Generic Drug User Fee Rates for Fiscal Year 2024, 48864-48870 [2023-16081]
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Federal Register / Vol. 88, No. 144 / Friday, July 28, 2023 / Notices
the FD&C Act). Noncompliance may
include the following: (1) not initiating
a recall as ordered by FDA; (2) not
conducting the recall in the manner
specified by FDA in the recall order; or
(3) not providing FDA with requested
information regarding the recall, as
ordered by FDA.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
B. Who will be responsible for paying
this fee?
AGENCY:
The fee is based on the number of
direct hours spent on taking action in
response to the firm’s failure to comply
with a recall order. Types of activities
could include conducting recall audit
checks, reviewing periodic status
reports, analyzing the status reports and
the results of the audit checks,
conducting inspections, traveling to and
from locations, and monitoring product
disposition. The direct hours spent on
each such recall will be billed at the
appropriate hourly rate shown in table
2 of this document.
D. How must the fees be paid?
An invoice will be sent to the
responsible party for paying the fee after
FDA completes the work on which the
invoice is based. Payment must be made
within 30 days of the invoice date in
U.S. currency by check, bank draft, or
U.S. postal money order payable to the
order of the Food and Drug
Administration. Detailed payment
information will be included with the
invoice when it is issued.
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V. What are the consequences of not
paying these fees?
Under section 743(e)(2) of the FD&C
Act, any fee that is not paid within 30
days after it is due shall be treated as a
claim of the U.S. Government subject to
provisions of subchapter II of chapter 37
of title 31, United States Code.
BILLING CODE 4164–01–P
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Generic Drug User Fee Rates for Fiscal
Year 2024
ACTION:
C. How much will this fee be?
[FR Doc. 2023–15927 Filed 7–27–23; 8:45 am]
[Docket No. FDA–2023–N–3059]
Food and Drug Administration,
HHS.
Section 743(a)(1)(B) of the FD&C Act
states that the fee is to be paid by the
responsible party for a domestic facility
(as defined in section 415(b) of the
FD&C Act) and an importer who does
not comply with a recall order under
section 423 or under section 412(f) of
the FD&C Act. In other words, the party
paying the fee would be the party that
received the recall order.
Dated: July 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
Food and Drug Administration
Notice.
The Federal Food, Drug, and
Cosmetic Act (FD&C Act or statute), as
amended by the Generic Drug User Fee
Amendments of 2022 (GDUFA III),
authorizes the Food and Drug
Administration (FDA, Agency, or we) to
assess and collect fees for abbreviated
new drug applications (ANDAs); drug
master files (DMFs); generic drug active
pharmaceutical ingredient (API)
facilities, finished dosage form (FDF)
facilities, and contract manufacturing
organization (CMO) facilities; and
generic drug applicant program user
fees. In this document, FDA is
announcing fiscal year (FY) 2024 rates
for GDUFA III fees. These fees are
effective on October 1, 2023, and will
remain in effect through September 30,
2024.
FOR FURTHER INFORMATION CONTACT:
Olufunmilayo Ariyo, Office of Financial
Management, Food and Drug
Administration, 4041 Powder Mill Rd.,
Rm. 62080, Beltsville, MD 20705–4304,
240–402–4989; or the User Fees Support
Staff at OO-OFBAP-OFM-UFSSGovernment@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
Sections 744A and 744B of the FD&C
Act (21 U.S.C. 379j–41 and 379j–42), as
amended by GDUFA III, authorize FDA
to assess and collect fees associated
with human generic drug products. Fees
are assessed on: (1) certain types of
applications for human generic drug
products; (2) certain facilities where
APIs and FDFs are produced; (3) certain
DMFs associated with human generic
drug products; and (4) generic drug
applicants who have ANDAs (the
program fee) (see section 744B(a)(2)
through (5) of the FD&C Act). For more
information about GDUFA III, please
refer to the FDA website (https://
www.fda.gov/gdufa).
For FY 2024, the generic drug fee
rates are ANDA ($252,453), DMF
($94,682), domestic API facility
($40,464), foreign API facility ($55,464),
domestic FDF facility ($220,427),
foreign FDF facility ($235,427),
domestic CMO facility ($52,902), foreign
CMO facility ($67,902), large size
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operation generic drug applicant
program ($1,729,629), medium size
operation generic drug applicant
program ($691,852), and small business
generic drug applicant program
($172,963). These fees are effective on
October 1, 2023, and will remain in
effect through September 30, 2024. The
fee rates for FY 2024 are set out in table
1.
TABLE 1—FEE SCHEDULE FOR FY
2024
Generic drug fee category
Applications
Abbreviated New Drug Application (ANDA) ............
Drug Master File (DMF) ....
Facilities
Active Pharmaceutical Ingredient (API)—Domestic ...................................
API—Foreign .....................
Finished Dosage Form
(FDF)—Domestic ...........
FDF—Foreign ....................
Contract Manufacturing Organization (CMO)—Domestic .............................
CMO—Foreign ..................
GDUFA Program
Large size operation generic drug applicant .......
Medium size operation generic drug applicant .......
Small business generic
drug applicant ................
Fees rates
for
FY 2024
$252,453
94,682
40,464
55,464
220,427
235,427
52,902
67,902
1,729,629
691,852
172,963
II. Fee Revenue Amount for FY 2024
Under section 744B(b)(1)(B)(ii) of the
FD&C Act, the base revenue amount for
FY 2024 for GDUFA III is $582,500,000.
Under section 744B(c)(1) of the FD&C
Act, applicable inflation adjustments to
base revenue shall be made beginning
with FY 2024.
Under section 744B(c)(2) of the FD&C
Act, beginning with FY 2024, FDA shall,
in addition to the inflation adjustment,
apply a capacity planning adjustment to
further adjust, as needed, the fee
revenue and fees to reflect changes in
the resource capacity needs of FDA for
human generic drug activities.
Under section 744B(c)(3) of the FD&C
Act, beginning with FY 2024, FDA may,
in addition to the inflation and capacity
planning adjustments, apply an
operating reserve adjustment to further
increase the fee revenue and fees if
necessary to provide operating reserves
of carryover user fees for human generic
drug activities for not more than the
number of weeks specified in such
section (or as applicable, shall apply
such adjustment to decrease the fee
revenues and fees to provide for not
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more than 12 weeks of such operating
reserves).
A. Inflation Adjustment
As noted, above, the base revenue
amount for FY 2024 is $582,500,000.
This is the total revenue amount
specified for the prior fiscal year, FY
2023, pursuant to the statute (see
section 744B(b)(1)(A) of the FD&C Act).1
GDUFA III specifies that the
$582,500,000 is to be adjusted for
costs to total FDA costs of human
generic drug activities for the first 3 of
the preceding 4 fiscal years (see section
744B(c)(1)(B) of the FD&C Act).
Table 2 summarizes the actual cost
and total FTEs for the specified fiscal
years and provides the percent change
from the previous fiscal year and the
average percent change over the first 3
of the 4 fiscal years preceding FY 2024.
The 3-year average is 3.9280 percent.
inflation for FY 2024 using two separate
adjustments—one for personnel
compensation and benefits (PC&B) and
one for non-PC&B costs (see sections
744B(c)(1)(B) and (C) of the FD&C Act).
The component of the inflation
adjustment for PC&B costs shall be the
average annual percent change in the
cost of all PC&B paid per full-time
equivalent (FTE) position at FDA for the
first 3 of the 4 preceding fiscal years,
multiplied by the proportion of PC&B
TABLE 2—FDA PERSONNEL COMPENSATION AND BENEFITS (PC&B) EACH YEAR AND PERCENT CHANGE
Fiscal year
2020
Total PC&B ........................................................................................
Total FTEs .........................................................................................
PC&B per FTE ...................................................................................
Percent Change from Previous Year ................................................
The statute specifies that this 3.9280
percent should be multiplied by the
proportion of PC&B expended for
2021
$2,875,592,000
17,535
$163,992
7.3063%
2022
$3,039,513,000
18,501
$164,289
0.1811%
human generic drug activities for the
first 3 of the preceding 4 fiscal years.
Table 3 shows the amount of PC&B and
$3,165,477,000
18,474
$171,348
4.2967%
3-Year
average
....................
....................
....................
3.9280%
the total amount obligated for human
generic drug activities from FY 2020
through FY 2022.
TABLE 3—PC&B AS A PERCENT OF FEE REVENUES SPENT ON HUMAN GENERIC DRUG ACTIVITIES OVER THE LAST 3
YEARS
Fiscal year
2020
PC&B .................................................................................................
Non-PC&B .........................................................................................
Total Costs .........................................................................................
PC&B Percent ....................................................................................
Non-PC&B Percent ............................................................................
The payroll adjustment is 3.9280
percent multiplied by 58.2180 percent
(or 2.2868 percent).
The statute specifies that the portion
of the inflation adjustment for nonPC&B costs for FY 2024 is the average
annual percent change that occurred in
the Consumer Price Index (CPI) for
urban consumers (Washington-
2021
$397,392,785
300,692,399
698,085,185
56.9261%
43.0739%
2022
$410,587,565
271,328,560
681,916,125
60.2109%
39.7891%
Arlington-Alexandria Area, DC-VA-MDWV; not seasonally adjusted; all items;
annual index) for the first 3 of the
preceding 4 years of available data
multiplied by the proportion of all costs
other than PC&B costs to total costs of
human generic drug activities for the
first 3 years of the preceding 4 fiscal
years (see section 744B(c)(1)(C) of the
$391,922,747
289,479,265
681,402,012
57.5171%
42.4829%
3-Year
average
....................
....................
....................
58.2180%
41.7820%
FD&C Act). Table 4 provides the
summary data for the percent change in
the specified CPI. 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 4—ANNUAL AND 3-YEAR AVERAGE PERCENT CHANGE IN CPI FOR WASHINGTON-ARLINGTON-ALEXANDRIA AREA
Year
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Annual CPI .......................................................................................................................
Annual Percent Change ..................................................................................................
2020
2021
2022
267.16
0.8989%
277.73
3.9568%
296.12
6.6212%
3-Year
average
....................
3.8256%
To calculate the inflation adjustment
for non-pay costs, we multiply the 3year average percent change in the CPI
(3.8256 percent) by the proportion of all
costs other than PC&B to total costs of
human generic drug activities obligated.
Because 58.2180 percent was obligated
for PC&B as shown in table 3, 41.7820
percent is the portion of costs other than
PC&B. The non-pay adjustment is
3.8256 percent times 41.7820 percent, or
1.5984 percent.
To complete the inflation adjustment
for FY 2024, we add the PC&B
component (2.2868 percent) to the nonPC&B component (1.5984 percent) for a
total inflation adjustment of 3.8852
percent (rounded), and then add 1,
1 Under section 744B(b)(1)(B)(ii), the base revenue
amount for a fiscal year is equal to the total revenue
amount established for the previous fiscal year, not
including any adjustments for such previous fiscal
year under section 744B(c)(3). For FY 2023,
adjustments under section 744B(c)(3) were
inapplicable.
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making an inflation adjustment multiple
of 1.038852. We then multiply the base
revenue amount for FY 2024
($582,500,000) by 1.038852, yielding an
inflation-adjusted amount of
$605,131,290.
B. FY 2024 Statutory Fee Revenue
Adjustments for Capacity Planning
The statute specifies that after the
base revenue amount for FY 2024 of
$582,500,000 has been adjusted for
inflation as described in section A
above, the resulting amount shall be
further adjusted to reflect changes in the
resource capacity needs for human
generic drug activities (see section
744B(c)(2) of the FD&C Act). Following
a process required in the statute, FDA
established the capacity planning
adjustment (CPA) methodology that is
derived from the methodology and
recommendations made in the report
titled ‘‘Independent Evaluation of the
GDUFA Resource Capacity Planning
Adjustment Methodology: Evaluation
and Recommendations’’ as announced
in the Federal Register of August 3,
2020, and incorporating approaches and
attributes determined appropriate by the
Agency, except that the workload
drivers are limited to those specified in
the GDUFA Reauthorization
Performance Goals and Program
Enhancements Fiscal Years 2023–2027
(GDUFA III Commitment Letter).2 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 the accuracy of its
data and estimates over time.3
The CPA methodology consists of 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 4 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 fiscal year, and
whether the additional 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.
Table 5 summarizes the forecasted
workload volumes for the Center for
Drug Evaluation and Research (CDER)
for FY 2024 based on predictive models,
as well as historical actuals from FY
2022 for comparison.
TABLE 5—CDER ACTUAL FY 2022 WORKLOAD VOLUMES AND PREDICTED FY 2024 WORKLOAD VOLUMES
FY 2022
actuals
Workload driver category
ANDA Originals 1 .....................................................................................................................................................
ANDA Supplements 2 ...............................................................................................................................................
Pre-ANDA Meetings ................................................................................................................................................
Controlled Correspondences 3 .................................................................................................................................
Suitability Petitions ...................................................................................................................................................
Annual Reports 4 ......................................................................................................................................................
Active REMS Programs 4 5 ......................................................................................................................................
813
9,716
132
3,677
21
11,826
45
FY 2024
predictions
801
10,434
103
3,505
25
12,624
45
1 Excludes
response to refused to receive (RTR) and Orig-2+. ANDA Original and Resubmissions/Amendments captured in time reporting data.
changes being effected and prior approval supplement Manufacturing and Labeling Supplements. PAS exclude response to RTRs,
risk evaluation and mitigation strategies (REMS) and Bioequivalence Supplements. ANDA Supplement and Resubmissions/Amendments captured in time reporting data.
3 Includes all requesting controlled correspondences.
4 Represents post-marketing safety activities developed in alignment with Prescription Drug User Fee Act and biosimilar user fee amendments
as applicable.
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 Includes
Utilizing the resource forecast
algorithms, the forecasted workload
volumes for FY 2024 were then
converted into estimated FTE needs for
FDA’s GDUFA direct review-related
work. The resulting expected FY 2024
FTE need for GDUFA was compared to
current onboard capacity for GDUFA
direct review-related work to determine
the FY 2024 resource delta, as
summarized in table 6.
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TABLE 6—CDER FY 2024 GDUFA RESOURCE DELTA
Center
Current
resource
capacity
FY 2024
resource
forecast
Predicted
FY 2024
FTE delta
CDER ...........................................................................................................................................
1,024
1,059
35
The projected 35 FTE delta was
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 assessing current hiring capacity
and existing funded vacancies, CDER
adjusted the 35 FTE delta to 25 FTEs.
2 Section 744B(c)(2)(B) of the FD&C Act; see also
section VIII.B.2.e. of the GDUFA III Commitment
Letter available at https://www.fda.gov/media/
153631/download.
3 For example, starting with FY 2025, FDA will
aim to refine the CPA methodology to reflect a more
comprehensive assessment of the applicable
workload drivers across the Agency.
4 Full-time equivalents refer to a paid staff year,
rather than a count of individual employees.
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The adjusted 25 FTE delta was then
assessed by FDA to determine if the
delta exceeded the CPA cap as specified
in statute (section 744B(c)(2)(C)(ii))
which articulates that for FY 2024, the
CPA shall not exceed 3 percent of
inflation-adjusted base revenue, except
that the CPA cap may be increased to 4
percent of inflation-adjusted base
revenue if the following conditions are
met during the period from April 1,
2021 through March 31, 2023: (1) the
total number of ANDAs submitted was
greater than or equal to 2,000 or (2) 35
percent or more of ANDAs submitted
related to complex products (as defined
in section XI of the letters described in
FDA determined that the criteria to
increase the CPA cap was not, and
therefore, the GDUFA CPA cap for FY
2024 is 3 percent of inflation-adjusted
base revenue. FDA further determined
that the 25 FTE delta when converted to
dollars did not exceed 3 percent of FY
2024 inflation-adjusted base revenue,
and therefore, this 25 FTE delta required
no further adjustment.
The FY 2024 GDUFA CPA is therefore
$8,406,725, as summarized in table 8.
section 3001(b) of the Generic Drug User
Fee Amendments of 2022).5
Table 7 summarizes the total number
of ANDAs submitted and the percentage
of such applications that were related to
complex products from April 1, 2021
through March 31, 2023:
TABLE 7—GDUFA CPA CAP
ASSESSMENT METRICS
Abbreviated New Drug Applications
Submitted between April 1, 2021
through March 31, 2023 .................
Percentage of Abbreviated New Drug
Applications Submitted that are
Complex Submitted between April
1, 2021 through March 31, 2023 ....
48867
1,675
16%
TABLE 8—FY 2024 GDUFA CPA
Center
Additional
FTEs for 2024
Cost for
each
additional FTE
CDER FY
2024
GDUFA CPA
CDER ...........................................................................................................................................
25
$336,269
$8,406,725
more than 12 weeks of such operating
TABLE 9—BASE REVENUE AMOUNT
AND SECTION 744B(c)(1) AND (2) reserves).
The upward operating reserve
ADJUSTMENT AMOUNTS
adjustment is discretionary—for FY
2024, FDA may take an adjustment to
provide for not more than 8 weeks of
Statutory Fee Revenue Base
operating reserve. If carryover is more
Amount (section
than 12 weeks of operating reserve, FDA
744B(b)(1) of the FD&C
must decrease the fee revenues and fees
Act) ....................................
$582,500,000
to provide for not more than 12 weeks
Statutory Fee Revenue Adof operating reserve. To calculate the 8justments for Inflation (secweek and 12-week threshold amounts
tion 744B(c)(1) of the
FD&C Act) .........................
22,631,290 for the FY 2024 operating reserve
Statutory Fee Revenue Adadjustment, the FY 2024 estimated
justments for Capacity
adjusted revenue amount, $613,538,015
Planning (section
is divided by 52, resulting in a
744B(c)(2) of the FD&C
$11,798,808 cost of operation for 1
Act) ....................................
8,406,725
week. The 1-week value is then
Cumulative Adjusted Revmultiplied by 8 weeks to generate the 8enue Amount (sections
week operating reserve threshold
744B(b)(1), 744B(c)(1),
amount for FY 2024 of $94,390,464. The
and 744B(c)(2) of the
FD&C Act ..........................
613,538,015 1-week value is multiplied by 12 to
generate the 12-week operating reserve
threshold amount for FY 2024 of
C. FY 2024 Statutory Fee Revenue
Adjustments for Operating Reserve
$141,585,696.
To determine the FY 2023 end-of-year
Under section 744B(c)(3) of the FD&C
Act, beginning with FY 2024, FDA may, operating reserves of carryover user fees,
in addition to the inflation and capacity the Agency assessed the operating
reserve of carryover fees at the end of
planning adjustments, apply an
June 2023 and forecast collections and
operating reserve adjustment to further
obligations in the fourth quarter of FY
increase the fee revenue and fees if
2023 combined. This provides an
necessary to provide operating reserves
of carryover user fees for human generic estimated end-of-year FY 2023 operating
reserve of carryover user fees of
drug activities for not more than the
$130,218,707 which equates to 11.04
number of weeks specified in such
weeks of operations.
section (or as applicable, shall apply
such adjustment to decrease the fee
The statutory criteria for an operating
revenues and fees to provide for not
reserve adjustment were not met. Table
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TABLE 10—TOTAL ESTIMATED
ADJUSTED REVENUE AMOUNT
Amount
5 Definition of complex products in section XI of
the GDUFA III Commitment Letter https://
www.fda.gov/media/153631/download.
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6 Section
Fee
Statutory Fee Revenue Base
Amount (section
744B(b)(1) of the FD&C
Act) ....................................
Statutory Fee Revenue Adjustments for Inflation (section 744B(c)(1) of the
FD&C Act) .........................
Statutory Fee Revenue Adjustments for Capacity
Planning (section
744B(c)(2) of the FD&C
Act) ....................................
Operating Reserve Adjustment (section 744B(c)(3)
of the FD&C Act) ..............
Total Revenue Amount
(rounded to the nearest
thousand dollars) (sections
744B(b)(1), 744B(c)(1),
744B(c)(2) and 744B(c)(3)
of the FD&C Act) ..............
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$582,500,000
22,631,290
8,406,725
........................
613,538,000
III. ANDA Filing Fee
Under GDUFA III, the FY 2024 ANDA
filing fee is owed by each applicant that
submits an ANDA on or after October 1,
2023.6 This fee is due on the submission
date of the ANDA. Section 744B(b)(2)(B)
of the FD&C Act specifies that the
ANDA fee will make up 33 percent of
744B(a)(3) of the FD&C Act.
Frm 00082
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the $613,538,000, which is
$202,467,540.
To calculate the ANDA fee, FDA
estimated the number of full application
equivalents (FAEs) that will be
submitted in FY 2024. The submissions
are broken down into three categories:
new originals (submissions that have
not been received by FDA previously),
submissions that FDA RTR for reasons
other than failure to pay fees, and
applications that are resubmitted after
an RTR decision for reasons other than
failure to pay fees. An ANDA counts as
one FAE; however, 75 percent of the fee
paid for an ANDA that has been RTR
shall be refunded according to GDUFA
III if: (1) the ANDA is refused for a cause
other than failure to pay fees or (2) the
ANDA has been withdrawn prior to
receipt (section 744B(a)(3)(D)(i) of the
FD&C Act). Therefore, an ANDA that is
considered not to have been received by
FDA due to reasons other than failure to
pay fees or withdrawn prior to receipt
counts as one-fourth of an FAE. After an
ANDA has been RTR, the applicant has
the option of resubmitting. For user fee
purposes, these resubmissions are
equivalent to new original submissions:
ANDA resubmissions are charged the
full amount for an application (one
FAE).
As shown in table 5, FDA estimates
that 801 new original ANDAs will be
submitted and incur filing fees in FY
2024. Not all of the new original ANDAs
will be received by FDA and some of
those not received will be resubmitted
in the same fiscal year. Therefore, FDA
expects that the FAE count for ANDAs
will be 802 for FY 2024.
The FY 2024 ANDA filing fee is
estimated by dividing the number of
FAEs that will incur the fee in FY 2024
(802) into the fee revenue amount to be
derived from ANDA filing fees in FY
2024 ($202,467,540). The result,
rounded to the nearest dollar, is a fee of
$252,453 per ANDA.
The statute provides that those
ANDAs that include information about
the production of APIs other than by
reference to a DMF will pay an
additional fee that is based on the
number of such APIs and the number of
facilities proposed to produce those
ingredients (see section 744B(a)(3)(F) of
the FD&C Act). FDA anticipates that this
additional fee is unlikely to be assessed
often; therefore, FDA has not included
projections concerning the amount of
this fee in calculating the fees for
ANDAs.
IV. DMF Fee
Under GDUFA III, the DMF fee is
owed by each person that owns a type
II API DMF that is referenced, on or
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after October 1, 2012, in a generic drug
submission by an initial letter of
authorization.7 This is a one-time fee for
each DMF. This fee is due on the earlier
of the date on which the first generic
drug submission is submitted that
references the associated DMF or the
date on which the DMF holder requests
the initial completeness assessment.
Under section 744B(a)(2)(D)(iii) of the
FD&C Act, if a DMF has successfully
undergone an initial completeness
assessment and the fee is paid, the DMF
will be placed on a publicly available
list documenting DMFs available for
reference.
To calculate the DMF fee, FDA
assessed the volume of DMF
submissions over time. We assessed
DMFs from October 1, 2021, to April 30,
2023, and concluded that averaging the
number of fee-paying DMFs provided
the most accurate model for predicting
fee-paying DMFs for FY 2024. The
monthly average of paid DMF
submissions FDA received during FY
2022 and FY 2023 is 27. To determine
the FY 2024 projected number of feepaying DMFs, the average of 27 DMF
submissions is multiplied by 12 months,
which results in 324 estimated FY 2024
fee-paying DMFs. FDA is estimating 324
fee-paying DMFs for FY 2024.
The FY 2024 DMF fee is determined
by dividing the DMF target revenue by
the estimated number of fee-paying
DMFs in FY 2024. Section 744B(b)(2)(A)
of the FD&C Act specifies that the DMF
fees will make up 5 percent of the
$613,538,000, which is $30,676,900.
Dividing the DMF revenue amount
($30,676,900) by the estimated feepaying DMFs (324), and rounding to the
nearest dollar, yields a DMF fee of
$94,682 for FY 2024.
V. Foreign Facility Fee Differential
Under GDUFA III, the fee for a facility
located outside the United States and its
territories and possessions shall be
$15,000 higher than the amount of the
fee for a facility located in the United
States and its territories and
possessions.8 The basis for this
differential is the extra cost incurred by
conducting an inspection outside the
United States and its territories and
possessions.
VI. FDF and CMO Facility Fees
Under GDUFA III, the annual FDF
facility fee is owed by each person who
owns an FDF facility that is identified
in at least one approved generic drug
submission owned by that person or its
PO 00000
affiliates.9 The CMO facility fee is owed
by each person who owns an FDF
facility that is identified in at least one
approved ANDA but is not identified in
an approved ANDA held by the owner
of that facility or its affiliates.10 Section
744B(b)(2)(C) of the FD&C Act specifies
that the FDF and CMO facility fee
revenue will make up 20 percent of the
$613,538,000, which is $122,707,600.
To calculate the fees, data from FDA’s
Integrity Services (IS) were utilized as
the primary source of facility
information for determining the
denominators of each facility fee type.
IS is the master data steward for all
facility information provided in generic
drug submissions received by FDA. A
facility’s reference status in an approved
generic drug submission is extracted
directly from submission data rather
than relying on data from selfidentification. This information
provided the number of facilities
referenced as FDF manufacturers in at
least one approved generic drug
submission. Based on FDA’s IS data, the
FDF and CMO facility denominators are
173 FDF domestic, 307 FDF foreign, 81
CMO domestic, and 118 CMO foreign
facilities for FY 2024.
GDUFA III specifies that the CMO
facility fee is to be equal to 24 percent
of the FDF facility fee.11 Therefore, to
generate the target collection revenue
amount from FDF and CMO facility fees
($122,707,600), FDA must weight a
CMO facility as 24 percent of an FDF
facility. FDA set fees based on the
estimate of 173 FDF domestic, 307 FDF
foreign, 19.44 CMO domestic (81
multiplied by 24 percent), and 28.32
CMO foreign facilities (118 multiplied
by 24 percent), which equals 528 total
weighted FDF and CMO facilities for FY
2024.
To calculate the fee for domestic
facilities, FDA first determines the total
fee revenue that will result from the
foreign facility differential by
subtracting the fee revenue resulting
from the foreign facility fee differential
from the target collection revenue
amount ($122,707,600) as follows: the
foreign facility fee differential revenue
equals the foreign facility fee differential
($15,000) multiplied by the number of
FDF foreign facilities (307) plus the
foreign facility fee differential ($15,000)
multiplied by the number of CMO
foreign facilities (118), totaling
$6,375,000. This results in foreign fee
differential revenue of $6,375,000 from
9 Section
744B(a)(4)(A) of the FD&C Act.
744A(5) and 744B(b)(2)(C) of the FD&C
10 Section
7 Section
8 Section
744B(a)(2) of the FD&C Act.
744B(b)(2)(C) and (D) of the FD&C Act.
Frm 00083
Fmt 4703
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Act.
11 Section
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744B(b)(2)(C) of the FD&C Act.
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the total FDF and CMO facility fee target
collection revenue.
Subtracting the foreign facility
differential fee revenue ($6,375,000)
from the total FDF and CMO facility
target collection revenue ($122,707,600)
results in a remaining facility fee
revenue balance of $116,332,600. To
determine the domestic FDF facility fee,
FDA divides the $116,332,600 by the
total weighted number of FDF and CMO
facilities (527.76), which results in a
domestic FDF facility fee of $220,427.
The foreign FDF facility fee is $15,000
more than the domestic FDF facility fee,
or $235,427.
According to GDUFA III, the domestic
CMO fee is calculated as 24 percent of
the amount of the domestic FDF facility
fee.12 Therefore, the domestic CMO fee
is $52,902, rounded to the nearest
dollar. The foreign CMO fee is
calculated as the domestic CMO fee plus
the foreign fee differential of $15,000.
Therefore, the foreign CMO fee is
$67,902.
VII. API Facility Fee
Under GDUFA III, the annual API
facility fee is owed by each person who
owns a facility that is identified in at
least one approved generic drug
submission in which the facility is
approved to produce one or more API or
in a Type II API DMF referenced in at
least one approved generic drug
submission.13 Section 744B(b)(2)(D) of
the FD&C Act specifies the API facility
fee will make up 6 percent of
$613,538,000 in fee revenue, which is
$36,812,280.
To calculate the API facility fee, data
from FDA’s IS were utilized as the
primary source of facility information
for determining the denominator. As
stated above, IS is the master data
steward for all facility information
provided in generic drug submissions
received by FDA. A facility’s reference
status in an approved generic drug
submission is extracted directly from
submission data rather than relying on
data from self-identification. This
information provided the number of
facilities referenced as API
manufacturers in at least one approved
generic drug submission.
The total number of API facilities
identified was 684; of that number, 75
were domestic and 609 were foreign
facilities. The foreign facility differential
is $15,000. To calculate the fee for
domestic facilities, FDA must first
subtract the fee revenue that will result
from the foreign facility fee differential.
FDA takes the foreign facility
12 Section
13 Section
744B(b)(2)(C) of the FD&C Act.
744B(a)(4)(A)(ii) of the FD&C Act.
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17:16 Jul 27, 2023
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differential ($15,000) and multiplies it
by the number of foreign facilities (609)
to determine the total fee revenue that
will result from the foreign facility
differential. As a result of this
calculation, the foreign fee differential
revenue will make up $9,135,000 of the
total API fee revenue. Subtracting the
foreign facility differential fee revenue
($9,135,000) from the total API facility
target revenue ($36,812,280) results in a
remaining balance of $27,677,280. To
determine the domestic API facility fee,
we divide the $27,677,280 by the total
number of facilities (684), which gives
us a domestic API facility fee of
$40,464. The foreign API facility fee is
$15,000 more than the domestic API
facility fee, or $55,464.
VIII. Generic Drug Applicant Program
Fee
Under GDUFA III, if a person and its
affiliates own at least one but not more
than five approved ANDAs on October
1, 2023, the person and its affiliates
shall owe a small business generic drug
applicant program fee.14 If a person and
its affiliates own at least 6 but not more
than 19 approved ANDAs, the person
and its affiliates shall owe a medium
size operation generic drug applicant
program fee.15 If a person and its
affiliates own at least 20 approved
ANDAs, the person and its affiliates
shall owe a large size operation generic
drug applicant program fee.16 Section
744B(b)(2)(E) of the FD&C Act specifies
the GDUFA program fee will make up
36 percent of $613,538,000 in fee
revenue, which is $220,873,680.
To determine the appropriate number
of parent companies for each tier, FDA
asked companies to claim their ANDAs
and affiliates in the CDER NextGen
Portal. The companies were able to
confirm relationships currently present
in FDA’s records, while also reporting
newly approved ANDAs, newly
acquired ANDAs, and new affiliations.
In determining the appropriate
number of approved ANDAs, FDA has
factored in a number of variables that
could affect the collection of the target
revenue: (1) inactive ANDAs: applicants
who have not submitted an annual
report for one or more of their approved
applications within the past 2 years; (2)
Program Fee Arrears List: parent
companies that are on the arrears list for
any fiscal year; (3) Large and Medium
Tier Adjustment: the frequency of largetiered companies dropping to the
medium tier and medium-tiered
744B(a)(5)(A) and 744B(b)(2)(E)(i) of
the FD&C Act.
15 Id.
16 Id.
PO 00000
14 Sections
Frm 00084
Fmt 4703
Sfmt 4703
48869
companies moving to the small tier after
the completion of the program fee
methodology and tier determination; (4)
CBER-approved ANDAs: applicants and
their affiliates with CBER-approved
ANDAs in addition to CDER’s approved
ANDAs; and (5) withdrawals of
approved ANDAs by April 1: applicants
who have submitted a written request
for withdrawal of approval by April 1 of
the previous fiscal year.
The list of original approved ANDAs
from the Generic Drug Review Platform
as of April 30, 2023, in addition to
CBER’s database, shows 248 applicants
in the small business tier, 71 applicants
in the medium size tier, and 82
applicants in the large size tier.
Factoring in all the variables, we
estimate there will be 205 applicants in
the small business tier, 68 applicants in
the medium size tier, and 80 applicants
in the large size tier for FY 2024.
To calculate the GDUFA program fee,
GDUFA III provides that large size
operation generic drug applicants pay
the full fee, medium size operation
applicants pay two-fifths of the full fee,
and small business applicants pay onetenth of the full fee.17 To generate the
target collection revenue amount from
GDUFA program fees ($220,873,680),
we must weigh medium and small
tiered applicants as a subset of a large
size operation generic drug applicant.
FDA will set fees based on the weighted
estimate of 20.5 applicants in the small
business tier (205 multiplied by 10
percent), 27.2 applicants in the medium
size tier (68 multiplied by 40 percent),
and 80 applicants in the large size tier,
arriving at 127.7 total weighted
applicants for FY 2024.
To generate the large size operation
GDUFA program fee, FDA divides the
target revenue amount of $220,873,680
by 127.7, which equals $1,729,629. The
medium size operation GDUFA program
fee is 40 percent of the full fee
($691,852), and the small business
GDUFA program fee is 10 percent of the
full fee ($172,963).
IX. Fee Schedule For FY 2024
The fee rates for FY 2024 are set out
in table 11.
TABLE 11—FEE SCHEDULE FOR FY
2024
Generic drug fee category
Applications
Abbreviated New Drug Application (ANDA) ............
Drug Master File (DMF) ...........
Facilities
17 Section
E:\FR\FM\28JYN1.SGM
Fees rates
for FY 2024
$252,453
94,682
744B(b)(2)(E)(i) of the FD&C Act.
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Federal Register / Vol. 88, No. 144 / Friday, July 28, 2023 / Notices
TABLE 11—FEE SCHEDULE FOR FY
2024—Continued
Generic drug fee category
lotter on DSK11XQN23PROD with NOTICES1
Active Pharmaceutical Ingredient (API)—Domestic ...................................
API—Foreign .....................
Finished Dosage Form
(FDF)—Domestic ...........
FDF—Foreign ....................
Contract Manufacturing Organization (CMO)—Domestic .............................
CMO—Foreign ..................
GDUFA Program
Large size operation generic drug applicant .......
Medium size operation generic drug applicant .......
Small business generic
drug applicant ................
Fees rates
for FY 2024
40,464
55,464
220,427
235,427
52,902
67,902
1,729,629
691,852
172,963
‘‘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 less than $25,000.
If the balance exceeds this amount, only
the ACH option is available. Payments
must be made using U.S. bank accounts
as well as U.S. credit cards.
If a check, bank draft, or postal money
order is submitted, make it payable to
the order of the Food and Drug
Administration and include the user fee
ID number to ensure that the payment
is applied to the correct fee(s). Payments
can be mailed to: Food and Drug
Administration, P.O. Box 979108, St.
Louis, MO 63197–9000. If checks are to
be sent by a courier that requests a street
address, the courier can deliver checks
to U.S. Bank, Attention: Government
Lockbox 979108, 1005 Convention
Plaza, St. Louis, MO 63101. (Note: This
U.S. Bank address is for courier delivery
only. For questions concerning courier
delivery, U.S. Bank can be contacted at
314–418–4013. This telephone number
is only for questions about courier
delivery.) The FDA post office box
number (P.O. Box 979108) must be
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. 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. Include
applicable wire transfer fees with
payment to ensure fees are fully paid.
Questions about wire transfer fees
should be addressed to the financial
institution. The following account
information should be used to send
payments by wire transfer: U.S.
Department of the Treasury, TREAS
NYC, 33 Liberty St., New York, NY
10045, account number: 75060099,
routing number: 021030004, SWIFT:
FRNYUS33. FDA’s tax identification
number is 53–0196965.
X. Fee Payment Options and
Procedures
The new fee rates are effective on
October 1, 2023, and will remain in
effect through September 30, 2024.
Under sections 744B(a)(4) and (5) of the
FD&C Act, respectively, facility and
program fees are generally due on the
later of the first business day on or after
October 1 of each fiscal year or the first
business day after the enactment of an
appropriations act providing for the
collection and obligation of GDUFA fees
for the fiscal year.
To pay the ANDA, DMF, API facility,
FDF facility, CMO facility, and GDUFA
program fees, complete the Generic
Drug User Fee Cover Sheet, available at
https://www.fda.gov/gdufa and https://
userfees.fda.gov/OA_HTML/
gdufaCAcdLogin.jsp, and generate a user
fee identification (ID) number. Payment
must be made in U.S. currency drawn
on a U.S. bank by electronic check,
check, bank draft, U.S. postal money
order, credit card, or wire transfer. The
preferred payment method is online
using electronic check (Automated
Clearing House (ACH), also known as
eCheck) or credit card (Discover, VISA,
MasterCard, American Express). FDA
has partnered with the U.S. Department
of the Treasury to utilize Pay.gov, a webbased payment application, for online
electronic payment. The Pay.gov feature
Dated: July 25, 2023.
is available on the FDA website after
completing the Generic Drug User Fee
Lauren K. Roth,
Cover Sheet and generating the user fee
Associate Commissioner for Policy.
ID number.
[FR Doc. 2023–16081 Filed 7–27–23; 8:45 am]
Secure electronic payments can be
BILLING CODE 4164–01–P
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,
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–2965]
Medical Device User Fee Rates for
Fiscal Year 2024
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
fee rates and payment procedures for
medical device user fees for fiscal year
(FY) 2024. The Federal Food, Drug, and
Cosmetic Act (FD&C Act), as amended
by the Medical Device User Fee
Amendments of 2022 (MDUFA V),
authorizes FDA to collect user fees for
certain medical device submissions and
annual fees both for certain periodic
reports and for establishments subject to
registration. This notice establishes the
fee rates for FY 2024, which apply from
October 1, 2023, through September 30,
2024, and provides information on how
the fees for FY 2024 were determined,
the payment procedures you should
follow, and how you may qualify for
reduced small business fees.
FOR FURTHER INFORMATION CONTACT:
For information on Medical Device
User Fees: https://www.fda.gov/
industry/fda-user-fee-programs/
medical-device-user-fee-amendmentsmdufa.
For questions relating to the MDUFA
Small Business Program, please visit the
Center for Devices and Radiological
Health’s website: https://www.fda.gov/
medical-devices/premarketsubmissions/reduced-medical-deviceuser-fees-small-business-determinationsbd-program.
For questions relating to this notice:
Olufunmilayo Ariyo, Office of Financial
Management, Food and Drug
Administration, 4041 Powder Mill Rd.,
Beltsville, MD 20705–4304, 240–402–
4989; or the User Fee Support Staff at
OO-OFBAP-OFM-UFFS-Government@
fda.hhs.gov.
SUMMARY:
SUPPLEMENTARY INFORMATION:
I. Background
The FD&C Act, as amended by
MDUFA V, authorizes FDA to collect
user fees for certain medical device
submissions and annual fees both for
certain periodic reports and for
establishments subject to registration.
Section 738 of the FD&C Act (21 U.S.C.
379j) establishes fees for certain medical
device applications, submissions,
supplements, notices, and requests (for
E:\FR\FM\28JYN1.SGM
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]]>Agencies
[Federal Register Volume 88, Number 144 (Friday, July 28, 2023)]
[Notices]
[Pages 48864-48870]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-16081]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-3059]
Generic Drug User Fee Rates for Fiscal Year 2024
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Federal Food, Drug, and Cosmetic Act (FD&C Act or
statute), as amended by the Generic Drug User Fee Amendments of 2022
(GDUFA III), authorizes the Food and Drug Administration (FDA, Agency,
or we) to assess and collect fees for abbreviated new drug applications
(ANDAs); drug master files (DMFs); generic drug active pharmaceutical
ingredient (API) facilities, finished dosage form (FDF) facilities, and
contract manufacturing organization (CMO) facilities; and generic drug
applicant program user fees. In this document, FDA is announcing fiscal
year (FY) 2024 rates for GDUFA III fees. These fees are effective on
October 1, 2023, and will remain in effect through September 30, 2024.
FOR FURTHER INFORMATION CONTACT: Olufunmilayo Ariyo, Office of
Financial Management, Food and Drug Administration, 4041 Powder Mill
Rd., Rm. 62080, Beltsville, MD 20705-4304, 240-402-4989; or the User
Fees Support Staff at [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Sections 744A and 744B of the FD&C Act (21 U.S.C. 379j-41 and 379j-
42), as amended by GDUFA III, authorize FDA to assess and collect fees
associated with human generic drug products. Fees are assessed on: (1)
certain types of applications for human generic drug products; (2)
certain facilities where APIs and FDFs are produced; (3) certain DMFs
associated with human generic drug products; and (4) generic drug
applicants who have ANDAs (the program fee) (see section 744B(a)(2)
through (5) of the FD&C Act). For more information about GDUFA III,
please refer to the FDA website (https://www.fda.gov/gdufa).
For FY 2024, the generic drug fee rates are ANDA ($252,453), DMF
($94,682), domestic API facility ($40,464), foreign API facility
($55,464), domestic FDF facility ($220,427), foreign FDF facility
($235,427), domestic CMO facility ($52,902), foreign CMO facility
($67,902), large size operation generic drug applicant program
($1,729,629), medium size operation generic drug applicant program
($691,852), and small business generic drug applicant program
($172,963). These fees are effective on October 1, 2023, and will
remain in effect through September 30, 2024. The fee rates for FY 2024
are set out in table 1.
Table 1--Fee Schedule for FY 2024
------------------------------------------------------------------------
Fees rates
Generic drug fee category for FY 2024
------------------------------------------------------------------------
Applications
Abbreviated New Drug Application (ANDA)................ $252,453
Drug Master File (DMF)................................. 94,682
Facilities
Active Pharmaceutical Ingredient (API)--Domestic....... 40,464
API--Foreign........................................... 55,464
Finished Dosage Form (FDF)--Domestic................... 220,427
FDF--Foreign........................................... 235,427
Contract Manufacturing Organization (CMO)--Domestic.... 52,902
CMO--Foreign........................................... 67,902
GDUFA Program
Large size operation generic drug applicant............ 1,729,629
Medium size operation generic drug applicant........... 691,852
Small business generic drug applicant.................. 172,963
------------------------------------------------------------------------
II. Fee Revenue Amount for FY 2024
Under section 744B(b)(1)(B)(ii) of the FD&C Act, the base revenue
amount for FY 2024 for GDUFA III is $582,500,000. Under section
744B(c)(1) of the FD&C Act, applicable inflation adjustments to base
revenue shall be made beginning with FY 2024.
Under section 744B(c)(2) of the FD&C Act, beginning with FY 2024,
FDA shall, in addition to the inflation adjustment, apply a capacity
planning adjustment to further adjust, as needed, the fee revenue and
fees to reflect changes in the resource capacity needs of FDA for human
generic drug activities.
Under section 744B(c)(3) of the FD&C Act, beginning with FY 2024,
FDA may, in addition to the inflation and capacity planning
adjustments, apply an operating reserve adjustment to further increase
the fee revenue and fees if necessary to provide operating reserves of
carryover user fees for human generic drug activities for not more than
the number of weeks specified in such section (or as applicable, shall
apply such adjustment to decrease the fee revenues and fees to provide
for not
[[Page 48865]]
more than 12 weeks of such operating reserves).
A. Inflation Adjustment
As noted, above, the base revenue amount for FY 2024 is
$582,500,000. This is the total revenue amount specified for the prior
fiscal year, FY 2023, pursuant to the statute (see section
744B(b)(1)(A) of the FD&C Act).\1\ GDUFA III specifies that the
$582,500,000 is to be adjusted for inflation for FY 2024 using two
separate adjustments--one for personnel compensation and benefits
(PC&B) and one for non-PC&B costs (see sections 744B(c)(1)(B) and (C)
of the FD&C Act).
---------------------------------------------------------------------------
\1\ Under section 744B(b)(1)(B)(ii), the base revenue amount for
a fiscal year is equal to the total revenue amount established for
the previous fiscal year, not including any adjustments for such
previous fiscal year under section 744B(c)(3). For FY 2023,
adjustments under section 744B(c)(3) were inapplicable.
---------------------------------------------------------------------------
The component of the inflation adjustment for PC&B costs shall be
the average annual percent change in the cost of all PC&B paid per
full-time equivalent (FTE) position at FDA for the first 3 of the 4
preceding fiscal years, multiplied by the proportion of PC&B costs to
total FDA costs of human generic drug activities for the first 3 of the
preceding 4 fiscal years (see section 744B(c)(1)(B) of the FD&C Act).
Table 2 summarizes the actual cost and total FTEs for the specified
fiscal years and provides the percent change from the previous fiscal
year and the average percent change over the first 3 of the 4 fiscal
years preceding FY 2024. The 3-year average is 3.9280 percent.
Table 2--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Change
----------------------------------------------------------------------------------------------------------------
3-Year
Fiscal year 2020 2021 2022 average
----------------------------------------------------------------------------------------------------------------
Total PC&B................................ $2,875,592,000 $3,039,513,000 $3,165,477,000 ...........
Total FTEs................................ 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 should be multiplied
by the proportion of PC&B expended for human generic drug activities
for the first 3 of the preceding 4 fiscal years. Table 3 shows the
amount of PC&B and the total amount obligated for human generic drug
activities from FY 2020 through FY 2022.
Table 3--PC&B as a Percent of Fee Revenues Spent on Human Generic Drug Activities Over the Last 3 Years
----------------------------------------------------------------------------------------------------------------
3-Year
Fiscal year 2020 2021 2022 average
----------------------------------------------------------------------------------------------------------------
PC&B...................................... $397,392,785 $410,587,565 $391,922,747 ...........
Non-PC&B.................................. 300,692,399 271,328,560 289,479,265 ...........
Total Costs............................... 698,085,185 681,916,125 681,402,012 ...........
PC&B Percent.............................. 56.9261% 60.2109% 57.5171% 58.2180%
Non-PC&B Percent.......................... 43.0739% 39.7891% 42.4829% 41.7820%
----------------------------------------------------------------------------------------------------------------
The payroll adjustment is 3.9280 percent multiplied by 58.2180
percent (or 2.2868 percent).
The statute specifies that the portion of the inflation adjustment
for non-PC&B costs for FY 2024 is the average annual percent change
that occurred in the Consumer Price Index (CPI) for urban consumers
(Washington-Arlington-Alexandria Area, DC-VA-MD-WV; not seasonally
adjusted; all items; annual index) for the first 3 of the preceding 4
years of available data multiplied by the proportion of all costs other
than PC&B costs to total costs of human generic drug activities for the
first 3 years of the preceding 4 fiscal years (see section
744B(c)(1)(C) of the FD&C Act). Table 4 provides the summary data for
the percent change in the specified CPI. 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 4--Annual and 3-Year Average Percent Change in CPI for Washington-Arlington-Alexandria Area
----------------------------------------------------------------------------------------------------------------
3-Year
Year 2020 2021 2022 average
----------------------------------------------------------------------------------------------------------------
Annual CPI.................................................. 267.16 277.73 296.12 ...........
Annual Percent Change....................................... 0.8989% 3.9568% 6.6212% 3.8256%
----------------------------------------------------------------------------------------------------------------
To calculate the inflation adjustment for non-pay costs, we
multiply the 3-year average percent change in the CPI (3.8256 percent)
by the proportion of all costs other than PC&B to total costs of human
generic drug activities obligated. Because 58.2180 percent was
obligated for PC&B as shown in table 3, 41.7820 percent is the portion
of costs other than PC&B. The non-pay adjustment is 3.8256 percent
times 41.7820 percent, or 1.5984 percent.
To complete the inflation adjustment for FY 2024, we add the PC&B
component (2.2868 percent) to the non-PC&B component (1.5984 percent)
for a total inflation adjustment of 3.8852 percent (rounded), and then
add 1,
[[Page 48866]]
making an inflation adjustment multiple of 1.038852. We then multiply
the base revenue amount for FY 2024 ($582,500,000) by 1.038852,
yielding an inflation-adjusted amount of $605,131,290.
B. FY 2024 Statutory Fee Revenue Adjustments for Capacity Planning
The statute specifies that after the base revenue amount for FY
2024 of $582,500,000 has been adjusted for inflation as described in
section A above, the resulting amount shall be further adjusted to
reflect changes in the resource capacity needs for human generic drug
activities (see section 744B(c)(2) of the FD&C Act). Following a
process required in the statute, FDA established the capacity planning
adjustment (CPA) methodology that is derived from the methodology and
recommendations made in the report titled ``Independent Evaluation of
the GDUFA Resource Capacity Planning Adjustment Methodology: Evaluation
and Recommendations'' as announced in the Federal Register of August 3,
2020, and incorporating approaches and attributes determined
appropriate by the Agency, except that the workload drivers are limited
to those specified in the GDUFA Reauthorization Performance Goals and
Program Enhancements Fiscal Years 2023-2027 (GDUFA III Commitment
Letter).\2\ 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 the accuracy of
its data and estimates over time.\3\
---------------------------------------------------------------------------
\2\ Section 744B(c)(2)(B) of the FD&C Act; see also section
VIII.B.2.e. of the GDUFA III Commitment Letter available at https://www.fda.gov/media/153631/download.
\3\ For example, starting with FY 2025, FDA will aim to refine
the CPA methodology to reflect a more comprehensive assessment of
the applicable workload drivers across the Agency.
---------------------------------------------------------------------------
The CPA methodology consists of 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 \4\ for direct review-related effort.
This is then compared to current available resources for the direct
review-related workload.
---------------------------------------------------------------------------
\4\ 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 fiscal year, and whether the
additional 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.
Table 5 summarizes the forecasted workload volumes for the Center
for Drug Evaluation and Research (CDER) for FY 2024 based on predictive
models, as well as historical actuals from FY 2022 for comparison.
Table 5--CDER Actual FY 2022 Workload Volumes and Predicted FY 2024
Workload Volumes
------------------------------------------------------------------------
FY 2022 FY 2024
Workload driver category actuals predictions
------------------------------------------------------------------------
ANDA Originals \1\...................... 813 801
ANDA Supplements \2\.................... 9,716 10,434
Pre-ANDA Meetings....................... 132 103
Controlled Correspondences \3\.......... 3,677 3,505
Suitability Petitions................... 21 25
Annual Reports \4\...................... 11,826 12,624
Active REMS Programs \4\ \5\............ 45 45
------------------------------------------------------------------------
\1\ Excludes response to refused to receive (RTR) and Orig-2+. ANDA
Original and Resubmissions/Amendments captured in time reporting data.
\2\ Includes changes being effected and prior approval supplement
Manufacturing and Labeling Supplements. PAS exclude response to RTRs,
risk evaluation and mitigation strategies (REMS) and Bioequivalence
Supplements. ANDA Supplement and Resubmissions/Amendments captured in
time reporting data.
\3\ Includes all requesting controlled correspondences.
\4\ Represents post-marketing safety activities developed in alignment
with Prescription Drug User Fee Act and biosimilar user fee amendments
as applicable.
\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.
Utilizing the resource forecast algorithms, the forecasted workload
volumes for FY 2024 were then converted into estimated FTE needs for
FDA's GDUFA direct review-related work. The resulting expected FY 2024
FTE need for GDUFA was compared to current onboard capacity for GDUFA
direct review-related work to determine the FY 2024 resource delta, as
summarized in table 6.
Table 6--CDER FY 2024 GDUFA Resource Delta
----------------------------------------------------------------------------------------------------------------
Current FY 2024
Center resource resource Predicted FY
capacity forecast 2024 FTE delta
----------------------------------------------------------------------------------------------------------------
CDER......................................................... 1,024 1,059 35
----------------------------------------------------------------------------------------------------------------
The projected 35 FTE delta was 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 assessing current hiring capacity and existing funded
vacancies, CDER adjusted the 35 FTE delta to 25 FTEs.
[[Page 48867]]
The adjusted 25 FTE delta was then assessed by FDA to determine if
the delta exceeded the CPA cap as specified in statute (section
744B(c)(2)(C)(ii)) which articulates that for FY 2024, the CPA shall
not exceed 3 percent of inflation-adjusted base revenue, except that
the CPA cap may be increased to 4 percent of inflation-adjusted base
revenue if the following conditions are met during the period from
April 1, 2021 through March 31, 2023: (1) the total number of ANDAs
submitted was greater than or equal to 2,000 or (2) 35 percent or more
of ANDAs submitted related to complex products (as defined in section
XI of the letters described in section 3001(b) of the Generic Drug User
Fee Amendments of 2022).\5\
---------------------------------------------------------------------------
\5\ Definition of complex products in section XI of the GDUFA
III Commitment Letter https://www.fda.gov/media/153631/download.
---------------------------------------------------------------------------
Table 7 summarizes the total number of ANDAs submitted and the
percentage of such applications that were related to complex products
from April 1, 2021 through March 31, 2023:
Table 7--GDUFA CPA Cap Assessment Metrics
------------------------------------------------------------------------
------------------------------------------------------------------------
Abbreviated New Drug Applications Submitted between April 1, 1,675
2021 through March 31, 2023....................................
Percentage of Abbreviated New Drug Applications Submitted that 16%
are Complex Submitted between April 1, 2021 through March 31,
2023...........................................................
------------------------------------------------------------------------
FDA determined that the criteria to increase the CPA cap was not,
and therefore, the GDUFA CPA cap for FY 2024 is 3 percent of inflation-
adjusted base revenue. FDA further determined that the 25 FTE delta
when converted to dollars did not exceed 3 percent of FY 2024
inflation-adjusted base revenue, and therefore, this 25 FTE delta
required no further adjustment.
The FY 2024 GDUFA CPA is therefore $8,406,725, as summarized in
table 8.
Table 8--FY 2024 GDUFA CPA
----------------------------------------------------------------------------------------------------------------
Additional FTEs Cost for each CDER FY 2024
Center for 2024 additional FTE GDUFA CPA
----------------------------------------------------------------------------------------------------------------
CDER......................................................... 25 $336,269 $8,406,725
----------------------------------------------------------------------------------------------------------------
Table 9--Base Revenue Amount and Section 744B(c)(1) and (2) Adjustment
Amounts
------------------------------------------------------------------------
Fee Amount
------------------------------------------------------------------------
Statutory Fee Revenue Base Amount (section 744B(b)(1) of $582,500,000
the FD&C Act)..........................................
Statutory Fee Revenue Adjustments for Inflation (section 22,631,290
744B(c)(1) of the FD&C Act)............................
Statutory Fee Revenue Adjustments for Capacity Planning 8,406,725
(section 744B(c)(2) of the FD&C Act)...................
Cumulative Adjusted Revenue Amount (sections 744B(b)(1), 613,538,015
744B(c)(1), and 744B(c)(2) of the FD&C Act.............
------------------------------------------------------------------------
C. FY 2024 Statutory Fee Revenue Adjustments for Operating Reserve
Under section 744B(c)(3) of the FD&C Act, beginning with FY 2024,
FDA may, in addition to the inflation and capacity planning
adjustments, apply an operating reserve adjustment to further increase
the fee revenue and fees if necessary to provide operating reserves of
carryover user fees for human generic drug activities for not more than
the number of weeks specified in such section (or as applicable, shall
apply such adjustment to decrease the fee revenues and fees to provide
for not more than 12 weeks of such operating reserves).
The upward operating reserve adjustment is discretionary--for FY
2024, FDA may take an adjustment to provide for not more than 8 weeks
of operating reserve. If carryover is more than 12 weeks of operating
reserve, FDA must decrease the fee revenues and fees to provide for not
more than 12 weeks of operating reserve. To calculate the 8-week and
12-week threshold amounts for the FY 2024 operating reserve adjustment,
the FY 2024 estimated adjusted revenue amount, $613,538,015 is divided
by 52, resulting in a $11,798,808 cost of operation for 1 week. The 1-
week value is then multiplied by 8 weeks to generate the 8-week
operating reserve threshold amount for FY 2024 of $94,390,464. The 1-
week value is multiplied by 12 to generate the 12-week operating
reserve threshold amount for FY 2024 of $141,585,696.
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 $130,218,707 which equates to 11.04 weeks of operations.
The statutory criteria for an operating reserve adjustment were not
met. Table 10 below summarizes FY 2024 fee revenue.
Table 10--Total Estimated Adjusted Revenue Amount
------------------------------------------------------------------------
Fee Amount
------------------------------------------------------------------------
Statutory Fee Revenue Base Amount (section 744B(b)(1) of $582,500,000
the FD&C Act)..........................................
Statutory Fee Revenue Adjustments for Inflation (section 22,631,290
744B(c)(1) of the FD&C Act)............................
Statutory Fee Revenue Adjustments for Capacity Planning 8,406,725
(section 744B(c)(2) of the FD&C Act)...................
Operating Reserve Adjustment (section 744B(c)(3) of the ..............
FD&C Act)..............................................
Total Revenue Amount (rounded to the nearest thousand 613,538,000
dollars) (sections 744B(b)(1), 744B(c)(1), 744B(c)(2)
and 744B(c)(3) of the FD&C Act)........................
------------------------------------------------------------------------
III. ANDA Filing Fee
Under GDUFA III, the FY 2024 ANDA filing fee is owed by each
applicant that submits an ANDA on or after October 1, 2023.\6\ This fee
is due on the submission date of the ANDA. Section 744B(b)(2)(B) of the
FD&C Act specifies that the ANDA fee will make up 33 percent of
[[Page 48868]]
the $613,538,000, which is $202,467,540.
---------------------------------------------------------------------------
\6\ Section 744B(a)(3) of the FD&C Act.
---------------------------------------------------------------------------
To calculate the ANDA fee, FDA estimated the number of full
application equivalents (FAEs) that will be submitted in FY 2024. The
submissions are broken down into three categories: new originals
(submissions that have not been received by FDA previously),
submissions that FDA RTR for reasons other than failure to pay fees,
and applications that are resubmitted after an RTR decision for reasons
other than failure to pay fees. An ANDA counts as one FAE; however, 75
percent of the fee paid for an ANDA that has been RTR shall be refunded
according to GDUFA III if: (1) the ANDA is refused for a cause other
than failure to pay fees or (2) the ANDA has been withdrawn prior to
receipt (section 744B(a)(3)(D)(i) of the FD&C Act). Therefore, an ANDA
that is considered not to have been received by FDA due to reasons
other than failure to pay fees or withdrawn prior to receipt counts as
one-fourth of an FAE. After an ANDA has been RTR, the applicant has the
option of resubmitting. For user fee purposes, these resubmissions are
equivalent to new original submissions: ANDA resubmissions are charged
the full amount for an application (one FAE).
As shown in table 5, FDA estimates that 801 new original ANDAs will
be submitted and incur filing fees in FY 2024. Not all of the new
original ANDAs will be received by FDA and some of those not received
will be resubmitted in the same fiscal year. Therefore, FDA expects
that the FAE count for ANDAs will be 802 for FY 2024.
The FY 2024 ANDA filing fee is estimated by dividing the number of
FAEs that will incur the fee in FY 2024 (802) into the fee revenue
amount to be derived from ANDA filing fees in FY 2024 ($202,467,540).
The result, rounded to the nearest dollar, is a fee of $252,453 per
ANDA.
The statute provides that those ANDAs that include information
about the production of APIs other than by reference to a DMF will pay
an additional fee that is based on the number of such APIs and the
number of facilities proposed to produce those ingredients (see section
744B(a)(3)(F) of the FD&C Act). FDA anticipates that this additional
fee is unlikely to be assessed often; therefore, FDA has not included
projections concerning the amount of this fee in calculating the fees
for ANDAs.
IV. DMF Fee
Under GDUFA III, the DMF fee is owed by each person that owns a
type II API DMF that is referenced, on or after October 1, 2012, in a
generic drug submission by an initial letter of authorization.\7\ This
is a one-time fee for each DMF. This fee is due on the earlier of the
date on which the first generic drug submission is submitted that
references the associated DMF or the date on which the DMF holder
requests the initial completeness assessment. Under section
744B(a)(2)(D)(iii) of the FD&C Act, if a DMF has successfully undergone
an initial completeness assessment and the fee is paid, the DMF will be
placed on a publicly available list documenting DMFs available for
reference.
---------------------------------------------------------------------------
\7\ Section 744B(a)(2) of the FD&C Act.
---------------------------------------------------------------------------
To calculate the DMF fee, FDA assessed the volume of DMF
submissions over time. We assessed DMFs from October 1, 2021, to April
30, 2023, and concluded that averaging the number of fee-paying DMFs
provided the most accurate model for predicting fee-paying DMFs for FY
2024. The monthly average of paid DMF submissions FDA received during
FY 2022 and FY 2023 is 27. To determine the FY 2024 projected number of
fee-paying DMFs, the average of 27 DMF submissions is multiplied by 12
months, which results in 324 estimated FY 2024 fee-paying DMFs. FDA is
estimating 324 fee-paying DMFs for FY 2024.
The FY 2024 DMF fee is determined by dividing the DMF target
revenue by the estimated number of fee-paying DMFs in FY 2024. Section
744B(b)(2)(A) of the FD&C Act specifies that the DMF fees will make up
5 percent of the $613,538,000, which is $30,676,900. Dividing the DMF
revenue amount ($30,676,900) by the estimated fee-paying DMFs (324),
and rounding to the nearest dollar, yields a DMF fee of $94,682 for FY
2024.
V. Foreign Facility Fee Differential
Under GDUFA III, the fee for a facility located outside the United
States and its territories and possessions shall be $15,000 higher than
the amount of the fee for a facility located in the United States and
its territories and possessions.\8\ The basis for this differential is
the extra cost incurred by conducting an inspection outside the United
States and its territories and possessions.
---------------------------------------------------------------------------
\8\ Section 744B(b)(2)(C) and (D) of the FD&C Act.
---------------------------------------------------------------------------
VI. FDF and CMO Facility Fees
Under GDUFA III, the annual FDF facility fee is owed by each person
who owns an FDF facility that is identified in at least one approved
generic drug submission owned by that person or its affiliates.\9\ The
CMO facility fee is owed by each person who owns an FDF facility that
is identified in at least one approved ANDA but is not identified in an
approved ANDA held by the owner of that facility or its affiliates.\10\
Section 744B(b)(2)(C) of the FD&C Act specifies that the FDF and CMO
facility fee revenue will make up 20 percent of the $613,538,000, which
is $122,707,600.
---------------------------------------------------------------------------
\9\ Section 744B(a)(4)(A) of the FD&C Act.
\10\ Section 744A(5) and 744B(b)(2)(C) of the FD&C Act.
---------------------------------------------------------------------------
To calculate the fees, data from FDA's Integrity Services (IS) were
utilized as the primary source of facility information for determining
the denominators of each facility fee type. IS is the master data
steward for all facility information provided in generic drug
submissions received by FDA. A facility's reference status in an
approved generic drug submission is extracted directly from submission
data rather than relying on data from self-identification. This
information provided the number of facilities referenced as FDF
manufacturers in at least one approved generic drug submission. Based
on FDA's IS data, the FDF and CMO facility denominators are 173 FDF
domestic, 307 FDF foreign, 81 CMO domestic, and 118 CMO foreign
facilities for FY 2024.
GDUFA III specifies that the CMO facility fee is to be equal to 24
percent of the FDF facility fee.\11\ Therefore, to generate the target
collection revenue amount from FDF and CMO facility fees
($122,707,600), FDA must weight a CMO facility as 24 percent of an FDF
facility. FDA set fees based on the estimate of 173 FDF domestic, 307
FDF foreign, 19.44 CMO domestic (81 multiplied by 24 percent), and
28.32 CMO foreign facilities (118 multiplied by 24 percent), which
equals 528 total weighted FDF and CMO facilities for FY 2024.
---------------------------------------------------------------------------
\11\ Section 744B(b)(2)(C) of the FD&C Act.
---------------------------------------------------------------------------
To calculate the fee for domestic facilities, FDA first determines
the total fee revenue that will result from the foreign facility
differential by subtracting the fee revenue resulting from the foreign
facility fee differential from the target collection revenue amount
($122,707,600) as follows: the foreign facility fee differential
revenue equals the foreign facility fee differential ($15,000)
multiplied by the number of FDF foreign facilities (307) plus the
foreign facility fee differential ($15,000) multiplied by the number of
CMO foreign facilities (118), totaling $6,375,000. This results in
foreign fee differential revenue of $6,375,000 from
[[Page 48869]]
the total FDF and CMO facility fee target collection revenue.
Subtracting the foreign facility differential fee revenue
($6,375,000) from the total FDF and CMO facility target collection
revenue ($122,707,600) results in a remaining facility fee revenue
balance of $116,332,600. To determine the domestic FDF facility fee,
FDA divides the $116,332,600 by the total weighted number of FDF and
CMO facilities (527.76), which results in a domestic FDF facility fee
of $220,427. The foreign FDF facility fee is $15,000 more than the
domestic FDF facility fee, or $235,427.
According to GDUFA III, the domestic CMO fee is calculated as 24
percent of the amount of the domestic FDF facility fee.\12\ Therefore,
the domestic CMO fee is $52,902, rounded to the nearest dollar. The
foreign CMO fee is calculated as the domestic CMO fee plus the foreign
fee differential of $15,000. Therefore, the foreign CMO fee is $67,902.
---------------------------------------------------------------------------
\12\ Section 744B(b)(2)(C) of the FD&C Act.
---------------------------------------------------------------------------
VII. API Facility Fee
Under GDUFA III, the annual API facility fee is owed by each person
who owns a facility that is identified in at least one approved generic
drug submission in which the facility is approved to produce one or
more API or in a Type II API DMF referenced in at least one approved
generic drug submission.\13\ Section 744B(b)(2)(D) of the FD&C Act
specifies the API facility fee will make up 6 percent of $613,538,000
in fee revenue, which is $36,812,280.
---------------------------------------------------------------------------
\13\ Section 744B(a)(4)(A)(ii) of the FD&C Act.
---------------------------------------------------------------------------
To calculate the API facility fee, data from FDA's IS were utilized
as the primary source of facility information for determining the
denominator. As stated above, IS is the master data steward for all
facility information provided in generic drug submissions received by
FDA. A facility's reference status in an approved generic drug
submission is extracted directly from submission data rather than
relying on data from self-identification. This information provided the
number of facilities referenced as API manufacturers in at least one
approved generic drug submission.
The total number of API facilities identified was 684; of that
number, 75 were domestic and 609 were foreign facilities. The foreign
facility differential is $15,000. To calculate the fee for domestic
facilities, FDA must first subtract the fee revenue that will result
from the foreign facility fee differential. FDA takes the foreign
facility differential ($15,000) and multiplies it by the number of
foreign facilities (609) to determine the total fee revenue that will
result from the foreign facility differential. As a result of this
calculation, the foreign fee differential revenue will make up
$9,135,000 of the total API fee revenue. Subtracting the foreign
facility differential fee revenue ($9,135,000) from the total API
facility target revenue ($36,812,280) results in a remaining balance of
$27,677,280. To determine the domestic API facility fee, we divide the
$27,677,280 by the total number of facilities (684), which gives us a
domestic API facility fee of $40,464. The foreign API facility fee is
$15,000 more than the domestic API facility fee, or $55,464.
VIII. Generic Drug Applicant Program Fee
Under GDUFA III, if a person and its affiliates own at least one
but not more than five approved ANDAs on October 1, 2023, the person
and its affiliates shall owe a small business generic drug applicant
program fee.\14\ If a person and its affiliates own at least 6 but not
more than 19 approved ANDAs, the person and its affiliates shall owe a
medium size operation generic drug applicant program fee.\15\ If a
person and its affiliates own at least 20 approved ANDAs, the person
and its affiliates shall owe a large size operation generic drug
applicant program fee.\16\ Section 744B(b)(2)(E) of the FD&C Act
specifies the GDUFA program fee will make up 36 percent of $613,538,000
in fee revenue, which is $220,873,680.
---------------------------------------------------------------------------
\14\ Sections 744B(a)(5)(A) and 744B(b)(2)(E)(i) of the FD&C
Act.
\15\ Id.
\16\ Id.
---------------------------------------------------------------------------
To determine the appropriate number of parent companies for each
tier, FDA asked companies to claim their ANDAs and affiliates in the
CDER NextGen Portal. The companies were able to confirm relationships
currently present in FDA's records, while also reporting newly approved
ANDAs, newly acquired ANDAs, and new affiliations.
In determining the appropriate number of approved ANDAs, FDA has
factored in a number of variables that could affect the collection of
the target revenue: (1) inactive ANDAs: applicants who have not
submitted an annual report for one or more of their approved
applications within the past 2 years; (2) Program Fee Arrears List:
parent companies that are on the arrears list for any fiscal year; (3)
Large and Medium Tier Adjustment: the frequency of large-tiered
companies dropping to the medium tier and medium-tiered companies
moving to the small tier after the completion of the program fee
methodology and tier determination; (4) CBER-approved ANDAs: applicants
and their affiliates with CBER-approved ANDAs in addition to CDER's
approved ANDAs; and (5) withdrawals of approved ANDAs by April 1:
applicants who have submitted a written request for withdrawal of
approval by April 1 of the previous fiscal year.
The list of original approved ANDAs from the Generic Drug Review
Platform as of April 30, 2023, in addition to CBER's database, shows
248 applicants in the small business tier, 71 applicants in the medium
size tier, and 82 applicants in the large size tier. Factoring in all
the variables, we estimate there will be 205 applicants in the small
business tier, 68 applicants in the medium size tier, and 80 applicants
in the large size tier for FY 2024.
To calculate the GDUFA program fee, GDUFA III provides that large
size operation generic drug applicants pay the full fee, medium size
operation applicants pay two-fifths of the full fee, and small business
applicants pay one-tenth of the full fee.\17\ To generate the target
collection revenue amount from GDUFA program fees ($220,873,680), we
must weigh medium and small tiered applicants as a subset of a large
size operation generic drug applicant. FDA will set fees based on the
weighted estimate of 20.5 applicants in the small business tier (205
multiplied by 10 percent), 27.2 applicants in the medium size tier (68
multiplied by 40 percent), and 80 applicants in the large size tier,
arriving at 127.7 total weighted applicants for FY 2024.
---------------------------------------------------------------------------
\17\ Section 744B(b)(2)(E)(i) of the FD&C Act.
---------------------------------------------------------------------------
To generate the large size operation GDUFA program fee, FDA divides
the target revenue amount of $220,873,680 by 127.7, which equals
$1,729,629. The medium size operation GDUFA program fee is 40 percent
of the full fee ($691,852), and the small business GDUFA program fee is
10 percent of the full fee ($172,963).
IX. Fee Schedule For FY 2024
The fee rates for FY 2024 are set out in table 11.
Table 11--Fee Schedule for FY 2024
------------------------------------------------------------------------
Fees rates
Generic drug fee category for FY 2024
------------------------------------------------------------------------
Applications
Abbreviated New Drug Application (ANDA)................ $252,453
Drug Master File (DMF)..................................... 94,682
Facilities
[[Page 48870]]
Active Pharmaceutical Ingredient (API)--Domestic....... 40,464
API--Foreign........................................... 55,464
Finished Dosage Form (FDF)--Domestic................... 220,427
FDF--Foreign........................................... 235,427
Contract Manufacturing Organization (CMO)--Domestic.... 52,902
CMO--Foreign........................................... 67,902
GDUFA Program
Large size operation generic drug applicant............ 1,729,629
Medium size operation generic drug applicant........... 691,852
Small business generic drug applicant.................. 172,963
------------------------------------------------------------------------
X. Fee Payment Options and Procedures
The new fee rates are effective on October 1, 2023, and will remain
in effect through September 30, 2024. Under sections 744B(a)(4) and (5)
of the FD&C Act, respectively, facility and program fees are generally
due on the later of the first business day on or after October 1 of
each fiscal year or the first business day after the enactment of an
appropriations act providing for the collection and obligation of GDUFA
fees for the fiscal year.
To pay the ANDA, DMF, API facility, FDF facility, CMO facility, and
GDUFA program fees, complete the Generic Drug User Fee Cover Sheet,
available at https://www.fda.gov/gdufa and https://userfees.fda.gov/OA_HTML/gdufaCAcdLogin.jsp, and generate a user fee identification (ID)
number. Payment must be made in U.S. currency drawn on a U.S. bank by
electronic check, check, bank draft, U.S. postal money order, credit
card, or wire transfer. The preferred payment method is online using
electronic check (Automated Clearing House (ACH), also known as eCheck)
or credit card (Discover, VISA, MasterCard, American Express). FDA has
partnered with the U.S. Department of the Treasury to utilize Pay.gov,
a web-based payment application, for online electronic payment. The
Pay.gov feature is available on the FDA website after completing the
Generic 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 less than $25,000. If
the balance exceeds this amount, only the ACH option is available.
Payments must be made using U.S. bank accounts as well as U.S. credit
cards.
If a check, bank draft, or postal money order is submitted, make it
payable to the order of the Food and Drug Administration and include
the user fee ID number to ensure that the payment is applied to the
correct fee(s). Payments can be mailed to: Food and Drug
Administration, P.O. Box 979108, St. Louis, MO 63197-9000. If checks
are to be sent by a courier that requests a street address, the courier
can deliver checks to U.S. Bank, Attention: Government Lockbox 979108,
1005 Convention Plaza, St. Louis, MO 63101. (Note: This U.S. Bank
address is for courier delivery only. For questions concerning courier
delivery, U.S. Bank can be contacted at 314-418-4013. This telephone
number is only for questions about courier delivery.) The FDA post
office box number (P.O. Box 979108) must be 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.
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. Include applicable wire transfer fees with
payment to ensure fees are fully paid. Questions about wire transfer
fees should be addressed to the financial institution. The following
account information should be used to send payments by wire transfer:
U.S. Department of the Treasury, TREAS NYC, 33 Liberty St., New York,
NY 10045, account number: 75060099, routing number: 021030004, SWIFT:
FRNYUS33. FDA's tax identification number is 53-0196965.
Dated: July 25, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-16081 Filed 7-27-23; 8:45 am]
BILLING CODE 4164-01-P
