[Federal Register Volume 79, Number 146 (Wednesday, July 30, 2014)]
[Notices]
[Pages 44178-44184]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-17902]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0007]


Medical Device User Fee Rates for Fiscal Year 2015

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) 2015. The Federal Food, Drug, and Cosmetic Act (the FD&C 
Act), as amended by the Medical Device User Fee Amendments of 2012 
(MDUFA III), authorizes FDA to collect user fees for certain medical 
device submissions and annual fees both for certain periodic reports 
and for establishments subject to registration. This notice establishes 
the fee rates for FY 2015, which apply from October 1, 2014, through 
September 30, 2015. To avoid delay in the review of your application, 
you should pay the standard 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 recognized by the U.S. Treasury. If you 
want to pay a reduced small business fee, you must qualify as a small 
business before making your submission to FDA; if you do not qualify as 
a small business before making your submission to FDA, you will have to 
pay the higher standard fee. Please note that the establishment 
registration fee is not eligible for a reduced small business fee. As a 
result, if the establishment registration fee is the only medical 
device user fee that you will pay in FY 2015, you should not submit a 
FY 2015 Small Business Qualification and Certification request. This 
document provides information on how the fees for FY 2015 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 Medical Device User 
Fees: Visit FDA's Web site at http://www.fda.gov/mdufa.
    For questions relating to this notice: David Miller, Office of 
Financial Management, Food and Drug Administration, 8455 Colesville Rd. 
(COLE-14202E), Silver Spring, MD 20993-0002, 301-796-7103.

SUPPLEMENTARY INFORMATION:

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'' or ``applications''); 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).) Additionally, the Secretary of Health and Human Services (the 
Secretary) may, at the Secretary's sole discretion, grant a fee waiver 
or reduction if the Secretary finds that such waiver or reduction is in 
the interest of public health. (See 21 U.S.C. 379j(f).)
    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 base fee for a 
premarket application for each year from FY 2013 through FY 2017; the 
base fee for a premarket application received by FDA during FY 2015 is 
$258,019. From this starting point, this document establishes FY 2015 
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 base fee for establishment registration 
for each year from FY 2013 through FY 2017; the base fee for an 
establishment registration in FY 2015 is $3,750. There is no reduction 
in the registration fee for small businesses. Each establishment that 
is registered (or is required to register) with the Secretary under 
section 510 of the FD&C Act (21 U.S.C. 360) because such establishment 
is engaged in the manufacture, preparation, propagation, compounding, 
or processing of a device is required to pay the annual fee for 
establishment registration.

[[Page 44179]]

II. Revenue Amount for FY 2015

    The base revenue amount for FY 2015 is $125,767,107, as set forth 
in the statute prior to the inflation adjustment. (See 21 U.S.C. 
379j(b)(3)(C).) MDUFA directs FDA to use the yearly revenue amount as a 
starting point to set the standard fee rates for each fee type. The fee 
calculations for FY 2015 are described in this document.

Inflation Adjustment

    MDUFA specifies that the $125,767,107 is to be further adjusted for 
inflation increases for FY 2015 using two separate adjustments--one for 
payroll costs and one for non-pay cost (see 21 U.S.C. 379j(c)(2)).
    The component of the inflation adjustment for payroll costs shall 
be the sum of one plus the average annual percent change in the cost of 
all personnel compensation and benefits (PC&B) paid per full-time 
equivalent position (FTE) at FDA for the first 3 of the 4 preceding 
FYs, multiplied by 0.60, or 60 percent (see 21 U.S.C. 379j(c)(2)(C)). 
The data on total PC&B paid and numbers of FTE paid, from which the 
average cost per FTE can be derived, are published in FDA's 
Justification of Estimates for Appropriations Committees.
    Table 1 summarizes the actual cost and FTE data for the specified 
FYs, and provides the percent change from the previous FY and the 
average percent change over the first 3 of the 4 FYs preceding FY 2015. 
The 3-year average is 1.8829 percent.

                                Table 1--FDA PC&B's Each Year and Percent Change
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             Fiscal year                     2011               2012               2013          3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B..........................     $1,761,655,000     $1,824,703,000     $1,927,703,000  .................
Total FTE...........................             13,331             13,382             13,974  .................
PC&B per FTE........................           $132,147           $136,355           $137,949  .................
Percent change from previous year...            1.2954%            3.1843%            1.1690%            1.8829%
----------------------------------------------------------------------------------------------------------------

    The payroll adjustment is 1.8829 percent multiplied by 60 percent, 
or 1.1297 percent.
    The statute specifies that the portion of the inflation adjustment 
for non-payroll costs for FY 2015 is the average annual percent change 
that occurred in the Consumer Price Index (CPI) for urban consumers 
(Washington-Baltimore, DC-MD-VA-WV; not seasonally adjusted; all items; 
annual index) for the first 3 of the preceding 4 years of available 
data multiplied by 0.40, or 40 percent (see 21 U.S.C. 379j(c)(2)(C)).
    Table 2 provides the summary data and the 3-year average percent 
change in the specified CPI for the Baltimore-Washington area. This 
data is published by the Bureau of Labor Statistics and can be found on 
their Web site at http://data.bls.gov/cgi-bin/surveymost?cu by checking 
the box marked ``Washington-Baltimore All Items, November 1996=100--
CUURA311SA0'' and then clicking on the ``Retrieve Data'' button.

               Table 2--Annual and 3-Year Average Percent Change in Baltimore-Washington Area CPI
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             Fiscal year                     2011               2012               2013          3-Year average
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Annual CPI..........................            146.975            150.212            152.500  .................
Annual percent change...............            3.3449%            2.2024%            1.5232%  .................
3-Year average percent change in CPI  .................  .................  .................            2.3568%
----------------------------------------------------------------------------------------------------------------

    The non-pay adjustment is 2.3568 percent multiplied by 40 percent, 
or 0.9427 percent.
    To complete the inflation adjustment, the payroll adjustment 
(1.1297 percent) is added to the non-pay adjustment (0.9427 percent), 
for a total of 2.0724 percent, and plus one equals to 1.020724.
    MDUFA III provides for this inflation adjustment to be compounded 
beginning in FY 2015 (see 21 U.S.C. 379j(c)(2)(B)(ii)). The FY 2015 
inflation rate is multiplied by the FY 2014 inflation rate of 1.02198 
percent as published in the Federal Register of August 2, 2013 (78 FR 
46970), to reach the compound rate of 1.04316. The base revenue amount 
for FY 2015 ($125,767,107) is then multiplied by the compound inflation 
rate of 1.04316, yielding an inflation adjusted amount of $131,195,000 
(rounded to the nearest thousand dollars).

III. Fees for FY 2015

    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)). For FY 2015, the base fee 
will be adjusted as specified in the FD&C Act for inflation (see 21 
U.S.C. 379j(b) and (c)). Table 3 provides the last 3 years of fee 
paying submission counts and the 3-year average. These numbers are used 
to project the fee paying submission counts that FDA will receive in FY 
2015. The fee paying submission counts are published in the MDUFA 
Financial Report to Congress each year.

                                Table 3--3-Year Average of Fee Paying Submissions
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          Application type              FY 2011 actual     FY 2012 actual     FY 2013 actual     3-Year average
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Full Fee Applications...............                 24                 25                 23                 24
    Small Business..................                  7                  6                  9                  7
Panel-Track Supplement..............                  7                 12                 19                 13
    Small Business..................                  1                  0                  0                  0
180-Day Supplements.................                 92                145                128                122
    Small Business..................                 15                 21                 21                 19

[[Page 44180]]

 
Real-Time Supplements...............                145                196                182                174
    Small Business..................                 17                 22                 23                 21
510(k)s.............................              2,398              2,865              3,149              2,804
    Small Business..................                938              1,086              1,202              1,075
30-Day Notice.......................                755                801                956                837
    Small Business..................                 67                 60                 69                 65
513(g) Request for Classification                    40                 46                 65                 50
 Information........................
    Small Business..................                 35                 30                 38                 34
Annual Fee for Periodic Reporting...                466                478                614                519
    Small Business..................                 78                 39                 54                 57
                                     ---------------------------------------------------------------------------
Establishment Registration \1\......  .................  .................             24,462             24,462
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\1\ Estimate for establishment registration based on FY 2013 actual numbers because the criteria for this fee
  changed beginning in FY 2013 and no comparable data for a 3-year average is available.

    The information in Table 3 is necessary to estimate the amount of 
revenue that will be collected based on the fee amounts. Table 4 
displays both the estimated revenue using the FY 2015 base fees set in 
statute and the estimated revenue adding the inflation adjustment to 
the FY 2015 base fees. Using the fees set in statute and the 3-year 
averages of fee paying submissions, the collections would total 
$134,915,821, which is $3,720,821 higher than the statutory revenue 
amount. Accordingly the PMA and establishment fee should be decreased 
by 2.761%, rounded to the nearest whole dollar, so that collections 
come as close to the statutory limit of $131,195,000 as possible 
without exceeding the limit. The fees in the second column from the 
right are those we are establishing in FY 2015, which are the standard 
fees.

                           Table 4--Fees Needed to Achieve New FY 2015 Revenue Target
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                                                                             Adjusted FY 2015   FY 2015 revenue
          Application type            FY 2015 statutory    Resulting 2015      fees to meet      from  adjusted
                                             fees             revenue         revenue target          fees
----------------------------------------------------------------------------------------------------------------
Full Fee Applications...............           $258,019         $6,192,456           $250,895         $6,021,480
    Small Business..................             64,505            451,535             62,724            439,068
Panel-Track Supplement..............            193,514          2,515,682            188,171          2,446,223
    Small Business..................             48,379                  0             47,043                  0
180-Day Supplements.................             38,703          4,721,766             37,634          4,591,348
    Small Business..................              9,676            183,844              9,409            178,771
Real-Time Supplements...............             18,061          3,142,614             17,563          3,055,962
    Small Business..................              4,515             94,815              4,391             92,211
510(k)s.............................              5,160         14,468,640              5,018         14,070,472
    Small Business..................              2,580         2,773, 500              2,509          2,697,175
30-Day Notice.......................              4,128          3,455,136              4,014          3,359,718
    Small Business..................              2,064            134,160              2,007            130,455
513(g) Request for Classification                 3,483            174,150              3,387            169,350
 Information........................
    Small Business..................              1,742             59,228              1,694             57,596
Annual Fee for Periodic Reporting...              9,031          4,687,089              8,781          4,557,339
    Small Business..................              2,258            128,706              2,195            130,455
Establishment Registration..........              3,750         91,732,500              3,646         89,188,452
                                     ---------------------------------------------------------------------------
    Total...........................  .................        134,915,821  .................        131,180,735
----------------------------------------------------------------------------------------------------------------

    The standard fee (adjusted base amount) for a premarket 
application, including a BLA, and for a premarket report and a BLA 
efficacy supplement, is $250,895 for FY 2015. The fees set by reference 
to the standard fee for a premarket application are:
     For a panel-track supplement, 75 percent of the standard 
fee;
     For a 180-day supplement, 15 percent of the standard fee;
     For a real-time supplement, 7 percent of the standard fee;
     For a 510(k) premarket notification, 2 percent of the 
standard fee;
     For a 30-day notice, 1.6 percent of the standard fee;
     For a 513(g) request for classification information, 1.35 
percent of the standard fee; and
     For an annual fee for periodic reporting concerning a 
class III device, 3.5 percent of the standard 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 for the 
submission. (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 for the submission. (See 21 U.S.C. 379j(d)(2)(C) 
and (e)(2)(C).)
    The annual fee for establishment registration, after adjustment, is 
set at $3,646 for FY 2015. There is no small business rate for the 
annual establishment registration fee; all establishments pay the same 
fee.
    Table 5 summarizes the FY 2015 rates for all medical device fees.

[[Page 44181]]



                                    Table 5--Medical Device Fees for FY 2015
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                                                  Standard fee (as a percent of
                                                the standard fee for a premarket      FY 2015      FY 2015 small
                                                          application)             standard fee    business fee
----------------------------------------------------------------------------------------------------------------
Application fee type:
    Premarket application (a PMA submitted      Base fee adjusted as specified          $250,895         $62,724
     under section 515(c)(1) of the FD&C Act     in the statute.
     (21 U.S.C. 360e(c)(1)), a PDP submitted
     under section 515(f) of the FD&C Act (21
     U.S.C. 360e(f)), or a BLA submitted under
     section 351 of the Public Health Service
     Act (the PHS Act) (42 U.S.C. 262)).
    Premarket report (submitted under section   100%............................        $250,895         $62,724
     515(c)(2) of the FD&C Act).
    Efficacy supplement (to an approved BLA     100%............................        $250,895         $62,724
     under section 351 of the PHS Act).
    Panel-track supplement....................  75%.............................        $188,171         $47,043
    180-day supplement........................  15%.............................         $37,634          $9,409
    Real-time supplement......................  7%..............................         $17,563          $4,391
    510(k) premarket notification submission..  2%..............................          $5,018          $2,509
    30-day notice.............................  1.60%...........................          $4,014          $2,007
    513(g) (21 U.S.C. 360c(g)) request for      1.35%...........................          $3,387          $1,694
     classification information.
Annual Fee Type:
    Annual fee for periodic reporting on a      3.50%...........................          $8,781          $2,195
     class III device.
    Annual establishment registration fee (to   Base fee adjusted as specified            $3,646          $3,646
     be paid by the establishment engaged in     in the statute.
     the manufacture, preparation,
     propagation, compounding, or processing
     of a device, 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. 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 (full) fee for that submission.
    If your business qualified as a small business for FY 2014, your 
status as a small business will expire at the close of business on 
September 30, 2014. You must re-qualify for FY 2015 in order to pay 
small business fees during FY 2015.
    If you are a domestic (U.S.) business, and wish to qualify as a 
small business for FY 2015, you must submit the following to FDA:
    1. A completed FY 2015 MDUFA Small Business Qualification 
Certification (Form FDA 3602). This form is provided in FDA's guidance 
document, ``FY 2015 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 2014, 
except:
    If you submit your FY 2015 MDUFA Small Business Qualification 
before April 15, 2015, and you have not yet filed your return for 2014, 
you may use tax year 2013.
    If you submit your FY 2015 MDUFA Small Business Qualification on or 
after April 15, 2015, and have not yet filed your 2014 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 must 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 2015, you must submit the following:
    1. A completed FY 2015 MDUFA Foreign Small Business Qualification 
Certification (Form FDA 3602A). This form is provided in FDA's guidance 
document, ``FY 2015 Medical Device User Fee Small Business 
Qualification and Certification,'' available on FDA's Internet site at 
http://www.fda.gov/mdufa. 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.

[[Page 44182]]

    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 (2014 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 must 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, 2014, through September 30, 
2015, you must pay the fee in effect for FY 2015. The later of the date 
that the application is received in the reviewing center's document 
room or the date the U.S. Treasury recognizes the payment determines 
whether the fee rates for FY 2014 or FY 2015 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 below before 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. Secure a Payment Identification Number (PIN) and Medical Device User 
Fee Cover Sheet From FDA Before Submitting Either the Application or 
the Payment

    Log on to the MDUFA Web site at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/default.htm and click on 
``MDUFA FORMS'' at the left side of the page, and then under the MDUFA 
Forms heading, click on the link ``Create MDUFA 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, 2014. One choice is for applications and fees 
that will be received on or before September 30, 2014, which are 
subject to FY 2014 fee rates. A second choice is for applications and 
fees received on or after October 1, 2014, which are subject to FY 2015 
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. Electronically Transmit a Copy of the Printed Cover Sheet With the 
PIN

    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 password 
to assure data security in the creation and electronic submission of 
cover sheets.

C. Submit Payment for the Completed Medical Device User Fee Cover Sheet

    1. 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 system, for online electronic 
payment. You may make a payment via electronic check or credit card 
after submitting your cover sheet. To pay online, select the ``Pay 
Now'' button. Credit card transactions for cover sheets are limited to 
$49,999.99.
    2. 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 979033, St. Louis, MO 
63197-9000. (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, the courier may deliver 
the check to: U.S. Bank, Attn: Government Lockbox 979033, 1005 
Convention Plaza, St. Louis, MO 63101. (Note: This address is for 
courier delivery only. Contact U.S. Bank at 314-418-4013 if you have 
any questions concerning courier delivery.)
    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 may be 
delayed.
     The originating financial institution may charge a wire 
transfer fee. Please ask your financial institution about the fee and 
add it to 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, 8455 Colesville Rd., 
Silver Spring, MD 20993-0002.
    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 the U.S. Treasury recognizes the payment. It is helpful if the 
fee arrives at the bank at least 1 day before the application arrives 
at FDA.

D. 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, 10903 New Hampshire Ave., Bldg. 66, Rm. 0609, 
Silver Spring, MD 20993-0002.
    2. Biologics license applications should be sent to: Food and Drug 
Administration, Center for Biologics Evaluation and Research, Document 
Control Center, 10903 New Hampshire Ave, Bldg. 71, Rm. G112, Silver 
Spring, MD 20993-0002.

VI. Procedures for Paying the Annual Fee for Periodic Reporting

    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

[[Page 44183]]

PMA file. You are responsible to ensure your billing information is 
kept up-to-date, and you may update your contact information 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 on the check.
     Mail the paper check and a copy of invoice to: Food and 
Drug Administration, P.O. Box 979033, St. Louis, MO 63197-9000.
    (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, the courier may deliver 
the check to: U.S. Bank, Attn: Government Lockbox 979033, 1005 
Convention Plaza, St. Louis, MO 63101. (Note: This address is for 
courier delivery only. Contact the U.S. Bank at 314-418-4013 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. Please ask your financial institution about the fee and 
add it to 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 the Treasury, TREAS 
NYC, 33 Liberty St., New York, NY 10045, Acct. No. 75060099, Routing 
No. 021030004, SWIFT: FRNYUS33, Beneficiary: FDA, 8455 Colesville Rd., 
Silver Spring, MD 20993-0002.

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.) 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 
2015 until it has completed the steps below to register and pay any 
applicable fee. (See 21 U.S.C. 379j(g)(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. 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 FY 2015 store. Complete the DFUF 
order by entering the number of establishments you are registering that 
require payment. Once you are satisfied that the information in 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. Pay For Your DFUF Order

    Unless paying by credit card, all payments must be in U. S. 
currency and drawn on a U.S. bank.
    1. If paying by 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 check. 
Follow the instructions provided to make an electronic payment.
    2. If paying with a paper check:
    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 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 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 post office box number (P.O. Box 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.
    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 DFUF 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 may charge a wire transfer 
fee. Please ask your financial institution about the fee and add it to 
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, 8455 Colesville Rd., Silver Spring, MD 
20993-0002.
    FDA's tax identification number is 53-0196965.

C. Complete the Information Online To Update Your Establishment's 
Annual Registration for FY 2015, or To Register a New Establishment for 
FY 2015

    Go to the Center for Devices and Radiological Health's Web site at 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/default.htm and click the 
``Access Electronic Registration'' link on the left side 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 ``Access Electronic Registration'' link in 
the middle 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 2014. 
Manufacturers of licensed biologics 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,

[[Page 44184]]

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 choices on 
the DRLM menu. Once you choose to register or update your annual 
registration, the system will prompt you through the entry of 
information about your establishment and your devices. If you have any 
problems with this process, email: [email protected] or call 301-
796-7400 for assistance. (Note: this email 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 BERS 
should be directed to http://www.accessdata.fda.gov/scripts/email/cber/bldregcontact.cfm or call 240-402-8360.

D. 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 establishments engaged 
only in the manufacture, preparation, propagation, compounding, or 
processing of licensed biologic devices. CBER will send invoices for 
payment of the establishment registration fee to such establishments.

    Dated: July 23, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-17902 Filed 7-29-14; 8:45 am]
BILLING CODE 4164-01-P