[Federal Register Volume 87, Number 196 (Wednesday, October 12, 2022)]
[Notices]
[Pages 61601-61605]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-22099]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration.

[Docket No. FDA-2022-N-2354]


Generic Drug User Fee Rates for Fiscal Year 2023

AGENCY: Food and Drug Administration, Department of Health and Human 
Services (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) 2023 rates for GDUFA III fees. These fees are effective on 
October 1, 2022, and will remain in effect through September 30, 2023.

FOR FURTHER INFORMATION CONTACT: Robert Marcarelli, Office of Financial 
Management, Food and Drug Administration, 4041 Powder Mill Rd., Rm. 
61075, Beltsville, MD 20705-4304, and the User Fees Support Staff at 
[email protected], 301-796-7223.

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

[[Page 61602]]

DMFs associated with human generic drug products; and (4) generic drug 
applicants who have ANDAs (the program fee) (see section 744B(a)(2) 
through (5) of the FD&C Act). For more information about GDUFA III, 
please refer to the FDA website (https://www.fda.gov/gdufa).
    For FY 2023, the generic drug fee rates are: ANDA ($240,582), DMF 
($78,293), domestic API facility ($37,544), foreign API facility 
($52,544), domestic FDF facility ($213,134), foreign FDF facility 
($228,134), domestic CMO facility ($51,152), foreign CMO facility 
($66,152), large size operation generic drug applicant program 
($1,620,556), medium size operation generic drug applicant program 
($648,222), and small business generic drug applicant program 
($162,056). These fees are effective on October 1, 2022, and will 
remain in effect through September 30, 2023. The fee rates for FY 2023 
are set out in table 1.

                    Table 1--Fee Schedule for FY 2023
------------------------------------------------------------------------
                                                         Fees rates for
              Generic drug fee category                     FY 2023
------------------------------------------------------------------------
Applications
    Abbreviated New Drug Application (ANDA)..........           $240,582
    Drug Master File (DMF)...........................             78,293
Facilities
    Active Pharmaceutical Ingredient (API)--Domestic.             37,544
    API--Foreign.....................................             52,544
    Finished Dosage Form (FDF)--Domestic.............            213,134
    FDF--Foreign.....................................            228,134
    Contract Manufacturing Organization (CMO)--......             51,152
Domestic
    CMO--Foreign.....................................             66,152
GDUFA Program
    Large size operation generic drug applicant......          1,620,556
    Medium size operation generic drug applicant.....            648,222
    Small business operation generic drug applicant..            162,056
------------------------------------------------------------------------

II. Fee Revenue Amount for FY 2023

    The fee revenue amount for FY 2023 for GDUFA III is $582,500,000. 
Since this is the first fiscal year of the GDUFA III authorization 
period, there is no inflation adjustment. Applicable inflation 
adjustments shall be made beginning with FY 2024.
    Beginning with FY 2024, FDA shall, in addition to the inflation 
adjustment, apply the capacity planning adjustment under section 
744B(c)(2) of the FD&C Act 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.
    Beginning with FY 2024, FDA may, in addition to the inflation and 
capacity planning Adjustments, apply the operating reserve adjustment 
under section 744B(c)(3) of the FD&C Act 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).

III. Fee Amounts for FY 2023

    GDUFA III directs FDA to use the annual revenue amount determined 
under the statute as a starting point to set the fee rates for each fee 
type. The fee revenue amount for FY 2023 is $582,500,000. The ANDA, 
DMF, API facility, FDF facility, CMO facility, and generic drug 
applicant program fee (GDUFA program fee) calculations for FY 2023 are 
described in this document.

A. ANDA Filing Fee

    Under GDUFA III, the FY 2023 ANDA filing fee is owed by each 
applicant that submits an ANDA on or after October 1, 2022. 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 
$582,500,000, which is $192,225,000.
    To calculate the ANDA fee, FDA estimated the number of full 
application equivalents (FAEs) that will be submitted in FY 2023. The 
submissions are broken down into three categories: new originals 
(submissions that have not been received by FDA previously); 
submissions that FDA refused to receive (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).
    FDA utilized data from ANDAs submitted from October 1, 2020, to 
April 30, 2022, to estimate the number of new original ANDAs that will 
incur filing fees in FY 2023. For FY 2023, FDA estimates that 
approximately 800 new original ANDAs will be submitted and incur filing 
fees. Not all of the new original ANDAs will be received by FDA and 
some of those not received will be resubmitted in the same fiscal year. 
Therefore, FDA expects that the FAE count for ANDAs will be 799 for FY 
2023.
    The FY 2023 application fee is estimated by dividing the number of 
FAEs that will pay the fee in FY 2023 (799) into the fee revenue amount 
to be derived from ANDA application fees in FY 2023 ($192,225,000). The 
result, rounded to the nearest dollar, is a fee of $240,582 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

[[Page 61603]]

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.

B. 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. This is 
a one-time fee for each DMF. This fee is due on the earlier of the date 
on which the first generic drug submission is submitted that references 
the associated DMF or the date on which the DMF holder requests the 
initial completeness assessment. Under section 744B(a)(2)(D)(iii) of 
the FD&C Act, if a DMF has successfully undergone an initial 
completeness assessment and the fee is paid, the DMF will be placed on 
a publicly available list documenting DMFs available for reference.
    To calculate the DMF fee, FDA assessed the volume of DMF 
submissions over time. We assessed DMFs from October 1, 2020, to April 
30, 2022, and concluded that averaging the number of fee-paying DMFs 
provided the most accurate model for predicting fee-paying DMFs for FY 
2023. The monthly average of paid DMF submissions FDA received in FY 
2021 and FY 2022 is 31. To determine the FY 2023 projected number of 
fee-paying DMFs, the average of 31 DMF submissions is multiplied by 12 
months, which results in 372 estimated FY 2023 fee-paying DMFs. FDA is 
estimating 372 fee-paying DMFs for FY 2023.
    The FY 2023 DMF fee is determined by dividing the DMF target 
revenue by the estimated number of fee-paying DMFs in FY 2023. Section 
744B(b)(2)(A) of the FD&C Act specifies that the DMF fees will make up 
5 percent of the $582,500,000, which is $29,125,000. Dividing the DMF 
revenue amount ($29,125,000) by the estimated fee-paying DMFs (372), 
and rounding to the nearest dollar, yields a DMF fee of $78,293 for FY 
2023.

C. 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. The basis for this differential is the 
extra cost incurred by conducting an inspection outside the United 
States and its territories and possessions.

D. 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. 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. 
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 $582,500,000, which 
is $116,500,000.
    To calculate the fees, data from FDA's Integrity Services (IS) were 
utilized as the primary source of facility information for determining 
the denominators of each facility fee type. IS is the master data 
steward for all facility information provided in generic drug 
submissions received by FDA. A facility's reference status in an 
approved generic drug submission is extracted directly from submission 
data rather than relying on data from self-identification. This 
information provided the number of facilities referenced as FDF 
manufacturers in at least one approved generic drug submission. Based 
on FDA's IS data, the FDF and CMO facility denominators are 176 FDF 
domestic, 293 FDF foreign, 90 CMO domestic, and 114 CMO foreign 
facilities for FY 2023.
    GDUFA III specifies that the CMO facility fee is to be equal to 24 
percent of the FDF facility fee. Therefore, to generate the target 
collection revenue amount from FDF and CMO facility fees 
($116,500,000), FDA must weight a CMO facility as 24 percent of an FDF 
facility. FDA set fees based on the estimate of 176 FDF domestic, 293 
FDF foreign, 21.60 CMO domestic (90 multiplied by 24 percent), and 
27.36 CMO foreign facilities (114 multiplied by 24 percent), which 
equals 518 total weighted FDF and CMO facilities for FY 2023.
    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 
($116,500,000) as follows: the foreign facility fee differential 
revenue equals the foreign facility fee differential ($15,000) 
multiplied by the number of FDF foreign facilities (293) plus the 
foreign facility fee differential ($15,000) multiplied by the number of 
CMO foreign facilities (114), totaling $6,105,000. This results in 
foreign fee differential revenue of $6,105,000 from the total FDF and 
CMO facility fee target collection revenue.
    Subtracting the foreign facility differential fee revenue 
($6,105,000) from the total FDF and CMO facility target collection 
revenue ($116,500,000) results in a remaining facility fee revenue 
balance of $110,395,000. To determine the domestic FDF facility fee, 
FDA divides the $110,395,000 by the total weighted number of FDF and 
CMO facilities (518), which results in a domestic FDF facility fee of 
$213,134. The foreign FDF facility fee is $15,000 more than the 
domestic FDF facility fee, or $228,134.
    According to GDUFA III, the domestic CMO fee is calculated as 24 
percent of the amount of the domestic FDF facility fee. Therefore, the 
domestic CMO fee is $51,152, 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 $66,152.

E. 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 or a Type II API DMF referenced in at least one 
approved generic drug submission. Section 744B(b)(2)(D) of the FD&C Act 
specifies the API facility fee will make up 6 percent of $582,500,000 
in fee revenue, which is $34,950,000.
    To calculate the API facility fee, data from FDA's IS were utilized 
as the primary source of facility information for determining the 
denominator. As stated above, IS is the master data steward for all 
facility information provided in generic drug submissions received by 
FDA. A facility's reference status in an approved generic drug 
submission is extracted directly from submission data rather than 
relying on data from self-identification. This information provided the 
number of facilities referenced as API manufacturers in at least one 
approved generic drug submission.
    The total number of API facilities identified was 688; of that 
number, 80 were domestic and 608 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 (608) to determine the total fee revenue that

[[Page 61604]]

will result from the foreign facility differential. As a result of this 
calculation, the foreign fee differential revenue will make up 
$9,120,000 of the total API fee revenue. Subtracting the foreign 
facility differential fee revenue ($9,120,000) from the total API 
facility target revenue ($34,950,000) results in a remaining balance of 
$25,830,000. To determine the domestic API facility fee, we divide the 
$25,830,000 by the total number of facilities (688), which gives us a 
domestic API facility fee of $37,544. The foreign API facility fee is 
$15,000 more than the domestic API facility fee, or $52,544.

F. 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, 2022, the person 
and its affiliates shall owe a small business GDUFA program fee. 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 
GDUFA program fee. If a person and its affiliates own at least 20 
approved ANDAs, the person and its affiliates shall owe a large size 
operation GDUFA program fee. Section 744B(b)(2)(E) of the FD&C Act 
specifies the GDUFA program fee will make up 36 percent of $582,500,000 
in fee revenue, which is $209,700,000.
    To determine the appropriate number of parent companies for each 
tier, FDA asked companies to claim their ANDAs and affiliates in the 
Center for Drug Evaluation and Research (CDER) NextGen Portal. The 
companies were able to confirm relationships currently present in FDA's 
records, while also reporting newly approved ANDAs, newly acquired 
ANDAs, and new affiliations.
    In determining the appropriate number of approved ANDAs, FDA has 
factored in a number of variables that could affect the collection of 
the target revenue: (1) inactive ANDAs: applicants who have not 
submitted an annual report for one or more of their approved 
applications within the past 2 years; (2) Program Fee Arrears List: 
parent companies that are on the arrears list for any fiscal year; (3) 
Large Tier Adjustment: the frequency of large-tiered companies dropping 
to the medium tier and medium-tiered companies moving to the large tier 
after the completion of the program fee methodology and tier 
determination; (4) Center for Biologics Evaluation and Research (CBER) 
approved ANDAs: applicants and their affiliates with CBER-approved 
ANDAs in addition to CDER's approved ANDAs; and (5) withdrawals of 
approved ANDAs by April 1: applicants who have submitted a written 
request for withdrawal of approval by April 1 of the previous fiscal 
year.
    The list of original approved ANDAs from the Generic Drug Review 
Platform as of April 30, 2022, shows 253 applicants in the small 
business tier, 75 applicants in the medium size tier, and 79 applicants 
in the large size tier. Factoring in all the variables, we estimate 
there will be 220 applicants in the small business tier, 76 applicants 
in the medium size tier, and 77 applicants in the large size tier for 
FY 2023.
    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. To generate the target 
collection revenue amount from GDUFA program fees ($209,700,000), 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 22 applicants in the small business tier (220 
multiplied by 10 percent), 30.4 applicants in the medium size tier (76 
multiplied by 40 percent), and 77 applicants in the large size tier, 
arriving at 129.4 total weighted applicants for FY 2023.
    To generate the large size operation GDUFA program fee, FDA divides 
the target revenue amount of $209,700,000 by 129.4, which equals 
$1,620,556. The medium size operation GDUFA program fee is 40 percent 
of the full fee ($648,222), and the small business operation GDUFA 
program fee is 10 percent of the full fee ($162,056).

IV. Fee Schedule For FY 2023

    The fee rates for FY 2023 are set out in table 2.

                    Table 2--Fee Schedule for FY 2023
------------------------------------------------------------------------
                                                         Fees rates for
              Generic drug fee category                     FY 2023
------------------------------------------------------------------------
Applications:
    Abbreviated New Drug Application (ANDA)..........           $240,582
    Drug Master File (DMF)...........................             78,293
Facilities:
    Active Pharmaceutical Ingredient (API)--Domestic.             37,544
    API--Foreign.....................................             52,544
    Finished Dosage Form (FDF)--Domestic.............            213,134
    FDF--Foreign.....................................            228,134
    Contract Manufacturing Organization (CMO)--......             51,152
Domestic:
    CMO--Foreign.....................................             66,152
GDUFA Program:
    Large size operation generic drug applicant......          1,620,556
    Medium size operation generic drug applicant.....            648,222
    Small business operation generic drug applicant..            162,056
------------------------------------------------------------------------

V. Fee Payment Options and Procedures

    The new fee rates are effective October 1, 2022, and will remain in 
effect through September 30, 2023. 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. Here, that date is October 3, 2022. However, 
given the late date of the GDUFA reauthorization for FYs 2023 through 
2027, facility and program fees for FY 2023 should be paid within 30 
days from the issue date of this notice.

[[Page 61605]]

    To pay the ANDA, DMF, API facility, FDF facility, CMO facility, and 
GDUFA program fees, a Generic Drug User Fee Cover Sheet must be 
completed, available at https://www.fda.gov/gdufa and https://
userfees.fda.gov/OA_HTML/gdufaCAcdLogin.jsp, and a user fee 
identification (ID) number must be generated. 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.
    The user fee ID number must be included on the check, bank draft, 
or postal money order and must be made payable to the order of the Food 
and Drug Administration. Payments can be mailed to: Food and Drug 
Administration, P.O. Box 979108, St. Louis, MO 63197-9000. If checks 
are to be sent by a courier that requests a street address, the courier 
can deliver checks to U.S. Bank, Attention: Government Lockbox 979108, 
1005 Convention Plaza, St. Louis, MO 63101. (Note: This U.S. Bank 
address is for courier delivery only. For questions concerning courier 
delivery, U.S. Bank can be contacted at 314-418-4013. This telephone 
number is only for questions about courier delivery.) The FDA post 
office box number (P.O. Box 979108) must be written on the check, bank 
draft, or postal money order.
    For payments made by wire transfer, the unique user fee ID number 
must be referenced. 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. Applicable wire transfer 
fees must be included with payment to ensure fees are fully paid. 
Questions about wire transfer fees should be addressed to the financial 
institution. The following account information should be used to send 
payments by wire transfer: U.S. Department of the Treasury, TREAS NYC, 
33 Liberty St., New York, NY 10045, account number: 75060099, routing 
number: 021030004, SWIFT: FRNYUS33. FDA's tax identification number is 
53-0196965.

    Dated: October 5, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-22099 Filed 10-6-22; 11:15 am]
BILLING CODE 4164-01-P