Document ID: FDA-2020-N-1700-0001
Agency: fda
Document Type: Notice
Title: Prescription Drug User Fee Rates for Fiscal Year 2021
Posted Date: 2020-08-03T04:00Z

[Federal Register Volume 85, Number 149 (Monday, August 3, 2020)]
[Notices]
[Pages 46651-46657]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16833]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1700]

Prescription Drug User Fee Rates for Fiscal Year 2021

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the rates 
for prescription drug user fees for fiscal year (FY) 2021. 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 2021.

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.

[[Page 46652]]

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 2021 is $1,065,707,676. The FY 2021 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 or 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 2021 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 2021 for an application 
requiring clinical data ($2,875,842), for an application not requiring 
clinical data ($1,437,921), and for the prescription drug program fee 
($336,432). 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 $1,065,707,676 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 2021 Statutory Fee Revenue Adjustments for Inflation

    PDUFA VI specifies that the $1,065,707,676 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 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 preceding 4 FYs, 
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 FYs (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 
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 Personnel Compensation and Benefits (PC&B) Each Year and Percent Changes
----------------------------------------------------------------------------------------------------------------
              Fiscal year                       2017               2018               2019        3-Year average
----------------------------------------------------------------------------------------------------------------
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%
----------------------------------------------------------------------------------------------------------------

    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 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 FYs.

        Table 2--PC&B as a Percent of Total Cost of the Process for the Review of Human Drug Applications
----------------------------------------------------------------------------------------------------------------
              Fiscal year                       2017               2018               2019        3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B.............................       $711,016,627       $792,900,647       $872,087,636
Total Costs............................     $1,206,657,269     $1,374,508,527     $1,430,338,888
PC&B Percent...........................           58.9245%           57.6861%           60.9707%        59.1938%
----------------------------------------------------------------------------------------------------------------

    The payroll adjustment is 1.2644 percent from table 1 multiplied by 
59.1938 percent (or 0.7484 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 FYs (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-

[[Page 46653]]

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\ 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.

        Table 3--Annual and 3-Year Average Percent Change in CPI for Washington-Arlington-Alexandria Area
----------------------------------------------------------------------------------------------------------------
                  Year                          2017               2018               2019        3-year average
----------------------------------------------------------------------------------------------------------------
Annual CPI.............................            256.221            261.445            264.777
Annual Percent Change..................            1.1045%            2.0389%            1.2745%         1.4726%
----------------------------------------------------------------------------------------------------------------

    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 human drug applications obligated. Because 59.1938 
percent was obligated for PC&B (as shown in table 2), 40.8062 percent 
is the portion of costs other than PC&B (100 percent minus 59.1938 
percent equals 40.8062 percent). The non-payroll adjustment is 1.4726 
percent times 40.8062 percent, or 0.6009 percent.
    Next, we add the payroll adjustment (0.7484 percent) to the non-
payroll adjustment (0.6009 percent), for a total inflation adjustment 
of 1.3493 percent (rounded) for FY 2021.
    We then multiply the base revenue amount for FY 2021 
($1,065,707,676) by 1.013493, yielding an inflation-adjusted amount of 
$1,080,087,270.

B. FY 2021 Statutory Fee Revenue Adjustments for Capacity Planning

    The statute specifies that after $1,065,707,676 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). 
The statute directed FDA to utilize an interim capacity planning 
adjustment until a new methodology could be developed and made 
effective.
    As a first step toward the new methodology, FDA committed to 
establish modernized time reporting and a resource capacity planning 
capability. Modernized time reporting was implemented in the Center for 
Biologics Evaluation and Research (CBER) in 2018 and in the Center for 
Drug Evaluation and Research (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 new methodology to 
accurately assess changes in the resource and capacity needs of the 
process for the review of human drug 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 new CPA methodology for the setting of FY 2021 fee amounts.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    The new CPA methodology is intended to resolve issues with the 
previous interim methodology.\4\ First, the interim methodology was a 
lagging indicator as it utilized changes in average workload volumes 
during prior years--specifically, the adjustment was based on the 
change in the 3-year average ending in the most recent year for which 
data is available over the 3-year average for the previous year. The 
new methodology replaces the comparison of prior 3-year averages with 
predictive models to forecast future workload volumes, where feasible. 
Second, the interim CPA methodology did not convert the volume of 
workload into resource demands; its adjustments simply reflected 
changes in average number of workload units. The new methodology 
translates the expected workload volumes into forecasted staffing needs 
in terms of FTEs, facilitating a more straightforward calculation of 
both future resource and funding needs.
---------------------------------------------------------------------------

    \4\ Under the interim methodology, the capacity planning 
adjustment for a fiscal year was based on the product of the annual 
base revenue for the year, as adjusted for inflation, and an 
adjustment percentage. The adjustment percentage was a weighted 
change in the 3-year average ending in the most recent year for 
which data are available, over the 3-year average in the previous 
year, for: (1) The total number of human drug applications, efficacy 
supplements, and manufacturing supplements submitted to FDA; (2) the 
total number of active commercial investigational new drug 
applications; and (3) the total number of formal meetings scheduled 
by FDA and written responses issued by the Agency in lieu of such 
formal meetings, as set forth in section 1.H. of the PDUFA 
commitment letter.
---------------------------------------------------------------------------

    The new CPA methodology includes four steps:
    (1) Forecast workload volumes: Predictive models estimate the 
volume of workload for the upcoming fiscal year. Workload categories in 
the CPA for PDUFA include original new drug applications (NDAs)/
biologics license applications (BLAs), commercial investigational new 
drug applications (INDs) with activity, supplements (efficacy, labeling 
and manufacturing), and formal industry meetings scheduled (Type A-C 
meetings ,\5\ including written-response only (WRO) meetings)
---------------------------------------------------------------------------

    \5\ The PDUFA VI commitment letter defines these meeting types 
in section 1.H.: https://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm511438.pdf.
---------------------------------------------------------------------------

    (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 effort. 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 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.
    Further, FDA is adopting an iterative, continuous improvement 
approach as part of its new CPA methodology. For FY 2021, FDA is 
applying the new methodology to core review activities, for which 
significant data collection and analysis has been completed. Going 
forward, the Agency intends to refine its

[[Page 46654]]

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 human drug applications under PDUFA, potentially including, 
for example, postmarket 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 PDUFA program resource needs, 
and that this new methodology represents a significant improvement over 
the previous CPA methodology.
    To determine the FY 2021 capacity planning adjustment, FDA 
calculated a PDUFA CPA for CDER and CBER individually. The final 
Center-level results were then combined to determine the total FY 2021 
PDUFA CPA. The following section outlines the major components of each 
Center's FY 2021 PDUFA CPA.
    Table 4 summarizes the forecasted workload volumes for CDER in FY 
2021 based on predictive models, as well as historical actuals from FY 
2019 for comparison.

   Table 4--CDER Actual FY 2019 Workload Volumes and Predicted FY 2021
                            Workload Volumes
------------------------------------------------------------------------
                                              FY 2019         FY 2021
            Workload category                 actuals       predictions
------------------------------------------------------------------------
Efficacy Supplements....................             287             322
Labeling Supplements....................           1,320           1,584
Manufacturing Supplements...............           2,024           2,187
NDA/BLA Original........................             156             171
PDUFA Industry Meetings Scheduled and              3,186           3,249
 WROs...................................
Active Commercial INDs \1\..............           8,233           8,565
------------------------------------------------------------------------
\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.

    \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.
    Utilizing the resource forecast algorithms, the forecasted workload 
volumes for FY 2021 were then converted into estimated FTE needs for 
CDER's PDUFA direct review-related work. The resulting expected FY 2021 
FTE need for CDER was compared to current onboard capacity for direct 
review related work to determine the FY 2021 resource delta, as 
summarized in table 5.

                                     Table 5--CDER FY21 PDUFA Resource Delta
----------------------------------------------------------------------------------------------------------------
                                                                   Current          FY 2021
                            Center                                 resource         resource       Predicted FY
                                                                   capacity         forecast      2021 FTE delta
----------------------------------------------------------------------------------------------------------------
CDER.........................................................         1,594.1          1,859.7            265.6
----------------------------------------------------------------------------------------------------------------

    The projected 265.6 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. After accounting for the range of recent years 
historical net FTE gains within CDER and subtracting previously funded 
PDUFA vacancies, a range of 6 to 59 FTEs was established as a realistic 
adjustment for FY 2021. CDER adjusted to the lower portion of this 
range until the pace of net gains increases and is sustained. CDER also 
recognized that some resources may be required to sustain increases in 
PDUFA workload resulting from the impacts of the COVID-19 pandemic. In 
summary, after accounting for these internal factors, FDA determined 
that an adjustment for $3,922,113 to fund an equivalent of 13 FTEs in 
FY 2021 was needed and realistic.

                                         Table 6--CDER FY 2021 PDUFA CPA
----------------------------------------------------------------------------------------------------------------
                                                               Additional FTEs   Cost for each   CDER FY21 PDUFA
                            Center                               for FY 2021     additional FTE        CPA
----------------------------------------------------------------------------------------------------------------
CDER.........................................................              13         $301,701       $3,922,113
----------------------------------------------------------------------------------------------------------------

    To calculate the FY 2021 PDUFA CPA for CBER, FDA followed the same 
approach outlined above. Table 7 summarizes the forecasted workload 
volumes for CBER in FY 2021 as well as the corresponding historical 
actuals from FY 2019 for comparison.

[[Page 46655]]

   Table 7--CBER Actual FY 2019 Workload Volumes and Predicted FY 2021
                            Workload Volumes
------------------------------------------------------------------------
                                              FY 2019         FY 2021
            Workload category                 Actuals       predictions
------------------------------------------------------------------------
Efficacy Supplements....................              12              15
Labeling Supplements....................              66              64
Manufacturing Supplements...............             541             576
NDA/BLA Original........................               7               7
PDUFA Industry Meetings Scheduled and                541             738
 WROs...................................
Active Commercial INDs\1\...............           1,361           1,571
------------------------------------------------------------------------

    The forecasted CBER PDUFA workload for FY 2021 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 2021 PDUFA Resource Delta
----------------------------------------------------------------------------------------------------------------
                                                                   Current          FY 2021
                            Center                                 resource         resource       Predicted FY
                                                                   capacity         forecast      2021 FTE delta
----------------------------------------------------------------------------------------------------------------
CBER.........................................................           322.7            385.1             62.4
----------------------------------------------------------------------------------------------------------------

    The projected 62.4 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 29 additional FTEs 
within CBER for FY 2021 was determined to be both needed and realistic 
to support significant growth in some PDUFA products and PDUFA workload 
stemming from the COVID-19 pandemic. The FY 2021 PDUFA CPA for CBER is 
therefore $8,641,681, as summarized in table 9.

                                         Table 9--CBER FY 2021 PDUFA CPA
----------------------------------------------------------------------------------------------------------------
                                                               Additional FTEs   Cost for each     CBER FY 2021
                            Center                               for FY 2021     additional FTE     PDUFA CPA
----------------------------------------------------------------------------------------------------------------
CBER.........................................................              29         $297,989       $8,641,681
----------------------------------------------------------------------------------------------------------------

    The CDER and CBER CPA amounts were then added together to determine 
the PDUFA CPA for FY 2021 of $12,563,794, as outlined in table 10.

                       Table 10--FY 2021 PDUFA CPA
------------------------------------------------------------------------
                                                           FY 2021 PDUFA
                         Center                                 CPA
------------------------------------------------------------------------
CDER....................................................      $3,922,113
CBER....................................................      $8,641,681
Total...................................................     $12,563,794
------------------------------------------------------------------------

    Table 11 shows the calculation of the inflation and capacity 
planning adjusted amount for FY 2021. The FY 2021 base revenue amount, 
$1,065,707,676, shown on line 1 is multiplied by the inflation 
adjustment factor of 1.013493, resulting in the inflation-adjusted 
amount of $1,080,087,270 shown on line 3. The FY 2021 CPA of 
$12,563,794 is then added on line 4, resulting in the inflation and 
capacity planning adjusted amount of $1,092,651,064 shown on line 5.

 Table 11.--PDUFA Inflation and Capacity Planning Adjusted Amount for FY
                        2021, Summary Calculation
------------------------------------------------------------------------
 
------------------------------------------------------------------------
FY 2021 Revenue Amount..........     $1,065,707,676  Line 1
Inflation Adjustment Factor for            1.013493  Line 2
 FY 2021 (1 plus 1.3493 percent).
Inflation-Adjusted Amount.......     $1,080,087,270  Line 3
Capacity Planning Adjustment for        $12,563,794  Line 4
 FY 2021.
Inflation and Capacity Planning      $1,092,651,064  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 \6\).
---------------------------------------------------------------------------

    \6\ The PDUFA VI commitment letter can be viewed at https://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm511438.pdf.
---------------------------------------------------------------------------

C. FY 2021 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 PDUFA VI

[[Page 46656]]

enhancements outlined in the PDUFA VI commitment letter. The amount for 
FY 2021 is $5,426,896 (see section 736(b)(1)(F) of the FD&C Act). 
Adding this amount to the inflation and capacity planning adjusted 
revenue amount, $1,092,651,064, equals $1,098,077,960.

D. FY 2021 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 2021 
annual base revenue adjusted for inflation, capacity planning, and 
additional dollar amounts, $1,098,077,960 is divided by 52, and then 
multiplied by 14. The 14-week operating reserve amount for FY 2021 is 
$295,636,374.
    To determine the end of year operating reserve amount, the Agency 
must assess actual operating reserve at the end of the third quarter of 
FY 2020 and forecast collections and obligations in the fourth quarter 
of FY 2020. The estimated end of year FY 2020 operating reserve is 
$217,070,092.
    Because the estimated end of year FY 2021 PDUFA operating reserve 
does not exceed the 14-week operating reserve for FY 2021, FDA will not 
reduce the FY 2021 PDUFA fee revenue in FY 2021.

E. FY 2021 Statutory Fee Revenue Adjustments for Additional Direct Cost

    PDUFA VI specifies that $8,730,000, adjusted for inflation, be 
added in addition to the operating reserve adjustment to account for 
additional direct costs in FY 2021. This additional direct cost 
adjustment is adjusted for inflation by multiplying $8,730,000 by the 
Consumer Price Index 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 2020 and subsequent years. The 
annual index for 2019, 264.777, divided by such index for 2016, 
253.422, results in an adjustment factor of 1.044807, making the 
additional direct cost adjustment equal to $9,121,165.
    The final FY 2021 PDUFA target revenue is $1,107,199,000 (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 $221,439,800 in FY 2021.

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

    FDA will estimate the total number of fee-paying full application 
equivalents (FAEs) it expects to receive during the next FY by 
averaging the number of fee-paying FAEs received in the 3 most recently 
completed FYs. Prior year FAE totals are updated annually to reflect 
refunds and waivers processed after the close of the FY.
    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 the most recent 3-year period is 77 FAEs. FDA will set fees 
for FY 2021 based on this estimate as the number of full application 
equivalents that will pay 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
  FY.

    The FY 2021 application fee is estimated by dividing the average 
number of full applications that paid fees over the latest 3 years, 77, 
into the fee revenue amount to be derived from application fees in FY 
2021, $221,439,800. The result is a fee of $2,875,842 per full 
application requiring clinical data, and $1,437,921 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; in addition, 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 2,793 program fees will be invoiced in FY 2021 before 
factoring in waivers, refunds, and exemptions. FDA approximates that 
there will be 124 waivers and refunds granted. In addition, FDA 
approximates that another 36.2 program fees will be exempted in FY 2021 
based on the orphan drug exemption in section 736(k) of the FD&C Act. 
FDA estimates 2,632.8 program fees in FY 2021, after allowing for an 
estimated 160.2 waivers and reductions, including the orphan drug 
exemptions. The FY 2021 prescription drug program fee rate is 
calculated by dividing the adjusted total revenue from program fees 
($885,759,200) by the estimated 2,632.8 program fees, for a FY 2021 
program fee of $336,432 (rounded to the nearest dollar).

V. Fee Schedule for FY 2021

    The fee rates for FY 2021 are displayed in table 13.

[[Page 46657]]

                   Table 13--Fee Schedule for FY 2021
------------------------------------------------------------------------
                                                           Fee rates for
                      Fee Category                            FY 2021
------------------------------------------------------------------------
Application:
Requiring clinical data.................................      $2,875,842
Not requiring clinical data.............................      $1,437,921
Program.................................................        $336,432
------------------------------------------------------------------------

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, 2020. 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. The originating financial institution may charge a wire 
transfer fee. Applicable wire transfer fees must be included with 
payment to ensure fees are fully paid. 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 2021 
program fees under the new fee schedule in August 2020. Payment will be 
due on October 1, 2020. FDA will issue invoices in December 2020 for FY 
2021 program fees that qualify for fee assessments after the August 
2020 billing.

    Dated: July 29, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.

[FR Doc. 2020-16833 Filed 7-29-20; 4:15 pm]
BILLING CODE 4164-01-P