[Federal Register Volume 75, Number 148 (Tuesday, August 3, 2010)]
[Notices]
[Pages 45641-45646]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-19038]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0363]
Medical Device User Fee Rates for Fiscal Year 2011
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
[[Page 45642]]
fee rates and payment procedures for medical device user fees for
fiscal year (FY) 2011. The Federal Food, Drug, and Cosmetic Act (the
act), as amended by 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 2011 fee
rates are provided in this document. These fees apply from October 1,
2010, through September 30, 2011. 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 2011 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/MedicalDeviceUserFeeandModernizationActMDUFMA/default.htm.
For questions relating to this notice: David Miller, Office of
Financial Management (HFA-100), Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850, 301-796-7103.
SUPPLEMENTARY INFORMATION:
I. Background
Section 738 of the act (21 U.S.C. 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 license 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 2011 is $236,298. From
this starting point, this document establishes FY 2011 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
2011 is $2,179. 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 2011 go into effect on October 1, 2010, and will
remain in effect through September 30, 2011.
II. Fees for FY 2011
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 $236,298 for FY 2011 (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) (21 U.S.C. 360c(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
$2,179 in FY 2011, 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
2011 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).) The number of establishments submitting fees in FY 2009
was 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 2011 rates for all medical
device fees.
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Table 1.--Medical Device Fees for FY 2011
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Standard Fee, as a
Percent of the Standard FY 2011 Small
Application Fee Type Fee for a Premarket FY 2011 Standard Fee Business Fee
Application
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Premarket application (a PMA submitted under Set in Statute $236,298 $59,075
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))
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Premarket report (submitted under section 100% $236,298 $59,075
515(c)(2) of the act)
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Efficacy supplement (to an approved BLA under 100% $236,298 $59,075
section 351 of the PHS Act)
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Panel-track supplement 75% $177,224 $44,306
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180-day supplement 15% $35,445 $8,861
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Real-time supplement 7% $16,541 $4,135
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510(k) premarket notification submission 1.84% $4,348 $2,174
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30-day notice 1.6% $3,781 $1,890
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513(g) request for classification information 1.35% $3,190 $1,595
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Annual Fee Type
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Annual fee for periodic reporting on a class 3.5% $8,270 $2,068
III device
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Annual establishment registration fee (to be Set in Statute $2,179 $2,179
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 2010, your
status as a small business will expire at the close of business on
September 30, 2010. You must re-qualify for FY 2011 in order to pay
small business fees during FY 2011.
If you are a domestic (U.S.) business, and wish to qualify as a
small business for FY 2011, you must submit the following to FDA:
1. A completed FY 2011 MDUFMA Small Business Qualification
Certification (Form FDA 3602). This form is provided in FDA's guidance
document, ``FY 2011 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 2010,
except--
If you submit your FY 2011 MDUFMA Small Business
Qualification before April 15, 2011, and you have not yet filed your
return for 2010, you may use tax year 2009.
If you submit your FY 2011 MDUFMA Small Business
Qualification on or after April 15, 2011, and have not yet filed your
2010 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 2011, you must submit the following:
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1. A completed FY 2011 MDUFMA Foreign Small Business Qualification
Certification (Form FDA 3602A). This form is provided in FDA's guidance
document, ``FY 2011 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 (2009 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, 2010, through September 30,
2011, you must pay the fee in effect for FY 2011. 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 2010 or FY 2011 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 2010 and FY 2011 fee
rates will be available on the Cover Sheet Web Site beginning on the
date of publication of this document, and only the FY 2011 rates will
appear after September 30, 2010)
Log on to the MDUFMA Web site at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/default.htm and, under
the MDUFMA Forms heading, click on the link ``Create a 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, 2010. One choice is for applications that
will be received on or before September 30, 2010, which will be subject
to FY 2010 fee rates. A second choice is for applications that will be
received on or after October 1, 2010, which will be subject to FY 2011
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 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 $5,000.00.
(3) If paying with a wire transfer:
Please include your application's unique PIN, from the
upper right-hand corner of your completed Medical 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
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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, 1350 Piccard Dr.,
Rockville, MD 20850.
D. Step Four--Submit Your Application to FDA With a Copy of the
Completed Medical Device User Fee Cover Sheet
Please submit your application and a copy of the completed Medical
Device User Fee cover sheet to one of the following addresses:
1. Medical device applications should be submitted to: 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 User 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 2011 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 DFUF 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 2011 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: Wells Fargo, Attn: Food and Drug
Administration--Lockbox 70961, rm. NC0810, 1525 West WT Harris Blvd.,
Charlotte, NC 28262. (Note: This Wells Fargo 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, U.S. 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 2011, or to Register a New
Establishment for FY 2011
Go to CDRH's Web site at http://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 or FY 2010.
Biologics manufacturers should register in the BER system at http://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 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
[[Page 45646]]
you have any problems with this process, e-mail: [email protected]
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 [email protected]
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 29, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-19038 Filed 8-2-10; 8:45 am]
BILLING CODE 4160-01-S