[Federal Register Volume 78, Number 149 (Friday, August 2, 2013)]
[Notices]
[Pages 46970-46976]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-18623]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0007]


Medical Device User Fee Rates for Fiscal Year 2014

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) 2014. The Federal Food, Drug, and Cosmetic Act (the FD&C 
Act), as amended by the Medical Device User Fee Amendments of 2012, 
which was signed by the President on July 9, 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. The FY 2014 fee rates are 
provided in this document. These fees apply from October 1, 2013, 
through September 30, 2014. 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 recognized by the U.S. Treasury. 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 2014 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 (HFA-100), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 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 2014 is 
$252,960. From this starting point, this document establishes FY 2014 
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 2014 is $3,200. 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.

II. Revenue Amount for FY 2014

    The base revenue amount for FY 2014 is $112,580,497, as set forth 
in the statute prior to the inflation adjustment. MDUFA directs FDA to 
use the yearly revenue amount as a starting point to set the fee rates 
for each fee type. The fee calculations for FY 2014 are described in 
this document.

[[Page 46971]]

Inflation Adjustment

    MDUFA specifies that the $112,580,497 is to be further adjusted for 
inflation increases for FY 2014 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 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 .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 that 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 2014. 
The 3-year average is 2.05 percent.

                                Table 1--FDA PC&B's Each Year and Percent Change
----------------------------------------------------------------------------------------------------------------
             Fiscal year                     2010               2011               2012          3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B..........................     $1,634,108,000     $1,761,655,000     $1,824,703,000  .................
Total FTE...........................             12,526             13,331             13,382  .................
PC&B per FTE........................           $130,457           $132,147           $136,355  .................
Percent change from previous year...              1.67%              1.30%              3.18%              2.05%
----------------------------------------------------------------------------------------------------------------

    The payroll adjustment is 2.05 percent multiplied by 60 percent, or 
1.23 percent.
    The statute specifies that the portion of the inflation adjustment 
for non-payroll costs for FY 2014 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 .40, or 40 percent (see 21 U.S.C. 379j(c)(2)(C)).
    Table 2 provides the summary data for the 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
----------------------------------------------------------------------------------------------------------------
                Year                         2010               2011               2012          3-Year average
----------------------------------------------------------------------------------------------------------------
Annual CPI..........................            142.218            146.975            150.212  .................
Annual percent change...............              1.72%              3.34%              2.20%              2.42%
----------------------------------------------------------------------------------------------------------------

    The non-pay adjustment is 2.42 percent times 40 percent, or .968 
percent.
    To complete the inflation adjustment, the payroll component (1.230 
percent) is added to the non-pay component (0.968 percent), for a total 
inflation adjustment of 2.198 percent (rounded), and then one is added, 
making 1.02198. The base revenue amount for FY 2014 ($112,580,497) is 
then multiplied by 1.02198, yielding an inflation adjusted amount of 
$115,055,000 (rounded to the nearest thousand dollars).

III. Fees for FY 2014

    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 2014, 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. These numbers are used to project the fee 
paying submission that FDA will receive in FY 2014. The fee paying 
submission counts are published in the Agency's MDUFA Financial Report 
to Congress each year.

                                Table 3--3-Year Average of Fee Paying Submissions
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                Application type                  FY 2010 actual  FY 2011 actual  FY 2012 actual  3-Year average
----------------------------------------------------------------------------------------------------------------
Full Fee Applications...........................              32              24              25              27
    Small Business..............................               8               7               6               7
Panel Track Supplement..........................              11               7              12              10
    Small Business..............................               2               1               0               1
180-Day Supplements.............................             103              92             145             113
    Small Business..............................              20              15              21              19
Real-Time Supplements...........................             146             145             196             162
    Small Business..............................              20              17              22              20
510(k)s.........................................           2,367           2,398           2,865           2,543
    Small Business..............................           1,032             938           1,086           1,019
30-Day Notice...................................             669             755             801             742
    Small Business..............................              78              67              60              68
513(g) Request for Classification Information...              56              40              46              47
    Small Business..............................              25              35              30              30
Annual Fee for Periodic Reporting...............             427             466             478             457
    Small Business..............................              78              78              39              65

[[Page 46972]]

 
Establishment Registration \1\ *................  ..............  ..............  ..............          22,500
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\1\ Estimate for establishment registration based on preliminary FY 2013 numbers because the criteria for this
  fee changed beginning in FY 2013.

    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 2014 base fees set in 
statute and the estimated revenue adding the inflation adjustment to 
the FY 2014 base fees. The increases to the base fees are needed in 
order to collect the new revenue target of $115,055,000.

                           Table 4--Fees Needed To Achieve New FY 2014 Revenue Target
----------------------------------------------------------------------------------------------------------------
                                                                                    Adjusted FY
                Application type                   FY 2014 base      Estimated       2014 fees       Adjusted
                                                       fees           revenue     (standard fee)      revenue
----------------------------------------------------------------------------------------------------------------
Full Fee Applications...........................        $252,960      $6,829,920        $258,520      $6,980,040
    Small Business..............................          63,240         442,680          64,630         452,410
Panel-Track Supplement..........................         189,720       1,897,200         193,890       1,938,900
    Small Business..............................          47,430          47,430          48,473          48,473
180-Day Supplements.............................          37,944       4,287,672          38,778       4,381,914
    Small Business..............................           9,486         180,234           9,695         184,205
Real-Time Supplements...........................          17,707       2,868,566          18,096       2,931,552
    Small Business..............................           4,427          88,536           4,524          90,480
510(k)s.........................................           5,059      12,865,546           5,170      13,147,310
    Small Business..............................           2,530       2,577,662           2,585       2,634,115
30-Day Notice...................................           4,047       3,003,141           4,136       3,068,912
    Small Business..............................           2,024         137,610           2,068         140,624
513(g) Request for Classification Information...           3,415         160,503           3,490         164,030
    Small Business..............................           1,707          51,224           1,745          52,350
Annual Fee for Periodic Reporting...............           8,854       4,046,095           9,048       4,134,936
    Small Business..............................           2,213         143,871           2,262         147,030
Establishment Registration......................           3,200      72,000,000           3,313      74,542,500
                                                 ---------------------------------------------------------------
    Total.......................................  ..............     111,627,891  ..............     115,039,781
----------------------------------------------------------------------------------------------------------------

    The PMA and establishment registration fees were increased over the 
base by the inflation adjustment (2.198%) as determined earlier in this 
document. An additional $43 (rounded to the nearest whole dollar) was 
added to the establishment registration fee in order to collect the 
shortfall in revenue that resulted. This was done because the statute 
directs that, after the inflation adjustment is made, the base 
establishment registration fee amounts shall be further adjusted, as 
necessary, for total fee collections to achieve the total revenue 
amount specified after inflation adjustment (see 21 U.S.C. 379j(c)(3)). 
Without this additional adjustment to the establishment registration 
fee, the total collections would fall almost $1 million below the total 
specified revenue after adjustment for inflation.
    The standard fee (adjusted base amount) for a premarket 
application, including a BLA, and for a premarket report and a BLA 
efficacy supplement, is $258,520 for FY 2014. 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 30-day notice, 1.6 percent of the standard fee;
     For a 510(k) premarket notification, 2 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 $3,313 for FY 2014. There is no small business rate for the 
annual establishment registration fee; all establishments pay the same 
fee.
    Table 5 sets out the FY 2014 rates for all medical device fees.

                                    Table 5--Medical Device Fees for FY 2014
----------------------------------------------------------------------------------------------------------------
                                                  Standard fee (as a percent of
                                                the standard fee for a premarket      FY 2014      FY 2014 Small
                                                          application)             Standard fee    Business fee
----------------------------------------------------------------------------------------------------------------
Application Fee Type:

[[Page 46973]]

 
    Premarket application (a PMA submitted      Base Fee Adjusted as Specified          $258,520         $64,630
     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%............................         258,520          64,630
     515(c)(2) of the FD&C Act).
    Efficacy supplement (to an approved BLA     100%............................         258,520          64,630
     under section 351 of the PHS Act).
    Panel-track supplement....................  75%.............................         193,890          48,473
    180-day supplement........................  15%.............................          38,778           9,695
    Real-time supplement......................  7%..............................          18,096           4,524
    510(k) premarket notification submission..  2%..............................           5,170           2,585
    30-day notice.............................  1.6%............................           4,136           2,068
    513(g) (21 U.S.C. 360c(g)) request for      1.35%...........................           3,490           1,745
     classification information.
Annual Fee Type:                                ................................  ..............  ..............
    Annual fee for periodic reporting on a      3.5%............................           9,048           2,262
     class III device.
    Annual establishment registration fee (to   Base Fee Adjusted as Specified             3,313           3,313
     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 2013, your 
status as a small business will expire at the close of business on 
September 30, 2013. You must re-qualify for FY 2014 in order to pay 
small business fees during FY 2014.
    If you are a domestic (U.S.) business, and wish to qualify as a 
small business for FY 2014, you must submit the following to FDA:
    1. A completed FY 2014 MDUFA Small Business Qualification 
Certification (Form FDA 3602). This form is provided in FDA's guidance 
document, ``FY 2014 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 2013, 
except:
    If you submit your FY 2014 MDUFA Small Business Qualification 
before April 15, 2014, and you have not yet filed your return for 2013, 
you may use tax year 2012.
    If you submit your FY 2014 MDUFA Small Business Qualification on or 
after April 15, 2014, and have not yet filed your 2013 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 2014, you must submit the following:
    1. A completed FY 2014 MDUFA Foreign Small Business Qualification 
Certification (Form FDA 3602A). This form is provided in FDA's guidance 
document, ``FY 2014 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

[[Page 46974]]

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 (2013 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, 2013, through September 30, 
2014, you must pay the fee in effect for FY 2014. 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 2013 or FY 2014 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. 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

    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, 2013. One choice is for applications and fees 
that will be received on or before September 30, 2013, which are 
subject to FY 2013 fee rates. A second choice is for applications and 
fees received on or after October 1, 2013, which are subject to FY 2014 
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 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 314-418-4013 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 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.
    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 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.
    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, 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

[[Page 46975]]

Radiological Health, Document Mail Center, Bldg. 66, 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 MDUFA 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 is 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 on the check.
     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 FedEx, DHL, 
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 314-418-4013 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, 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://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 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 2014 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. 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 FY 2014 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 are 
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 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:
    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 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. 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 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, 1350 Piccard Dr., Rockville, MD 20850.

C. Step Three--Complete the Information Online To Update Your 
Establishment's Annual Registration for FY 2014, or To Register a New 
Establishment for FY 2014

    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 of the page. This 
opens up a new

[[Page 46976]]

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 2013. 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, 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 
[email protected] or call 301-827-3546.

D. Step Four--Enter Your DFUF Order PIN and PCN

    After completing your annual or initial registration and device 
listing, you will be prompted to enter your DFUF order PIN and PCN, 
when applicable. This process does not apply to 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 29, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-18623 Filed 8-1-13; 8:45 am]
BILLING CODE 4160-01-P