[Federal Register Volume 70, Number 154 (Thursday, August 11, 2005)]
[Notices]
[Pages 46872-46874]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-15863]


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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://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
----------------------------------------------------------------------------------------------------------------

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://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://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

[[Page 46874]]

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://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]
BILLING CODE 4160-01-S