DEPARTMENT
OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG
ADMINISTRATION
MEDICAL DEVICE USER FEE COVER SHEET
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PAYMENT
IDENTIFICATION NUMBER: MD
-956733
Write the
Payment Identification number on your check.
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A
completed Cover Sheet must accompany each original
application or supplement subject to fees. The following
actions must be taken to properly submit your application
and fee payment:
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1.
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Electronically
submits the completed Cover Sheet to the Food and Drug
Administration (FDA) before payment is sent.
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2.
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Include
printed copy of this completed Cover Sheet with a check
made payable to the Food and Drug Administration.
Remember that the Payment Identification Number must be
written on the check.
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3.
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Mail
Check and Cover Sheet to the US Bank Lock Box, FDA
Account, P.O. Box 956733, St. Louis, MO 63195-6733.
(Note:
In no case should payment be submitted with the
application.)
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4.
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If
you prefer to send a check by a courier, the courier may
deliver the check and Cover Sheet to: US Bank, Attn:
Government Lockbox 956733, 1005 Convention Plaza, St.
Louis, MO 63101. (Note: This address is for courier
delivery only. Contact the US Bank at 314-418-4821 if you
have any questions concerning courier delivery.)
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5.
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For
Wire Transfer Payment Procedures, please refer to the
MDUFMA Fee Payment Instructions at the following URL:
http://www.fda.gov/cdrh/mdufma/faqs.html#3a. You are
responsible for paying all fees associated with wire
transfer.
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6.
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Include
a copy of the complete Cover Sheet in volume one of the
application when submitting to the FDA at either the CBER
or CDRH Document Mail Center.
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1.
COMPANY NAME AND ADDRESS (include name, street address,
city state, country, and post office code)
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1.1
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EMPLOYER
IDENTIFICATION NUMBER (EIN)
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2.
CONTACT NAME
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2.1
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E-MAIL
ADDRESS
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2.2
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TELEPHONE
NUMBER (include Area code)
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2.3
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FACSIMILE
(FAX) NUMBER (Include Area code)
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3.
TYPE OF PREMARKET APPLICATION (Select one of the
following in each column; if you are unsure, please refer
to the application descriptions at the following web
site: http://www.fda.gov/dc/mdufma
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Select
an application type:
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3.1
Select one of the types below
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[
] Premarket notification(510(k)); except for third
party
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[
] Original Application
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[ ] Biologics
License Application (BLA)
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Supplement
Types:
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[ ] Premarket
Approval Application (PMA)
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[ ] Efficacy
(BLA)
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[ ] Modular
PMA
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[ ] Panel
Track (PMA, PMR, PDP)
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[ ] Product
Development Protocol (PDP)
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[ ] Real-Time
(PMA, PMR, PDP)
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[ ] Premarket
Report (PMR)
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[ ] 180-day
(PMA, PMR, PDP)
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4.
ARE YOU A SMALL BUSINESS? (See the instructions for more
information on determining this status)
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[
] YES, I meet the small business criteria and
have submitted the required qualifying documents to FDA
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[
] NO, I am not a small business
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4.1
If Yes, please enter your Small Business Decision
Number:
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5.
IS THIS PREMARKET APPLICATION COVERED BY ANY OF THE
FOLLOWING USER FEE EXCEPTIONS? IF SO, CHECK THE
APPLICABLE EXCEPTION.
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[ ] This
application is the first PMA submitted by a qualified
small business, including any affiliates, parents, and
partner firms
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[ ] The
sole purpose of the application is to support conditions
of use for a pediatric population
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[ ] This
biologics application is submitted under secion 351 of
the Public Health Service Act for a product licensed for
further manufacturing use only
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[ ] The
application is submitted by a state or federal government
entity for a device that is not to be distributed
commercially
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6.
IS THIS A SUPPLEMENT TO A PREMARKET APPLICATION FOR WHICH
FEES WERE WAIVED DUE TO SOLE USE IN A PEDIATRIC
POPULATION THAT NOW PROPOSES CONDITION OF USE FOR ANY
ADULT POPULATION? (If so, the application is subject to
the fee that applies for an original premarket approval
application (PMA).)
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[ ] YES
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[X] NO
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7.
USER FEE PAYMENT AMOUNT SUBMITTED FOR THIS PREMARKET
APPLICATION (FOR FISCAL YEAR 2007)
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$
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31-Oct-2006
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