[Federal Register Volume 84, Number 149 (Friday, August 2, 2019)]
[Notices]
[Pages 37882-37886]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16435]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0007]


Prescription Drug User Fee Rates for Fiscal Year 2020

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the rates 
for prescription drug user fees for fiscal year (FY) 2020. 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 2020.

FOR FURTHER INFORMATION CONTACT: Melissa Hurley, Office of Financial 
Management, Food and Drug Administration, 4041 Powder Mill Rd., Rm. 
61075, Beltsville, MD 20705-4304, 240-402-4585.

SUPPLEMENTARY INFORMATION: 

I. Background

    Sections 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 fee (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 2020 is $1,001,479,592. The FY 2020 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). 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 2020 revenue amount may be adjusted 
further, if necessary, to provide for

[[Page 37883]]

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 2020 for an application 
requiring clinical data ($2,942,965), for an application not requiring 
clinical data ($1,471,483), and for the prescription drug program fee 
($325,424). These fees are effective on October 1, 2019, and will 
remain in effect through September 30, 2020. For applications that are 
submitted on or after October 1, 2019, the new fee schedule must be 
used.

II. Fee Revenue Amount for FY 2020

    The base revenue amount for FY 2020 is $1,001,479,592 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 2020 Statutory Fee Revenue Adjustments for Inflation

    PDUFA VI specifies that the $1,001,479,592 is to be adjusted for 
inflation increases for FY 2020 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 
2020. The 3-year average is 3.1175 percent.

              Table 1--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Changes
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             Fiscal year                     2016               2017               2018          3-Year Average
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Total PC&B..........................     $2,414,728,159     $2,581,551,000     $2,690,678,000  .................
Total FTE...........................             16,381             17,022             17,023  .................
PC&B per FTE........................           $147,408           $151,660           $158,061  .................
Percent Change From Previous Year...             2.2474             2.8845             4.2206             3.1175
----------------------------------------------------------------------------------------------------------------

    The statute specifies that this 3.1175 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
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             Fiscal year                     2016               2017               2018          3-Year average
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Total PC&B..........................       $652,508,273       $711,016,627       $792,900,647  .................
Total Costs.........................     $1,157,817,695     $1,206,657,269     $1,374,508,527  .................
PC&B Percent........................            56.3567            58.9245            57.6861            57.6558
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    The payroll adjustment is 3.1175 percent from table 1 multiplied by 
57.6558 percent (or 1.7974 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-Alexandria index will be used 
in calculating the relevant adjustment factors for FY 2020 and 
subsequent years. Table 3 provides the summary data for the percent 
changes in the specified CPI for the Washington-Arlington-Alexandria 
area. The data are published by the Bureau of Labor Statistics and can 
be found on its website at: https://data.bls.gov/pdq/SurveyOutputServlet?data_tool=dropmap&series_id=CUURS35ASA0,CUUSS35ASA0.

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    \1\ The Bureau of Labor Statistics' announcement of the 
geographical revision can be viewed at https://www.bls.gov/cpi/additional-resources/geographic-revision-2018.htm.

        Table 3--Annual and 3-Year Average Percent Change in CPI for Washington-Arlington-Alexandria Area
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                Year                         2016               2017               2018          3-Year average
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Annual CPI..........................            253.422            256.221            261.445  .................
Annual Percent Change...............             1.1003             1.1045             2.0389             1.4146
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[[Page 37884]]

    The statute specifies that this 1.4146 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 57.6558 
percent was obligated for PC&B (as shown in table 2), 42.3442 percent 
is the portion of costs other than PC&B (100 percent minus 57.6558 
percent equals 42.3442 percent). The non-payroll adjustment is 1.4146 
percent times 42.3442 percent, or 0.5990 percent.
    Next, we add the payroll adjustment (1.7974 percent) to the non-
payroll adjustment (0.5990 percent), for a total inflation adjustment 
of 2.3964 percent (rounded) for FY 2020.
    We then multiply the base revenue amount for FY 2020 
($1,001,479,592) by 1.023964, yielding an inflation-adjusted amount of 
$1,025,479,049.

B. FY 2020 Statutory Fee Revenue Adjustments for Capacity Planning

    The statute specifies that after $1,001,479,592 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 prescribes an interim capacity planning adjustment be 
utilized until a new methodology can be developed through a process 
involving an independent evaluation as well as obtaining public 
comment. The interim capacity planning adjustment is applied to FY 2020 
fee setting.
    To determine the FY 2020 capacity planning adjustment, FDA 
calculated the average number of each of the five elements specified in 
the capacity planning adjustment provision: (1) Human drug applications 
(new drug applications (NDAs)/biologics license applications (BLAs)); 
(2) active commercial investigational new drug applications (INDs) (IND 
applications that have at least one submission during the previous 12 
months); (3) efficacy supplements; (4) manufacturing supplements; and 
(5) formal meetings, type A, B, B(EoP), C, and written responses only 
(WRO) issued in lieu of such formal meetings, over the 3-year period 
that ended on June 30, 2018, and the average number of each of these 
elements over the most recent 3-year period that ended June 30, 2019.
    The calculations are summarized in table 4. The 3-year averages for 
each element are provided in column 1 (``3-Year Average Ending 2018'') 
and column 2 (``3-Year Average Ending 2019''). Column 3 reflects the 
percent change from column 1 to column 2. Column 4 shows the weighting 
factor for each element. The weighting factor methodology has been 
updated for PDUFA VI. The previous methodology relied on the relative 
value of the standard costs for the elements included in the adjuster, 
and summed to 100 percent. The weighting factor now is the time 
invested in activities related to the element expressed as a percentage 
of total time invested in PDUFA activities, and will adjust only the 
costs attributed to the elements included in the model (hence the 
weighting factor does not now sum to 100 percent). Column 5 is the 
weighted percent change in each element. This is calculated by 
multiplying the weighting factor in each line in column 4 by the 
percent change in column 3. The values in column 5 are summed, 
reflecting an adjustment of 2.2697 percent (rounded).

                Table 4--Capacity Planning Adjuster (Interim Methodology) Calculation for FY 2020
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                                                                     Column 3
                                    Column 1 3-     Column 2 3-       Percent        Column 4        Column 5
             Element               Year  average   Year  average      change         Weighting       Weighted
                                    ending 2018     ending 2019    (column 1 to       factor          percent
                                                                     column 2)       (percent)        Lchange
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NDAs/BLAs.......................          162.00          168.67          4.1152         16.5464          0.6809
Active Commercial INDs..........        8,057.00        8,335.67          3.4587         22.2644          0.7701
Efficacy Supplements............          234.33          262.33         11.9488          4.1340          0.4940
Manufacturing Supplements.......        2,561.67        2,578.67          0.6636          5.2980          0.0352
Meetings Scheduled and WROs.....        3,136.33        3,295.33          5.0696          5.7119          0.2896
FY 2020 Capacity Planning                 2.2697  ..............  ..............  ..............  ..............
 Adjuster.......................
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    Table 5 shows the calculation of the inflation and capacity 
planning adjusted amount for FY 2020. The FY 2020 base revenue amount, 
$1,001,479,592, shown on line 1 is multiplied by the inflation 
adjustment factor of 1.023964, resulting in the inflation-adjusted 
amount of $1,025,479,049 shown on line 3. That amount is then 
multiplied by one, plus the capacity planning adjustment of 2.2697 
percent, resulting in the inflation and capacity planning adjusted 
amount of $1,048,754,347 shown on line 5.

  Table 5--PDUFA Inflation and Capacity Planning Adjusted Amount for FY
                        2020, Summary Calculation
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------------------------------------------------------------------------
FY 2020 Revenue Amount........     $1,001,479,592  Line 1.
Inflation Adjustment Factor              1.023964  Line 2.
 for FY 2020 (1 plus 2.3964
 percent).
Inflation-Adjusted Amount.....     $1,025,479,049  Line 3.
Capacity Planning Adjustment             1.022697  Line 4.
 Factor for FY 2020 (1 plus
 2.2697 percent).
Inflation and Capacity             $1,048,754,347  Line 5.
 Planning Adjusted Amount.
------------------------------------------------------------------------

    The capacity planning adjustment adds $23,275,298 to the fee 
revenue amount for FY 2020. This increase is driven by the fact that 
the counts of elements for 2019 (year ending June 30) are at or near 
the highest levels since the first incorporation of the workload 
adjuster in 2003. The NDA/BLA count in 2019 is the second highest 
annual number recorded since the advent of the workload adjuster 
methodology in 2003. Active commercial INDs, efficacy supplements, and 
meetings/WROs are higher in 2019 than in any previous year recorded in 
the workload adjuster (note: meetings/WROs have been recorded only 
since 2014, while the other elements have been recorded since 2003). 
The manufacturing supplement count is approximately 6 percent below the 
highest number recorded in the

[[Page 37885]]

history of the workload adjuster. Comparing 2019 to 2016, the first 
year included in the average in column 1 in the adjustment, NDA/BLAs 
are 14 percent higher, active commercial INDs are 11 percent higher, 
efficacy supplements are 39 percent higher, manufacturing supplements 
are 2 percent higher, and meetings scheduled and WROs are 16 percent 
higher. This significant and across the board increase in submission 
activity is the driver of the $23,275,298 upward adjustment to the fee 
revenue 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).\2\
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    \2\ The PDUFA VI commitment letter can be viewed at https://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm511438.pdf.
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C. FY 2020 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 
enhancements outlined in the PDUFA VI commitment letter. The amount for 
FY 2020 is $16,953,329 (see section 736(b)(1)(F) of the FD&C Act). 
Adding this amount to the inflation and capacity planning adjusted 
revenue amount, $1,048,754,347, equals $1,065,707,676.

D. FY 2020 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 2020 
annual base revenue adjusted for inflation, capacity planning, and 
additional dollar amounts, $1,065,707,676, is divided by 52, and then 
multiplied by 14. The 14-week operating reserve amount for FY 2020 is 
$286,921,297.
    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 2019, and forecast collections and obligations in the fourth quarter 
of FY 2019. The estimated end of year FY 2019 operating reserve is 
$186,273,705.
    Because the estimated end of year FY 2020 PDUFA operating reserve 
does not exceed the 14-week operating reserve for FY 2020, FDA will not 
reduce the FY 2020 PDUFA fee revenue in FY 2020.

E. FY 2020 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 2020. 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 2018, 261.445, divided by such index for 2016, 
253.422, results in an adjustment factor of 1.031659, making the 
additional direct cost adjustment equal to $9,006,383.
    The final FY 2020 PDUFA target revenue is $1,074,714,000 (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 $214,942,800 in FY 2020.

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 6 shows, the average number of fee-paying FAEs received 
annually in the most recent 3-year period is 73.036145 FAEs. FDA will 
set fees for FY 2020 based on this estimate as the number of full 
application equivalents that will pay fees.

                                            Table 6--Fee-Paying FAEs
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               FY                        2016                2017                2018           3-Year average
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Fee-Paying FAEs.................          70.483437           79.750000           68.874999           73.036145
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Note: Prior year FAE totals are updated annually to reflect refunds and waivers processed after the close of the
  FY.

    The FY 2020 application fee is estimated by dividing the average 
number of full applications that paid fees over the latest 3 years, 
73.036145, into the fee revenue amount to be derived from application 
fees in FY 2020, $214,942,800. The result is a fee of $2,942,965 per 
full application requiring clinical data, and $1,471,483 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

[[Page 37886]]

program fees for a fiscal year for prescription drug products 
identified in a single approved NDA or BLA (see section 736(a)(2)(C)). 
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 2,740 program fees will be invoiced in FY 2020 before 
factoring in waivers, refunds, and exemptions. FDA approximates that 
there will be 54 waivers and refunds granted. In addition, FDA 
approximates that another 44 program fees will be exempted in FY 2020 
based on the orphan drug exemption in section 736(k) of the FD&C Act. 
FDA estimates 2,642 program fees in FY 2020, after allowing for an 
estimated 98 waivers and reductions, including the orphan drug 
exemptions. The FY 2020 prescription drug program fee rate is 
calculated by dividing the adjusted total revenue from program fees 
($859,771,200) by the estimated 2,642 program fees, for a FY 2020 
program fee of $325,424.

V. Fee Schedule for FY 2020

    The fee rates for FY 2020 are displayed in table 7:

                    Table 7--Fee Schedule for FY 2020
------------------------------------------------------------------------
                                                              Fee rates
                        Fee category                         for FY 2020
------------------------------------------------------------------------
Application:
    Requiring clinical data................................   $2,942,965
    Not requiring clinical data............................    1,471,483
Program....................................................      325,424
------------------------------------------------------------------------

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, 2019. 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 2020 
program fees under the new fee schedule in August 2019. Payment will be 
due on October 1, 2019. FDA will issue invoices in December 2019 for FY 
2020 program fees that qualify for fee assessments after the August 
2019 billing.

    Dated: July 29, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-16435 Filed 8-1-19; 8:45 am]
 BILLING CODE 4164-01-P