Biosimilar User Fee Rates for Fiscal Year 2025, 61441-61446 [2024-16884]
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Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Notices
premarket approval fees. An applicant
may also request a fee waiver for their
first premarket application or premarket
report (section 738(d) of the FD&C Act).
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 Waiver
For FY 2025, 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
section 738(a)(2)(D) of the FD&C Act.
Dated: July 26, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–16883 Filed 7–30–24; 8:45 am]
BILLING CODE 4164–01–P
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.
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
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SUMMARY:
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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 OO-OFBAP-OFM-UFSSGovernment@fda.hhs.gov.
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
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61441
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
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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).
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
FY 2021
Total PC&B ..........................................................................................
Total FTE .............................................................................................
PC&B per FTE .....................................................................................
Percent Change from Previous Year ...................................................
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
FY 2022
$3,039,513,000
18,501
$164,289
0.1811%
$3,165,477,000
18,474
$171,348
4.2967%
biological product applications. Table 2
shows the PC&B and the total
obligations for the process for the
review of biosimilar biological product
3-Year
average
FY 2023
$3,436,513,000
18,729
$183,486
7.0838%
3.8539%
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
2021
Total PC&B (proportion of costs) ........................................................
Total Costs ...........................................................................................
PC&B percent ......................................................................................
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
2022
$30,932,267
$55,928,075
55.3072%
$34,065,826
$68,521,689
49.7154%
consumers (Washington-ArlingtonAlexandria, 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
3-Year
average
2023
$45,893,774
$86,101,288
53.3021%
........................
........................
52.7749%
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 WashingtonArlington-Alexandria area.2
TABLE 3—ANNUAL AND 3-YEAR AVERAGE PERCENT CHANGE IN CPI FOR WASHINGTON-ARLINGTON-ALEXANDRIA AREA
Fiscal year
2021
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Annual CPI .......................................................................................................
Annual Percent Change ..................................................................................
277.728
3.9568%
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.
1 Full-time equivalents refer to a paid staff year,
rather than a count of individual employees.
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_
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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
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2022
296.117
6.6212%
3-Year
average
2023
305.317
3.1069%
........................
4.5616%
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
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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 reviewrelated 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
actuals
Workload category
Original Biosimilar Supplements 1 ...........................................................................................................................
Manufacturing Supplements ....................................................................................................................................
Biosimilar Biological Product Applications ...............................................................................................................
BsUFA Industry Meetings (BIA, BPD Type 1–4) ....................................................................................................
Participating BPD Programs 2 ..................................................................................................................................
Annual Reports 3 ......................................................................................................................................................
PMR/PMC-Related Documents 3 .............................................................................................................................
Active REMS Programs 2 3 ......................................................................................................................................
FY 2025
predictions
40
92
19
130
114
48
23
0
48
95
17
150
111
52
31
1
1 Includes
Supplements with Clinical Data and Labeling Supplements.
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.
2 Represents
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.
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TABLE 5—FY 2025 BSUFA III RESOURCE DELTA
Current resource capacity
FY 2025 resource
forecast
Predicted FY 2025
FTE delta
84 .................................................................................................................................................................
96
12
The projected 12 FTE delta was then
assessed by FDA in the context of
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additional operational and internal
factors to ensure that a fee adjustment
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is only made for resources which can be
utilized in the fiscal year and for which
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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
Additional FTEs for FY 2025
Cost for each
additional FTE
FY 2024
BsUFA III CPA
7 ...................................................................................................................................................................
$380,675
$2,664,725
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 Act) ........................................................................................................
Inflation Adjustment (Section 744H(c)(1) of the FD&C Act) ...............................................................................................................
Strategic Hiring and Retention Adjustment (Section 744H(c)(2) of the FD&C Act) ...........................................................................
Capacity Planning Adjustment (Section 744H(c)(3) of the FD&C Act) ...............................................................................................
Additional Dollar Amount .....................................................................................................................................................................
Cumulative Revenue Amount Prior to Operative Reserve Adjustment ..............................................................................................
$51,058,823
2,138,395
150,000
2,664,725
........................
56,011,943
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 21week 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 21week threshold allowable operating
reserve of carryover user fees for FY
2025 of $22,620,208 and above the 10week 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.
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TABLE 8—TOTAL ESTIMATED ADJUSTED REVENUE AMOUNT
Fee
Amount
Base Revenue Amount (Section 744H(b)–(c) of the FD&C Act) ........................................................................................................
Inflation Adjustment (Section 744H(c)(1) of the FD&C Act) ...............................................................................................................
Strategic Hiring and Retention Adjustment (Section 744H(c)(2) of the FD&C Act) ...........................................................................
Capacity Planning Adjustment (Section 744H(c)(3) of the FD&C Act) ...............................................................................................
Additional Dollar Amount .....................................................................................................................................................................
Operating Reserve Adjustment ...........................................................................................................................................................
Total Revenue Amount in sections 744H(b)–(c), 744H(c)(1), (2), (3) of the FD&C Act .....................................................................
Total Revenue Amount in sections 744H(b)–(c), 744H(c)(1), (2), (3) of the FD&C Act (rounded to the nearest thousand dollars)
$51,058,823
2,138,395
150,000
2,664,725
........................
........................
56,011,943
56,012,000
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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.
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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
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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.
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TABLE 9—FEE SCHEDULE FOR FY
2025—Continued
Fee category
Program Fee .............................
Fee rates
for FY 2025
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
C. Initial and Annual BPD Fees, and
biological product application for the
Reactivation Fees
product or within 7 calendar days after
To estimate the number of BPD fees
FDA grants the first BPD meeting for the
to be paid in FY 2025, FDA must
product, whichever occurs first.
consider the number of new BPD
Sponsors who have discontinued
programs, the number of current BPD
participation in the BPD program for a
programs, and the number of BPD
product or have been administratively
programs that will be reactivated. These removed from the BPD program for a
estimates provide information that,
product, and seek to resume
when aggregated, allows FDA to set BPD participation in the BPD program for the
fees (initial BPD fees, annual BPD fees,
product must pay all annual BPD fees
reactivation fees).
previously assessed for such product
FDA analyzed available data to
and still owed and the reactivation fee
estimate the total number of BPD
by the earlier of the following dates: no
programs for FY 2025. In FY 2025, FDA later than 7 calendar days after FDA
estimates approximately 23 new BPD
grants the sponsor’s request for a BPD
programs, no reactivations (a single
meeting for that product, or upon the
reactivation is weighted as two BPD
date of submission by the sponsor of an
fees), and approximately 88 BPD
IND describing an investigation that
programs to pay the annual BPD fee,
FDA determines is intended to support
yielding a rounded total estimated
a biosimilar biological product
equivalent of 111 BPD fees to be
application for that product.
collected in FY 2025. The remainder of
The application fee for a biosimilar
the target revenue of $1,110,000 or 2
biological product is due upon
percent is to be collected from the BPD
submission of the application (see
fees. Dividing this amount by the
section 744H(a)(2)(C) of the FD&C Act).
To make a payment of the initial BPD,
estimated 111 BPD fees to be paid
reactivation, or application fee,
equals an initial BPD and annual BPD
complete the Biosimilar User Fee Cover
fee amount of $10,000 (rounded to the
Sheet, available on FDA’s website
nearest dollar). The reactivation fee is
(https://www.fda.gov/bsufa) and
set at twice the initial/annual BPD
generate a user fee identification (ID)
amount at $20,000 (rounded to the
number. Payment must be made in U.S.
nearest dollar).
currency by electronic check, check,
IV. Fee Schedule for FY 2025
bank draft, U.S. postal money order, or
The fee rates for FY 2025 are
wire transfer. The preferred payment
displayed in table 9.
method is online using electronic check
(Automated Clearing House (ACH) also
TABLE 9—FEE SCHEDULE FOR FY
known as eCheck) or credit card
(Discover, VISA, MasterCard, American
2025
Express). FDA has partnered with the
Fee
rates
U.S. Department of the Treasury to use
Fee category
for FY 2025 www.pay.gov, a web-based payment
application, for online electronic
Initial BPD .................................
$10,000
payment. The www.pay.gov feature is
Annual BPD ..............................
10,000
Reactivation ..............................
20,000 available on the FDA website after the
user fee ID number is generated. Secure
Applications:
Requiring Clinical Data .........
1,471,118 electronic payments can be submitted
Not Requiring Clinical Data ..
735,559 using the User Fees Payment Portal at
PO 00000
Frm 00049
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61446
Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Notices
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.
lotter on DSK11XQN23PROD with NOTICES1
B. Annual BPD and Program Fees
FDA will issue invoices with payment
instructions for FY 2025 annual BPD
VerDate Sep<11>2014
17:29 Jul 30, 2024
Jkt 262001
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–3404]
Generic Drug User Fee Rates for Fiscal
Year 2025
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Federal Food, Drug, and
Cosmetic Act (FD&C Act or statute), as
amended by the Generic Drug User Fee
Amendments of 2022 (GDUFA III),
authorizes the Food and Drug
Administration (FDA, Agency, or we) to
assess and collect fees for abbreviated
SUMMARY:
PO 00000
Frm 00050
Fmt 4703
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new drug applications (ANDAs); drug
master files (DMFs); generic drug active
pharmaceutical ingredient (API)
facilities, finished dosage form (FDF)
facilities, and contract manufacturing
organization (CMO) facilities; and
generic drug applicant program user
fees. In this document, FDA is
announcing fiscal year (FY) 2025 rates
for GDUFA III fees. These fees are
effective on October 1, 2024, and will
remain in effect 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 20903, 240–
402–4989; or the User Fees Support
Staff at OO-OFBAP-OFM-UFSSGovernment@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Sections 744A and 744B of the FD&C
Act (21 U.S.C. 379j–41 and 379j–42), as
amended by GDUFA III, authorize FDA
to assess and collect fees associated
with human generic drug products. Fees
are assessed on: (1) certain types of
applications for human generic drug
products; (2) certain facilities where
APIs and FDFs are produced; (3) certain
DMFs associated with human generic
drug products; and (4) generic drug
applicants who own one or more
approved ANDAs (the program fee) (see
section 744B(a)(2) through (5) of the
FD&C Act). For more information about
GDUFA III, please refer to the FDA
website (https://www.fda.gov/gdufa).
For FY 2025, the generic drug user fee
rates are ANDA ($321,920), DMF
($95,084), domestic API facility
($41,580), foreign API facility ($56,580),
domestic FDF facility ($231,952),
foreign FDF facility ($246,952),
domestic CMO facility ($55,668), foreign
CMO facility ($70,668), large size
operation generic drug applicant
program ($1,891,664), medium size
operation generic drug applicant
program ($756,666), and small business
generic drug applicant program
($189,166). These fees are effective on
October 1, 2024, and will remain in
effect through September 30, 2025. The
fee rates for FY 2025 are set out in table
1.
E:\FR\FM\31JYN1.SGM
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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).
---------------------------------------------------------------------------
\1\ Full-time equivalents refer to a paid staff year, rather
than a count of individual employees.
---------------------------------------------------------------------------
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%
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
3-Year
2021 2022 2023 average
----------------------------------------------------------------------------------------------------------------
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%
----------------------------------------------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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
----------------------------------------------------------------------------------------------------------------
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%
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
FY 2025 resource Predicted FY 2025
Current resource capacity forecast FTE delta
----------------------------------------------------------------------------------------------------------------
84...................................................................... 96 12
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Cost for each FY 2024 BsUFA III
Additional FTEs for FY 2025 additional FTE CPA
----------------------------------------------------------------------------------------------------------------
7....................................................................... $380,675 $2,664,725
----------------------------------------------------------------------------------------------------------------
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
