Notice2021-16084
Biosimilar User Fee Rates for Fiscal Year 2022
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Published
July 28, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is announcing the rates for biosimilar user fees for fiscal year (FY) 2022. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Biosimilar User Fee Amendments of 2017 (BsUFA II), 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 II 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, 2021, through September 30, 2022.
Full Text
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<title>Federal Register, Volume 86 Issue 142 (Wednesday, July 28, 2021)</title>
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[Federal Register Volume 86, Number 142 (Wednesday, July 28, 2021)]
[Notices]
[Pages 40567-40571]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-16084]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0708]
Biosimilar User Fee Rates for Fiscal Year 2022
AGENCY: Food and Drug Administration, Health and Human Services (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) 2022. The Federal
Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Biosimilar
User Fee Amendments of 2017 (BsUFA II), 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 II 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, 2021, through
September 30, 2022.
FOR FURTHER INFORMATION CONTACT: Melissa Hurley, Office of Financial
Management, Food and Drug Administration, 4041 Powder Mill Rd., Rm.
61075, Beltsville, MD 20705-4304, 240-402-4585.
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 II (title IV of the FDA
Reauthorization Act of 2017, Pub. L. 115-52), 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 5 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 or the sponsor
discontinues participation in FDA's 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 and wants to reengage
with FDA on development of the product, the sponsor must pay a
reactivation fee to resume participation in the program. The sponsor
must pay the reactivation fee by the earlier of the following dates: No
later than 5 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 sponsor will be assessed an annual BPD fee beginning
with the first fiscal year after payment of the reactivation fee.
BsUFA II also authorizes fees for certain biosimilar biological
product
[[Page 40568]]
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 2018 through FY 2022, the base revenue amounts for the total
revenues from all BsUFA fees are established by BsUFA II. For FY 2022,
the base revenue amount is the FY 2021 inflation-adjusted fee revenue
amount of $42,493,066. The FY 2022 base revenue amount is to be
adjusted for inflation and to reflect changes in the resource capacity
needs for the process for the review of biosimilar biological product
applications. Additionally, it may be reduced, as appropriate, for
long-term financial planning purposes.
This document provides fee rates for FY 2022 for the initial and
annual BPD fee ($57,184), for the reactivation fee ($114,368), 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, 2021, and will
remain in effect through September 30, 2022. For applications that are
submitted on or after October 1, 2021, the new fee schedule must be
used.
II. Fee Revenue Amount for FY 2022
The base revenue amount for FY 2022 is $42,493,066 prior to
adjustments for inflation, resource capacity, and operating reserves
(see section 744H(c)(1) through (3) of the FD&C Act).
A. FY 2022 Statutory Fee Revenue Adjustments for Inflation
BsUFA II specifies that the $42,493,066 is to be adjusted for
inflation increases for FY 2022 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 2022. The 3-year average is 2.7383 percent.
Table 1--FDA PC&B Each Year and Percent Changes
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Fiscal year 2018 2019 2020 3-Year average
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Total PC&B.............................. $2,690,678,000 $2,620,052,000 $2,875,592,000 ................
Total FTE............................... 17,023 17,144 17,535 ................
PC&B per FTE............................ $158,061 $152,826 $163,992 ................
Percent Change From Previous Year....... 4.2206% -3.3120% 7.3063% 2.7383%
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The statute specifies that this 2.7383 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.
Table 2--PC&B as a Percent of Total Cost of the Process for the Review of Biosimilar Biological Product
Applications
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Fiscal year 2018 2019 2020 3-Year average
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Total PC&B.............................. $35,477,032 $32,946,252 $25,445,175 ................
Total Costs............................. $62,604,122 $65,210,467 $56,798,694 ................
PC&B Percent............................ 56.6688% 50.5230% 44.7989% 50.6636%
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The payroll adjustment is 2.7383 percent from table 1 multiplied by
50.6636 percent (or 1.3873 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-
Baltimore, DC-MD-VA-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). As a result of a
geographical revision made by the Bureau of Labor and Statistics in
January 2018,\1\ the Washington-Baltimore, DC-MD-VA-WV index was
discontinued and replaced with two separate indices (i.e., Washington-
Arlington-Alexandria, DC-VA-MD-WV and Baltimore-Columbia-Towson, MD).
In order to continue applying a CPI which best reflects the geographic
region in which FDA is headquartered and which provides the most
current data available, the Washington-Arlington-Alexandria index will
be used in calculating the relevant adjustment factors for FY 2020 and
subsequent years. Table 3 provides the summary data for the percent
changes in the specified CPI for the Washington-Arlington-Alexandria
area. 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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\1\ The Bureau of Labor Statistics' announcement of the
geographical revision can be viewed at <a href="https://www.bls.gov/cpi/additional-resources/geographic-revision-2018.htm">https://www.bls.gov/cpi/additional-resources/geographic-revision-2018.htm</a>.
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Table 3--Annual and Three-Year Average Percent Change in CPI for Washington-Arlington-Alexandria Area
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Year 2018 2019 2020 3-Year average
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Annual CPI...................................... 261.445 264.777 267.157 ..............
Annual Percent Change........................... 2.0389% 1.2745% 0.8989% 1.4041%
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The statute specifies that this 1.4041 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 50.6636 percent was obligated for PC&B (as shown in table 2),
49.3364 percent is the portion of costs other than PC&B (100 percent
minus 50.6636 percent equals 49.3364 percent). The nonpayroll
adjustment is 1.4041 percent times 49.3364 percent, 0.6927 percent.
Next, we add the payroll adjustment (1.3873 percent) to the
nonpayroll adjustment (0.6927 percent), for a total inflation
adjustment of 2.0800 percent (rounded) for FY 2022.
We then multiply the base revenue amount for FY 2022 ($42,493,066)
by one plus the inflation adjustment (1.0208), yielding an inflation-
adjusted amount of $43,376,922.
B. FY 2022 Statutory Fee Revenue Adjustments for Capacity Planning
The statute specifies a process to establish and implement a
capacity planning adjustment (CPA) to adjust the total revenue amount
to reflect changes in the resource capacity needs for the process for
the review of biosimilar biological product applications (see section
744H(c)(2) 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
new methodology is described in the Federal Register at 85 FR 47220.
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 refers 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 the FDA will be able to utilize
additional funds during the fiscal year and the funds are required to
support additional review capacity. FTE amounts are adjusted, if
needed.
4. Convert the FTE need to dollars: utilizing the 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 2022
BsUFA CPA. Table 4 summarizes the forecasted workload volumes for BsUFA
in FY 2022 based on predictive models, as well as historical actuals
from FY 2020 for comparison.
Table 4--BsUFA Actual FY 2020 Workload Volumes & Predicted FY 2022
Workload Volumes
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FY 2020 FY 2022
Workload category actuals predictions
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Supplements with Clinical Data.......... 2 4
Labeling Supplements.................... 4 8
Manufacturing Supplements............... 79 111
Biosimilar Biological Product 7 7
Applications...........................
BsUFA Industry Meetings (BIA, BPD Type 1- 95 120
4).....................................
Participating BPD Programs.............. 104 131
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Utilizing the resource forecast algorithms, the forecasted workload
volumes for FY 2022 were then converted into estimated FTE needs for
FDA's BsUFA direct review-related work. The resulting expected FY 2022
FTE need for BsUFA was compared to current onboard capacity for BsUFA
direct review-related work to determine the FY 2022 resource delta, as
summarized in table 5.
Table 5--FY 2022 BsUFA Resource Delta
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Current resource FY 2022 resource Predicted FY 2022
capacity forecast FTE delta
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54 71 17
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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 determined that the expected net FTE gains could
be funded through the expected FY 2022 collections amount without a
further adjustment from the CPA. In summary, after accounting for these
internal factors, FDA determined that in FY 2022 the BsUFA fee amounts
did not need adjustment from the CPA to provide funds for the realistic
estimated net FTE gains.
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Table 6--FY 2022 BsUFA CPA
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Cost for
each FY 2022
Additional FTEs for FY 2022 additional BsUFA CPA
FTE
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0........................................... $312,185 $0
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Although an adjustment to the fee amounts for resource needs by the
CPA will not be made in FY 2022, FDA will evaluate the need for a fee
adjustment from the CPA in future fiscal years and will make
adjustments as warranted.
C. FY 2022 Statutory Fee Revenue Adjustments for Operating Reserve
BsUFA II provides for an operating reserve adjustment to allow FDA
to adjust the fee revenue and fees for any given fiscal year during
BsUFA II, after FY 2018, to maintain an appropriate operating reserve
of carryover user fees. Beginning in FY 2019, FDA may reduce the fee
revenue and fees for long-term financial planning purposes. Once the
capacity planning adjustment is effective, FDA also may, if necessary,
increase the fee revenue and fees to maintain not more than 21 weeks of
operating reserve of carryover user fees.
As described in the BsUFA II commitment letter, Biosimilar
Biological Product Reauthorization Goals and Procedures Fiscal Years
2018 Through 2022,\3\ FDA is committed to reducing the BsUFA carryover
reserve to an amount no greater than 21 weeks of operating reserve of
carryover user fees by the end of FY 2022. Based on estimates published
in the FY 2021 update to the BsUFA II Five-Year Financial Plan, FDA
currently shows an operating reserve amount that currently exceeds the
committed amount. As such, FDA is applying a downward operating reserve
adjustment of $3,336,686 (rounded to the nearest dollar), an amount
equivalent to 4 weeks of operations. With this operating reserve
adjustment, the inflation-adjusted amount, $43,376,922, will be lowered
by $3,336,686, yielding the FY 2022 target revenue amount of
$40,040,000 (rounded to the nearest thousand).
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\3\ See: <a href="https://www.fda.gov/media/100573/download">https://www.fda.gov/media/100573/download</a>.
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III. Fee Amounts for FY 2022
Under section 744H(b)(3)(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. In establishing the fee amounts for
the final year of BsUFA II, FDA considered how best to balance the fee
allocation to provide stable funding and reasonable fee amounts.
A. Application Fees
In establishing the biosimilar biological product application fee
amount for FY 2022, FDA utilized an average of the 3 most recently
completed fiscal years (i.e., FY 2018-2020) of biosimilar biological
product application submissions. Based on the available information,
FDA estimates it will receive 7 biosimilar biological product
applications requiring clinical data for approval in FY 2022.
FDA will maintain the biosimilar biological product application fee
for FY 2022 at the same level as FY 2021, which is $1,746,745. This is
estimated to provide a total of $12,227,215 representing 31 percent
(rounded to the nearest whole number) of the FY 2022 target revenue
amount.
B. Biosimilar Biological Product Program Fee
Under BsUFA II, 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 only for biosimilar biological products identified in
a biosimilar biological product application approved as of October 1 of
such fiscal year.
Based on available information, FDA estimates that 67 program fees
will be invoiced for FY 2022, including currently approved products and
products with the potential to be approved in pending applications with
goal dates in FY 2021. For products invoiced in the FY 2022 regular
billing cycle, FDA anticipates that zero program fees will be refunded.
FDA will maintain the biosimilar biological product program fee for
FY 2022 at the same level as FY 2021, which is $304,162. This is
estimated to provide a total of $20,378,854, representing 51 percent
(rounded to the nearest whole number) of the FY 2022 target revenue
amount.
C. Initial and Annual BPD Fees, Reactivation Fees
To estimate the number of BPD fees to be paid in FY 2022, 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 analyzes available data to estimate the total number of BPD
programs for FY 2022. In FY 2022, FDA estimates 39 new BPD programs, no
reactivations (a single reactivation is weighted as two BPD fees), and
91 BPD programs (out of 92 invoiced) to pay the annual BPD fee,
yielding a total estimated equivalent of 130 BPD fees to be collected
in FY 2022.
The remainder of the target revenue of $7,433,931, or 19 percent
(rounded to the nearest whole number), is to be collected from the BPD
fees. Dividing this amount by the estimated 130 BPD fees to be paid
equals an initial BPD and annual BPD fee amount of $57,184. The
reactivation fee is set at twice the initial/annual BPD amount at
$114,368 (rounded to the nearest dollar). This represents a reduction
of the BPD fees from the FY 2021 levels.
IV. Fee Schedule for FY 2022
The fee rates for FY 2022 are displayed in table 7.
Table 7--Fee Schedule for FY 2022
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Fee rates for
Fee category FY 2022
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Initial BPD............................................. $57,184
Annual BPD.............................................. 57,184
Reactivation............................................ 114,368
Applications:
Requiring clinical data............................... 1,746,745
Not requiring clinical data........................... 873,373
Program................................................. 304,162
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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 2022,
i.e., the period from October 1, 2021, through September 30, 2022. 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 5 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 and seek to resume participation in such program must pay the
reactivation fee by the earlier of the following dates: No later than 5
calendar
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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://Pay.gov">Pay.gov</a>, a web-based payment
application, for online electronic payment. The <a href="http://Pay.gov">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 payments can be made online). Once you search for
your invoice, click ``Pay Now'' to be redirected to <a href="http://Pay.gov">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 2022
annual BPD and program fees under the new fee schedule in August 2021.
Payment will be due on October 1, 2021. If sponsors join the BPD
program after the annual BPD invoices have been issued in August 2021,
FDA will issue invoices in December 2021 to firms subject to fees for
FY 2022 that qualify for the annual BPD fee after the August 2021
billing. FDA will issue invoices in December 2021 for any annual
program fees for FY 2022 that qualify for fee assessments and were not
issued in August 2021.
Dated: July 23, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-16084 Filed 7-27-21; 8:45 am]
BILLING CODE 4164-01-P
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