Notice2023-15918
Biosimilar User Fee Rates for Fiscal Year 2024
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Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 28, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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[Federal Register Volume 88, Number 144 (Friday, July 28, 2023)]
[Notices]
[Pages 48855-48861]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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.
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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 <a href="/cdn-cgi/l/email-protection#a7e8e88ae8e1e5e6f78ae8e1ea8af2e1f4f48ae0c8d1c2d5c9cac2c9d3e7c1c3c689cfcfd489c0c8d1"><span class="__cf_email__" data-cfemail="82cdcdafcdc4c0c3d2afcdc4cfafd7c4d1d1afc5edf4e7f0ecefe7ecf6c2e4e6e3aceaeaf1ace5edf4">[email protected]</span></a>.
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\
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\1\ The data are published by the Bureau of Labor Statistics and
can be found on its website at: <a href="https://data.bls.gov/pdq/SurveyOutputServlet?data_tool=dropmap&series_id=CUURS35ASA0,CUUSS35ASA0">https://data.bls.gov/pdq/SurveyOutputServlet?data_tool=dropmap&series_id=CUURS35ASA0,CUUSS35ASA0</a>.
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[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.
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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 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.
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[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 (<a href="https://www.fda.gov/bsufa">https://www.fda.gov/bsufa</a>) 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 <a href="http://www.pay.gov">www.pay.gov</a>, a web-based
payment application, for online electronic payment. The <a href="http://www.pay.gov">www.pay.gov</a>
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 <a href="https://userfees.fda.gov/pay">https://userfees.fda.gov/pay</a> (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 <a href="http://www.pay.gov">www.pay.gov</a>. 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
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