[Federal Register: August 3, 2009 (Volume 74, Number 147)]
[Notices]
[Page 38444-38449]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03au09-77]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0338]
Medical Device User Fee Rates for Fiscal Year 2010
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) 2010. The Federal Food, Drug, and Cosmetic Act (the
act), as amended by the Medical Device User Fee and Modernization Act
of 2002 (MDUFMA), the Medical Device User Fee Stabilization Act of 2005
(MDUFSA), and the Medical Device User Fee Amendments of 2007 (title II
of the Food and Drug Administration Amendments Act of 2007 (FDAAA)),
authorizes FDA to collect user fees for certain medical device
submissions, and annual fees both for certain periodic reports and for
certain establishments subject to registration.
The FY 2010 fee rates
are provided in this document. These fees apply from October 1, 2009,
through September 30, 2010. To avoid delay in the review of your
application, you should pay the fee before or at the time you submit
your application to FDA. The fee you must pay is the fee that is in
effect on the later of the date that your application is received by
FDA or the date your fee payment is received. If you want to pay a
reduced small business fee, you must qualify as a small business before
you make your submission to FDA; if you do not qualify as a small
business before you make your submission to FDA, you will have to pay
the higher standard fee. This document provides information on how the
fees for FY 2010 were determined, the payment procedures you should
follow, and how you may qualify for reduced small business fees.
FOR FURTHER INFORMATION CONTACT:
For information on MDUFMA: Visit FDA's Web site,
http://
www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/
MedicalDeviceUserFeeand/ModernizationActMDUFMA/default.htm.
For questions relating to this notice: David Miller, Office of
Financial Management (HFA-100), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-3917.
SUPPLEMENTARY INFORMATION:
I. Background Section 738 of the act (21 USC 379j) establishes fees for certain
medical device applications, submissions, supplements, and notices (for
simplicity, this document refers to these collectively as
``submissions''); for periodic reporting on class III devices; and for
the registration of certain establishments. Under statutorily-defined
conditions, a qualified applicant may receive a fee waiver or may pay a
lower small business fee. (See 21 U.S.C. 379j(d) and (e).)
Under the act, the fee rate for each type of submission 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 (PDP), or a biologics licensing
application (BLA)). The act specifies the standard fee for a premarket
application for each year from FY 2008 through FY 2012; the standard
fee for a premarket application received by FDA during FY 2010 is
$217,787. From this starting point, this document establishes FY 2010
fee rates for other types of submissions, and for periodic reporting,
by applying criteria specified in the act.
The act specifies the annual fee for establishment registration for
each year from FY 2008 through FY 2012;
the registration fee for FY
2010 is $2,008. There is no reduction in the registration fee for small
businesses. An establishment must pay the registration fee if it is any
of the following types of establishments:
Manufacturer. An establishment that makes by any means any
article that is a device, including an establishment that sterilizes or
otherwise makes such article for or on behalf of a specification
developer or any other person.
Single-Use Device Reprocessor. An establishment that
performs additional processing and manufacturing operations on a
single-use device that has previously been used on a patient.
Specification Developer. An establishment that develops
specifications for a device that is distributed under the
establishment's name but which performs no manufacturing, including an
establishment that, in addition to developing specifications, also
arranges for the manufacturing of devices labeled with another
establishment's name by a contract manufacturer.
The fees for FY 2010 go into effect on October 1, 2009, and will
remain in effect through September 30, 2010.
II. Fees for FY 2010
Under the act, all submission fees and the periodic reporting fee
are set as a percent of the standard (full) fee for a premarket
application (see 21 U.S.C. 379j(a)(2)(A)), and the act sets the
standard fee for a premarket application, including a BLA, a premarket
report, and an efficacy supplement, at $217,787 for FY 2010 (see 21
U.S.C. 379j(b)); this is referred to as the ``base fee''). The fees set
by reference to the base fee are--
For a panel-track supplement, 75 percent of the base fee;
For a 180-day supplement, 15 percent of the base fee;
For a real-time supplement, 7 percent of the base fee;
For a 30-day notice, 1.6 percent of the base fee;
For a 510(k) premarket notification, 1.84 percent of the
base fee;
For a 513(g) request for classification information, 1.35
percent of the base fee; and
For an annual fee for periodic reporting concerning a
class III device, 3.5 percent of the base fee.
For all submissions other than a 510(k) premarket notification, a
30-day notice, and a 513(g) request for classification information, the
small business fee is 25 percent of the standard (full) fee. (See 21
U.S.C. 379j(d)(2)(C).) For a 510(k) premarket notification submission,
a 30-day notice, and a 513(g) request for classification information,
the small business fee is 50 percent of the standard (full) fee. (See
21 U.S.C. 379j(e)(2)(C).)
The statute sets the annual fee for establishment registration at
$2,008 on FY 2010, and there is no small business rate for the annual
establishment registration fee; all establishments pay the same fee.
The statute authorizes increases in the annual establishment fee for FY
2010 and subsequent years if the estimated number of establishments
submitting fees for FY 2009 is fewer than 12,250. (See 21 U.S.C.
379j(c)(2)(A).) FDA estimates that the number of establishments
submitting fees in FY 2009 will be in excess of 12,250, so no
establishment fee increase is warranted under this provision of the
statute.
Table 1 of this document sets out the FY 2010 rates for all medical
device fees.
Table 1.--Medical Device Fees for FY 2010
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Standard Fee, as a Percent
Application Fee Type of the Standard Fee for a FY 2010 Standard Fee FY 2010 Small Business Fee
Premarket Application
----------------------------------------------------------------------------------------------------
Premarket application (a PMA Set in statute $217,787 $54,447
submitted under section
515(c)(1) of the act (21
U.S.C. 360e(c)(1)), a PDP
submitted under section
515(f) of the Act, or a BLA
submitted under section 351
of the Public Health Service
(PHS) Act (42 U.S.C. 262))
---------------------------------------------------------------------------------------------------Premarket report (submitted 100% $217,787 $54,447
under section 515(c)(2) of
the act)
----------------------------------------------------------------------------------------------------
Efficacy supplement (to an 100% $217,787 $54,447
approved BLA under section
351 of the PHS Act)
----------------------------------------------------------------------------------------------------
Panel-track supplement 75% $163,340 $40,835
----------------------------------------------------------------------------------------------------
180-day supplement 15% $32,668 $8,167
----------------------------------------------------------------------------------------------------
Real-time supplement 7% $15,245 $3,811
----------------------------------------------------------------------------------------------------
510(k) premarket notification 1.84% $4,007 $2,004
submission
----------------------------------------------------------------------------------------------------
30-day notice 1.6% $3,485 $1,742
----------------------------------------------------------------------------------------------------
513(g) (21 U.S.C. 360c(g)) 1.35% $2,940 $1,470
request for classification
information
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Annual Fee Type ..........................
----------------------------------------------------------------------------------------------------
Annual fee for periodic 3.5% $7,623 $1,906
reporting on a class III
device
----------------------------------------------------------------------------------------------------
Annual establishment Set in statute $2,008 $2,008
registration fee (to be paid
by each establishment that
is a manufacturer, a single-
use device reprocessor, or a
specification developer, as
defined by 21 U.S.C.
379i(13))
----------------------------------------------------------------------------------------------------
III. How to Qualify as a Small Business for Purposes of Medical Device
Fees
If your business has gross receipts or sales of no more than $100
million for the most-recent tax year, you may qualify for reduced small
business fees. If your business has gross sales or receipts of no more
than $30 million, you may also qualify for a waiver of the fee for your
first premarket application (PMA, PDP, or BLA) or premarket report. You
must include the gross receipts or sales of all of your affiliates
along with your own gross receipts or sales when determining whether
you meet the $100 million or $30 million threshold. If you want to pay
the small business fee rate for a submission, or you want to receive a
waiver of the fee for your first premarket application or premarket
report, you should submit the materials showing you qualify as a small
business 60 days before you send your submission to FDA. If you make a
submission before FDA finds that you qualify as a small business, you
must pay the standard fee for that submission.
If your business qualified as a small business for FY 2009, your
status as a small business will expire at the close of business on
September 30, 2009. You must re-qualify for FY 2010 in order to pay
small business fees during FY 2010.
If you are a domestic (U.S.) business, and wish to qualify as a
small business for FY 2010, you must submit the following to FDA:
(1) A completed FY 2010 MDUFMA Small Business Qualification
Certification (Form FDA 3602). This form is provided in FDA's guidance
document, ``FY 2010 Medical Device User Fee Small Business
Qualification and Certification,'' available on FDA's Web site at
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/
MedicalDeviceUserFeeandModernizationActMDUFMA/default.htm. This form is
not available separate from the guidance document.
(2) A certified copy of your Federal (U.S.) Income Tax Return for
the most recent tax year. The most recent tax year will be 2009,
except--
If you submit your FY 2010 MDUFMA Small Business
Qualification before April 15, 2010, and you have not yet filed your
return for 2009, you may use tax year 2008.
If you submit your FY 2010 MDUFMA Small Business
Qualification on or after April 15, 2010, and have not yet filed your
2009 return because you obtained an extension, you may submit your
most-recent return filed prior to the extension.
(3) For each of your affiliates, either--
If the affiliate is a domestic (U.S.) business, a
certified copy of the affiliate's Federal (U.S.) income tax return for
the most recent tax year, or
If the affiliate is a foreign business and cannot submit a
Federal (U.S.) Income Tax Return, a National Taxing Authority
Certification completed by, and bearing the official seal of, the
National Taxing Authority of the country in which the firm is
headquartered. The National Taxing Authority is the foreign equivalent
of the U.S. Internal Revenue Service. This certification must show the
amount of gross receipts or sales for the most recent tax year, in both
U.S. dollars and the local currency of the country, the exchange rate
used in converting the local currency to U.S. dollars, and the dates of
the gross receipts or sales collected. The applicant should also submit
a statement signed by the head of the applicant's firm or by its chief
financial officer that the applicant has submitted certifications for
all of its affiliates, identifying the name of each affiliate, or that the
applicant has no affiliates.
If you are a foreign business, and wish to qualify as a small
business for FY 2010, you must submit the following:
(1) A completed FY 2010 MDUFMA Foreign Small Business Qualification
Certification (Form FDA 3602A). This form is provided in FDA's guidance
document, ``FY 2010 Medical Device User Fee Small Business
Qualification and Certification,'' available on FDA's Internet site at
http://www.fda.gov/cdrh/mdufma. This form is not available separate
from the guidance document.
(2) A National Taxing Authority Certification, completed by, and
bearing the official seal of, the National Taxing Authority of the
country in which the firm is headquartered. This Certification must
show the amount of gross receipts or sales for the most recent tax
year, in both U.S. dollars and the local currency of the country, the
exchange rate used in converting the local currency to U.S. dollars,
and the dates of the gross receipts or sales collected.
(3) For each of your affiliates, either--
If the affiliate is a domestic (U.S.) business, a
certified copy of the affiliate's Federal (U.S.) Income Tax Return for
the most recent tax year (2008 or later), or
If the affiliate is a foreign business and cannot submit a
Federal (U.S.) Income Tax Return, a National Taxing Authority
Certification completed by, and bearing the official seal of, the
National Taxing Authority of the country in which the firm is
headquartered. The National Taxing Authority is the foreign equivalent
of the U.S. Internal Revenue Service. This certification must show the
amount of gross receipts or sales for the most recent tax year, in both
U.S. dollars and the local currency of the country, the exchange rate
used in converting the local currency to U.S. dollars, and the dates
for the gross receipts or sales collected. The applicant should also
submit a statement signed by the head of the applicant's firm or by its
chief financial officer that the applicant has submitted certifications
for all of its affiliates, identifying the name of each affiliate, or
that the applicant has no affiliates.
