[Federal Register Volume 75, Number 148 (Tuesday, August 3, 2010)]
[Notices]
[Pages 45641-45646]
From the Federal Register Online via the Government Printing 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
----------------------------------------------------------------------------------------------------------------
                                                  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
----------------------------------------------------------------------------------------------------------------
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))
----------------------------------------------------------------------------------------------------------------
Premarket report (submitted under section                         100%              $236,298             $59,075
 515(c)(2) of the act)
----------------------------------------------------------------------------------------------------------------
Efficacy supplement (to an approved BLA under                     100%              $236,298             $59,075
 section 351 of the PHS Act)
----------------------------------------------------------------------------------------------------------------
Panel-track supplement                                             75%              $177,224             $44,306
----------------------------------------------------------------------------------------------------------------
180-day supplement                                                 15%               $35,445              $8,861
----------------------------------------------------------------------------------------------------------------
Real-time supplement                                                7%               $16,541              $4,135
----------------------------------------------------------------------------------------------------------------
510(k) premarket notification submission                         1.84%                $4,348              $2,174
----------------------------------------------------------------------------------------------------------------
30-day notice                                                     1.6%                $3,781              $1,890
----------------------------------------------------------------------------------------------------------------
513(g) request for classification information                    1.35%                $3,190              $1,595
----------------------------------------------------------------------------------------------------------------
Annual Fee Type
----------------------------------------------------------------------------------------------------------------
Annual fee for periodic reporting on a class                      3.5%                $8,270              $2,068
 III device
----------------------------------------------------------------------------------------------------------------
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))
----------------------------------------------------------------------------------------------------------------

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: 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 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