Notice2024-16884
Biosimilar User Fee Rates for Fiscal Year 2025
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Published
July 31, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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[Federal Register Volume 89, Number 147 (Wednesday, July 31, 2024)]
[Notices]
[Pages 61441-61446]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="/cdn-cgi/l/email-protection#024d4d2f4d444043522f4d444f2f574451512f456d7467706c6f676c76426466632c6a6a712c656d74"><span class="__cf_email__" data-cfemail="521d1d7f1d141013027f1d141f7f071401017f153d2437203c3f373c26123436337c3a3a217c353d24">[email protected]</span></a>.
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
----------------------------------------------------------------------------------------------------------------
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%
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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: <a href="https://data.bls.gov/pdq/SurveyOutputServlet?data_tool=dropmap&series_id=CUURS35ASA0,CUUSS35ASA0">https://data.bls.gov/pdq/SurveyOutputServlet?data_tool=dropmap&series_id=CUURS35ASA0,CUUSS35ASA0</a>.
Table 3--Annual and 3-Year Average Percent Change in CPI for Washington-Arlington-Alexandria Area
----------------------------------------------------------------------------------------------------------------
Fiscal year 2021 2022 2023 3-Year average
----------------------------------------------------------------------------------------------------------------
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.............................................
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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 (<a href="https://www.fda.gov/bsufa">https://www.fda.gov/bsufa</a>) 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 <a href="http://www.pay.gov">www.pay.gov</a>, a web-based
payment application, for online electronic payment. The <a href="http://www.pay.gov">www.pay.gov</a>
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]]
<a href="https://userfees.fda.gov/pay">https://userfees.fda.gov/pay</a> (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 <a href="http://www.pay.gov">www.pay.gov</a>. 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
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</html>Indexed from Federal Register on July 31, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.