Document ID: FDA-2011-N-0542-0001
Agency: fda
Document Type: Notice
Title: Medical Device User Fee Rates for Fiscal Year 2012
Posted Date: 2011-08-01T04:00Z

[Federal Register Volume 76, Number 147 (Monday, August 1, 2011)]
[Notices]
[Pages 45826-45831]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-19335]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0542]

Medical Device User Fee Rates for Fiscal Year 2012

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the fee 
rates and payment procedures for medical device user fees for fiscal 
year (FY) 2012. The Federal Food, Drug, and Cosmetic Act (the FD&C 
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 for certain periodic reports and 
for certain establishments subject to registration. The FY 2012 fee 
rates are provided in this document. These fees apply from October 1, 
2011, through September 30, 2012. 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. In order 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 be required to pay the 
higher standard fee. This document provides information on how the fees 
for FY 2012 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 the Medical Device 
User Fee and Modernization Act (MDUFMA): visit FDA's Web site, http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/default.htm.
    For questions relating to this notice: Contact David Miller, Office 
of Financial Management (HFA-100), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 301-796-7103.

SUPPLEMENTARY INFORMATION:

[[Page 45827]]

I. Background

    Section 738 of the FD&C 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 FD&C 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 FD&C Act specifies the standard fee for 
a premarket application for each year from FY 2008 through FY 2012; 
however, the standard fee for a premarket application received by FDA 
during FY 2012, which is set in the statute ($256,384), is adjusted in 
accordance with the offset provisions of the FD&C Act. Using this 
adjusted fee rate for FY 2012 as a starting point, this document 
establishes FY 2012 fee rates for other types of submissions, and for 
periodic reporting, by applying criteria specified in the FD&C Act.
    The FD&C Act specifies the annual fee for establishment 
registration for each year from FY 2008 through FY 2012; the 
registration fee for FY 2012 is $2,364, which is also adjusted in 
accordance with the offset provisions of the FD&C Act. 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 establishment:
     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.

II. Offsetting Fee Amounts for Collections in Excess of Appropriations 
in FY 2008 through FY 2011

    Under the offset provision of the FD&C Act (see section 739(h)(4) 
(21 U.S.C. 379j-11(h)(4))), if the cumulative amount of fees collected 
during FY 2008 through FY 2010, together with the estimated amount to 
be collected in FY 2011, exceeds the aggregate amounts specified to be 
appropriated in these four FYs in section 739(h)(3) of the FD&C Act, 
the aggregate amount in excess shall be credited to the appropriation 
account of FDA and subtracted from the amount of fees that would 
otherwise be collected in FY 2012. Table 1 of this document presents 
the amount of MDUFMA fees collected during FY 2008 through FY 2010 
(actuals), and the amount estimated to be collected in FY 2011, and 
compares those amounts with the fees specified to be appropriated in 
these four FYs in section 739(h)(3) of the FD&C Act.

        Table 1--Statement of Fees Appropriated, Fees Collected, and Differences as of September 30, 2010
----------------------------------------------------------------------------------------------------------------
                                                                       Fees
                           Fiscal year                             appropriated   Fees collected    Difference
----------------------------------------------------------------------------------------------------------------
2008 Actual.....................................................     $48,431,000     $49,314,691        $883,691
2009 Actual.....................................................      52,547,000      59,731,482       7,184,482
2010 Actual.....................................................      57,014,000      66,949,587       9,935,587
2011 Estimate...................................................      61,860,000      61,860,000               0
                                                                 -----------------------------------------------
    Cumulative Total............................................  ..............  ..............      18,003,760
----------------------------------------------------------------------------------------------------------------
    Unearned Revenue Included in Above Amount...................  ..............  ..............       8,491,930
    Excess Collections Less Unearned Revenue (Offset Amount)....  ..............  ..............       9,511,830
----------------------------------------------------------------------------------------------------------------

    The total amount FDA expects to have collected in excess of 
appropriations by the end of FY 2011 is $18,003,760. However, of that 
amount, a total of $8,491,930 represents unearned revenue--primarily 
fees paid for applications that have not yet been received. The 
unearned revenue is held in reserve either to refund, if no application 
is submitted, or to apply toward the future FY when the application is 
received. The net of these two figures, $9,511,830, is the amount that 
FDA has received in excess of appropriations that is available for 
obligation, and the amount by which fee revenue will be offset in FY 
2012.
    For FY 2012, the statute authorizes $67,118,000 in user fees (see 
section 738(h)(3)(E)). In order to determine the revised collection 
amount, we deduct the net excess collection amount of $9,511,830 from 
$67,118,000, and the revised revenue target for FY 2012 becomes 
$57,606,170. Stated as a percent, this is 85.8281 percent of the 
original revenue target for FY 2012. Accordingly, if we multiply this 
percentage by the revenue amounts for the two fees set in statute, 
$256,384 for a Premarket Application fee and $2,364 for an 
Establishment Registration Fee (see 21 U.S.C. 379j(b)), the reduced 
fees for FY 2012 are $220,050 for a premarket application fee and 
$2,029 for the annual establishment registration fee.
    It is important to note that the appropriation for FY 2012 still 
must be $67,118,000 as specified in the statute, so that the $9,511,830 
in user fees collected in prior years is appropriated and available for 
obligation.

III. Fees for FY 2012

    Under the FD&C 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 offset fee for the 
standard premarket application, including a BLA, a premarket report, 
and an efficacy supplement, for FY 2012. As calculated previously, the 
FY 2012 premarket application fee is $220,050. This is referred to as 
the ``base fee.'' The fees set by reference to the base fee are as 
follows:
     For a panel-track supplement, 75 percent of the base fee;

[[Page 45828]]

     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. 360(c)(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(d)(2)(C) and 379j(e)(2)(C).)
    The annual fee for establishment registration, after reduction as 
calculated in the previous section, is $2,029 in FY 2012. 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 2 of this document sets out the FY 2012 rates for all medical 
device fees.

                                    Table 2--Medical Device Fees for FY 2012
----------------------------------------------------------------------------------------------------------------
                                                  Standard Fee, as a Percent of
             Application fee type               the standard fee for a premarket      FY 2012      FY 2012 small
                                                           application             standard fee    business fee
----------------------------------------------------------------------------------------------------------------
Premarket application (a PMA submitted under    Set in statute at $256,382, but         $220,050         $55,013
 section 515(c)(1) of the FD&C Act (21 U.S.C.    offset by multiplying by
 360e(c)(1)), a PDP submitted under section      85.8281 percent.
 515(f) of the FD&C 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%............................         220,050          55,013
 515(c)(2) of the FD&C Act).
Efficacy supplement (to an approved BLA under   100%............................         220,050          55,013
 section 351 of the PHS Act).
Panel-track supplement........................  75%.............................         165,038          41,259
180-day supplement............................  15%.............................          33,008           8,252
Real-time supplement..........................  7%..............................          15,404           3,851
510(k) premarket notification submission......  1.84%...........................           4,049           2,024
30-day notice.................................  1.6%............................           3,521           1,760
513(g) (21 U.S.C. 360c(g)) request for          1.35%...........................           2,971           1,485
 classification information.
----------------------------------------------------------------------------------------------------------------
                                                 Annual Fee Type
----------------------------------------------------------------------------------------------------------------
Annual fee for periodic reporting on a class    3.5%............................           7,702           1,925
 III device.
Annual establishment registration fee (to be    Set in statute at $2,364, but              2,029           2,029
 paid by each establishment that is a            offset by multiplying by
 manufacturer, a single-use device               85.8281 percent.
 reprocessor, or a specification developer, as
 defined by 21 U.S.C. 379i(13)).
----------------------------------------------------------------------------------------------------------------

IV. 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. In order to pay the 
small business fee rate for a submission, or 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 2011, your 
status as a small business will expire at the close of business on 
September 30, 2011. You must re-qualify for FY 2012 in order to pay 
small business fees during FY 2012.
    If you are a domestic (U.S.) business, and wish to qualify as a 
small business for FY 2012, you must submit the following to FDA:
    1. A completed FY 2012 MDUFMA Small Business Qualification 
Certification (Form FDA 3602). This form is provided in FDA's guidance 
document, ``FY 2012 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 2011, 
except:
     If you submit your FY 2012 MDUFMA Small Business 
Qualification before April 15, 2012, and you have not yet filed your 
return for 2011, you may use tax year 2010.
     If you submit your FY 2012 MDUFMA Small Business 
Qualification on or after April 15, 2012, and have not yet filed your 
2011 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

[[Page 45829]]

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 2012, you must submit the following:
    1. A completed FY 2012 MDUFMA Foreign Small Business Qualification 
Certification (Form FDA 3602A). This form is provided in FDA's guidance 
document, ``FY 2012 Medical Device User Fee Small Business 
Qualification and Certification,'' available on FDA's Web 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 (2010 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.

V. Procedures for Paying Application Fees

    If your application or submission is subject to a fee and your 
payment is received by FDA from October 1, 2011, through September 30, 
2012, you must pay the fee in effect for FY 2012. The later of the date 
that the application 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 2011 or FY 2012 apply. FDA must receive 
the correct fee at the time that an application is submitted, or the 
application will not be accepted for filing or review.
    FDA requests that you follow the steps in the paragraphs that 
follow when submitting a medical device application subject to a fee 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. Both the FY 2011 and FY 2012 Fee Rates Will 
Be Available on the User Fee Web Site Beginning on the Date of 
Publication of This Document, and Only the FY 2012 Rates Will Appear 
After September 30, 2011)

    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, 2011. One choice is for applications that 
will be received on or before September 30, 2011, which are subject to 
FY 2011 fee rates. A second choice is for applications that will be 
received on or after October 1, 2011, which are subject to FY 2012 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.)
    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. It is helpful if the fee 
arrives at the bank at least 1 day before the application arrives at 
FDA. U.S. Bank is required to notify FDA within 1 working day, using 
the PIN described previously in this document.
    2. If paying with a 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 system,

[[Page 45830]]

for online electronic payment. You may 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.
    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 your application will be 
delayed.
     The originating financial institution may charge a wire 
transfer fee between $15 and $35. 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.

VI. Procedures for Paying the Annual Fee for Periodic Reporting

    As of FY 2011, you are no longer able to create a cover sheet and 
obtain a PIN to pay the MDUFMA Annual Fee for Periodic Reporting. 
Instead, you will be invoiced at the end of the quarter in which your 
PMA Periodic Report is due. Invoices will be sent based on the details 
included on your PMA file; you are responsible to ensure your billing 
information are kept up-to-date (you can update your contact for the 
PMA by submitting an amendment).
    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 invoice number.
     Mail the paper check and a copy of invoice 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.)
    2. If paying with a wire transfer:
     Please include your invoice number in your wire transfer. 
Without the invoice number, your payment may not be applied and you may 
be referred to collections.
     The originating financial institution may charge a wire 
transfer fee between $15 and $35. Please ask your financial institution 
about the fee and include it with your payment to ensure that your 
invoice 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.

VII. Procedures for Paying Annual Establishment Fees

    In order to pay the annual establishment fee, firms must access the 
Device Facility User Fee (DFUF) Web site at https://userfees.fda.gov/OA_HTML/furls.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). The Web site includes a 
short interactive questionnaire to help you ascertain whether an annual 
registration payment is required for your type of facility. If you are 
required to pay an annual establishment registration fee, you must pay 
for each establishment prior to registration. You will create a DFUF 
order and 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 
2012 until it has completed the steps in the paragraphs that follow 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 Evaluation and 
Research (CBER) will send establishment registration fee invoices 
annually to these companies.

A. Step One--Submit a Device Facility User Fee (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 through the User Fee Web site listed 
previously in this section. After creating a user name and password, 
log into the Establishment Registration User Fee 2012 store. Complete 
the DFUF order by entering the number of establishments you are 
registering that require payment. 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 a 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: U.S. Bank, Attn: 
Government Lockbox 979108, St. Louis, MO 63197-9000. (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

[[Page 45831]]

deliver the check to: U.S. Bank, Attn: Government Lockbox 979108, 1005 
Convention Plaza, St. Louis, MO 63101. (Note: This U.S. 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 lockbox number (Lockbox 979108) 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 and $35. 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 2012, or to Register a New 
Establishment for FY 2012

    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 2010 or FY 2011. 
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, click on the Device Registration 
and Listing Module (DRLM) of FURLS button. New establishments will need 
to register and existing establishments will update their annual 
registration using selections 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 26, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-19335 Filed 7-29-11; 8:45 am]
BILLING CODE 4160-01-P