[Federal Register: August 11, 2005 (Volume 70, Number 154)]
[Notices]
[Page 46872-46874]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11au05-85]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Medical Device User Fee Rates for Fiscal Year 2006
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the fee
rates and payment procedures for medical device user fees for fiscal
year (FY) 2006. The Federal Food, Drug, and Cosmetic Act (the act), as
amended by the Medical Device User Fee and Modernization Act of 2002
(MDUFMA) and the Medical Device User Fee Stabilization Act of 2005
(MDUFSA), authorizes FDA to collect user fees for certain medical
device applications. The FY 2006 fee rates are provided in this notice.
For all applications submitted on or after October 1, 2005, and through
September 30, 2006, fees must be paid
[[Page 46873]]
at the FY 2006 rates at the time the applications are submitted to FDA.
The fee you must pay is the fee that is in effect on the date your
application is received by FDA or on the date your check is received,
whichever is later. This notice provides details on how fees for FY
2006 were determined and payment procedures for medical device
applications subject to user fees.
FOR FURTHER INFORMATION CONTACT:
For further information on MDUFMA: Visit the FDA Web site http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/mdufma
.
For questions relating to this notice: Frank Claunts, Office of
Management (HF-20), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-4427.
SUPPLEMENTARY INFORMATION:
I. Background
Section 738 of the act (21 USC 379j) establishes fees for certain
medical device applications and supplements. Under statutorily defined
conditions, FDA may waive or reduce fees (21 U.S.C. 379j(d) and (e)).
Under MDUFMA, the fee rate for each type of application is set at a
specified percentage of the standard fee for a premarket application (a
premarket application is a premarket approval application (PMA), a
product development protocol, or a biologic licensing application).
MDUFSA specifies that the standard fee for a premarket application
submitted during FY 2006 is $259,600. From this starting point, this
notice establishes fee rates for FY 2006. These fees are effective on
October 1, 2005, and will remain in effect through September 30, 2006.
II. Fee Calculations for FY 2006
Under the act, all fees are set as a percentage of the full fee for
a premarket application (see 21 U.S.C. 379j(a)(1)(A)), and the act sets
the standard fee for a premarket application at $259,600 for FY 2006
(see 21 U.S.C. 379j(c)(1); this is referred to as the ``base fee.'' A
180-day supplement is set at 21.5 percent of the base fee; the fee for
a real-time supplement is set at 7.2 percent of the base fee (see 21
U.S.C. 379j(a)(1)(A)).
For all applications other than premarket notification submissions
(510(k)s), the small business rate is 38 percent of the standard (full
fee) rate (see 21 U.S.C. 379j(d)(2)(C)). For 510(k) premarket
notification submissions, the fees are to be set so that fees from all
510(k)s would produce revenue as if all were assessed a fee of 1.42
percent of the base fee, but these fee rates are to be adjusted so that
the fee paid by a qualifying small business is 80 percent of the full
rate for a 510(k) premarket notification submission (see 21 U.S.C.
379j(e)(2)(C)). Based on FDA's estimates, about 19 percent of 510(k)
premarket notifications will qualify for the small business fee, and
about 81 percent will pay the standard (full) fee. The FY 2006 fee
rates for all application categories are set out in table 1 of this
document.
Table 1.--Fee Types, Percent of PMA Fee, and FY 2006 Fee Rates
----------------------------------------------------------------------------------------------------------------
Full Fee Amount as a
Application Fee Type Percent of Premarket FY 2006 Full Fee FY 2006 Small Business
Application Fee Fee
----------------------------------------------------------------------------------------------------------------
PMA (submitted under section ........................... $259,600 $98,648
515(c)(1) or 515(f) of the act
or section 351 of the Public
Health Service Act)
----------------------------------------------------------------------------------------------------------------
Premarket Reporting (submitted 100% $259,600 $98,648
under section 515(c)(2) of the
act)
----------------------------------------------------------------------------------------------------------------
Panel Track Supplement 100% $259,600 $98,648
----------------------------------------------------------------------------------------------------------------
Efficacy Supplement (to an 100% $259,600 $98,648
approved premarket application
under section 351 of the PHS
Act)
----------------------------------------------------------------------------------------------------------------
180-Day Supplement 21.5% $55,814 $21,209
----------------------------------------------------------------------------------------------------------------
Real Time Supplement 7.2% $18,691 $7,103
----------------------------------------------------------------------------------------------------------------
510(k) 1.42% in aggregate $3,833 $3,066
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III. Small Business Qualification for Purposes of MDUFMA Fees
Firms with annual gross sales or receipts of $30 million or less,
including the gross sales and receipts of all affiliates, partners, and
parent firms, may qualify for a fee waiver for their first PMA. Firms
with annual gross sales or receipts of $100 million or less, including
the gross sales and receipts of all affiliates, partners, and parent
firms, may qualify for lower rates for all applications that are
subject to a fee.
Even if a firm qualified under the act as a small business for
MDUFMA fees in FY 2005, it must obtain a new small business
certification and decision number for FY 2006 and for each subsequent
FY. This can be initiated any time after the publication of this
notice. A firm that does not have an FY 2006 small business
qualification decision number from FDA will not be permitted to submit
the reduced small business fees for applications submitted during FY
2006. FDA urges firms to apply for this qualification at least 60 days
before they intend to submit their application and fee.
To qualify, you are required to submit the following:
(1) A completed FY 2006 Small Business Qualification Certification
(Form FDA 3602). This form is provided in FDA's guidance document, FY
2006 MDUFMA Small Business Qualification Worksheet and Certification,
available on FDA's Web site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/mdufma. This
form is not available separate from the guidance document.
(2) Certified copies of your Federal Income Tax Return for the most
recent taxable year (2004 or later), and certified copies of the income
tax returns of your affiliates, partners, and parent firms.
You can find information for determining if an applicant qualifies
for a small business first-time PMA waiver and lower rates for
subsequent applications on the FDA Web site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/mdufma
, under the heading ``Guidance Documents,'' click on the link
``Qualifying as a Small Business.'' This Web site provides detailed
instructions and the address for mailing
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documentation to support qualification as a small business under
MDUFMA.
IV. Procedures for Paying Application Fees
Any application or supplement subject to fees under MDUFMA that is
received on or after October 1, 2005, through September 30, 2006, is
subject to the FY 2006 fee rate. The later of the date that the
application is received in the reviewing center's document room or the
date that the check is received by US Bank determines whether the fee
rates for FY 2005 or FY 2006 apply. FDA must receive the correct fee at
the time that an application is submitted, or the application will not
be accepted for filing or review.
FDA requests that you follow the steps below before submitting a
medical device application subject to a fee. Please pay close attention
to these procedures to ensure that FDA links the fee with the correct
application. (Note: In no case should the check for the fee be
submitted to FDA with the application.)
A. Step One--Secure a Payment Identification Number and Medical Device
User Fee Cover Sheet From FDA Before Submitting Either the Application
or the Payment. Note: FY 2006 Fee Rates Will be Available on the Cover
Sheet Web Site Beginning on September 6, 2005
Log onto the MDUFMA Web site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/oc/mdufma and
under the forms heading, click on the link ``User Fee Cover Sheet.''
Complete the Medical Device User Fee Cover Sheet. Be sure you choose
the correct application submission date range. (Two choices will be
offered from September 6 until October 1, 2005. One choice is for
applications that will be received on or before September 30, 2005,
which will be subject to FY 2005 fee rates. A second choice is for
applications that will be received on or after October 1, 2005, which
will be subject to FY 2006 fee rates.) After completing data entry,
print a copy of the Medical Device User Fee Cover Sheet and note the
unique Payment Identification Number located in the upper right-hand
corner of the printed cover sheet.
B. Step Two--Electronically Transmit a Copy of the Printed Cover Sheet
with the Payment Identification Number to FDA's Office of Financial
Management
Once you are satisfied that the data on the cover sheet is
accurate, electronically transmit that data to FDA according to
instructions on the screen. Since electronic transmission is possible,
applicants are required to set up a user account and use passwords to
assure data security in the creation and electronic submission of cover
sheets.
C. Step Three--Mail Payment and a Copy of the Completed Medical Device
User Fee Cover Sheet to the St. Louis Address Specified Below
Make the payment in U.S. currency by check, bank draft, or
U.S. Postal money order payable to the Food and Drug Administration.
(The tax identification number of the Food and Drug Administration is
53-0196965, should your accounting department need this information.)
Please write your application's unique Payment
Identification Number, from the upper right-hand corner of your
completed Medical Device User Fee Cover Sheet, on your check, bank
draft, or U.S. Postal money order.
Mail the payment and a copy of the completed Medical
Device User Fee Cover Sheet to: Food and Drug Administration, P.O. Box
956733, St. Louis, MO, 63195-6733.
If you prefer to send a check by a courier (such as FEDEX, DHL,
UPS, etc.), the courier may deliver the check 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.)
It is helpful if the fee arrives at the bank at least 1 day before
the application arrives at FDA. FDA records the official application
receipt date as the later of the following:
The date the application was received by FDA.
The date US Bank receives the payment. US Bank is required
to notify FDA within 1 working day, using the Payment Identification
Number described previously.
D. Step Four--Submit your Application to FDA with a Copy of the
Completed Medical Device User Fee Cover Sheet
Please submit your application and a copy of the completed Medical
Device User Fee Cover Sheet to one of the following addresses:
Medical device applications should be submitted to: Food
and Drug Administration, Center for Devices and Radiological Health,
Document Mail Center (HFZ-401), 9200 Corporate Blvd., Rockville, MD
20850.
Biologic applications should be sent to: Food and Drug
Administration, Center for Biologics Evaluation and Research, Document
Control Center (HFM-99), suite 200N, 1401 Rockville Pike, Rockville, MD
20852-1448.
Dated: August 5, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-15863 Filed 8-10-05; 8:45 am]
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