Notice2025-14413
Prescription Drug User Fee Rates for Fiscal Year 2026
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Published
July 30, 2025
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 prescription drug user fees for fiscal year (FY) 2026. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Prescription Drug User Fee Amendments of 2022 (PDUFA VII), authorizes FDA to collect application fees for certain applications for the review of human drug and biological products and prescription drug program fees for certain approved products. This notice establishes the fee rates for FY 2026.
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<title>Federal Register, Volume 90 Issue 144 (Wednesday, July 30, 2025)</title>
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[Federal Register Volume 90, Number 144 (Wednesday, July 30, 2025)]
[Notices]
[Pages 35866-35872]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-14413]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-2245]
Prescription Drug User Fee Rates for Fiscal Year 2026
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 prescription drug user fees for fiscal year
(FY) 2026. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as
amended by the Prescription Drug User Fee Amendments of 2022 (PDUFA
VII), authorizes FDA to collect application fees for certain
applications for the review of human drug and biological products and
prescription drug program fees for certain approved products. This
notice establishes the fee rates for FY 2026.
DATES: These fees apply to the period from October 1, 2025, through
September 30, 2026.
FOR FURTHER INFORMATION CONTACT: For more information on prescription
drug fees, visit FDA's website at: <a href="https://www.fda.gov/industry/fda-user-fee-programs/prescription-drug-user-fee-amendments">https://www.fda.gov/industry/fda-user-fee-programs/prescription-drug-user-fee-amendments</a>. For questions
relating to this notice: Olufunmilayo Ariyo, Office of Financial
Management, Food and Drug Administration, 10903 New Hampshire Ave.,
Silver Spring, MD 20993, 240-402-4989; or the User Fees Support Staff
at <a href="/cdn-cgi/l/email-protection#b8edfeebebf8dedcd996d0d0cb96dfd7ce"><span class="__cf_email__" data-cfemail="491c0f1a1a092f2d286721213a672e263f">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Sections 735 and 736 of the FD&C Act (21 U.S.C. 379g and 379h)
establish two different kinds of user fees. Fees are assessed as
follows: (1) application fees are assessed on certain types of
applications for the review of human drug and biological products and
(2) prescription drug program fees are assessed on certain approved
products (section 736(a) of the FD&C Act). The statute also includes
conditions under which such fees may be waived or reduced (section
736(d) of the FD&C Act), or under which fee exceptions, refunds, or
exemptions apply (sections 736(a)(1)(C) through (H), 736(a)(2)(B)
through (C), and 736(k) of the FD&C Act).
For FY 2023 through FY 2027, the base revenue amounts for the total
revenues from all PDUFA fees are established by PDUFA VII. The base
revenue amount for FY 2026 is $1,434,377,467. The FY 2026 base revenue
amount is adjusted for (1) inflation, (2) strategic hiring and
retention, and for (3) the resource capacity needs for the process for
the review of human drug applications (the capacity planning adjustment
(CPA). This amount is further adjusted to include the additional dollar
amount as specified in the statute (see section 736(b)(1)(G) of the
FD&C Act) to provide for additional full-time equivalent (FTE) \1\
positions to support PDUFA VII initiatives. If applicable, an operating
reserve adjustment is added to provide sufficient operating reserves of
carryover user fees. The amount from the preceding adjustments is then
adjusted to provide for additional direct costs to fund PDUFA VII
initiatives. Fee amounts are to be established each year so that
revenues from application fees provide 20 percent of the total revenue,
and prescription drug program fees provide 80 percent of the total
revenue (see section 736(b)(2) of the FD&C Act).
---------------------------------------------------------------------------
\1\ Full-time equivalents refer to a paid staff year, rather
than a count of individual employees.
---------------------------------------------------------------------------
This document provides fee rates for FY 2026 for an application
requiring covered clinical data \2\ ($4,682,003), for an application
not requiring covered clinical data ($2,341,002), and for the
prescription drug program fee ($442,213). These fees are effective on
October 1, 2025, and will remain in effect through September 30, 2026.
For applications that are submitted on or after October 1, 2025, the
new fee schedule must be used.
---------------------------------------------------------------------------
\2\ As used herein, ``covered clinical data'' is ``clinical data
(other than bioavailability or bioequivalence studies) with respect
to safety or effectiveness [that] are required for approval'' (see
section 736(a)(1)(A) of the FD&C Act).
---------------------------------------------------------------------------
II. Fee Revenue Amount for FY 2026
The base revenue amount for FY 2026 is $1,434,377,467 (see section
736(b)(1)(A) and (b)(3) of the FD&C Act). This amount is prior to any
adjustments made for inflation, the strategic hiring and retention
adjustment, CPA, additional dollar amount, operating reserve adjustment
(if applicable), and additional direct costs (see section 736(b)(1) of
the FD&C Act).
A. FY 2026 Statutory Fee Revenue Adjustments for Inflation
PDUFA VII specifies that the $1,434,377,467 is to be adjusted for
inflation increases for FY 2026 using two separate adjustments: one for
personnel compensation and benefits (PC&B) and one for non-PC&B costs
(see section 736(c)(1) of the FD&C Act).
The component of the inflation adjustment for payroll costs is the
average annual percent change in the cost of all PC&B paid per FTE
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 human drug applications for the first 3 of
the preceding 4 fiscal years (see section 736(c)(1)(A) and (B)(i) of
the FD&C Act).
Table 1 summarizes the actual cost and FTE data for the specified
fiscal years, provides the percent changes from the previous fiscal
years, and provides the average percent changes over the first 3 of the
4 fiscal years preceding FY 2026. The 3-year average is 5.4494 percent.
Table 1--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Changes
----------------------------------------------------------------------------------------------------------------
2022 2023 2024 3-year average
----------------------------------------------------------------------------------------------------------------
Total PC&B.......................... $3,165,477,000 $3,436,513,000 $3,791,729,000 .................
Total FTEs.......................... 18,474 18,729 19,687 .................
PC&B per FTE........................ $171,348 $183,486 $192,601 .................
[[Page 35867]]
Percent Change from Previous Year... 4.2967% 7.0838% 4.9677% 5.4494%
----------------------------------------------------------------------------------------------------------------
The statute specifies that this 5.4494 percent be multiplied by the
proportion of PC&B costs to the total FDA costs of the process for the
review of human drug applications. Table 2 shows the PC&B and the total
obligations for the process for the review of human drug 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 Human Drug Applications
----------------------------------------------------------------------------------------------------------------
2022 2023 2024 3-year average
----------------------------------------------------------------------------------------------------------------
Total PC&B (proportion of costs).... $931,302,114 $1,040,590,183 $1,139,962,844 .................
Total Costs......................... $1,480,601,875 $1,686,733,841 $1,772,198,497 .................
PC&B percent........................ 62.9002% 61.6926% 64.3248% 62.9725%
----------------------------------------------------------------------------------------------------------------
The payroll adjustment is 5.4494 percent from table 1 multiplied by
62.9725 percent from table 2 resulting in 3.4316 percent.
The statute specifies that the portion of the inflation adjustment
for non-payroll 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
personnel compensation and benefits costs to total costs of the process
for the review of human drug applications (as defined in section
735(6)) for the first 3 years of the preceding 4 fiscal years (see
section 736(c)(1)(A) and (B)(ii)). Table 3 provides the summary data
for the percent changes in the specified CPI for the Washington-
Arlington-Alexandria area.\3\
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\3\ 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
----------------------------------------------------------------------------------------------------------------
2022 2023 2024 3-year average
----------------------------------------------------------------------------------------------------------------
Annual CPI.......................... 296.117 305.317 315.186 .................
Annual Percent Change............... 6.6212% 3.1069% 3.2324% 4.3202%
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The statute specifies that this 4.3202 percent be multiplied by the
proportion of all costs other than PC&B to total costs of the process
for the review of human drug applications obligated. Because 62.9725
percent was obligated for PC&B (as shown in table 2), 37.0275 percent
is the portion of costs other than PC&B (100 percent minus 62.9725
percent equals 37.0275 percent). The non-payroll adjustment is 4.3202
percent times 37.0275 percent, or 1.5997 percent.
Next, we add the payroll adjustment (3.4316 percent) to the non-
payroll adjustment (1.5997 percent), for a total inflation adjustment
of 5.0313 percent (rounded) for FY 2026.
We then multiply the base revenue amount for FY 2026
($1,434,377,467) by 5.0313 percent, which produces an inflation
adjustment amount of $72,167,833. Adding this amount to the base
revenue amount yields an inflation-adjusted base revenue amount of
$1,506,545,300.
Table 4--Base Revenue Amount and Section 736(c)(1) Adjustment Amount
------------------------------------------------------------------------
Fee Amount
------------------------------------------------------------------------
Statutory Fee Revenue Base Amount (section 736(b)(3) $1,434,377,467
of the FD&C Act)....................................
Inflation Adjustment (section 736(c)(1) of the FD&C 72,167,833
Act)................................................
Revenue Amount after Adjustments in sections 1,506,545,300
736(c)(1) of the FD&C Act...........................
------------------------------------------------------------------------
B. FY 2026 Strategic Hiring and Retention Adjustment
For each fiscal year, after the annual base revenue established in
section II is adjusted for inflation in accordance with section II.A,
the statute directs FDA to further increase the fee revenue and fees to
support strategic hiring and retention. For FY 2026, this amount is
$4,000,000 (see section 736(c)(2)(A) of the FD&C Act).
Table 5--Base Revenue Amount and Section 736(c)(1) Through (2)
Adjustment Amounts
------------------------------------------------------------------------
Fee Amount
------------------------------------------------------------------------
Statutory Fee Revenue Base Amount (section 736(b)(3) $1,434,377,467
of the FD&C Act)....................................
[[Page 35868]]
Inflation Adjustment (section 736(c)(1) of the FD&C 72,167,833
Act)................................................
Strategic Hiring and Retention Adjustment (section 4,000,000
736(c)(2) of the FD&C Act)..........................
Revenue Amount after Adjustments in sections 1,510,545,300
736(c)(1) and (2) of the FD&C Act...................
------------------------------------------------------------------------
C. FY 2026 Statutory Fee Revenue Adjustments for Capacity Planning
The statute specifies that after the base revenue amount for FY
2026 of $1,434,377,467 has been adjusted as described in sections II.A
and II.B, this amount shall be further adjusted to reflect changes in
the resource capacity needs for the process of human drug application
reviews (see section 736(c)(3) of the FD&C Act). Following a process
agreed upon by FDA and industry during PDUFA VI reauthorization
discussions and subsequently required in statute, FDA established a new
CPA methodology and first applied it in the setting of FY 2021 fees.
The establishment of this methodology is described in the Federal
Register of August 3, 2020 (85 FR 46651). 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. An adjustment for workload has
been a critical aspect of the PDUFA program since PDUFA III in FY 2003
as it enables the program to adjust to shifts in review workload
resulting from industry submissions to the Agency. The annual
adjustment process allows greater accuracy than would be expected if
workload adjustments were fixed at the start of the reauthorization
period. The CPA is an evolution of the PDUFA workload adjuster and was
implemented through a process agreed to by FDA and industry during
PDUFA VI. The CPA builds on the concepts of the workload adjuster but
realizes enhancements including the use of leading indicators of
workload, use of full-time reporting data, the introduction of a
managerial adjustment process as an internal check on the
reasonableness of any adjustment, outputs measured in full-time
equivalent employees, and the incorporation of adjustments into the
base revenue amounts to ensure sustainability of payroll to support any
new hires.
The CPA methodology includes four steps:
1. Forecast workload volumes: predictive models estimate the volume
of workload for the upcoming FY.
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.
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 FY, and whether the
funds are required to support additional review capacity. FTE amounts
are adjusted, if needed.
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.
FDA calculated workload models for the Center for Drug Evaluation
and Research (CDER) and the Center for Biologics Evaluation and
Research (CBER) in the Fall of 2024.
Table 6 summarizes the forecasted workload volumes for CDER in FY
2026 based on predictive models, as well as historical actuals from FY
2024 for comparison.
Table 6--CDER Actual FY 2024 Workload Volumes and Predicted FY 2026
Workload Volumes
------------------------------------------------------------------------
FY 2024 FY 2026
Workload category Actuals Predictions
------------------------------------------------------------------------
Efficacy Supplements.................... 257 241
Labeling Supplements.................... 1,047 996
Manufacturing Supplements............... 2,463 2,574
NDA/BLA \1\ Original.................... 115 127
PDUFA Industry Meetings (including WROs 4,028 3,843
\2\)...................................
Active Commercial INDs \3\.............. 10,015 10,758
Annual Reports \4\...................... 3,518 3,659
PMR/PMC-Related Documents \4\........... 1,770 1,583
Active REMS Programs \4\ \5\............ 25 25
------------------------------------------------------------------------
\1\ New drug applications (NDA)/biological license applications (BLA).
\2\ Written responses only (WROs).
\3\ For purpose of the CPA, this is defined as an active commercial
investigational new drug (IND) for which a document has been received
in the past 18 months.
\4\ Represents activities related to the review of materials submitted
to the application file after approval.
\5\ Represents the percentage of active risk evaluation and management
strategy (REMS) programs proportional to Center and User Fee by total
number of qualifying products with the exclusion of the Opioid Shared
System.
Table 7 summarizes the forecasted workload volumes for CBER in FY
2026 based on predictive models, as well as the corresponding
historical actuals from 2024 for comparison.
[[Page 35869]]
Table 7--CBER Actual FY 2024 Workload Volumes and Predicted FY 2026
Workload Volumes
------------------------------------------------------------------------
FY 2024 FY 2026
Workload category Actuals Predictions
------------------------------------------------------------------------
Efficacy Supplements.................... 24 23
Labeling Supplements.................... 61 61
Manufacturing Supplements............... 833 869
NDA/BLA \1\ Original.................... 12 13
PDUFA Industry Meetings (including WROs 923 1,011
\2\)...................................
Active Commercial INDs \3\.............. 1,873 2,104
Annual Reports \4\...................... 311 315
PMR/PMC-Related Documents \4\........... 188 156
Active REMS Programs \4\ \5\............ 2 2
------------------------------------------------------------------------
\1\ New drug applications (NDA)/biological license applications (BLA).
\2\ Written responses only (WROs).
\3\ For purpose of the CPA, this is defined as an active commercial
investigational new drug (IND) for which a document has been received
in the past 18 months.
\4\ Represents activities related to the review of materials submitted
to the application file after approval.
\5\ Represents the percentage of active REMS programs proportional to
Center and User Fee by total number of qualifying products with the
exclusion of the Opioid Shared System.
FDA anticipates that any FTE gains could be funded through the
expected FY 2026 collections amount without further adjustment from the
CPA. As such, FDA determined that in FY 2026 the PDUFA fee amounts do
not need adjustment from the CPA to provide funds for the program.
Table 8--FY 2026 PDUFA CPA
------------------------------------------------------------------------
FY 2026 PDUFA
Center CPA
------------------------------------------------------------------------
CDER................................................. $0
CBER................................................. 0
------------------
Total.............................................. 0
------------------------------------------------------------------------
Table 9--Base Revenue Amount and Section 736(c)(1) Through (3)
Adjustment Amounts
------------------------------------------------------------------------
Fee Amount
------------------------------------------------------------------------
Statutory Fee Revenue Base Amount (section 736(b)(3) $1,434,377,467
of the FD&C Act)....................................
Inflation Adjustment (section 736(c)(1) of the FD&C 72,167,833
Act)................................................
Strategic Hiring and Retention Adjustment (section 4,000,000
736(c)(2) of the FD&C Act)..........................
Capacity Planning Adjustment (section 736(c)(3) of 0
the FD&C Act).......................................
Revenue Amount after Adjustments in sections 1,510,545,300
736(c)(1), (2), and (3) of the FD&C Act.............
------------------------------------------------------------------------
D. FY 2026 Statutory Fee Revenue Adjustments for Additional Dollar
Amounts
PDUFA VII provides an additional dollar amount for each of the 5
fiscal years covered by PDUFA VII for additional FTEs to support
enhancements outlined in the PDUFA VII commitment letter. The
additional dollar amount for FY 2026 as outlined in statute is
$4,864,860 (see section 736(b)(1)(G)(iv) of the FD&C Act). This amount
will be added to the total FY 2026 PDUFA VII revenue amount.
Table 10--Base Revenue Amount and Section 736(c)(1) Through (3)
Adjustment Amounts
------------------------------------------------------------------------
Fee Amount
------------------------------------------------------------------------
Statutory Fee Revenue Base Amount (section 736(b)(3) $1,434,377,467
of the FD&C Act)....................................
Inflation Adjustment (section 736(c)(1) of the FD&C 72,167,833
Act)................................................
Strategic Hiring and Retention Adjustment (section 4,000,000
736(c)(2) of the FD&C Act)..........................
Capacity Planning Adjustment (section 736(c)(3) of 0
the FD&C Act).......................................
Additional Dollar Amounts Adjustment (section 4,864,860
736(b)(1)(G) of the FD&C Act).......................
Cumulative Revenue Amount after Adjustments in 1,515,410,160
sections 736(c)(1), (2), and (3) of the FD&C Act....
------------------------------------------------------------------------
E. FY 2026 Statutory Fee Revenue Adjustments for Operating Reserve
PDUFA VII provides for an operating reserve adjustment that may
result in an increase or decrease in fee revenue and fees for a given
FY (see section 736(c)(4) of the FD&C Act). For FY 2026, FDA is
required to further increase fee revenue and fees if an adjustment is
necessary to provide for at least 10 weeks of operating reserves of
carryover user fees (see section 736(c)(4)(A)(iii) of the FD&C Act). If
FDA has carryover balances of user fees in excess of 14 weeks of
operating reserves, FDA is required to
[[Page 35870]]
decrease fee revenue and fees to provide for not more than 14 weeks of
operating reserves of carryover user fees (see section 736(c)(4)(B) of
the FD&C Act).
To determine the dollar amounts for the 10-week and 14-week
operating reserve thresholds, the adjustments (inflation, strategic
hiring and retention, capacity planning, and additional dollar amount)
discussed in sections II.A, II.B, II.C, and II.D are applied to the FY
2026 base revenue (see section 736(c)(4)(A) of the FD&C Act), resulting
in $1,515,410,160. This amount is then divided by 52 to generate the 1-
week operating amount of $29,142,503. The 1-week operating amount is
then multiplied by 10 and 14. This results in a 10-week threshold
amount of $291,425,030 and a 14-week threshold amount of $407,995,042.
To determine the FY 2025 end-of-year operating reserves of
carryover user fees, the Agency assessed the operating reserve of
carryover fees at the end of June 2025 and forecasted collections and
obligations in the fourth quarter of FY 2025 combined. This provides an
estimated end-of-year FY 2025 operating reserve of carryover user fees
of $299,623,185, which equates to 10.28 weeks of operations.\4\
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\4\ For purposes of the operating reserve adjustment under PDUFA
VII, the operating reserve of carryover user fees includes only user
fee funds that are available for obligation. FDA excludes from the
operating reserve of carryover user fee funds that were collected
prior to 2010 and that are held by FDA, but which are considered
unavailable for obligation due to lack of an appropriation
($78,850,995).
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Because the estimated FY 2025 end-of-year operating reserves of
carryover user fees are within the 10-week and 14-week thresholds, FDA
will not increase or reduce the FY 2026 fees or fee revenue under the
statutory provision for operating reserve adjustments.
Table 11--Base Revenue Amount and Section 736(c)(1) through (4)
Adjustment Amounts
------------------------------------------------------------------------
Fee Amount
------------------------------------------------------------------------
Statutory Fee Revenue Base Amount (section 736(b)(3) $1,434,377,467
of the FD&C Act)....................................
Inflation Adjustment (section 736(c)(1) of the FD&C 72,167,833
Act)................................................
Strategic Hiring and Retention Adjustment (section 4,000,000
736(c)(2) of the FD&C Act)..........................
Capacity Planning Adjustment (section 736(c)(3) of 0
the FD&C Act).......................................
Additional Dollar Amounts Adjustment (section 4,864,860
736(b)(1)(G) of the FD&C Act).......................
Operating Reserve Adjustment (section (736(c)(4) of 0
the FD&C Act).......................................
Cumulative Revenue Amount after Adjustments in 1,515,410,160
sections 736(c)(1), (2), (3), and (4) of the FD&C
Act.................................................
------------------------------------------------------------------------
F. FY 2026 Statutory Fee Revenue Adjustments for Additional Direct Cost
PDUFA VII specifies that an additional direct cost of $40,627,674
is to be added to the total FY 2026 PDUFA revenue amount (see section
736(c)(5)(ii) of the FD&C Act). With respect to target revenue for FY
2026, adding the additional direct cost amount of $40,627,674 to the
inflation, strategic hiring and retention, CPA, additional dollar
amount, and operating reserve adjustment results in the total revenue
amount of $1,556,038,000 (rounded to the nearest thousand dollars).
Table 12--Total Estimated Adjusted Revenue Amount
------------------------------------------------------------------------
Fee Amount
------------------------------------------------------------------------
Statutory Fee Revenue Base Amount (section 736(b)(3) $1,434,377,467
of the FD&C Act)....................................
Inflation Adjustment (section 736(c)(1) of the FD&C 72,167,833
Act)................................................
Strategic Hiring and Retention Adjustment (section 4,000,000
736(c)(2)(B) of the FD&C Act).......................
Capacity Planning Adjustment (section 736(c)(3) of 0
the FD&C Act).......................................
Additional Dollar Amounts Adjustment (section 4,864,860
736(b)(1)(G) of the FD&C Act).......................
Operating Reserve Adjustment (section (736(c)(4) of 0
the FD&C Act).......................................
Additional Direct Cost Adjustment (section 736(c)(5) 40,627,674
of the FD&C Act)....................................
Cumulative Revenue Amount after Adjustments in 1,556,037,834
sections 736(c)(1), (2), (3), (4), and (5) of the
FD&C Act............................................
Cumulative Revenue Amount after Adjustments in 1,556,038,000
sections 736(c)(1), (2), (3), (4), and (5) of the
FD&C Act (rounded to the nearest thousand)..........
------------------------------------------------------------------------
III. Application Fee Calculations
A. Application Fee Revenues and Application Fees
Application fees will be set to generate 20 percent of the total
revenue amount, amounting to $311,207,600 in FY 2026.
B. Estimate of the Number of Fee-Paying Applications and Setting the
Application Fees
FDA has estimated the total number of fee-paying full application
equivalents (FAEs) it expects to receive during the next fiscal year by
averaging the number of fee-paying FAEs received in the ten most
recently completed fiscal years. For FY 2026 fee setting, the 10
relevant fiscal years are FY 2015-2024. Prior year FAE totals are
updated annually to reflect refunds and waivers processed after the
close of the fiscal year.\5\
---------------------------------------------------------------------------
\5\ In the PDUFA fee setting FRNs for FYs 2023 and 2024, this
adjustment for refunds was erroneously excluded, resulting in an
overstatement of the historical FAE data.
---------------------------------------------------------------------------
In estimating the number of fee-paying FAEs, an application
requiring covered clinical data \6\ counts as one FAE. An application
not requiring covered clinical data counts as one-half of an FAE. An
application that is withdrawn before filing, or refused for filing,
counts as one-fourth of an FAE if the applicant initially paid a full
application fee, or one-eighth of an FAE if the applicant initially
paid one-half of the full application fee amount.
---------------------------------------------------------------------------
\6\ As defined in section 736(a)(1)(A)(i) of the FD&C Act.
---------------------------------------------------------------------------
As table 13 shows, the average number of fee-paying FAEs received
annually in FY 2015 through FY 2024 is 66.469. FDA will set fees for FY
2026 based on this estimate as the number of
[[Page 35871]]
full application equivalents that will be subject to fees.
Table 13--Fee-Paying FAEs
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
10-year
2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 average
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Fee-Paying FAEs............................................. 81.956 70.483 79.750 68.875 80.000 56.750 78.875 45.125 49.500 53.375 66.469
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Note: Prior year FAE totals are updated annually to reflect refunds and waivers processed after the close of the fiscal year.
The FY 2026 application fee is estimated by dividing the average
number of full applications that paid fees from FY 2015 through FY
2024, 66.469, into the fee revenue amount to be derived from
application fees in FY 2026, $311,207,600. The result is a fee of
$4,682,003 per full application requiring clinical data, and $2,341,002
per application not requiring clinical data.
IV. Fee Calculation for Prescription Drug Program Fees
PDUFA VII assesses prescription drug program fees for certain
prescription drug products. Program fees will be set to generate 80
percent of the total target revenue, amounting to $1,244,830,400 in FY
2026.
An applicant will not be assessed more than five program fees for a
FY for prescription drug products identified in a single approved NDA
or BLA (see section 736(a)(2)(C) of the FD&C Act). Applicants are
assessed a program fee for a FY for user fee eligible prescription drug
products identified in a human drug application approved as of October
1 of such FY. Additionally, applicants are assessed a program fee for a
product that is not a prescription drug product on October 1 because it
is included in the discontinued section of the Orange Book or the CDER/
CBER Billable Biologics List on that date, if the product becomes a
fee-eligible prescription drug product during the FY.
FDA estimates 2,971 program fees will be invoiced in FY 2026 before
factoring in waivers, refunds, exceptions, and exemptions. FDA
approximates that there will be 97 waivers and refunds granted.
Additionally, FDA approximates that another 59 program fees will be
exempted in FY 2026 based on the orphan drug exemption in section
736(k) of the FD&C Act.
FDA estimates 2,815 program fees in FY 2026, after allowing for an
estimated 156 waivers and reductions, including the orphan drug
exemptions, excepted and exempted fee-liable products. The FY 2026
prescription drug program fee rate is calculated by dividing the
adjusted total revenue from program fees ($1,244,830,400) by the
estimated 2815 program fees, resulting in a FY 2026 program fee of
$442,213 (rounded to the nearest dollar).
V. Fee Schedule for FY 2026
The fee rates for FY 2026 are displayed in table 14.
Table 14--Fee Schedule for FY 2026
------------------------------------------------------------------------
Fee rates
Fee category for FY
2026
------------------------------------------------------------------------
Application:
Requiring clinical data.................................. $4,682,003
Not requiring clinical data.............................. 2,341,002
Program.................................................... 442,213
------------------------------------------------------------------------
VI. Fee Payment Options and Procedures
A. Application Fees
The appropriate application fee established in the new fee schedule
must be paid for any application subject to fees under PDUFA VII that
is submitted on or after October 1, 2025. To pay, complete the
Prescription Drug User Fee Cover Sheet, available at <a href="https://userfees.fda.gov/OA_HTML/pdufaCAcdLogin.jsp">https://userfees.fda.gov/OA_HTML/pdufaCAcdLogin.jsp</a>, and generate a user fee
identification (ID) number. Payment must be made in U.S. currency by
electronic check or wire transfer.\7\ 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).
---------------------------------------------------------------------------
\7\ See ``Change in Federal Payment and Collection Options''
announcement published in the Federal Register on June 27, 2025 (90
FR 27639).
---------------------------------------------------------------------------
FDA has partnered with the U.S. Department of the Treasury to use
<a href="http://Pay.gov">Pay.gov</a>, a web-based payment application, for online electronic
payment. The <a href="http://Pay.gov">Pay.gov</a> feature is available on FDA's website after
completing the Prescription Drug User Fee Cover Sheet and generating
the user fee ID number. Secure electronic payments can be submitted
using the User Fees Payment Portal at <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 an invoice is located, ``Pay Now'' should be selected to
be redirected to <a href="http://Pay.gov">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.
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,
which could result in FDA not filing an application and other
penalties. Note: the originating financial institution may charge a
wire transfer fee, especially for international wire transfers.
Applicable wire transfer fees must be included with payment to ensure
fees are paid in full. Questions about wire transfer fees should be
addressed to the financial institution. The account information for
wire transfers is as follows: U.S. Department of the Treasury, TREAS
NYC, 33 Liberty St., New York, NY 10045, Acct. No.: 75060099, Routing
No.: 021030004, SWIFT: FRNYUS33. If needed, FDA's tax identification
number is 53-0196965.
B. Prescription Drug Program Fees
FDA will issue invoices and payment instructions for FY 2026
program fees under the new fee schedule in August 2025. Under section
736(a)(2)(A)(i) of the FD&C Act, prescription drug program fees are due
on October 1, 2025.
FDA will issue invoices in December 2026 for products that qualify
for FY 2026 program fee assessments after the October 2025 billing.
C. Fee Waivers and Refunds
To qualify for consideration for a waiver or reduction under
section 736(d) of the FD&C Act, an exemption under section 736(k) of
the FD&C Act, or the return of an application or program fee paid under
section 736 of the FD&C Act, including if the fee is claimed to have
been paid in error, a person must submit to FDA a written request
justifying such waiver,
[[Page 35872]]
reduction, exemption or return not later than 180 days after such fee
is due (section 736(i) of the FD&C Act). A request submitted under this
paragraph must include any legal authorities under which the request is
made.
Dated: July 25, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-14413 Filed 7-29-25; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on July 30, 2025.
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.