[Federal Register Volume 83, Number 146 (Monday, July 30, 2018)]
[Notices]
[Pages 36598-36604]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16178]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0007]


Medical Device User Fee Rates for Fiscal Year 2019

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) 2019. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as 
amended by the Medical Device User Fee Amendments of 2017 (MDUFA IV), 
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 2019, which apply from October 1, 2018, through September 
30, 2019. 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 2019, you should not submit a 
Small Business Certification Request. This document provides 
information on how the fees for FY 2019 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 website 
at: https://www.fda.gov/ForIndustry/UserFees/MedicalDeviceUserFee/ucm20081521.htm.
    For questions relating to the MDUFA Small Business Program, please 
visit CDRH's website: https://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/ucm577696.htm.
    For questions relating to this notice: David Haas, Office of 
Financial Management, Food and Drug Administration, 8455 Colesville Rd. 
(COLE-14202I), Silver Spring, MD 20993-0002, 240-402-9845.

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, notices, 
and requests (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)).
    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 2018 through FY 2022; the 
base fee for a premarket application received by FDA during FY 2019 is 
$300,000. From this starting point, this document establishes FY 2019 
fee rates for certain 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 2018 through FY 2022; the base fee for an 
establishment registration in FY 2019 is $4,548. There is no reduction 
in the registration fee for small businesses. Each establishment that 
is registered (or is required to register) with the Secretary of Health 
and Human Services 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 2019

    The total revenue amount for FY 2019 is $190,654,875, as set forth 
in the statute prior to the inflation adjustment (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 2019 are described in this document.

Inflation Adjustment

    MDUFA specifies that the $190,654,875 is to be adjusted for 
inflation increases for FY 2019 using two separate adjustments--one for 
payroll costs and one for non-payroll costs (see 21 U.S.C. 379j(c)(2)). 
The base inflation adjustment for FY 2019 is the sum of one plus these 
two separate adjustments, and is compounded as specified in the statute 
(see 21 U.S.C. 379j(c)(2)(C) and 379j(c)(2)(B)).
    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 2019. 
The 3-year average is 2.4152 percent (rounded).

                                 Table 1--FDA PC&Bs Each Year and Percent Change
----------------------------------------------------------------------------------------------------------------
                 Fiscal year                        2015             2016             2017        3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B..................................   $2,232,304,000   $2,414,728,159   $2,581,551,000  ...............

[[Page 36599]]

 
Total FTE...................................           15,484           16,381           17,022  ...............
PC&B per FTE................................         $144,168         $147,408         $151,660  ...............
Percent change from previous year...........           2.1136           2.2474           2.8845           2.4152
----------------------------------------------------------------------------------------------------------------

    The payroll adjustment is 2.4152 percent multiplied by 60 percent, 
or 1.4491 percent.
    The statute specifies that the component of the inflation 
adjustment for non-payroll costs for FY 2019 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. These 
data are published by the Bureau of Labor Statistics and can be found 
on their website at: https://data.bls.gov/pdq/SurveyOutputServlet?data_tool=dropmap&series_id=CUURA311SA0,CUUSA311SA0.


               Table 2--Annual and 3-Year Average Percent Change in Baltimore-Washington Area CPI
----------------------------------------------------------------------------------------------------------------
                 Fiscal year                        2015             2016             2017        3-Year average
----------------------------------------------------------------------------------------------------------------
Annual CPI..................................          155.353          157.180          159.202  ...............
Annual Percent Change.......................           0.3268           1.1760           1.2864  ...............
3-Year Average Percent Change in CPI........  ...............  ...............  ...............           0.9297
----------------------------------------------------------------------------------------------------------------

    The non-pay adjustment is 0.9297 percent multiplied by 40 percent, 
or 0.3719 percent.
    Next, the payroll adjustment (1.4491 percent or 0.014491) is added 
to the non-payroll adjustment (0.3719 percent or 0.003719), for a total 
of 1.8210 percent (or 0.018210). To complete the inflation adjustment, 
1 (100 percent or 1.0) is added for a total base inflation adjustment 
of 1.018210 for FY 2019.
    MDUFA IV provides for this inflation adjustment to be compounded 
for FY 2019 and each subsequent fiscal year (see 21 U.S.C. 
379j(c)(2)(B)(ii)). The base inflation adjustment for FY 2019 
(1.018210) is compounded by multiplying it by the compounded applicable 
inflation factor from FY 2018 (1.054618). To complete the compounded 
inflation adjustment for FY 2019, the FY 2018 compounded adjustment 
(1.054618) is multiplied by the FY 2019 base inflation adjustment 
(1.018210) to reach the applicable inflation adjustment of 1.073823 
(rounded) for FY 2019. We then multiply the total revenue amount for FY 
2019 ($190,654,875) by 1.073823, yielding an inflation adjusted total 
revenue amount of $204,730,000 (rounded to the nearest thousand 
dollars).

III. Fees for FY 2019

    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)).

A. Inflation Adjustment

    MDUFA specifies that the base fees of $300,000 (premarket 
application) and $4,548 (establishment registration) are to be adjusted 
for FY 2019 using the same methodology as that for the total revenue 
inflation adjustment in section II (see 21 U.S.C. 379j(c)(2)(D)(i)). 
Multiplying the base fees by the compounded inflation adjustment of 
1.073823 yields inflation adjusted base fees of $322,147 (premarket 
application) and $4,884 (establishment registration).

B. Further Adjustments

    After the applicable inflation adjustment to fees is done, FDA may 
increase, if necessary to achieve the inflation adjusted total revenue 
amount, the base fee amounts on a uniform proportionate basis (see 21 
U.S.C. 379j(c)(2)(D)(ii)). If necessary after this adjustment, FDA may 
further increase the base establishment registration fees to generate 
the inflation adjusted total revenue amount (see 21 U.S.C. 379j(c)(3)).

C. Calculation of Fee Rates

    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 2019. Most of the 
fee-paying submission counts are published in the MDUFA Financial 
Report to Congress each year.

                              Table 3--Three-Year Average of Fee-Paying Submissions
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        Application type            FY 2015 actual      FY 2016 actual      FY 2017 actual      3-Year average
----------------------------------------------------------------------------------------------------------------
Full Fee Applications...........                  42                  37                  40                  40
    Small Business..............                   7                  10                   7                   8
Panel-Track Supplement..........                  22                  17                  27                  22
    Small Business..............                   3                   1                   2                   2
De Novo Classification Request    ..................  ..................                  24                  24
 \1\............................
    Small Business \1\..........  ..................  ..................                  31                  31
180-Day Supplements.............                 143                 116                 184                 148
    Small Business..............                  15                  16                  36                  22
Real-Time Supplements...........                 204                 179                 195                 193
    Small Business..............                  28                  27                  20                  25
510(k)s.........................               2,768               2,599               3,141               2,836
    Small Business..............               1,037               1,005               1,125               1,056

[[Page 36600]]

 
30-Day Notice...................                 920                 929               1,080                 976
    Small Business..............                  71                  76                  82                  76
513(g) (21 U.S.C. 360c(g))                        75                  68                  98                  80
 Request for Classification
 Information....................
    Small Business..............                  33                  46                  41                  40
Annual Fee for Periodic                          554                 582                 429                 522
 Reporting \2\..................
    Small Business \2\..........                  73                  75                  37                  62
Establishment Registration......              25,363              26,046              27,268              26,226
----------------------------------------------------------------------------------------------------------------
\1\ Three-year average for De Novo is based on estimate for FY 2019.
\2\ Includes collection of quarter 4 billing for FY 2017 during FY 2018.

    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 the FY 2019 base fees set in statute (column one) and the 
inflation adjusted base fees (per calculations in section III.A.) 
(column two). Using the inflation adjusted fees and the 3-year averages 
of fee paying submissions, collections are projected to total 
$207,708,611, which is $2,978,611 higher than the inflation adjusted 
total revenue amount. The fees in column two are those we are 
establishing in FY 2019, which are the standard fees.

                           Table 4--Fees Needed to Achieve New FY 2019 Revenue Target
----------------------------------------------------------------------------------------------------------------
                                                                           FY 2019 inflation
                                                       FY 2019 statutory  adjusted statutory    FY 2019 revenue
                  Application type                     fees (base fees)        base fees      from adjusted fees
                                                                            (standard fees)
----------------------------------------------------------------------------------------------------------------
Full Fee Applications...............................            $300,000            $322,147         $12,885,880
    Small Business..................................              75,000              80,537             644,296
Panel-Track Supplement..............................             225,000             241,610           5,315,420
    Small Business..................................              56,250              60,403             120,806
De Novo Classification Request......................              90,000              96,644           2,319,456
    Small Business..................................              22,500              24,161             748,991
180-Day Supplements.................................              45,000              48,322           7,151,656
    Small Business..................................              11,250              12,081             265,782
Real-Time Supplements...............................              21,000              22,550           4,352,150
    Small Business..................................               5,250               5,638             140,950
510(k)s.............................................              10,200              10,953          31,062,708
    Small Business..................................               2,550               2,738           2,891,328
30-Day Notice.......................................               4,800               5,154           5,030,304
    Small Business..................................               2,400               2,577             195,852
513(g) Request for Classification Information.......               4,050               4,349             347,920
    Small Business..................................               2,025               2,175              87,000
Annual Fee for Periodic Reporting...................              10,500              11,275           5,885,550
    Small Business..................................               2,625               2,819             174,778
Establishment Registration..........................               4,548               4,884         128,087,784
                                                     -----------------------------------------------------------
    Total...........................................  ..................  ..................         207,708,611
----------------------------------------------------------------------------------------------------------------

    The standard fee (adjusted base amount) for a premarket 
application, including a BLA, and for a premarket report and a BLA 
efficacy supplement, is $322,147 for FY 2019. 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 de novo classification request, 30 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 an annual fee for periodic reporting concerning a 
class III device, 3.5 percent of the standard fee;
     For a 510(k) premarket notification, 3.4 percent of the 
standard fee;
     For a 30-day notice, 1.6 percent of the standard fee; and
     For a 513(g) request for classification information, 1.35 
percent of the standard fee.
    For all submissions other than 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) and (e)(2)(C)). For 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)).
    The annual fee for establishment registration, after adjustment, is 
set at $4,884 for FY 2019. There is no small business rate for the 
annual establishment registration fee; all establishments pay the same 
fee.
    Table 5 summarizes the FY 2019 rates for all medical device fees.

[[Page 36601]]



                                    Table 5--Medical Device Fees for FY 2019
----------------------------------------------------------------------------------------------------------------
                                       Standard fee (as a percent of the
         Application fee type             standard fee for a premarket     FY 2019 standard      FY 2019 small
                                                  application)                    fee            business fee
----------------------------------------------------------------------------------------------------------------
Premarket application (a PMA           Base fee specified in statute....            $322,147             $80,537
 submitted under section 515(c)(1) of
 the FD&C Act (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      100..............................             322,147              80,537
 section 515(c)(2) of the FD&C Act).
Efficacy supplement (to an approved    100..............................             322,147              80,537
 BLA under section 351 of the PHS
 Act).
Panel-track supplement...............  75...............................             241,610              60,403
De novo classification request.......  30...............................              96,644              24,161
180-day supplement...................  15...............................              48,322              12,081
Real-time supplement.................  7................................              22,550               5,638
510(k) premarket notification          3.40.............................              10,953               2,738
 submission.
30-day notice........................  1.60.............................               5,154               2,577
513(g) request for classification      1.35.............................               4,349               2,175
 information.
Annual Fee Type......................  .................................  ..................  ..................
Annual fee for periodic reporting on   3.50.............................              11,275               2,819
 a class III device.
Annual establishment registration fee  Base fee specified in statute....               4,884               4,884
 (to be paid by the establishment
 engaged in 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, including your affiliates, 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, 
including your affiliates, 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 (i.e. PMA, PDP, or BLA) or premarket 
report. 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 at least 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 2018, your 
status as a small business will expire at the close of business on 
September 30, 2018. You must re-qualify for FY 2019 in order to pay 
small business fees during FY 2019.
    If you are a domestic (U.S.) business, and wish to qualify as a 
small business for FY 2019, you must submit the following to FDA:
    1. A completed MDUFA Small Business Certification Request For a 
Business Headquartered in the U.S. (Form FDA 3602). Form FDA 3602 is 
provided in the FDA Forms database: https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM573420.pdf.
    2. A signed certified copy of your Federal (U.S.) Income Tax Return 
for the most recent tax year. The most recent tax year will be 2018, 
except:
    If you submit your MDUFA Small Business Certification Request for 
FY 2019 before April 15, 2019, and you have not yet filed your return 
for 2018, you may use tax year 2017.
    If you submit your MDUFA Small Business Certification Request for 
FY 2019 on or after April 15, 2019, and have not yet filed your 2018 
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 business must also submit a 
statement signed by the head of the business's firm or by its chief 
financial officer that the business has submitted certifications for 
all of its affiliates, identifying the name of each affiliate, or that 
the business has no affiliates.
    If you are a foreign business, and wish to qualify as a small 
business for FY 2019, you must submit the following:
    1. A completed MDUFA Foreign Small Business Certification Request 
For a Business Headquartered Outside the United States (Form FDA 
3602A). Form FDA 3602A is provided in the FDA Forms database: https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM573423.pdf.
    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 (2018 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

[[Page 36602]]

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 business must also submit a statement signed by the head 
of the business'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 business 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, 2018, and September 30, 
2019, you must pay the fee in effect for FY 2019. 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 2018 or FY 2019 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, 2018. One choice is for 
applications and fees that will be received on or before September 30, 
2018, which are subject to FY 2018 fee rates. A second choice is for 
applications and fees received on or after October 1, 2018, which are 
subject to FY 2019 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. Note: Only full payments are 
accepted. No partial payments can be made online. Once you search for 
your invoice, select ``Pay Now'' to be redirected to Pay.gov. 
Electronic payment options are based on the balance due. Payment by 
credit card is available for balances that are less than $25,000. If 
the balance exceeds this amount, only the ACH option is available. 
Payments must be made using 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 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. If the financial institution charges a wire transfer fee 
it is required that you add that amount to the payment to ensure that 
the invoice is paid in full.
    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.
    FDA records the official application receipt date as the later of 
the following: (1) The date the application was received by the FDA 
Document Control Center for the reviewing Center 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 the address located at https://www.fda.gov/cdrhsubmissionaddress.

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 pending PMA 
or a supplement to the approved PMA.
    1. The preferred payment method is online using electronic check 
(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 (Note: 
Only full payments are accepted. No partial payments can be made 
online). Once you search for your invoice, select ``Pay Now'' to be 
redirected to Pay.gov. Note that electronic payment options are based 
on the balance due. Payment by

[[Page 36603]]

credit card is available for balances that are less than $25,000. If 
the balance exceeds this amount, only the ACH option is available. 
Payments must be made using U.S. bank accounts as well as U.S. credit 
cards.
    2. If paying with a paper check:
    The check 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 the 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.)
    To send a check by a courier, the courier must deliver the check 
and printed copy of the cover sheet 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 U.S. Bank at 314-418-
4013. This telephone number is only for questions about courier 
delivery).
    3. When paying by a wire transfer it is required that the invoice 
number is included, without the invoice number the payment may not be 
applied. If the payment amount is not applied the invoice amount would 
be referred to collections. The originating financial institution may 
charge a wire transfer fee. If the financial institution charges a wire 
transfer fee it is required that you add that amount to the payment to 
ensure that the invoice is paid in full.
    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.

VII. Procedures for Paying Annual Establishment Registration Fees

    To pay the annual establishment registration fee, firms must access 
the Device Facility User Fee (DFUF) website at https://userfees.fda.gov/OA_HTML/furls.jsp. (FDA has verified the website 
address, but FDA is not responsible for any subsequent changes to the 
website 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 2019 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 website listed previously 
in this section. After creating a user name and password, log into the 
Establishment Registration User Fee FY 2019 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:
    The check must be in U.S. currency and drawn on a U.S. bank, and 
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 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 
registration 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 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. If the financial institution charges a wire transfer fee it is 
required that you add that amount to the payment to ensure that the 
invoice is paid in full. 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. If needed, FDA's tax identification number is 53-
0196965.

C. Complete the Information Online To Update Your Establishment's 
Annual Registration for FY 2019, or To Register a New Establishment for 
FY 2019

    Go to the Center for Devices and Radiological Health's website at 
https://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 2018. 
Manufacturers of licensed biologics should register in the BER system 
at https://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 36604]]

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 the BER system should be directed to 
https://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 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-16178 Filed 7-27-18; 8:45 am]
 BILLING CODE 4164-01-P