[Federal Register Volume 89, Number 147 (Wednesday, July 31, 2024)]
[Notices]
[Pages 61441-61446]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-16884]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-3423]


Biosimilar User Fee Rates for Fiscal Year 2025

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing the rates for biosimilar user fees for fiscal year (FY) 
2025. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended 
by the Biosimilar User Fee Amendments of 2022 (BsUFA III), authorizes 
FDA to assess and collect user fees for certain activities in 
connection with biosimilar biological product development; review of 
certain applications for approval of biosimilar biological products; 
and each biosimilar biological product approved in a biosimilar 
biological product application. BsUFA III directs FDA to establish, 
before the beginning of each fiscal year, the amount of initial and 
annual biosimilar biological product development (BPD) fees, the 
reactivation fee, and the biosimilar biological product application and 
program fees for such year. These fees apply to the period from October 
1, 2024, through September 30, 2025.

FOR FURTHER INFORMATION CONTACT: Olufunmilayo Ariyo, Office of 
Financial Management, Food and Drug Administration, 10903 New Hampshire 
Ave., Silver Spring, MD 20993, 240-402-4989, and the User Fees Support 
Staff at [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Sections 744G, 744H, and 744I of the FD&C Act (21 U.S.C. 379j-51, 
379j-52, and 379j-53), as amended by BsUFA III, authorize the 
collection of fees for biosimilar biological products. Under section 
744H(a)(1)(A) of the FD&C Act, the initial BPD fee for a product is due 
when the sponsor submits an investigational new drug (IND) application 
that FDA determines is intended to support a biosimilar biological 
product application or within 7 calendar days after FDA grants the 
first BPD meeting, whichever occurs first. A sponsor who has paid the 
initial BPD fee is considered to be participating in FDA's BPD program 
for that product.
    Under section 744H(a)(1)(B) of the FD&C Act, once a sponsor has 
paid the initial BPD fee for a product, the annual BPD fee is assessed 
beginning with the next fiscal year. The annual BPD fee is assessed for 
the product each fiscal year until the sponsor submits a marketing 
application for the product that is accepted for filing, the sponsor 
discontinues participation in FDA's BPD program for the product, or the 
sponsor has been administratively removed from the BPD program for the 
product.
    Under section 744H(a)(1)(D) of the FD&C Act, if a sponsor has 
discontinued participation in FDA's BPD program or has been 
administratively removed from the BPD program for a product and wants 
to reengage with FDA on development of the product, the sponsor must 
pay all annual BPD fees previously assessed for such product and still 
owed, and a reactivation fee to resume participation in the program. 
The sponsor must pay the reactivation fee by the earlier of the 
following dates: (1) no later than 7 calendar days after FDA grants the 
sponsor's request for a BPD meeting for that product or (2) upon the 
date of submission by the sponsor of an IND describing an investigation 
that FDA determines is intended to support a biosimilar biological 
product application for that product. The sponsor will be assessed an 
annual BPD fee beginning in the next fiscal year after payment of the 
reactivation fee.
    BsUFA III also authorizes fees for certain biosimilar biological 
product applications and for each biosimilar biological product 
identified in an approved biosimilar biological product application 
(section 744H(a)(2) and (3) of the FD&C Act). Under certain conditions, 
FDA will grant a small business a waiver of the biosimilar biological 
product application fee (section 744H(d)(1) of the FD&C Act).
    For FY 2023 through FY 2027, the base revenue amounts for the total 
revenues from all BsUFA fees are established by BsUFA III. For FY 2025, 
the base revenue amount is the FY 2024 total revenue amount excluding 
any operating reserve adjustment, which equates to the amount of 
$51,058,823. The FY 2025 base revenue amount is to be adjusted by the 
inflation adjustment, strategic hiring and retention adjustment, 
capacity planning adjustment (CPA), operating reserve adjustment, and 
the additional dollar amount. Each of these adjustments will be 
discussed in the sections below.
    This document provides fee rates for FY 2025 for the initial and 
annual BPD fee ($10,000), for the reactivation fee ($20,000), for an 
application requiring clinical data ($1,471,118) for an application not 
requiring clinical data ($735,559) and for the program fee ($256,168). 
These fees are effective on October 1, 2024, and will remain in effect 
through September 30, 2025. For applications that are submitted on or 
after October 1, 2024, the new fee schedule must be used.

II. Fee Revenue Amount for FY 2025

    The base revenue amount for FY 2025 is $51,058,823 prior to 
adjustments for inflation, strategic hiring and retention, capacity 
planning, operating reserves, and the additional dollar amount (see 
section 744H(b) and (c) of the FD&C Act).

A. FY 2025 Statutory Fee Revenue Adjustments for Inflation

    BsUFA III specifies that the $51,058,823 is to be adjusted for 
inflation increases for FY 2025 using two separate adjustments: one for 
personnel compensation and benefits (PC&B) and one for non-PC&B costs 
(see section 744H(c)(1) of the FD&C Act).
    The component of the inflation adjustment for payroll costs shall 
be the average annual percent change in the cost of all PC&B paid per 
full-time

[[Page 61442]]

equivalent (FTE \1\) positions at FDA for the first 3 of the preceding 
4 fiscal years, multiplied by the proportion of PC&B costs to total FDA 
costs of the process for the review of biosimilar biological product 
applications for the first 3 of the preceding 4 fiscal years (see 
section 744H(c)(1)(B) of the FD&C Act).
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    \1\ Full-time equivalents refer to a paid staff year, rather 
than a count of individual employees.
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    Table 1 summarizes the actual cost and FTE data for the specified 
fiscal years and provides the percent changes from the previous fiscal 
years and the average percent changes over the first 3 of the 4 fiscal 
years preceding FY 2025. The 3-year average is 3.8539 percent.

                                 Table 1--FDA PC&B Each Year and Percent Changes
----------------------------------------------------------------------------------------------------------------
                                                                                                      3-Year
                                                 FY 2021           FY 2022           FY 2023          average
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Total PC&B................................    $3,039,513,000    $3,165,477,000    $3,436,513,000         3.8539%
Total FTE.................................            18,501            18,474            18,729
PC&B per FTE..............................          $164,289          $171,348          $183,486
Percent Change from Previous Year.........           0.1811%           4.2967%           7.0838%
----------------------------------------------------------------------------------------------------------------

    The statute specifies that this 3.8539 percent be multiplied by the 
proportion of PC&B costs to the total FDA costs of the process for the 
review of biosimilar biological product applications. Table 2 shows the 
PC&B and the total obligations for the process for the review of 
biosimilar biological product applications for the first 3 of the 
preceding 4 fiscal years.

     Table 2--PC&B as a Percent of Total Cost of the Process for the Review of Biosimilar Biological Product
                                                  Applications
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                                                                                                      3-Year
                                                  2021              2022              2023            average
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Total PC&B (proportion of costs)..........       $30,932,267       $34,065,826       $45,893,774  ..............
Total Costs...............................       $55,928,075       $68,521,689       $86,101,288  ..............
PC&B percent..............................          55.3072%          49.7154%          53.3021%        52.7749%
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    The payroll adjustment is 3.8539 percent from table 1 multiplied by 
52.7749 percent (or 2.0339 percent).
    The statute specifies that the portion of the inflation adjustment 
for nonpayroll costs 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 years of the preceding 4 years of 
available data multiplied by the proportion of all costs other than 
PC&B costs to total costs of the process for the review of biosimilar 
biological product applications for the first 3 years of the preceding 
4 fiscal years (see section 744H(c)(1)(B) of the FD&C Act). Table 3 
provides the summary data for the percent changes in the specified CPI 
for the Washington-Arlington-Alexandria area.\2\
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    \2\ The data are published by the Bureau of Labor Statistics and 
can be found on its website at: https://data.bls.gov/pdq/SurveyOutputServlet?data_tool=dropmap&series_id=CUURS35ASA0,CUUSS35ASA0.

        Table 3--Annual and 3-Year Average Percent Change in CPI for Washington-Arlington-Alexandria Area
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                   Fiscal year                         2021            2022            2023       3-Year average
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Annual CPI......................................         277.728         296.117         305.317  ..............
Annual Percent Change...........................         3.9568%         6.6212%         3.1069%         4.5616%
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    The statute specifies that this 4.5616 percent be multiplied by the 
proportion of all costs other than PC&B to total costs of the process 
for the review of biosimilar biological product applications obligated. 
Since 52.7749 percent was obligated for PC&B (as shown in table 2), 
47.2251 percent is the portion of costs other than PC&B (100 percent 
minus 52.7749 percent equals 47.2251 percent). The non-payroll 
adjustment is 4.5616 percent times 47.2251 percent, 2.1542 percent.
    Next, we add the payroll adjustment (2.0339 percent) to the 
nonpayroll adjustment (2.1542 percent), for a total inflation 
adjustment of 4.1881 percent (rounded) for FY 2025.
    We then multiply the base revenue amount for FY 2025 ($51,058,823) 
by the inflation adjustment percentage (4.1881 percent), yielding an 
inflation adjustment of $2,138,395. Adding this amount yields an 
inflation-adjusted amount of $53,197,218.

B. Strategic Hiring and Retention Adjustment

    The statute specifies that for each fiscal year, after the annual 
base revenue is adjusted for inflation, FDA shall further increase the 
fee revenue and fees by the strategic hiring and retention adjustment, 
which is $150,000 for FY 2025 (see section 744H(c)(2) of the FD&C Act).

C. FY 2025 Statutory Fee Revenue Adjustments for Capacity Planning

    The statute specifies that the fee revenue and fees shall be 
further adjusted to reflect changes in the resource capacity needs for 
the process for the review of biosimilar biological product 
applications (see section 744H(c)(3) of the FD&C Act). Following a 
process agreed upon by FDA and

[[Page 61443]]

industry during BsUFA II reauthorization discussions and subsequently 
required in statute, FDA established the capacity planning adjustment 
methodology and first applied it in the setting of FY 2021 fees. The 
establishment of this methodology is described in the Federal Register 
at 85 FR 47220. This methodology includes a continuous, iterative 
improvement approach, under which the Agency intends to refine its data 
and estimates for the core review activities to improve their accuracy 
over time.
    Improvements adopted for the FY 2025 CPA include the incorporation 
of hiring plans and attrition estimates within the capacity 
calculation. In prior years, the impacts of expected hiring on the 
review capacity of the program were considered a step within the 
managerial adjustment process. The FY 2025 resource capacity number 
includes an estimate of the onboard capacity for direct review-related 
work, as well as an estimate of the additional capacity that would be 
provided from any additional positions expected to be added through the 
course of FY 2024. No additional deduction for positions planned to be 
added prior to the end of FY 2024 then needs to be deducted within the 
managerial adjustment moving forward. Because of this change, the 
resource capacity numbers presented in this Federal Register Notice 
cannot be directly compared to those provided in prior years' fee-
setting notices.
    The CPA methodology consists of four steps:
    1. Forecast workload volumes: predictive models estimate the volume 
of workload for the upcoming fiscal year.
    2. Forecast the resource needs: forecast algorithms are generated 
utilizing time reporting data. These algorithms estimate the required 
demand in FTEs for direct review-related effort. This is then compared 
to current available resources for the direct review-related workload.
    The current available resources for the direct review-related 
workload (presented as current resource capacity below) is a measure of 
the percentage of time onboard staff report to direct review-related 
workload activities, plus a percentage of the additional positions that 
are targeted to be hired within the remainder of FY 2024. Of note, the 
current resource capacity is not directly a function of the change in 
submission volume from one year to the next, but rather a summation of 
the percent of total staff time plus vacancies estimated to be 
available for direct review work. As time reporting is a direct input 
into the current review capacity calculations, the current review 
capacity may be impacted by factors such as shifts in the level of 
effort required for review work, staff reporting time exceeding their 
tour of duty, or other shifts impacting the workload of the program.
    3. A managerial adjustment to assess the resource forecast in the 
context of additional internal factors: program leadership examines 
operational, financial, and resourcing data to assess whether FDA will 
be able to utilize additional funds during the fiscal year and whether 
the funds are required to support additional review capacity. FTE 
amounts are adjusted, if needed. The managerial adjustment process 
includes consideration of prior years' forecast performance, future 
year considerations, hiring capacity considerations, and other relevant 
considerations.
    4. Convert the FTE need to dollars: utilizing FDA's fully loaded 
FTE cost model, the final feasible FTEs are converted to an equivalent 
dollar amount. The fully loaded FTE cost model is higher in FY 2025 
than in prior years primarily due to the impact of inflation.
    The following section outlines the major components of the FY 2025 
BsUFA III CPA. Table 4 summarizes the forecasted workload volumes for 
BsUFA III in FY 2025 based on predictive models, as well as historical 
actuals from FY 2023 for comparison.

 Table 4--BsUFA III Actual FY 2023 Workload Volumes & Predicted FY 2025
                            Workload Volumes
------------------------------------------------------------------------
                                              FY 2023         FY 2025
            Workload category                 actuals       predictions
------------------------------------------------------------------------
Original Biosimilar Supplements \1\.....              40              48
Manufacturing Supplements...............              92              95
Biosimilar Biological Product                         19              17
 Applications...........................
BsUFA Industry Meetings (BIA, BPD Type 1-            130             150
 4).....................................
Participating BPD Programs \2\..........             114             111
Annual Reports \3\......................              48              52
PMR/PMC-Related Documents \3\...........              23              31
Active REMS Programs 2 3................               0               1
------------------------------------------------------------------------
\1\ Includes Supplements with Clinical Data and Labeling Supplements.
\2\ Represents activities related to the review of materials submitted
  to the application file after approval.
\3\ Represents the number of Active REMS Programs proportional to Center
  and User Fee by total number of qualifying products with the exclusion
  of the Opioid Shared System.

    Utilizing the resource forecast algorithms, the forecasted workload 
volumes for FY 2025 were then converted into estimated FTE needs for 
FDA's BsUFA III direct review-related work. The resulting expected FY 
2025 FTE need for BsUFA III was compared to current onboard capacity 
for BsUFA III direct review-related work to determine the FY 2025 
resource delta, as summarized in table 5.

                                    Table 5--FY 2025 BsUFA III Resource Delta
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                                                                           FY 2025 resource    Predicted FY 2025
                        Current resource capacity                              forecast            FTE delta
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84......................................................................                 96                  12
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    The projected 12 FTE delta was then assessed by FDA in the context 
of additional operational and internal factors to ensure that a fee 
adjustment is only made for resources which can be utilized in the 
fiscal year and for which

[[Page 61444]]

funds are required to support additional review capacity. In prior 
years, FDA adjusted the BsUFA FTE delta to 0 FTEs as there were 
additional funds available to support the needed FTEs. Due to large 
downward operating reserve adjustments in prior years, additional funds 
are needed to sustain additional FTE positions. BsUFA has also 
experienced sustained growth in review workload over recent years which 
is expected to continue. As such, FDA is adjusting the FTE delta to 7 
FTE to provide a modest adjustment to support the sustained increases 
in review workload.

                                         Table 6--FY 2025 BsUFA III CPA
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                                                                             Cost for each    FY 2024  BsUFA III
                       Additional FTEs for FY 2025                          additional FTE            CPA
----------------------------------------------------------------------------------------------------------------
7.......................................................................           $380,675          $2,664,725
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D. FY 2025 Additional Dollar Amount

    For FY 2023 and FY 2024, BsUFA III provided an additional dollar 
amount for additional FTE for the biosimilar biological product review 
program to support enhancements outlined in the BsUFA III Commitment 
Letter. For FY 2024, the statute directed FDA to further increase the 
fee revenue and fees by the additional dollar amount, which was 
$320,569 for FY 2024 (see section 744H(b)(1)(G) of the FD&C Act). For 
FY 2025 no additional amount is specified in statute.

 Table 7--Base Revenue Amount and Adjustments Prior to Operative Reserve
                               Adjustment
------------------------------------------------------------------------
                           Fee                                Amount
------------------------------------------------------------------------
Base Revenue Amount (Section 744H(b)-(c) of the FD&C         $51,058,823
 Act)...................................................
Inflation Adjustment (Section 744H(c)(1) of the FD&C           2,138,395
 Act)...................................................
Strategic Hiring and Retention Adjustment (Section               150,000
 744H(c)(2) of the FD&C Act)............................
Capacity Planning Adjustment (Section 744H(c)(3) of the        2,664,725
 FD&C Act)..............................................
Additional Dollar Amount................................  ..............
Cumulative Revenue Amount Prior to Operative Reserve          56,011,943
 Adjustment.............................................
------------------------------------------------------------------------

E. FY 2025 Statutory Fee Revenue Adjustments for Operating Reserve

    BsUFA III sets forth an operating reserve adjustment to the fee 
revenue and fees. Specifically, for FY 2025, the statute directs FDA: 
(1) to increase the fee revenue and fees if such an adjustment is 
necessary to provide for at least 10 weeks of operating reserves of 
carryover user fees for the process for the review of biosimilar 
biological product applications and (2) if FDA has carryover balances 
for such process in excess of 21 weeks of such operating reserves, to 
decrease such fee revenue and fees to provide for not more than 21 
weeks of such operating reserves (see section 744H(c)(4) of the FD&C 
Act).
    To calculate the 10-week and 21-week threshold amounts for the FY 
2025 operating reserve adjustment, the estimated adjusted revenue 
amount (i.e., the base revenue amount and adjustments prior to the 
operating reserve adjustment), $56,011,943 is divided by 52, resulting 
in a $1,077,153 cost of operation for 1 week (rounded to the nearest 
dollar). The 1-week value ($1,077,153) is then multiplied by 10 weeks 
to generate the 10-week operating reserve threshold amount for FY 2025 
of $10,771,528. The 1-week value is multiplied by 21 to generate the 
21-week operating reserve threshold amount for FY 2025 of $22,620,208.
    To calculate the estimated operating reserve of carryover user fees 
at the end of FY 2024, FDA estimated the operating reserves of 
carryover fees at the end of June 2024. The balance of operating 
reserves of carryover fees at the end of June 2024 is combined with the 
forecasted collections and obligations for the remainder of FY 2024 to 
generate a full year estimate for FY 2024. The estimated operating 
reserve of carryover user fees at the end of FY 2024 is $14,245,046.
    The estimated operating reserve of carryover user fees at the end 
of FY 2024 of $14,245,046 is below the 21-week threshold allowable 
operating reserve of carryover user fees for FY 2025 of $22,620,208 and 
above the 10-week minimum operating reserve carryover user fees for FY 
2025 of $10,771,528. As such, FDA is not applying a downward or upward 
operating reserve adjustment at the start of FY 2025, summarized below.

            Table 8--Total Estimated Adjusted Revenue Amount
------------------------------------------------------------------------
                           Fee                                Amount
------------------------------------------------------------------------
Base Revenue Amount (Section 744H(b)-(c) of the FD&C         $51,058,823
 Act)...................................................
Inflation Adjustment (Section 744H(c)(1) of the FD&C           2,138,395
 Act)...................................................
Strategic Hiring and Retention Adjustment (Section               150,000
 744H(c)(2) of the FD&C Act)............................
Capacity Planning Adjustment (Section 744H(c)(3) of the        2,664,725
 FD&C Act)..............................................
Additional Dollar Amount................................  ..............
Operating Reserve Adjustment............................  ..............
Total Revenue Amount in sections 744H(b)-(c),                 56,011,943
 744H(c)(1), (2), (3) of the FD&C Act...................
Total Revenue Amount in sections 744H(b)-(c),                 56,012,000
 744H(c)(1), (2), (3) of the FD&C Act (rounded to the
 nearest thousand dollars)..............................
------------------------------------------------------------------------


[[Page 61445]]

III. Fee Amounts for FY 2025

    Under section 744H(b)(2)(A) of the FD&C Act, FDA must determine the 
percentage of the total revenue amount for a fiscal year to be derived 
from: (1) initial and annual BPD fees, and reactivation fees; (2) 
biosimilar biological product application fees; and (3) biosimilar 
biological product program fees. As described above, an operating 
reserve adjustment is not required for FY 2025.

A. Application Fees

    In establishing the biosimilar biological product application fee 
amount for FY 2025, FDA assessed multiple modeling options. Considering 
available factors, FDA selected a model that forecasts 17 biosimilar 
biological product applications requiring clinical data submitted for 
approval in FY 2025 and zero applications that do not require clinical 
data. Given recent years' data regarding biosimilar biological product 
applications that are refused to file and withdrawals before filing, 
the 17 submissions will be assumed to equate to 16.25 full application 
equivalents.
    For FY 2025 the biosimilar biological product application fee for 
applications requiring clinical data is $1,471,118. Applications not 
requiring clinical data pay half that fee, or $735,559. This is 
estimated to provide a total of $23,905,668 representing 43 percent 
(rounded to the nearest whole number) of the FY 2025 target revenue 
amount.

B. Biosimilar Biological Product Program Fee

    Under BsUFA III, FDA assesses biosimilar biological product program 
fees (``program fees''). An applicant in a biosimilar biological 
product application shall not be assessed more than five program fees 
for a fiscal year for biosimilar biological products identified in a 
single biosimilar biological product application (see section 
744H(a)(3)(D) of the FD&C Act). Applicants are assessed a program fee 
for a fiscal year for biosimilar biological products that are 
identified in a biosimilar biological product application approved as 
of October 1 of such fiscal year; that may be dispensed only under 
prescription pursuant to section 503(b) of the FD&C Act; and that, as 
of October 1 of such fiscal year, do not appear on a list developed and 
maintained by FDA of discontinued biosimilar biological products. An 
approved biosimilar biological product that appears on the list of 
discontinued biosimilar biological products as of October 1 of a fiscal 
year would also be assessed the program fee if it is removed from the 
discontinued list during the fiscal year and the other statutory 
criteria for fee assessment are satisfied (see section 
744H(a)(3)(E)(iii) of the FD&C Act).
    Based on available information, FDA estimates that 121 program fees 
will be invoiced for FY 2025. For products invoiced in the FY 2025 
regular billing cycle, FDA anticipates that zero program fees will be 
refunded.
    For FY 2025, the biosimilar biological product program fee is 
$256,168. This is estimated to provide a total of $30,996,328, 
representing 55 percent (rounded to the nearest whole number) of the FY 
2025 target revenue amount.

C. Initial and Annual BPD Fees, and Reactivation Fees

    To estimate the number of BPD fees to be paid in FY 2025, FDA must 
consider the number of new BPD programs, the number of current BPD 
programs, and the number of BPD programs that will be reactivated. 
These estimates provide information that, when aggregated, allows FDA 
to set BPD fees (initial BPD fees, annual BPD fees, reactivation fees).
    FDA analyzed available data to estimate the total number of BPD 
programs for FY 2025. In FY 2025, FDA estimates approximately 23 new 
BPD programs, no reactivations (a single reactivation is weighted as 
two BPD fees), and approximately 88 BPD programs to pay the annual BPD 
fee, yielding a rounded total estimated equivalent of 111 BPD fees to 
be collected in FY 2025. The remainder of the target revenue of 
$1,110,000 or 2 percent is to be collected from the BPD fees. Dividing 
this amount by the estimated 111 BPD fees to be paid equals an initial 
BPD and annual BPD fee amount of $10,000 (rounded to the nearest 
dollar). The reactivation fee is set at twice the initial/annual BPD 
amount at $20,000 (rounded to the nearest dollar).

IV. Fee Schedule for FY 2025

    The fee rates for FY 2025 are displayed in table 9.

                    Table 9--Fee Schedule for FY 2025
------------------------------------------------------------------------
                                                              Fee rates
                        Fee category                         for FY 2025
------------------------------------------------------------------------
Initial BPD................................................      $10,000
Annual BPD.................................................       10,000
Reactivation...............................................       20,000
Applications:
  Requiring Clinical Data..................................    1,471,118
  Not Requiring Clinical Data..............................      735,559
Program Fee................................................      256,168
------------------------------------------------------------------------

V. Fee Payment Options and Procedures

A. Initial BPD, Reactivation, and Application Fees

    The fees established in the new fee schedule apply to FY 2025, 
i.e., the period from October 1, 2024, through September 30, 2025. The 
initial BPD fee for a product is due when the sponsor submits an IND 
that FDA determines is intended to support a biosimilar biological 
product application for the product or within 7 calendar days after FDA 
grants the first BPD meeting for the product, whichever occurs first. 
Sponsors who have discontinued participation in the BPD program for a 
product or have been administratively removed from the BPD program for 
a product, and seek to resume participation in the BPD program for the 
product must pay all annual BPD fees previously assessed for such 
product and still owed and the reactivation fee by the earlier of the 
following dates: no later than 7 calendar days after FDA grants the 
sponsor's request for a BPD meeting for that product, or upon the date 
of submission by the sponsor of an IND describing an investigation that 
FDA determines is intended to support a biosimilar biological product 
application for that product.
    The application fee for a biosimilar biological product is due upon 
submission of the application (see section 744H(a)(2)(C) of the FD&C 
Act).
    To make a payment of the initial BPD, reactivation, or application 
fee, complete the Biosimilar User Fee Cover Sheet, available on FDA's 
website (https://www.fda.gov/bsufa) and generate a user fee 
identification (ID) number. Payment must be made in U.S. currency by 
electronic check, check, bank draft, U.S. postal money order, or wire 
transfer. 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 use www.pay.gov, a web-based 
payment application, for online electronic payment. The www.pay.gov 
feature is available on the FDA website after the user fee ID number is 
generated. Secure electronic payments can be submitted using the User 
Fees Payment Portal at

[[Page 61446]]

https://userfees.fda.gov/pay (Note: only full payments are accepted. No 
partial payments can be made online). Once you search for your invoice, 
click ``Pay Now'' to be redirected to www.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.
    If a check, bank draft, or postal money order is submitted, make it 
payable to the order of the Food and Drug Administration and include 
the user fee ID number to ensure that the payment is applied to the 
correct fee(s). Payments can be mailed to: Food and Drug 
Administration, P.O. Box 979108, St. Louis, MO 63197-9000. If a check, 
bank draft, or money order is to be sent by a courier that requests a 
street address, the courier should deliver your payment to U.S. Bank, 
Attention: Government Lockbox 979108, 3180 Rider Trail South, Earth 
City, MO 63045. (Note: this U.S. Bank address is for courier delivery 
only. If you have any questions concerning courier delivery, contact 
U.S. Bank at 800-495-4981 (this telephone number is only for questions 
about courier delivery). Please make sure that the FDA post office box 
number (P.O. Box 979108) and ID number is written on the check, bank 
draft, or postal money order.
    For payments made by wire transfer, include the unique user fee ID 
number to ensure that the payment is applied to the correct fee(s). 
Without the unique user fee ID number, the payment may not be applied. 
The originating financial institution may charge a wire transfer fee. 
Include applicable wire transfer fees with payment to ensure fees are 
fully paid. Questions about wire transfer fees should be addressed to 
the financial institution. The following account information should be 
used to send payments by 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's tax 
identification number is 53-0196965.

B. Annual BPD and Program Fees

    FDA will issue invoices with payment instructions for FY 2025 
annual BPD and program fees under the new fee schedule in August 2024. 
Under sections 744H(a)(1)(B)(ii) and 744H(a)(3)(B) of the FD&C Act, 
annual BPD and program fees will be due on October 1, 2024.
    If sponsors join the BPD program after the annual BPD invoices have 
been issued in August 2024 FDA will issue invoices in December 2024 to 
sponsors subject to fees for FY 2025 that qualify for the annual BPD 
fee after the August 2024 billing. FDA will issue invoices in December 
2025 for any products that qualify for the annual program fee after the 
August 2024 billing.

C. Waivers and Returns

    To qualify for consideration for a small business waiver under 
section 744H(d) of the FD&C Act, or the return of any fee paid under 
section 744H of the FD&C Act, including if the fee is claimed to have 
been paid in error, a person shall submit to FDA a written request 
justifying such waiver or return and, except as otherwise specified in 
section 744H of the FD&C Act, such written request shall be submitted 
to FDA not later than 180 days after such fee is due. Such written 
request shall include any legal authorities under which the request is 
made. See section 744H(h) of the FD&C Act.

    Dated: July 26, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-16884 Filed 7-30-24; 8:45 am]
BILLING CODE 4164-01-P