[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]


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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.

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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).
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    \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).
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    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%
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    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
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                Fiscal year                       2021              2022              2023        3-Year average
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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%
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    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
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                   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%
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    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).
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    \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.
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    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.
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    \4\ Full-time equivalents refer to a paid staff year, rather 
than a count of individual employees.
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    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
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                                              FY 2023         FY 2025
        Workload driver category              actuals       predictions
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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
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                           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)..............................................
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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.
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    \5\ Section 744B(a)(3) of the FD&C Act.
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    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.
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    \6\ Section 744B(a)(2) of the FD&C Act.
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    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.
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    \7\ Section 744B(b)(2)(C) and (D) of the FD&C Act.
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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.
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    \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.
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    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.
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    \10\ Section 744B(b)(2)(C) of the FD&C Act.
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    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.
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    \11\ Section 744B(b)(2)(C) of the FD&C Act.
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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.
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    \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.
---------------------------------------------------------------------------

    \17\ Section 744B(b)(2)(E)(i) of the FD&C Act.
---------------------------------------------------------------------------

    To generate the large size operation GDUFA program fee, FDA divides 
the target revenue amount of $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