Medical Device User Fee Rates for Fiscal Year 2021, 46673-46679 [2020-16793]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 85, Number 149 (Monday, August 3, 2020)]
[Notices]
[Pages 46673-46679]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16793]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-3505]


Medical Device User Fee Rates for Fiscal Year 2021

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) 2021. 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 2021, which apply from October 1, 2020, through September 
30, 2021. 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

[[Page 46674]]

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 2021, you should not submit a Small Business Certification 
Request. This document provides information on how the fees for FY 2021 
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: https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa.
    For questions relating to the MDUFA Small Business Program, please 
visit the Center for Devices and Radiological Health's website: https://www.fda.gov/medical-devices/premarket-submissions/reduced-medical-device-user-fees-small-business-determination-sbd-program.
    For questions relating to this notice: David Haas, Office of 
Financial Management, Food and Drug Administration, 4041 Powder Mill 
Rd., Rm. 62041A, Beltsville, MD 20705, 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 2021 is 
$328,000. From this starting point, this document establishes FY 2021 
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 2021 is $4,975. 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 2021

    The total revenue amount for FY 2021 is $211,748,789, 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 2021 are described in this document.

Inflation Adjustment

    MDUFA specifies that the $211,748,789 is to be adjusted for 
inflation increases for FY 2021 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 2021 is the sum of one plus the 
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 2021. 
The 3-year average is 1.2644 percent (rounded).

                                 Table 1--FDA PC&Bs Each Year and Percent Change
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             Fiscal year                     2017               2018               2019          3-Year average
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Total PC&B..........................     $2,581,551,000     $2,690,678,000     $2,620,052,000  .................
Total FTE...........................             17,022             17,023             17,144  .................
PC&B per FTE........................           $151,660           $158,061           $152,826  .................
Percent change from previous year...             2.8845             4.2206            -3.3120             1.2644
----------------------------------------------------------------------------------------------------------------

    The payroll adjustment is 1.2644 percent multiplied by 60 percent, 
or 0.7586 percent. The statute specifies that the component of the 
inflation adjustment for non-payroll costs for FY 2021 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)). As a result of a geographical revision made by 
the Bureau of Labor and Statistics in January 2018,\1\ the 
``Washington-Baltimore, DC-MD-VA-WV'' index was discontinued and 
replaced with two separate indices (i.e., ``Washington-Arlington-
Alexandria, DC-VA-MD-WV'' and ``Baltimore-Columbia-Towson, MD''). In 
order to continue applying a CPI that best reflects the geographic 
region in which FDA is headquartered and that provides the most current 
data available, the Washington-Arlington-Alexandria index will be used 
in calculating the relevant adjustment factors for FY 2021 and 
subsequent years.
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    \1\ The Bureau of Labor Statistics' Announcement of the 
geographical revision can be viewed at https://www.bls.gov/cpi/additional-resources/geographic-revision-2018.htm.
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    Table 2 provides the summary data and the 3-year average percent 
change in the specified CPI for the Washington-Arlington-Alexandria 
area. These data are published by the Bureau of Labor Statistics and 
can be found on their website under series Id CUURS35ASA0 at: https://data.bls.gov/pdq/SurveyOutputServlet?data_tool=dropmap&series_id=CUURS35ASA0,CUUSS35ASA0.


[[Page 46675]]



          Table 2--Annual and 3-Year Average Percent Change in Washington-Arlington-Alexandria Area CPI
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                   Fiscal year                         2017            2018            2019       3-Year average
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Annual CPI......................................         256.221         261.445         264.777  ..............
Annual Percent Change...........................          1.1045          2.0389          1.2745  ..............
3-Year Average Percent Change in CPI............  ..............  ..............  ..............          1.4726
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    The non-payroll adjustment is 1.4726 percent multiplied by 40 
percent, or 0.5890 percent. Next, the payroll adjustment (0.7586 
percent or 0.007586) is added to the non-payroll adjustment (0.5890 
percent or .005890), for a total of 1.3476 percent (or 0.013476). To 
complete the inflation adjustment, 1 (100 percent or 1.0) is added for 
a total base inflation adjustment of 1.013476 for FY 2021.
    MDUFA IV provides for this inflation adjustment to be compounded 
for FY 2021 and each subsequent fiscal year (see 21 U.S.C. 
379j(c)(2)(B)(ii)). To complete the compounded inflation adjustment for 
FY 2021, the FY 2020 compounded adjustment (1.099985) is multiplied by 
the FY 2021 base inflation adjustment (1.013476) to reach the 
applicable inflation adjustment of 1.114808 (rounded) for FY 2021. We 
then multiply the total revenue amount for FY 2021 ($211,748,789) by 
1.114808, yielding an inflation adjusted total revenue amount of 
$236,059,000 (rounded to the nearest thousand dollars).

III. Fees for FY 2021

    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 $328,000 (premarket 
application) and $4,975 (establishment registration) are to be adjusted 
for FY 2021 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 
1.114808 yields inflation adjusted base fees of $365,657 (premarket 
application) and $5,546 (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 2021.

                              Table 3--Three-Year Average of Fee-Paying Submissions
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                                                      FY 2017         FY 2018         FY 2019         3-Year
                Application type                      actual          actual          actual          average
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Full Fee Applications...........................              37              38              32              36
    Small Business..............................               6               7               8               7
Panel-Track Supplement..........................              22              23              14              20
    Small Business..............................               2               5               4               4
De Novo Classification Request \1\..............  ..............              27              12              20
    Small Business \1\..........................  ..............              29              37              33
180-Day Supplements.............................             167             133             124             141
    Small Business..............................              33              27              23              28
Real-Time Supplements...........................             187             169             213             190
    Small Business..............................              19              34              43              32
510(k)s.........................................           2,969           2,122           2,069           2,387
    Small Business..............................           1,072           1,385           1,558           1,338
30-Day Notice...................................             998           1,058             925             994
    Small Business..............................              78              98             111              96
513(g) (21 U.S.C. 360c(g)) Request for                        93              84              75              84
 Classification Information.....................
    Small Business..............................              41              33              54              43
Annual Fee for Periodic Reporting \2\...........             618             624             629             624
    Small Business \2\..........................              57              74              96              76
Establishment Registration......................          27,115          27,544          27,734          27,464
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\1\ Two-year average for De Novo is based on actuals from available data.
\2\ Includes collection of quarter 4 billing for FY 2019 during FY 2020.

    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 2021 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 
$236,842,961, which is $783,961 higher than the inflation adjusted 
total revenue amount (in section II). The fees in column two are those 
we are establishing in FY 2021, which are the standard fees.

[[Page 46676]]



                           Table 4--Fees Needed To Achieve New FY 2021 Revenue Target
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                                                         FY 2021 inflation
                                                              adjusted      3-Year average of   FY 2021 revenue
          Application type            FY 2021 statutory    statutory base       fee-paying       from adjusted
                                       fees (base fees)    fees (standard      submissions            fees
                                                               fees)
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Full Fee Applications...............           $328,000           $365,657                 36        $13,163,652
    Small Business..................             82,000             91,414                  7            639,898
Panel-Track Supplement..............            246,000            274,243                 20          5,484,860
    Small Business..................             61,500             68,561                  4            274,244
De Novo Classification Request......             98,400            109,697                 20          2,193,940
    Small Business..................             24,600             27,424                 33            904,992
180-Day Supplements.................             49,200             54,849                141          7,733,709
    Small Business..................             12,300             13,712                 28            383,936
Real-Time Supplements...............             22,960             25,596                190          4,863,240
    Small Business..................              5,740              6,399                 32            204,768
510(k)s.............................             11,152             12,432              2,387         29,675,184
    Small Business..................              2,788              3,108              1,338          4,158,504
30-Day Notice.......................              5,248              5,851                994          5,815,894
    Small Business..................              2,624              2,926                 96            280,896
513(g) Request for Classification                 4,428              4,936                 84            414,624
 Information........................
    Small Business..................              2,214              2,468                 43            106,124
Annual Fee for Periodic Reporting...             11,480             12,798                624          7,985,952
    Small Business..................              2,870              3,200                 76            243,200
Establishment Registration..........              4,975              5,546             27,464        152,315,344
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        Total.......................  .................  .................  .................        236,842,961
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    The standard fee (adjusted base amount) for a premarket 
application, including a BLA, and for a premarket report and a BLA 
efficacy supplement, is $365,657 for FY 2021. 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 $5,546 for FY 2021. There is no small business rate for the 
annual establishment registration fee; all establishments pay the same 
fee.
    Table 5 summarizes the FY 2021 rates for all medical device fees.

                                    Table 5--Medical Device Fees for FY 2021
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                                                      Standard fee (as a percent
                Application fee type                   of the standard fee for a      FY 2021      FY 2021 small
                                                        premarket  application)    standard fee    business fee
----------------------------------------------------------------------------------------------------------------
Premarket application (a PMA submitted under section  Base fee specified in             $365,657         $91,414
 515(c)(1) of the FD&C Act (21 U.S.C. 360e(c)(1)), a   statute.
 PDP submitted under section 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 515(c)(2)   100.......................         365,657          91,414
 of the FD&C Act).
Efficacy supplement (to an approved BLA under         100.......................         365,657          91,414
 section 351 of the PHS Act).
Panel-track supplement..............................  75........................         274,243          68,561
De novo classification request......................  30........................         109,697          27,424
180-day supplement..................................  15........................          54,849          13,712
Real-time supplement................................  7.........................          25,596           6,399
510(k) premarket notification submission............  3.40......................          12,432           3,108
30-day notice.......................................  1.60......................           5,851           2,926
513(g) request for classification information.......  1.35......................           4,936           2,468
Annual Fee Type.....................................  ..........................  ..............  ..............
Annual fee for periodic reporting on a class III      3.50......................          12,798           3,200
 device.
Annual establishment registration fee (to be paid by  Base fee specified in                5,546           5,546
 the establishment engaged in the manufacture,         statute.
 preparation, propagation, compounding, or
 processing of a device, as defined by 21 U.S.C.
 379i(14)).
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[[Page 46677]]

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 2020, your 
status as a small business will expire at the close of business on 
September 30, 2020. You must re-qualify for FY 2021 in order to pay 
small business fees during FY 2021.
    If you are a domestic (U.S.) business and wish to qualify as a 
small business for FY 2021, 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 copy of your Federal (U.S.) Income Tax Return for the 
most recent tax year. The most recent tax year will be 2020, except:
    If you submit your MDUFA Small Business Certification Request for 
FY 2021 before April 15, 2021, and you have not yet filed your return 
for 2020, you may use tax year 2019.
    If you submit your MDUFA Small Business Certification Request for 
FY 2021 on or after April 15, 2021, and have not yet filed your 2020 
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 signed 
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 2021, 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 signed 
copy of the affiliate's Federal (U.S.) Income Tax Return for the most 
recent tax year (2020 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 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, 2020, and September 30, 
2021, you must pay the fee in effect for FY 2021. 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 2020 or FY 2021 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, 2020. One choice is for 
applications and fees that will be received on or before September 30, 
2020, which are subject to FY 2020 fee rates. A second choice is for 
applications and fees received on or after October 1, 2020, which are 
subject to FY 2021 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.

[[Page 46678]]

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 the 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 that 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 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 2021 until it has completed the steps below to 
register and pay any applicable fee (see 21 U.S.C. 379j(f)(2)).
    Companies that do not manufacture any product other than a licensed

[[Page 46679]]

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 2021 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 U.S. 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 the 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 2021, or To Register a New Establishment for 
FY 2021

    Go to the Center for Devices and Radiological Health's website at 
https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing 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 2020. Manufacturers of 
licensed biologics should register in the Biologics Establishment 
Registration (BER) system at https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-establishment-registration.
    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 
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 29, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-16793 Filed 7-29-20; 4:15 pm]
BILLING CODE 4164-01-P