Biosimilar User Fee Rates for Fiscal Year 2024, 48855-48861 [2023-15918]
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Federal Register / Vol. 88, No. 144 / Friday, July 28, 2023 / Notices
48855
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Recommended information collection activity: Fostering
medical device improvement: FDA activities and engagement with the voluntary Improvement Program
Average
burden per
response
Total annual
responses
Total hours
Site manufacturer application ...........................................
Aggregate data reporting ..................................................
Summary of site appraisal ................................................
1
1
1
400
4
400
400
4
400
0.08 (5 minutes)
8 .......................
20 .....................
33
32
8,000
Total ...........................................................................
........................
........................
........................
...........................
8,065
1 There
are no capital or operating and maintenance costs associated with the information collection.
Site Manufacturer Application
In section IV.A of the guidance, we
explain that manufacturers wishing to
apply for an appraisal may do so at the
third-party appraiser’s application
portal. As part of the VIP process (see
section IV.D, Process Flow, of the
guidance), the site manufacturers’
application information is provided to
FDA by the third-party appraiser. We
assume it will take the third-party
appraiser approximately 5 minutes to
notify FDA of the availability of each
application. Such notification is
provided via email and FDA may then
access the information via the thirdparty appraiser’s online portal.
Aggregate Data Reporting
As discussed in sections III and IV of
the guidance, the third-party appraiser
provides FDA with aggregated data
across all participating manufacturer
sites quarterly. We assume that it will
take approximately 8 hours to prepare
and submit the aggregate data.
Summary of Site Appraisal
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Number of
responses
per
respondent
Number of
respondents
In section IV.D of the guidance, we
communicate that the third-party
appraiser will provide FDA a summary
of the appraisal result for each
participating site. We assume an average
of 20 hours is necessary to prepare and
submit the summary.
This is a new information collection.
Specifically, we are accounting for
third-party appraiser burden to provide
the site manufacturer’s information to
FDA under the VIP process. We believe
associated recordkeeping by
participating manufactures to be usual
and customary business practice and
have therefore not included estimates
for VIP application activities by
manufacturers. The estimated average
burden per response is largely based on
our experience with the program pilot
and informal communications with
participants.
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Dated: July 25, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–16079 Filed 7–27–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–2966]
Biosimilar User Fee Rates for Fiscal
Year 2024
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the rates for
biosimilar user fees for fiscal year (FY)
2024. The Federal Food, Drug, and
Cosmetic Act (FD&C Act), as amended
by the Biosimilar User Fee Amendments
of 2022 (BsUFA III), authorizes FDA to
assess and collect user fees for certain
activities in connection with biosimilar
biological product development; review
of certain applications for approval of
biosimilar biological products; and each
biosimilar biological product approved
in a biosimilar biological product
application. BsUFA III directs FDA to
establish, before the beginning of each
fiscal year, the amount of initial and
annual biosimilar biological product
development (BPD) fees, the
reactivation fee, and the biosimilar
biological product application and
program fees for such year. These fees
apply to the period from October 1,
2023, through September 30, 2024.
FOR FURTHER INFORMATION CONTACT:
Olufunmilayo (Funmi) Ariyo, Office of
Financial Management, Food and Drug
Administration, 4041 Powder Mill Rd.,
6th Floor, Beltsville, MD 20705–4304,
240–402–4989, and the User Fees
Support Staff at OO-OFBAP-OFM-UFSSGovernment@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
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I. Background
Sections 744G, 744H, and 744I of the
FD&C Act (21 U.S.C. 379j–51, 379j–52,
and 379j–53), as amended by BsUFA III,
authorize the collection of fees for
biosimilar biological products. Under
section 744H(a)(1)(A) of the FD&C Act,
the initial BPD fee for a product is due
when the sponsor submits an
investigational new drug (IND)
application that FDA determines is
intended to support a biosimilar
biological product application or within
7 calendar days after FDA grants the
first BPD meeting, whichever occurs
first. A sponsor who has paid the initial
BPD fee is considered to be participating
in FDA’s BPD program for that product.
Under section 744H(a)(1)(B) of the
FD&C Act, once a sponsor has paid the
initial BPD fee for a product, the annual
BPD fee is assessed beginning with the
next fiscal year. The annual BPD fee is
assessed for the product each fiscal year
until the sponsor submits a marketing
application for the product that is
accepted for filing, the sponsor
discontinues participation in FDA’s
BPD program for the product, or the
sponsor has been administratively
removed from the BPD program for the
product.
Under section 744H(a)(1)(D) of the
FD&C Act, if a sponsor has discontinued
participation in FDA’s BPD program or
has been administratively removed from
the BPD program for a product and
wants to reengage with FDA on
development of the product, the sponsor
must pay all annual BPD fees previously
assessed for such product and still
owed, and a reactivation fee to resume
participation in the program. The
sponsor must pay the reactivation fee by
the earlier of the following dates: (1) no
later than 7 calendar days after FDA
grants the sponsor’s request for a BPD
meeting for that product or (2) upon the
date of submission by the sponsor of an
IND describing an investigation that
FDA determines is intended to support
a biosimilar biological product
application for that product. The
sponsor will be assessed an annual BPD
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amount. Each of these adjustments will
be discussed in the sections below.
This document provides fee rates for
FY 2024 for the initial and annual BPD
fee ($10,000), for the reactivation fee
($20,000), for an application requiring
clinical data ($1,018,753) for an
application not requiring clinical data
($509,377) and for the program fee
($177,397). These fees are effective on
October 1, 2023, and will remain in
effect through September 30, 2024. For
applications that are submitted on or
after October 1, 2023, the new fee
schedule must be used.
The statute specifies that this 3.9280
percent be multiplied by the proportion
of PC&B costs to the total FDA costs of
the process for the review of biosimilar
biological product applications. Table 2
shows the PC&B and the total
obligations for the process for the
review of biosimilar biological product
applications for the first 3 of the
preceding 4 fiscal years.
The payroll adjustment is 3.9280
percent from table 1 multiplied by
49.9405 percent (or 1.9617 percent).
The statute specifies that the portion
of the inflation adjustment for
nonpayroll costs is the average annual
percent change that occurred in the
Consumer Price Index (CPI) for urban
consumers (Washington-ArlingtonAlexandria, DC-VA-MD-WV; not
seasonally adjusted; all items; annual
index) for the first 3 years of the
preceding 4 years of available data
multiplied by the proportion of all costs
other than PC&B costs to total costs of
the process for the review of biosimilar
biological product applications for the
first 3 years of the preceding 4 fiscal
years (see section 744H(c)(1)(B) of the
FD&C Act). Table 3 provides the
summary data for the percent changes in
the specified CPI for the WashingtonArlington-Alexandria area.1
1 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.
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II. Fee Revenue Amount for FY 2024
The base revenue amount for FY 2024
is $48,700,243 prior to adjustments for
inflation, strategic hiring and retention,
capacity planning, operating reserves,
and the additional dollar amount (see
section 744H(b) and (c) of the FD&C
Act).
A. FY 2024 Statutory Fee Revenue
Adjustments for Inflation
BsUFA III specifies that the
$48,700,243 is to be adjusted for
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inflation increases for FY 2024 using
two separate adjustments: one for
personnel compensation and benefits
(PC&B) and one for non-PC&B costs (see
section 744H(c)(1) of the FD&C Act).
The component of the inflation
adjustment for payroll 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 preceding 4 fiscal years,
multiplied by the proportion of PC&B
costs to total FDA costs of the process
for the review of biosimilar biological
product applications for the first 3 of the
preceding 4 fiscal years (see section
744H(c)(1)(B) of the FD&C Act).
Table 1 summarizes the actual cost
and FTE data for the specified fiscal
years and provides the percent changes
from the previous fiscal years and the
average percent changes over the first 3
of the 4 fiscal years preceding FY 2024.
The 3-year average is 3.9280 percent.
fee beginning in the next fiscal year after
payment of the reactivation fee.
BsUFA III also authorizes fees for
certain biosimilar biological product
applications and for each biosimilar
biological product identified in an
approved biosimilar biological product
application (section 744H(a)(2) and (3)
of the FD&C Act). Under certain
conditions, FDA will grant a small
business a waiver of the biosimilar
biological product application fee
(section 744H(d)(1) of the FD&C Act).
For FY 2023 through FY 2027, the
base revenue amounts for the total
revenues from all BsUFA fees are
established by BsUFA III. For FY 2024,
the base revenue amount is the FY 2023
total revenue amount excluding any
operating reserve adjustment, which
equates to the amount of $48,700,243.
The FY 2024 base revenue amount is to
be adjusted by the inflation adjustment,
strategic hiring and retention
adjustment, capacity planning
adjustment (CPA), operating reserve
adjustment, and the additional dollar
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B. Strategic Hiring and Retention
Adjustment
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The statute specifies that for each
fiscal year, after the annual base revenue
is adjusted for inflation, FDA shall
further increase the fee revenue and fees
by the strategic hiring and retention
adjustment, which is $150,000 for FY
2024 (see section 744H(c)(2) of the
FD&C Act).
C. FY 2024 Statutory Fee Revenue
Adjustments for Capacity Planning
The statute specifies that the fee
revenue and fees shall be further
adjusted to reflect changes in the
resource capacity needs for the process
for the review of biosimilar biological
product applications (see section
744H(c)(3) of the FD&C Act). Following
a process required in statute, FDA
established the capacity planning
adjustment methodology and first
applied it in the setting of FY 2021 fees.
The establishment of this methodology
is described in the Federal Register at
85 FR 47220. 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 their accuracy over time.
In FY 2023, updates were made to
refine the time reporting categories
included within the CPA to reflect
program changes in the current
authorization period. As such, time
reporting data and baseline capacity
were revised to match the refinements.
For FY 2024, additional updates were
made including to account for
additional activities that are also
directly related to the direct review of
biosimilar biological product
applications and supplements as
provided for in the statute. These
updates include additional formal
meeting types and the direct review of
postmarketing commitments (PMC) and
requirements (PMR) (see table 4), the
direct review of risk evaluation and
mitigation strategies (REMS), and the
direct review of annual reports for
approved biosimilar biological products.
These updates necessitated an
additional re-baselining of capacity.
The CPA methodology consists of four
steps:
1. Forecast workload volumes:
predictive models estimate the volume
of workload for the upcoming fiscal
year.
2. Forecast the resource needs:
forecast algorithms are generated
utilizing time reporting data. These
algorithms estimate the required
demand in FTEs 2 for direct reviewrelated effort. This is then compared to
current available resources for the direct
review-related workload.
3. Assess the resource forecast in the
context of additional internal factors:
program leadership examines
operational, financial, and resourcing
data to assess whether FDA will be able
to utilize additional funds during the
fiscal year and those 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.
The following section outlines the
major components of the FY 2024
BsUFA III CPA. Table 4 summarizes the
forecasted workload volumes for BsUFA
III in FY 2024 based on predictive
models, as well as historical actuals
from FY 2022 for comparison.
2 Full-time equivalents refer to a paid staff year,
rather than a count of individual employees.
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The statute specifies that this 3.8256
percent be multiplied by the proportion
of all costs other than PC&B to total
costs of the process for the review of
biosimilar biological product
applications obligated. Since 49.9405
percent was obligated for PC&B (as
shown in table 2), 50.0595 percent is the
portion of costs other than PC&B (100
percent minus 49.9405 percent equals
50.0595 percent). The non-payroll
adjustment is 3.8256 percent times
50.0595 percent, 1.9151 percent.
Next, we add the payroll adjustment
(1.9617 percent) to the nonpayroll
adjustment (1.9151 percent), for a total
inflation adjustment of 3.8768 percent
(rounded) for FY 2024.
We then multiply the base revenue
amount for FY 2024 ($48,700,243) by
the inflation adjustment percentage
(3.8768 percent), yielding an inflation
adjustment of $1,888,011. Adding this
amount yields an inflation-adjusted
amount of $50,588,254.
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FDA’s BsUFA III direct review-related
work. The resulting expected FY 2024
FTE need for BsUFA III was compared
to current onboard capacity for BsUFA
III direct review-related work to
determine the FY 2024 resource delta,
as summarized in table 5.
The projected nine FTE delta was
then assessed by FDA in the context of
additional operational and internal
factors to ensure that a fee adjustment
is only made for resources that can be
utilized in the fiscal year and for which
funds are required to support additional
review capacity. FDA determined that
realistic expected net FTE gains could
be funded through the expected FY
2024 collections amount without further
adjustment from the CPA. As such, FDA
determined that in FY 2024 the BsUFA
fee amounts do not need adjustment
from the CPA to provide funds for the
realistic estimated net FTE gains.
Although an adjustment to the fee
amounts for resource needs by the CPA
will not be made in FY 2024, FDA will
evaluate the need for a fee adjustment
from the CPA in future fiscal years and
will make adjustments as warranted.
D. FY 2024 Additional Dollar Amount
For FY 2023 and FY 2024, BsUFA III
provides an additional dollar amount
for additional FTE for the biosimilar
biological product review program to
support enhancements outlined in the
BsUFA III Commitment Letter. For FY
2024, the statute directs FDA to further
increase the fee revenue and fees by the
additional dollar amount, which is
$320,569 for FY 2024 (see section
744H(b)(1)(G) of the FD&C Act).
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Utilizing the resource forecast
algorithms, the forecasted workload
volumes for FY 2024 were then
converted into estimated FTE needs for
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E. FY 2024 Statutory Fee Revenue
Adjustments for Operating Reserve
BsUFA III sets forth an operating
reserve adjustment to the fee revenue
and fees. Specifically, for FY 2024, the
statute directs FDA: (1) to increase the
fee revenue and fees if such an
adjustment is necessary to provide for at
least 10 weeks of operating reserves of
carryover user fees for the process for
the review of biosimilar biological
product applications and (2) if FDA has
carryover balances for such process in
excess of 27 weeks of such operating
reserves, to decrease such fee revenue
and fees to provide for not more than 27
weeks of such operating reserves (see
section 744H(c)(4) of the FD&C Act).
To calculate the 10-week and 27-week
threshold amounts for the FY 2024
operating reserve adjustment, the
estimated adjusted revenue amount (i.e.,
the base revenue amount and
adjustments prior to the operating
reserve adjustment), $51,058,823 is
divided by 52, resulting in a $981,900
cost of operation for 1 week (rounded to
the nearest dollar). The 1-week value
(981,900) is then multiplied by 10
weeks to generate the 10-week operating
reserve threshold amount for FY 2024 of
$9,819,004. The 1-week value is
multiplied by 27 to generate the 27week operating reserve threshold
amount for FY 2024 of $26,511,312.
To calculate the estimated operating
reserve of carryover user fees at the end
of FY 2023, FDA estimated the
operating reserves of carryover fees at
the end of June 2023. The balance of
operating reserves of carryover fees at
the end of June 2023 is combined with
the forecasted collections and
obligations for the remainder of FY 2023
to generate a full year estimate for FY
2023. The estimated operating reserve of
carryover user fees at the end of FY
2023 is $46,551,292.
The estimated operating reserve of
carryover user fees at the end of FY
2023 of $46,551,292 is above the 27week threshold allowable operating
reserve of carryover user fees for FY
2024 of $26,511,312. As such, FDA is
applying a downward operating reserve
adjustment of $20,039,980 (rounded to
the nearest dollar), an amount
equivalent to a reduction of
approximately 20 weeks of operations,
to bring the operating reserve of
carryover user fees to $26,511,312 or 27
weeks of operations at the start of FY
2024. With this operating reserve
adjustment, the estimated adjusted
revenue amount of $51,058,823 will be
lowered by $20,039,980, yielding the FY
2024 target revenue amount of
$31,019,000 (rounded to the nearest
thousand), summarized below.
III. Fee Amounts for FY 2024
A. Application Fees
Under section 744H(b)(2)(A) of the
FD&C Act, FDA must determine the
percentage of the total revenue amount
for a fiscal year to be derived from: (1)
initial and annual BPD fees, and
reactivation fees; (2) biosimilar
biological product application fees; and
(3) biosimilar biological product
program fees. As described above, a
downward operating reserve adjustment
is required for FY 2024. The operating
reserve adjustment in subsequent years
may not be as large. As such, the target
revenue in FY 2024 may be lower than
in prior or future years, and thereby the
fee amounts may also be lower than in
prior or future years.
In establishing the biosimilar
biological product application fee
amount for FY 2024, FDA assessed
multiple modeling options. The model
performing the best when tested against
historical data forecasts 14 biosimilar
biological product applications
requiring clinical data submitted for
approval in FY 2024 and 0 applications
that do not require clinical data. Given
recent years’ data regarding biosimilar
biological product applications that are
refused to file and withdrawals before
filing, the 14 submissions will be
assumed to equate to 13.25 full
application equivalents.
For FY 2024 the biosimilar biological
product application fee for applications
requiring clinical data is $1,018,753.
Applications not requiring clinical data
pay half that fee, or $509,377. This is
estimated to provide a total of
$13,498,477 representing 44 percent
(rounded to the nearest whole number)
of the FY 2024 target revenue amount.
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Under BsUFA III, FDA assesses
biosimilar biological product program
fees (‘‘program fees’’). An applicant in a
biosimilar biological product
application shall not be assessed more
than five program fees for a fiscal year
for biosimilar biological products
identified in a single biosimilar
biological product application (see
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B. Biosimilar Biological Product
Program Fee
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section 744H(a)(3)(D) of the FD&C Act).
Applicants are assessed a program fee
for a fiscal year for biosimilar biological
products that are identified in a
biosimilar biological product
application approved as of October 1 of
such fiscal year; that may be dispensed
only under prescription pursuant to
section 503(b) of the FD&C Act (21
U.S.C. 353(b)); and that, as of October 1
of such fiscal year, do not appear on a
list developed and maintained by FDA
of discontinued biosimilar biological
products. An approved biosimilar
biological product that appears on the
list of discontinued biosimilar biological
products as of October 1 of a fiscal year
would also be assessed the program fee
if it is removed from the discontinued
list during the fiscal year and the other
statutory criteria for fee assessment are
satisfied (see section 744H(a)(3)(E)(iii) of
the FD&C Act).
Based on available information, FDA
estimates that 92 program fees will be
invoiced for FY 2024. For products
invoiced in the FY 2024 regular billing
cycle, FDA anticipates that zero
program fees will be refunded.
For FY 2024, the biosimilar biological
product program fee is $177,397. This is
estimated to provide a total of
$16,320,524, representing 53 percent
(rounded to the nearest whole number)
of the FY 2024 target revenue amount.
V. Fee Payment Options and
Procedures
participation in the BPD program for the
product must pay all annual BPD fees
previously assessed for such product
and still owed and the reactivation fee
by the earlier of the following dates: no
later than 7 calendar days after FDA
grants the sponsor’s request for a BPD
meeting for that product, or upon the
date of submission by the sponsor of an
IND describing an investigation that
FDA determines is intended to support
a biosimilar biological product
application for that product.
The application fee for a biosimilar
biological product is due upon
submission of the application (see
section 744H(a)(2)(C) of the FD&C Act).
To make a payment of the initial BPD,
reactivation, or application fee,
complete the Biosimilar User Fee Cover
Sheet, available on FDA’s website
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A. Initial BPD, Reactivation, and
Application Fees
The fees established in the new fee
schedule apply to FY 2024, i.e., the
period from October 1, 2023, through
September 30, 2024. The initial BPD fee
for a product is due when the sponsor
submits an IND that FDA determines is
intended to support a biosimilar
biological product application for the
product or within 7 calendar days after
FDA grants the first BPD meeting for the
product, whichever occurs first.
Sponsors who have discontinued
participation in the BPD program for a
product or have been administratively
removed from the BPD program for a
product, and seek to resume
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C. Initial and Annual BPD Fees, and
Reactivation Fees
To estimate the number of BPD fees
to be paid in FY 2024, FDA must
consider the number of new BPD
programs, the number of current BPD
programs, and the number of BPD
programs that will be reactivated. These
estimates provide information that,
when aggregated, allows FDA to set BPD
fees (initial BPD fees, annual BPD fees,
reactivation fees).
FDA analyzed available data to
estimate the total number of BPD
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programs for FY 2024. In FY 2024, FDA
estimates approximately 23 new BPD
programs, no reactivations (a single
reactivation is weighted as two BPD
fees), and approximately 97 BPD
programs to pay the annual BPD fee,
yielding a rounded total estimated
equivalent of 120 BPD fees to be
collected in FY 2024. The remainder of
the target revenue of $1,199,999 or 4
percent is to be collected from the BPD
fees. Dividing this amount by the
estimated 120 BPD fees to be paid
equals an initial BPD and annual BPD
fee amount of $10,000 (rounded to the
nearest dollar). The reactivation fee is
set at twice the initial/annual BPD
amount at $20,000 (rounded to the
nearest dollar).
IV. Fee Schedule for FY 2024
The fee rates for FY 2024 are
displayed in table 9.
(https://www.fda.gov/bsufa) and
generate a user fee identification (ID)
number. Payment must be made in U.S.
currency by electronic check, check,
bank draft, U.S. postal money order, 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 use
www.pay.gov, a web-based payment
application, for online electronic
payment. The www.pay.gov feature is
available on the FDA website after the
user fee ID number is generated. 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
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payments can be made online.) Once
you search for your invoice, click ‘‘Pay
Now’’ to be redirected to www.pay.gov.
Electronic payment options are based on
the balance due. Payment by credit card
is available for balances that are 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 a check, bank
draft, or money order is to be sent by a
courier that requests a street address,
the courier should deliver your payment
to U.S. Bank, Attention: Government
Lockbox 979108, 1005 Convention
Plaza, St. Louis, MO 63101. (Note: this
U.S. Bank address is for courier delivery
only. If you have any questions
concerning courier delivery, contact
U.S. Bank at 314–418–4013. This
telephone number is only for questions
about courier delivery). Please make
sure that the FDA post office box
number (P.O. Box 979108) and ID
number is written on the check, bank
draft, or postal money order.
For payments made by wire transfer,
include the unique user fee ID number
to ensure that the payment is applied to
the correct fee(s). Without the unique
user fee ID number, the payment may
not be applied. The originating financial
institution may charge a wire transfer
fee. Include applicable wire transfer fees
with payment to ensure fees are fully
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, Acct. No: 75060099, Routing No:
021030004, SWIFT: FRNYUS33. FDA’s
tax identification number is 53–
0196965.
B. Annual BPD and Program Fees
FDA will issue invoices with payment
instructions for FY 2024 annual BPD
and program fees under the new fee
schedule in August 2023. Under section
744H(a)(1)(B)(ii) and (a)(3)(B) of the
FD&C Act, annual BPD and program
fees will be due on October 2, 2023.
If sponsors join the BPD program after
the annual BPD invoices have been
issued in August 2023, FDA will issue
invoices in December 2023 to sponsors
VerDate Sep<11>2014
17:16 Jul 27, 2023
Jkt 259001
subject to fees for FY 2024 that qualify
for the annual BPD fee after the August
2023 billing. FDA will issue invoices in
December 2024 for any products that
qualify for the annual program fee after
the August 2023 billing.
C. Waivers and Refunds
To qualify for consideration for a
small business waiver under section
744H(d) of the FD&C Act, or the return
of any fee paid under section 744H of
the FD&C Act, including if the fee is
claimed to have been paid in error, a
person shall submit to FDA a written
request justifying such waiver or return
and, except as otherwise specified in
section 744H of the FD&C Act, such
written request shall be submitted to
FDA not later than 180 days after such
fee is due. Such written request shall
include any legal authorities under
which the request is made. See section
744H(h) of the FD&C Act.
Dated: July 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–15918 Filed 7–27–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–2896]
Food Safety Modernization Act
Domestic and Foreign Facility
Reinspection, Recall, and Importer
Reinspection Fee Rates for Fiscal Year
2024
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing the fiscal year (FY) 2024 fee
rates for certain domestic and foreign
facility reinspections, failures to comply
with a recall order, and importer
reinspections that are authorized by the
Federal Food, Drug, and Cosmetic Act
(FD&C Act), as amended by the FDA
Food Safety Modernization Act (FSMA).
DATES: These fees are effective on
October 1, 2023, and will remain in
effect through September 30, 2024.
FOR FURTHER INFORMATION CONTACT:
Olufunmilayo Ariyo, Office of Food
Policy and Response, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993, 240–
402–4989, FSMAFeeStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
PO 00000
Frm 00076
Fmt 4703
Sfmt 4703
48861
I. Background
Section 107 of the FSMA (Pub. L.
111–353) added section 743 to the FD&C
Act (21 U.S.C. 379j–31) to provide FDA
with the authority to assess and collect
fees from, in part: (1) the responsible
party for each domestic facility and the
U.S. agent for each foreign facility
subject to a reinspection to cover
reinspection-related costs; (2) the
responsible party for a domestic facility
and an importer who does not comply
with a recall order to cover food 1 recall
activities associated with such order;
and (3) each importer subject to a
reinspection to cover reinspectionrelated costs (sections 743(a)(1)(A), (B),
and (D) of the FD&C Act). Section 743
of the FD&C Act directs FDA to
establish fees for each of these activities
based on an estimate of 100 percent of
the costs of each activity for each year
(sections 743(b)(2)(A)(i), (ii), and (iv)),
and these fees must be made available
solely to pay for the costs of each
activity for which the fee was incurred
(section 743(b)(3)). These fees are
effective on October 1, 2023, and will
remain in effect through September 30,
2024. Section 743(b)(2)(B)(iii) of the
FD&C Act directs FDA to develop a
proposed set of guidelines in
consideration of the burden of fee
amounts on small businesses. As a first
step in developing these guidelines,
FDA invited public comment on the
potential impact of the fees authorized
by section 743 of the FD&C Act on small
businesses (76 FR 45818, August 1,
2011). The comment period for this
request ended November 30, 2011. As
stated in FDA’s September 2011
‘‘Guidance for Industry: Implementation
of the Fee Provisions of Section 107 of
the FDA Food Safety Modernization
Act,’’ (https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/guidance-industryimplementation-fee-provisions-section107-fda-food-safety-modernization-act),
because FDA recognizes that for small
businesses the full cost recovery of FDA
reinspection or recall oversight could
impose severe economic hardship, FDA
intends to consider reducing certain fees
for those firms. FDA does not intend to
issue invoices for reinspection or recall
order fees until FDA publishes a
guidance document outlining the
process through which firms may
request a reduction in fees.
In addition, as stated in the
September 2011 Guidance, FDA is in
the process of considering various
issues associated with the assessment
1 The term ‘‘food’’ for purposes of this document
has the same meaning as such term in section 201(f)
of the FD&C Act (21 U.S.C. 321(f)).
E:\FR\FM\28JYN1.SGM
28JYN1
]]>Agencies
[Federal Register Volume 88, Number 144 (Friday, July 28, 2023)]
[Notices]
[Pages 48855-48861]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-15918]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-2966]
Biosimilar User Fee Rates for Fiscal Year 2024
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the rates for biosimilar user fees for fiscal year (FY)
2024. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended
by the Biosimilar User Fee Amendments of 2022 (BsUFA III), authorizes
FDA to assess and collect user fees for certain activities in
connection with biosimilar biological product development; review of
certain applications for approval of biosimilar biological products;
and each biosimilar biological product approved in a biosimilar
biological product application. BsUFA III directs FDA to establish,
before the beginning of each fiscal year, the amount of initial and
annual biosimilar biological product development (BPD) fees, the
reactivation fee, and the biosimilar biological product application and
program fees for such year. These fees apply to the period from October
1, 2023, through September 30, 2024.
FOR FURTHER INFORMATION CONTACT: Olufunmilayo (Funmi) Ariyo, Office of
Financial Management, Food and Drug Administration, 4041 Powder Mill
Rd., 6th Floor, Beltsville, MD 20705-4304, 240-402-4989, and the User
Fees Support Staff at [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Sections 744G, 744H, and 744I of the FD&C Act (21 U.S.C. 379j-51,
379j-52, and 379j-53), as amended by BsUFA III, authorize the
collection of fees for biosimilar biological products. Under section
744H(a)(1)(A) of the FD&C Act, the initial BPD fee for a product is due
when the sponsor submits an investigational new drug (IND) application
that FDA determines is intended to support a biosimilar biological
product application or within 7 calendar days after FDA grants the
first BPD meeting, whichever occurs first. A sponsor who has paid the
initial BPD fee is considered to be participating in FDA's BPD program
for that product.
Under section 744H(a)(1)(B) of the FD&C Act, once a sponsor has
paid the initial BPD fee for a product, the annual BPD fee is assessed
beginning with the next fiscal year. The annual BPD fee is assessed for
the product each fiscal year until the sponsor submits a marketing
application for the product that is accepted for filing, the sponsor
discontinues participation in FDA's BPD program for the product, or the
sponsor has been administratively removed from the BPD program for the
product.
Under section 744H(a)(1)(D) of the FD&C Act, if a sponsor has
discontinued participation in FDA's BPD program or has been
administratively removed from the BPD program for a product and wants
to reengage with FDA on development of the product, the sponsor must
pay all annual BPD fees previously assessed for such product and still
owed, and a reactivation fee to resume participation in the program.
The sponsor must pay the reactivation fee by the earlier of the
following dates: (1) no later than 7 calendar days after FDA grants the
sponsor's request for a BPD meeting for that product or (2) upon the
date of submission by the sponsor of an IND describing an investigation
that FDA determines is intended to support a biosimilar biological
product application for that product. The sponsor will be assessed an
annual BPD
[[Page 48856]]
fee beginning in the next fiscal year after payment of the reactivation
fee.
BsUFA III also authorizes fees for certain biosimilar biological
product applications and for each biosimilar biological product
identified in an approved biosimilar biological product application
(section 744H(a)(2) and (3) of the FD&C Act). Under certain conditions,
FDA will grant a small business a waiver of the biosimilar biological
product application fee (section 744H(d)(1) of the FD&C Act).
For FY 2023 through FY 2027, the base revenue amounts for the total
revenues from all BsUFA fees are established by BsUFA III. For FY 2024,
the base revenue amount is the FY 2023 total revenue amount excluding
any operating reserve adjustment, which equates to the amount of
$48,700,243. The FY 2024 base revenue amount is to be adjusted by the
inflation adjustment, strategic hiring and retention adjustment,
capacity planning adjustment (CPA), operating reserve adjustment, and
the additional dollar amount. Each of these adjustments will be
discussed in the sections below.
This document provides fee rates for FY 2024 for the initial and
annual BPD fee ($10,000), for the reactivation fee ($20,000), for an
application requiring clinical data ($1,018,753) for an application not
requiring clinical data ($509,377) and for the program fee ($177,397).
These fees are effective on October 1, 2023, and will remain in effect
through September 30, 2024. For applications that are submitted on or
after October 1, 2023, the new fee schedule must be used.
II. Fee Revenue Amount for FY 2024
The base revenue amount for FY 2024 is $48,700,243 prior to
adjustments for inflation, strategic hiring and retention, capacity
planning, operating reserves, and the additional dollar amount (see
section 744H(b) and (c) of the FD&C Act).
A. FY 2024 Statutory Fee Revenue Adjustments for Inflation
BsUFA III specifies that the $48,700,243 is to be adjusted for
inflation increases for FY 2024 using two separate adjustments: one for
personnel compensation and benefits (PC&B) and one for non-PC&B costs
(see section 744H(c)(1) of the FD&C Act).
The component of the inflation adjustment for payroll 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
preceding 4 fiscal years, multiplied by the proportion of PC&B costs to
total FDA costs of the process for the review of biosimilar biological
product applications for the first 3 of the preceding 4 fiscal years
(see section 744H(c)(1)(B) of the FD&C Act).
Table 1 summarizes the actual cost and FTE data for the specified
fiscal years and provides the percent changes from the previous fiscal
years and the average percent changes over the first 3 of the 4 fiscal
years preceding FY 2024. The 3-year average is 3.9280 percent.
[GRAPHIC] [TIFF OMITTED] TN28JY23.038
The statute specifies that this 3.9280 percent be multiplied by the
proportion of PC&B costs to the total FDA costs of the process for the
review of biosimilar biological product applications. Table 2 shows the
PC&B and the total obligations for the process for the review of
biosimilar biological product applications for the first 3 of the
preceding 4 fiscal years.
[GRAPHIC] [TIFF OMITTED] TN28JY23.039
The payroll adjustment is 3.9280 percent from table 1 multiplied by
49.9405 percent (or 1.9617 percent).
The statute specifies that the portion of the inflation adjustment
for nonpayroll costs is the average annual percent change that occurred
in the Consumer Price Index (CPI) for urban consumers (Washington-
Arlington-Alexandria, DC-VA-MD-WV; not seasonally adjusted; all items;
annual index) for the first 3 years of the preceding 4 years of
available data multiplied by the proportion of all costs other than
PC&B costs to total costs of the process for the review of biosimilar
biological product applications for the first 3 years of the preceding
4 fiscal years (see section 744H(c)(1)(B) of the FD&C Act). Table 3
provides the summary data for the percent changes in the specified CPI
for the Washington-Arlington-Alexandria area.\1\
---------------------------------------------------------------------------
\1\ 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.
---------------------------------------------------------------------------
[[Page 48857]]
[GRAPHIC] [TIFF OMITTED] TN28JY23.040
The statute specifies that this 3.8256 percent be multiplied by the
proportion of all costs other than PC&B to total costs of the process
for the review of biosimilar biological product applications obligated.
Since 49.9405 percent was obligated for PC&B (as shown in table 2),
50.0595 percent is the portion of costs other than PC&B (100 percent
minus 49.9405 percent equals 50.0595 percent). The non-payroll
adjustment is 3.8256 percent times 50.0595 percent, 1.9151 percent.
Next, we add the payroll adjustment (1.9617 percent) to the
nonpayroll adjustment (1.9151 percent), for a total inflation
adjustment of 3.8768 percent (rounded) for FY 2024.
We then multiply the base revenue amount for FY 2024 ($48,700,243)
by the inflation adjustment percentage (3.8768 percent), yielding an
inflation adjustment of $1,888,011. Adding this amount yields an
inflation-adjusted amount of $50,588,254.
B. Strategic Hiring and Retention Adjustment
The statute specifies that for each fiscal year, after the annual
base revenue is adjusted for inflation, FDA shall further increase the
fee revenue and fees by the strategic hiring and retention adjustment,
which is $150,000 for FY 2024 (see section 744H(c)(2) of the FD&C Act).
C. FY 2024 Statutory Fee Revenue Adjustments for Capacity Planning
The statute specifies that the fee revenue and fees shall be
further adjusted to reflect changes in the resource capacity needs for
the process for the review of biosimilar biological product
applications (see section 744H(c)(3) of the FD&C Act). Following a
process required in statute, FDA established the capacity planning
adjustment methodology and first applied it in the setting of FY 2021
fees. The establishment of this methodology is described in the Federal
Register at 85 FR 47220. 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
their accuracy over time.
In FY 2023, updates were made to refine the time reporting
categories included within the CPA to reflect program changes in the
current authorization period. As such, time reporting data and baseline
capacity were revised to match the refinements. For FY 2024, additional
updates were made including to account for additional activities that
are also directly related to the direct review of biosimilar biological
product applications and supplements as provided for in the statute.
These updates include additional formal meeting types and the direct
review of postmarketing commitments (PMC) and requirements (PMR) (see
table 4), the direct review of risk evaluation and mitigation
strategies (REMS), and the direct review of annual reports for approved
biosimilar biological products. These updates necessitated an
additional re-baselining of capacity.
The CPA methodology consists of four steps:
1. Forecast workload volumes: predictive models estimate the volume
of workload for the upcoming fiscal year.
2. Forecast the resource needs: forecast algorithms are generated
utilizing time reporting data. These algorithms estimate the required
demand in FTEs \2\ for direct review-related effort. This is then
compared to current available resources for the direct review-related
workload.
---------------------------------------------------------------------------
\2\ Full-time equivalents refer to a paid staff year, rather
than a count of individual employees.
---------------------------------------------------------------------------
3. Assess the resource forecast in the context of additional
internal factors: program leadership examines operational, financial,
and resourcing data to assess whether FDA will be able to utilize
additional funds during the fiscal year and those 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.
The following section outlines the major components of the FY 2024
BsUFA III CPA. Table 4 summarizes the forecasted workload volumes for
BsUFA III in FY 2024 based on predictive models, as well as historical
actuals from FY 2022 for comparison.
[[Page 48858]]
[GRAPHIC] [TIFF OMITTED] TN28JY23.041
Utilizing the resource forecast algorithms, the forecasted workload
volumes for FY 2024 were then converted into estimated FTE needs for
FDA's BsUFA III direct review-related work. The resulting expected FY
2024 FTE need for BsUFA III was compared to current onboard capacity
for BsUFA III direct review-related work to determine the FY 2024
resource delta, as summarized in table 5.
[GRAPHIC] [TIFF OMITTED] TN28JY23.042
The projected nine FTE delta was then assessed by FDA in the
context of additional operational and internal factors to ensure that a
fee adjustment is only made for resources that can be utilized in the
fiscal year and for which funds are required to support additional
review capacity. FDA determined that realistic expected net FTE gains
could be funded through the expected FY 2024 collections amount without
further adjustment from the CPA. As such, FDA determined that in FY
2024 the BsUFA fee amounts do not need adjustment from the CPA to
provide funds for the realistic estimated net FTE gains.
[GRAPHIC] [TIFF OMITTED] TN28JY23.043
Although an adjustment to the fee amounts for resource needs by the
CPA will not be made in FY 2024, FDA will evaluate the need for a fee
adjustment from the CPA in future fiscal years and will make
adjustments as warranted.
D. FY 2024 Additional Dollar Amount
For FY 2023 and FY 2024, BsUFA III provides an additional dollar
amount for additional FTE for the biosimilar biological product review
program to support enhancements outlined in the BsUFA III Commitment
Letter. For FY 2024, the statute directs FDA to further increase the
fee revenue and fees by the additional dollar amount, which is $320,569
for FY 2024 (see section 744H(b)(1)(G) of the FD&C Act).
[[Page 48859]]
[GRAPHIC] [TIFF OMITTED] TN28JY23.044
E. FY 2024 Statutory Fee Revenue Adjustments for Operating Reserve
BsUFA III sets forth an operating reserve adjustment to the fee
revenue and fees. Specifically, for FY 2024, the statute directs FDA:
(1) to increase the fee revenue and fees if such an adjustment is
necessary to provide for at least 10 weeks of operating reserves of
carryover user fees for the process for the review of biosimilar
biological product applications and (2) if FDA has carryover balances
for such process in excess of 27 weeks of such operating reserves, to
decrease such fee revenue and fees to provide for not more than 27
weeks of such operating reserves (see section 744H(c)(4) of the FD&C
Act).
To calculate the 10-week and 27-week threshold amounts for the FY
2024 operating reserve adjustment, the estimated adjusted revenue
amount (i.e., the base revenue amount and adjustments prior to the
operating reserve adjustment), $51,058,823 is divided by 52, resulting
in a $981,900 cost of operation for 1 week (rounded to the nearest
dollar). The 1-week value (981,900) is then multiplied by 10 weeks to
generate the 10-week operating reserve threshold amount for FY 2024 of
$9,819,004. The 1-week value is multiplied by 27 to generate the 27-
week operating reserve threshold amount for FY 2024 of $26,511,312.
To calculate the estimated operating reserve of carryover user fees
at the end of FY 2023, FDA estimated the operating reserves of
carryover fees at the end of June 2023. The balance of operating
reserves of carryover fees at the end of June 2023 is combined with the
forecasted collections and obligations for the remainder of FY 2023 to
generate a full year estimate for FY 2023. The estimated operating
reserve of carryover user fees at the end of FY 2023 is $46,551,292.
The estimated operating reserve of carryover user fees at the end
of FY 2023 of $46,551,292 is above the 27-week threshold allowable
operating reserve of carryover user fees for FY 2024 of $26,511,312. As
such, FDA is applying a downward operating reserve adjustment of
$20,039,980 (rounded to the nearest dollar), an amount equivalent to a
reduction of approximately 20 weeks of operations, to bring the
operating reserve of carryover user fees to $26,511,312 or 27 weeks of
operations at the start of FY 2024. With this operating reserve
adjustment, the estimated adjusted revenue amount of $51,058,823 will
be lowered by $20,039,980, yielding the FY 2024 target revenue amount
of $31,019,000 (rounded to the nearest thousand), summarized below.
[GRAPHIC] [TIFF OMITTED] TN28JY23.045
III. Fee Amounts for FY 2024
Under section 744H(b)(2)(A) of the FD&C Act, FDA must determine the
percentage of the total revenue amount for a fiscal year to be derived
from: (1) initial and annual BPD fees, and reactivation fees; (2)
biosimilar biological product application fees; and (3) biosimilar
biological product program fees. As described above, a downward
operating reserve adjustment is required for FY 2024. The operating
reserve adjustment in subsequent years may not be as large. As such,
the target revenue in FY 2024 may be lower than in prior or future
years, and thereby the fee amounts may also be lower than in prior or
future years.
A. Application Fees
In establishing the biosimilar biological product application fee
amount for FY 2024, FDA assessed multiple modeling options. The model
performing the best when tested against historical data forecasts 14
biosimilar biological product applications requiring clinical data
submitted for approval in FY 2024 and 0 applications that do not
require clinical data. Given recent years' data regarding biosimilar
biological product applications that are refused to file and
withdrawals before filing, the 14 submissions will be assumed to equate
to 13.25 full application equivalents.
For FY 2024 the biosimilar biological product application fee for
applications requiring clinical data is $1,018,753. Applications not
requiring clinical data pay half that fee, or $509,377. This is
estimated to provide a total of $13,498,477 representing 44 percent
(rounded to the nearest whole number) of the FY 2024 target revenue
amount.
B. Biosimilar Biological Product Program Fee
Under BsUFA III, FDA assesses biosimilar biological product program
fees (``program fees''). An applicant in a biosimilar biological
product application shall not be assessed more than five program fees
for a fiscal year for biosimilar biological products identified in a
single biosimilar biological product application (see
[[Page 48860]]
section 744H(a)(3)(D) of the FD&C Act). Applicants are assessed a
program fee for a fiscal year for biosimilar biological products that
are identified in a biosimilar biological product application approved
as of October 1 of such fiscal year; that may be dispensed only under
prescription pursuant to section 503(b) of the FD&C Act (21 U.S.C.
353(b)); and that, as of October 1 of such fiscal year, do not appear
on a list developed and maintained by FDA of discontinued biosimilar
biological products. An approved biosimilar biological product that
appears on the list of discontinued biosimilar biological products as
of October 1 of a fiscal year would also be assessed the program fee if
it is removed from the discontinued list during the fiscal year and the
other statutory criteria for fee assessment are satisfied (see section
744H(a)(3)(E)(iii) of the FD&C Act).
Based on available information, FDA estimates that 92 program fees
will be invoiced for FY 2024. For products invoiced in the FY 2024
regular billing cycle, FDA anticipates that zero program fees will be
refunded.
For FY 2024, the biosimilar biological product program fee is
$177,397. This is estimated to provide a total of $16,320,524,
representing 53 percent (rounded to the nearest whole number) of the FY
2024 target revenue amount.
C. Initial and Annual BPD Fees, and Reactivation Fees
To estimate the number of BPD fees to be paid in FY 2024, FDA must
consider the number of new BPD programs, the number of current BPD
programs, and the number of BPD programs that will be reactivated.
These estimates provide information that, when aggregated, allows FDA
to set BPD fees (initial BPD fees, annual BPD fees, reactivation fees).
FDA analyzed available data to estimate the total number of BPD
programs for FY 2024. In FY 2024, FDA estimates approximately 23 new
BPD programs, no reactivations (a single reactivation is weighted as
two BPD fees), and approximately 97 BPD programs to pay the annual BPD
fee, yielding a rounded total estimated equivalent of 120 BPD fees to
be collected in FY 2024. The remainder of the target revenue of
$1,199,999 or 4 percent is to be collected from the BPD fees. Dividing
this amount by the estimated 120 BPD fees to be paid equals an initial
BPD and annual BPD fee amount of $10,000 (rounded to the nearest
dollar). The reactivation fee is set at twice the initial/annual BPD
amount at $20,000 (rounded to the nearest dollar).
IV. Fee Schedule for FY 2024
The fee rates for FY 2024 are displayed in table 9.
[GRAPHIC] [TIFF OMITTED] TN28JY23.046
V. Fee Payment Options and Procedures
A. Initial BPD, Reactivation, and Application Fees
The fees established in the new fee schedule apply to FY 2024,
i.e., the period from October 1, 2023, through September 30, 2024. The
initial BPD fee for a product is due when the sponsor submits an IND
that FDA determines is intended to support a biosimilar biological
product application for the product or within 7 calendar days after FDA
grants the first BPD meeting for the product, whichever occurs first.
Sponsors who have discontinued participation in the BPD program for a
product or have been administratively removed from the BPD program for
a product, and seek to resume participation in the BPD program for the
product must pay all annual BPD fees previously assessed for such
product and still owed and the reactivation fee by the earlier of the
following dates: no later than 7 calendar days after FDA grants the
sponsor's request for a BPD meeting for that product, or upon the date
of submission by the sponsor of an IND describing an investigation that
FDA determines is intended to support a biosimilar biological product
application for that product.
The application fee for a biosimilar biological product is due upon
submission of the application (see section 744H(a)(2)(C) of the FD&C
Act).
To make a payment of the initial BPD, reactivation, or application
fee, complete the Biosimilar User Fee Cover Sheet, available on FDA's
website (https://www.fda.gov/bsufa) and generate a user fee
identification (ID) number. Payment must be made in U.S. currency by
electronic check, check, bank draft, U.S. postal money order, 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 use www.pay.gov, a web-based
payment application, for online electronic payment. The www.pay.gov
feature is available on the FDA website after the user fee ID number is
generated. 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
[[Page 48861]]
payments can be made online.) Once you search for your invoice, click
``Pay Now'' to be redirected to www.pay.gov. Electronic payment options
are based on the balance due. Payment by credit card is available for
balances that are 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 a check,
bank draft, or money order is to be sent by a courier that requests a
street address, the courier should deliver your payment to U.S. Bank,
Attention: Government Lockbox 979108, 1005 Convention Plaza, St. Louis,
MO 63101. (Note: this U.S. Bank address is for courier delivery only.
If you have any questions concerning courier delivery, contact U.S.
Bank at 314-418-4013. This telephone number is only for questions about
courier delivery). Please make sure that the FDA post office box number
(P.O. Box 979108) and ID number is written on the check, bank draft, or
postal money order.
For payments made by wire transfer, include the unique user fee ID
number to ensure that the payment is applied to the correct fee(s).
Without the unique user fee ID number, the payment may not be applied.
The originating financial institution may charge a wire transfer fee.
Include applicable wire transfer fees with payment to ensure fees are
fully 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, Acct. No:
75060099, Routing No: 021030004, SWIFT: FRNYUS33. FDA's tax
identification number is 53-0196965.
B. Annual BPD and Program Fees
FDA will issue invoices with payment instructions for FY 2024
annual BPD and program fees under the new fee schedule in August 2023.
Under section 744H(a)(1)(B)(ii) and (a)(3)(B) of the FD&C Act, annual
BPD and program fees will be due on October 2, 2023.
If sponsors join the BPD program after the annual BPD invoices have
been issued in August 2023, FDA will issue invoices in December 2023 to
sponsors subject to fees for FY 2024 that qualify for the annual BPD
fee after the August 2023 billing. FDA will issue invoices in December
2024 for any products that qualify for the annual program fee after the
August 2023 billing.
C. Waivers and Refunds
To qualify for consideration for a small business waiver under
section 744H(d) of the FD&C Act, or the return of any fee paid under
section 744H of the FD&C Act, including if the fee is claimed to have
been paid in error, a person shall submit to FDA a written request
justifying such waiver or return and, except as otherwise specified in
section 744H of the FD&C Act, such written request shall be submitted
to FDA not later than 180 days after such fee is due. Such written
request shall include any legal authorities under which the request is
made. See section 744H(h) of the FD&C Act.
Dated: July 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-15918 Filed 7-27-23; 8:45 am]
BILLING CODE 4164-01-P
