[Federal Register Volume 86, Number 155 (Monday, August 16, 2021)]
[Notices]
[Pages 45732-45738]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-17505]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0709]


Prescription Drug User Fee Rates for Fiscal Year 2022

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the rates 
for prescription drug user fees for fiscal year (FY) 2022. The Federal 
Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Prescription 
Drug User Fee Amendments of 2017 (PDUFA VI), authorizes FDA to collect 
application fees for certain applications for the review of human drug 
and biological products, and prescription drug program fees for certain 
approved products. This notice establishes the fee rates for FY 2022.

FOR FURTHER INFORMATION CONTACT: Misbah Tareen, Office of Financial 
Management, Food and Drug Administration, 4041 Powder Mill Rd., Rm. 
61077A, Beltsville, MD 20705-4304, 301-796-3997.

SUPPLEMENTARY INFORMATION:

I. Background

    Sections 735 and 736 of the FD&C Act (21 U.S.C. 379g and 379h, 
respectively) establish two different kinds of user fees. Fees are 
assessed as follows: (1) Application fees are assessed on certain types 
of applications for the review of human drug and biological products 
and (2) prescription drug program fees are assessed on certain approved 
products (section 736(a) of the FD&C Act). When specific conditions are 
met, FDA may waive or reduce fees (section 736(d) of the FD&C Act) or 
exempt certain prescription drug products from fees (section 736(k) of 
the FD&C Act).
    For FY 2018 through FY 2022, the base revenue amounts for the total 
revenues from all PDUFA fees are established by PDUFA VI. The base 
revenue amount for FY 2022 is $1,098,077,960. The FY 2022 base revenue 
amount is adjusted for inflation and for the resource capacity needs 
for the process for the review of human drug applications (the capacity 
planning adjustment (CPA)). An additional dollar amount specified in 
the statute (see section 736(b)(1)(F) of the FD&C Act) is then added to 
provide for additional full-time equivalent (FTE) positions to support 
PDUFA VI initiatives. The FY 2022 revenue amount may be adjusted 
further, if necessary, to provide for sufficient operating reserves of 
carryover user fees. Finally, the amount is adjusted to provide for 
additional direct costs to fund PDUFA VI initiatives. Fee amounts are 
to be established each year so that revenues from application fees 
provide 20 percent of the total revenue, and prescription drug program 
fees provide 80 percent of the total revenue.
    This document provides fee rates for FY 2022 for an application 
requiring clinical data ($3,117,218), for an application not requiring 
clinical data ($1,558,609), and for the prescription drug program fee 
($369,413). 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 $1,098,077,960 prior to 
adjustments for inflation, capacity planning, additional FTE, operating 
reserve, and additional direct costs (see section 736(b)(1) of the FD&C 
Act).

A. FY 2022 Statutory Fee Revenue Adjustments for Inflation

    PDUFA VI specifies that the $1,098,077,960 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 736(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 FTE positions at FDA for the first 3 of the

[[Page 45733]]

preceding 4 fiscal years, multiplied by the proportion of PC&B costs to 
total FDA costs of the process for the review of human drug 
applications for the first 3 of the preceding 4 fiscal years (see 
section 736(c)(1)(A) and (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 Personnel Compensation and Benefits (PC&B) Each Year and Percent Changes
----------------------------------------------------------------------------------------------------------------
                Fiscal year                       2018              2019              2020        3-Year average
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------

    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 human drug applications. Table 2 shows the PC&B and the total 
obligations for the process for the review of human drug 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 Human Drug Applications
----------------------------------------------------------------------------------------------------------------
                Fiscal year                       2018              2019              2020        3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B................................      $792,900,647      $872,087,636      $891,395,106  ..............
Total Costs...............................    $1,374,508,527    $1,430,338,888    $1,471,144,928  ..............
PC&B Percent..............................           57.6861           60.9707           60.5919         59.7496
----------------------------------------------------------------------------------------------------------------

    The payroll adjustment is 2.7383 percent from table 1 multiplied by 
59.7496 percent (or 1.6361 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 human drug 
applications for the first 3 years of the preceding 4 fiscal years (see 
section 736(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 that best reflects the geographic region in 
which FDA is headquartered and that 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.

---------------------------------------------------------------------------

    \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 3-Year Average Percent Change in CPI for Washington-Arlington-Alexandria Area
----------------------------------------------------------------------------------------------------------------
                      Year                             2018            2019            2020       3-Year average
----------------------------------------------------------------------------------------------------------------
Annual CPI......................................         261.445         264.777         267.157  ..............
Annual Percent Change...........................          2.0389          1.2745          0.8989          1.4041
----------------------------------------------------------------------------------------------------------------

    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 human drug applications obligated. Because 59.7496 
percent was obligated for PC&B (as shown in table 2), 40.2504 percent 
is the portion of costs other than PC&B (100 percent minus 59.7496 
percent equals 40.2504 percent). The non-payroll adjustment is 1.4041 
percent times 40.2504 percent, or 0.5652 percent.
    Next, we add the payroll adjustment (1.6361 percent) to the non-
payroll adjustment (0.5652 percent), for a total inflation adjustment 
of 2.2013 percent (rounded) for FY 2022.
    We then multiply the base revenue amount for FY 2022 
($1,098,077,960) by 1.022013, yielding an inflation-adjusted amount of 
$1,122,249,950.

B. FY 2022 Statutory Fee Revenue Adjustments for Capacity Planning

    The statute specifies that after $1,098,077,960 has been adjusted 
for inflation, the inflation-adjusted amount shall be further adjusted 
to reflect changes in the resource capacity needs for the process of 
human drug application reviews (see section 736(c)(2) of the FD&C Act). 
Following a process required in statute, the FDA

[[Page 45734]]

established a new 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 46651.
    The CPA methodology includes 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.
---------------------------------------------------------------------------

    \2\ Full-time equivalents refers to a paid staff year, rather 
than a count of individual employees.
---------------------------------------------------------------------------

    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 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.
    To determine the FY 2022 capacity planning adjustment, FDA 
calculated a PDUFA CPA for the Center for Drug Evaluation and Research 
(CDER) and the Center for Biologics Evaluation and Research (CBER) 
individually. The final Center-level results were then combined to 
determine the total FY 2022 PDUFA CPA. The following section outlines 
the major components of each Center's FY 2022 PDUFA CPA.
    Table 4 summarizes the forecasted workload volumes for CDER in FY 
2022 based on predictive models, as well as historical actuals from FY 
2020 for comparison.

   Table 4--CDER Actual FY 2020 Workload Volumes and Predicted FY 2022
                            Workload Volumes
------------------------------------------------------------------------
                                              FY 2020         FY 2022
            Workload category                 actuals       predictions
------------------------------------------------------------------------
Efficacy Supplements....................             293             316
Labeling Supplements....................           1,122           1,043
Manufacturing Supplements...............           2,350           2,388
NDA/BLA \1\ Original....................             150             161
PDUFA Industry Meetings (including WROs            3,950           4,534
 \2\)...................................
Active Commercial INDs \3\..............           8,243           9,549
------------------------------------------------------------------------
\1\ New drug applications (NDA)/biological license applications (BLA).
\2\ Written responses only (WRO).
\3\ For purpose of the capacity planning adjustment, this is defined as
  an active commercial investigational new drugs (IND) for which a
  document has been received in the past 18 months.

    Utilizing the resource forecast algorithms, the forecasted workload 
volumes for FY 2022 were then converted into estimated FTE needs for 
CDER's PDUFA direct review-related work. The resulting expected FY 2022 
FTE need for CDER was compared to current onboard capacity for direct 
review related work to determine the FY 2022 resource delta, as 
summarized in table 5.

                                     Table 5--CDER FY22 PDUFA Resource Delta
----------------------------------------------------------------------------------------------------------------
                                                                   Current          FY 2022
                            Center                                 resource         resource       Predicted FY
                                                                   capacity         forecast      2022 FTE delta
----------------------------------------------------------------------------------------------------------------
CDER.........................................................           1,686            1,861              175
----------------------------------------------------------------------------------------------------------------

    The projected 175 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. With recent enhancements to its hiring capability, 
CDER's ability to net gain PDUFA FTEs moving forward is expected to 
outpace recent years' net gains. As such, hiring capacity is not 
expected to be a significant impediment to onboarding the needed net 
gains for the PDUFA program.
    After assessing current hiring capacity and existing funded 
vacancies, CDER adjusted the 175 FTE delta to 78 FTEs. The FY 2022 
PDUFA CPA for CDER is therefore $24,350,430, as summarized in table 6.
    FDA recognizes that this adjustment for CDER is significantly 
larger than in the previous year's capacity planning adjustment. A 
relatively small adjustment of 13 FTEs was made for CDER in the 
capacity planning adjustment in FY 2021 fee-setting. FDA took a 
conservative approach to the capacity planning adjustment for CDER in 
FY 2021 until the pace of net gains increased and was sustained. CDER 
is now experiencing a sustained increase in its ability to increase its 
staffing. In addition, the capacity planning adjustment has now 
demonstrated a sustained gap in the number of CDER staff needed to 
deliver on the expected forecasted workload. CDER has been performing 
its mission with a staffing level less than that required of its 
increasing submission workload. The FTEs enabled through this 
adjustment should significantly reduce this gap, once fully onboarded.

[[Page 45735]]



                                         Table 6--CDER FY 2022 PDUFA CPA
----------------------------------------------------------------------------------------------------------------
                                                               Additional FTEs   Cost for each   CDER FY22 PDUFA
                            Center                               for FY 2022     additional FTE        CPA
----------------------------------------------------------------------------------------------------------------
CDER.........................................................              78         $312,185      $24,350,430
----------------------------------------------------------------------------------------------------------------

    To calculate the FY 2022 PDUFA CPA for CBER, FDA followed the same 
approach outlined above. Table 7 summarizes the forecasted workload 
volumes for CBER in FY 2022 as well as the corresponding historical 
actuals from FY 2020 for comparison.

   Table 7--CBER Actual FY 2020 Workload Volumes and Predicted FY 2022
                            Workload Volumes
------------------------------------------------------------------------
                                              FY 2020         FY 2022
            Workload category                 actuals       predictions
------------------------------------------------------------------------
Efficacy Supplements....................              29              16
Labeling Supplements....................              57              63
Manufacturing Supplements...............             677             647
NDA/BLA Original........................               8               9
PDUFA Industry Meetings (including WROs)             701             657
Active Commercial INDs \1\..............           1,436           1,770
------------------------------------------------------------------------
\1\ For purpose of the capacity planning adjustment, this is defined as
  an active commercial IND for which a document has been received in the
  past 18 months.

    The forecasted CBER PDUFA workload for FY 2022 was then converted 
into expected FTE resources and compared to current onboard capacity 
for PDUFA direct review work, as summarized in table 8.

                                   Table 8--CBER FY 2022 PDUFA Resource Delta
----------------------------------------------------------------------------------------------------------------
                                                                   Current          FY 2022
                            Center                                 resource         resource       Predicted FY
                                                                   capacity         forecast      2022 FTE delta
----------------------------------------------------------------------------------------------------------------
CBER.........................................................             334              394               60
----------------------------------------------------------------------------------------------------------------

    The projected 60 FTE delta for CBER was also assessed in the 
context of other operational and financial factors that may impact the 
need and/or feasibility of obtaining the additional resources. After 
accounting for historical net FTE gains within CBER and subtracting 
previously funded PDUFA vacancies, an adjustment of 7 additional FTEs 
within CBER for FY 2022 was determined to be needed. The FY 2022 PDUFA 
CPA for CBER is therefore $2,152,969, as summarized in table 9.

                                         Table 9--CBER FY 2022 PDUFA CPA
----------------------------------------------------------------------------------------------------------------
                                                               Additional FTEs   Cost for each     CBER FY 2022
                            Center                               for FY 2022     additional FTE     PDUFA CPA
----------------------------------------------------------------------------------------------------------------
CBER.........................................................               7         $307,567       $2,152,969
----------------------------------------------------------------------------------------------------------------

    The CDER and CBER CPA amounts were then added together to determine 
the PDUFA CPA for FY 2022 of $26,503,399, as outlined in table 10. FDA 
will track the utilization of the CPA funds to ensure they are 
supporting the organizational review components engaged in PDUFA direct 
review work to enhance resources and expand staff capacity and 
capability. Should FDA be unable to utilize any amounts of the CPA 
funds during the fiscal year, it will not spend those funds and the 
unspent funds will be transferred to the carryover balance at the end 
of the fiscal year.

                       Table 10--FY 2022 PDUFA CPA
------------------------------------------------------------------------
                                                           FY 2022 PDUFA
                         Center                                 CPA
------------------------------------------------------------------------
CDER....................................................     $24,350,430
CBER....................................................      $2,152,969
                                                         ---------------
    Total...............................................     $26,503,399
------------------------------------------------------------------------

    Table 11 shows the calculation of the inflation and capacity 
planning adjusted amount for FY 2022. The FY 2022 base revenue amount, 
$1,098,077,960, shown on line 1 is multiplied by the inflation 
adjustment factor of 1.022013, resulting in the inflation-adjusted 
amount of $1,122,249,950 shown on line 3. The FY 2022 CPA of 
$26,503,399 is then added on line 4, resulting in the inflation and 
capacity planning adjusted amount of $1,148,753,349 shown on line 5.

[[Page 45736]]



 Table 11--PDUFA Inflation and Capacity Planning Adjusted Amount for FY
                        2022, Summary Calculation
------------------------------------------------------------------------
 
------------------------------------------------------------------------
FY 2021 Revenue Amount.............    $1,098,077,960  Line 1.
Inflation Adjustment Factor for FY           1.022013  Line 2.
 2022 (1 plus 1.022013 percent).
Inflation-Adjusted Amount..........    $1,122,249,950  Line 3.
Capacity Planning Adjustment for FY       $26,503,399  Line 4.
 2022.
Inflation and Capacity Planning        $1,148,753,349  Line 5.
 Adjusted Amount.
------------------------------------------------------------------------

    Per the commitments made in PDUFA VI, this increase in the revenue 
amount will be allocated to and used by organizational review 
components engaged in direct review work to enhance resources and 
expand staff capacity and capability (see II.A.4 on p. 37 of the PDUFA 
VI commitment letter \3\).
---------------------------------------------------------------------------

    \3\ The PDUFA VI commitment letter can be viewed at https://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm511438.pdf.
---------------------------------------------------------------------------

C. FY 2022 Statutory Fee Revenue Adjustments for Additional Dollar 
Amounts

    PDUFA VI provides an additional dollar amount for each of the 5 
fiscal years covered by PDUFA VI for additional FTE to support 
enhancements outlined in the PDUFA VI commitment letter. The amount for 
FY 2022 is $2,769,609 (see section 736(b)(1)(F) of the FD&C Act). 
Adding this amount to the inflation and capacity planning adjusted 
revenue amount, $1,148,753,349, equals $1,151,522,958.

D. FY 2022 Statutory Fee Revenue Adjustments for Operating Reserve

    PDUFA VI provides for an operating reserve adjustment to allow FDA 
to increase the fee revenue and fees for any given fiscal year during 
PDUFA VI to maintain up to 14 weeks of operating reserve of carryover 
user fees. If the carryover balance exceeds 14 weeks of operating 
reserves, FDA is required to decrease fees to provide for not more than 
14 weeks of operating reserves of carryover user fees.
    To determine the 14-week operating reserve amount, the FY 2022 
annual base revenue adjusted for inflation, capacity planning, and 
additional dollar amounts, $1,151,522,958 is divided by 52, and then 
multiplied by 14. The 14-week operating reserve amount for FY 2022 is 
$310,025,412.
    To determine the end of year operating reserve amount, the Agency 
must assess the operating reserve at the end of the third quarter of FY 
2021 and forecast collections and obligations in the fourth quarter of 
FY 2021. The estimated end of year FY 2021 operating reserve of 
carryover user fees is $225,724,631. Note that under PDUFA VI, this 
amount includes both user fee funds available for obligation 
$126,873,636 and funds that are considered unavailable due to a lack of 
appropriations $98,850,995.\4\
---------------------------------------------------------------------------

    \4\ Please refer to the PDUFA Financial Reports for details on 
unavailable carryover amounts at https://www.fda.gov/about-fda/user-fee-financial-reports/pdufa-financial-reports.
---------------------------------------------------------------------------

    Because the estimated end of year FY 2021 PDUFA operating reserve 
does not exceed the 14-week operating reserve for FY 2022, FDA will not 
reduce the FY 2022 PDUFA fee revenue in FY 2022. However, FDA will 
apply an operating reserve adjustment to increase the fee revenue and 
fees for FY 2022. The statute authorizes FDA to raise the fee revenue 
by up to $84,300,781 ($310,025,412 minus $225,724,631) for the 
operating reserve adjustment. FDA has decided to exercise its 
discretion to make a smaller operating reserve adjustment, of 
$39,402,923.
    In making this decision, FDA focused on the amount of available 
operating reserves. Maintaining an appropriate level of available 
operating reserves enables FDA to mitigate financial risks to the 
program, including for example, the risk of under collecting fees and 
the risk of a lapse in appropriations. FDA considers maintaining an 
operating reserve balance of between 8-10 weeks of available funds as a 
reasonable range to mitigate these risks. FDA has decided to make an 
available operating reserve adjustment that is intended to increase the 
amount of available funds to approximately 7 weeks by the end of FY 
2022 as an incremental step toward the 8-10 week range while mitigating 
the impact on fee amounts. FDA estimates the cost of operations per 
week is $22,144,672. Before the operating adjustment, the estimated end 
of year FY 2022 available operating reserve is $125,677,240, which 
equates to just over 5 weeks of available operating reserves. Adding 
the FY 2022 operating reserve adjustment of $39,402,923 to this amount 
is expected to provide approximately 7 weeks of available operating 
reserve, or $165,080,162, and an operating reserve (including 
unavailable funds) of $263,931,157.
    With respect to target revenue for FY 2022, adding the operating 
reserve adjustment amount of $39,402,923 to the inflation, capacity 
planning adjustment and additional dollar amount, $1,151,522,958 equals 
$1,190,925,881.

E. FY 2022 Statutory Fee Revenue Adjustments for Additional Direct Cost

    PDUFA VI specifies that $8,730,000, adjusted for inflation, be 
added after the operating reserve adjustment to account for additional 
direct costs in FY 2022. This additional direct cost adjustment is 
adjusted for inflation by multiplying $8,730,000 by the CPI for urban 
consumers (Washington-Baltimore, DC-MD-VA-WV; Not Seasonally Adjusted; 
All Items; Annual Index) for the most recent year of available data, 
divided by such index for 2016 (see section 736(c)(4)(B) of the FD&C 
Act). Because of the geographical revision made by the Bureau of Labor 
and Statistics, the Washington-Arlington-Alexandria index will be used 
in calculating the direct cost adjustment inflation factor for FY 2021 
and subsequent years. The annual index for 2020, 267.157, divided by 
such index for 2016, 253.422, results in an adjustment factor of 
1.054198, making the additional direct cost adjustment equal to 
$9,203,149.
    The final FY 2022 PDUFA target revenue is $1,200,129,000 (rounded 
to the nearest thousand dollars).

III. Application Fee Calculations

A. Application Fee Revenues and Application Fees

    Application fees will be set to generate 20 percent of the total 
target revenue amount, or $240,025,800 in FY 2022.

B. Estimate of the Number of Fee-Paying Applications and Setting the 
Application Fees

    Historically, FDA has estimated the total number of fee-paying full 
application equivalents (FAEs) it expects to receive during the next 
fiscal year by averaging the number of fee-paying FAEs received in the 
3 most recently completed fiscal years. For estimating the FY 2022 
FAEs, FDA decided to average the number of FAEs from FY 2017 through FY 
2019 instead of FY 2018 through FY 2020. FDA made this adjustment 
because the FY 2020 FAE count (62.77) is abnormally low,

[[Page 45737]]

potentially due to the impact of the COVID-19 pandemic on sponsor 
submissions. Thus, FDA changed the estimate for FY 2022 to remove this 
potential outlier from the 3-year moving average forecast method. FDA 
believes that this change will result in a more realistic FAE estimate 
for FY 2022. Prior year FAE totals are updated annually to reflect 
refunds and waivers processed after the close of the fiscal year.
    In estimating the number of fee-paying FAEs, a full application 
requiring clinical data counts as one FAE. An application not requiring 
clinical data counts as one-half of an FAE. An application that is 
withdrawn before filing, or refused for filing, counts as one-fourth of 
an FAE if the applicant initially paid a full application fee, or one-
eighth of an FAE if the applicant initially paid one-half of the full 
application fee amount. Prior to PDUFA VI, the FAE amount also included 
supplements; supplements have been removed from the FAE calculation as 
the supplement fee has been discontinued in PDUFA VI.
    As table 12 shows, the average number of fee-paying FAEs received 
annually in FY 2017 through FY 2019 is 77.00. FDA will set fees for FY 
2022 based on this estimate as the number of full application 
equivalents that will be subject to fees.

                                            Table 12--Fee-Paying FAEs
----------------------------------------------------------------------------------------------------------------
                     FY                             2017             2018             2019        3-Year average
----------------------------------------------------------------------------------------------------------------
Fee-Paying FAEs.............................           79.75            68.87            82.38            77.00
----------------------------------------------------------------------------------------------------------------
Note: Prior year FAE totals are updated annually to reflect refunds and waivers processed after the close of the
  fiscal year.

    The FY 2022 application fee is estimated by dividing the average 
number of full applications that paid fees from FY 2017 through FY 
2019, 77.00, into the fee revenue amount to be derived from application 
fees in FY 2022, $240,025,800. The result is a fee of $3,117,218 per 
full application requiring clinical data, and $1,558,609 per 
application not requiring clinical data.

IV. Fee Calculations for Prescription Drug Program Fees

    PDUFA VI assesses prescription drug program fees for certain 
prescription drug products. An applicant will not be assessed more than 
five program fees for a fiscal year for prescription drug products 
identified in a single approved NDA or BLA (see section 736(a)(2)(C) of 
the FD&C Act). Applicants are assessed a program fee for a fiscal year 
only for user fee eligible prescription drug products identified in a 
human drug application approved as of October 1 of such fiscal year.
    FDA estimates 2,806 program fees will be invoiced in FY 2022 before 
factoring in waivers, refunds, and exemptions. FDA approximates that 
there will be 161 waivers and refunds granted. In addition, FDA 
approximates that another 46 program fees will be exempted in FY 2022 
based on the orphan drug exemption in section 736(k) of the FD&C Act. 
FDA estimates 2,599 program fees in FY 2022, after allowing for an 
estimated 207 waivers and reductions, including the orphan drug 
exemptions. The FY 2022 prescription drug program fee rate is 
calculated by dividing the adjusted total revenue from program fees 
($960,103,200) by the estimated 2,599 program fees, for a FY 2022 
program fee of $369,413 (rounded to the nearest dollar).

V. Fee Schedule for FY 2022

    The fee rates for FY 2022 are displayed in table 13.

                   Table 13--Fee Schedule for FY 2022
------------------------------------------------------------------------
                                                           Fee rates for
                      Fee category                            FY 2022
------------------------------------------------------------------------
Application:
  Requiring clinical data...............................      $3,117,218
  Not requiring clinical data...........................       1,558,609
Program.................................................         369,413
------------------------------------------------------------------------

VI. Fee Payment Options and Procedures

A. Application Fees

    The appropriate application fee established in the new fee schedule 
must be paid for any application subject to fees under PDUFA that is 
submitted on or after October 1, 2021. Payment must be made in U.S. 
currency by electronic check, check, bank draft, wire transfer, or U.S. 
postal money order payable to the order of the Food and Drug 
Administration. 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 
completing the Prescription Drug User Fee Cover Sheet and generating 
the user fee ID number. 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 an invoice is located, ``Pay Now'' should be selected 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 979107, 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 979107, 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 the 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 979107) 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, 
which could result in FDA not filing an application and other 
penalties. Note: The originating financial institution may charge a 
wire

[[Page 45738]]

transfer fee, especially for international wire transfers. Applicable 
wire transfer fees must be included with payment to ensure fees are 
paid in full. Questions about wire transfer fees should be addressed to 
the financial institution. The account information for wire transfers 
is as follows: U.S. Department of the Treasury, TREAS NYC, 33 Liberty 
St., New York, NY 10045, Acct. No.: 75060099, Routing No.: 021030004, 
SWIFT: FRNYUS33. If needed, FDA's tax identification number is 53-
0196965.

B. Prescription Drug Program Fees

    FDA will issue invoices and payment instructions for FY 2022 
program fees under the new fee schedule in August 2021. Payment will be 
due on October 1, 2021. FDA will issue invoices in December 2021 for 
products that qualify for FY 2022 program fee assessments after the 
August 2021 billing.

    Dated: August 11, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-17505 Filed 8-13-21; 8:45 am]
BILLING CODE 4164-01-P


