[Federal Register Volume 81, Number 146 (Friday, July 29, 2016)]
[Notices]
[Pages 49987-49993]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-17903]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0007]


Medical Device User Fee Rates for Fiscal Year 2017

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) 2017. 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 2017, which apply from October 1, 2016, through 
September 30, 2017. To avoid delay in the review of your application, 
you should pay the application 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 2017, you should 
not submit a FY 2017 Small Business Qualification and Certification 
request. This document provides information on how the fees for FY 2017 
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/ForIndustry/UserFees/MedicalDeviceUserFee/ucm20081521.htm.
    For questions relating to this notice: Maurille Beheton, Office of 
Financial Management, Food and Drug Administration, 8455 Colesville Rd. 
(COLE-14202C), Silver Spring, MD 20993-0002, 301-796-4689.

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 2017 is 
$268,443. From this starting point, this document establishes FY 2017 
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 2017 is $3,872. 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 2017

    The total revenue amount for FY 2017 is $130,184,348, as set forth 
in the statute prior to the inflation adjustment and offset of excess 
collections (see 21 U.S.C. 379j(b)(3)). MDUFA directs FDA to use the 
yearly total revenue amount as a starting point to set the standard fee 
rates for each fee type. The fee calculations for FY 2017 are described 
in this document.

A. Inflation Adjustment

    MDUFA specifies that the $130,184,348 is to be adjusted for 
inflation increases for FY 2017 using two separate adjustments--one for 
payroll costs and one for non-pay cost (see 21 U.S.C. 379j(c)(2)). The 
base inflation adjustment for FY 2017 is the sum of one plus these two 
separate adjustments, and is compounded as specified (see 21 U.S.C. 
379j(c)(2)(C)(1) and 379j(c)(2)(B)(ii)).
    The component of the inflation adjustment for payroll costs is 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)).
    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 2017. 
The 3-year average is 1.8759 percent (rounded).

                                 Table 1--FDA PC&Bs Each Year and Percent Change
----------------------------------------------------------------------------------------------------------------
                                                                                                      3-Year
              Fiscal Year                       2013               2014               2015            average
----------------------------------------------------------------------------------------------------------------
Total PC&B.............................     $1,927,703,000     $2,054,937,000     $2,232,304,000  ..............
Total FTE..............................             13,974             14,555             15,484  ..............
PC&B per FTE...........................           $137,949           $141,184           $144,168  ..............
Percent change from previous year......            1.1690%            2.3451%            2.1136%         1.8759%
----------------------------------------------------------------------------------------------------------------


[[Page 49988]]

    The payroll adjustment is 1.8759 percent multiplied by 60 percent, 
or 1.1255 percent.
    The statute specifies that the component of the inflation 
adjustment for non-payroll costs for FY 2017 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
----------------------------------------------------------------------------------------------------------------
                                                                                                      3-Year
                   Fiscal year                         2013            2014            2015           average
----------------------------------------------------------------------------------------------------------------
Annual CPI......................................         152.500         154.847         155.353  ..............
Annual Percent Change...........................         1.5232%         1.5390%         0.3268%  ..............
3-Year Avg. Percent Change in CPI...............  ..............  ..............  ..............         1.1297%
----------------------------------------------------------------------------------------------------------------

    The non-pay adjustment is 1.1297 percent multiplied by 40 percent, 
or 0.4519 percent.
    Next, the payroll adjustment (1.1255 percent or 0.011255) is added 
to the non-pay adjustment (0.4519 percent or 0.004519), for a total of 
1.5774 percent (or 0.015774). To complete the inflation adjustment, 1 
(100 percent or 1.0) is added for a total base inflation adjustment of 
1.015774 for FY 2017.
    MDUFA III provides for this inflation adjustment to be compounded 
for FY 2015 and each subsequent fiscal year (see 21 U.S.C. 
379j(c)(2)(B)(ii)). The base inflation adjustment for FY 2017 
(1.015774) is compounded by multiplying it by the compounded applicable 
inflation adjustment for FY 2016 (1.064457), as published in the 
Federal Register of August 3, 2015 (80 FR 46033 to 46039), to reach the 
applicable inflation adjustment of 1.081248 (rounded) (1.015774 times 
1.064457) for FY 2017. We then multiply the total revenue amount for FY 
2017 ($130,184,348) by 1.081248, yielding an inflation adjusted total 
revenue amount of $140,762,000 (rounded to the nearest thousand 
dollars).

 B. Offset for Excess Collections Through FY 2016

    Under the offset provision of the FD&C Act (see section 738(i)(4) 
(21 U.S.C. 379j(i)(4))), if the cumulative amount of fees collected 
during FY 2013 through FY 2015, added to the amount estimated to be 
collected for FY 2016, exceeds the cumulative amount appropriated for 
these four FYs, the excess shall be credited to the appropriation 
account of the Food and Drug Administration and shall be subtracted 
from the amount of fees that would otherwise be authorized to be 
collected for FY 2017. Table 3 presents the amount of MDUFA fees 
collected during FY 2013 through FY 2015 (actuals), and the amount 
estimated to be collected for FY 2016, and compares those amounts with 
the fees specified to be appropriated in these four FYs.

          Table 3--Statement of Fees Appropriated, Fees Collected, and Differences as of June 30, 2016
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                                                          Fee
                    Fiscal year                      appropriated   Fees collected    Difference
--------------------------------------------------------------------------------------------------
2013 Actual.......................................     $97,722,000    $103,991,182      $6,269,182
2014 Actual.......................................     114,833,000     124,297,628       9,464,628
2015 Actual.......................................     128,282,000     139,712,238      11,430,238
2016 Estimate.....................................     134,667,000     134,667,000               0
                                                   -------------------------------------------------------------
    Total.........................................     478,504,000     505,668,048      27,164,048
Unearned Revenue Included in Above Amount.........  ..............  ..............      12,485,897
Excess Collections Less Unearned Revenue (Offset    ..............  ..............      14,678,151
 Amount)..........................................
----------------------------------------------------------------------------------------------------------------

    The total amount FDA expects to have collected in excess of 
appropriations by the end of FY 2016 is $27,164,048. However, of that 
amount, a total of $12,485,897 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, $14,678,151, 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 
2017.
    For FY 2017, the statute authorizes $140,762,000 in user fees. In 
order to determine the revised collection amount, we deduct the net 
excess collection amount of $14,678,151 from $140,762,000, and the 
revised revenue target for FY 2017 becomes $126,083,000 (rounded down 
to the nearest thousand dollars).

III. Fees for FY 2017

    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)). Table 4 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 2017. Most of the fee paying submission counts are 
published in the MDUFA Financial Report to Congress each year.

[[Page 49989]]



                                Table 4--3-Year Average of Fee Paying Submissions
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                                                      FY 2013         FY 2014         FY 2015         3-Year
                Application type                      actual          actual          actual          average
----------------------------------------------------------------------------------------------------------------
Full Fee Applications...........................              23              25              42              30
    Small Business..............................               9               5               7               7
Panel-Track Supplement..........................              19              12              22              18
    Small Business..............................               0               3               3               2
180-Day Supplements.............................             128             122             143             131
    Small Business..............................              21              24              15              20
Real-Time Supplements...........................             182             192             204             193
    Small Business..............................              23              19              28              23
510(k)s.........................................           3,149           3,034           2,768           2,984
    Small Business..............................           1,202           1,037           1,037           1,092
30-Day Notice...................................             956             934             920             937
    Small Business..............................              69              91              71              77
513(g) (21 U.S.C. 360c(g)) Request for                        65              69              75              70
 Classification Information.....................
    Small Business..............................              38              31              33              34
Annual Fee for Periodic Reporting \1\...........             614             514             544             557
    Small Business \1\..........................              54              56              68              59
Establishment Registration \2\..................          23,477          24,026          25,363          24,289
----------------------------------------------------------------------------------------------------------------
\1\ Includes collection of quarter 4 billing for FY 2015 during FY 2016.
\2\ Establishment Registration total comes from the registration system and will vary from the financial report.

    The information in table 4 is necessary to estimate the amount of 
revenue that will be collected based on the fee amounts. Table 5 
displays both the estimated revenue using the FY 2017 base fees set in 
statute and the estimated revenue after the inflation adjustment and 
offset of excess collections to the FY 2017 base fees. Using the fees 
set in statute and the 3 year averages of fee paying submissions, the 
collections would total $144,335,998, which is $18,252,998 higher than 
the statutory revenue limit. Accordingly the PMA and establishment fee 
need to be decreased so that collections come as close to the statutory 
revenue limit of $126,083,000 as possible without exceeding the limit. 
This is done by calculating the percentage difference between the 
statutory revenue limit and the estimated resulting 2017 revenue 
collections, and then lowering the fees proportionally by that 
percentage (rounded to the nearest dollar). The fees in the second 
column from the right are those we are establishing in FY 2017, which 
are the standard fees.

                           Table 5--Fees Needed To Achieve New FY 2017 Revenue Target
----------------------------------------------------------------------------------------------------------------
                                                                                    Adjusted FY
                                                      FY 2017                      2017 fees to
                                                     Statutory       Estimated     meet revenue       FY 2017
                Application type                    fees  (base      resulting        target       Revenue from
                                                       fees)       2017  revenue     (standard     adjusted fees
                                                                                       fees)
----------------------------------------------------------------------------------------------------------------
Full Fee Applications...........................        $268,443      $8,053,290        $234,495      $7,034,850
    Small Business..............................          67,111         469,777          58,624         410,368
Panel-Track Supplement..........................         201,332       3,623,976         175,871       3,165,678
    Small Business..............................          50,333         100,666          43,968          87,936
180-Day Supplements.............................          40,266       5,274,846          35,174       4,607,794
    Small Business..............................          10,067         201,340           8,794         175,880
Real-Time Supplements...........................          18,791       3,626,663          16,415       3,168,095
    Small Business..............................           4,698         108,054           4,104          94,392
510(k)s.........................................           5,369      16,021,096           4,690      13,994,960
    Small Business..............................           2,685       2,932,020           2,345       2,560,740
30-Day Notice...................................           4,295       4,024,415           3,752       3,515,624
    Small Business..............................           2,148         165,396           1,876         144,452
513(g) Request for Classification Information...           3,624         253,680           3,166         221,620
    Small Business..............................           1,812          61,608           1,583          53,822
Annual Fee for Periodic Reporting...............           9,396       5,233,572           8,207       4,571,299
    Small Business..............................           2,349         138,591           2,052         121,068
Establishment Registration......................           3,872      94,047,008           3,382      82,145,398
                                                 ---------------------------------------------------------------
    Total.......................................  ..............     144,335,998  ..............     126,073,976
----------------------------------------------------------------------------------------------------------------

    The standard fee (adjusted base amount) for a premarket 
application, including a BLA, and for a premarket report and a BLA 
efficacy supplement, is $234,495 for FY 2017. 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;

[[Page 49990]]

     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 $3,382 for FY 2017. There is no small business rate for the 
annual establishment registration fee; all establishments pay the same 
fee.
    Table 6 summarizes the FY 2017 rates for all medical device fees.

                                    Table 6--Medical Device Fees for FY 2017
----------------------------------------------------------------------------------------------------------------
                                                 Standard fee  (as a percent of
             Application fee type                    the standard fee  for a          FY 2017      FY 2017 Small
                                                     premarket application)        Standard fee    business fee
----------------------------------------------------------------------------------------------------------------
Premarket application (a PMA submitted under    Base fee specified in statute at        $234,495         $58,624
 section 515(c)(1) of the FD&C Act (21 U.S.C.    $268,443, but multiplied by
 360e(c)(1)), a PDP submitted under section      87.3538 percent.
 515(f) of the FD&C Act, 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.............................         234,495          58,624
 515(c)(2) of the FD&C Act).
Efficacy supplement (to an approved BLA under   100.............................         234,495          58,624
 section 351 of the PHS Act).
Panel-track supplement........................  75..............................         175,871          43,968
180-day supplement............................  15..............................          35,174           8,794
Real-time supplement..........................  7...............................          16,415           4,104
510(k) premarket notification submission......  2...............................           4,690           2,345
30-day notice.................................  1.60............................           3,752           1,876
513(g) request for classification information.  1.35............................           3,166           1,583
Annual Fee Type:
    Annual fee for periodic reporting on a      3.50............................           8,207           2,052
     class III device.
    Annual establishment registration fee (to   Base fee specified in statute at           3,382           3,382
     be paid by the establishment engaged in     $3,872, but multiplied by
     the manufacture, preparation,               87.3538 percent.
     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. FDA will 
review your information and determine whether you qualify as a small 
business eligible for the reduced fee and/or fee waiver. 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 2016, your 
status as a small business will expire at the close of business on 
September 30, 2016. You must re-qualify for FY 2017 in order to pay 
small business fees during FY 2017.
    If you are a domestic (U.S.) business, and wish to qualify as a 
small business for FY 2017, you must submit the following to FDA:
    1. A completed FY 2017 MDUFA Small Business Qualification 
Certification (Form FDA 3602). This form is provided in FDA's guidance 
document, ``FY 2017 Medical Device User Fee Small Business 
Qualification and Certification,'' available on FDA's Web site at 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm.
    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 2016, 
except:
    If you submit your FY 2017 MDUFA Small Business Qualification 
before April 15, 2017, and you have not yet filed your return for 2016, 
you may use tax year 2015.
    If you submit your FY 2017 MDUFA Small Business Qualification on or 
after April 15, 2017, and have not yet filed your 2016 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

[[Page 49991]]

affiliate, or that the applicant has no affiliates.
    If you are a foreign business, and wish to qualify as a small 
business for FY 2017, you must submit the following:
    1. A completed FY 2017 MDUFA Foreign Small Business Qualification 
Certification (Form FDA 3602A). This form is provided in FDA's guidance 
document, ``FY 2017 Medical Device User Fee Small Business 
Qualification and Certification,'' available on FDA's Internet site at 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm.
    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 (2016 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 between October 1, 2016, and September 30, 
2017, you must pay the fee in effect for FY 2017. 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 2016 or FY 2017 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: Do not send your user fee 
check 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 into the User Fee System at: https://userfees.fda.gov/OA_HTML/mdufmaCAcdLogin.jsp. 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, 2016. One choice is for 
applications and fees that will be received on or before September 30, 
2016, which are subject to FY 2016 fee rates. A second choice is for 
applications and fees received on or after October 1, 2016, which are 
subject to FY 2017 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

    When you are satisfied that the data on the cover sheet is 
accurate, electronically transmit that data to FDA according to 
instructions on the screen. 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. The preferred payment method is online using electronic check 
(Automated Clearing House (ACH) also known as eCheck) or credit card 
(Discover, VISA, MasterCard, American Express). 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. 
Secure electronic payments can be submitted using the User Fees Payment 
Portal at https://userfees.fda.gov/pay. Once you search for your 
invoice, click ``Pay Now'' to be redirected to Pay.gov. Note that 
electronic payment options are based on the balance due. Payment by 
credit card is available for balances less than $25,000. If the balance 
exceeds this amount, only the ACH option is available. Payments must be 
drawn on U.S bank accounts as well as U.S. credit cards.
    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. (If needed, FDA's 
tax identification number is 53-0196965.)
     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 U.S. Bank address is 
for courier delivery only. If you have any questions concerning courier 
delivery contact the U.S. Bank at 314-418-4013. This telephone number 
is only for questions about 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. 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: 
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 Road, 14th Floor, 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

[[Page 49992]]

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 Control Center, 10903 New Hampshire Ave., Building 66, Rm. 
0609, Silver Spring, MD 20993-0002.
    2. Biologics license applications and other medical device 
submissions reviewed by the Center for Biologics Evaluation and 
Research should be sent to: Food and Drug Administration, Center for 
Biologics Evaluation and Research, Document Control Center, 10903 New 
Hampshire Ave, Building 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 PMA file. You are responsible for ensuring FDA has 
your current billing information, and you may update your contact 
information for the PMA by submitting an amendment to the PMA.
    1. The preferred payment method is online using electronic check 
(Automated Clearing House (ACH) also known as eCheck) or credit card 
(Discover, VISA, MasterCard, American Express). Secure electronic 
payments can be submitted using the User Fees Payment Portal at https://userfees.fda.gov/pay. Once you search for your invoice, click ``Pay 
Now'' to be redirected to Pay.gov. Note that electronic payment options 
are based on the balance due. Payment by credit card is available for 
balances less than $25,000. If the balance exceeds this amount, only 
the ACH option is available. Payments must be drawn on U.S bank 
accounts as well as U.S. credit cards.
    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. (If needed, FDA's tax 
identification number is 53-0196965,)
     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 U.S. Bank address is 
for courier delivery only. If you have any questions concerning courier 
delivery contact the U.S. Bank at 314-418-4013. This telephone number 
is only for questions about courier delivery).
    3. 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. 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: 
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., 14th Floor, Silver Spring, MD 
20993-0002.

VII. Procedures for Paying Annual Establishment Fees

    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 address after 
this document publishes in the Federal Register.) Create a DFUF order 
and you will be issued a PIN when 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 2017 
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 2016 store. Complete the DFUF 
order by entering the number of establishments you are registering that 
require payment. When 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 or eCheck):
    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. If you have any questions 
concerning courier delivery contact the U.S. Bank at 314-418-4013. This 
telephone number is only for questions about courier delivery).
    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. Include a copy of your printed order 
when you mail 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 (in the upper right-hand corner of 
your

[[Page 49993]]

completed DFUF order) in your wire transfer. Without the PIN, your 
payment may not be applied to your facility and your registration may 
be delayed.
    The originating financial institution may charge a wire transfer 
fee. 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: 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., 14th Floor, Silver Spring, MD 20993-0002. (If 
needed, FDA's tax identification number is 53-0196965.)

C. Complete the Information Online To Update Your Establishment's 
Annual Registration for FY 2017, or To Register a New Establishment for 
FY 2017

    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 2016. 
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. When 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; they are not to be used for questions 
related to 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 25, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-17903 Filed 7-28-16; 8:45 am]
 BILLING CODE 4164-01-P