[Federal Register: February 25, 2003 (Volume 68, Number 37)]
[Notices]
[Page 8773-8775]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25fe03-63]
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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.
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
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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)
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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)
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[[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)
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\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
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