Notice2023-15911
Prescription Drug User Fee Rates for Fiscal Year 2024
Primary source
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Published
July 28, 2023
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) 2024. 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 2024.
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[Federal Register Volume 88, Number 144 (Friday, July 28, 2023)]
[Notices]
[Pages 48881-48888]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-15911]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-2850]
Prescription Drug User Fee Rates for Fiscal Year 2024
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing the rates for prescription drug user fees for fiscal year
(FY) 2024. 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 2024.
DATES: These fees apply to the period from October 1, 2023, through
September 30, 2024.
FOR FURTHER INFORMATION CONTACT: Olufunmilayo Ariyo, Office of
Financial Management, Food and Drug Administration, 4041 Powder Mill
Rd., 6th Floor, Beltsville, MD 20705, 240-402-4989; and the User Fee
Support Staff at <a href="/cdn-cgi/l/email-protection#8dc2c2a0c2cbcfccdda0c2cbc0a0d8cbdedea0cae2fbe8ffe3e0e8e3f9cdebe9eca3e5e5fea3eae2fb"><span class="__cf_email__" data-cfemail="6d222240222b2f2c3d40222b2040382b3e3e402a021b081f03000803192d0b090c4305051e430a021b">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Sections 735 and 736 of the FD&C Act (21 U.S.C. 379g and 379h,
respectively)
[[Page 48882]]
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 2024 is $1,256,844,387. The FY 2024 base revenue
amount is adjusted for inflation, strategic hiring and retention, and
for 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)(F) of the FD&C Act) to
provide for additional full-time equivalent (FTE) 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).
This document provides fee rates for FY 2024 for an application
requiring covered clinical data \1\ ($4,048,695), for an application
not requiring covered clinical data ($2,024,348), and for the
prescription drug program fee ($416,429). These fees are effective on
October 1, 2023, and will remain in effect through September 30, 2024.
For applications that are submitted on or after October 1, 2023, the
new fee schedule must be used.
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\1\ 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).
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II. Fee Revenue Amount for FY 2024
The base revenue amount for FY 2024 is $1,256,844,387 (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 2024 Statutory Fee Revenue Adjustments for Inflation
PDUFA VII specifies that the $1,256,844,387 is to be adjusted for
inflation increases for FY 2024 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 2024. The 3-year average is 3.9280 percent.
Table 1--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Changes
----------------------------------------------------------------------------------------------------------------
FY 2020 FY 2021 FY 2022 3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B.............................. $2,875,592,000 $3,039,513,000 $3,165,477,000 ................
Total FTE............................... $17,535 $18,501 $18,474 ................
PC&B per FTE............................ $163,992 $164,289 $171,348 ................
Percent Change from Previous Year....... 7.3063% 0.1811% 4.2967% 3.9280%
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The statute specifies that this 3.9280 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
----------------------------------------------------------------------------------------------------------------
FY 2020 FY 2021 FY 2022 3-Year average
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Total PC&B.............................. $891,395,106 $959,387,333 $931,302,114 ................
Total Costs............................. $1,471,144,928 $1,499,064,056 $1,480,601,875 ................
PC&B Percent............................ 60.5919% 63.9991% 62.9002% 62.4971%
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The payroll adjustment is 3.9280 percent from table 1 multiplied by
62.4971 percent resulting in 2.4549 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 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
[[Page 48883]]
the Washington-Arlington-Alexandria area.\2\
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\2\ The data are published by the Bureau of Labor Statistics and
can be found on its website at: <a href="https://data.bls.gov/pdq/SurveyOutputServlet?data_tool=dropmap&series_id=CUURS35ASA0,CUUSS35ASA0">https://data.bls.gov/pdq/SurveyOutputServlet?data_tool=dropmap&series_id=CUURS35ASA0,CUUSS35ASA0</a>.
Table 3--Annual and 3-Year Average Percent Change in CPI for Washington-Arlington-Alexandria Area
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FY 2020 FY 2021 FY 2022 3-Year average
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Annual CPI.............................. 267.16 277.73 296.12 ................
Annual Percent Change................... 0.8989% 3.9568% 6.6212% 3.8256%
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The statute specifies that this 3.8256 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 62.4971
percent was obligated for PC&B (as shown in table 2), 37.5029 percent
is the portion of costs other than PC&B (100 percent minus 62.4971
percent equals 37.5029 percent). The non-payroll adjustment is 3.8256
percent times 37.5029 percent, or 1.4347 percent.
Next, we add the payroll adjustment (2.4549 percent) to the non-
payroll adjustment (1.4347 percent), for a total inflation adjustment
of 3.8896 percent (rounded) for FY 2024.
We then multiply the base revenue amount for FY 2024
($1,256,844,387) by 3.8896 percent, which produces an inflation
adjustment amount of $48,886,219. Adding this amount to the base
revenue amount yields an inflation-adjusted base revenue amount of
$1,305,730,606.
B. FY 2024 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
above, the statute directs FDA to further increase the fee revenue and
fees to support strategic hiring and retention. For FY 2024, this
amount is $4,000,000 (see section 736(c)(2)(A) of the FD&C Act).
C. FY 2024 Statutory Fee Revenue Adjustments for Capacity Planning
The statute specifies that after the base revenue amount for FY
2024 of $1,256,844,387 has been adjusted as described in sections II.A
and II.B above, 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 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.
In FY 2023, updates were made to refine the time reporting
categories included within the CPA to reflect program changes in the
current authorization period. As such, the time reporting data and
baseline capacity were revised to match the refinements. For FY 2024
fees, additional updates were made to account for additional activities
that are also directly related to the direct review of applications and
supplements as provided for in the statute. The updates include
additional formal meeting types and the direct review of postmarketing
commitments (PMC) and requirements (PMR) (see tables 4 and 7), the
direct review of risk evaluation and mitigation strategies, and the
direct review of annual reports for approved prescription drug
products. The Center for Biologics Evaluation and Research (CBER) CPA
was also updated to reflect the PDUFA VII revision of the definition of
``human drug application'' and ``prescription drug product'' to include
allergenic products licensed on or after October 1, 2022. These
additions necessitated an additional re-baselining of capacity.
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 \3\ for direct review-related effort. This is then
compared to current available resources for the direct review-related
workload.
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\3\ Full-time equivalents refer to a paid staff year, rather
than a count of individual employees.
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3. 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 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.
To determine the FY 2024 CPA, FDA calculated a CPA for the Center
for Drug Evaluation and Research (CDER) and CBER individually. The
final Center-level results were then combined to determine the total FY
2024 PDUFA CPA. The following section outlines the major components of
each Center's FY 2024 PDUFA CPA.
Table 4 summarizes the forecasted workload volumes for CDER in FY
2024 based on predictive models, as well as historical actuals from FY
2022 for comparison.
Table 4--CDER Actual FY 2022 Workload Volumes and Predicted FY 2024 Workload Volumes
----------------------------------------------------------------------------------------------------------------
Workload category FY 2022 actuals FY 2024 predictions
----------------------------------------------------------------------------------------------------------------
Efficacy Supplements................................................ 236 203
Labeling Supplements................................................ 902 714
Manufacturing Supplements........................................... 2,084 2,174
NDA/BLA \1\ Original................................................ 128 1,136
PDUFA Industry Meetings (including WROs \2\)........................ 3,647 3,504
[[Page 48884]]
Active Commercial INDs \3\.......................................... 9,535 10,632
Annual Reports \4\.................................................. 3,394 3,504
PMR/PMC-Related Documents \4\....................................... 1,567 1,631
Active REMS Programs \4\ \5\........................................ 21 20
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\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.
Utilizing the resource forecast algorithms, the forecasted workload
volumes for FY 2024 were then converted into estimated FTE needs for
CDER's PDUFA direct review-related work. The resulting expected FY 2024
FTE need for CDER was compared to current resource capacity for direct
review related work to determine the FY 2024 resource delta, as
summarized in table 5. Hiring and re-baselining of current resource
capacity resulted in an increase of both the resource capacity and
resource forecast relative to prior years.
Table 5--CDER FY24 PDUFA Resource Delta
----------------------------------------------------------------------------------------------------------------
Current resource FY 2024 resource Predicted FY 2024
Center capacity forecast FTE delta
----------------------------------------------------------------------------------------------------------------
CDER....................................... 1,931 2,001 70
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The projected 70 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 that can be utilized in the
fiscal year and for which funds are required to support additional
review capacity. After accounting for funded vacancies that are
intended to address direct review workload that is within scope of the
workload accounted for by the capacity planning adjustment, CDER's
delta was adjusted to 38 FTE. The FY 2024 PDUFA CPA for CDER is
therefore $12,778,222, as summarized in table 6.
Table 6--CDER FY 2024 PDUFA CPA
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Additional FTEs for Cost for each CDER FY 2024 PDUFA
Center FY 2024 additional FTE CPA
----------------------------------------------------------------------------------------------------------------
CDER....................................... 38 $336,269 $12,778,222
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To calculate the FY 2024 PDUFA CPA for CBER, FDA followed the
approach outlined above. Table 7 summarizes the forecasted workload
volumes for CBER in FY 2024 as well as the corresponding historical
actuals from FY 2022 for comparison.
Table 7--CBER Actual FY 2022 Workload Volumes and Predicted FY 2024 Workload Volumes
----------------------------------------------------------------------------------------------------------------
Workload category FY 2022 actuals FY 2024 predictions
----------------------------------------------------------------------------------------------------------------
Efficacy Supplements................................................ 22 23
Labeling Supplements................................................ 52 45
Manufacturing Supplements........................................... 684 692
NDA/BLA \1\ Original................................................ 13 11
PDUFA Industry Meetings (including WROs \2\)........................ 635 715
Active Commercial INDs \3\.......................................... 1,694 1,974
Annual Reports \4\.................................................. 292 304
PMR/PMC-Related Documents \4\....................................... 140 151
Active REMS Programs \4\ \5\........................................ 2 2
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\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.
[[Page 48885]]
The forecasted CBER PDUFA workload for FY 2024 was then converted
into expected FTE resources and compared to current resource capacity
for PDUFA direct review work, as summarized in table 8. Hiring and re-
baselining of current resource capacity resulted in an increase of both
the resource capacity and resource forecast relative to prior years.
Table 8--CBER FY 2024 PDUFA Resource Delta
----------------------------------------------------------------------------------------------------------------
Current resource FY 2024 resource Predicted FY 2024 FTE
Center capacity forecast delta
----------------------------------------------------------------------------------------------------------------
CBER....................................... 408 452 44
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The projected 44 FTE delta for CBER was also assessed in the
context of other operational and financial factors that may impact the
need and/or feasibility of obtaining the additional resources. After
considering subject matter expert input on industry trends and
workload, reviewing the historical accuracy of workload forecasts,
accounting for historical net FTE gains within CBER and the hiring
necessary to meet the hiring commitments set forth for FY 2024 in the
PDUFA VII commitment letter, and subtracting previously funded PDUFA
vacancies aligned with CPA-covered activities, CBER determined that an
adjustment of 34 additional FTEs for FY 2024 is needed. The FY 2024 CPA
for CBER is therefore $11,157,847, as summarized in table 9.
Table 9--CBER FY 2024 PDUFA CPA
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Additional FTEs for Cost for each
Center FY 2024 additional FTE CBER FY 2024 CPA
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CBER....................................... 34 $328,172 $11,157,847
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The CDER and CBER CPA amounts were then added together to determine
the PDUFA CPA for FY 2024 of $23,936,069, as outlined in table 10. FDA
will track the utilization of the CPA funds to ensure they are
supporting the organizational components engaged in PDUFA direct review
work to enhance resources and expand staff capacity and capability.
Should FDA be unable to utilize any amounts of the CPA funds during the
fiscal year, it will not spend those funds and the unspent funds will
be transferred to the carryover balance at the end of the fiscal year.
Table 10--FY 2024 PDUFA CPA
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Center FY 2024 PDUFA CPA
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CDER.............................................. $12,778,222
CBER.............................................. 11,157,847
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Total......................................... 23,936,069
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D. FY 2024 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 FTE to support
enhancements outlined in the PDUFA VII commitment letter. The
additional dollar amount for FY 2024 as outlined in statute is
$25,097,671 (see section 736(b)(1)(F) of the FD&C Act). This amount
will be added to the total FY 2024 PDUFA VII revenue amount.
Table 11--Base Revenue Amount and Section 736(c)(1) Through (3)
Adjustment Amounts
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Fee Amount
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Statutory Fee Revenue Base Amount (section 736(b)(3) $1,256,844,387
of the FD&C Act).....................................
Statutory Fee Revenue Adjustments for Inflation 48,886,219
(section 736(c)(1) of the FD&C Act)..................
Strategic Hiring and Retention Adjustment (section 4,000,000
736(c)(2)(A) of the FD&C Act)........................
Statutory Fee Revenue Adjustments for Capacity 23,936,069
Planning (section 736(c)(3) of the FD&C Act).........
Statutory Fee Revenue Adjustments for Additional 25,097,671
Dollar Amounts (section 736(b)(1)(F) of the FD&C Act)
-----------------
Cumulative Revenue Amount after Adjustments in 1,358,764,346
sections 736(c)(1), (2), (3), and (4) of the FD&C
Act..............................................
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E. FY 2024 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 2024, FDA is
required to further increase fee revenue and fees if an adjustment is
necessary to provide for at least 9 weeks of operating reserves of
carryover user fees (see section 736(c)(4)(A)(i) 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 decrease fee
[[Page 48886]]
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 9-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
2024 base revenue (see section 736(c)(4)(A) of the FD&C Act), resulting
in $1,358,764,346. This amount is then divided by 52 to generate the 1-
week operating amount of $26,130,084. The 1-week operating amount is
then multiplied by 9 and 14. This results in a 9-week threshold amount
of $235,170,752 and a 14-week threshold amount of $365,821,170.
To determine the FY 2023 end-of-year operating reserves of
carryover user fees, the Agency assessed the operating reserve of
carryover fees at the end of June 2023 and forecast collections and
obligations in the fourth quarter of FY 2023 combined. This provides an
estimated end-of-year FY 2023 operating reserve of carryover user fees
of $321,648,510, which equates to 12.3 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 2023 end-of-year operating reserves of
carryover user fees are within the 9-week and 14-week thresholds, FDA
will not increase or reduce the FY 2024 fees or fee revenue under the
statutory provision for operating reserve adjustments.
Table 12--Base Revenue Amount and Section 736(c)(1) Through (4)
Adjustment Amounts
------------------------------------------------------------------------
Fee Amount
------------------------------------------------------------------------
Statutory Fee Revenue Base Amount (section 736(b)(3) $1,256,844,387
of the FD&C Act).....................................
Statutory Fee Revenue Adjustments for Inflation 48,886,219
(section 736(c)(1) of the FD&C Act)..................
Strategic Hiring and Retention Adjustment (section 4,000,000
736(c)(2)(A) of the FD&C Act)........................
Statutory Fee Revenue Adjustments for Capacity 23,936,069
Planning (section 736(c)(3) of the FD&C Act).........
Statutory Fee Revenue Adjustments for Additional 25,097,671
Dollar Amounts (section 736(b)(1)(F) of the FD&C Act)
Operating Reserve Adjustment (section 736(c)(4) of the ................
FD&C Act)............................................
-----------------
Cumulative Revenue after Adjustments in sections 1,358,764,346
736(c)(1), (2), (3), and (4) of the FD&C Act.....
------------------------------------------------------------------------
F. FY 2024 Statutory Fee Revenue Adjustments for Additional Direct Cost
PDUFA VII specifies that an additional direct cost of $63,339,404
is to be added to the total FY 2024 PDUFA revenue amount (see section
736(c)(5) of the FD&C Act). With respect to target revenue for FY 2024,
adding the additional direct cost amount of $63,339,404 to the
inflation, strategic hiring and retention, CPA, additional dollar
amount, and operating reserve adjustment of $1,358,764,346 results in
the total revenue amount of $1,422,104,000 (rounded to the nearest
thousand dollars).
Table 13--Total Estimated Adjusted Revenue Amount
------------------------------------------------------------------------
------------------------------------------------------------------------
Statutory Fee Revenue Base Amount (section 736(b)(3) $1,256,844,387
of the FD&C Act).....................................
Statutory Fee Revenue Adjustments for Inflation 48,886,219
(section 736(c)(1) of the FD&C Act)..................
Strategic Hiring and Retention Adjustment (section 4,000,000
736(c)(2)(A) of the FD&C Act)........................
Statutory Fee Revenue Adjustments for Capacity 23,936,069
Planning (section 736(c)(3) of the FD&C Act).........
Statutory Fee Revenue Adjustments for Additional 25,097,671
Dollar Amounts (section 736(b)(1)(F) of the FD&C Act)
Operating Reserve Adjustment (section 736(c)(4) of the ................
FD&C Act)............................................
Additional Direct Cost (section 736(c)(5) of the FD&C 63,339,404
Act).................................................
-----------------
Cumulative Revenue Amount after Adjustments in 1,422,104,000
sections 736(c)(1), (2), (3), and (4) of the FD&C
Act..............................................
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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 $284,420,800 in FY 2024.
B. Estimate of the Number of Fee-Paying Applications and Setting the
Application Fees
Historically, 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
three most recently completed fiscal years. For FY 2024 fee setting,
the 3 relevant fiscal years are FYs 2020,\5\ 2021, and 2022. Prior year
FAE totals are updated annually to reflect refunds and waivers
processed after the close of the fiscal year.
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\5\ FY 2020 data was omitted in FY 2022 methodology as FDA took
into account the global COVID-19 pandemic situation at the time.
However, after reviewing the data trend, FY 2020 data is included in
this year's methodology given the higher FAE count for FY 2021. See
table 14.
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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 14 shows, the average number of fee-paying FAEs received
annually in FY 2020 through FY 2022 is 70.25. FDA will set fees for FY
2024 based on this estimate as the number of full application
equivalents that will be subject to fees.
[[Page 48887]]
Table 14--Fee-Paying FAEs
----------------------------------------------------------------------------------------------------------------
FY 2020 FY 2021 FY 2022 3-Year average
----------------------------------------------------------------------------------------------------------------
Fee-Paying FAEs..................... 65.25 90.50 55.00 70.25
----------------------------------------------------------------------------------------------------------------
Note: Prior year FAE totals are updated annually to reflect refunds and waivers processed after the close of the
fiscal year.
The FY 2024 application fee is estimated by dividing the average
number of full applications that paid fees from FY 2020 through FY
2022, 70.25, into the fee revenue amount to be derived from application
fees in FY 2024, $284,420,800. The result is a fee of $4,048,695 per
full application requiring clinical data, and $2,024,348 per
application not requiring clinical data.
IV. Fee Calculation for Prescription Drug 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 $1,137,683,200 in FY
2024.
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 fiscal year for user fee eligible
prescription drug products identified in a human drug application
approved as of October 1 of such fiscal year. 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 fiscal year.
FDA estimates 2,928 program fees will be invoiced in FY 2024 before
factoring in waivers, refunds, exceptions, and exemptions. FDA
approximates that there will be 55 waivers and refunds granted. In
addition, FDA approximates that another 41 program fees will be
exempted in FY 2024 based on the orphan drug exemption in section
736(k) of the FD&C Act.
PDUFA VII changed the definition of the same product exception for
program fees. FDA determined that 102 products may be eligible for the
pharmaceutical equivalence same product exception. An additional
exception for program fees for skin-test diagnostic products is
included in the PDUFA VII. FDA has determined that there are nine skin-
test diagnostic application products that may be eligible for the
exception for skin diagnostic tests. FDA estimates 2,730 program fees
in FY 2024, after allowing for an estimated 198 waivers and reductions,
including the orphan drug exemptions, excepted and exempted fee-liable
products. The FY 2024 prescription drug program fee rate is calculated
by dividing the adjusted total revenue from program fees
($1,137,683,200) by the estimated 2,730 program fees, resulting in a FY
2024 program fee of $416,734 (rounded to the nearest dollar).
V. Fee Schedule for FY 2024
The fee rates for FY 2024 are displayed in table 15.
Table 15--Fee Schedule for FY 2024
------------------------------------------------------------------------
Fee rates
Fee category for FY 2024
------------------------------------------------------------------------
Application:
Requiring clinical data................................ $4,048,695
Not requiring clinical data............................ 2,024,348
Program.................................................... 416,734
------------------------------------------------------------------------
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, 2023. Payment must be made in U.S.
currency by electronic check, check, bank draft, wire transfer, or U.S.
postal money order payable to the order of the Food and Drug
Administration. The preferred payment method is online using electronic
check (Automated Clearing House (ACH) also known as eCheck) or credit
card (Discover, VISA, MasterCard, American Express).
FDA has partnered with the U.S. Department of the Treasury to use
<a href="http://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 the FDA 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.
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 979107, 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 979107, 1005 Convention Plaza, St. Louis,
MO 63101. (Note: This U.S. Bank address is for courier delivery only.
If you have any questions concerning courier delivery, contact the U.S.
Bank at 314-418-4013. This telephone number is only for questions about
courier delivery.) Please make sure that the FDA post office box number
(P.O. Box 979107) 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,
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.
[[Page 48888]]
B. Prescription Drug Program Fees
FDA will issue invoices and payment instructions for FY 2024
program fees under the new fee schedule in August 2023. Under section
736(a)(2)(A)(i) of the FD&C Act, prescription drug program fees are due
on October 2, 2023.
FDA will issue invoices in December 2024 for products that qualify
for FY 2024 program fee assessments after the October 2023 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, 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 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-15911 Filed 7-27-23; 8:45 am]
BILLING CODE 4164-01-P
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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.