[Federal Register Volume 86, Number 142 (Wednesday, July 28, 2021)]
[Notices]
[Pages 40567-40571]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: 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.

[[Page 40569]]



      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.

[[Page 40570]]



                       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: https://www.fda.gov/media/100573/download.
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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
------------------------------------------------------------------------
                                                           Fee rates for
                      Fee category                            FY 2022
------------------------------------------------------------------------
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
------------------------------------------------------------------------

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

[[Page 40571]]

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 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 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


