[Federal Register Volume 68, Number 37 (Tuesday, February 25, 2003)]
[Notices]
[Pages 8773-8775]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-4490]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drugs Administration


Medical Device User Fee Payment Procedures

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
payment procedures for medical device user fees for fiscal year (FY) 
2003. The Federal Food, Drug, and Cosmetic Act (the act), as amended by 
the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), 
authorizes FDA to collect user fees for certain medical device 
applications. The FY 2003 fee rates were published in the Federal 
Register of November 21, 2002 (67 FR 70228 at 70229, as amended by the 
Federal Registers of January 10, 2003, and January 22, 2003 (68 FR 1469 
and 68 FR 3033)); however, FDA could not begin to collect these fees 
until enabling appropriations were enacted. Those enabling 
appropriations were enacted on February 20, 2003, so FDA is now able to 
collect Medical Device User Fees for FY 2003. Accordingly, FDA will 
issue invoices for all fees payable for applications submitted between 
October 1, 2002, and March 31, 2003. Those invoices will be due and 
payable within 30 days of issuance. For all applications submitted on 
or after April 1, 2003, fees must be paid at the time that applications 
are submitted to FDA. This notice provides payment procedures for those 
submitting medical device applications that may be subject to user 
fees.

FOR FURTHER INFORMATION CONTACT: For further information on MDUFMA 
visit the FDA Web site http://www.fda.gov/oc/mdufma or contact James G. 
Norman, Office of Systems and Management (HFZ-2), Food and Drug 
Administration, Center for Devices and Radiological Health (CDRH), 9200 
Corporate Blvd., Rockville, MD 20850, 301-827-6829.

SUPPLEMENTARY INFORMATION:

I. Background

    Sections 737 and 738 of the act (21 U.S.C. 379i and j) establish 
fees for certain medical device applications and supplements. When 
certain conditions are met, FDA may waive or reduce fees (21 U.S.C. 
379j(d) and (e)).
    MDUFMA establishes aggregate revenue amounts for application fee 
revenues each year for FY 2003 through FY 2007. Revenue amounts 
established for years after FY 2003 are subject to adjustment for 
inflation, workload, and revenue shortfalls from previous years. FDA 
will set and publish fees each year so that total revenues will 
approximate the levels established in the statute, after those amounts 
have been adjusted for inflation, workload, and, if required, revenue 
shortfalls from previous years.

II. What Are the Fees for Applications Submitted in FY 2003?

    Table 1 of this document provides fee rates for applications 
submitted on October 1, 2002, and remaining in effect through September 
30, 2003, as previously published (67 FR 70228 at 70229, as amended by 
68 FR 1469 and 68 FR 3033).

                          Table 1--Fee Types, Percent of PMA Fee, and FY 2003 Fee Rates
----------------------------------------------------------------------------------------------------------------
                                                       Full Fee Amount as a      FY 2003 Full     FY 2003 Small
               Application Fee Type                    Percent of PMA Fee            Fee          Business Fee
----------------------------------------------------------------------------------------------------------------
Premarket Approval (PMA), Product Development                           100     $154,000           $58,520
 Protocol (PDP), Biologic License Application
 (BLA) (submitted under section 515(c) or (f) of
 the act (21 U.S.C. 360e(c) or (f)) or section 351
 of the Public Health Service Act (the PHS Act) ,
 respectively)
----------------------------------------------------------------------------------------------------------------
Premarket Report (PMR)(submitted under section                          100     $154,000           $58,520
 515(c)(2) of the act)
----------------------------------------------------------------------------------------------------------------
Panel Track Supplement (submitted under section                         100     $154,000           $58,520
 515 of the act to an approved PMA, PDP, or PMR
 that requests a significant change in design or
 performance of the device, or a new indication
 for use of the device, and for which clinical
 data are generally necessary to provide
 reasonable assurance of safety and effectiveness)
----------------------------------------------------------------------------------------------------------------
Efficacy Supplement (submitted under section 351                        100     $154,000           $58,520
 of the PHS Act to an approved BLA)
----------------------------------------------------------------------------------------------------------------
180-Day Supplement (submitted under section 515 of                     21.5      $33,110           $12,582
 the act to an approved PMA, PDP or PMR that is
 not a panel track supplement and requests a
 significant change in components, materials,
 design, specification, software, color additives,
 or labeling)
----------------------------------------------------------------------------------------------------------------

[[Page 8774]]

 
Real Time Supplement (submitted under section 515                       7.2      $11,088            $4,213
 of the act to an approved PMA or PMR that is not
 a panel track supplement and requests a minor
 change to the device, such as a minor change to
 the device design, software, manufacturing,
 sterilization, or labeling, and for which the
 applicant has requested and the agency has
 granted a meeting or similar forum to jointly
 review and determine the status of the supplement
 or an approved PDP)
----------------------------------------------------------------------------------------------------------------
Premarket Notification (submitted under section                        1.42       $2,187         $2,187\1\
 510(k) of the act)
----------------------------------------------------------------------------------------------------------------
\1\ A small business will pay the full (standard) fee of $2,187 for a premarket notification submitted to FDA
  during FY 2003. A small business fee, set at 80 percent of the standard 510K fee, will be available beginning
  FY 2004.

III. Are All Device Applications and Submissions Subject to Fees?

    Premarket applications and submissions not listed in table I are 
not subject to a MDUFMA user fee. The following are examples of 
submissions that do not require a MDUFMA fee:
    [sbull] Any type of investigational device exemption submission 
made under section 520(g) of the act (21 U.S.C. 360j(g)).
    [sbull] A request made under section 513(f)(2) of the act (21 
U.S.C. 360c(f)(2)) for an evaluation of automatic class III designation 
(also known as a de novo or risk-based classification).
    [sbull] A modification to the manufacturing procedures or method of 
manufacturing submitted as a 30-day notice or as a 135-day supplement 
if notified by FDA that such a supplement is needed.
    [sbull] An ``express PMA supplement'' for a manufacturing facility 
site change.
    [sbull] Annual (or other periodic) reports required for an approved 
PMA.
    In addition to the types of submissions described above that are 
not subject to MDUFMA fees, certain applications are exempt from fees. 
Exempted applications include:
    [sbull] Applications submitted under section 520(m) of the act that 
qualify for a humanitarian device exemption (21 U.S.C. 
379j(a)(1)(B)(i)).
    [sbull] Applications submitted under section 351 of the Public 
Health Service Act for a product licensed for further manufacturing use 
only (21 U.S.C. 379j(a)(1)(B)(ii)).
    [sbull] Applications submitted by a State or U.S. Federal 
Government entity for a device that is not to be distributed 
commercially (21 U.S.C. 379j(a)(1)(B)(iii)).
    [sbull] Premarket notification submissions reviewed by an 
accredited third party (21 U.S.C. 379j(a)(1)(B)(iv)).
    [sbull] Applications or supplements whose sole purpose is to 
support conditions of use in a pediatric population (21 U.S.C. 
379j(a)(1)(B)(v)).
    [sbull] First time PMA/PDP/BLA submissions from small businesses as 
discussed in section V of this document.
    If you are unsure of whether a planned submission will be subject 
to a MDUFMA user fee, please contact CDRH's Division of Small 
Manufacturers, International and Consumer Assistance, on 1-800-638-2041 
or 301-443-6597, for assistance.

IV. Where May I Find Guidance on the Type of Fees Applicable to My 
Application?

    For guidance on which type of fee applies to your application, 
please see the document entitled ``Assessing User Fees: PMA Supplement 
Definitions, Modular PMA Fees, BLA and Efficacy Supplement Definitions, 
Bundling Multiple Devices in a Single Application, and Fees for 
Combination Products: Guidance for Industry and FDA.'' You may find a 
link to this document on FDA's Web site at: http://www.fda.gov/oc/mdufma. At that Web site, under the heading ``Guidance Documents'' 
click on the link ``Assessing User Fees--PMA Supplements, Modular PMAs, 
BLAs and Efficacy Supplements, Bundling, and Combination Products.'' 
This guidance will help you determine fees for PMA supplements (panel-
track, 180-day, and real-time), modular PMAs, as well as combination 
products. It also provides information on when bundling multiple 
devices in a single application would be appropriate.

V. How Does a Firm Qualify as a Small Business for Purposes of MDUFMA 
Fees?

    Firms with annual gross sales and revenues of $30 million or less, 
including gross sales and revenues of all affiliates, partners, and 
parent firms, may qualify for a fee waiver for their first PMA, and for 
lower rates for subsequent PMAs, premarket reports, and supplements. 
Such firms may also qualify for lower rates for premarket notification 
submissions in FY 2004 and subsequent years.
    To qualify, you are required to submit the following:
    (1) Certified copies of your Federal Income Tax Return for the most 
recent taxable year, including certified copies of the income tax 
returns of your affiliates, partners, and parent firms.
    (2) A certified list of all parents, partners, and affiliate firms 
since October 1, 2002.
    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/oc/mdufma. At that Web site, 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 
documentation to support qualification as a small business under 
MDUFMA.

VI. When Do I Submit a Fee for an Application Submitted On or After 
October 1, 2002, and On or Before the Date of Publication of This 
Notice?

    You must pay a fee for any medical device application subject to a 
fee that you submitted on or after October 1, 2002 (21 U.S.C. 
379j(a)(1)(A)). (Section III of this document addresses applications 
exempted from fees and procedures related to them.) FDA will issue 
invoices to all applicants who submitted medical device applications on 
or after October 1, 2002, and through the date of this notice. FDA will 
issue those invoices during March and April 2003, and payment will be 
due within 30 days of issuance date. FDA will include detailed payment 
instructions with the invoices. Please include the invoice numbers on 
all payments submitted in response to these invoices.

[[Page 8775]]

VII. When Do I Submit the Fee for Applications Submitted On or After 
the Date of Publication of This Notice?

A. Payment Options for Firms Submitting Medical Device Applications 
between Today and March 31, 2003.

    If you submit a medical device application subject to fees on or 
after the date of publication of this notice, and before April 1, 2003, 
you may either:
    (1) Submit the application without first submitting payment, and 
pay the fee when an invoice is received; or
    (2) Pay the fee at the time the application is submitted.

B. Payment Requirement for Firms Submitting Medical Device Applications 
On or After April 1, 2003.

    If you submit a medical device application subject to fees on or 
after April 1, 2003, you must pay the fee for the application at or 
before the time the application is submitted. If you have not paid all 
fees owed, FDA will consider the application incomplete and will not 
accept it for filing (21 U.S.C. 379j(f)).

VIII. What Are the Procedures for Paying Application Fees?

    FDA requests that you adhere to the following steps before 
submitting a medical device application subject to a fee. Please pay 
close attention to these procedures to ensure that FDA associates 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.

    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 and print a 
copy. Note the unique Payment Identification Number located in the 
upper right-hand corner of the printed cover sheet.

B. Step Two--Fax a Copy of the Printed Cover Sheet With the Payment 
Identification Number to FDA's Office of Financial Management.

    The FDA facsimile machine phone number to receive this completed 
Medical Device User Fee Cover Sheet is 301-827-9213. FDA will then 
enter the information into its accounting system, in order to associate 
payments with submitters. (Note: Later this year, after the Web site is 
upgraded, you will be able to transmit the completed form 
electronically and you will not need to fax a copy to FDA.)

C. Step Three--Mail a Copy of the Completed Medical Device User Fee 
Cover Sheet and the Payment for Your Application to the St. Louis 
Address Specified in Item 3 as Follows:

    1. Make the payment in U.S. currency by check, bank draft, or U.S. 
postal money order payable to FDA. (The tax identification number of 
FDA is 53-0196965, should your accounting department need this 
information.)
    2. Please note on your payment your application's unique Payment 
Identification Number from the upper right-hand corner of your printed 
Medical Device User Fee Cover Sheet.
    3. 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, the courier may deliver 
the checks to: US Bank, Attn: Government Lockbox, SL-MOC1GL, 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 as the application receipt 
date the latter of the following:
    a. The date the application was received by FDA; or
    b. The date US Bank notifies FDA that payment has been received. US 
Bank is required to notify FDA within 1-working day, using the Payment 
Identification Number described in section VIII, C.2 of this document.

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.
    1. Medical device applications should be submitted to: Document 
Mail Center (HFZ-401), Center for Devices and Radiological Health, Food 
and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850.
    2. Biologic applications should be sent to: Center for Biologics 
Evaluation and Research, Food and Drug Administration, 1401 Rockville 
Pike, Rockville, MD 20852-1428.

    Dated: February 13, 2003.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 03-4490 Filed 2-21-03; 11:22 am]
BILLING CODE 4160-01-S