Generic Drug User Fee Rates for Fiscal Year 2020, 36101-36105 [2019-15906]
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for plan submission every third year and
to complete the annual program report.
The program plan is the application for
NEW program funding and documents
how the grantee will carry out its NEW
program. The program report provides
HHS, Congress, and grantees
information to document and assess the
activities and accomplishments of the
NEW program. ACF proposes to extend
data collection with revisions, including
the deletion of guidance for NEW
programs included in Public Law 102–
477 programs.
Respondents: Indian tribes and tribal
coalitions that run NEW programs.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
NEW program plan guidance for non-477 Tribes ...........................................
NEW program report .......................................................................................
Number of
responses per
respondent
1 14
1
1
2 42
Average
burden hours
per response
29
15
Annual
burden hours
406
630
1 We estimate that 42 of the 78 NEW grantees will not include their NEW programs in Public Law 102–477 projects. 42 grantees divided by 3
(because grantees submit the NEW plan once every 3 years) = 14.
2 We estimate that 42 of the 78 NEW grantees will not include their NEW programs in Public Law 102–477 projects and therefore will submit
the NEW program report to HHS.
Management, Food and Drug
Administration, 4041 Powder Mill Rd.,
Rm. 61075, Beltsville, MD 20705–4304,
240–402–4585.
SUPPLEMENTARY INFORMATION:
Estimated Total Annual Burden
Hours: 1036 3
Authority: 42 U.S.C. 612.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019–15909 Filed 7–25–19; 8:45 am]
BILLING CODE 4184–36–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0007]
Generic Drug User Fee Rates for Fiscal
Year 2020
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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SUMMARY: The Federal Food, Drug, and
Cosmetic Act (FD&C Act or statute), as
amended by the Generic Drug User Fee
Amendments of 2017 (GDUFA II),
authorizes the Food and Drug
Administration (FDA, Agency, or we) to
assess and collect fees for abbreviated
new drug applications (ANDAs), drug
master files (DMFs), generic drug active
pharmaceutical ingredient (API)
facilities, finished dosage form (FDF)
facilities, contract manufacturing
organization (CMO) facilities, and
generic drug applicant program user
fees. In this document, FDA is
announcing fiscal year (FY) 2020 rates
for GDUFA II fees.
FOR FURTHER INFORMATION CONTACT:
Melissa Hurley, Office of Financial
I. Background
Sections 744A and 744B of the FD&C
Act (21 U.S.C. 379j-41 and 379j-42)
establish fees associated with human
generic drug products. Fees are assessed
on: (1) Certain types of applications for
human generic drug products; (2)
certain facilities where APIs and FDFs
are produced; (3) certain DMFs
associated with human generic drug
products; and (4) generic drug
applicants who have approved ANDAs
(the program fee) (see section 744B(a)(2)
to (5) of the FD&C Act).
GDUFA II stipulates that user fees
should total $493,600,000 annually
adjusted each year for inflation. For FY
2020, the generic drug fee rates are:
ANDA ($176,237), DMF ($57,795),
domestic API facility ($44,400), foreign
API facility ($59,400), domestic FDF
facility ($195,662), foreign FDF facility
($210,662), domestic CMO facility
($65,221), foreign CMO facility
($80,221), large size operation generic
drug applicant program ($1,661,684),
medium size operation generic drug
applicant program ($664,674), and small
business generic drug applicant program
($166,168). These fees are effective on
October 1, 2019, and will remain in
effect through September 30, 2020.
II. Fee Revenue Amount for FY 2020
GDUFA II directs FDA to use the
yearly revenue amount determined
under the statute as a starting point to
set the fee rates for each fee type. For
more information about GDUFA II,
please refer to the FDA website (https://
www.fda.gov/gdufa). The ANDA, DMF,
API facility, FDF facility, CMO facility,
and generic drug applicant program fee
(GDUFA program fee) calculations for
FY 2020 are described in this document.
The base revenue amount for FY 2020
is $501,721,201. This is the amount
calculated for the prior fiscal year, FY
2019, pursuant to the statute (see
section 744B(b)(1) of the FD&C Act).
GDUFA II specifies that the
$501,721,201 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
sections 744B(c)(1)(B) and (C) of the
FD&C Act).
The component of the inflation
adjustment for PC&B costs shall be one
plus the average annual percent change
in the cost of all PC&B paid per full-time
equivalent position (FTE) at FDA for the
first 3 of the 4 preceding fiscal years,
multiplied by the proportion of PC&B
costs to total FDA costs of human
generic drug activities for the first 3 of
the preceding 4 fiscal years (see section
744B(c)(1)(B) of the FD&C Act).
Table 1 summarizes the actual cost
and total FTEs for the specified fiscal
years, and provides the percent change
from the previous fiscal year and the
average percent change over the first 3
of the 4 fiscal years preceding FY 2020.
The 3-year average is 3.1175 percent.
3 Two additional programs joined the Public Law
102–477 since the publication of FR1, hence the
burden is different.
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TABLE 1—FDA PERSONNEL COMPENSATION AND BENEFITS (PC&B) EACH YEAR AND PERCENT CHANGE
Fiscal year
2016
Total PC&B ......................................................................................
Total FTEs .......................................................................................
PC&B per FTE .................................................................................
Percent Change from Previous Year ..............................................
The statute specifies that this 3.1175
percent should be multiplied by the
proportion of PC&B expended for
2017
$2,414,728,159
16,381
$147,408
2.2474
2018
$2,581,551,000
17,022
$151,660
2.8845
human generic drug activities for the
first 3 of the preceding 4 fiscal years.
Table 2 shows the amount of PC&B and
$2,690,678,00
17,023
$158,061
4.2206
3-Year
average
............................
............................
............................
3.1175
the total amount obligated for human
generic drug activities from FY 2016
through FY 2018.
TABLE 2—PC&B AS A PERCENT OF FEE REVENUES SPENT ON THE PROCESS OF HUMAN GENERIC DRUG APPLICATIONS
OVER THE LAST 3 YEARS
Fiscal year
2016
PC&B ...............................................................................................
Non-PC&B .......................................................................................
Total Costs .......................................................................................
PC&B Percent ..................................................................................
Non-PC&B Percent ..........................................................................
The payroll adjustment is 3.1175
percent multiplied by 51.5550 percent
(or 1.6072 percent).
The statute specifies that the portion
of the inflation adjustment for nonPC&B costs for FY 2020 is the average
annual percent change that occurred in
the Consumer Price Index (CPI) for
urban consumers (WashingtonBaltimore, DC-MD-VA-WV; not
seasonally adjusted; all items; annual
index) for the first 3 of the preceding 4
years of available data multiplied by the
proportion of all costs other than PC&B
2017
$242,963,571
$250,987,599
$493,951,170
49.1878
50.8122
2018
$271,748,229
$262,058,852
$533,807,081
50.9076
49.0924
costs to total costs of human generic
drug activities (see section 744B(c)(1)(C)
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
$332,617,643
$276,911,265
$609,528,908
54.5696
45.4304
3-Year
average
............................
............................
............................
51.5550
48.4450
and provides the most current data
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 change in the
specified CPI. 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
2016
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Annual CPI .......................................................................................
Annual Percent Change ..................................................................
2017
253.422
1.1003
To calculate the inflation adjustment
for non-pay costs, we multiply the 3year average percent change in the CPI
(1.4146 percent) by the proportion of all
costs other than PC&B to total costs of
human generic drug activities obligated.
Because 51.5550 percent was obligated
for PC&B as shown in table 2, 48.4450
percent is the portion of costs other than
PC&B. The non-pay adjustment is
1.4146 percent times 48.4450 percent, or
0.6853 percent.
To complete the inflation adjustment
for FY 2020, we add the PC&B
component (1.6072 percent) to the non-
PC&B component (0.6853 percent) for a
total inflation adjustment of 2.2925
percent (rounded), making 1.022925.
We then multiply the base revenue
amount for FY 2020 ($501,721,201) by
1.022925, yielding an inflation-adjusted
amount of $513,223,000 (rounded to the
nearest thousand dollars).
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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III. ANDA Filing Fee
Under GDUFA II, the FY 2020 ANDA
filing fee is owed by each applicant that
submits an ANDA on or after October 1,
2019. This fee is due on the submission
date of the ANDA. Section 744B(b)(2)(B)
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2018
256.221
1.1045
261.445
2.0389
3-Year
average
............................
1.4146
of the FD&C Act specifies that the
ANDA fee will make up 33 percent of
the $513,223,000, which is
$169,363,590.
To calculate the ANDA fee, FDA
estimated the number of full application
equivalents (FAEs) that will be
submitted in FY 2020. The submissions
are broken down into three categories:
New originals (submissions that have
not been received by FDA previously);
submissions that have been refused to
receive (RTR) for reasons other than
failure to pay fees; and applications that
are resubmitted after having been RTR
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for reasons other than failure to pay
fees. An ANDA counts as one FAE;
however, 75 percent of the fee paid for
an ANDA that has been RTR shall be
refunded according to GDUFA II if (1)
the ANDA is refused for a cause other
than failure to pay fees, or (2) the ANDA
has been withdrawn prior to receipt
(section 744B(a)(3)(D)(i) of the FD&C
Act). Therefore, an ANDA that is
considered not to have been received by
FDA due to reasons other than failure to
pay fees or withdrawn prior to receipt
counts as one-fourth of an FAE. After an
ANDA has been RTR, the applicant has
the option of resubmitting. For user fee
purposes, these resubmissions are
equivalent to new original
submissions—ANDA resubmissions are
charged the full amount for an
application (one FAE).
FDA utilized data from ANDAs
submitted from October 1, 2017, to
April 30, 2019, to estimate the number
of new original ANDAs that will incur
filing fees in FY 2020. For FY 2020, the
Agency estimates that approximately
953 new original ANDAs will be
submitted and incur filing fees. Not all
of the new original ANDAs will be
received by the Agency and some of
those not received will be resubmitted
in the same fiscal year. Therefore, the
Agency expects that the FAE count for
ANDAs will be 961 for FY 2020.
The FY 2020 application fee is
estimated by dividing the number of
FAEs that will pay the fee in FY 2020
(961) into the fee revenue amount to be
derived from ANDA application fees in
FY 2020 ($169,363,590). The result,
rounded to the nearest dollar, is a fee of
$176,237 per ANDA.
The statute provides that those
ANDAs that include information about
the production of active pharmaceutical
ingredients other than by reference to a
DMF will pay an additional fee that is
based on the number of such active
pharmaceutical ingredients and the
number of facilities proposed to
produce those ingredients (see section
744B(a)(3)(F) of the FD&C Act). FDA
anticipates that this additional fee is
unlikely to be assessed often; therefore,
FDA has not included projections
concerning the amount of this fee in
calculating the fees for ANDAs.
IV. DMF Fee
Under GDUFA II, the DMF fee is
owed by each person that owns a type
II active pharmaceutical ingredient DMF
that is referenced, on or after October 1,
2012, in a generic drug submission by
an initial letter of authorization. This is
a one-time fee for each DMF. This fee is
due on the earlier of the date on which
the first generic drug submission is
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submitted that references the associated
DMF or the date on which the drug
master file holder requests the initial
completeness assessment. Under section
744B(a)(2)(D)(iii) of the FD&C Act, if a
DMF has successfully undergone an
initial completeness assessment and the
fee is paid, the DMF will be placed on
a publicly available list documenting
DMFs available for reference.
To calculate the DMF fee, FDA
assessed the volume of DMF
submissions over time. The Agency
assessed DMFs from October 1, 2017, to
April 30, 2019, and concluded that
averaging the number of fee-paying
DMFs provided the most accurate model
for predicting fee-paying DMFs for FY
2020. The monthly average of paid DMF
submissions the Agency received in FY
2018 and FY 2019 is 37. To determine
the FY 2020 projected number of feepaying DMFs, the average of 37 DMF
submissions is multiplied by 12 months,
which results in 444 estimated FY 2020
fee-paying DMFs. FDA is estimating 444
fee-paying DMFs for FY 2020.
The FY 2020 DMF fee is determined
by dividing the DMF target revenue by
the estimated number of fee-paying
DMFs in FY 2020. Section 744B(b)(2)(A)
of the FD&C Act specifies that the DMF
fees will make up 5 percent of the
$513,223,000, which is $25,661,150.
Dividing the DMF revenue amount
($25,661,150) by the estimated feepaying DMFs (444), and rounding to the
nearest dollar, yields a DMF fee of
$57,795 for FY 2020.
V. Foreign Facility Fee Differential
Under GDUFA II, the fee for a facility
located outside the United States and its
territories and possessions shall be
$15,000 higher than the amount of the
fee for a facility located in the United
States and its territories and
possessions. The basis for this
differential is the extra cost incurred by
conducting an inspection outside the
United States and its territories and
possessions.
VI. FDF and CMO Facility Fees
Under GDUFA II, the annual FDF
facility fee is owed by each person who
owns an FDF facility that is identified
in at least one approved generic drug
submission owned by that person or its
affiliates. The CMO facility fee is owed
by each person who owns an FDF
facility that is identified in at least one
approved ANDA but is not identified in
an approved ANDA held by the owner
of that facility or its affiliates. These fees
are due no later than the first business
day on or after October 1 of each such
year. Section 744B(b)(2)(C) of the FD&C
Act specifies that the FDF and CMO
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facility fee revenue will make up 20
percent of the $513,223,000, which is
$102,644,600.
To calculate the fees, data from FDA’s
Integrity Services (IS) were utilized as
the primary source of facility
information for determining the
denominators of each facility fee type.
IS is the master data steward for all
facility information provided in generic
drug submissions received by FDA. A
facility’s reference status in an approved
generic drug submission is extracted
directly from submission data rather
than relying on data from selfidentification. This information
provided the number of facilities
referenced as FDF manufacturers in at
least one approved generic drug
submission. Based on FDA’s IS data, the
FDF and CMO facility denominators are
192 FDF domestic, 248 FDF foreign, 75
CMO domestic, and 99 CMO foreign
facilities for FY 2020.
GDUFA II specifies that the CMO
facility fee is to be equal to one-third the
amount of the FDF facility fee.
Therefore, to generate the target
collection revenue amount from FDF
and CMO facility fees ($102,644,600),
FDA must weight a CMO facility as onethird of an FDF facility. FDA set fees
based on the estimate of 192 FDF
domestic, 248 FDF foreign, 25 CMO
domestic (75 multiplied by one-third),
and 33 CMO foreign facilities (99
multiplied by one-third), which equals
498 total weighted FDF and CMO
facilities for FY 2020.
To calculate the fee for domestic
facilities, FDA first determines the total
fee revenue that will result from the
foreign facility differential by
subtracting the fee revenue resulting
from the foreign facility fee differential
from the target collection revenue
amount ($102,644,600) as follows. The
foreign facility fee differential revenue
equals the foreign facility fee differential
($15,000) multiplied by the number of
FDF foreign facilities (248) plus the
foreign facility fee differential ($15,000)
multiplied by the number of CMO
foreign facilities (99), totaling
$5,205,000. This results in foreign fee
differential revenue of $5,205,000 from
the total FDF and CMO facility fee target
collection revenue. Subtracting the
foreign facility differential fee revenue
($5,205,000) from the total FDF and
CMO facility target collection revenue
($102,644,600) results in a remaining
facility fee revenue balance of
$97,439,600. To determine the domestic
FDF facility fee, FDA divides the
$97,439,600 by the total weighted
number of FDF and CMO facilities
(498), which results in a domestic FDF
facility fee of $195,662. The foreign FDF
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facility fee is $15,000 more than the
domestic FDF facility fee, or $210,662.
According to GDUFA II, the domestic
CMO fee is calculated as one-third the
amount of the domestic FDF facility fee.
Therefore, the domestic CMO fee is
$65,221, rounded to the nearest dollar.
The foreign CMO fee is calculated as the
domestic CMO fee plus the foreign fee
differential of $15,000. Therefore, the
foreign CMO fee is $80,221.
($8,220,000) from the total API facility
target revenue ($35,925,610) results in a
remaining balance of $27,705,610. To
determine the domestic API facility fee,
we divide the $27,705,610 by the total
number of facilities (624), which gives
us a domestic API facility fee of
$44,400. The foreign API facility fee is
$15,000 more than the domestic API
facility fee, or $59,400.
VII. API Facility Fee
VIII. Generic Drug Applicant Program
Fee
Under GDUFA II, the annual API
facility fee is owed by each person who
owns a facility that is identified in (1)
at least one approved generic drug
submission or (2) in a Type II API DMF
referenced in at least one approved
generic drug submission. These fees are
due no later than the first business day
on or after October 1 of each such year.
Section 744B(b)(2)(D) of the FD&C Act
specifies the API facility fee will make
up 7 percent of $513,223,000 in fee
revenue, which is $35,925,610.
To calculate the API facility fee, data
from FDA’s IS were utilized as the
primary source of facility information
for determining the denominator. As
stated above, IS is the master data
steward for all facility information
provided in generic drug submissions
received by FDA. A facility’s reference
status in an approved generic drug
submission is extracted directly from
submission data rather than relying on
data from self-identification. This
information provided the number of
facilities referenced as API
manufacturers in at least one approved
generic drug submission.
The total number of API facilities
identified was 624; of that number, 76
were domestic and 548 were foreign
facilities. The foreign facility differential
is $15,000. To calculate the fee for
domestic facilities, FDA must first
subtract the fee revenue that will result
from the foreign facility fee differential.
FDA takes the foreign facility
differential ($15,000) and multiplies it
by the number of foreign facilities (548)
to determine the total fee revenue that
will result from the foreign facility
differential. As a result of that
calculation, the foreign fee differential
revenue will make up $8,220,000 of the
total API fee revenue. Subtracting the
foreign facility differential fee revenue
Under GDUFA II, if a person and its
affiliates own at least one but not more
than five approved ANDAs on October
1, 2019, the person and its affiliates
shall owe a small business GDUFA
program fee. If a person and its affiliates
own at least 6 but not more than 19
approved ANDAs, the person and its
affiliates shall owe a medium size
operation GDUFA program fee. If a
person and its affiliates own at least 20
approved ANDAs, the person and its
affiliates shall owe a large size operation
GDUFA program fee. These fees are due
no later than the first business day on
or after October 1 of each such year.
Section 744B(b)(2)(E) of the FD&C Act
specifies the GDUFA program fee will
make up 35 percent of $513,223,000 in
fee revenue, which is $179,628,050.
To determine the appropriate number
of parent companies for each tier, the
Agency asked companies to claim their
ANDAs and affiliates in the Center for
Drug Evaluation and Research (CDER)
NextGen Portal. The companies were
able to confirm relationships currently
present in the Agency’s records, while
also reporting newly approved ANDAs,
newly acquired ANDAs, and new
affiliations.
In determining the appropriate
number of approved ANDAs, the
Agency has factored in a number of
variables that could affect the collection
of the target revenue: (1) Inactive
ANDAs—applicants who have not
submitted an annual report for one or
more of their approved applications
within the past 2 years; (2) FY 2018
Program Fee Arrears List—applicants
who failed to satisfy the FY 2018
program fee and were unresponsive to
attempts to collect; (3) Center for
Biologics Evaluation and Research
(CBER) approved ANDAs—applicants
and their affiliates with CBER-approved
ANDAs in addition to CDER’s approved
ANDAs; (4) withdrawals of approved
ANDAs by April 1st—applicants who
have submitted a written request for
withdrawal of approval by April 1st of
the previous fiscal year; (5) Abbreviated
Antibiotic Applications (AADA)
conversions—ANDAs (previously
AADAs) for bulk antibiotic drug
substance converted and refiled as
DMFs; and (6) ANDAs with Conditional
Approval status—a small number of pre1984 ANDAs that are considered
approved for marketing, but as to which
additional information has been
requested. The list of original approved
ANDAs from the Generic Drug Review
Platform as of April 30, 2019, shows 265
applicants in the small business tier, 71
applicants in the medium size tier, and
64 applicants in the large size tier.
Factoring in all the variables for the
third year of GDUFA II, the Agency
estimates there will be 199 applicants in
the small business tier, 63 applicants in
the medium size tier, and 63 applicants
in the large size tier for FY 2020.
To calculate the GDUFA program fee,
GDUFA II provides that large size
operation generic drug applicants pay
the full fee, medium size operation
applicants pay two-fifths of the full fee,
and small business applicants pay onetenth of the full fee. To generate the
target collection revenue amount from
GDUFA program fees ($179,628,050),
we must weigh medium and small
tiered applicants as a subset of a large
size operation generic drug applicant.
FDA will set fees based on the weighted
estimate of 19.90 applicants in the small
business tier (199 multiplied by 10
percent), 25.20 applicants in the
medium size tier (63 multiplied by 40
percent), and 63 applicants in the large
size tier, arriving at 108.10 total
weighted applicants for FY 2020.
To generate the large size operation
GDUFA program fee, FDA divides the
target revenue amount of $179,628,050
by 108.10, which equals $1,661,684.
The medium size operation GDUFA
program fee is 40 percent of the full fee
($664,674), and the small business
operation GDUFA program fee is 10
percent of the full fee ($166,168).
IX. Fee Schedule for FY 2020
The fee rates for FY 2020 are set out
in table 4.
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TABLE 4—FEE SCHEDULE FOR FY 2020
Fees rates for
FY 2020
Fee category
Applications:
Abbreviated New Drug Application (ANDA) .................................................................................................................................
Drug Master File (DMF) ...............................................................................................................................................................
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$176,237
57,795
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TABLE 4—FEE SCHEDULE FOR FY 2020—Continued
Fees rates for
FY 2020
Fee category
Facilities:
Active Pharmaceutical Ingredient (API) Domestic .......................................................................................................................
API—Foreign ................................................................................................................................................................................
Finished Dosage Form (FDF)—Domestic ....................................................................................................................................
FDF—Foreign ...............................................................................................................................................................................
Contract Manufacturing Organization (CMO)—Domestic ............................................................................................................
CMO—Foreign ..............................................................................................................................................................................
GDUFA Program:
Large size operation generic drug applicant ................................................................................................................................
Medium size operation generic drug applicant ............................................................................................................................
Small business operation generic drug applicant ........................................................................................................................
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X. Fee Payment Options and
Procedures
The new fee rates are effective
October 1, 2019. To pay the ANDA,
DMF, API facility, FDF facility, CMO
facility, and GDUFA program fees, a
Generic Drug User Fee Cover Sheet must
be completed, available at https://
www.fda.gov/gdufa and https://
userfees.fda.gov/OA_HTML/gdufaCA
cdLogin.jsp, and a user fee identification
(ID) number must be generated.
Payment must be made in U.S. currency
drawn on a U.S. bank by electronic
check, check, bank draft, U.S. postal
money order, credit card, or wire
transfer. 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
utilize Pay.gov, a web-based payment
application, for online electronic
payment. The Pay.gov feature is
available on the FDA website after
completing the Generic 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 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.
The user fee ID number must be
included on the check, bank draft, or
postal money order and must be made
payable to the order of the Food and
Drug Administration. Payments can be
mailed to: Food and Drug
VerDate Sep<11>2014
17:54 Jul 25, 2019
Jkt 247001
Administration, P.O. Box 979108, St.
Louis, MO 63197–9000. If checks are to
be sent by a courier that requests a street
address, the courier can deliver checks
to: U.S. Bank, Attention: Government
Lockbox 979108, 1005 Convention
Plaza, St. Louis, MO 63101. (Note: This
U.S. Bank address is for courier delivery
only. For questions concerning courier
delivery, U.S. Bank can be contacted at
314–418–4013. This telephone number
is only for questions about courier
delivery.) The FDA post office box
number (P.O. Box 979108) must be
written on the check, bank draft, or
postal money order.
For payments made by wire transfer,
the unique user fee ID number must be
referenced. Without the unique user fee
ID number, the payment may not be
applied. If the payment amount is not
applied, the invoice amount will be
referred to collections. 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 following account information
should be used to send payments by
wire transfer: U.S. Department of the
Treasury, TREAS NYC, 33 Liberty St.,
New York, NY 10045, account number:
75060099, routing number: 021030004,
SWIFT: FRNYUS33. FDA’s tax
identification number is 53–0196965.
Dated: July 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–15906 Filed 7–25–19; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
44,400
59,400
195,662
210,662
65,221
80,221
1,661,684
664,674
166,168
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–1771]
Metal Expandable Biliary Stents—
Premarket Notification (510(k))
Submissions; Guidance for Industry
and Food and Drug Administration
Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
SUMMARY: The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance entitled ‘‘Metal Expandable
Biliary Stents—Premarket Notification
(510(k)) Submissions.’’ This guidance
provides recommendations for
information and testing that should be
included in 510(k) submissions for
metal expandable biliary stents and
their associated delivery systems
intended to provide luminal patency of
malignant strictures in the biliary tree.
DATES: The announcement of the
guidance is published in the Federal
Register on July 26, 2019.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
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
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,
E:\FR\FM\26JYN1.SGM
26JYN1
]]>Agencies
[Federal Register Volume 84, Number 144 (Friday, July 26, 2019)]
[Notices]
[Pages 36101-36105]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15906]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0007]
Generic Drug User Fee Rates for Fiscal Year 2020
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Federal Food, Drug, and Cosmetic Act (FD&C Act or
statute), as amended by the Generic Drug User Fee Amendments of 2017
(GDUFA II), authorizes the Food and Drug Administration (FDA, Agency,
or we) to assess and collect fees for abbreviated new drug applications
(ANDAs), drug master files (DMFs), generic drug active pharmaceutical
ingredient (API) facilities, finished dosage form (FDF) facilities,
contract manufacturing organization (CMO) facilities, and generic drug
applicant program user fees. In this document, FDA is announcing fiscal
year (FY) 2020 rates for GDUFA II fees.
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 744A and 744B of the FD&C Act (21 U.S.C. 379j-41 and 379j-
42) establish fees associated with human generic drug products. Fees
are assessed on: (1) Certain types of applications for human generic
drug products; (2) certain facilities where APIs and FDFs are produced;
(3) certain DMFs associated with human generic drug products; and (4)
generic drug applicants who have approved ANDAs (the program fee) (see
section 744B(a)(2) to (5) of the FD&C Act).
GDUFA II stipulates that user fees should total $493,600,000
annually adjusted each year for inflation. For FY 2020, the generic
drug fee rates are: ANDA ($176,237), DMF ($57,795), domestic API
facility ($44,400), foreign API facility ($59,400), domestic FDF
facility ($195,662), foreign FDF facility ($210,662), domestic CMO
facility ($65,221), foreign CMO facility ($80,221), large size
operation generic drug applicant program ($1,661,684), medium size
operation generic drug applicant program ($664,674), and small business
generic drug applicant program ($166,168). These fees are effective on
October 1, 2019, and will remain in effect through September 30, 2020.
II. Fee Revenue Amount for FY 2020
GDUFA II directs FDA to use the yearly revenue amount determined
under the statute as a starting point to set the fee rates for each fee
type. For more information about GDUFA II, please refer to the FDA
website (https://www.fda.gov/gdufa). The ANDA, DMF, API facility, FDF
facility, CMO facility, and generic drug applicant program fee (GDUFA
program fee) calculations for FY 2020 are described in this document.
The base revenue amount for FY 2020 is $501,721,201. This is the
amount calculated for the prior fiscal year, FY 2019, pursuant to the
statute (see section 744B(b)(1) of the FD&C Act). GDUFA II specifies
that the $501,721,201 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 sections 744B(c)(1)(B)
and (C) of the FD&C Act).
The component of the inflation adjustment for PC&B costs shall be
one plus the average annual percent change in the cost of all PC&B paid
per full-time equivalent position (FTE) at FDA for the first 3 of the 4
preceding fiscal years, multiplied by the proportion of PC&B costs to
total FDA costs of human generic drug activities for the first 3 of the
preceding 4 fiscal years (see section 744B(c)(1)(B) of the FD&C Act).
Table 1 summarizes the actual cost and total FTEs for the specified
fiscal years, and provides the percent change from the previous fiscal
year and the average percent change over the first 3 of the 4 fiscal
years preceding FY 2020. The 3-year average is 3.1175 percent.
[[Page 36102]]
Table 1--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Change
----------------------------------------------------------------------------------------------------------------
Fiscal year 2016 2017 2018 3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B.............................. $2,414,728,159 $2,581,551,000 $2,690,678,00 ................
Total FTEs.............................. 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 should be multiplied
by the proportion of PC&B expended for human generic drug activities
for the first 3 of the preceding 4 fiscal years. Table 2 shows the
amount of PC&B and the total amount obligated for human generic drug
activities from FY 2016 through FY 2018.
Table 2--PC&B as a Percent of Fee Revenues Spent on the Process of Human Generic Drug Applications Over the Last
3 Years
----------------------------------------------------------------------------------------------------------------
Fiscal year 2016 2017 2018 3-Year average
----------------------------------------------------------------------------------------------------------------
PC&B.................................... $242,963,571 $271,748,229 $332,617,643 ................
Non-PC&B................................ $250,987,599 $262,058,852 $276,911,265 ................
Total Costs............................. $493,951,170 $533,807,081 $609,528,908 ................
PC&B Percent............................ 49.1878 50.9076 54.5696 51.5550
Non-PC&B Percent........................ 50.8122 49.0924 45.4304 48.4450
----------------------------------------------------------------------------------------------------------------
The payroll adjustment is 3.1175 percent multiplied by 51.5550
percent (or 1.6072 percent).
The statute specifies that the portion of the inflation adjustment
for non-PC&B costs for FY 2020 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 of the preceding 4 years of available
data multiplied by the proportion of all costs other than PC&B costs to
total costs of human generic drug activities (see section 744B(c)(1)(C)
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 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 change in the specified CPI.
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
----------------------------------------------------------------------------------------------------------------
To calculate the inflation adjustment for non-pay costs, we
multiply the 3-year average percent change in the CPI (1.4146 percent)
by the proportion of all costs other than PC&B to total costs of human
generic drug activities obligated. Because 51.5550 percent was
obligated for PC&B as shown in table 2, 48.4450 percent is the portion
of costs other than PC&B. The non-pay adjustment is 1.4146 percent
times 48.4450 percent, or 0.6853 percent.
To complete the inflation adjustment for FY 2020, we add the PC&B
component (1.6072 percent) to the non-PC&B component (0.6853 percent)
for a total inflation adjustment of 2.2925 percent (rounded), making
1.022925. We then multiply the base revenue amount for FY 2020
($501,721,201) by 1.022925, yielding an inflation-adjusted amount of
$513,223,000 (rounded to the nearest thousand dollars).
III. ANDA Filing Fee
Under GDUFA II, the FY 2020 ANDA filing fee is owed by each
applicant that submits an ANDA on or after October 1, 2019. This fee is
due on the submission date of the ANDA. Section 744B(b)(2)(B) of the
FD&C Act specifies that the ANDA fee will make up 33 percent of the
$513,223,000, which is $169,363,590.
To calculate the ANDA fee, FDA estimated the number of full
application equivalents (FAEs) that will be submitted in FY 2020. The
submissions are broken down into three categories: New originals
(submissions that have not been received by FDA previously);
submissions that have been refused to receive (RTR) for reasons other
than failure to pay fees; and applications that are resubmitted after
having been RTR
[[Page 36103]]
for reasons other than failure to pay fees. An ANDA counts as one FAE;
however, 75 percent of the fee paid for an ANDA that has been RTR shall
be refunded according to GDUFA II if (1) the ANDA is refused for a
cause other than failure to pay fees, or (2) the ANDA has been
withdrawn prior to receipt (section 744B(a)(3)(D)(i) of the FD&C Act).
Therefore, an ANDA that is considered not to have been received by FDA
due to reasons other than failure to pay fees or withdrawn prior to
receipt counts as one-fourth of an FAE. After an ANDA has been RTR, the
applicant has the option of resubmitting. For user fee purposes, these
resubmissions are equivalent to new original submissions--ANDA
resubmissions are charged the full amount for an application (one FAE).
FDA utilized data from ANDAs submitted from October 1, 2017, to
April 30, 2019, to estimate the number of new original ANDAs that will
incur filing fees in FY 2020. For FY 2020, the Agency estimates that
approximately 953 new original ANDAs will be submitted and incur filing
fees. Not all of the new original ANDAs will be received by the Agency
and some of those not received will be resubmitted in the same fiscal
year. Therefore, the Agency expects that the FAE count for ANDAs will
be 961 for FY 2020.
The FY 2020 application fee is estimated by dividing the number of
FAEs that will pay the fee in FY 2020 (961) into the fee revenue amount
to be derived from ANDA application fees in FY 2020 ($169,363,590). The
result, rounded to the nearest dollar, is a fee of $176,237 per ANDA.
The statute provides that those ANDAs that include information
about the production of active pharmaceutical ingredients other than by
reference to a DMF will pay an additional fee that is based on the
number of such active pharmaceutical ingredients and the number of
facilities proposed to produce those ingredients (see section
744B(a)(3)(F) of the FD&C Act). FDA anticipates that this additional
fee is unlikely to be assessed often; therefore, FDA has not included
projections concerning the amount of this fee in calculating the fees
for ANDAs.
IV. DMF Fee
Under GDUFA II, the DMF fee is owed by each person that owns a type
II active pharmaceutical ingredient DMF that is referenced, on or after
October 1, 2012, in a generic drug submission by an initial letter of
authorization. This is a one-time fee for each DMF. This fee is due on
the earlier of the date on which the first generic drug submission is
submitted that references the associated DMF or the date on which the
drug master file holder requests the initial completeness assessment.
Under section 744B(a)(2)(D)(iii) of the FD&C Act, if a DMF has
successfully undergone an initial completeness assessment and the fee
is paid, the DMF will be placed on a publicly available list
documenting DMFs available for reference.
To calculate the DMF fee, FDA assessed the volume of DMF
submissions over time. The Agency assessed DMFs from October 1, 2017,
to April 30, 2019, and concluded that averaging the number of fee-
paying DMFs provided the most accurate model for predicting fee-paying
DMFs for FY 2020. The monthly average of paid DMF submissions the
Agency received in FY 2018 and FY 2019 is 37. To determine the FY 2020
projected number of fee-paying DMFs, the average of 37 DMF submissions
is multiplied by 12 months, which results in 444 estimated FY 2020 fee-
paying DMFs. FDA is estimating 444 fee-paying DMFs for FY 2020.
The FY 2020 DMF fee is determined by dividing the DMF target
revenue by the estimated number of fee-paying DMFs in FY 2020. Section
744B(b)(2)(A) of the FD&C Act specifies that the DMF fees will make up
5 percent of the $513,223,000, which is $25,661,150. Dividing the DMF
revenue amount ($25,661,150) by the estimated fee-paying DMFs (444),
and rounding to the nearest dollar, yields a DMF fee of $57,795 for FY
2020.
V. Foreign Facility Fee Differential
Under GDUFA II, the fee for a facility located outside the United
States and its territories and possessions shall be $15,000 higher than
the amount of the fee for a facility located in the United States and
its territories and possessions. The basis for this differential is the
extra cost incurred by conducting an inspection outside the United
States and its territories and possessions.
VI. FDF and CMO Facility Fees
Under GDUFA II, the annual FDF facility fee is owed by each person
who owns an FDF facility that is identified in at least one approved
generic drug submission owned by that person or its affiliates. The CMO
facility fee is owed by each person who owns an FDF facility that is
identified in at least one approved ANDA but is not identified in an
approved ANDA held by the owner of that facility or its affiliates.
These fees are due no later than the first business day on or after
October 1 of each such year. Section 744B(b)(2)(C) of the FD&C Act
specifies that the FDF and CMO facility fee revenue will make up 20
percent of the $513,223,000, which is $102,644,600.
To calculate the fees, data from FDA's Integrity Services (IS) were
utilized as the primary source of facility information for determining
the denominators of each facility fee type. IS is the master data
steward for all facility information provided in generic drug
submissions received by FDA. A facility's reference status in an
approved generic drug submission is extracted directly from submission
data rather than relying on data from self-identification. This
information provided the number of facilities referenced as FDF
manufacturers in at least one approved generic drug submission. Based
on FDA's IS data, the FDF and CMO facility denominators are 192 FDF
domestic, 248 FDF foreign, 75 CMO domestic, and 99 CMO foreign
facilities for FY 2020.
GDUFA II specifies that the CMO facility fee is to be equal to one-
third the amount of the FDF facility fee. Therefore, to generate the
target collection revenue amount from FDF and CMO facility fees
($102,644,600), FDA must weight a CMO facility as one-third of an FDF
facility. FDA set fees based on the estimate of 192 FDF domestic, 248
FDF foreign, 25 CMO domestic (75 multiplied by one-third), and 33 CMO
foreign facilities (99 multiplied by one-third), which equals 498 total
weighted FDF and CMO facilities for FY 2020.
To calculate the fee for domestic facilities, FDA first determines
the total fee revenue that will result from the foreign facility
differential by subtracting the fee revenue resulting from the foreign
facility fee differential from the target collection revenue amount
($102,644,600) as follows. The foreign facility fee differential
revenue equals the foreign facility fee differential ($15,000)
multiplied by the number of FDF foreign facilities (248) plus the
foreign facility fee differential ($15,000) multiplied by the number of
CMO foreign facilities (99), totaling $5,205,000. This results in
foreign fee differential revenue of $5,205,000 from the total FDF and
CMO facility fee target collection revenue. Subtracting the foreign
facility differential fee revenue ($5,205,000) from the total FDF and
CMO facility target collection revenue ($102,644,600) results in a
remaining facility fee revenue balance of $97,439,600. To determine the
domestic FDF facility fee, FDA divides the $97,439,600 by the total
weighted number of FDF and CMO facilities (498), which results in a
domestic FDF facility fee of $195,662. The foreign FDF
[[Page 36104]]
facility fee is $15,000 more than the domestic FDF facility fee, or
$210,662.
According to GDUFA II, the domestic CMO fee is calculated as one-
third the amount of the domestic FDF facility fee. Therefore, the
domestic CMO fee is $65,221, rounded to the nearest dollar. The foreign
CMO fee is calculated as the domestic CMO fee plus the foreign fee
differential of $15,000. Therefore, the foreign CMO fee is $80,221.
VII. API Facility Fee
Under GDUFA II, the annual API facility fee is owed by each person
who owns a facility that is identified in (1) at least one approved
generic drug submission or (2) in a Type II API DMF referenced in at
least one approved generic drug submission. These fees are due no later
than the first business day on or after October 1 of each such year.
Section 744B(b)(2)(D) of the FD&C Act specifies the API facility fee
will make up 7 percent of $513,223,000 in fee revenue, which is
$35,925,610.
To calculate the API facility fee, data from FDA's IS were utilized
as the primary source of facility information for determining the
denominator. As stated above, IS is the master data steward for all
facility information provided in generic drug submissions received by
FDA. A facility's reference status in an approved generic drug
submission is extracted directly from submission data rather than
relying on data from self-identification. This information provided the
number of facilities referenced as API manufacturers in at least one
approved generic drug submission.
The total number of API facilities identified was 624; of that
number, 76 were domestic and 548 were foreign facilities. The foreign
facility differential is $15,000. To calculate the fee for domestic
facilities, FDA must first subtract the fee revenue that will result
from the foreign facility fee differential. FDA takes the foreign
facility differential ($15,000) and multiplies it by the number of
foreign facilities (548) to determine the total fee revenue that will
result from the foreign facility differential. As a result of that
calculation, the foreign fee differential revenue will make up
$8,220,000 of the total API fee revenue. Subtracting the foreign
facility differential fee revenue ($8,220,000) from the total API
facility target revenue ($35,925,610) results in a remaining balance of
$27,705,610. To determine the domestic API facility fee, we divide the
$27,705,610 by the total number of facilities (624), which gives us a
domestic API facility fee of $44,400. The foreign API facility fee is
$15,000 more than the domestic API facility fee, or $59,400.
VIII. Generic Drug Applicant Program Fee
Under GDUFA II, if a person and its affiliates own at least one but
not more than five approved ANDAs on October 1, 2019, the person and
its affiliates shall owe a small business GDUFA program fee. If a
person and its affiliates own at least 6 but not more than 19 approved
ANDAs, the person and its affiliates shall owe a medium size operation
GDUFA program fee. If a person and its affiliates own at least 20
approved ANDAs, the person and its affiliates shall owe a large size
operation GDUFA program fee. These fees are due no later than the first
business day on or after October 1 of each such year. Section
744B(b)(2)(E) of the FD&C Act specifies the GDUFA program fee will make
up 35 percent of $513,223,000 in fee revenue, which is $179,628,050.
To determine the appropriate number of parent companies for each
tier, the Agency asked companies to claim their ANDAs and affiliates in
the Center for Drug Evaluation and Research (CDER) NextGen Portal. The
companies were able to confirm relationships currently present in the
Agency's records, while also reporting newly approved ANDAs, newly
acquired ANDAs, and new affiliations.
In determining the appropriate number of approved ANDAs, the Agency
has factored in a number of variables that could affect the collection
of the target revenue: (1) Inactive ANDAs--applicants who have not
submitted an annual report for one or more of their approved
applications within the past 2 years; (2) FY 2018 Program Fee Arrears
List--applicants who failed to satisfy the FY 2018 program fee and were
unresponsive to attempts to collect; (3) Center for Biologics
Evaluation and Research (CBER) approved ANDAs--applicants and their
affiliates with CBER-approved ANDAs in addition to CDER's approved
ANDAs; (4) withdrawals of approved ANDAs by April 1st--applicants who
have submitted a written request for withdrawal of approval by April
1st of the previous fiscal year; (5) Abbreviated Antibiotic
Applications (AADA) conversions--ANDAs (previously AADAs) for bulk
antibiotic drug substance converted and refiled as DMFs; and (6) ANDAs
with Conditional Approval status--a small number of pre-1984 ANDAs that
are considered approved for marketing, but as to which additional
information has been requested. The list of original approved ANDAs
from the Generic Drug Review Platform as of April 30, 2019, shows 265
applicants in the small business tier, 71 applicants in the medium size
tier, and 64 applicants in the large size tier. Factoring in all the
variables for the third year of GDUFA II, the Agency estimates there
will be 199 applicants in the small business tier, 63 applicants in the
medium size tier, and 63 applicants in the large size tier for FY 2020.
To calculate the GDUFA program fee, GDUFA II provides that large
size operation generic drug applicants pay the full fee, medium size
operation applicants pay two-fifths of the full fee, and small business
applicants pay one-tenth of the full fee. To generate the target
collection revenue amount from GDUFA program fees ($179,628,050), we
must weigh medium and small tiered applicants as a subset of a large
size operation generic drug applicant. FDA will set fees based on the
weighted estimate of 19.90 applicants in the small business tier (199
multiplied by 10 percent), 25.20 applicants in the medium size tier (63
multiplied by 40 percent), and 63 applicants in the large size tier,
arriving at 108.10 total weighted applicants for FY 2020.
To generate the large size operation GDUFA program fee, FDA divides
the target revenue amount of $179,628,050 by 108.10, which equals
$1,661,684. The medium size operation GDUFA program fee is 40 percent
of the full fee ($664,674), and the small business operation GDUFA
program fee is 10 percent of the full fee ($166,168).
IX. Fee Schedule for FY 2020
The fee rates for FY 2020 are set out in table 4.
Table 4--Fee Schedule for FY 2020
------------------------------------------------------------------------
Fees rates for
Fee category FY 2020
------------------------------------------------------------------------
Applications:
Abbreviated New Drug Application (ANDA)............. $176,237
Drug Master File (DMF).............................. 57,795
[[Page 36105]]
Facilities:
Active Pharmaceutical Ingredient (API) Domestic..... 44,400
API--Foreign........................................ 59,400
Finished Dosage Form (FDF)--Domestic................ 195,662
FDF--Foreign........................................ 210,662
Contract Manufacturing Organization (CMO)--Domestic. 65,221
CMO--Foreign........................................ 80,221
GDUFA Program:
Large size operation generic drug applicant......... 1,661,684
Medium size operation generic drug applicant........ 664,674
Small business operation generic drug applicant..... 166,168
------------------------------------------------------------------------
X. Fee Payment Options and Procedures
The new fee rates are effective October 1, 2019. To pay the ANDA,
DMF, API facility, FDF facility, CMO facility, and GDUFA program fees,
a Generic Drug User Fee Cover Sheet must be completed, available at
https://www.fda.gov/gdufa and https://userfees.fda.gov/OA_HTML/gdufaCAcdLogin.jsp, and a user fee identification (ID) number must be
generated. Payment must be made in U.S. currency drawn on a U.S. bank
by electronic check, check, bank draft, U.S. postal money order, credit
card, or wire transfer. 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 utilize Pay.gov,
a web-based payment application, for online electronic payment. The
Pay.gov feature is available on the FDA website after completing the
Generic 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 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.
The user fee ID number must be included on the check, bank draft,
or postal money order and must be made payable to the order of the Food
and Drug Administration. Payments can be mailed to: Food and Drug
Administration, P.O. Box 979108, St. Louis, MO 63197-9000. If checks
are to be sent by a courier that requests a street address, the courier
can deliver checks to: U.S. Bank, Attention: Government Lockbox 979108,
1005 Convention Plaza, St. Louis, MO 63101. (Note: This U.S. Bank
address is for courier delivery only. For questions concerning courier
delivery, U.S. Bank can be contacted at 314-418-4013. This telephone
number is only for questions about courier delivery.) The FDA post
office box number (P.O. Box 979108) must be written on the check, bank
draft, or postal money order.
For payments made by wire transfer, the unique user fee ID number
must be referenced. Without the unique user fee ID number, the payment
may not be applied. If the payment amount is not applied, the invoice
amount will be referred to collections. 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 following account information should be used to send
payments by wire transfer: U.S. Department of the Treasury, TREAS NYC,
33 Liberty St., New York, NY 10045, account number: 75060099, routing
number: 021030004, SWIFT: FRNYUS33. FDA's tax identification number is
53-0196965.
Dated: July 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-15906 Filed 7-25-19; 8:45 am]
BILLING CODE 4164-01-P
