Medical Device User Fee Rates for Fiscal Year 2010, 38444-38449 [E9-18456]
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38444
Federal Register / Vol. 74, No. 147 / Monday, August 3, 2009 / Notices
implicated in a number of CNS
disorders, including psychostimulant
abuse, psychosis and Parkinson’s
disease. Compounds that bind with high
affinity and selectivity to D3 receptors
can not only provide important tools
with which to study the structure and
function of this receptor subtype, but
may also have therapeutic potential in
the treatment of numerous psychiatric
and neurologic disorders.
The 4-phenylpiperazine derivatives
are an important class of dopamine D3
selective ligands. However, due to their
highly lipophilic nature, these
compounds suffer from solubility
problems in aqueous media and reduced
bioavailability. To address this problem,
a process was designed to introduce
functionality into the carbon chain
linker of these compounds. Compared to
currently available dopamine D3
receptor ligands, the resulting
compounds show improved
pharmacological properties and D3
selectivities but due to their more
hydrophilic nature, these derivatives are
predicted to have improved water
solubility and bioavailability.
Applications:
• Therapeutics for a variety of
psychiatric and neurologic disorders
• Research tools to study D3 receptor
structure and function
Advantages:
• Improved pharmacological
properties and selectivity over existing
dopamine D3 receptor ligands
• Hydrophilic nature likely to lead to
improved water solubility and
bioavailability
Development Status: Pre-clinical
discovery.
Further R&D Needed:
• Evaluate selected compounds in
animal models of drug abuse, psychosis,
obesity and Parkinson’s disease.
• Design and synthesize novel,
functionalized analogs using both
classical and computational drug design
to improve D3 receptor affinity and
selectivity.
• Evaluate compounds for binding in
D3 and D2 receptor expressing cell lines
and in in vitro functional assays.
• Correlate in vitro binding affinities
with in vivo function in rats and
monkeys and evaluate compounds in
knockout mice models.
• Pursue PET and SPECT imaging
agents by radiolabel of D3 ligands and
evaluation in rats and non-human
primates.
Inventors: Amy H. Newman (NIDA),
Peter Grundt (NIDA), Jianjing Cao
(NIDA), et al.
Patent Status: PCT Application No.
Pct/US2007/71412 filed 15 Jun 2007,
which published as WO 2008/153573
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16:05 Jul 31, 2009
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on 18 Dec 2008 (HHS Reference No. E–
128–2006/0–PCT–01).
Licensing Status: Available for
licensing.
Licensing Contact: Charlene Sydnor,
PhD; 301–435–4689;
sydnorc@mail.nih.gov.
Collaborative Research Opportunity:
The National Institute on Drug Abuse’s
Medications Discovery Research Branch
is seeking statements of capability or
interest from parties interested in
collaborative research to further
develop, evaluate, or commercialize 4phenylpiperazine derivatives as
dopamine D3 selective ligands. Please
contact Vio Conley, MS at 301–435–
2031 or conleyv@mail.nih.gov for
additional information.
High-Yield Methods of Producing
Biliverdin
Description of the Technology: This
invention describes methods of making
high yields of biliverdin, the
pharmaceutical compositions of
biliverdin made using that process, and
methods of using the compositions
therapeutically.
In reaction to a wide range of cellular
stresses, hemoglobin is naturally
metabolized to biliverdin, which is then
quickly metabolized to bilirubin, a bile
pigment, through a highly conserved set
of enzymes. Both bilirubin and
biliverdin are normally processed for
rapid excretion, and excessive serum
levels of bilirubin have known toxic
effects (most notably jaundice).
Surprisingly, research in the past
decade has shown that decreasing
serum levels correlate inversely with the
prognosis of various disorders, such as
ischemia/reperfusion injuries,
atherosclerosis, organ transplantation,
and several autoimmune diseases.
Indeed, in animal-model studies,
inducing a mild case of jaundice
actually improved outcome.
Unfortunately, bilirubin is relatively
insoluble, and so is not a practical
pharmaceutical itself.
Biliverdin has lower direct toxicity
and substantially greater solubility than
bilirubin, and also appears to have some
direct therapeutic effects similar to
bilirubin. Accordingly, biliverdin has
been widely studied lately. Generating
high yields of pure biliverdin is
difficult, however, because any system
with the enzymes to break down
hemoglobin also has enzymes
converting biliverdin to bilirubin. The
inventors have created a system of
generating microorganisms (yeast)
lacking the enzymes that break
biliverdin down to bilirubin.
Applications: Production of biliverdin
for immunomodulatory and
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cytoprotective therapy (or adjuvant) in
any condition involving an overactive
immune response.
Advantages:
• High yield of biliverdin with low
contamination of bilirubin.
• Produces only active isomers of
biliverdin.
• Unlike prior methods, new method
uses starting material that is
inexpensive and plentiful.
Development Status: Successful
generation of Candida albicans with
biliverdin-generating system.
Inventors: Michael L. Pendrak and
David D. Roberts (NCI).
Patent Status: HHS Reference No. E–
040–2004/0—Issued U.S. Patent
7,504,243; Pending U.S. Application 12/
364,054 (divisional, filed 02 Feb 2009).
Relevant Publication: ML Pendrak et
al. Heme oxygenase in Candida albicans
is regulated by hemoglobin and is
necessary for metabolism of exogenous
heme and hemoglobin to alphabiliverdin. J Biol Chem. 20 Jan
2004;279(5):3426–3433.
Licensing Status: Available for
licensing.
Licensing Contact: Bruce Goldstein,
JD, MS; (301) 435–5470;
goldsteb@mail.nih.gov.
Collaborative Research Opportunity:
The Laboratory of Pathology in the
Center for Cancer Research of the
National Cancer Institute is seeking
parties interested in collaborative
research directed toward clinical
applications of biliverdin. For more
information about the research, please
contact either Dr. Michael Pendrak
(NCI/CCR Laboratory of Pathology) at
(301) 496–6264, or Dr. April Franks
(NCI Technology Transfer Center) at
(301) 496–0477.
Dated: July 28, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E9–18496 Filed 7–31–09; 8:45 am]
BILLING CODE 4140–01–P
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.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
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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, https://
www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
Overview/MedicalDevice
UserFeeand/Modernization
ActMDUFMA/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:
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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
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collectively as ‘‘submissions’’); for
periodic reporting on class III devices;
and for the registration of certain
establishments. Under statutorilydefined 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.
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38445
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.
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TABLE 1.—MEDICAL DEVICE FEES FOR FY 2010
Standard Fee, as a Percent of
the Standard Fee for a
Premarket Application
Application Fee Type
Premarket application (a PMA 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))
FY 2010 Standard Fee
FY 2010 Small Business
Fee
Set in statute
$217,787
$54,447
Premarket report (submitted under section 515(c)(2)
of the act)
100%
$217,787
$54,447
Efficacy supplement (to an approved BLA under section 351 of the PHS Act)
100%
$217,787
$54,447
Panel-track supplement
75%
$163,340
$40,835
180-day supplement
15%
$32,668
$8,167
Real-time supplement
7%
$15,245
$3,811
1.84%
$4,007
$2,004
1.6%
$3,485
$1,742
1.35%
$2,940
$1,470
3.5%
$7,623
$1,906
Set in statute
$2,008
$2,008
510(k) premarket notification submission
30-day notice
513(g) (21 U.S.C. 360c(g)) request for classification
information
Annual Fee Type
Annual fee for periodic reporting on a class III device
Annual establishment 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))
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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
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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 https://www.fda.gov/
MedicalDevices/Device
RegulationandGuidance/Overview/
MedicalDeviceUserFee
andModernizationActMDUFMA/
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
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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
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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 https://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.
reviewing center’s document room or
the date that the check is received by
U.S. Bank determines whether the fee
rates for FY 2009 or FY 2010 apply.
FDA must receive the correct fee at the
time that an application or annual
report is submitted, or the application or
annual report will not be accepted for
filing or review.
FDA requests that you follow the
steps below before submitting a medical
device application or annual report
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.)
IV. Procedures for Paying Application
and Annual Report Fees
If your application or submission is
subject to a fee and your payment is
received by FDA from October 1, 2009,
through September 30, 2010, you must
pay the fee in effect for FY 2010. The
later of the date that the application or
annual report is received in the
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.
Because 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.
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A. Step One—Secure a Payment
Identification Number (PIN) and
Medical Device User Fee Cover Sheet
From FDA Before Submitting Either the
Application or the Payment (Note: Both
the FY 2009 and FY 2010 fee rates will
be available on the Cover Sheet Web
Site beginning on the date of
publication of this document, and only
the FY 2010 rates will appear after
September 30, 2009)
Log on to the MDUFMA Web site at:
https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
Overview/MedicalDeviceUser
FeeandModernizationActMDUFMA/
default.htm and, under the MDUFMA
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 until October 1, 2009.
One choice is for applications that will
be received on or before September 30,
2009, which will be subject to FY 2009
fee rates. A second choice is for
applications that will be received on or
after October 1, 2009, which will be
subject to FY 2010 fee rates.) After
completing data entry, print a copy of
the Medical Device User Fee cover sheet
and note the unique PIN 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
PIN to FDA’s Office of Financial
Management
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38447
C. Step Three—Submit Payment for the
Completed Medical Device User Fee
Cover Sheet as Described in this
Section, Depending on the Method You
Will Use to Make Payment
(1) If paying with a paper check:
• All paper checks must be in U.S.
currency from a U.S. bank and made
payable to the Food and Drug
Administration. (FDA’s tax
identification number is 53–0196965,
should your accounting department
need this information.)
• Please write your application’s
unique PIN, from the upper right-hand
corner of your completed Medical
Device User Fee cover sheet, on your
check.
• Mail the paper check and a copy of
the completed cover sheet to: Food and
Drug Administration, P.O. Box 956733,
St. Louis, MO, 63195–6733. (Please note
that this address is for payments of
application and annual report fees only
and is not to be used for payment of
annual establishment registration fees.)If
you prefer to send a check by a courier
(such as Federal Express (FEDEX), DHL,
United Parcel Service (UPS), etc.), the
courier may deliver the check to: U.S.
Bank, Attn: Government Lockbox
956733, 1005 Convention Plaza, St.
Louis, MO 63101. (Note: This address is
for courier delivery only. Contact the
U.S. 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: (1) The date
the application was received by FDA or
(2) the date U.S. Bank receives the
payment. U.S. Bank is required to notify
FDA within 1 working day, using the
PIN described previously in this
document.
(2) If Paying With Credit Card or
Electronic Check (Automated Clearing
House (ACH)):
FDA has partnered with the U.S.
Department of the Treasury to utilize
Pay.gov, a web based payment
application, for online electronic
payment. Pay.gov can now be used to
submit online payments for cover sheets
to the FDA. You now have the option
to make a payment via electronic check
or credit card after submitting your
coversheet. To pay online, select the
‘‘Pay Now’’ button. Credit card
transactions for cover sheets are limited
to $4,000.00.
(3) If paying with a wire transfer:
• Please include your application’s
unique PIN, from the upper right-hand
corner of your completed Medical
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Device User Fee cover sheet, in your
wire transfer. Without the PIN your
payment may not be applied to your
cover sheet and review of you
application will be delayed.
• The originating financial institution
usually charges a wire transfer fee
between $15.00 and $35.00. Please ask
your financial institution about the fee
and include it with your payment to
ensure that your cover sheet is fully
paid.Use the following account
information when sending a wire
transfer: New York Federal Reserve
Bank, U.S. Department of Treasury,
TREAS NYC, 33 Liberty St, New York,
NY 10045, Acct. No. 75060099, Routing
No. 021030004, SWIFT: FRNYUS33,
Beneficiary: FDA, 5600 Fishers Lane,
Rockville, MD 20857.
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D. Step Four—Submit Your Application
to FDA With a Copy of the Completed
Medical Device User Fee Cover Sheet
For all applications sent after August
1, 2009, 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: Food and Drug
Administration, Center for Devices and
Radiological Health, Document Mail
Center— WO66, rm. 0609, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002.
(2) 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.
V. Procedures for Paying Annual
Establishment Fees
If you are required to pay an annual
establishment registration fee, you must
pay for each establishment prior to
registration. Payment must be submitted
by first creating a Device Facility Use
Fee (DFUF) order through the User Fee
Web site at https://fdasfinapp8.fda.gov/
OA_HTML/fdaCAcdLogin.jsp. (FDA has
verified the Web site address, but FDA
is not responsible for any subsequent
changes to the Web site after this
document publishes in the Federal
Register.) You will be issued a PIN once
you place your order. After payment has
been processed, you will be issued a
payment confirmation number (PCN).
You will not be able to register your
establishment if you do not have a PIN
and a PCN. An establishment required
to pay an annual establishment
registration fee is not legally registered
in FY 2010 until it has completed the
steps below to register and pay any
applicable fee. (See 21 U.S.C. 379j(f)(2).)
VerDate Nov<24>2008
16:05 Jul 31, 2009
Jkt 217001
A. Step One—Submit a Device Facility
User Fee Order With a PIN From FDA
Before Registering or Submitting
Payment
To submit a DFUF Order, you must
create or have previously created a user
account and password for the User Fee
Web site listed previously in this
section. After creating a user name and
password, log into the Establishment
Registration User Fee 2010 store.
Complete the DFUF order by entering
the number of establishments you are
registering. Once you are satisfied that
the data on the order is accurate,
electronically transmit that data to FDA
according to instructions on the screen.
Print a copy of the final DFUF order and
note the unique PIN located in the
upper right-hand corner of the printed
order.
printed order should also be mailed
along with your check. FDA’s tax
identification number is 53–0196965.
(3) If paying with a wire transfer:
Wire transfers may also be used to pay
annual establishment fees. To send a
wire transfer, please read and comply
with the following information:
• Include your order’s unique PIN,
from the upper right-hand corner of
your completed Medical Device User
Fee order, in your wire transfer. Without
the PIN your payment may not be
applied to your facility and your
registration will be delayed.
• The originating financial institution
usually charges a wire transfer fee
between $15.00 and $35.00. Please ask
your financial institution about the fee
and include it with your payment to
ensure that your order is fully paid. Use
the following account information when
sending a wire transfer: New York
Federal Reserve Bank, US.. Dept of
Treasury, TREAS NYC, 33 Liberty St,
New York, NY 10045, Acct. No.
75060099, Routing No. 021030004,
SWIFT: FRNYUS33, Beneficiary: FDA,
5600 Fishers Lane, Rockville, MD
20857.
B. Step Two—Pay For Your Device
Facility User Fee Order
Unless paying by credit card, all
payments must be in U. S. currency and
drawn on a U.S. bank.
(1) If paying with credit card or
electronic check (ACH):
The DFUF order will include payment
information, including details on how
you can pay online using a credit card
or electronic checks. Follow the
instructions provided to make an
electronic payment.
(2) If paying with a paper check:
If you prefer not to pay online, you
may pay by a check, in U.S. dollars and
drawn on a U.S. bank, mailed to: Food
and Drug Administration, P.O. Box
70961, Charlotte, NC 28272–0961.
(Note: This address is different from the
address for payments of application and
annual report fees and is to be used only
for payment of annual establishment
registration fees.)
If a check is sent by a courier that
requests a street address, the courier can
deliver the check to: Wachovia Bank,
Attn: Food and Drug Administration—
Lockbox 70961, rm. NC0810, 1525 West
WT Harris Blvd., Charlotte, NC 28262.
(Note: This Wachovia Bank address is
for courier delivery only; do not send
mail to this address.)
Please make sure that both of the
following are written on your check: (1)
The FDA post office box number (P.O.
Box 70961) and (2) the PIN that is
printed on your order. A copy of your
C. Step Three—Complete the
Information Online to Update Your
Establishment’s Annual Registration for
FY 2010, or to Register a New
Establishment for FY 2010
Go to CDRH’s Web site at https://
www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
HowtoMarketYourDevice/
RegistrationandListing/default.htm and
click the ‘‘Access Electronic
Registration’’ link on the left of the page.
This opens up a new page with
important information about the FDA
Unified Registration and Listing System
(FURLS). After reading this information,
click on the link (Access Electronic
Registration) at the bottom of the page.
This link takes you to an FDA Industry
Systems page with tutorials that
demonstrate how to create a new FURLS
user account if your establishment did
not create an account in FY 2009.
Biologics license manufacturers should
register in the BER system at https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/EstablishmentRegistration/
BloodEstablishmentRegistration/
default.htm.
Enter your existing account ID and
password to log into FURLS. From the
FURLS/FDA Industry Systems menu,
there will be a button that you will click
to go to the Device Registration and
Listing Module (DRLM) of FURLS. New
establishments will need to register and
existing establishments will update
Companies that do not manufacture
any product other than a licensed
biologic are required to register in the
Blood Establishment Registration (BER)
system. FDA’s Center for Biologics and
Research (CBER) will send
establishment registration fee invoices
annually to these companies.
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Federal Register / Vol. 74, No. 147 / Monday, August 3, 2009 / Notices
their annual registration using choices
on the DRLM menu. Once you choose
to register or update your annual
registration the system will prompt you
through the entry of information about
your establishment and your devices. If
you have any problems with this
process, e-mail: reglist@cdrh.fda.gov or
call 301–796–7400 for assistance. (Note:
this e-mail address and this telephone
number are for assistance with
establishment registration only, and not
for any other aspects of medical device
user fees.) Problems with BER should be
directed to bloodregis@fda.hhs.gov or
call 301–827–3546.
D. Step Four—Enter Your DFUF Order
PIN and PCN
After completing your annual or
initial registration and device listing,
you will be prompted to enter your
DFUF order PIN and PCN, when
applicable. This process does not apply
to licensed biologic devices. CBER will
send invoices for payment of the
establishment registration fee to
companies who only manufacture
licensed biologics devices. Fees are only
required for those establishments
defined in section I of this document.
Dated: July 28, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–18456 Filed 7–31–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
sroberts on DSKD5P82C1PROD with NOTICES
Notice of Meeting; Moving Into the
Future—New Dimensions and
Strategies for Women’s Health
Research for the National Institutes of
Health
Notice is hereby given that the Office
of Research on Women’s Health
(ORWH), Office of the Director, National
Institutes of Health, Department of
Health and Human Services, in
collaboration with the Warren Alpert
Medical School of Brown University
and the Women & Infants Hospital of
Rhode Island, will convene a public
hearing and scientific workshop on
September 21–23, 2009, at the Women
& Infants Hospital of Rhode Island
Conference Center, Providence, Rhode
Island.
Purpose of the Meeting
With rapid advances in science and
wider global understanding of women’s
health and sex/gender contributions to
VerDate Nov<24>2008
16:05 Jul 31, 2009
Jkt 217001
well-being and disease, the purpose of
the meeting is to ensure that NIH
continues to support cutting-edge
women’s health research that is based
upon the most advanced techniques and
methodologies. The meeting format is
designed to promote an interactive
discussion involving leading scientists,
advocacy groups, public policy experts,
health care providers, and the general
public. The Providence meeting is the
third in a series that will be convened
throughout the Nation to help the
ORWH and NIH move into the next
decade of women’s health research.
As science and technology advance
and fields such as computational
biology demonstrate the power of
interdisciplinary research, it remain
critical for sex and gender factors to be
integrated into broad experimental
methodologies and scientific
approaches across the lifespan.
Biomedical and behavioral research are
also necessary to understand how
cultural, ethnic, and racial differences
influence the causes, diagnosis,
progression, treatment, and outcome of
disease among different populations,
including women of diverse geographic
locations and socioeconomic
backgrounds. Furthermore, health
differences among diverse populations
of women remain a critical area in need
of continued focus and attention.
The ORWH challenges all meeting
attendees to assist the NIH in defining
the women’s health research agenda of
the future by thinking beyond
traditional women’s health issues. The
ORWH and NIH ask meeting
participants to consider creative
strategies to identify areas of research
that are best poised for advancement,
identify innovative ways in which
persistent issues of health and disease
can be addressed, and explore new
horizons of scientific concepts and
investigative approaches. Attention also
needs to be paid to new areas of science
application, new technologies, and
continuing basic science investigations.
Clinical questions that are not currently
the focus of research priorities need to
be considered to ensure that women’s
health research is optimally served and
that the ORWH can continue to provide
leadership for the benefit of women’s
health, nationally and internationally.
Meeting Format
The meeting will consist of public
testimony, scientific panels, and eight
concurrent scientific working groups.
Specifically, on September 21,
individuals representing a full spectrum
of organizations interested in
biomedical and behavioral research on
women’s health issues will have an
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38449
opportunity to provide public testimony
from 1:30 to 5:30 p.m. On September 22
and 23, plenary sessions will focus on
the intersection of health care, public
policy, and biomedical research; on
emerging issues and trends in health
care; and on research paradigms of the
future. The eight concurrent afternoon
sessions on September 22 will focus on
a range of research areas, including
Prenatal, Infancy, and Childhood Years;
Adolescent Years; Reproductive and
Middle Years; Pregnancy; Menopausal
Transition; Elderly, Frail Elderly, and
Healthy Aging; Oral Health and
Systemic Conditions; and Careers in
Dentistry, Bioengineering, and other
Non-Medical Disciplines.
On September 23 the morning session
will be devoted to reports by the
working group co-chairs regarding the
recommendations emerging from
working group deliberations on the
previous day. The meeting will adjourn
at 1:15 p.m. on September 23.
Public Testimony
The ORWH invites individuals with
an interest in research related to
women’s health to provide written and/
or oral testimony on these topics and/
or on issues related to the sustained
advancement of women in various
biomedical careers. Due to time
constraints, only one representative
from an organization or professional
specialty group may give oral testimony.
Individuals not representing an
organized entity but a personal point of
view are similarly invited to present
written and/or oral testimony. A letter
of intent to present oral testimony is
necessary and should be sent
electronically to https://
www.orwhmeetings.com/
movingintothefuture/ or by mail to Ms.
Jory Barone, Educational Services, Inc.,
4350 East-West Highway, Suite 1100,
Bethesda, MD 20814, no later than
September 13, 2009. The date of receipt
of the communication will establish the
order of those selected to give oral
testimony at the September meeting.
Those wishing to present oral
testimony are also asked to submit a
written form of their testimony that is
limited to a maximum of 10 pages,
double spaced, 12-point font, and
should include a brief description of
their organization. Electronic
submission to the above Web site is
preferred; however, for those who do
not have access to electronic means,
written testimony, bound by the
restrictions previously noted and
postmarked no later than September 13,
2009, can be mailed to Ms. Jory Barone
at the above address. All written
presentations must meet the established
E:\FR\FM\03AUN1.SGM
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Agencies
[Federal Register Volume 74, Number 147 (Monday, August 3, 2009)]
[Notices]
[Pages 38444-38449]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-18456]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
[[Page 38445]]
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, https://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.
[[Page 38446]]
Table 1.--Medical Device Fees for FY 2010
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
https://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
[[Page 38447]]
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
https://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.
IV. Procedures for Paying Application and Annual Report Fees
If your application or submission is subject to a fee and your
payment is received by FDA from October 1, 2009, through September 30,
2010, you must pay the fee in effect for FY 2010. The later of the date
that the application or annual report is received in the reviewing
center's document room or the date that the check is received by U.S.
Bank determines whether the fee rates for FY 2009 or FY 2010 apply. FDA
must receive the correct fee at the time that an application or annual
report is submitted, or the application or annual report will not be
accepted for filing or review.
FDA requests that you follow the steps below before submitting a
medical device application or annual report 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 (PIN) and Medical
Device User Fee Cover Sheet From FDA Before Submitting Either the
Application or the Payment (Note: Both the FY 2009 and FY 2010 fee
rates will be available on the Cover Sheet Web Site beginning on the
date of publication of this document, and only the FY 2010 rates will
appear after September 30, 2009)
Log on to the MDUFMA Web site at: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/default.htm and, under
the MDUFMA 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 until October 1, 2009. One choice is for applications that will
be received on or before September 30, 2009, which will be subject to
FY 2009 fee rates. A second choice is for applications that will be
received on or after October 1, 2009, which will be subject to FY 2010
fee rates.) After completing data entry, print a copy of the Medical
Device User Fee cover sheet and note the unique PIN 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 PIN 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. Because 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--Submit Payment for the Completed Medical Device User Fee
Cover Sheet as Described in this Section, Depending on the Method You
Will Use to Make Payment
(1) If paying with a paper check:
All paper checks must be in U.S. currency from a U.S. bank
and made payable to the Food and Drug Administration. (FDA's tax
identification number is 53-0196965, should your accounting department
need this information.)
Please write your application's unique PIN, from the upper
right-hand corner of your completed Medical Device User Fee cover
sheet, on your check.
Mail the paper check and a copy of the completed cover
sheet to: Food and Drug Administration, P.O. Box 956733, St. Louis, MO,
63195-6733. (Please note that this address is for payments of
application and annual report fees only and is not to be used for
payment of annual establishment registration fees.)If you prefer to
send a check by a courier (such as Federal Express (FEDEX), DHL, United
Parcel Service (UPS), etc.), the courier may deliver the check to: U.S.
Bank, Attn: Government Lockbox 956733, 1005 Convention Plaza, St.
Louis, MO 63101. (Note: This address is for courier delivery only.
Contact the U.S. 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: (1) The date the
application was received by FDA or (2) the date U.S. Bank receives the
payment. U.S. Bank is required to notify FDA within 1 working day,
using the PIN described previously in this document.
(2) If Paying With Credit Card or Electronic Check (Automated
Clearing House (ACH)):
FDA has partnered with the U.S. Department of the Treasury to
utilize Pay.gov, a web based payment application, for online electronic
payment. Pay.gov can now be used to submit online payments for cover
sheets to the FDA. You now have the option to make a payment via
electronic check or credit card after submitting your coversheet. To
pay online, select the ``Pay Now'' button. Credit card transactions for
cover sheets are limited to $4,000.00.
(3) If paying with a wire transfer:
Please include your application's unique PIN, from the
upper right-hand corner of your completed Medical
[[Page 38448]]
Device User Fee cover sheet, in your wire transfer. Without the PIN
your payment may not be applied to your cover sheet and review of you
application will be delayed.
The originating financial institution usually charges a
wire transfer fee between $15.00 and $35.00. Please ask your financial
institution about the fee and include it with your payment to ensure
that your cover sheet is fully paid.Use the following account
information when sending a wire transfer: New York Federal Reserve
Bank, U.S. Department of Treasury, TREAS NYC, 33 Liberty St, New York,
NY 10045, Acct. No. 75060099, Routing No. 021030004, SWIFT: FRNYUS33,
Beneficiary: FDA, 5600 Fishers Lane, Rockville, MD 20857.
D. Step Four--Submit Your Application to FDA With a Copy of the
Completed Medical Device User Fee Cover Sheet
For all applications sent after August 1, 2009, 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: Food and
Drug Administration, Center for Devices and Radiological Health,
Document Mail Center-- WO66, rm. 0609, 10903 New Hampshire Ave., Silver
Spring, MD 20993-0002.
(2) 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.
V. Procedures for Paying Annual Establishment Fees
If you are required to pay an annual establishment registration
fee, you must pay for each establishment prior to registration. Payment
must be submitted by first creating a Device Facility Use Fee (DFUF)
order through the User Fee Web site at https://fdasfinapp8.fda.gov/OA_HTML/fdaCAcdLogin.jsp. (FDA has verified the Web site address, but FDA
is not responsible for any subsequent changes to the Web site after
this document publishes in the Federal Register.) You will be issued a
PIN once you place your order. After payment has been processed, you
will be issued a payment confirmation number (PCN). You will not be
able to register your establishment if you do not have a PIN and a PCN.
An establishment required to pay an annual establishment registration
fee is not legally registered in FY 2010 until it has completed the
steps below to register and pay any applicable fee. (See 21 U.S.C.
379j(f)(2).)
Companies that do not manufacture any product other than a licensed
biologic are required to register in the Blood Establishment
Registration (BER) system. FDA's Center for Biologics and Research
(CBER) will send establishment registration fee invoices annually to
these companies.
A. Step One--Submit a Device Facility User Fee Order With a PIN From
FDA Before Registering or Submitting Payment
To submit a DFUF Order, you must create or have previously created
a user account and password for the User Fee Web site listed previously
in this section. After creating a user name and password, log into the
Establishment Registration User Fee 2010 store. Complete the DFUF order
by entering the number of establishments you are registering. Once you
are satisfied that the data on the order is accurate, electronically
transmit that data to FDA according to instructions on the screen.
Print a copy of the final DFUF order and note the unique PIN located in
the upper right-hand corner of the printed order.
B. Step Two--Pay For Your Device Facility User Fee Order
Unless paying by credit card, all payments must be in U. S.
currency and drawn on a U.S. bank.
(1) If paying with credit card or electronic check (ACH):
The DFUF order will include payment information, including details
on how you can pay online using a credit card or electronic checks.
Follow the instructions provided to make an electronic payment.
(2) If paying with a paper check:
If you prefer not to pay online, you may pay by a check, in U.S.
dollars and drawn on a U.S. bank, mailed to: Food and Drug
Administration, P.O. Box 70961, Charlotte, NC 28272-0961. (Note: This
address is different from the address for payments of application and
annual report fees and is to be used only for payment of annual
establishment registration fees.)
If a check is sent by a courier that requests a street address, the
courier can deliver the check to: Wachovia Bank, Attn: Food and Drug
Administration--Lockbox 70961, rm. NC0810, 1525 West WT Harris Blvd.,
Charlotte, NC 28262. (Note: This Wachovia Bank address is for courier
delivery only; do not send mail to this address.)
Please make sure that both of the following are written on your
check: (1) The FDA post office box number (P.O. Box 70961) and (2) the
PIN that is printed on your order. A copy of your printed order should
also be mailed along with your check. FDA's tax identification number
is 53-0196965.
(3) If paying with a wire transfer:
Wire transfers may also be used to pay annual establishment fees.
To send a wire transfer, please read and comply with the following
information:
Include your order's unique PIN, from the upper right-hand
corner of your completed Medical Device User Fee order, in your wire
transfer. Without the PIN your payment may not be applied to your
facility and your registration will be delayed.
The originating financial institution usually charges a
wire transfer fee between $15.00 and $35.00. Please ask your financial
institution about the fee and include it with your payment to ensure
that your order is fully paid. Use the following account information
when sending a wire transfer: New York Federal Reserve Bank, US.. Dept
of Treasury, TREAS NYC, 33 Liberty St, New York, NY 10045, Acct. No.
75060099, Routing No. 021030004, SWIFT: FRNYUS33, Beneficiary: FDA,
5600 Fishers Lane, Rockville, MD 20857.
C. Step Three--Complete the Information Online to Update Your
Establishment's Annual Registration for FY 2010, or to Register a New
Establishment for FY 2010
Go to CDRH's Web site at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/default.htm and click the ``Access Electronic
Registration'' link on the left of the page. This opens up a new page
with important information about the FDA Unified Registration and
Listing System (FURLS). After reading this information, click on the
link (Access Electronic Registration) at the bottom of the page. This
link takes you to an FDA Industry Systems page with tutorials that
demonstrate how to create a new FURLS user account if your
establishment did not create an account in FY 2009. Biologics license
manufacturers should register in the BER system at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/EstablishmentRegistration/BloodEstablishmentRegistration/default.htm.
Enter your existing account ID and password to log into FURLS. From
the FURLS/FDA Industry Systems menu, there will be a button that you
will click to go to the Device Registration and Listing Module (DRLM)
of FURLS. New establishments will need to register and existing
establishments will update
[[Page 38449]]
their annual registration using choices on the DRLM menu. Once you
choose to register or update your annual registration the system will
prompt you through the entry of information about your establishment
and your devices. If you have any problems with this process, e-mail:
reglist@cdrh.fda.gov or call 301-796-7400 for assistance. (Note: this
e-mail address and this telephone number are for assistance with
establishment registration only, and not for any other aspects of
medical device user fees.) Problems with BER should be directed to
bloodregis@fda.hhs.gov or call 301-827-3546.
D. Step Four--Enter Your DFUF Order PIN and PCN
After completing your annual or initial registration and device
listing, you will be prompted to enter your DFUF order PIN and PCN,
when applicable. This process does not apply to licensed biologic
devices. CBER will send invoices for payment of the establishment
registration fee to companies who only manufacture licensed biologics
devices. Fees are only required for those establishments defined in
section I of this document.
Dated: July 28, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-18456 Filed 7-31-09; 8:45 am]
BILLING CODE 4160-01-S