Generic Drug User Fee Rates for Fiscal Year 2023, 61601-61605 [2022-22099]
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Federal Register / Vol. 87, No. 196 / Wednesday, October 12, 2022 / Notices
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FOR FURTHER INFORMATION CONTACT:
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SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the
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61601
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William N. Parham, III,
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[FR Doc. 2022–22077 Filed 10–11–22; 8:45 am]
BILLING CODE 4120–01–P
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
Food and Drug Administration,
Department of Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
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 OOOFBAP-OFM-UFSS-Government@
fda.hhs.gov, 301–796–7223.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
Sections 744A and 744B of the FD&C
Act (21 U.S.C. 379j–41 and 379j–42), as
amended by GDUFA III, authorize FDA
to assess and collect fees associated
with human generic drug products. Fees
are assessed on: (1) certain types of
applications for human generic drug
products; (2) certain facilities where
APIs and FDFs are produced; (3) certain
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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
FY 2023
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 operation generic drug applicant ..................................................................................................................
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
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$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
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$240,582
78,293
37,544
52,544
213,134
228,134
51,152
66,152
1,620,556
648,222
162,056
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
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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.
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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 feepaying 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
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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 selfidentification. This information
provided the number of facilities
referenced as FDF manufacturers in at
least one approved generic drug
submission. Based on FDA’s IS data, the
FDF and CMO facility denominators are
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
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61603
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
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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 largetiered 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 onetenth 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
FY 2023
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 operation generic drug applicant ..................................................................................................................
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
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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
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$240,582
78,293
37,544
52,544
213,134
228,134
51,152
66,152
1,620,556
648,222
162,056
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.
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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
VerDate Sep<11>2014
18:37 Oct 11, 2022
Jkt 259001
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–2274]
Medical Devices; Voluntary Total
Product Life Cycle Advisory Program
Pilot
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; request for comments.
The Food and Drug
Administration’s (FDA, Agency, or we)
Center for Devices and Radiological
Health (CDRH or Center) is announcing
its voluntary Total Product Life Cycle
(TPLC) Advisory Program (TAP) Pilot
that will begin in fiscal year (FY) 2023
with the initial phase, hereafter referred
to as the TAP Pilot Soft Launch. The
TAP Pilot is one of the commitments
agreed to between FDA and industry as
part of the reauthorization of the
Medical Device User Fee Amendments
for FY 2023 through FY 2027 (MDUFA
V). The long-term vision for TAP is to
help spur more rapid development and
more rapid and widespread patient
access to safe, effective, high-quality
medical devices of public health
importance. Over the course of MDUFA
V, the voluntary TAP Pilot is intended
to demonstrate the feasibility and
benefits of process improvements to
FDA’s early interactions with
participants and of FDA’s facilitation of
interactions between participants and
stakeholders that support the vision for
TAP.
DATES: Beginning January 1, 2023, FDA
is seeking requests for enrollment in the
TAP Pilot Soft Launch for FY 2023.
Either electronic or written comments
SUMMARY:
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
61605
on this notice must be submitted by
January 10, 2023 to ensure that the
Agency considers your comment on this
notice before it begins work on the next
phase of the TAP Pilot.
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
January 10, 2023. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are received on or before
that date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions.’’)
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2022–N–2274 for ‘‘Medical Devices;
Voluntary Total Product Life Cycle
E:\FR\FM\12OCN1.SGM
12OCN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
