Prescription Drug User Fee Rates for Fiscal Year 2022, 45732-45738 [2021-17505]
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SUPPLEMENTARY INFORMATION: NIOSH
published a notice and request for
information in the Federal Register on
June 24, 2021 (86 FR 33296) regarding
the Needs and Challenges in Personal
Protective Equipment (PPE) Use for
Underserved User Populations. This
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Food and Drug Administration
[Docket No. FDA–2021–N–0709]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Prescription Drug User Fee Rates for
Fiscal Year 2022
Centers for Disease Control and
Prevention
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
Needs and Challenges in Personal
Protective Equipment (PPE) Use for
Underserved User Populations;
Extension of Comment Period
National Institute for
Occupational Safety and Health
(NIOSH) of the Centers for Disease
Control and Prevention (CDC),
Department of Health and Human
Services (HHS).
ACTION: Extension of comment period.
AGENCY:
On June 24, 2021, NIOSH
opened a notice to request information
on the Needs and Challenges in
Personal Protective Equipment (PPE)
Use for Underserved User Populations.
Written comments were to be received
by August 23, 2021. NIOSH is extending
the public comment period to October
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SUMMARY:
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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:
SUMMARY:
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
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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
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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
Total PC&B ..........................................................................................
Total FTE .............................................................................................
PC&B per FTE .....................................................................................
Percent Change From Previous Year .................................................
The statute specifies that this 2.7383
percent be multiplied by the proportion
of PC&B costs to the total FDA costs of
2019
$2,690,678,000
17,023
$158,061
4.2206
2020
$2,620,052,000
17,144
$152,826
¥3.3120
the process for the review of human
drug applications. Table 2 shows the
PC&B and the total obligations for the
$2,875,592,000
17,535
$163,992
7.3063
3-Year
average
........................
........................
........................
2.7383
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
Total PC&B ..........................................................................................
Total Costs ...........................................................................................
PC&B Percent ......................................................................................
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 nonpayroll costs is the average annual
percent change that occurred in the
Consumer Price Index (CPI) for urban
consumers (Washington-Baltimore, DCMD-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
2019
$792,900,647
$1,374,508,527
57.6861
2020
$872,087,636
$1,430,338,888
60.9707
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, DCVA-MD-WV and Baltimore-ColumbiaTowson, MD). In order to continue
applying a CPI that best reflects the
geographic region in which FDA is
headquartered and that provides the
$891,395,106
$1,471,144,928
60.5919
3-Year
average
........................
........................
59.7496
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 WashingtonArlington-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.
TABLE 3—ANNUAL AND 3-YEAR AVERAGE PERCENT CHANGE IN CPI FOR WASHINGTON-ARLINGTON-ALEXANDRIA AREA
Year
2018
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Annual CPI .......................................................................................................
Annual Percent Change ..................................................................................
261.445
2.0389
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.
1 The Bureau of Labor Statistics’ announcement of
the geographical revision can be viewed at https://
www.bls.gov/cpi/additional-resources/geographicrevision-2018.htm.
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2019
2020
264.777
1.2745
267.157
0.8989
3-Year
average
........................
1.4041
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
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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.
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
actuals
Workload category
Efficacy Supplements ..............................................................................................................................................
Labeling Supplements .............................................................................................................................................
Manufacturing Supplements ....................................................................................................................................
NDA/BLA 1 Original ..................................................................................................................................................
PDUFA Industry Meetings (including WROs 2) .......................................................................................................
Active Commercial INDs 3 .......................................................................................................................................
FY 2022
predictions
293
1,122
2,350
150
3,950
8,243
316
1,043
2,388
161
4,534
9,549
1 New
drug applications (NDA)/biological license applications (BLA).
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.
2 Written
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.
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TABLE 5—CDER FY22 PDUFA RESOURCE DELTA
Center
Current
resource
capacity
FY 2022
resource
forecast
Predicted
FY 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.
2 Full-time equivalents refers to a paid staff year,
rather than a count of individual employees.
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TABLE 6—CDER FY 2022 PDUFA CPA
Center
Additional
FTEs for
FY 2022
Cost for each
additional FTE
CDER FY22
PDUFA 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
actuals
Workload category
Efficacy Supplements ..............................................................................................................................................
Labeling Supplements .............................................................................................................................................
Manufacturing Supplements ....................................................................................................................................
NDA/BLA Original ....................................................................................................................................................
PDUFA Industry Meetings (including WROs) .........................................................................................................
Active Commercial INDs 1 .......................................................................................................................................
FY 2022
predictions
29
57
677
8
701
1,436
16
63
647
9
657
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
Center
Current
resource
capacity
FY 2022
resource
forecast
Predicted
FY 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.
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TABLE 9—CBER FY 2022 PDUFA CPA
Center
Additional
FTEs for
FY 2022
Cost for each
additional FTE
CBER FY
2022 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
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funds will be transferred to the
carryover balance at the end of the fiscal
year.
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
TABLE 10—FY 2022 PDUFA CPA
on line 1 is multiplied by the inflation
adjustment factor of 1.022013, resulting
FY 2022
in the inflation-adjusted amount of
Center
PDUFA CPA
$1,122,249,950 shown on line 3. The FY
CDER ....................................
$24,350,430 2022 CPA of $26,503,399 is then added
CBER ....................................
$2,152,969 on line 4, resulting in the inflation and
capacity planning adjusted amount of
Total ...............................
$26,503,399 $1,148,753,349 shown on line 5.
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TABLE 11—PDUFA INFLATION AND CAPACITY PLANNING ADJUSTED AMOUNT FOR FY 2022, SUMMARY CALCULATION
FY 2021 Revenue Amount ............................................................................................................................................
Inflation Adjustment Factor for FY 2022 (1 plus 1.022013 percent) ............................................................................
Inflation-Adjusted Amount .............................................................................................................................................
Capacity Planning Adjustment for FY 2022 ..................................................................................................................
Inflation and Capacity Planning Adjusted Amount ........................................................................................................
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 14week 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
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
3 The PDUFA VI commitment letter can be
viewed at https://www.fda.gov/downloads/
forindustry/userfees/prescriptiondruguserfee/
ucm511438.pdf.
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.
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).
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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.
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$1,098,077,960
1.022013
$1,122,249,950
$26,503,399
$1,148,753,349
Line
Line
Line
Line
Line
1.
2.
3.
4.
5.
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, DCMD-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 feepaying 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,
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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 feepaying 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
45737
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.
lotter on DSK11XQN23PROD with NOTICES1
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
VerDate Sep<11>2014
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Jkt 253001
of $369,413 (rounded to the nearest
dollar).
userfees.fda.gov/pay (Note: Only full
payments are accepted. No partial
payments can be made online). Once an
V. Fee Schedule for FY 2022
invoice is located, ‘‘Pay Now’’ should be
The fee rates for FY 2022 are
selected to be redirected to Pay.gov.
displayed in table 13.
Electronic payment options are based on
the balance due. Payment by credit card
TABLE 13—FEE SCHEDULE FOR FY
is available for balances that are less
2022
than $25,000. If the balance exceeds this
amount, only the ACH option is
Fee rates for
available. Payments must be made using
Fee category
FY 2022
U.S. bank accounts as well as U.S. credit
cards.
Application:
If a check, bank draft, or postal money
Requiring clinical data .......
$3,117,218
Not requiring clinical data
1,558,609 order is submitted, make it payable to
Program ................................
369,413 the order of the Food and Drug
Administration and include the user fee
ID number to ensure that the payment
VI. Fee Payment Options and
is applied to the correct fee(s). Payments
Procedures
can be mailed to: Food and Drug
A. Application Fees
Administration, P.O. Box 979107, St.
The appropriate application fee
Louis, MO 63197–9000. If a check, bank
established in the new fee schedule
draft, or money order is to be sent by a
must be paid for any application subject courier that requests a street address,
to fees under PDUFA that is submitted
the courier should deliver your payment
on or after October 1, 2021. Payment
to: U.S. Bank, Attention: Government
must be made in U.S. currency by
Lockbox 979107, 1005 Convention
electronic check, check, bank draft, wire Plaza, St. Louis, MO 63101. (Note: This
transfer, or U.S. postal money order
U.S. Bank address is for courier delivery
payable to the order of the Food and
only. If you have any questions
Drug Administration. The preferred
concerning courier delivery, contact the
payment method is online using
U.S. Bank at 314–418–4013. This
electronic check (Automated Clearing
telephone number is only for questions
House (ACH) also known as eCheck) or
about courier delivery). Please make
credit card (Discover, VISA, MasterCard, sure that the FDA post office box
American Express).
number (P.O. Box 979107) is written on
FDA has partnered with the U.S.
the check, bank draft, or postal money
Department of the Treasury to use
order.
Pay.gov, a web-based payment
For payments made by wire transfer,
application, for online electronic
include the unique user fee ID number
payment. The Pay.gov feature is
to ensure that the payment is applied to
available on the FDA website after
the correct fee(s). Without the unique
completing the Prescription Drug User
user fee ID number, the payment may
Fee Cover Sheet and generating the user not be applied, which could result in
fee ID number. Secure electronic
FDA not filing an application and other
payments can be submitted using the
penalties. Note: The originating
User Fees Payment Portal at https://
financial institution may charge a wire
PO 00000
Frm 00036
Fmt 4703
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E:\FR\FM\16AUN1.SGM
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45738
Federal Register / Vol. 86, No. 155 / Monday, August 16, 2021 / Notices
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
action to allow interested persons
additional time to submit comments.
These comments will be considered in
preparing a response from the United
States to the World Health Organization
(WHO) regarding the abuse liability and
diversion of these drugs. WHO will use
this information to consider whether to
recommend that certain international
restrictions be placed on these drug
substances.
FDA is reopening the comment
period for the notice published July 23,
2021 (86 FR 39038). Submit either
electronic or written comments by
August 24, 2021.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before August 24,
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of August 24, 2021.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are received on or before that
date.
DATES:
Electronic Submissions
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0739]
International Drug Scheduling;
Convention on Psychotropic
Substances; Single Convention on
Narcotic Drugs; 4F–MDMB–BICA (4F–
MDMB–BUTICA); Brorphine;
Metonitazene; Eutylone (bk-EBDB);
BMDP (3,4-Methylenedioxy-Nbenzylcathinone); Kratom
(mitragynine, 7-hydroxymitragynine);
Phenibut; Reopening Comment Period
Food and Drug Administration,
Department of Health and Human
Services (HHS).
ACTION: Notice; reopening comment
period.
AGENCY:
The Food and Drug
Administration (FDA or Agency) is
reopening the comment period for the
notice entitled ‘‘International Drug
Scheduling; Convention on
Psychotropic Substances; Single
Convention on Narcotic Drugs; 4F–
MDMB–BICA (4F–MDMB–BUTICA);
Brorphine; Metonitazene; Eutylone (bkEBDB); BMDP (3,4-Methylenedioxy-Nbenzylcathinone); Kratom (mitragynine,
7-hydroxymitragynine); Phenibut’’ that
appeared in the Federal Register of July
23, 2021. The Agency is taking this
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:21 Aug 13, 2021
Jkt 253001
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2021–N–0739 for ‘‘International Drug
Scheduling; Convention on
Psychotropic Substances; Single
Convention on Narcotic Drugs; 4F–
MDMB–BICA (4F–MDMB–BUTICA);
Brorphine; Metonitazene; Eutylone (bkEBDB); BMDP (3,4-Methylenedioxy-Nbenzylcathinone); Kratom (mitragynine,
7-hydroxymitragynine); Phenibut;
Request for Comments.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
E:\FR\FM\16AUN1.SGM
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]]>Agencies
[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
