Prescription Drug User Fee Rates for Fiscal Year 2020, 37882-37886 [2019-16435]
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Federal Register / Vol. 84, No. 149 / Friday, August 2, 2019 / Notices
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Haleh Saber, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 2117, Silver Spring,
MD 20993–0002, 301–796–7550; or John
Leighton, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 2204, Silver Spring,
MD 20993–0002, 301–796–7550.
SUPPLEMENTARY INFORMATION:
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I. Background
FDA is announcing the availability of
a final guidance for industry entitled
‘‘Oncology Therapeutic
Radiopharmaceuticals: Nonclinical
Studies and Labeling
Recommendations.’’ This guidance
represents FDA’s current thinking on
nonclinical studies needed in support of
FIH studies and for approval for
therapeutic radiopharmaceuticals.
Therapeutic radiopharmaceutical refers
to a pharmaceutical that contains a
radionuclide and is used in patients
with cancer to treat the disease or
palliate tumor-related symptoms (e.g.,
pain). This guidance discusses the
following concepts: Evaluation of
toxicities from the ligand; evaluation of
radiation toxicities; and information for
product labeling as related to
reproductive toxicity, genotoxicity,
carcinogenicity, contraception, and use
in lactating women.
Currently, no FDA or International
Council for Harmonisation guidance
addresses nonclinical studies in support
of FIH trials and approval for
radiopharmaceuticals for treatment of
cancer. The guidance for industry
‘‘Nonclinical Evaluation of Late
Radiation Toxicity of Therapeutic
Radiopharmaceuticals’’ (available at
https://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatory
Information/Guidances/
UCM079242.pdf) describes nonclinical
studies to address late radiation toxicity
only. This guidance, however, provides
further clarification of recommendations
made in that guidance for the timing
and design of late radiation toxicity
studies. This guidance is intended to
bring consistency in nonclinical safety
assessment and in product labeling for
therapeutic radiopharmaceuticals and to
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reduce the number of nonclinical
studies that are not informative for
product use.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Oncology
Therapeutic Radiopharmaceuticals:
Nonclinical Studies and Labeling
Recommendations.’’ It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations. This
guidance is not subject to Executive
Order 12866.
II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collection of information in
21 CFR 312.23(a)(8) for submitting
pharmacological and toxicology
information has been approved under
OMB control number 0910–0014; the
collection of information in 21 CFR
201.56 and 201.57 for preparing human
prescription drug labeling has been
approved under OMB control number
0910–0572; the collection of
information in the ‘‘Content and Format
of Labeling for Human Prescription
Drug and Biological Products;
Requirements for Pregnancy and
Lactation Labeling’’ final rule has been
approved under OMB control number
0910–0624.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs or https://
www.regulations.gov.
Dated: July 29, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–16504 Filed 8–1–19; 8:45 am]
BILLING CODE 4164–01–P
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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.
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:
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
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
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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
Fiscal year
2016
Total PC&B ..............................................................................
Total FTE .................................................................................
PC&B per FTE .........................................................................
Percent Change From Previous Year .....................................
The statute specifies that this 3.1175
percent be multiplied by the proportion
of PC&B costs to the total FDA costs of
$2,414,728,159
16,381
$147,408
2.2474
2017
2018
$2,581,551,000
17,022
$151,660
2.8845
the process for the review of human
drug applications. Table 2 shows the
PC&B and the total obligations for the
$2,690,678,000
17,023
$158,061
4.2206
3-Year Average
..............................
..............................
..............................
3.1175
process for the review of human drug
applications for the first 3 of the
preceding 4 FYs.
TABLE 2—PC&B AS A PERCENT OF TOTAL COST OF THE PROCESS FOR THE REVIEW OF HUMAN DRUG APPLICATIONS
Fiscal year
2016
Total PC&B ..............................................................................
Total Costs ...............................................................................
PC&B Percent ..........................................................................
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 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
$652,508,273
$1,157,817,695
56.3567
2017
2018
$711,016,627
$1,206,657,269
58.9245
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 ‘‘WashingtonBaltimore, DC-MD-VA-WV’’ index was
discontinued and replaced with two
separate indices (i.e., ‘‘WashingtonArlington-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
$792,900,647
$1,374,508,527
57.6861
3-Year average
..............................
..............................
57.6558
available, the Washington-ArlingtonAlexandria 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
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Year
2016
Annual CPI ...............................................................................
Annual Percent Change ..........................................................
1 The Bureau of Labor Statistics’ announcement of
the geographical revision can be viewed at https://
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2017
253.422
1.1003
2018
256.221
1.1045
261.445
2.0389
www.bls.gov/cpi/additional-resources/geographicrevision-2018.htm.
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3-Year average
..............................
1.4146
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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 (‘‘3Year 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
Column 1
3-Year
average
ending 2018
Element
NDAs/BLAs ..........................................................................
Active Commercial INDs ......................................................
Efficacy Supplements ..........................................................
Manufacturing Supplements ................................................
Meetings Scheduled and WROs .........................................
FY 2020 Capacity Planning Adjuster ...................................
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
162.00
8,057.00
234.33
2,561.67
3,136.33
2.2697
Column 2
3-Year
average
ending 2019
Column 3
Percent
change
(column 1 to
column 2)
Column 4
Weighting
factor
(percent)
Column 5
Weighted
percent
Lchange
168.67
8,335.67
262.33
2,578.67
3,295.33
........................
4.1152
3.4587
11.9488
0.6636
5.0696
........................
16.5464
22.2644
4.1340
5.2980
5.7119
........................
0.6809
0.7701
0.4940
0.0352
0.2896
........................
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 .............................................................................................................................
Inflation Adjustment Factor for FY 2020 (1 plus 2.3964 percent) ..................................................................
Inflation-Adjusted Amount ...............................................................................................................................
Capacity Planning Adjustment Factor for FY 2020 (1 plus 2.2697 percent) .................................................
Inflation and Capacity 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
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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
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$1,001,479,592
1.023964
$1,025,479,049
1.022697
$1,048,754,347
Line
Line
Line
Line
Line
1.
2.
3.
4.
5.
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
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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
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 14week 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.
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.
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, 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
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.
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
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 feepaying 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 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
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
FY
2016
2017
2018
3-Year average
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.
2 The PDUFA VI commitment letter can be
viewed at https://www.fda.gov/downloads/
forindustry/userfees/prescriptiondruguserfee/
ucm511438.pdf.
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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
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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
V. Fee Schedule for FY 2020
to: U.S. Bank, Attention: Government
The fee rates for FY 2020 are
Lockbox 979107, 1005 Convention
displayed in table 7:
Plaza, St. Louis, MO 63101. (Note: This
U.S. Bank address is for courier delivery
TABLE 7—FEE SCHEDULE FOR FY
only. If you have any questions
2020
concerning courier delivery, contact the
U.S. Bank at 314–418–4013. This
Fee rates
telephone number is only for questions
Fee category
for FY 2020 about courier delivery). Please make
sure that the FDA post office box
Application:
Requiring clinical data .......
$2,942,965 number (P.O. Box 979107) is written on
Not requiring clinical data ..
1,471,483 the check, bank draft, or postal money
Program ....................................
325,424 order.
For payments made by wire transfer,
include the unique user fee ID number
VI. Fee Payment Options and
to ensure that the payment is applied to
Procedures
the correct fee(s). Without the unique
A. Application Fees
user fee ID number, the payment may
The appropriate application fee
not be applied, which could result in
established in the new fee schedule
FDA not filing an application and other
must be paid for any application subject penalties. The originating financial
to fees under PDUFA that is submitted
institution may charge a wire transfer
on or after October 1, 2019. Payment
fee. Applicable wire transfer fees must
must be made in U.S. currency by
be included with payment to ensure fees
electronic check, check, bank draft, wire are fully paid. Questions about wire
transfer, or U.S. postal money order
transfer fees should be addressed to the
payable to the order of the Food and
financial institution. The account
Drug Administration. The preferred
information for wire transfers is as
payment method is online using
follows: U.S. Department of the
electronic check (Automated Clearing
Treasury, TREAS NYC, 33 Liberty St.,
House (ACH) also known as eCheck) or
New York, NY 10045, Acct. No.:
credit card (Discover, VISA, MasterCard, 75060099, Routing No.: 021030004,
American Express).
SWIFT: FRNYUS33. If needed, FDA’s
FDA has partnered with the U.S.
tax identification number is 53–
Department of the Treasury to use
0196965.
Pay.gov, a web-based payment
B. Prescription Drug Program Fees
application, for online electronic
payment. The Pay.gov feature is
FDA will issue invoices and payment
available on the FDA website after
instructions for FY 2020 program fees
jbell on DSK3GLQ082PROD with NOTICES
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.
VerDate Sep<11>2014
18:02 Aug 01, 2019
Jkt 247001
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–D–2837]
Testing and Labeling Medical Devices
for Safety in the Magnetic Resonance
Environment; Draft Guidance for
Industry and Food and Drug
Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the draft
guidance entitled ‘‘Testing and Labeling
Medical Devices for Safety in the
Magnetic Resonance (MR)
Environment.’’ FDA developed this
draft guidance to provide FDA’s
recommendations on the testing needed
for assessing the safety and
compatibility of medical devices in the
Magnetic Resonance (MR) Environment
and the recommended format for
Magnetic Resonance Imaging (MRI)
Safety Information in medical device
labeling. This draft guidance document
is anticipated to aid in consistency of
reviews, testing, and MRI safety labeling
across a variety of medical devices. This
draft guidance is not final nor is it in
effect at this time.
DATES: Submit either electronic or
written comments on the draft guidance
by October 1, 2019 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:
Electronic Submissions
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
E:\FR\FM\02AUN1.SGM
02AUN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Fiscal year 2016 2017 2018 3-Year Average
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Fiscal year 2016 2017 2018 3-Year average
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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 2016 2017 2018 3-Year average
----------------------------------------------------------------------------------------------------------------
Annual CPI.......................... 253.422 256.221 261.445 .................
Annual Percent Change............... 1.1003 1.1045 2.0389 1.4146
----------------------------------------------------------------------------------------------------------------
[[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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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.......................
----------------------------------------------------------------------------------------------------------------
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
------------------------------------------------------------------------
------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\2\ The PDUFA VI commitment letter can be viewed at https://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm511438.pdf.
---------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
FY 2016 2017 2018 3-Year average
----------------------------------------------------------------------------------------------------------------
Fee-Paying FAEs................. 70.483437 79.750000 68.874999 73.036145
----------------------------------------------------------------------------------------------------------------
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
