Generic Drug User Fee Rates for Fiscal Year 2025, 61446-61453 [2024-16896]
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Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Notices
https://userfees.fda.gov/pay (Note: only
full payments are accepted. No partial
payments can be made online). Once
you search for your invoice, click ‘‘Pay
Now’’ to be redirected to www.pay.gov.
Electronic payment options are based on
the balance due. Payment by credit card
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If a check, bank draft, or postal money
order is submitted, make it payable to
the order of the Food and Drug
Administration and include the user fee
ID number to ensure that the payment
is applied to the correct fee(s). Payments
can be mailed to: Food and Drug
Administration, P.O. Box 979108, St.
Louis, MO 63197–9000. If a check, bank
draft, or money order is to be sent by a
courier that requests a street address,
the courier should deliver your payment
to U.S. Bank, Attention: Government
Lockbox 979108, 3180 Rider Trail
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concerning courier delivery, contact
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number is written on the check, bank
draft, or postal money order.
For payments made by wire transfer,
include the unique user fee ID number
to ensure that the payment is applied to
the correct fee(s). Without the unique
user fee ID number, the payment may
not be applied. The originating financial
institution may charge a wire transfer
fee. Include applicable wire transfer fees
with payment to ensure fees are fully
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10045, Acct. No: 75060099, Routing No:
021030004, SWIFT: FRNYUS33. FDA’s
tax identification number is 53–
0196965.
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B. Annual BPD and Program Fees
FDA will issue invoices with payment
instructions for FY 2025 annual BPD
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and program fees under the new fee
schedule in August 2024. Under
sections 744H(a)(1)(B)(ii) and
744H(a)(3)(B) of the FD&C Act, annual
BPD and program fees will be due on
October 1, 2024.
If sponsors join the BPD program after
the annual BPD invoices have been
issued in August 2024 FDA will issue
invoices in December 2024 to sponsors
subject to fees for FY 2025 that qualify
for the annual BPD fee after the August
2024 billing. FDA will issue invoices in
December 2025 for any products that
qualify for the annual program fee after
the August 2024 billing.
C. Waivers and Returns
To qualify for consideration for a
small business waiver under section
744H(d) of the FD&C Act, or the return
of any fee paid under section 744H of
the FD&C Act, including if the fee is
claimed to have been paid in error, a
person shall submit to FDA a written
request justifying such waiver or return
and, except as otherwise specified in
section 744H of the FD&C Act, such
written request shall be submitted to
FDA not later than 180 days after such
fee is due. Such written request shall
include any legal authorities under
which the request is made. See section
744H(h) of the FD&C Act.
Dated: July 26, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–16884 Filed 7–30–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–3404]
Generic Drug User Fee Rates for Fiscal
Year 2025
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Federal Food, Drug, and
Cosmetic Act (FD&C Act or statute), as
amended by the Generic Drug User Fee
Amendments of 2022 (GDUFA III),
authorizes the Food and Drug
Administration (FDA, Agency, or we) to
assess and collect fees for abbreviated
SUMMARY:
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new drug applications (ANDAs); drug
master files (DMFs); generic drug active
pharmaceutical ingredient (API)
facilities, finished dosage form (FDF)
facilities, and contract manufacturing
organization (CMO) facilities; and
generic drug applicant program user
fees. In this document, FDA is
announcing fiscal year (FY) 2025 rates
for GDUFA III fees. These fees are
effective on October 1, 2024, and will
remain in effect through September 30,
2025.
FOR FURTHER INFORMATION CONTACT:
Olufunmilayo Ariyo, Office of Financial
Management, Food and Drug
Administration, 10903 New Hampshire
Ave, Silver Spring, MD 20903, 240–
402–4989; or the User Fees Support
Staff at OO-OFBAP-OFM-UFSSGovernment@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Sections 744A and 744B of the FD&C
Act (21 U.S.C. 379j–41 and 379j–42), as
amended by GDUFA III, authorize FDA
to assess and collect fees associated
with human generic drug products. Fees
are assessed on: (1) certain types of
applications for human generic drug
products; (2) certain facilities where
APIs and FDFs are produced; (3) certain
DMFs associated with human generic
drug products; and (4) generic drug
applicants who own one or more
approved ANDAs (the program fee) (see
section 744B(a)(2) through (5) of the
FD&C Act). For more information about
GDUFA III, please refer to the FDA
website (https://www.fda.gov/gdufa).
For FY 2025, the generic drug user fee
rates are ANDA ($321,920), DMF
($95,084), domestic API facility
($41,580), foreign API facility ($56,580),
domestic FDF facility ($231,952),
foreign FDF facility ($246,952),
domestic CMO facility ($55,668), foreign
CMO facility ($70,668), large size
operation generic drug applicant
program ($1,891,664), medium size
operation generic drug applicant
program ($756,666), and small business
generic drug applicant program
($189,166). These fees are effective on
October 1, 2024, and will remain in
effect through September 30, 2025. The
fee rates for FY 2025 are set out in table
1.
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TABLE 1—FEE SCHEDULE FOR FY 2025
Fees rates for
FY 2025
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 ....................................................................................................................................
II. Fee Revenue Amount for FY 2025
Under section 744B(b)(1)(B)(ii) of the
FD&C Act, the base revenue amount for
FY 2025 for GDUFA III is $613,538,015.
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, for FY 2025, 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, for FY 2025, 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).
A. Inflation Adjustment
As noted above, the base revenue
amount for FY 2025 is $613,538,015.
This is the total revenue amount
specified for the prior fiscal year, FY
2024, pursuant to the statute (see
section 744B(b)(1)(A) of the FD&C Act).1
GDUFA III specifies that the
$613,538,015 is to be adjusted for
inflation for FY 2025 using two separate
adjustments: one for personnel
$321,920
95,084
41,580
56,580
231,952
246,952
55,668
70,668
1,891,664
756,666
189,166
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) positions 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 2025.
The 3-year average is 3.8539 percent.
TABLE 2—FDA PERSONNEL COMPENSATION AND BENEFITS (PC&B) EACH YEAR AND PERCENT CHANGE
Fiscal year
2021
Total PC&B ..........................................................................................
Total FTEs ...........................................................................................
PC&B per FTE .....................................................................................
Percent Change from Previous Year ...................................................
The statute specifies that this 3.8539
percent should be multiplied by the
proportion of PC&B expended for
2022
$3,039,513,000
18,501
$164,289
0.1811%
2023
$3,165,477,000
18,474
$171,348
4.2967%
human generic drug activities for the
first 3 of the preceding 4 fiscal years.
Table 3 shows the amount of PC&B and
$3,436,513,000
18,729
$183,486
7.0838%
3-Year
average
........................
........................
........................
3.8539%
the total amount obligated for human
generic drug activities from FY 2021
through FY 2023.
TABLE 3—PC&B AS A PERCENT OF FEE REVENUES SPENT ON HUMAN GENERIC DRUG ACTIVITIES OVER THE LAST 3
YEARS
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Fiscal year
2021
PC&B ...................................................................................................
Non-PC&B ...........................................................................................
Total Costs ...........................................................................................
PC&B Percent ......................................................................................
1 Under section 744B(b)(1)(B)(ii) of the FD&C Act,
the base revenue amount for a fiscal year is equal
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2022
$410,587,565
$271,328,560
$681,916,125
60.2109%
$391,922,747
$289,479,265
$681,402,012
57.5171%
to the total revenue amount established for the
previous fiscal year, not including any adjustments
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2023
$441,930,068
$301,930,017
$743,860,085
59.4104%
3-Year
average
........................
........................
........................
59.0461%
for such previous fiscal year under section
744B(c)(3).
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TABLE 3—PC&B AS A PERCENT OF FEE REVENUES SPENT ON HUMAN GENERIC DRUG ACTIVITIES OVER THE LAST 3
YEARS—Continued
Fiscal year
2021
Non-PC&B Percent ..............................................................................
The payroll adjustment is 3.8539
percent multiplied by 59.0461 percent
(or 2.2756 percent).
The statute specifies that the portion
of the inflation adjustment for nonPC&B costs for FY 2025 is the average
annual percent change that occurred in
the Consumer Price Index (CPI) for
urban consumers (Washington-
2022
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
2023
42.4829%
40.5896%
3-Year
average
40.9539%
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
2021
Annual CPI ...........................................................................................
Annual Percent Change ......................................................................
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To calculate the inflation adjustment
for non-pay costs, we multiply the 3year average percent change in the CPI
(4.5616 percent) by the proportion of all
costs other than PC&B to total costs of
human generic drug activities obligated.
Because 59.0461 percent was obligated
for PC&B as shown in table 3, 40.9539
percent is the portion of costs other than
PC&B. The non-pay adjustment is
4.5616 percent times 40.9539 percent, or
1.8682 percent.
To complete the inflation adjustment
for FY 2025, we add the PC&B
component (2.2756 percent) to the nonPC&B component (1.8682 percent) for a
total inflation adjustment of 4.1438
percent (rounded), and then add 1,
making an inflation adjustment multiple
of 1.041438. We then multiply the base
revenue amount for FY 2025
($613,538,015) by 1.041438, yielding an
inflation-adjusted amount of
$638,961,803.
B. FY 2025 Statutory Fee Revenue
Adjustments for Capacity Planning
The statute specifies that after the
base revenue amount for FY 2025 of
$613,538,015 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
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.
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2022
277.73
3.9568%
2023
296.12
6.6212%
305.32
3.1069%
3-Year
average
........................
4.5616%
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
Improvements adopted for the FY2025
CPA include the incorporation of hiring
plans and attrition estimates within the
capacity calculation. In calculation of
GDUFA fees for the prior fiscal year (FY
2024), the impacts of expected hiring on
the review capacity of the program were
considered within the managerial
adjustment process (described below).
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. The current
available resources for the direct review
related workload are a measure of the
percentage of time onboard staff report
to direct review workload activities,
plus a percentage of the additional
positions that are targeted to be hired
within the remainder of FY 2024.
3. A managerial adjustment to assess
the resource forecast in the context of
additional internal factors: Program
leadership examines operational,
financial, and resourcing data to assess
whether FDA will be able to utilize
additional funds during the fiscal year,
and whether the 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)
3 For example, 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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for FY 2025 based on predictive models,
as well as historical actuals from FY
2023 for comparison.
TABLE 5—CDER ACTUAL FY 2023 WORKLOAD VOLUMES AND PREDICTED FY 2025 WORKLOAD VOLUMES
FY 2023
actuals
Workload driver category
ANDA Originals 1 .....................................................................................................................................................
ANDA Supplements 2 ...............................................................................................................................................
Pre-ANDA Meetings ................................................................................................................................................
Controlled Correspondences 3 .................................................................................................................................
Suitability Petitions ...................................................................................................................................................
ANDA Annual Reports 4 ...........................................................................................................................................
Active REMS Programs 4 5 ......................................................................................................................................
685
10,237
114
3,580
14
12,162
49
FY 2025
predictions
651
12,045
106
3,156
32
13,230
49
1 Excludes
response to refused to receive (RTR) and Orig-2+. ANDA Original and Resubmissions/Amendments captured in time reporting data.
changes being effected (CBE) and prior approval supplement (PAS) 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 Data represents workload related to resource needs for post-marketing safety activities (developed in alignment with the methodology used in
fee-setting under PDUFA (section 736 of the FD&C Act) (21 U.S.C. 379h) and BsUFA (section 744H of the FD&C Act) (21 U.S.C. 379j–52)), 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 2025 were then
converted into estimated FTE needs for
FDA’s GDUFA direct review-related
work. The resulting expected FY 2025
FTE need for GDUFA was compared to
current onboard capacity for GDUFA
direct review-related work. Based on
this comparison, FDA determined that
the GDUFA program had sufficient
resources to perform expected
workload. Therefore, no CPA is
applicable for FY 2025 fee setting.
TABLE 6—BASE REVENUE AMOUNT AND SECTION 744B(c)(1) AND (2) ADJUSTMENT AMOUNTS
Fee
Amount
Statutory Fee Revenue Base Amount (section 744B(b)(1) of the FD&C Act) ...................................................................................
Inflation Adjustment (section 744B(c)(1) of the FD&C Act) ................................................................................................................
Capacity Planning Adjustment (section 744B(c)(2) of the FD&C Act) ................................................................................................
Revenue Amount after Adjustments in sections 744B(b)(1), 744B(c)(1), and 744B(c)(2) of the FD&C Act .....................................
C. FY 2025 Statutory Fee Revenue
Adjustments for Operating Reserve
Under section 744B(c)(3) of the FD&C
Act, for FY 2025, 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
2025, FDA may take an adjustment to
provide for not more than 9 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 9week and 12-week threshold amounts
for the FY 2025 operating reserve
adjustment, the FY 2025 adjusted
revenue amount, $638,961,803 is
divided by 52, resulting in a
$12,287,727 cost of operation for 1
week. The 1-week value is then
multiplied by 9 weeks to generate the 9week operating reserve threshold
amount for FY 2025 of $110,589,543.
The 1-week value is multiplied by 12 to
generate the 12-week operating reserve
$613,538,015
25,423,788
0
638,961,803
threshold amount for FY 2025 of
$147,452,724.
To determine the FY 2024 end-of-year
operating reserves of carryover user fees,
the Agency assessed the operating
reserve of carryover fees at the end of
June 2024 and forecast collections and
obligations in the fourth quarter of FY
2024 combined. This provides an
estimated end-of-year FY 2024 operating
reserve of carryover user fees of
$110,920,103 which equates to 9.03
weeks of operations. As the estimated
end-of-year FY 2024 operating reserve is
within the thresholds, there will not be
an operating reserve adjustment.
Table 7 below summarizes FY 2025
fee revenue.
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TABLE 7—TOTAL ESTIMATED ADJUSTED REVENUE AMOUNT
Fee
Amount
Statutory Fee Revenue Base Amount (section 744B(b)(1) of the FD&C Act) ...................................................................................
Inflation Adjustment (section 744B(c)(1) of the FD&C Act) ................................................................................................................
Capacity Planning Adjustment (section 744B(c)(2) of the FD&C Act) ................................................................................................
Operating Reserve Adjustment (section (744B(c)(3) of the FD&C Act) .............................................................................................
Total Revenue Amount (sections 744B(b)(1), 744B(c)(1), 744B(c)(2) and 744B(c)(3) of the FD&C Act) .........................................
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$613,538,015
25,423,788
0
0
638,961,803
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TABLE 7—TOTAL ESTIMATED ADJUSTED REVENUE AMOUNT—Continued
Fee
Amount
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) (rounded to the nearest thousand) .....................................................................................................................
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III. ANDA Filing Fee
Under GDUFA III, the FY 2025 ANDA
filing fee is owed by each applicant that
submits an ANDA on or after October 1,
2024.5 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
the $638,962,000, which is
$210,857,460.
To calculate the ANDA fee, FDA
estimated the number of full application
equivalents (FAEs) that will be
submitted in FY 2025. 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 651 new original ANDAs will be
submitted and incur filing fees in FY
2025. Not all 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 655 for FY 2025.
The FY 2025 ANDA filing fee is
estimated by dividing the number of
FAEs that will incur the fee in FY 2025
(655) into the fee revenue amount to be
derived from ANDA filing fees in FY
2025 ($210,857,460). The result,
rounded to the nearest dollar, is a fee of
$321,920 per ANDA.
5 Section
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.6 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. FDA assessed
DMFs from October 1, 2022, to April 30,
2024, and concluded that averaging the
number of fee-paying DMFs provided
the most accurate model for predicting
fee-paying DMFs for FY 2025. The
monthly average of paid DMF
submissions FDA received during FY
2023 and FY 2024 is 28. To determine
the FY 2025 projected number of feepaying DMFs, the average of 28 DMF
submissions is multiplied by 12 months,
which results in 336 estimated FY 2025
fee-paying DMFs. FDA is estimating 336
fee-paying DMFs for FY 2025.
The FY 2025 DMF fee is determined
by dividing the DMF target revenue by
the estimated number of fee-paying
DMFs in FY 2025. Section 744B(b)(2)(A)
of the FD&C Act specifies that the DMF
fees will make up 5 percent of the
$638,962,000, which is $31,948,100.
744B(a)(3) of the FD&C Act.
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638,962,000
Dividing the DMF revenue amount
($31,948,100) by the estimated feepaying DMFs (336), and rounding to the
nearest dollar, yields a DMF fee of
$95,084 for FY 2025.
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.7 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
affiliates.8 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.9 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
$638,962,000, which is $127,792,400.
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. These findings were
compared against facility statuses from
FDA’s Office Regulatory Affairs (ORA)
to exclude facilities that are no longer
operational.
7 Section
744B(b)(2)(C) and (D) of the FD&C Act.
744B(a)(4)(A) of the FD&C Act.
9 Section 744A(5) and 744B(b)(2)(C) of the FD&C
Act.
8 Section
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Based on these data, the FDF and
CMO facility denominators are 160 FDF
domestic, 311 FDF foreign, 83 CMO
domestic, and 131 CMO foreign
facilities for FY 2025.
GDUFA III specifies that the CMO
facility fee is to be equal to 24 percent
of the FDF facility fee.10 Therefore, to
generate the target collection revenue
amount from FDF and CMO facility fees
($127,792,400), FDA must weight a
CMO facility as 24 percent of an FDF
facility. FDA set fees based on the
estimate of 160 FDF domestic, 311 FDF
foreign, 19.92 CMO domestic (83
multiplied by 24 percent), and 31.44
CMO foreign facilities (131 multiplied
by 24 percent), which equals 522.36
total weighted FDF and CMO facilities
for FY 2025.
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 ($127,792,400) as follows: the
foreign facility fee differential revenue
equals the foreign facility fee differential
($15,000) multiplied by the number of
FDF foreign facilities (311) plus the
foreign facility fee differential ($15,000)
multiplied by the number of CMO
foreign facilities (131), totaling
$6,630,000. This results in foreign fee
differential revenue of $6,630,000 from
the total FDF and CMO facility fee target
collection revenue.
Subtracting the foreign facility
differential fee revenue ($6,630,000)
from the total FDF and CMO facility
target collection revenue ($127,792,400)
results in a remaining facility fee
revenue balance of $121,162,400. To
determine the domestic FDF facility fee,
FDA divides the $121,162,400 by the
total weighted number of FDF and CMO
facilities (522.36), which results in a
domestic FDF facility fee of $231,952.
The foreign FDF facility fee is $15,000
more than the domestic FDF facility fee,
or $246,952.
According to GDUFA III, the domestic
CMO fee is calculated as 24 percent of
the amount of the domestic FDF facility
fee.11 Therefore, the domestic CMO fee
is $55,668, 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
$70,668.
10 Section
11 Section
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.12 Section 744B(b)(2)(D) of
the FD&C Act specifies the API facility
fee will make up 6 percent of
$638,962,000 in fee revenue, which is
$38,337,720.
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. These findings
were compared against facility statuses
from FDA’s ORA to exclude facilities
that are no longer operational.
Based on these data, the total number
of API facilities identified was 698; of
that number, 77 were domestic and 621
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 (621) 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 $9,315,000 of the
total API fee revenue. Subtracting the
foreign facility differential fee revenue
($9,315,000) from the total API facility
target revenue ($38,337,720) results in a
remaining balance of $29,022,720. To
determine the domestic API facility fee,
we divide the $29,022,720 by the total
number of facilities (698), which gives
us a domestic API facility fee of
$41,580. The foreign API facility fee is
$15,000 more than the domestic API
facility fee, or $56,580.
VIII. Generic Drug Applicant Program
Fee
Under GDUFA III, if a person and its
affiliates own at least one but not more
744B(b)(2)(C) of the FD&C Act.
744B(b)(2)(C) of the FD&C Act.
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61451
than five approved ANDAs on October
1, 2024, the person and its affiliates
shall owe a small business generic drug
applicant program fee.13 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.14 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.15 Section
744B(b)(2)(E) of the FD&C Act specifies
the GDUFA program fee will make up
36 percent of $638,962,000 in fee
revenue, which is $230,026,320.
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) 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; 16 (2) inactive
ANDAs: applicants who have not
submitted an annual report for one or
more of their approved applications
within the past 2 years; (3) CBERapproved ANDAs: applicants and their
affiliates with CBER-approved ANDAs
are added to CDER’s population of
approved ANDAs; (4) Program Fee
Arrears List: parent companies that are
on the arrears list for any fiscal year; (5)
Out of Business companies: parent
companies that are no longer in
operation; and (6) Tier Adjustment: the
frequency of large-tier, medium-tier, and
small-tier companies moving to
different tiers (or as applicable,
dropping out of any tier) after the
completion of the program fee
methodology and tier determination.
The list of original approved ANDAs
from the Generic Drug Review Platform
as of April 30, 2024, in addition to
CBER’s database, shows 241 applicants
in the small business tier, 74 applicants
in the medium size tier, and 81
applicants in the large size tier.
Factoring in all the variables, we
estimate there will be 194 applicants in
13 Sections 744B(a)(5)(A) and 744B(b)(2)(E)(i) of
the FD&C Act.
14 Id.
15 Id.
16 See section 744B(b)(2)(E)(ii) of the FD&C Act.
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the small business tier, 68 applicants in
the medium size tier, and 75 applicants
in the large size tier for FY 2025.
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 ($230,026,320),
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 19.40 applicants in the small
business tier (194 multiplied by 10
percent), 27.2 applicants in the medium
size tier (68 multiplied by 40 percent),
and 75 applicants in the large size tier,
arriving at 121.60 total weighted
applicants for FY 2025.
To generate the large size operation
GDUFA program fee, FDA divides the
target revenue amount of $230,026,320
by 121.60, which equals $1,891,664.
The medium size operation GDUFA
program fee is 40 percent of the full fee
($756,666), and the small business
GDUFA program fee is 10 percent of the
full fee ($189,166).
IX. Fee Schedule for FY 2025
The fee rates for FY 2025 are set out
in table 8.
TABLE 8—FEE SCHEDULE FOR FY 2025
Fees rates for
FY 2025
Generic drug fee category
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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 ....................................................................................................................................
X. Fee Payment Options and
Procedures
The new fee rates are effective on
October 1, 2024, and will remain in
effect through September 30, 2025.
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 web17 Section
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
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41,580
56,580
231,952
246,952
55,668
70,668
1,891,664
756,666
189,166
Lockbox 979108, 3180 Rider Trail S,
Earth City, MO 63045. (Note: This U.S.
Bank address is for courier delivery
only). For questions concerning courier
delivery, U.S. Bank can be contacted at
800–495–4981. 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:
744B(b)(2)(E)(i) of the FD&C Act.
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$321,920
95,084
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Electronic Submissions
FRNYUS33. FDA’s tax identification
number is 53–0196965.
Dated: July 26, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–16896 Filed 7–30–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–2865]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Generic Clearance
for Quantitative Testing for the
Development of Food and Drug
Administration Communications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on generic clearance
for quantitative testing for the
development of FDA communications,
which collects individual generic
quantitative information (e.g., surveys,
experimental studies) to test
communications or educational
messages on FDA-regulated food and
cosmetic products, dietary supplements,
and animal food and feed while they are
being developed or are in review.
DATES: Either electronic or written
comments on the collection of
information must be submitted by
September 30, 2024.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
September 30, 2024. Comments received
by mail/hand delivery/courier (for
written/paper submissions) will be
considered timely if they are received
on or before that date.
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SUMMARY:
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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–
2024–N–2865 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Generic
Clearance for Quantitative Testing for
the Development of Food and Drug
Administration Communications.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in 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
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61453
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.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3521), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
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[Federal Register Volume 89, Number 147 (Wednesday, July 31, 2024)]
[Notices]
[Pages 61446-61453]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-16896]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-3404]
Generic Drug User Fee Rates for Fiscal Year 2025
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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) 2025 rates for GDUFA III fees. These fees are effective on
October 1, 2024, and will remain in effect through September 30, 2025.
FOR FURTHER INFORMATION CONTACT: Olufunmilayo Ariyo, Office of
Financial Management, Food and Drug Administration, 10903 New Hampshire
Ave, Silver Spring, MD 20903, 240-402-4989; or the User Fees Support
Staff at [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 own one or more approved ANDAs (the program fee) (see
section 744B(a)(2) through (5) of the FD&C Act). For more information
about GDUFA III, please refer to the FDA website (https://www.fda.gov/gdufa).
For FY 2025, the generic drug user fee rates are ANDA ($321,920),
DMF ($95,084), domestic API facility ($41,580), foreign API facility
($56,580), domestic FDF facility ($231,952), foreign FDF facility
($246,952), domestic CMO facility ($55,668), foreign CMO facility
($70,668), large size operation generic drug applicant program
($1,891,664), medium size operation generic drug applicant program
($756,666), and small business generic drug applicant program
($189,166). These fees are effective on October 1, 2024, and will
remain in effect through September 30, 2025. The fee rates for FY 2025
are set out in table 1.
[[Page 61447]]
Table 1--Fee Schedule for FY 2025
------------------------------------------------------------------------
Fees rates for
Generic drug fee category FY 2025
------------------------------------------------------------------------
Applications:
Abbreviated New Drug Application (ANDA)........... $321,920
Drug Master File (DMF)............................ 95,084
Facilities:
Active Pharmaceutical Ingredient (API)--Domestic.. 41,580
API--Foreign...................................... 56,580
Finished Dosage Form (FDF)--Domestic.............. 231,952
FDF--Foreign...................................... 246,952
Contract Manufacturing Organization (CMO)-- 55,668
Domestic.........................................
CMO--Foreign...................................... 70,668
GDUFA Program:
Large size operation generic drug applicant....... 1,891,664
Medium size operation generic drug applicant...... 756,666
Small business generic drug applicant............. 189,166
------------------------------------------------------------------------
II. Fee Revenue Amount for FY 2025
Under section 744B(b)(1)(B)(ii) of the FD&C Act, the base revenue
amount for FY 2025 for GDUFA III is $613,538,015. 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, for FY 2025, 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, for FY 2025, 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).
A. Inflation Adjustment
As noted above, the base revenue amount for FY 2025 is
$613,538,015. This is the total revenue amount specified for the prior
fiscal year, FY 2024, pursuant to the statute (see section
744B(b)(1)(A) of the FD&C Act).\1\ GDUFA III specifies that the
$613,538,015 is to be adjusted for inflation for FY 2025 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) of the FD&C Act, 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).
---------------------------------------------------------------------------
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) positions 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 2025. The 3-year average is 3.8539 percent.
Table 2--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Change
----------------------------------------------------------------------------------------------------------------
Fiscal year 2021 2022 2023 3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B................................ $3,039,513,000 $3,165,477,000 $3,436,513,000 ..............
Total FTEs................................ 18,501 18,474 18,729 ..............
PC&B per FTE.............................. $164,289 $171,348 $183,486 ..............
Percent Change from Previous Year......... 0.1811% 4.2967% 7.0838% 3.8539%
----------------------------------------------------------------------------------------------------------------
The statute specifies that this 3.8539 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 2021 through FY 2023.
Table 3--PC&B as a Percent of Fee Revenues Spent on Human Generic Drug Activities Over the Last 3 Years
----------------------------------------------------------------------------------------------------------------
Fiscal year 2021 2022 2023 3-Year average
----------------------------------------------------------------------------------------------------------------
PC&B...................................... $410,587,565 $391,922,747 $441,930,068 ..............
Non-PC&B.................................. $271,328,560 $289,479,265 $301,930,017 ..............
Total Costs............................... $681,916,125 $681,402,012 $743,860,085 ..............
PC&B Percent.............................. 60.2109% 57.5171% 59.4104% 59.0461%
[[Page 61448]]
Non-PC&B Percent.......................... 39.7891% 42.4829% 40.5896% 40.9539%
----------------------------------------------------------------------------------------------------------------
The payroll adjustment is 3.8539 percent multiplied by 59.0461
percent (or 2.2756 percent).
The statute specifies that the portion of the inflation adjustment
for non-PC&B costs for FY 2025 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
----------------------------------------------------------------------------------------------------------------
Year 2021 2022 2023 3-Year average
----------------------------------------------------------------------------------------------------------------
Annual CPI................................ 277.73 296.12 305.32 ..............
Annual Percent Change..................... 3.9568% 6.6212% 3.1069% 4.5616%
----------------------------------------------------------------------------------------------------------------
To calculate the inflation adjustment for non-pay costs, we
multiply the 3-year average percent change in the CPI (4.5616 percent)
by the proportion of all costs other than PC&B to total costs of human
generic drug activities obligated. Because 59.0461 percent was
obligated for PC&B as shown in table 3, 40.9539 percent is the portion
of costs other than PC&B. The non-pay adjustment is 4.5616 percent
times 40.9539 percent, or 1.8682 percent.
To complete the inflation adjustment for FY 2025, we add the PC&B
component (2.2756 percent) to the non-PC&B component (1.8682 percent)
for a total inflation adjustment of 4.1438 percent (rounded), and then
add 1, making an inflation adjustment multiple of 1.041438. We then
multiply the base revenue amount for FY 2025 ($613,538,015) by
1.041438, yielding an inflation-adjusted amount of $638,961,803.
B. FY 2025 Statutory Fee Revenue Adjustments for Capacity Planning
The statute specifies that after the base revenue amount for FY
2025 of $613,538,015 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\ Improvements adopted for the
FY2025 CPA include the incorporation of hiring plans and attrition
estimates within the capacity calculation. In calculation of GDUFA fees
for the prior fiscal year (FY 2024), the impacts of expected hiring on
the review capacity of the program were considered within the
managerial adjustment process (described below).
---------------------------------------------------------------------------
\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, 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. The current available resources for the direct review related
workload are a measure of the percentage of time onboard staff report
to direct review workload activities, plus a percentage of the
additional positions that are targeted to be hired within the remainder
of FY 2024.
---------------------------------------------------------------------------
\4\ Full-time equivalents refer to a paid staff year, rather
than a count of individual employees.
---------------------------------------------------------------------------
3. A managerial adjustment to assess the resource forecast in the
context of additional internal factors: Program leadership examines
operational, financial, and resourcing data to assess whether FDA will
be able to utilize additional funds during the fiscal year, and whether
the 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)
[[Page 61449]]
for FY 2025 based on predictive models, as well as historical actuals
from FY 2023 for comparison.
Table 5--CDER Actual FY 2023 Workload Volumes and Predicted FY 2025
Workload Volumes
------------------------------------------------------------------------
FY 2023 FY 2025
Workload driver category actuals predictions
------------------------------------------------------------------------
ANDA Originals \1\...................... 685 651
ANDA Supplements \2\.................... 10,237 12,045
Pre-ANDA Meetings....................... 114 106
Controlled Correspondences \3\.......... 3,580 3,156
Suitability Petitions................... 14 32
ANDA Annual Reports \4\................. 12,162 13,230
Active REMS Programs 4 5................ 49 49
------------------------------------------------------------------------
\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 (CBE) and prior approval supplement
(PAS) 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\ Data represents workload related to resource needs for post-
marketing safety activities (developed in alignment with the
methodology used in fee-setting under PDUFA (section 736 of the FD&C
Act) (21 U.S.C. 379h) and BsUFA (section 744H of the FD&C Act) (21
U.S.C. 379j-52)), 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 2025 were then converted into estimated FTE needs for
FDA's GDUFA direct review-related work. The resulting expected FY 2025
FTE need for GDUFA was compared to current onboard capacity for GDUFA
direct review-related work. Based on this comparison, FDA determined
that the GDUFA program had sufficient resources to perform expected
workload. Therefore, no CPA is applicable for FY 2025 fee setting.
Table 6--Base Revenue Amount and Section 744B(c)(1) and (2) Adjustment
Amounts
------------------------------------------------------------------------
Fee Amount
------------------------------------------------------------------------
Statutory Fee Revenue Base Amount (section 744B(b)(1) of $613,538,015
the FD&C Act)..........................................
Inflation Adjustment (section 744B(c)(1) of the FD&C 25,423,788
Act)...................................................
Capacity Planning Adjustment (section 744B(c)(2) of the 0
FD&C Act)..............................................
Revenue Amount after Adjustments in sections 744B(b)(1), 638,961,803
744B(c)(1), and 744B(c)(2) of the FD&C Act.............
------------------------------------------------------------------------
C. FY 2025 Statutory Fee Revenue Adjustments for Operating Reserve
Under section 744B(c)(3) of the FD&C Act, for FY 2025, 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
2025, FDA may take an adjustment to provide for not more than 9 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 9-week and
12-week threshold amounts for the FY 2025 operating reserve adjustment,
the FY 2025 adjusted revenue amount, $638,961,803 is divided by 52,
resulting in a $12,287,727 cost of operation for 1 week. The 1-week
value is then multiplied by 9 weeks to generate the 9-week operating
reserve threshold amount for FY 2025 of $110,589,543. The 1-week value
is multiplied by 12 to generate the 12-week operating reserve threshold
amount for FY 2025 of $147,452,724.
To determine the FY 2024 end-of-year operating reserves of
carryover user fees, the Agency assessed the operating reserve of
carryover fees at the end of June 2024 and forecast collections and
obligations in the fourth quarter of FY 2024 combined. This provides an
estimated end-of-year FY 2024 operating reserve of carryover user fees
of $110,920,103 which equates to 9.03 weeks of operations. As the
estimated end-of-year FY 2024 operating reserve is within the
thresholds, there will not be an operating reserve adjustment.
Table 7 below summarizes FY 2025 fee revenue.
Table 7--Total Estimated Adjusted Revenue Amount
------------------------------------------------------------------------
Fee Amount
------------------------------------------------------------------------
Statutory Fee Revenue Base Amount (section 744B(b)(1) of $613,538,015
the FD&C Act)..........................................
Inflation Adjustment (section 744B(c)(1) of the FD&C 25,423,788
Act)...................................................
Capacity Planning Adjustment (section 744B(c)(2) of the 0
FD&C Act)..............................................
Operating Reserve Adjustment (section (744B(c)(3) of the 0
FD&C Act)..............................................
Total Revenue Amount (sections 744B(b)(1), 744B(c)(1), 638,961,803
744B(c)(2) and 744B(c)(3) of the FD&C Act).............
[[Page 61450]]
Total Revenue Amount (rounded to the nearest thousand 638,962,000
dollars) (sections 744B(b)(1), 744B(c)(1), 744B(c)(2)
and 744B(c)(3) of the FD&C Act) (rounded to the nearest
thousand)..............................................
------------------------------------------------------------------------
III. ANDA Filing Fee
Under GDUFA III, the FY 2025 ANDA filing fee is owed by each
applicant that submits an ANDA on or after October 1, 2024.\5\ 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 the
$638,962,000, which is $210,857,460.
---------------------------------------------------------------------------
\5\ 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 2025. 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 651 new original ANDAs will
be submitted and incur filing fees in FY 2025. Not all 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 655 for FY 2025.
The FY 2025 ANDA filing fee is estimated by dividing the number of
FAEs that will incur the fee in FY 2025 (655) into the fee revenue
amount to be derived from ANDA filing fees in FY 2025 ($210,857,460).
The result, rounded to the nearest dollar, is a fee of $321,920 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.\6\ 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.
---------------------------------------------------------------------------
\6\ Section 744B(a)(2) of the FD&C Act.
---------------------------------------------------------------------------
To calculate the DMF fee, FDA assessed the volume of DMF
submissions over time. FDA assessed DMFs from October 1, 2022, to April
30, 2024, and concluded that averaging the number of fee-paying DMFs
provided the most accurate model for predicting fee-paying DMFs for FY
2025. The monthly average of paid DMF submissions FDA received during
FY 2023 and FY 2024 is 28. To determine the FY 2025 projected number of
fee-paying DMFs, the average of 28 DMF submissions is multiplied by 12
months, which results in 336 estimated FY 2025 fee-paying DMFs. FDA is
estimating 336 fee-paying DMFs for FY 2025.
The FY 2025 DMF fee is determined by dividing the DMF target
revenue by the estimated number of fee-paying DMFs in FY 2025. Section
744B(b)(2)(A) of the FD&C Act specifies that the DMF fees will make up
5 percent of the $638,962,000, which is $31,948,100. Dividing the DMF
revenue amount ($31,948,100) by the estimated fee-paying DMFs (336),
and rounding to the nearest dollar, yields a DMF fee of $95,084 for FY
2025.
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.\7\ The basis for this differential is
the extra cost incurred by conducting an inspection outside the United
States and its territories and possessions.
---------------------------------------------------------------------------
\7\ 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.\8\ 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.\9\
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 $638,962,000, which
is $127,792,400.
---------------------------------------------------------------------------
\8\ Section 744B(a)(4)(A) of the FD&C Act.
\9\ 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. These
findings were compared against facility statuses from FDA's Office
Regulatory Affairs (ORA) to exclude facilities that are no longer
operational.
[[Page 61451]]
Based on these data, the FDF and CMO facility denominators are 160
FDF domestic, 311 FDF foreign, 83 CMO domestic, and 131 CMO foreign
facilities for FY 2025.
GDUFA III specifies that the CMO facility fee is to be equal to 24
percent of the FDF facility fee.\10\ Therefore, to generate the target
collection revenue amount from FDF and CMO facility fees
($127,792,400), FDA must weight a CMO facility as 24 percent of an FDF
facility. FDA set fees based on the estimate of 160 FDF domestic, 311
FDF foreign, 19.92 CMO domestic (83 multiplied by 24 percent), and
31.44 CMO foreign facilities (131 multiplied by 24 percent), which
equals 522.36 total weighted FDF and CMO facilities for FY 2025.
---------------------------------------------------------------------------
\10\ 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
($127,792,400) as follows: the foreign facility fee differential
revenue equals the foreign facility fee differential ($15,000)
multiplied by the number of FDF foreign facilities (311) plus the
foreign facility fee differential ($15,000) multiplied by the number of
CMO foreign facilities (131), totaling $6,630,000. This results in
foreign fee differential revenue of $6,630,000 from the total FDF and
CMO facility fee target collection revenue.
Subtracting the foreign facility differential fee revenue
($6,630,000) from the total FDF and CMO facility target collection
revenue ($127,792,400) results in a remaining facility fee revenue
balance of $121,162,400. To determine the domestic FDF facility fee,
FDA divides the $121,162,400 by the total weighted number of FDF and
CMO facilities (522.36), which results in a domestic FDF facility fee
of $231,952. The foreign FDF facility fee is $15,000 more than the
domestic FDF facility fee, or $246,952.
According to GDUFA III, the domestic CMO fee is calculated as 24
percent of the amount of the domestic FDF facility fee.\11\ Therefore,
the domestic CMO fee is $55,668, 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 $70,668.
---------------------------------------------------------------------------
\11\ 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.\12\ Section 744B(b)(2)(D) of the FD&C Act
specifies the API facility fee will make up 6 percent of $638,962,000
in fee revenue, which is $38,337,720.
---------------------------------------------------------------------------
\12\ 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. These findings were compared against
facility statuses from FDA's ORA to exclude facilities that are no
longer operational.
Based on these data, the total number of API facilities identified
was 698; of that number, 77 were domestic and 621 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 (621) 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 $9,315,000 of the total API fee revenue. Subtracting the
foreign facility differential fee revenue ($9,315,000) from the total
API facility target revenue ($38,337,720) results in a remaining
balance of $29,022,720. To determine the domestic API facility fee, we
divide the $29,022,720 by the total number of facilities (698), which
gives us a domestic API facility fee of $41,580. The foreign API
facility fee is $15,000 more than the domestic API facility fee, or
$56,580.
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, 2024, the person
and its affiliates shall owe a small business generic drug applicant
program fee.\13\ 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.\14\ 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.\15\ Section 744B(b)(2)(E) of the FD&C Act
specifies the GDUFA program fee will make up 36 percent of $638,962,000
in fee revenue, which is $230,026,320.
---------------------------------------------------------------------------
\13\ Sections 744B(a)(5)(A) and 744B(b)(2)(E)(i) of the FD&C
Act.
\14\ Id.
\15\ 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) 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; \16\ (2) inactive
ANDAs: applicants who have not submitted an annual report for one or
more of their approved applications within the past 2 years; (3) CBER-
approved ANDAs: applicants and their affiliates with CBER-approved
ANDAs are added to CDER's population of approved ANDAs; (4) Program Fee
Arrears List: parent companies that are on the arrears list for any
fiscal year; (5) Out of Business companies: parent companies that are
no longer in operation; and (6) Tier Adjustment: the frequency of
large-tier, medium-tier, and small-tier companies moving to different
tiers (or as applicable, dropping out of any tier) after the completion
of the program fee methodology and tier determination.
---------------------------------------------------------------------------
\16\ See section 744B(b)(2)(E)(ii) of the FD&C Act.
---------------------------------------------------------------------------
The list of original approved ANDAs from the Generic Drug Review
Platform as of April 30, 2024, in addition to CBER's database, shows
241 applicants in the small business tier, 74 applicants in the medium
size tier, and 81 applicants in the large size tier. Factoring in all
the variables, we estimate there will be 194 applicants in
[[Page 61452]]
the small business tier, 68 applicants in the medium size tier, and 75
applicants in the large size tier for FY 2025.
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 ($230,026,320), 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 19.40 applicants in the small business tier (194
multiplied by 10 percent), 27.2 applicants in the medium size tier (68
multiplied by 40 percent), and 75 applicants in the large size tier,
arriving at 121.60 total weighted applicants for FY 2025.
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\17\ Section 744B(b)(2)(E)(i) of the FD&C Act.
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To generate the large size operation GDUFA program fee, FDA divides
the target revenue amount of $230,026,320 by 121.60, which equals
$1,891,664. The medium size operation GDUFA program fee is 40 percent
of the full fee ($756,666), and the small business GDUFA program fee is
10 percent of the full fee ($189,166).
IX. Fee Schedule for FY 2025
The fee rates for FY 2025 are set out in table 8.
Table 8--Fee Schedule for FY 2025
------------------------------------------------------------------------
Fees rates for
Generic drug fee category FY 2025
------------------------------------------------------------------------
Applications:
Abbreviated New Drug Application (ANDA)........... $321,920
Drug Master File (DMF)............................ 95,084
Facilities:
Active Pharmaceutical Ingredient (API)--Domestic.. 41,580
API--Foreign...................................... 56,580
Finished Dosage Form (FDF)--Domestic.............. 231,952
FDF--Foreign...................................... 246,952
Contract Manufacturing Organization (CMO)-- 55,668
Domestic.........................................
CMO--Foreign...................................... 70,668
GDUFA Program:
Large size operation generic drug applicant....... 1,891,664
Medium size operation generic drug applicant...... 756,666
Small business generic drug applicant............. 189,166
------------------------------------------------------------------------
X. Fee Payment Options and Procedures
The new fee rates are effective on October 1, 2024, and will remain
in effect through September 30, 2025. 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,
3180 Rider Trail S, Earth City, MO 63045. (Note: This U.S. Bank address
is for courier delivery only). For questions concerning courier
delivery, U.S. Bank can be contacted at 800-495-4981. 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:
[[Page 61453]]
FRNYUS33. FDA's tax identification number is 53-0196965.
Dated: July 26, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-16896 Filed 7-30-24; 8:45 am]
BILLING CODE 4164-01-P
