[Federal Register Volume 85, Number 150 (Tuesday, August 4, 2020)]
[Notices]
[Pages 47220-47225]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16858]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-3560]
Biosimilar User Fee Rates for Fiscal Year 2021
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the rates
for biosimilar user fees for fiscal year (FY) 2021. 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, 2020, through
September 30, 2021.
FOR FURTHER INFORMATION CONTACT: Andrew Bank, Office of Financial
[[Page 47221]]
Management, Food and Drug Administration, 4041 Powder Mill Rd., Rm.
62019A, Beltsville, MD 20705-4304, 301-796-0292.
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 re-engage
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 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 2021,
the base revenue amount is the FY 2020 inflation adjusted fee revenue
amount of $41,922,873. The FY 2021 base revenue amount is to be
adjusted for inflation and may be reduced, as appropriate, for long-
term financial planning purposes. Beginning in FY 2021, the inflation-
adjusted base revenue amount is also adjusted to reflect changes in the
resource capacity needs for the process for the review of biosimilar
biological product applications.
This document provides fee rates for FY 2021 for the initial and
annual BPD fee ($102,494), for the reactivation fee ($204,988), 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, 2020, and will
remain in effect through September 30, 2021. For applications that are
submitted on or after October 1, 2020, the new fee schedule must be
used.
II. Fee Revenue Amount for FY 2021
The base revenue amount for FY 2021 is $41,922,873 prior to
adjustments for inflation, resource capacity, and operating reserves
(see section 744H(c)(1), (c)(2), and (c)(3) of the FD&C Act).
A. FY 2021 Statutory Fee Revenue Adjustments for Inflation
BsUFA II specifies that the $41,922,873 is to be adjusted for
inflation increases for FY 2021 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 FYs, 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 FYs (see
section 744H(c)(1)(B) of the FD&C Act).
Table 1 summarizes the actual cost and FTE data for the specified
FYs and provides the percent changes from the previous FYs and the
average percent changes over the first 3 of the 4 FYs preceding FY
2021. The 3-year average is 1.2644 percent.
Table 1--FDA PC&B Each Year and Percent Changes
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Fiscal year 2017 2018 2019 3-Year average
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Total PC&B.............................. $2,581,551,000 $2,690,678,000 $2,620,052,000 ................
Total FTE............................... 17,022 17,023 17,144 ................
PC&B per FTE............................ $151,660 $158,061 $152,826 ................
Percent Change From Previous Year....... 2.8845% 4.2206% -3.3120% 1.2644%
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The statute specifies that this 1.2644 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 FYs.
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 2017 2018 2019 3-Year average
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Total PC&B.............................. $30,707,050 $35,477,032 $32,946,252 ................
Total Costs............................. $55,814,043 $62,604,122 $65,210,467 ................
[[Page 47222]]
PC&B Percent............................ 55.0167% 56.6688% 50.5230% 54.0695%
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The payroll adjustment is 1.2644 percent from Table 1 multiplied by
54.0695 percent (or 0.6837 percent).
The statute specifies that the portion of the inflation adjustment
for non-payroll 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 FYs (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: https://data.bls.gov/pdq/SurveyOutputServlet?data_tool=dropmap&series_id=CUURS35ASA0,CUUSS35ASA0.
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\1\ The Bureau of Labor Statistics' announcement of the
geographical revision can be viewed at https://www.bls.gov/cpi/additional-resources/geographic-revision-2018.htm.
Table 3--Annual and Three-Year Average Percent Change in CPI for Washington-Arlington-Alexandria Area
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Year 2017 2018 2019 3-Year average
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Annual CPI............................ 256.221 261.445 264.777 ........................
Annual Percent Change................. 1.1045% 2.0389% 1.2745% 1.4726%
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The statute specifies that this 1.4726 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 54.0695 percent was obligated for PC&B (as shown in Table 2),
45.9305 percent is the portion of costs other than PC&B (100 percent
minus 54.0695 percent equals 45.9305 percent). The non-payroll
adjustment is 1.4726 percent times 45.9305 percent, 0.6764 percent.
Next, we add the payroll adjustment (0.6837 percent) to the non-
payroll adjustment (0.6764 percent), for a total inflation adjustment
of 1.3601 percent (rounded) for FY 2021.
We then multiply the base revenue amount for FY 2021 ($41,922,873)
by one plus the inflation adjustment (1.013601), yielding an inflation-
adjusted amount of $42,493,000 (rounded to the nearest thousand).
B. FY 2021 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).
As a first step toward implementing the new methodology, FDA
committed to establish modernized time reporting and a resource
capacity planning capability. Modernized time reporting was implemented
in CBER in 2018 and in CDER in 2019. A resource capacity planning
capability was established in both CDER and CBER in 2020. In the
statute, FDA was directed to commission an independent report
evaluating options and recommendations for a methodology to accurately
assess changes in the resource and capacity needs of the process for
the review of biosimilar biological product applications, informed by
personnel time reporting data as an input, and to publish the report
for public comment. The evaluation was conducted by Booz Allen Hamilton
and published on the FDA website in April 2020.\2\ A docket was then
opened to receive public comment.\3\ After having reviewed the
evaluation and the public comment, FDA is establishing and implementing
the CPA methodology for the setting of FY 2021 fee amounts.
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\2\ See: https://www.fda.gov/media/136606/download.
\3\ See: https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2020-N-0989.
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The new CPA methodology consists of four steps:
1. Forecast workload volumes: Predictive models estimate the volume
of workload for the upcoming fiscal year. Workload categories for BsUFA
include biosimilar biological product applications, participating BPD
programs, supplements, and formal industry meetings scheduled
(biosimilar initial advisory (BIA) and BPD Type 1-4 meetings,\4\
including BIA and BPD Type 2 written-response only meetings)
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\4\ The BsUFA II commitment letter defines these meeting types
in section 1.I.: https://www.fda.gov/media/100573/download.
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2. Forecast the resource needs: Forecast algorithms are generated
utilizing time reporting data. These algorithms estimate the required
demand in FTEs for direct review-related efforts. This is then compared
to current available resources for the direct review workload.
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
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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.
Further, FDA is adopting an iterative, continuous improvement
approach as part of its CPA methodology. For FY 2021, FDA is applying
the methodology to core review activities, for which significant data
collection and analysis has been completed. Going forward, the Agency
intends to refine its data and estimates for the core review activities
to improve their accuracy, and also, as feasible, to apply the new
methodology to all major activities that impact the resource needs of
the process for the review of biosimilar biological product
applications under BsUFA, potentially including, for example, post-
market safety activities and some subsets of policy and guidance
development. This iterative, continuous improvement approach to the CPA
methodology was recommended by the independent evaluation and in the
public comments. FDA believes that its estimates will be continuously
improved over time as more robust data becomes available to more fully
account for total BsUFA program resource needs.
The following section outlines the major components of the FY 2021
BsUFA CPA. Table 4 summarizes the forecasted workload volumes for BsUFA
in FY 2021 based on predictive models, as well as historical actuals
from FY 2019 for comparison.
Table 4--BsUFA Actual FY 2019 Workload Volumes & Predicted FY 2021
Workload Volumes
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FY 2019 FY 2021
Workload category actuals predictions
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Efficacy Supplements.................... 12 8
Labeling Supplements.................... 10 7
Manufacturing Supplements............... 58 90
Biosimilar Biological Product 6 8
Applications...........................
BsUFA Industry Meetings (BIA, BPD Type 1- 114 102
4).....................................
Participating BPD Programs.............. 95 119
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Utilizing the resource forecast algorithms, the forecasted workload
volumes for FY 2021 were then converted into estimated FTE needs for
FDA's BsUFA direct review-related work. The resulting expected FY 2021
FTE need for BsUFA was compared to current onboard capacity for BsUFA
direct review-related work to determine the FY 2021 resource delta, as
summarized in Table 5.
Table 5--FY 2021 BsUFA Resource Delta
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Current resource capacity FY 2021 resource forecast Predicted FY 2021 FTE delta
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61.7 88.3 26.5
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The projected 26.5 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. After accounting for the range of recent years'
historical net FTE gains and one remaining previously funded BsUFA
vacancy, FDA determined that the realistic expected net FTE gains could
be funded through the expected FY 2021 collections amount without a
further adjustment from the CPA. In summary, after accounting for these
internal factors, FDA determined that in FY 2021 the BsUFA fee amounts
did not need adjustment from the CPA to provide funds for the realistic
estimated net FTE gains.
Table 6--FY 2021 BsUFA CPA
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Additional FTEs for FY 2021 Cost for each additional FTE FY 2021 BsUFA CPA
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26.5 $301,701 $0
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Although an adjustment to the fee amounts for resource needs by the
CPA will not be made in FY 2021, FDA will evaluate the need for a fee
adjustment from the CPA in future fiscal years and will make
adjustments as warranted.
C. FY 2021 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,\5\ FDA is committed to reducing the BsUFA carryover
reserve to an
[[Page 47224]]
amount no greater than 21 weeks of operating reserve of carryover user
fees by the end of FY 2022. FDA has determined that it shall not apply
an operating reserve adjustment to lower the FY 2021 target revenue
amount as FDA appears on track to reduce the carryover reserve to the
committed level.
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\5\ See: https://www.fda.gov/media/100573/download.
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III. Fee Amounts for FY 2021
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 fourth year of BsUFA II, FDA considered how best to balance the fee
allocation to provide stable funding and reasonable fee amounts. In
future years, FDA will consider the most appropriate means of
allocating the fee amounts to collect the adjusted target revenue
amount, subject to the relevant statutory provisions.
A. Application Fees
In establishing the biosimilar biological product application fee
amount for FY 2021, FDA utilized an average of the 3 most recently
completed fiscal years (i.e., fiscal years 2017-2019) of biosimilar
biological product application submissions. Based on the available
information, FDA estimates it will receive 8 biosimilar biological
product applications requiring clinical data for approval in FY 2021.
FDA will maintain the biosimilar biological product application fee
for FY 2021 at the same level as FY 2020, which is $1,746,745. This is
estimated to provide a total of $13,973,960 representing 33 percent
(rounded to the nearest whole number) of the FY 2021 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 FD&C Act section
744H(a)(3)(D)). 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 54 program fees
will be invoiced for FY 2021, including currently approved products and
products with the potential to be approved in pending applications with
goal dates in FY 2020. For products invoiced in the FY 2021 regular
billing cycle, FDA anticipates that zero program fees will be refunded.
FDA will maintain the biosimilar biological product program fee for
FY 2021 at the same level as FY 2020, which is $304,162. This is
estimated to provide a total of $16,424,748, representing 39 percent
(rounded to the nearest whole number) of the FY 2021 target revenue
amount.
C. Initial and Annual BPD Fees, Reactivation Fees
To estimate the number of BPD fees to be paid in FY 2021, 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 uses internal data and a survey of BPD sponsors to estimate the
total number of BPD programs for FY 2021. In FY 2021, FDA estimates 32
new BPD programs, no reactivations (a single reactivation is weighted
as two BPD fees), and 86 BPD programs to be invoiced for the annual BPD
fee, for a total equivalent of 118 BPD fees assessed in FY 2021.
The remainder of the target revenue of $12,094,292, or 28 percent
(rounded to the nearest whole number), is to be collected from the BPD
fees. Dividing this amount by the estimated 118 BPD fees to be paid
equals an initial BPD and annual BPD fee amount of $102,494. The
reactivation fee is set at twice the initial/annual BPD amount at
$204,988. This represents a reduction of the BPD fees from the FY 2020
levels.
IV. Fee Schedule for FY 2021
The fee rates for FY 2021 are displayed in Table 7.
Table 7--Fee Schedule for FY 2021
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Fee rates for
Fee category FY 2021
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Initial BPD............................................. $102,494
Annual BPD.............................................. 102,494
Reactivation............................................ 204,988
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 2021,
i.e., the period from October 1, 2020, through September 30, 2021. 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 five 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 five 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 Pay.gov, a web-based payment
application, for online electronic payment. The 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
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you search for your invoice, click ``Pay Now'' to be redirected to
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 2021
annual BPD and program fees under the new fee schedule in August 2020.
Payment will be due on October 1, 2020. If sponsors join the BPD
program after the annual BPD invoices have been issued in August 2020,
FDA will issue invoices in December 2020 to firms subject to fees for
FY 2021 that qualify for the annual BPD fee after the August 2020
billing. FDA will issue invoices in December 2020 for any annual
program fees for FY 2021 that qualify for fee assessments and were not
issued in August 2020.
Dated: July 29, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-16858 Filed 7-30-20; 4:15 pm]
BILLING CODE 4164-01-P