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documentation to support qualification up a user account and use passwords to Dated: August 5, 2005.
as a small business under MDUFMA. assure data security in the creation and Jeffrey Shuren,
electronic submission of cover sheets. Assistant Commissioner for Policy.
IV. Procedures for Paying Application
Fees C. Step Three—Mail Payment and a [FR Doc. 05–15863 Filed 8–10–05; 8:45 am]
Any application or supplement Copy of the Completed Medical Device BILLING CODE 4160–01–S
subject to fees under MDUFMA that is User Fee Cover Sheet to the St. Louis
received on or after October 1, 2005, Address Specified Below
DEPARTMENT OF HEALTH AND
through September 30, 2006, is subject • Make the payment in U.S. currency HUMAN SERVICES
to the FY 2006 fee rate. The later of the by check, bank draft, or U.S. Postal
date that the application is received in money order payable to the Food and Office of Inspector General
the reviewing center’s document room Drug Administration. (The tax
or the date that the check is received by identification number of the Food and Program Exclusions: July 2005
US Bank determines whether the fee Drug Administration is 53–0196965,
rates for FY 2005 or FY 2006 apply. AGENCY: Office of Inspector General,
should your accounting department HHS.
FDA must receive the correct fee at the need this information.)
time that an application is submitted, or • Please write your application’s ACTION: Notice of program exclusions.
the application will not be accepted for unique Payment Identification Number, During the month of July 2005, the
filing or review. from the upper right-hand corner of HHS Office of Inspector General
FDA requests that you follow the your completed Medical Device User imposed exclusions in the cases set
steps below before submitting a medical Fee Cover Sheet, on your check, bank forth below. When an exclusions is
device application subject to a fee. draft, or U.S. Postal money order. imposed, no program payment is made
Please pay close attention to these • Mail the payment and a copy of the to anyone for any items or services
procedures to ensure that FDA links the completed Medical Device User Fee (other than an emergency item or
fee with the correct application. (Note: Cover Sheet to: Food and Drug service not provided in a hospital
In no case should the check for the fee Administration, P.O. Box 956733, St. emergency room) furnished, ordered or
be submitted to FDA with the Louis, MO, 63195–6733. prescribed by an excluded party under
application.) If you prefer to send a check by a the Medicare, Medicaid, and all Federal
A. Step One—Secure a Payment courier (such as FEDEX, DHL, UPS, Health Care programs. In addition, no
Identification Number and Medical etc.), the courier may deliver the check program payment is made to any
Device User Fee Cover Sheet From FDA to: US Bank, Attn: Government Lockbox business or facility, e.g., a hospital, that
Before Submitting Either the 956733, 1005 Convention Plaza, St. submits bills for payment for items or
Application or the Payment. Note: FY Louis, MO 63101. services provided by an excluded party.
(Note: This address is for courier
2006 Fee Rates Will be Available on the Program beneficiaries remain free to
delivery only. Contact the US Bank at
Cover Sheet Web Site Beginning on decide for themselves whether they will
314–418–4821 if you have any questions
September 6, 2005 continue to use the services of an
concerning courier delivery.)
Log onto the MDUFMA Web site at excluded party even though no program
It is helpful if the fee arrives at the
http://www.fda.gov/oc/mdufma and payments will be made for items and
bank at least 1 day before the
under the forms heading, click on the services provided by that excluded
application arrives at FDA. FDA records
link ‘‘User Fee Cover Sheet.’’ Complete party. The exclusions have national
the official application receipt date as
the Medical Device User Fee Cover effect and also apply to all Executive
the later of the following:
Sheet. Be sure you choose the correct • The date the application was Branch procurement and non-
application submission date range. (Two received by FDA. procurement programs and activities.
choices will be offered from September • The date US Bank receives the
Effective
6 until October 1, 2005. One choice is payment. US Bank is required to notify Subject, city, state
date
for applications that will be received on FDA within 1 working day, using the
or before September 30, 2005, which Payment Identification Number PROGRAM-RELATED CONVICTIONS
will be subject to FY 2005 fee rates. A described previously.
second choice is for applications that AFSHARIAN, PAYAM .............. 8/18/2005
D. Step Four—Submit your Application SANTA MONICA, CA
will be received on or after October 1,
to FDA with a Copy of the Completed AQUATIC & PHYSICAL THER-
2005, which will be subject to FY 2006
Medical Device User Fee Cover Sheet APY ASSOCIATES ............... 8/18/2005
fee rates.) After completing data entry,
KALAMAZOO, MI
print a copy of the Medical Device User Please submit your application and a
AWAHMUKALAH, MARGARET 8/18/2005
Fee Cover Sheet and note the unique copy of the completed Medical Device AVONDALE, PA
Payment Identification Number located User Fee Cover Sheet to one of the BERGMAN, BARBARA ............ 8/18/2005
in the upper right-hand corner of the following addresses: RHINELANDER, WI
printed cover sheet. • Medical device applications should BILLS, BETTY .......................... 8/18/2005
be submitted to: Food and Drug OPA LOCKA, FL
B. Step Two—Electronically Transmit a Administration, Center for Devices and BROWN, KELENKA ................. 8/18/2005
Copy of the Printed Cover Sheet with the Radiological Health, Document Mail E CHICAGO, IN
Payment Identification Number to Center (HFZ–401), 9200 Corporate CABALLERO, HERMINIO ........ 8/18/2005
FDA’s Office of Financial Management Blvd., Rockville, MD 20850. MIAMI, FL
CAP PHARMACY, INC ............ 12/13/2004
Once you are satisfied that the data on • Biologic applications should be sent
DENVER, CO
the cover sheet is accurate, to: Food and Drug Administration, CERDA, LOURDES .................. 8/18/2005
electronically transmit that data to FDA Center for Biologics Evaluation and FONTANA, CA
according to instructions on the screen. Research, Document Control Center COCHRAN, JUDITH ................. 8/18/2005
Since electronic transmission is (HFM–99), suite 200N, 1401 Rockville GUTHRIE, OK
possible, applicants are required to set Pike, Rockville, MD 20852–1448. DANIELS, LANISHA ................. 8/18/2005
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