[Federal Register Volume 87, Number 194 (Friday, October 7, 2022)]
[Notices]
[Pages 61033-61039]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-21965]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-2352]
Biosimilar User Fee Rates for Fiscal Year 2023
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
rates for biosimilar user fees for fiscal year (FY) 2023. 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, 2022, 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, 301-796-7223, 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
[[Page 61034]]
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 fee beginning with the first 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 from its first 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 2023,
the base revenue amount is the FY 2022 total revenue amount minus the
operating reserve adjustment, which equates to the amount of
$43,376,922. The FY 2023 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 2023 for the initial and
annual BPD fee ($47,325), for the reactivation fee ($94,650), for an
application requiring clinical data ($1,746,745), for an application
not requiring clinical data ($873,373), and for the program fee
($304,162). These fees are effective on October 1, 2022, and will
remain in effect through September 30, 2023. For applications that are
submitted on or after October 1, 2023, the new fee schedule must be
used.
II. Fee Revenue Amount for FY 2023
The base revenue amount for FY 2023 is $43,376,922 prior to
adjustments for inflation, strategic hiring and retention, capacity
planning, operating reserves, and the additional dollar amount (see
section 744H(b)-(c) of the FD&C Act).
A. FY 2023 Statutory Fee Revenue Adjustments for Inflation
BsUFA III specifies that the $43,376,922 is to be adjusted for
inflation increases for FY 2023 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 one plus 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 2023. The 3-year average is 1.3918 percent.
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The statute specifies that this 1.3918 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] TN07OC22.020
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The payroll adjustment is 1.3918 percent from table 1 multiplied by
50.2097 percent (or 0.6988 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\
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\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.
[GRAPHIC] [TIFF OMITTED] TN07OC22.021
The statute specifies that this 2.0434 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 50.2097 percent was obligated for PC&B (as shown in table 2),
49.7903 percent is the portion of costs other than PC&B (100 percent
minus 50.2097 percent equals 49.7903 percent). The non-payroll
adjustment is 2.0434 percent times 49.7903 percent, 1.0174 percent.
Next, we add the payroll adjustment (0.6988 percent) to the
nonpayroll adjustment (1.0174 percent), for a total inflation
adjustment of 1.7162 percent (rounded) for FY 2023.
We then multiply the base revenue amount for FY 2023 ($43,376,922)
by the inflation adjustment percentage (1.7162 percent), yielding an
inflation adjustment of $744,435. Adding this amount yields an
inflation-adjusted amount of $44,121,357.
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 2023 (see section 744H(c)(2) of the FD&C Act).
C. FY 2023 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.
Beginning in FY 2023, updates were made to refine the time
reporting categories included within the CPA. As such, time reporting
data and baseline capacity have been revised to match the refinements;
in the coming fiscal years, additional updates are anticipated to be
made to account for additional activities that are also directly
related to the direct review of biosimilar biological product
applications and supplements, including additional formal meeting types
and the direct review of postmarketing commitments and requirements,
the direct review of risk evaluation and mitigation strategies, and the
direct review of annual reports for approved biosimilar biological
products.
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.
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\2\ Full-time equivalents refer to a paid staff year, rather
than a count of individual employees.
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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 2023
BsUFA III CPA. Table 4 summarizes the forecasted workload volumes for
BsUFA III in FY 2023 based on predictive models, as well as historical
actuals from FY 2021 for comparison.
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Utilizing the resource forecast algorithms, the forecasted workload
volumes for FY 2023 were then converted into estimated FTE needs for
FDA's BsUFA III direct review-related work. The resulting expected FY
2023 FTE need for BsUFA III was compared to current onboard capacity
for BsUFA III direct review-related work to determine the FY 2023
resource delta, as summarized in table 5.
[GRAPHIC] [TIFF OMITTED] TN07OC22.023
The projected 17 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 which can be utilized in the
fiscal year and for which funds are required to support additional
review capacity. FDA recognizes that FY 2023 presents significant
hiring commitments for the Agency, including the hiring goals set forth
for FY 2023 per the BsUFA III Commitment Letter, as well as hiring
commitments for other user fee programs. In addition, current labor
market conditions may present continuing hiring and retention
challenges. In light of these commitments and challenges, FDA
determined that there is no need for an adjustment from the CPA to
provide funds for the realistic estimated net FTE gains.
[GRAPHIC] [TIFF OMITTED] TN07OC22.024
Although an adjustment to the fee amounts for resource needs by the
CPA will not be made in FY 2023, FDA will evaluate the need for a fee
adjustment from the CPA in future fiscal years and will make
adjustments as warranted.
D. FY 2023 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 2023, the statute directs FDA to further increase the
fee revenue and fees by the additional dollar amount, which is
$4,428,886 for FY 2023 (see section 744H(b)(1)(F) of the FD&C Act).
E. FY 2023 Statutory Fee Revenue Adjustments for Operating Reserve
BsUFA III sets forth an operating reserve adjustment to the fee
revenue and fees. Specifically, for FY 2023, 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 33 weeks of such operating reserves, to
decrease such fee revenue and fees to provide for not more than 33
weeks of such operating reserves (see section 744H(c)(4) of the FD&C
Act).
To determine whether the operating reserve adjustment will be
applied, FDA uses an estimated adjusted revenue amount which estimates
FDA's costs of operations for BsUFA for FY 2023. To calculate the
estimated adjusted revenue amount, the FY 2023 annual base revenue is
adjusted for inflation, strategic hiring and retention, capacity
planning, and the additional dollar amount. The annual base revenue
amount for FY 2023 is $43,376,922. This amount is then multiplied by
1.7162 percent yielding an inflation-adjusted revenue amount of
$44,121,357. The next adjustment is the strategic hiring and retention
adjustment of $150,000. Adding the strategic hiring and retention
adjustment of $150,000 to the inflation-adjusted revenue amount results
in $44,271,357. Next, adding the FY 2023 CPA of $0 results in the
capacity planning-adjusted revenue amount of $44,271,357. Next, adding
the additional dollar amount of $4,428,886 generates the estimated
adjusted revenue amount. For FY 2023, the BsUFA estimated adjusted
revenue amount is $48,700,243.
To calculate the 10-week and 33-week threshold amounts for the FY
2023 operating reserve adjustment, the estimated adjusted revenue
amount is divided by 52, resulting in a $936,543 cost of operation for
1 week. The unrounded 1-week value is then multiplied by 10 weeks to
generate the 10-week operating reserve threshold amount for FY 2023 of
$9,365,431. The unrounded 1-week value is multiplied by 33 to generate
the 33-week operating reserve threshold amount for FY 2023 of
$30,905,923.
To calculate the estimated operating reserve of carryover user fees
at the end of FY 2022, FDA estimated the operating reserves of
carryover fees at the end of July 2022. The balance of operating
reserves of carryover fees at the end of July 2022 is combined with the
forecasted collections and obligations for the remainder of FY 2022 to
generate a full year estimate for FY 2022. The estimated operating
reserve of
[[Page 61037]]
carryover user fees at the end of FY 2022 is $38,005,821.
The estimated operating reserve of carryover user fees at the end
of FY 2022 of $38,005,821 exceeds the 33-week threshold allowable
operating reserve of carryover user fees for FY 2023 of $30,905,923. As
such, FDA is applying a downward operating reserve adjustment of
$7,099,898 (rounded to the nearest dollar), an amount equivalent to a
reduction of approximately 8 weeks of operations, to bring the
operating reserve of carryover user fees to $30,905,923 or 33 weeks of
operations at the start of FY2023. With this Operating Reserve
Adjustment, the estimated adjusted revenue amount of $48,700,243 will
be lowered by $7,099,898, yielding the FY 2023 target revenue amount of
$41,600,000 (rounded to the nearest thousand).
III. Fee Amounts for FY 2023
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 2023. The operating
reserve adjustment in subsequent years may not be as large. As such,
the target revenue in FY 2023 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 2023, FDA utilized an average of the three most recently
completed fiscal years (i.e., FY 2019 to 2022) of biosimilar biological
product application submissions. Based on the available information,
FDA estimates it will receive eight biosimilar biological product
applications requiring clinical data for approval in FY 2023 and zero
applications that do not require clinical data.
For FY 2023, FDA will maintain the biosimilar biological product
application fee at the same level as FY 2022, which is $1,746,745 for
applications requiring clinical data. Applications not requiring
clinical data pay half that fee, or $873,373. This is estimated to
provide a total of $13,973,960 representing 34 percent (rounded to the
nearest whole number) of the FY 2023 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 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; 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)(ii) of the FD&C Act).
Based on available information, FDA estimates that 72 program fees
will be invoiced for FY 2023. For products invoiced in the FY 2023
regular billing cycle, FDA anticipates that zero program fees will be
refunded.
For FY 2023, the biosimilar biological product program fee is
$304,162. This is estimated to provide a total of $21,899,664,
representing 53 percent (rounded to the nearest whole number) of the FY
2023 target revenue amount.
C. Initial and Annual BPD Fees, and Reactivation Fees
To estimate the number of BPD fees to be paid in FY 2023, 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 2023. In FY 2023, FDA estimates approximately 23.5 new
BPD programs, no reactivations (a single reactivation is weighted as
two BPD fees), and approximately 97.75 BPD programs to pay the annual
BPD fee, yielding a rounded total estimated equivalent of 121 BPD fees
to be collected in FY 2023. The remainder of the target revenue of
$5,726,376 or 14 percent (rounded to the nearest whole number), is to
be collected from the BPD fees. Dividing this amount by the estimated
121 BPD fees to be paid equals an initial BPD and annual BPD fee amount
of $47,325. The reactivation fee is set at twice the initial/annual BPD
amount at $94,650 (rounded to the nearest dollar).
IV. Fee Schedule for FY 2023
The fee rates for FY 2023 are displayed in table 7.
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V. Fee Payment Options and Procedures
A. Initial BPD, Reactivation, and Application Fees
The fees established in the new fee schedule apply to FY 2023,
i.e., the period from October 1, 2022, through September 30, 2023. 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 such program must pay
all annual biosimilar biological product development 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 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 2023
annual BPD and program fees under the new fee schedule in October 2022.
Under sections 744H(a)(1)(B)(ii) and 744H(a)(3)(B) of the FD&C Act,
annual BPD and program fees are generally due on October 3, 2022.
However, given the late date of the BsUFA reauthorization, invoices
should be paid within 30 days of invoice.
FDA will issue invoices in December 2023 for any products that
qualify for the annual program fee after the October 2022 billing.
C. Waivers and Refunds
To qualify for consideration for a 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
[[Page 61039]]
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: October 4, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-21965 Filed 10-5-22; 11:15 am]
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