Prescription Drug User Fee Rates for Fiscal Year 2024, 48881-48888 [2023-15911]
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Federal Register / Vol. 88, No. 144 / Friday, July 28, 2023 / Notices
to calculate the small business
adjustment factor for FY 2024.
Therefore, the establishment fee for a
non-small business for FY 2024 is
$15,000 multiplied by 1.239215 plus
$1,447, which equals $20,036 (rounded
to the nearest dollar).
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3. Reinspection Fee
Section 744K(c)(1)(B) of the FD&C Act
provides that the amount of the FY 2024
reinspection fee is equal to $15,000,
multiplied by the inflation adjustment
factor for that fiscal year. The inflation
adjustment factor for FY 2024 is
1.239215. Therefore, the reinspection
fee for FY 2024 is $15,000 multiplied by
1.239215, which equals $18,588
(rounded to the nearest dollar). There is
no reduction in this fee for small
businesses.
result in a loss of status as an
outsourcing facility on January 1, 2024.
Entities should submit their registration
information no later than December 10,
2023, to allow enough time for review
of the registration information,
invoicing, and payment of fees before
the end of the registration period.
B. Reinspection Fee
FDA will issue invoices for each
reinspection after the conclusion of the
reinspection, via email to the email
address indicated in the registration file
or via regular mail if email is not an
option. Payments must be made within
30 days of the invoice date.
C. Fee Payment Procedures
1. The preferred payment method is
online using electronic check
(Automated Clearing House (ACH) also
C. Summary of FY 2024 Fee Rates
known as eCheck) or credit card
(Discover, VISA, MasterCard, American
TABLE 4—OUTSOURCING FACILITY
Express). Secure electronic payments
FEES
can be submitted using the User Fees
Payment Portal at https://
Qualified Small Business Estabuserfees.fda.gov/pay. (Note: only full
lishment Fee ...........................
$6,196.00 payments are accepted. No partial
Non-Small Business Establishpayments can be made online.) Once
ment Fee .................................
20,036.00
Reinspection Fee ........................
18,588.00 you search for your invoice, click ‘‘Pay
Now’’ to be redirected to Pay.gov.
Electronic payment options are based on
III. Fee Payment Options and
the balance due. Payment by credit card
Procedures
is available for balances less than
A. Establishment Fee
$25,000. If the balance exceeds this
amount, only the ACH option is
Once an entity submits registration
available. Payments must be made using
information and FDA has determined
U.S. bank accounts as well as U.S. credit
that the information is complete, the
cards.
entity will incur the annual
2. If a check, bank draft, or postal
establishment fee. FDA will send an
money order is submitted, make it
invoice to the entity, via email to the
payable to the order of the Food and
email address indicated in the
Drug Administration and include the
registration file. The invoice will
user fee ID number to ensure that the
contain information regarding the
payment is applied to the correct fee(s).
obligation incurred, the amount owed,
and payment procedures. A facility will Payments can be mailed to: Food and
Drug Administration, P.O. Box 979107,
not be registered as an outsourcing
St. Louis, MO 63197–9000. If a check,
facility until it has paid the annual
establishment fee under section 744K of bank draft, or money order is to be sent
by a courier that requests a street
the FD&C Act. Accordingly, it is
address, the courier should deliver your
important that facilities seeking to
payment to: U.S. Bank, Attention:
operate as outsourcing facilities pay all
Government Lockbox 979107, 1005
fees immediately upon receiving an
invoice. If an entity does not pay the full Convention Plaza, St. Louis, MO 63101.
(Note: This U.S. Bank address is for
invoiced amount within 15 calendar
courier delivery only. If you have any
days after FDA issues the invoice, FDA
questions concerning courier delivery,
will consider the submission of
contact the U.S. Bank at 314–418–4013.
registration information to have been
This telephone number is only for
withdrawn and adjust the invoice to
questions about courier delivery.) Please
reflect that no fee is due.
Outsourcing facilities that registered
make sure that the FDA post office box
in FY 2023 and wish to maintain their
number (P.O. Box 979107) is written on
status as an outsourcing facility in FY
the check, bank draft, or postal money
2024 must register during the annual
order.
registration period that lasts from
3. For payments made by wire
October 1, 2023, to December 31, 2023.
transfer, the invoice number must be
Failure to register and complete
included. Without the invoice number
payment by December 31, 2023, will
the payment may not be applied.
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48881
Regarding reinspection fees, if the
payment amount is not applied, the
invoice amount will be referred to
collections. The originating financial
institution may charge a wire transfer
fee. If the financial institution charges a
wire transfer fee, it is required that the
outsourcing facility add that amount to
the payment to ensure that the invoice
is paid in full. Use the following
account information when sending a
wire transfer: U.S. Dept 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.
Dated: July 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–15909 Filed 7–27–23; 8:45 am]
BILLING CODE 4164–01–P
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.
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 OO-OFBAP-OFM-UFSSGovernment@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
Sections 735 and 736 of the FD&C Act
(21 U.S.C. 379g and 379h, respectively)
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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.
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
Total PC&B ......................................................................................
Total FTE .........................................................................................
PC&B per FTE .................................................................................
Percent Change from Previous Year ..............................................
The statute specifies that this 3.9280
percent be multiplied by the proportion
of PC&B costs to the total FDA costs of
FY 2021
$2,875,592,000
$17,535
$163,992
7.3063%
FY 2022
$3,039,513,000
$18,501
$164,289
0.1811%
the process for the review of human
drug applications. Table 2 shows the
PC&B and the total obligations for the
$3,165,477,000
$18,474
$171,348
4.2967%
3-Year average
............................
............................
............................
3.9280%
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
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Total PC&B ......................................................................................
Total Costs .......................................................................................
PC&B Percent ..................................................................................
FY 2021
$891,395,106
$1,471,144,928
60.5919%
FY 2022
$959,387,333
$1,499,064,056
63.9991%
$931,302,114
$1,480,601,875
62.9002%
3-Year average
............................
............................
62.4971%
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 nonpayroll costs is the average annual
percent change that occurred in the
Consumer Price Index for urban
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 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
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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the Washington-Arlington-Alexandria
area.2
TABLE 3—ANNUAL AND 3-YEAR AVERAGE PERCENT CHANGE IN CPI FOR WASHINGTON-ARLINGTON-ALEXANDRIA AREA
FY 2020
Annual CPI .......................................................................................
Annual Percent Change ..................................................................
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
FY 2021
267.16
0.8989%
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
FY 2022
277.73
3.9568%
3-Year average
296.12
6.6212%
............................
3.8256%
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 reviewrelated effort. This is then compared to
current available resources for the direct
review-related workload.
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 Centerlevel 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
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Workload category
FY 2022 actuals
Efficacy Supplements ......................................................................................................................
Labeling Supplements .....................................................................................................................
Manufacturing Supplements ............................................................................................................
NDA/BLA 1 Original ..........................................................................................................................
PDUFA Industry Meetings (including WROs 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_
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236
902
2,084
128
3,647
FY 2024 predictions
203
714
2,174
1,136
3,504
3 Full-time equivalents refer to a paid staff year,
rather than a count of individual employees.
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TABLE 4—CDER ACTUAL FY 2022 WORKLOAD VOLUMES AND PREDICTED FY 2024 WORKLOAD VOLUMES—Continued
Workload category
FY 2022 actuals
Active Commercial INDs 3 ...............................................................................................................
Annual Reports 4 ..............................................................................................................................
PMR/PMC-Related Documents 4 .....................................................................................................
Active REMS Programs 4 5 ..............................................................................................................
FY 2024 predictions
9,535
3,394
1,567
21
10,632
3,504
1,631
20
1 New
drug applications (NDA)/biological license applications (BLA).
responses only (WROs).
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.
2 Written
3 For
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
Center
Current
resource capacity
FY 2024
resource forecast
Predicted
FY 2024 FTE delta
CDER .......................................................................................................
1,931
2,001
70
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
Center
Additional FTEs
for FY 2024
Cost for each
additional FTE
CDER FY 2024
PDUFA CPA
CDER .......................................................................................................
38
$336,269
$12,778,222
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
Efficacy Supplements ......................................................................................................................
Labeling Supplements .....................................................................................................................
Manufacturing Supplements ............................................................................................................
NDA/BLA 1 Original ..........................................................................................................................
PDUFA Industry Meetings (including WROs 2) ...............................................................................
Active Commercial INDs 3 ...............................................................................................................
Annual Reports 4 ..............................................................................................................................
PMR/PMC-Related Documents 4 .....................................................................................................
Active REMS Programs 4 5 ..............................................................................................................
22
52
684
13
635
1,694
292
140
2
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1 New
FY 2024 predictions
23
45
692
11
715
1,974
304
151
2
drug applications (NDA)/biological license applications (BLA).
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.
2 Written
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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 rebaselining 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
Center
Current
resource capacity
FY 2024
resource forecast
Predicted
FY 2024 FTE delta
CBER .......................................................................................................
408
452
44
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
Center
Additional FTEs
for FY 2024
Cost for each
additional FTE
CBER FY 2024 CPA
CBER .......................................................................................................
34
$328,172
$11,157,847
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
Center
FY 2024 PDUFA CPA
CDER .......................................................................................................................................................................................
CBER .......................................................................................................................................................................................
$12,778,222
11,157,847
Total ..................................................................................................................................................................................
23,936,069
D. FY 2024 Statutory Fee Revenue
Adjustments for Additional Dollar
Amounts
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
PDUFA VII provides an additional
dollar amount for each of the 5 fiscal
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
Statutory Fee Revenue Base Amount (section 736(b)(3) of the FD&C Act) ..................................................................................
Statutory Fee Revenue Adjustments for Inflation (section 736(c)(1) of the FD&C Act) .................................................................
Strategic Hiring and Retention Adjustment (section 736(c)(2)(A) of the FD&C Act) ......................................................................
Statutory Fee Revenue Adjustments for Capacity Planning (section 736(c)(3) of the FD&C Act) ................................................
Statutory Fee Revenue Adjustments for Additional Dollar Amounts (section 736(b)(1)(F) of the FD&C Act) ...............................
$1,256,844,387
48,886,219
4,000,000
23,936,069
25,097,671
Cumulative Revenue Amount after Adjustments in sections 736(c)(1), (2), (3), and (4) of the FD&C Act ............................
1,358,764,346
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
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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
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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
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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 1week 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
Because the estimated FY 2023 endof-year operating reserves of carryover
user fees are within the 9-week and 14week 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) of the FD&C Act) ..................................................................................
Statutory Fee Revenue Adjustments for Inflation (section 736(c)(1) of the FD&C Act) .................................................................
Strategic Hiring and Retention Adjustment (section 736(c)(2)(A) of the FD&C Act) ......................................................................
Statutory Fee Revenue Adjustments for Capacity Planning (section 736(c)(3) of the FD&C Act) ................................................
Statutory Fee Revenue Adjustments for Additional Dollar Amounts (section 736(b)(1)(F) of the FD&C Act) ...............................
Operating Reserve Adjustment (section 736(c)(4) of the FD&C Act) .............................................................................................
$1,256,844,387
48,886,219
4,000,000
23,936,069
25,097,671
............................
Cumulative Revenue after Adjustments in sections 736(c)(1), (2), (3), and (4) of the FD&C Act ..........................................
1,358,764,346
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) of the FD&C Act) ..................................................................................
Statutory Fee Revenue Adjustments for Inflation (section 736(c)(1) of the FD&C Act) .................................................................
Strategic Hiring and Retention Adjustment (section 736(c)(2)(A) of the FD&C Act) ......................................................................
Statutory Fee Revenue Adjustments for Capacity Planning (section 736(c)(3) of the FD&C Act) ................................................
Statutory Fee Revenue Adjustments for Additional 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 Act) ...........................................................................................................
$1,256,844,387
48,886,219
4,000,000
23,936,069
25,097,671
............................
63,339,404
Cumulative Revenue Amount after Adjustments in sections 736(c)(1), (2), (3), and (4) of the FD&C Act ............................
1,422,104,000
III. Application Fee Calculations
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 feepaying 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.
In estimating the number of feepaying 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.
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.
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).
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.
6 As defined in section 736(a)(1)(A)(i) of the FD&C
Act.
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.
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B. Estimate of the Number of Fee-Paying
Applications and Setting the
Application Fees
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48887
TABLE 14—FEE-PAYING FAES
Fee-Paying FAEs .............................................................................
FY 2020
FY 2021
FY 2022
3-Year average
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.
lotter on DSK11XQN23PROD with NOTICES1
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
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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).
payments can be made online). Once an
invoice is located, ‘‘Pay Now’’ should be
selected to be redirected to 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
V. Fee Schedule for FY 2024
Administration and include the user fee
The fee rates for FY 2024 are
ID number to ensure that the payment
displayed in table 15.
is applied to the correct fee(s). Payments
can be mailed to: Food and Drug
TABLE 15—FEE SCHEDULE FOR FY
Administration, P.O. Box 979107, St.
2024
Louis, MO 63197–9000. If a check, bank
draft, or money order is to be sent by a
Fee
rates
Fee category
for FY 2024 courier that requests a street address,
the courier should deliver your payment
Application:
to: U.S. Bank, Attention: Government
Requiring clinical data .......
$4,048,695 Lockbox 979107, 1005 Convention
Not requiring clinical data ..
2,024,348 Plaza, St. Louis, MO 63101. (Note: This
Program ....................................
416,734
U.S. Bank address is for courier delivery
only. If you have any questions
VI. Fee Payment Options and
concerning courier delivery, contact the
Procedures
U.S. Bank at 314–418–4013. This
telephone number is only for questions
A. Application Fees
about courier delivery.) Please make
The appropriate application fee
sure that the FDA post office box
established in the new fee schedule
number (P.O. Box 979107) is written on
must be paid for any application subject
the check, bank draft, or postal money
to fees under PDUFA VII that is
order.
submitted on or after October 1, 2023.
For payments made by wire transfer,
Payment must be made in U.S. currency
include the unique user fee ID number
by electronic check, check, bank draft,
to ensure that the payment is applied to
wire transfer, or U.S. postal money
the correct fee(s). Without the unique
order payable to the order of the Food
and Drug Administration. The preferred user fee ID number, the payment may
not be applied, which could result in
payment method is online using
FDA not filing an application and other
electronic check (Automated Clearing
penalties. Note: the originating financial
House (ACH) also known as eCheck) or
credit card (Discover, VISA, MasterCard, institution may charge a wire transfer
fee, especially for international wire
American Express).
transfers. Applicable wire transfer fees
FDA has partnered with the U.S.
must be included with payment to
Department of the Treasury to use
ensure fees are paid in full. Questions
Pay.gov, a web-based payment
about wire transfer fees should be
application, for online electronic
addressed to the financial institution.
payment. The Pay.gov feature is
The account information for wire
available on the FDA website after
transfers is as follows: U.S. Department
completing the Prescription Drug User
Fee Cover Sheet and generating the user of the Treasury, TREAS NYC, 33 Liberty
St., New York, NY 10045, Acct. No.:
fee ID number. Secure electronic
75060099, Routing No.: 021030004,
payments can be submitted using the
User Fees Payment Portal at https://
SWIFT: FRNYUS33. If needed, FDA’s
userfees.fda.gov/pay (Note: only full
tax identification number is 53–
payments are accepted. No partial
0196965.
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Federal Register / Vol. 88, No. 144 / Friday, July 28, 2023 / Notices
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–D–0466]
Clinical Considerations for Studies of
Devices Intended To Treat Opioid Use
Disorder; Draft Guidance for Industry
and Food and Drug Administration
Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the draft
guidance entitled ‘‘Clinical
Considerations for Studies of Devices
Intended to Treat Opioid Use Disorder.’’
Design of clinical studies for devices
intended to treat opioid use disorder
(OUD) is challenging. This guidance
provides recommendations for the
design of pivotal clinical studies for
devices intended to treat opioid use
disorder (‘‘OUD device studies’’) and
used to support marketing submissions.
These recommendations are applicable
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
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to the design and development of
clinical studies to provide a reasonable
assurance of safety and effectiveness for
a device intended to treat OUD. This
draft guidance is not final nor is it for
implementation at this time.
DATES: Submit either electronic or
written comments on the draft guidance
by October 26, 2023 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2023–D–0466 for ‘‘Clinical
Considerations for Studies of Devices
Intended to Treat Opioid Use Disorder.’’
Received comments will be placed in
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the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
An electronic copy of the guidance
document is available for download
from the internet. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance. Submit written requests for a
single hard copy of the draft guidance
document entitled ‘‘Clinical
Considerations for Studies of Devices
Intended to Treat Opioid Use Disorder’’
to the Office of Policy, Guidance and
Policy Development, Center for Devices
E:\FR\FM\28JYN1.SGM
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]]>Agencies
[Federal Register Volume 88, Number 144 (Friday, July 28, 2023)]
[Notices]
[Pages 48881-48888]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-15911]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 [email protected].
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.
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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%
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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%
----------------------------------------------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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
----------------------------------------------------------------------------------------------------------------
FY 2020 FY 2021 FY 2022 3-Year average
----------------------------------------------------------------------------------------------------------------
Annual CPI.............................. 267.16 277.73 296.12 ................
Annual Percent Change................... 0.8989% 3.9568% 6.6212% 3.8256%
----------------------------------------------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\3\ Full-time equivalents refer to a paid staff year, rather
than a count of individual employees.
---------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Additional FTEs for Cost for each CDER FY 2024 PDUFA
Center FY 2024 additional FTE CPA
----------------------------------------------------------------------------------------------------------------
CDER....................................... 38 $336,269 $12,778,222
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Additional FTEs for Cost for each
Center FY 2024 additional FTE CBER FY 2024 CPA
----------------------------------------------------------------------------------------------------------------
CBER....................................... 34 $328,172 $11,157,847
----------------------------------------------------------------------------------------------------------------
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
------------------------------------------------------------------------
Center FY 2024 PDUFA CPA
------------------------------------------------------------------------
CDER.............................................. $12,778,222
CBER.............................................. 11,157,847
---------------------
Total......................................... 23,936,069
------------------------------------------------------------------------
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
------------------------------------------------------------------------
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)
-----------------
Cumulative Revenue Amount after Adjustments in 1,358,764,346
sections 736(c)(1), (2), (3), and (4) of the FD&C
Act..............................................
------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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..............................................
------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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
Pay.gov, a web-based payment application, for online electronic
payment. The Pay.gov 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 https://userfees.fda.gov/pay
(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 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 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
