[Federal Register: November 21, 2002 (Volume 67, Number 225)]
[Notices]
[Page 70228-70229]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21no02-85]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Establishment of Medical Device User Fee Rates for Fiscal Year
2003 and Interim Procedures
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the rates
and interim 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) (Public Law 107-250), authorizes FDA to collect user fees for
certain medical device applications. This notice establishes fee rates
for FY 2003. These fees are effective for applications submitted on
October 1, 2002, and will remain in effect through September 30, 2003.
However, FDA may not begin to collect these fees until enabling
appropriations are enacted. FDA will issue invoices for all fees
payable for applications submitted between October 1, 2002, and 30 days
after the date of the Federal Register notice the agency will issue
after enactment of enabling appropriations. Those invoices will be due
and payable within 30 days of issuance. Subsequently, fees must be
submitted to FDA at the time that applications are submitted.
ADDRESSES: Visit the FDA Web site that provides further information on
MDUFMA at http://www.fda.gov/cdrh/mdufma/index.html.
FOR FURTHER INFORMATION CONTACT: Frank Claunts, Office of Management
and Systems (HFA-20), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-4427.
SUPPLEMENTARY INFORMATION:
I. Background
The act establishes fees in sections 737 and 738 (21 U.S.C. 379i
and j) for different kinds of medical device applications. Fees are
assessed on certain types of medical device applications and
supplements. When certain conditions are met, FDA may waive or reduce
fees (21 U.S.C. 379j(d) and (e)).
For FY 2003 through FY 2007, MDUFMA establishes revenue amounts for
the aggregate of all application fee revenues. Revenue amounts
established for years after FY 2003 are subject to adjustment for
inflation, workload, and revenue shortfalls from previous years. Fees
for applications are to be established each year by FDA so that
revenues will approximate the levels established in the statute, after
those amounts have first been adjusted for inflation, workload, and, if
required, revenue shortfalls from previous years.
This notice establishes fee rates for FY 2003. These fees are
effective on October 1, 2002, and will remain in effect through
September 30, 2003.
II. Inflation, Workload, and Compensating Adjustment Process
MDUFMA provides that fee revenue amounts for each FY after 2003
shall be adjusted for inflation. The adjustment must reflect the
greater of: (1) The total percentage change that occurred in the
Consumer Price Index (all items, U.S. city average) during the 12-month
period ending on June 30 preceding the FY for which fees are being set,
or (2) the total percentage pay change for the previous FY for Federal
employees stationed in the Washington, DC metropolitan area. MDUFMA
provides for this annual adjustment to be cumulative and compounded
annually after 2003 (21 U.S.C. 379j(c)(1)). No inflation adjustment is
to be made with respect to fee revenue amounts established in the
statute for FY 2003.
For each FY beginning in FY 2004, MDUFMA provides that fee revenue
amounts, after they have been adjusted for inflation, shall be further
adjusted to reflect changes in workload for the process for the review
of medical device applications (21 U.S.C. 379j(c)(2)). No workload
adjustment is to made be with respect to fee revenue amounts
established in the statute for FY 2003.
For each FY beginning in FY 2004, MDUFMA provides that fee revenue
amounts, after they have been adjusted for inflation and workload,
shall be further adjusted, if necessary, to compensate for any
shortfall in fee revenue from previous years (21 U.S.C. 379j(c)(3)). No
compensating adjustment is to be made with respect to fee revenue
amounts established in the statute for FY 2003.
Inflation, workload, and compensating adjustments do not apply to
the revenue amounts established in MDUFMA for FY 2003.
III. Fee Calculations for FY 2003
MDUFMA establishes the fee for a premarket application (PMA) at
$154,000 in FY 2003. All other fees are set as a percent of this fee.
At these rates, the medical device user fees are expected to generate
$25,125,000 in FY 2003. The applications subject to fees, the rate of
each fee as a percent of a premarket application, and the FY 2003
[[Page 70229]]
fee rate are set out in table 1 of this document. For all applications
other than premarket notification submissions, the small business rate
is 38 percent of the full fee rate. For premarket notification
submissions, there is no small business rate in FY 2003. In FY 2004 and
subsequent fiscal years, fees for premarket notification submissions
will be set so that a small business fee will be 80 percent of a full
application fee.
Table 1.--Fee Types, Percent of PMA Fee, and FY 2003 Fee Rates
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Full Fee
Amount as FY 2003
a Percent FY 2003 Small
Application Fee Type of PMA Full Fee Business
Fee (dollars) Fee
(percent) (dollars)
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PMA (submitted under section 515(c)(1) or 515(f) of the act or section 351 of ......... 154,000 58,520
the Public Health Service Act (PHS Act))
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Premarket Report (PMR) (submitted under section 515(c)(2) of the act) 100 154,000 58,520
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Panel Track Supplement (to an approved PMA or PMR that requests a significant 100 154,000 58,520
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)
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Efficacy Supplement (to an approved PMA under section 351 of the PHS Act) 100 154,000 58,520
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180-Day Supplement (to an approved PMA or PMR that is not a panel track 21.5 33,110 12,582
supplement and requests a significant change in components, materials, design,
specification, software, color additives, or labeling)
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Real Time Supplement (to an approved PMA or PMR that is not a panel track 7.2 11,088 4,213
supplement and requests a minor change to the device, such as a minor change
to the design of the device, 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)
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Premarket Notification (submitted under section 510(k) of the act) 1.42 2,187 None in
FY 2003
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IV. Adjustment for Excess Collections in Previous Years
Under the provisions of MDUFMA, if the agency collects more fees
than were provided for in appropriations in any year, FDA is required
to reduce its anticipated fee collections in a subsequent year by that
amount (21 U.S.C. 379j(h)(4)). No adjustments under this provision are
required for fees assessed in FY 2003.
V. Implementation of Fee Collections
A. No Fees May Be Collected Until Enabling Appropriations are Enacted
Under section 738(h) of the act, fees authorized by MDUFMA may
neither be collected nor available for obligation unless they are first
provided for in appropriation acts. For this reason FDA is not able to
accept or deposit any fee revenues until such appropriations are
enacted for FY 2003. Therefore, no fees are to be submitted until such
appropriations are enacted. After the enactment of enabling
appropriations, FDA will publish another notice in the Federal Register
with detailed payment instructions.
B. Procedures for Firms Seeking to Qualify for Small Business Exemption
for First PMA or for Lower Fees for Subsequent Applications.
Firms with gross sales and revenues of $30 million or less,
including gross sales and revenues of all affiliate, partner, and
parent firms, may qualify for a waiver of the fee for their first PMA,
and for lower rates for subsequent PMAs, PMRs, and supplements. Such
firms may also qualify for lower rates for premarket notification
submissions in FY 2004 and subsequent years. To qualify, these firms
will have to submit certified copies of their Federal income tax return
for the most recent taxable year, including certified copies of the
income tax returns of their affiliate, partner, and parent firms. More
detailed procedures for qualifying for small business first-time PMA
waiver and lower rates will also be included in the Federal Register
notice published after the date of enabling appropriations.
C. Subsequent Payment of Fees
Any application or supplement subject to fees under MDUFMA that is
submitted after September 30, 2002, is subject to the fee set out in
table 1 of this document. FDA will issue invoices for all fees payable
for applications submitted between October 1, 2002, and 30 days after
the date of the Federal Register notice the agency will issue after
enactment of enabling appropriations. Those invoices will be due and
payable within 30 days of issuance. Subsequently, fees must be
submitted to FDA at the time that applications are submitted.
Payment, when due, must be made in U.S. currency by check, bank
draft, or U.S. postal money order payable to the order of FDA. More
complete payment instructions will be included in the Federal Register
notice published after the date of enabling appropriations.
Dated: November 15, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-29572 Filed 11-20-02; 8:45 am]
BILLING CODE 4160-01-S