Medical Device User Fee Rates for Fiscal Year 2024, 48870-48878 [2023-15919]

Agencies

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

[Federal Register Volume 88, Number 144 (Friday, July 28, 2023)]
[Notices]
[Pages 48870-48878]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-15919]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-2965]


Medical Device User Fee Rates for Fiscal Year 2024

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) 2024. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as 
amended by the Medical Device User Fee Amendments of 2022 (MDUFA V), 
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 2024, which apply from October 1, 2023, through September 
30, 2024, and provides information on how the fees for FY 2024 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: Olufunmilayo Ariyo, Office 
of Financial Management, Food and Drug Administration, 4041 Powder Mill 
Rd., Beltsville, MD 20705-4304, 240-402-4989; or the User Fee Support 
Staff at [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    The FD&C Act, as amended by MDUFA V, 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. 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

[[Page 48871]]

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 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 2023 through FY 2027; the 
base fee for a premarket application received by FDA during FY 2024 is 
$435,000. From this starting point, this document establishes FY 2024 
fee rates for certain types of submissions, and for periodic reporting, 
by applying criteria specified in the FD&C Act. 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)). For 
more information on fee waivers, please see Section IX. Small Business 
Fee Reductions and Fee Waivers.
    The FD&C Act specifies the base fee for establishment registration 
for each year from FY 2023 through FY 2027; the base fee for an 
establishment registration in FY 2024 is $6,875. 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. Total Revenue Amount for FY 2024

    The total revenue amount for FY 2024 is $335,750,000, as set forth 
in the statute prior to the inflation adjustment (see 21 U.S.C. 
379j(b)(3)). MDUFA V 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 2024 are described in this document.

Inflation Adjustment

    MDUFA specifies that the $335,750,000 is to be adjusted for 
inflation increases for FY 2024 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 2024 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, provides the percent change from the previous fiscal year, and 
provides the average percent change over the first 3 of the 4 fiscal 
years preceding FY 2024. The 3-year average is 3.9280 percent 
(rounded).

                                 Table 1--FDA PC&Bs Each Year and Percent Change
----------------------------------------------------------------------------------------------------------------
                                               FY 2020           FY 2021           FY 2022       3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B..............................    $2,875,592,000    $3,039,513,000    $3,165,477,000  ................
Total FTE...............................           $17,535           $18,501           $18,474  ................
PC&B per FTE............................          $163,922          $164,289          $171,348  ................
Percent change from previous year.......           7.3063%           0.1811%           4.2967%           3.9280%
----------------------------------------------------------------------------------------------------------------

    The payroll adjustment is 3.9280 percent multiplied by 60 percent, 
or 2.3568 percent. The statute specifies that the component of the 
inflation adjustment for non-payroll costs for FY 2024 is the average 
annual percent change that occurred in the Consumer Price Index (CPI) 
for urban consumers (Washington-Arlington-Alexandria, DC-VA-MD-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 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.


          Table 2--Annual and 3-Year Average Percent Change in Washington-Arlington-Alexandria Area CPI
----------------------------------------------------------------------------------------------------------------
                                                2020              2021              2022         3-Year average
----------------------------------------------------------------------------------------------------------------
Annual CPI..............................           267.157           277.728           296.117  ................
Annual Percent Change...................           0.8989%           3.9568%           6.6212%  ................
3-Year Average Percent Change in CPI....  ................  ................  ................           3.8256%
----------------------------------------------------------------------------------------------------------------

    The non-payroll adjustment is 3.8256 percent multiplied by 40 
percent, or 1.5302 percent. Next, the payroll adjustment (2.3568 
percent or 0.023568) is added to the non-payroll adjustment (1.5302 
percent or .015302), for a total of 3.8870 percent (or 0.038870). To 
complete the inflation adjustment, 1 (100 percent or 1.0) is added for 
a total base inflation adjustment of 1.03887 for FY 2024.
    MDUFA V provides for this inflation adjustment to be compounded for 
FY 2023 and each subsequent fiscal year (see 21 U.S.C. 
379j(c)(2)(B)(ii)). To complete the compounded inflation adjustment for 
FY 2024, the FY 2023 compounded adjustment (1.038870) is multiplied by 
the FY 2024 base inflation adjustment (1.038935) to reach the 
applicable inflation adjustment of 1.079318 (rounded) for FY 2024. We 
then multiply the total revenue amount for FY 2024 ($335,750,000) by 
1.079318, yielding an inflation adjusted total revenue amount of 
$362,381,000 (rounded to the nearest thousand dollars).

[[Page 48872]]

III. Adjustments to Base Fee Amounts for FY 2024

    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 $435,000 (premarket 
application) and $6,875 (establishment registration) are to be adjusted 
for FY 2024 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 
1.079318 yields inflation adjusted base fees of $469,503 (premarket 
application) and $7,420 (establishment registration).

B. Further Adjustments To Generate the Inflation-Adjusted Total Revenue 
Amount

    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)). After this adjustment, if necessary, 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. MDUFA V Adjustments Solely to Registration Fees

    MDUFA V has three new potential adjustments that will not change 
the total revenue amount but may impact collections by increasing or 
decreasing establishment registration base fees only. These adjustments 
are the performance improvement adjustment, the hiring adjustment, and 
the operating reserve adjustment. Only the operating reserve adjustment 
is potentially applicable in FY 2024.
1. Performance Improvement Adjustment
    For FY 2024, there is no performance improvement adjustment. 
Beginning with FY 2025, this adjustment allows FDA to collect fees in 
addition to the total revenue amount in FYs 2025, 2026, and 2027, if 
the Agency meets certain performance goals in FYs 2023, 2024, and 2025. 
If applicable, this provision further increases base establishment 
registration fee amounts to achieve an increase in total fee 
collections equal to the applicable performance improvement adjustment, 
which is set forth in the statute (see 21 U.S.C. 379j(c)(4)).
2. Hiring Adjustment
    For FY 2024, there is no hiring adjustment. Beginning with FY 2025, 
this adjustment provides for the reduction of base establishment 
registration fees in FYs 2025, 2026, and 2027, if specified hiring 
goals for FYs 2023, 2024, and 2025 are not met by a certain threshold. 
The hiring adjustment would serve to decrease the base establishment 
registration fee amounts as necessary to achieve a reduction in total 
fee collections equal to the hiring adjustment amount, which is set 
forth in the statute (see 21 U.S.C. 379j(c)(5)).
3. Operating Reserve Adjustment
    For FYs 2023 to 2027, the operating reserve adjustment requires FDA 
to decrease base establishment registration fees if the amount of 
operating reserves of carryover user fees exceeds the ``designated 
amount'' and such reduction is necessary to provide for not more than 
such designated amount of operating reserves of carryover user fees 
(see 21 U.S.C. 379j(c)(6)). In making this calculation for FYs 2023 to 
2026, a certain amount is excluded from the designated amount and is 
not subject to the decrease (see 21 U.S.C. 379j(c)(6)(C)). For FY 2024, 
this excluded amount is $100,600,981.
    The designated amount is equal to the sum of 13 weeks of operating 
reserves of carryover user fees plus 1 month of operating reserves 
described in 21 U.S.C. 379j(c)(8) (see 21 U.S.C. 379j(c)(6)(B)).
    To determine the 13-week operating reserves of carryover user fees 
amount, the FY 2024 inflation-adjusted total revenue amount, 
$362,381,000 is divided by 52, and then multiplied by 13. The 13-week 
operating reserve amount for FY 2024 is $90,595,250.
    To determine the 1 month of operating reserves described in 21 
U.S.C. 379j(c)(8), the FY 2024 inflation-adjusted total revenue amount 
of $362,381,000 is divided by 12. The 1 month of operating reserves for 
FY 2024 is $30,198,417.
    For FY 2024, the designated amount is equal to the 13-week 
operating reserve of $90,595,250 plus the 1 month of operating reserves 
of $30,198,417, totaling $120,793,667.
    To determine the FY 2023 end-of-year operating reserves of 
carryover user fees amount, FDA combined the actual collections and 
obligations at the end of the third quarter (June 2023) and added the 
forecasted collections and obligations for the fourth quarter of FY 
2023 to generate a full year estimate for FY 2023. The estimated end-
of-year FY 2023 operating reserves of carryover user fees is 
$30,019,132. (Note, this amount includes the 1-month reserve.)
    Note that under MDUFA V, for the purposes of calculating the 
operating reserve adjustment, this amount does not include user fee 
funds considered unappropriated ($26,680,243) or unearned revenue 
($65,418,275). In addition, as noted above, for purposes of the 
operating reserve adjustment, operating reserves of carryover user fees 
do not include the estimated $100,600,981 remaining to spend at the end 
of FY 2023 from the total of $118,000,000 intended to support the Total 
Product Life Cycle Advisory Program Pilot and Third-Party Review 
programs.
    Because the estimated end-of-year FY 2023 MDUFA operating reserves 
of carryover user fees amount totaling $30,019,132 does not exceed the 
FY 2024 designated amount of $120,793,667 FDA will not decrease the 
base establishment registration fee amounts for FY 2024 to provide for 
not more than such designated amount.

IV. Calculation of Fee Rates

    As noted in section II, the total revenue amount after the 
applicable inflation adjustment is $362,381,000 (rounded to the nearest 
thousand dollar). As noted in section III, there is no MDUFA V 
adjustment solely to registration fees for FY 2024.
    Table 3A provides fee-paying submission counts excluding 
establishment registration for the last 3 years and the 3-year average. 
Table 3B provides establishment registration fee-paying submission 
counts for the last 5 years and the 5-year average. Historically, FDA 
has estimated the total number of fee-paying submission counts it 
expects to receive during the next fiscal year by averaging the number 
of fee-paying submission counts received in the 3 most recently 
completed fiscal years; for FY 2024 fee-setting, this would be an 
average of FY 2020 through FY 2022. FDA received an abnormally high 
volume of fee paying establishment registrations due to the COVID-19 
pandemic in FY 2020 and FY 2021. The surge in fee-paying establishment 
registrations has been declining starting in FY 2022, trending back 
toward pre-pandemic levels. In an effort to normalize the projected 
volume of establishment registration submissions for the FY 2024 fee-
setting calculation and more accurately project the associated 
establishment registration revenue, FDA decided to average the number 
of establishment registrations from FY 2018 through FY 2022. FDA 
believes a 5-year average to estimate establishment registration volume 
will

[[Page 48873]]

minimize the impact of the surge in fee paying establishment 
registration volume in FY 2020 and FY 2021.

          Table 3A--Three-Year Average of Fee-Paying Submissions (Excluding Establishment Registration)
----------------------------------------------------------------------------------------------------------------
               Application type                 FY 2020 actual  FY 2021 actual  FY 2022 actual   3-Year average
----------------------------------------------------------------------------------------------------------------
Full Fee applications.........................              29              25              18                24
    Small Business............................               7               5               3                 5
Panel-Track Supplements.......................              23              31              21                25
    Small Business............................               6               6               1                 4
De Novo Classifications.......................              20              16              23                20
    Small Business............................              47              42              53                47
180-Day Supplements...........................             124              98              93               105
    Small Business............................              20              34              31                28
Real-Time Supplements.........................             175             150             140               155
    Small Business............................              28              20              12                20
510(k)s.......................................           2,048           2,133           2,012             2,064
    Small Business............................           1,667           1,846           1,757             1,757
30-Day Notice (Note also includes counts for               870             843             782               832
 135 Day Supplements).........................
    Small Business............................             104              77              67                83
513(g)(21 U.S.C. 360c(g)) Request for                       96              83              93                91
 Classification Information...................
    Small Business............................              57              53              58                56
Annual Fee for Periodic Reporting.............             622             613             620               618
    Small Business............................              95              84              87                89
----------------------------------------------------------------------------------------------------------------


                Table 3B--Five-Year Average of Fee-Paying Establishment Registration Submissions
----------------------------------------------------------------------------------------------------------------
      Application type          FY 2018      FY 2019      FY 2020      FY 2021      FY 2022      5-Year average
----------------------------------------------------------------------------------------------------------------
Establishment Registrations.      27,544       27,728       41,942       33,812       31,748             32,555
----------------------------------------------------------------------------------------------------------------

    The information in tables 3A and 3B is necessary to estimate the 
amount of revenue that will be collected based on the fee amounts. 
Tables 4A and B display the FY 2024 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, the 3-year 
average of fee-paying submissions (excluding establishment 
registration), and the 5-year average of fee-paying establishment 
registration submissions, collections are projected to total 
$351,531,781 which is $10,849,219 lower than the inflation adjusted 
total revenue amount (in section II). Accordingly, the next step in the 
fee setting process is to increase the base fee amounts on a uniform 
proportionate basis to generate the inflation adjusted total revenue 
amounts (see 21 U.S.C. 379j(c)(2)(D)(ii) and table 4A, column three).
    Applying these further adjusted fee rates to the 3-year average of 
fee paying submissions, and the 5-year average of fee-paying 
establishment registration submissions results in estimated total fee 
collections of $362,040,886, which is still $340,114 lower than the 
inflation adjusted total revenue amount (in Section II). The next step 
in the fee setting process, after the adjustment in (2)(D) is done, is 
to increase the base establishment registration fee amount as necessary 
for total fee collections to generate the inflation adjusted total 
revenue amount, as adjusted under paragraph (2) (see 21 U.S.C. 
379j(c)(3)). Accordingly, the base establishment registration fee was 
increased by $11 for an establishment registration fee rate of $7,653 
(see 21 U.S.C. 379j(c)(3)). The fees in column three in tables 4A and 
4B are those we are establishing for FY 2024, which are the standard 
fees.

                           Table 4A--Fees Needed To Achieve New FY 2024 Revenue Target
----------------------------------------------------------------------------------------------------------------
                                                   FY 2024
                                                  inflation     Adjusted FY 2024
                                  FY 2024         adjusted        fees to meet    3-Year average      FY 2024
      Application type        statutory fees   statutory base    revenue target    of fee-paying   revenue from
                                (base fees)    fees (standard    (standard fees)    submissions    adjusted fees
                                                    fees)
----------------------------------------------------------------------------------------------------------------
Full Fee Applications.......        $435,000          $469,503          $483,560              24     $11,605,440
    Small Business..........         108,750           117,376           120,890               5         604,450
Panel-Track Supplement......         348,000           375,603           386,848              25       9,671,200
    Small Business..........          87,000            93,901            96,712               4         386,848
De Novo Classification               130,500           140,851           145,068              20       2,901,360
 Request....................
    Small Business..........          32,625            35,213            36,267              47       1,704,549
180-Day Supplements.........          65,250            70,425            72,534             105       7,616,070
    Small Business..........          16,313            17,606            18,134              28         507,752
Real-Time Supplements.......          30,450            32,865            33,849             155       5,246,595
    Small Business..........           7,613             8,216             8,462              20         169,240
510(k)s.....................          19,575            21,128            21,760           2,064      44,912,640
    Small Business..........           4,894             5,282             5,440           1,757       9,558,080
30-Day Notice...............           6,960             7,512             7,737             832       6,437,184

[[Page 48874]]

 
    Small Business..........           3,480             3,756             3,869              83         321,127
513(g) Request for                     5,873             6,338             6,528              91         594,048
 Classification Information.
    Small Business..........           2,937             3,169             3,264              56         182,784
Annual Fee for Periodic               15,225            16,433            16,925             618      10,459,650
 Reporting..................
    Small Business..........           3,806             4,108             4,231              89         376,559
                             -----------------------------------------------------------------------------------
        Total...............  ..............  ................  ................  ..............     113,255,576
----------------------------------------------------------------------------------------------------------------


                                               Table 4B--Fees Needed To Achieve New FY 2024 Revenue Target
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                  FY 2024 inflation
                                                                     FY 2024           adjusted       Adjusted FY 2024   5-Year average  FY 2024 revenue
                        Application type                          statutory fees    statutory base      fees to meet     of fee-paying    from adjusted
                                                                   (base fees)      fees (standard     revenue target     submissions          fees
                                                                                        fees)         (standard fees)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Establishment Registrations....................................          $6,875             $7,420             $7,653           32,555     $249,143,415
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The standard fee (adjusted base amount) for a premarket 
application, including a BLA, and for a premarket report and a BLA 
efficacy supplement, is $483,560 for FY 2024. The fees set by reference 
to the standard fee for a premarket application are:
     For a panel-track supplement, 80 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, 4.5 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 adjustments, 
is set at $7,653 for FY 2024. For FY 2024, there is no small business 
waiver for the annual establishment registration fee; all 
establishments pay the same fee.
    For more information on reduced fees and waivers for small 
businesses, please see Section IX. Small Business Fee Reductions and 
Fee Waivers.
    Table 5 summarizes the FY 2024 rates for all medical device fees.

                                    Table 5--Medical Device Fees for FY 2024
----------------------------------------------------------------------------------------------------------------
                                             Standard fee (as a percent of the
          Application fee type                 standard fee for a premarket           FY 2024      FY 2024 small
                                                       application)                standard fee    business fee
----------------------------------------------------------------------------------------------------------------
Premarket application (a PMA submitted    Base fee specified in statute.........        $483,560        $120,890
 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,
 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...................................         483,560         120,890
 section 515(c)(2) of the FD&C Act).
Efficacy supplement (to an approved BLA   100...................................         483,560         120,890
 under section 351 of the PHS Act).
Panel-track supplement..................  80....................................         386,848          96,712
De novo classification request..........  30....................................         145,068          36,267
180-day supplement......................  15....................................          72,534          18,134
Real-time supplement....................  7.....................................          33,849           8,462
510(k) premarket notification submission  4.5...................................          21,760           5,440
30-day notice...........................  1.60..................................           7,737           3,869
513(g) request for classification         1.35..................................           6,528           3,264
 information.
Annual Fee Type.........................  ......................................  ..............  ..............
Annual fee for periodic reporting on a    3.50..................................          16,925           4,231
 class III device.
Annual establishment registration fee     Base fee specified in statute.........           7,653           7,653
 (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(14)).
----------------------------------------------------------------------------------------------------------------


[[Page 48875]]

V. 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 must submit the materials showing 
you qualify as a small business at least 60 days before you send your 
submission to FDA. For more information on fee waivers or reductions, 
please see Section IX. Small Business Fee Reductions and Fee Waivers.
    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 2024, you should not submit a Small Business Certification 
Request. 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 2023, your 
status as a small business will expire at the close of business on 
September 30, 2023. You must re-qualify for FY 2024 in order to pay 
small business fees during FY 2024.

A. Domestic (U.S.) Businesses

    If you are a domestic (U.S.) business and wish to qualify as a 
small business for FY 2024, submit the following to FDA:
    1. A completed MDUFA Small Business Certification Request for a 
Business Headquartered in the United States (Form FDA 3602). Form FDA 
3602 is provided in the FDA Forms database: https://www.fda.gov/media/128050/download.
    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 2023, except:
     If you submit your MDUFA Small Business Certification 
Request for FY 2024 before April 15, 2024, and you have not yet filed 
your return for 2023, you may use tax year 2022.
     If you submit your MDUFA Small Business Certification 
Request for FY 2024 on or after April 15, 2024, and have not yet filed 
your 2023 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, if extant, 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 your affiliate is headquartered in a country without a 
National Taxing Authority, please contact the Division of Industry and 
Consumer Education at 800-638-2041 or 301-796-7100 or email at 
[email protected].
    4. Once you have completed your Form FDA 3602, print and sign the 
form. Mail the completed form and your supporting documentation (copies 
of the Federal (U.S.) income tax returns) to Medical Device User Fee 
Small Business Certification Request mailing address, which is 
available at the following website: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/ucm577696.htm.
    If you need assistance, please contact the Division of Industry and 
Consumer Education at 800-638-2041 or 301-796-7100 or email at 
[email protected].

B. Foreign Businesses

    If you are a foreign business, and wish to qualify as a small 
business for FY 2024, 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/media/128059/download.
    2. A National Taxing Authority Certification, completed by, and 
bearing the official seal of, the National Taxing Authority, if extant, 
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.
    If your firm is headquartered in a country without a National 
Taxing Authority, please contact the Division of Industry and Consumer 
Education at 800-638-2041 or 301-796-7100 or email at [email protected].
    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 (2022 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, if extant, 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.
     If your affiliate is headquartered in a country without a 
National Taxing Authority, please contact the Division of Industry and 
Consumer Education at 800-638-2041 or 301-796-7100 or email at 
[email protected].
    4. Once you have completed your Form FDA 3602A, print and sign the 
form. Mail the completed form and your supporting documentation, 
including the following, to CDRH's Medical Device User Fee Small 
Business Certification Request address, which is available at the 
following website: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/ucm577696.htm.

[[Page 48876]]

     A copy of the most recent Federal (U.S.) income tax return 
for each of your affiliates headquartered in the U.S. and
     A copy of an MDUFA Foreign Small Business Certification 
Request for each of your foreign affiliates.
    If you need assistance, please contact the Division of Industry and 
Consumer Education at 800-638-2041 or 301-796-7100 or email at 
[email protected].

VI. 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, 2023, and September 30, 
2024, you must pay the fee in effect for FY 2024. To avoid delay in the 
review of your application, you should pay the application fee at the 
time you submit your application to FDA. 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 2023 or FY 2024 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, 2023. One choice is for 
applications and fees that will be received on or before September 30, 
2023, which are subject to FY 2023 fee rates. A second choice is for 
applications and fees received on or after October 1, 2024, which are 
subject to FY 2024 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 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.

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.

VII. 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 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.

[[Page 48877]]

    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.

VIII. 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 2024 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 
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 username and password, log into the 
Establishment Registration User Fee FY 2024 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 2024, or To Register a New Establishment for 
FY 2024

    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 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 2023. Manufacturers of 
licensed biologics should register in the electronic Blood 
Establishment Registration (eBER) 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

[[Page 48878]]

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 eBER 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.

IX. Small Business Fee Reductions and Fee Waivers

    To qualify for reduced fees for small businesses or a small 
business fee waiver, please see the requirements for qualification 
provided in Section V. How To Qualify as a Small Business for Purposes 
of Medical Device Fees. The applicant should submit a Small Business 
Certification Request and the supporting 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 you need assistance, please contact the Division of Industry and 
Consumer Education at 800-638-2041 or 301-796-7100 or email at 
[email protected].

A. Premarket Approval Fee Reduction or Waiver

    A small business applicant may request to pay a reduced rate for 
premarket approval fees. An applicant may also request a fee waiver for 
their first premarket application or premarket report (see 21 U.S.C. 
379j(d)).

B. Premarket Notification Submission Fee Reduction

    A small business applicant may request to pay a reduced rate for a 
premarket notification submission.

C. Annual Establishment Registration Fee

    There is no small business waiver for the annual establishment 
registration fee; all establishments pay the same fee.

X. Refunds

    To qualify for consideration for a refund, a person shall submit to 
FDA a written request for a refund not later than 180 days after such 
fee is due. FDA has discretion to refund a fee or a portion of the fee. 
A determination by FDA concerning a refund shall not be reviewable. For 
more information on qualifying and submitting a refund, see 21 U.S.C. 
379j(a)(2)(D).

    Dated: July 21, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-15919 Filed 7-27-23; 8:45 am]
BILLING CODE 4164-01-P