k) supplement.
See accompanying exceptions. Submit form FDA 3792 with the IND, application, and supplement, and place in the first volume with the cover
page (FORM FDA 1571 and FDA 356(h)). If payment is sent by U.S. mail or courier, please include a copy of this completed form with
payment. If you need assistance in completing the form call 301-796-7200
or email: userfees@fda.gov. Payment instructions and fee rates
can be found on FDA's Website.
Form FDA 3792 need not be submitted for a BPD meeting, an IND intended to support a 351(k) application, a 351(k) application, or a
351(k) supplement, if:
 The BPD meeting, IND, application, or supplement is for:
 whole blood or blood component for transfusion;
 an allergenic extract product;
 an in vitro diagnostic biological product;
 a biological product for further manufacturing use only;
 The BPD meeting, IND, application, or supplement cites as the reference product:
 a bovine blood product for topical application that was approved before September 1, 1992;
 a large volume parenteral drug product that was approved before September 1, 1992;
 You are a state or federal government entity being granted a BPD meeting, or submitting an IND, application, or supplement for a

product that is not distributed commercially.

Submit Form 3792 and
pay a fee for:

UNLESS specifically exempted above or

A BPD meeting1 for a product

You have already paid, in the current fiscal year:
 an initial BPD fee2 for the product;
 an annual BPD fee3 for the product;
 a reactivation fee4 for the product

OR
You submitted a 351(k) application for the product that was accepted for filing
An IND that is intended to support You have already paid, in the current fiscal year:
a 351(k) application
 an initial BPD fee for the product;
 an annual BPD fee for the product;
 a reactivation fee for the product

OR
A 351(k) application

You submitted a 351(k) application for the product that was accepted for filing
You are resubmitting the application, for the same product for the same indications, after submitting a 351
(k) application that was accepted for filing and was not approved or withdrawn

A 351(k) supplement

Your supplement does not require clinical data, other than comparative bioavailability studies, for approval;

OR
You are resubmitting the supplement, for the same product for the same indications, after submitting a 351
(k) supplement that was accepted for filing and was not approved or withdrawn.

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1 The term "BPD meeting" means any meeting, other than a "biosimilar initial advisory meeting", regarding the content of a biosimilar
development program, including a proposed design for, or data from, a study intended to support a biosimilar biological product application.
A "biosimilar initial advisory meeting" is a meeting that is limited to a general discussion regarding whether licensure under section 351(k) may
be feasible for a particular product, and, if so, general advice on the expected content of the development program. It does not include any
meeting that involves substantive review of summary data or full study reports. No fees are assessed for a biosimilar initial advisory meeting.
2 The "initial BPD fee" is the fee a sponsor pays to join FDA's BPD Program for a product.
3 The "annual BPD fee" is the fee a sponsor pays to continue participating in FDA's BPD Program for a product. Specifically, once a sponsor
has paid the initial BPD fee for a product, beginning in the next fiscal year, an annual BPD fee will be assessed for the product until the
sponsor or applicant submits a marketing application for the biological product that is accepted for filing, or discontinues participation in the
BPD Program for the product.
4 The "reactivation fee" is the fee a sponsor must pay to resume participation in the BPD Program for a product, if the sponsor previously
discontinued participation for that product.
Form FDA 3792 (08/12) (BACK)

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