Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2019, 48621-48625 [2018-20911]
Download as PDF
<![CDATA[
Federal Register / Vol. 83, No. 187 / Wednesday, September 26, 2018 / Notices
The Food and Drug
Administration (FDA) is announcing the
rates and payment procedures for fiscal
year (FY) 2019 animal drug user fees.
The Federal Food, Drug, and Cosmetic
Act (FD&C Act), as amended by the
Animal Drug User Fee Amendments of
2018 (ADUFA IV), authorizes FDA to
collect user fees for certain animal drug
applications and supplements, for
certain animal drug products, for certain
establishments where such products are
made, and for certain sponsors of such
animal drug applications and/or
investigational animal drug
submissions. This notice establishes the
fee rates for FY 2019.
FOR FURTHER INFORMATION CONTACT: Visit
FDA’s website at https://www.fda.gov/
ForIndustry/UserFees/
AnimalDrugUserFeeActADUFA/
default.htm or contact Lisa Kable,
Center for Veterinary Medicine (HFV–
10), Food and Drug Administration,
7500 Standish Pl., Rockville, MD 20855,
240–402–6888, Lisa.Kable@fda.hhs.gov.
For general questions, you may also
email the Center for Veterinary
Medicine (CVM) at: cvmadufa@
fda.hhs.gov.
for inflation and workload, and for
excess collections to reduce workloadbased increases or collection shortfalls
after FY 2020 (21 U.S.C. 379j–12(c) and
(g)). Fees for applications,
establishments, products, and sponsors
are to be established each year by FDA
so that the percentages of the total
revenue that are derived from each type
of user fee will be as follows: Revenue
from application fees shall be 20 percent
of total fee revenue; revenue from
product fees shall be 27 percent of total
fee revenue; revenue from establishment
fees shall be 26 percent of total fee
revenue; and revenue from sponsor fees
shall be 27 percent of total fee revenue
(21 U.S.C. 379j–12(b)(2)).
For FY 2019, the animal drug user fee
rates are: $449,348 for an animal drug
application; $224,674 for a
supplemental animal drug application
for which safety or effectiveness data are
required and for an animal drug
application subject to the criteria set
forth in section 512(d)(4) of the FD&C
Act (21 U.S.C. 360b(d)(4)); $10,747 for
an annual product fee; $146,038 for an
annual establishment fee; and $125,990
for an annual sponsor fee. FDA will
issue invoices for FY 2019 product,
establishment, and sponsor fees by
December 31, 2018, and payment will
be due by January 31, 2019. The
application fee rates are effective for
applications submitted on or after
October 1, 2018, and will remain in
effect through September 30, 2019.
Applications will not be accepted for
review until FDA has received full
payment of application fees and any
other animal drug user fees owed under
the Animal Drug User Fee program
(ADUFA program).
SUPPLEMENTARY INFORMATION:
II. Revenue Amount for FY 2019
I. Background
A. Statutory Fee Revenue Amounts
Section 740 of the FD&C Act (21
U.S.C. 379j–12) establishes four
different types of user fees: (1) Fees for
certain types of animal drug
applications and supplements; (2)
annual fees for certain animal drug
products; (3) annual fees for certain
establishments where such products are
made; and (4) annual fees for certain
sponsors of animal drug applications
and/or investigational animal drug
submissions (21 U.S.C. 379j–12(a)).
When certain conditions are met, FDA
will waive or reduce fees (21 U.S.C.
379j–12(d)).
For FY 2019 through FY 2023, the
FD&C Act establishes aggregate yearly
base revenue amounts for each fiscal
year (21 U.S.C. 379j–12(b)(1)). Base
revenue amounts established for years
after FY 2019 are subject to adjustment
ADUFA IV, Title I of Public Law 115–
234, specifies that the aggregate fee
revenue amount for FY 2019 for all
animal drug user fee categories is
$30,331,000 (rounded to the nearest
thousand dollars) (21 U.S.C. 379j–
12(b)(1)(A)).
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–0007]
Animal Drug User Fee Rates and
Payment Procedures for Fiscal Year
2019
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
daltland on DSKBBV9HB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
19:21 Sep 25, 2018
Jkt 244001
B. Inflation Adjustment to Fee Revenue
Amount
The fee revenue amounts established
in ADUFA IV for FY 2020 and
subsequent fiscal years are subject to an
inflation adjustment (21 U.S.C. 379j–
12(c)(2)).
ADUFA IV specifies that the annual
fee revenue amount is to be adjusted
using two separate adjustments—one for
personnel compensation and benefits
(PC&B) and one for non-PC&B costs (21
U.S.C. 379j–12(c)(2)(A)(ii) and (iii)). The
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
48621
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 full-time
equivalent position (FTE) at FDA for the
first 3 of the 4 preceding fiscal years,
multiplied by the average proportion of
PC&B costs to total FDA costs for the
first 3 of the 4 preceding fiscal years.
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
less food and energy; 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 FDA costs. Because the
adjustment for inflation does not take
effect until FY 2020, FDA will not
adjust the FY 2019 fee revenue amount
for inflation.
C. Workload Adjustment to Inflation
Adjusted Fee Revenue Amount
The fee revenue amounts established
in ADUFA IV for FY 2020 and
subsequent fiscal years are also subject
to adjustment to account for changes in
FDA’s review workload. A workload
adjustment will be applied to the
inflation adjusted fee revenue amount
(21 U.S.C. 379j–12(c)(3)).
ADUFA IV specifies that FDA shall
calculate the weighted average of the
change in the total number of each of
the five types of applications and
submissions specified in the workload
adjustment provision (animal drug
applications, supplemental animal drug
applications for which data with respect
to safety or efficacy are required,
manufacturing supplemental animal
drug applications, investigational
animal drug study submissions, and
investigational animal drug protocol
submissions). Because the adjustment
for workload does not take effect until
FY 2020, FDA will not adjust the FY
2019 fee revenue amount for workload
changes.
D. Reduction of Workload-Based
Increase by Amount of Certain Excess
Collections
Under section 740(c)(3)(B) of the
FD&C Act, for fiscal years 2021 through
2023, if application of the workload
adjustment increases the amount of fee
revenues established for the fiscal year,
as adjusted for inflation, the fee revenue
increase will be reduced by the amount
of any excess collections for the second
preceding fiscal year, up to the amount
of the fee revenue increase. Since this
provision will not take effect until FY
E:\FR\FM\26SEN1.SGM
26SEN1
48622
Federal Register / Vol. 83, No. 187 / Wednesday, September 26, 2018 / Notices
2021, FDA will not reduce the FY 2019
fee revenue amount for excess
collections.
E. Recovery of Collection Shortfalls
Under section 740(g)(5)(A) of the
FD&C Act, for FY 2021, the amount of
fees otherwise authorized to be
collected shall be increased by the
amount, if any, by which the amount
collected and appropriated for FY 2019
falls below the amount of fees
authorized for FY 2019. For FY 2022,
the amount of fees otherwise authorized
to be collected shall be increased by the
amount, if any, by which the amount
collected and appropriated for FY 2020
falls below the amount of fees
authorized for FY 2020. For FY 2023,
the amount of fees otherwise authorized
to be collected shall be increased by the
cumulative amount, if any, by which the
amount collected and appropriated for
fiscal years 2021 and 2022 (including
estimated collections for FY 2022) falls
below the cumulative amount of fees
authorized for those 2 fiscal years.
Because the recovery of collection
shortfalls does not take effect until FY
2021, FDA will not adjust the FY 2019
fee revenue amount for the recovery of
collection shortfalls.
F. Reduction of Shortfall-Based Fee
Increase by Prior Year Excess
Collections
Under section 740(g)(5)(B) of the
FD&C Act, where FDA’s calculations
under section 740(g)(5)(A) result in an
increase for that fiscal year to recover a
collection shortfall, FDA must reduce
the increase by the amount of any
excess collections for preceding fiscal
years (after fiscal year 2018) that have
not already been applied for purposes of
reducing workload-based fee increases.
Because the recovery of collection
shortfalls does not take effect until FY
2021, FDA will not adjust the FY 2019
fee revenue amount for the reduction of
shortfall-based fee increases by prior
year excess collections.
daltland on DSKBBV9HB2PROD with NOTICES
G. FY 2019 Fee Revenue Amounts
ADUFA IV specifies that the revenue
amount of $30,331,000 (rounded to the
nearest thousand dollars) for FY 2019 is
to be divided as follows: 20 percent, or
a total of $6,066,200, is to come from
application fees; 27 percent, or a total of
$8,189,370, is to come from product
fees; 26 percent, or a total of $7,886,060,
is to come from establishment fees; and
27 percent, or a total of $8,189,370, is
to come from sponsor fees (21 U.S.C.
379j-12(b)).
VerDate Sep<11>2014
19:21 Sep 25, 2018
Jkt 244001
III. Application Fee Calculations for FY
2019
A. Application Fee Revenues and
Numbers of Fee-Paying Applications
Each person that submits an animal
drug application or a supplemental
animal drug application shall be subject
to an application fee, with limited
exceptions (see 21 U.S.C. 379j–12(a)(1)).
The term ‘‘animal drug application’’
means an application for approval of
any new animal drug submitted under
section 512(b)(1) or an application for
conditional approval of a new animal
drug submitted under section 571 of the
FD&C Act (21 U.S.C. 360ccc) (see
section 739 of the FD&C Act (21 U.S.C.
379j–11)). As the expanded definition of
‘‘animal drug application’’ includes
applications for conditional approval
submitted under section 571 of the
FD&C Act, such applications are now
subject to ADUFA fees, except that fees
may be waived if the drug is intended
solely to provide for a minor use or
minor species (MUMS) indication (see
21 U.S.C. 379j–12(d)(1)(D)).
Prior to ADUFA IV, FDA only had
authority to grant conditional approval
for drugs intended for a MUMS
indication. Under ADUFA IV, FDA
retains authority to grant conditional
approval for drugs intended for MUMS
indications but also will be able to grant
conditional approval for certain drugs
not intended for a MUMS indication
provided certain criteria are met.
Beginning with FY 2019, ADUFA IV
provides an exception from application
fees for animal drug applications
submitted under section 512(b)(1) of the
FD&C Act if the application is submitted
by a sponsor who previously applied for
conditional approval under the new
non-MUMS pathway of section 571 for
the same product and paid an
application fee at the time they applied
for conditional approval. The purpose of
this exception is to prevent sponsors of
conditionally approved products from
having to pay a second application fee
at the time they apply for full approval
of their products under section 512(b)(1)
of the FD&C Act, provided the sponsor’s
application for full approval is filed
consistent with the timeframes
established in section 571(h) of the
FD&C Act.
A ‘‘supplemental animal drug
application’’ is defined as a request to
the Secretary of Health and Human
Services (Secretary) to approve a change
in an animal drug application that has
been approved, or a request to the
Secretary to approve a change to an
application approved under section
512(c)(2) of the FD&C Act for which
data with respect to safety or
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
effectiveness are required (21 U.S.C.
379j–11(2)). The application fees are to
be set so that they will generate
$6,066,200 in fee revenue for FY 2019.
The fee for a supplemental animal drug
application for which safety or
effectiveness data are required and for
an animal drug application subject to
criteria set forth in section 512(d)(4) of
the FD&C Act is to be set at 50 percent
of the animal drug application fee (21
U.S.C. 379j–12(a)(1)(A)(ii)).
To set animal drug application fees
and supplemental animal drug
application fees to realize $6,066,200,
FDA must first make some assumptions
about the number of fee-paying
applications and supplements the
Agency will receive in FY 2019.
The Agency knows the number of
applications that have been submitted
in previous years, which fluctuates
annually. In estimating the fee revenue
to be generated by animal drug
application fees in FY 2019, FDA is
assuming that the number of
applications for which fees will be paid
in FY 2019 will equal the average
number of submissions over the 5 most
recent completed years of the ADUFA
program (FY 2013 to FY 2017).
Over the 5 most recent completed
years, the average number of animal
drug applications that would have been
subject to the full fee was 7.2. Over this
same period, the average number of
supplemental applications for which
safety or effectiveness data are required
and applications subject to the criteria
set forth in section 512(d)(4) of the
FD&C Act that would have been subject
to half of the full fee was 12.6.
B. Application Fee Rates for FY 2019
FDA must set the fee rates for FY 2019
so that the estimated 7.2 applications for
which the full fee will be paid and the
estimated 12.6 supplemental
applications for which safety or
effectiveness data are required and
applications subject to the criteria set
forth in section 512(d)(4) of the FD&C
Act for which half of the full fee will be
paid will generate a total of $6,066,200.
To generate this amount, the fee for an
animal drug application, rounded to the
nearest dollar, will have to be $449,348,
and the fee for a supplemental animal
drug application for which safety or
effectiveness data are required and for
applications subject to the criteria set
forth in section 512(d)(4) of the FD&C
Act will have to be $224,674.
E:\FR\FM\26SEN1.SGM
26SEN1
Federal Register / Vol. 83, No. 187 / Wednesday, September 26, 2018 / Notices
daltland on DSKBBV9HB2PROD with NOTICES
IV. Product Fee Calculations for FY
2019
A. Product Fee Revenues and Numbers
of Fee-Paying Products
The animal drug product fee must be
paid annually by the person named as
the applicant in a new animal drug
application or supplemental new animal
drug application for an animal drug
product submitted for listing under
section 510 of the FD&C Act (21 U.S.C.
360) and who had an animal drug
application or supplemental animal
drug application pending at FDA after
September 1, 2003 (21 U.S.C. 379j–
12(a)(2)). The term ‘‘animal drug
product’’ means each specific strength
or potency of a particular active
ingredient or ingredients in final dosage
form marketed by a particular
manufacturer or distributor, which is
uniquely identified by the labeler code
and product code portions of the
national drug code, and for which an
animal drug application or a
supplemental animal drug application
has been approved (21 U.S.C. 379j–
11(3)). The product fees are to be set so
that they will generate $8,189,370 in fee
revenue for FY 2019.
To set animal drug product fees to
realize $8,189,370, FDA must make
some assumptions about the number of
products for which these fees will be
paid in FY 2019. FDA developed data
on all animal drug products that have
been submitted for listing under section
510 of the FD&C Act and matched this
to the list of all persons who had an
animal drug application or supplement
pending after September 1, 2003. As of
June 2018, FDA estimates that there are
a total of 786 products submitted for
listing by persons who had an animal
drug application or supplemental
animal drug application pending after
September 1, 2003. Based on this, FDA
estimates that a total of 786 products
will be subject to this fee in FY 2019.
In estimating the fee revenue to be
generated by animal drug product fees
in FY 2019, FDA is assuming that 3
percent of the products invoiced, or 24,
will not pay fees in FY 2019 due to fee
waivers and reductions. FDA has kept
this estimate at 3 percent this year,
based on historical data over the past 5
completed years of the ADUFA
program.
Accordingly, the Agency estimates
that a total of 762 (786 minus 24)
products will be subject to product fees
in FY 2019.
B. Product Fee Rates for FY 2019
FDA must set the fee rates for FY 2019
so that the estimated 762 products that
pay fees will generate a total of
VerDate Sep<11>2014
19:21 Sep 25, 2018
Jkt 244001
48623
$8,189,370. To generate this amount
will require the fee for an animal drug
product, rounded to the nearest dollar,
to be $10,747.
Accordingly, the Agency estimates
that a total of 54 establishments (60
minus 6) will be subject to
establishment fees in FY 2019.
V. Establishment Fee Calculations for
FY 2019
B. Establishment Fee Rates for FY 2019
A. Establishment Fee Revenues and
Numbers of Fee-Paying Establishments
The animal drug establishment fee
must be paid annually by the person
who: (1) Owns or operates, directly or
through an affiliate, an animal drug
establishment; (2) is named as the
applicant in an animal drug application
or supplemental animal drug
application for an animal drug product
submitted for listing under section 510
of the FD&C Act; (3) had an animal drug
application or supplemental animal
drug application pending at FDA after
September 1, 2003; and (4) whose
establishment engaged in the
manufacture of the animal drug product
during the fiscal year (see 21 U.S.C.
379j–12(a)(3)). An establishment subject
to animal drug establishment fees is
assessed only one such fee per fiscal
year. The term ‘‘animal drug
establishment’’ is defined as a foreign or
domestic place of business at one
general physical location, consisting of
one or more buildings, all of which are
within 5 miles of each other, at which
one or more animal drug products are
manufactured in final dosage form (21
U.S.C. 379j–11(4)). The establishment
fees are to be set so that they will
generate $7,886,060 in fee revenue for
FY 2019.
To set animal drug establishment fees
to realize $7,886,060, FDA must make
some assumptions about the number of
establishments for which these fees will
be paid in FY 2019. FDA developed data
on all animal drug establishments and
matched this to the list of all persons
who had an animal drug application or
supplement pending after September 1,
2003. As of June 2018, FDA estimates
that there are a total of 60
establishments owned or operated by
persons who had an animal drug
application or supplemental animal
drug application pending after
September 1, 2003. Based on this, FDA
believes that 60 establishments will be
subject to this fee in FY 2019.
In estimating the fee revenue to be
generated by animal drug establishment
fees in FY 2019, FDA is assuming that
10 percent of the establishments
invoiced, or six, will not pay fees in FY
2019 due to fee waivers and reductions.
FDA has made this estimate at 10
percent this year, based on historical
data over the past 5 completed years.
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
FDA must set the fee rates for FY 2019
so that the fees paid for the estimated 54
establishments will generate a total of
$7,886,060. To generate this amount
will require the fee for an animal drug
establishment, rounded to the nearest
dollar, to be $146,038.
VI. Sponsor Fee Calculations for FY
2019
A. Sponsor Fee Revenues and Numbers
of Fee-Paying Sponsors
The animal drug sponsor fee must be
paid annually by each person who: (1)
Is named as the applicant in an animal
drug application, except for an
approved application for which all
subject products have been removed
from listing under section 510 of the
FD&C Act, or has submitted an
investigational animal drug submission
that has not been terminated or
otherwise rendered inactive and (2) had
an animal drug application,
supplemental animal drug application,
or investigational animal drug
submission pending at FDA after
September 1, 2003 (see 21 U.S.C. 379j–
11(6) and 379j–12(a)(4)). An animal
drug sponsor is subject to only one such
fee each fiscal year (see 21 U.S.C. 379j–
12(a)(4)). The sponsor fees are to be set
so that they will generate $8,189,370 in
fee revenue for FY 2019.
To set animal drug sponsor fees to
realize $8,189,370, FDA must make
some assumptions about the number of
sponsors who will pay these fees in FY
2019. FDA estimates that a total of 196
sponsors will meet this definition in FY
2019.
In estimating the fee revenue to be
generated by animal drug sponsor fees
in FY 2019, FDA is assuming that 67
percent of the sponsors invoiced, or 131,
will not pay sponsor fees in FY 2019
due to fee waivers and reductions. FDA
has kept this estimate at 67 percent this
year, based on historical data over the
past 5 completed years of the ADUFA
program. FDA believes that this is a
reasonable basis for estimating the
number of fee-paying sponsors in FY
2019.
Accordingly, the Agency estimates
that a total of 65 sponsors (196 minus
131) will be subject to and pay sponsor
fees in FY 2019.
B. Sponsor Fee Rates for FY 2019
FDA must set the fee rates for FY 2019
so that the estimated 65 sponsors that
E:\FR\FM\26SEN1.SGM
26SEN1
48624
Federal Register / Vol. 83, No. 187 / Wednesday, September 26, 2018 / Notices
pay fees will generate a total of
$8,189,370. To generate this amount
will require the fee for an animal drug
sponsor, rounded to the nearest dollar,
to be $125,990.
VII. Fee Schedule for FY 2019
The fee rates for FY 2019 are
summarized in table 1.
TABLE 1—FY 2019 FEE RATES
Fee rate for
FY 2019
Animal drug user fee category
Animal Drug Application Fees:
Animal Drug Application ...............................................................................................................................................................
Supplemental Animal Drug Application for Which Safety or Effectiveness Data are Required or Animal Drug Application
Subject to the Criteria Set Forth in Section 512(d)(4) of the FD&C Act ..................................................................................
Animal Drug Product Fee ....................................................................................................................................................................
Animal Drug Establishment Fee 1 ........................................................................................................................................................
Animal Drug Sponsor Fee 2 .................................................................................................................................................................
1 An
2 An
224,674
10,747
146,038
125,990
animal drug establishment is subject to only one such fee each fiscal year.
animal drug sponsor is subject to only one such fee each fiscal year.
VIII. Fee Waiver or Reduction;
Exemption From Fees
A. Barrier to Innovation Waivers
Under section 740(d)(1)(A) of the
FD&C Act, an animal drug applicant
may qualify for a waiver or reduction of
one or more ADUFA fees if the fee
would present a significant barrier to
innovation because of limited resources
available to the applicant or due to other
circumstances. FDA CVM’s guidance for
industry (GFI) #170, entitled ‘‘Animal
Drug User Fees and Fee Waivers and
Reductions 1,’’ states that for purposes of
determining whether to grant a barrier
to innovation waiver or reduction of
ADUFA fees on financial grounds, FDA
has determined an applicant with
financial resources of less than
$20,000,000 (including the financial
resources of the applicant’s affiliates),
adjusted annually for inflation, has
limited resources available. Using the
CPI for urban consumers (U.S. city
average; not seasonally adjusted; all
items; annual index), the inflationadjusted level for FY 2019 will be
$20,742,100; this level represents the
financial resource ceiling that will be
used to determine if there are limited
resources available to an applicant
requesting a Barrier to Innovation
waiver on financial grounds for FY 2019
in addition to the criteria requiring the
product to be innovative.
B. Exemptions From Fees
daltland on DSKBBV9HB2PROD with NOTICES
$449,348
The types of fee waivers and
reductions that applied last fiscal year
still exist for FY 2019. However, two
new exemptions from fees were
established by ADUFA IV, as follows:
If an animal drug application,
supplemental animal drug application,
1 CVM’s guidance for industry (GFI) #170 is
located at: https://www.fda.gov/downloads/
AnimalVeterinary/GuidanceCompliance
Enforcement/GuidanceforIndustry/UCM052494.pdf.
VerDate Sep<11>2014
19:21 Sep 25, 2018
Jkt 244001
or investigational submission involves
the intentional genomic alteration of an
animal that is intended to produce a
human medical product, any person
who is the named applicant or sponsor
of that application or submission will
not be subject to sponsor, product, or
establishment fees under ADUFA based
solely on that application or submission
(21 U.S.C. 379j–12(d)(4)(B)).
Fees will not apply to any person who
not later than September 30, 2023,
submits to CVM a supplemental animal
drug application relating to a new
animal drug application approved under
section 512 of the FD&C Act, solely to
add the application number to the
labeling of the drug in the manner
specified in section 502(w)(3) of the
FD&C Act (21 U.S.C. 352(w)(3)), if that
person otherwise would be subject to
user fees under ADUFA based only on
the submission of the supplemental
application (21 U.S.C. 379j–12(d)(4)(A)).
IX. Procedures for Paying the FY 2019
Fees
A. Application Fees and Payment
Instructions
The appropriate application fee
established in the new fee schedule
must be paid for an animal drug
application or supplement subject to
fees under ADUFA IV that is submitted
on or after October 1, 2018. The
payment must be made in U.S. currency
by one of the following methods: Wire
transfer, electronically, check, bank
draft, or U.S. postal money order made
payable to 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). Secure electronic payments
can be submitted using the User Fees
Payment Portal at https://
userfees.fda.gov/pay, or the Pay.gov
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
payment option is available to you after
you submit a cover sheet. (Note: only
full payments are accepted. No partial
payments can be made online.) Once
you search for and find your invoice,
select ‘‘Pay Now’’ to be redirected to
https://www.pay.gov/. Electronic
payment options are based on the
balance due. Payment by credit card is
available only 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.
When paying by check, bank draft, or
U.S. postal money order, please write
your application’s unique Payment
Identification Number (PIN), beginning
with the letters AD, on the upper righthand corner of your completed Animal
Drug User Fee Cover Sheet. Also write
the FDA post office box number (P.O.
Box 979033) on the enclosed check,
bank draft, or money order. Mail the
payment and a copy of the completed
Animal Drug User Fee Cover Sheet to:
Food and Drug Administration, P.O.
Box 979033, St. Louis, MO 63197–9000.
When paying by wire transfer, the
invoice number needs to be included;
without the invoice number, the
payment may not be applied. If the
payment amount is not applied, the
invoice amount would be referred to
collections. The originating financial
institution may charge a wire transfer
fee. If the financial institution charges a
wire transfer fee, it is required to add
that amount to the payment to ensure
that the invoice is paid in full.
Use the following account
information when sending a payment by
wire transfer: U.S. Department of
Treasury, TREAS NYC, 33 Liberty St.,
New York, NY 10045, FDA Deposit
Account Number: 75060099, U.S.
Department of Treasury routing/transit
E:\FR\FM\26SEN1.SGM
26SEN1
Federal Register / Vol. 83, No. 187 / Wednesday, September 26, 2018 / Notices
daltland on DSKBBV9HB2PROD with NOTICES
number: 021030004, SWIFT Number:
FRNYUS33.
To send a check by a courier such as
Federal Express, the courier must
deliver the check and printed copy of
the cover sheet to: U.S. Bank, Attn:
Government Lockbox 979033, 1005
Convention Plaza, St. Louis, MO 63101.
(Note: This address is for courier
delivery only. If you have any questions
concerning courier delivery, contact
U.S. Bank at 314–418–4013. This
telephone number is only for questions
about courier delivery.)
It is important that the fee arrives at
the bank at least a day or two before the
application arrives at FDA’s CVM. FDA
records the official application receipt
date as the later of the following: The
date the application was received by
FDA’s CVM, or the date U.S. Bank
notifies FDA that your payment in the
full amount has been received, or when
the U.S. Treasury notifies FDA of
receipt of an electronic or wire transfer
payment. U.S. Bank and the U.S.
Treasury are required to notify FDA
within 1 working day, using the PIN
described previously.
The tax identification number of FDA
is 53–0196965. (Note: In no case should
the payment for the fee be submitted to
FDA with the application.)
B. Application Cover Sheet Procedures
Step One—Create a user account and
password. Log on to the ADUFA website
at https://www.fda.gov/ForIndustry/
UserFees/AnimalDrugUserFeeAct
ADUFA/default.htm and, under Tools
and Resources, click ‘‘The Animal Drug
User Fee Cover Sheet’’ and then select
‘‘Create ADUFA User Fee Cover Sheet.’’
For security reasons, each firm
submitting an application will be
assigned an organization identification
number, and each user will also be
required to set up a user account and
password the first time you use this site.
Online instructions will walk you
through this process.
Step Two—Create an Animal Drug
User Fee Cover Sheet, transmit it to
FDA, and print a copy. After logging
into your account with your user name
and password, complete the steps
required to create an Animal Drug User
Fee Cover Sheet. One cover sheet is
needed for each animal drug application
or supplement. Once you are satisfied
that the data on the cover sheet are
accurate and you have finalized the
cover sheet, you will be able to transmit
it electronically to FDA and you will be
able to print a copy of your cover sheet
showing your unique PIN.
Step Three—Send the payment for
your application as described in section
IX.A of this document.
VerDate Sep<11>2014
19:21 Sep 25, 2018
Jkt 244001
Step Four—Please submit your
application and a copy of the completed
Animal Drug User Fee Cover Sheet to
the following address: Food and Drug
Administration, Center for Veterinary
Medicine, Document Control Unit
(HFV–199), 7500 Standish Pl.,
Rockville, MD 20855.
C. Product, Establishment, and Sponsor
Fees
By December 31, 2018, FDA will issue
invoices and payment instructions for
product, establishment, and sponsor
fees for FY 2019 using this fee schedule.
Payment will be due by January 31,
2019. FDA will issue invoices in
November 2019 for any products,
establishments, and sponsors subject to
fees for FY 2019 that qualify for fees
after the December 2018 billing.
Dated: September 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–20911 Filed 9–25–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3552]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Experimental
Study of Cigarette Warnings
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on an experimental
study of cigarette warnings that is being
conducted in support of the graphic
label statement provision of the Family
Smoking Prevention and Tobacco
Control Act (the Tobacco Control Act).
DATES: Submit either electronic or
written comments on the collection of
information by November 26, 2018.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
SUMMARY:
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
48625
be submitted on or before November 26,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of November 26, 2018.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
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,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2018–N–3552 for ‘‘Experimental Study
of Cigarette Warnings.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
E:\FR\FM\26SEN1.SGM
26SEN1
]]>Agencies
[Federal Register Volume 83, Number 187 (Wednesday, September 26, 2018)]
[Notices]
[Pages 48621-48625]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-20911]
[[Page 48621]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-0007]
Animal Drug User Fee Rates and Payment Procedures for Fiscal Year
2019
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the rates
and payment procedures for fiscal year (FY) 2019 animal drug user fees.
The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the
Animal Drug User Fee Amendments of 2018 (ADUFA IV), authorizes FDA to
collect user fees for certain animal drug applications and supplements,
for certain animal drug products, for certain establishments where such
products are made, and for certain sponsors of such animal drug
applications and/or investigational animal drug submissions. This
notice establishes the fee rates for FY 2019.
FOR FURTHER INFORMATION CONTACT: Visit FDA's website at https://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/default.htm
or contact Lisa Kable, Center for Veterinary Medicine (HFV-10), Food
and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-
402-6888, [email protected]. For general questions, you may also
email the Center for Veterinary Medicine (CVM) at:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Section 740 of the FD&C Act (21 U.S.C. 379j-12) establishes four
different types of user fees: (1) Fees for certain types of animal drug
applications and supplements; (2) annual fees for certain animal drug
products; (3) annual fees for certain establishments where such
products are made; and (4) annual fees for certain sponsors of animal
drug applications and/or investigational animal drug submissions (21
U.S.C. 379j-12(a)). When certain conditions are met, FDA will waive or
reduce fees (21 U.S.C. 379j-12(d)).
For FY 2019 through FY 2023, the FD&C Act establishes aggregate
yearly base revenue amounts for each fiscal year (21 U.S.C. 379j-
12(b)(1)). Base revenue amounts established for years after FY 2019 are
subject to adjustment for inflation and workload, and for excess
collections to reduce workload-based increases or collection shortfalls
after FY 2020 (21 U.S.C. 379j-12(c) and (g)). Fees for applications,
establishments, products, and sponsors are to be established each year
by FDA so that the percentages of the total revenue that are derived
from each type of user fee will be as follows: Revenue from application
fees shall be 20 percent of total fee revenue; revenue from product
fees shall be 27 percent of total fee revenue; revenue from
establishment fees shall be 26 percent of total fee revenue; and
revenue from sponsor fees shall be 27 percent of total fee revenue (21
U.S.C. 379j-12(b)(2)).
For FY 2019, the animal drug user fee rates are: $449,348 for an
animal drug application; $224,674 for a supplemental animal drug
application for which safety or effectiveness data are required and for
an animal drug application subject to the criteria set forth in section
512(d)(4) of the FD&C Act (21 U.S.C. 360b(d)(4)); $10,747 for an annual
product fee; $146,038 for an annual establishment fee; and $125,990 for
an annual sponsor fee. FDA will issue invoices for FY 2019 product,
establishment, and sponsor fees by December 31, 2018, and payment will
be due by January 31, 2019. The application fee rates are effective for
applications submitted on or after October 1, 2018, and will remain in
effect through September 30, 2019. Applications will not be accepted
for review until FDA has received full payment of application fees and
any other animal drug user fees owed under the Animal Drug User Fee
program (ADUFA program).
II. Revenue Amount for FY 2019
A. Statutory Fee Revenue Amounts
ADUFA IV, Title I of Public Law 115-234, specifies that the
aggregate fee revenue amount for FY 2019 for all animal drug user fee
categories is $30,331,000 (rounded to the nearest thousand dollars) (21
U.S.C. 379j-12(b)(1)(A)).
B. Inflation Adjustment to Fee Revenue Amount
The fee revenue amounts established in ADUFA IV for FY 2020 and
subsequent fiscal years are subject to an inflation adjustment (21
U.S.C. 379j-12(c)(2)).
ADUFA IV specifies that the annual fee revenue amount is to be
adjusted using two separate adjustments--one for personnel compensation
and benefits (PC&B) and one for non-PC&B costs (21 U.S.C. 379j-
12(c)(2)(A)(ii) and (iii)). 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 full-time equivalent position (FTE) at
FDA for the first 3 of the 4 preceding fiscal years, multiplied by the
average proportion of PC&B costs to total FDA costs for the first 3 of
the 4 preceding fiscal years. 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 less food and energy; 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 FDA costs. Because the
adjustment for inflation does not take effect until FY 2020, FDA will
not adjust the FY 2019 fee revenue amount for inflation.
C. Workload Adjustment to Inflation Adjusted Fee Revenue Amount
The fee revenue amounts established in ADUFA IV for FY 2020 and
subsequent fiscal years are also subject to adjustment to account for
changes in FDA's review workload. A workload adjustment will be applied
to the inflation adjusted fee revenue amount (21 U.S.C. 379j-12(c)(3)).
ADUFA IV specifies that FDA shall calculate the weighted average of
the change in the total number of each of the five types of
applications and submissions specified in the workload adjustment
provision (animal drug applications, supplemental animal drug
applications for which data with respect to safety or efficacy are
required, manufacturing supplemental animal drug applications,
investigational animal drug study submissions, and investigational
animal drug protocol submissions). Because the adjustment for workload
does not take effect until FY 2020, FDA will not adjust the FY 2019 fee
revenue amount for workload changes.
D. Reduction of Workload-Based Increase by Amount of Certain Excess
Collections
Under section 740(c)(3)(B) of the FD&C Act, for fiscal years 2021
through 2023, if application of the workload adjustment increases the
amount of fee revenues established for the fiscal year, as adjusted for
inflation, the fee revenue increase will be reduced by the amount of
any excess collections for the second preceding fiscal year, up to the
amount of the fee revenue increase. Since this provision will not take
effect until FY
[[Page 48622]]
2021, FDA will not reduce the FY 2019 fee revenue amount for excess
collections.
E. Recovery of Collection Shortfalls
Under section 740(g)(5)(A) of the FD&C Act, for FY 2021, the amount
of fees otherwise authorized to be collected shall be increased by the
amount, if any, by which the amount collected and appropriated for FY
2019 falls below the amount of fees authorized for FY 2019. For FY
2022, the amount of fees otherwise authorized to be collected shall be
increased by the amount, if any, by which the amount collected and
appropriated for FY 2020 falls below the amount of fees authorized for
FY 2020. For FY 2023, the amount of fees otherwise authorized to be
collected shall be increased by the cumulative amount, if any, by which
the amount collected and appropriated for fiscal years 2021 and 2022
(including estimated collections for FY 2022) falls below the
cumulative amount of fees authorized for those 2 fiscal years. Because
the recovery of collection shortfalls does not take effect until FY
2021, FDA will not adjust the FY 2019 fee revenue amount for the
recovery of collection shortfalls.
F. Reduction of Shortfall-Based Fee Increase by Prior Year Excess
Collections
Under section 740(g)(5)(B) of the FD&C Act, where FDA's
calculations under section 740(g)(5)(A) result in an increase for that
fiscal year to recover a collection shortfall, FDA must reduce the
increase by the amount of any excess collections for preceding fiscal
years (after fiscal year 2018) that have not already been applied for
purposes of reducing workload-based fee increases. Because the recovery
of collection shortfalls does not take effect until FY 2021, FDA will
not adjust the FY 2019 fee revenue amount for the reduction of
shortfall-based fee increases by prior year excess collections.
G. FY 2019 Fee Revenue Amounts
ADUFA IV specifies that the revenue amount of $30,331,000 (rounded
to the nearest thousand dollars) for FY 2019 is to be divided as
follows: 20 percent, or a total of $6,066,200, is to come from
application fees; 27 percent, or a total of $8,189,370, is to come from
product fees; 26 percent, or a total of $7,886,060, is to come from
establishment fees; and 27 percent, or a total of $8,189,370, is to
come from sponsor fees (21 U.S.C. 379j-12(b)).
III. Application Fee Calculations for FY 2019
A. Application Fee Revenues and Numbers of Fee-Paying Applications
Each person that submits an animal drug application or a
supplemental animal drug application shall be subject to an application
fee, with limited exceptions (see 21 U.S.C. 379j-12(a)(1)). The term
``animal drug application'' means an application for approval of any
new animal drug submitted under section 512(b)(1) or an application for
conditional approval of a new animal drug submitted under section 571
of the FD&C Act (21 U.S.C. 360ccc) (see section 739 of the FD&C Act (21
U.S.C. 379j-11)). As the expanded definition of ``animal drug
application'' includes applications for conditional approval submitted
under section 571 of the FD&C Act, such applications are now subject to
ADUFA fees, except that fees may be waived if the drug is intended
solely to provide for a minor use or minor species (MUMS) indication
(see 21 U.S.C. 379j-12(d)(1)(D)).
Prior to ADUFA IV, FDA only had authority to grant conditional
approval for drugs intended for a MUMS indication. Under ADUFA IV, FDA
retains authority to grant conditional approval for drugs intended for
MUMS indications but also will be able to grant conditional approval
for certain drugs not intended for a MUMS indication provided certain
criteria are met. Beginning with FY 2019, ADUFA IV provides an
exception from application fees for animal drug applications submitted
under section 512(b)(1) of the FD&C Act if the application is submitted
by a sponsor who previously applied for conditional approval under the
new non-MUMS pathway of section 571 for the same product and paid an
application fee at the time they applied for conditional approval. The
purpose of this exception is to prevent sponsors of conditionally
approved products from having to pay a second application fee at the
time they apply for full approval of their products under section
512(b)(1) of the FD&C Act, provided the sponsor's application for full
approval is filed consistent with the timeframes established in section
571(h) of the FD&C Act.
A ``supplemental animal drug application'' is defined as a request
to the Secretary of Health and Human Services (Secretary) to approve a
change in an animal drug application that has been approved, or a
request to the Secretary to approve a change to an application approved
under section 512(c)(2) of the FD&C Act for which data with respect to
safety or effectiveness are required (21 U.S.C. 379j-11(2)). The
application fees are to be set so that they will generate $6,066,200 in
fee revenue for FY 2019. The fee for a supplemental animal drug
application for which safety or effectiveness data are required and for
an animal drug application subject to criteria set forth in section
512(d)(4) of the FD&C Act is to be set at 50 percent of the animal drug
application fee (21 U.S.C. 379j-12(a)(1)(A)(ii)).
To set animal drug application fees and supplemental animal drug
application fees to realize $6,066,200, FDA must first make some
assumptions about the number of fee-paying applications and supplements
the Agency will receive in FY 2019.
The Agency knows the number of applications that have been
submitted in previous years, which fluctuates annually. In estimating
the fee revenue to be generated by animal drug application fees in FY
2019, FDA is assuming that the number of applications for which fees
will be paid in FY 2019 will equal the average number of submissions
over the 5 most recent completed years of the ADUFA program (FY 2013 to
FY 2017).
Over the 5 most recent completed years, the average number of
animal drug applications that would have been subject to the full fee
was 7.2. Over this same period, the average number of supplemental
applications for which safety or effectiveness data are required and
applications subject to the criteria set forth in section 512(d)(4) of
the FD&C Act that would have been subject to half of the full fee was
12.6.
B. Application Fee Rates for FY 2019
FDA must set the fee rates for FY 2019 so that the estimated 7.2
applications for which the full fee will be paid and the estimated 12.6
supplemental applications for which safety or effectiveness data are
required and applications subject to the criteria set forth in section
512(d)(4) of the FD&C Act for which half of the full fee will be paid
will generate a total of $6,066,200. To generate this amount, the fee
for an animal drug application, rounded to the nearest dollar, will
have to be $449,348, and the fee for a supplemental animal drug
application for which safety or effectiveness data are required and for
applications subject to the criteria set forth in section 512(d)(4) of
the FD&C Act will have to be $224,674.
[[Page 48623]]
IV. Product Fee Calculations for FY 2019
A. Product Fee Revenues and Numbers of Fee-Paying Products
The animal drug product fee must be paid annually by the person
named as the applicant in a new animal drug application or supplemental
new animal drug application for an animal drug product submitted for
listing under section 510 of the FD&C Act (21 U.S.C. 360) and who had
an animal drug application or supplemental animal drug application
pending at FDA after September 1, 2003 (21 U.S.C. 379j-12(a)(2)). The
term ``animal drug product'' means each specific strength or potency of
a particular active ingredient or ingredients in final dosage form
marketed by a particular manufacturer or distributor, which is uniquely
identified by the labeler code and product code portions of the
national drug code, and for which an animal drug application or a
supplemental animal drug application has been approved (21 U.S.C. 379j-
11(3)). The product fees are to be set so that they will generate
$8,189,370 in fee revenue for FY 2019.
To set animal drug product fees to realize $8,189,370, FDA must
make some assumptions about the number of products for which these fees
will be paid in FY 2019. FDA developed data on all animal drug products
that have been submitted for listing under section 510 of the FD&C Act
and matched this to the list of all persons who had an animal drug
application or supplement pending after September 1, 2003. As of June
2018, FDA estimates that there are a total of 786 products submitted
for listing by persons who had an animal drug application or
supplemental animal drug application pending after September 1, 2003.
Based on this, FDA estimates that a total of 786 products will be
subject to this fee in FY 2019.
In estimating the fee revenue to be generated by animal drug
product fees in FY 2019, FDA is assuming that 3 percent of the products
invoiced, or 24, will not pay fees in FY 2019 due to fee waivers and
reductions. FDA has kept this estimate at 3 percent this year, based on
historical data over the past 5 completed years of the ADUFA program.
Accordingly, the Agency estimates that a total of 762 (786 minus
24) products will be subject to product fees in FY 2019.
B. Product Fee Rates for FY 2019
FDA must set the fee rates for FY 2019 so that the estimated 762
products that pay fees will generate a total of $8,189,370. To generate
this amount will require the fee for an animal drug product, rounded to
the nearest dollar, to be $10,747.
V. Establishment Fee Calculations for FY 2019
A. Establishment Fee Revenues and Numbers of Fee-Paying Establishments
The animal drug establishment fee must be paid annually by the
person who: (1) Owns or operates, directly or through an affiliate, an
animal drug establishment; (2) is named as the applicant in an animal
drug application or supplemental animal drug application for an animal
drug product submitted for listing under section 510 of the FD&C Act;
(3) had an animal drug application or supplemental animal drug
application pending at FDA after September 1, 2003; and (4) whose
establishment engaged in the manufacture of the animal drug product
during the fiscal year (see 21 U.S.C. 379j-12(a)(3)). An establishment
subject to animal drug establishment fees is assessed only one such fee
per fiscal year. The term ``animal drug establishment'' is defined as a
foreign or domestic place of business at one general physical location,
consisting of one or more buildings, all of which are within 5 miles of
each other, at which one or more animal drug products are manufactured
in final dosage form (21 U.S.C. 379j-11(4)). The establishment fees are
to be set so that they will generate $7,886,060 in fee revenue for FY
2019.
To set animal drug establishment fees to realize $7,886,060, FDA
must make some assumptions about the number of establishments for which
these fees will be paid in FY 2019. FDA developed data on all animal
drug establishments and matched this to the list of all persons who had
an animal drug application or supplement pending after September 1,
2003. As of June 2018, FDA estimates that there are a total of 60
establishments owned or operated by persons who had an animal drug
application or supplemental animal drug application pending after
September 1, 2003. Based on this, FDA believes that 60 establishments
will be subject to this fee in FY 2019.
In estimating the fee revenue to be generated by animal drug
establishment fees in FY 2019, FDA is assuming that 10 percent of the
establishments invoiced, or six, will not pay fees in FY 2019 due to
fee waivers and reductions. FDA has made this estimate at 10 percent
this year, based on historical data over the past 5 completed years.
Accordingly, the Agency estimates that a total of 54 establishments
(60 minus 6) will be subject to establishment fees in FY 2019.
B. Establishment Fee Rates for FY 2019
FDA must set the fee rates for FY 2019 so that the fees paid for
the estimated 54 establishments will generate a total of $7,886,060. To
generate this amount will require the fee for an animal drug
establishment, rounded to the nearest dollar, to be $146,038.
VI. Sponsor Fee Calculations for FY 2019
A. Sponsor Fee Revenues and Numbers of Fee-Paying Sponsors
The animal drug sponsor fee must be paid annually by each person
who: (1) Is named as the applicant in an animal drug application,
except for an approved application for which all subject products have
been removed from listing under section 510 of the FD&C Act, or has
submitted an investigational animal drug submission that has not been
terminated or otherwise rendered inactive and (2) had an animal drug
application, supplemental animal drug application, or investigational
animal drug submission pending at FDA after September 1, 2003 (see 21
U.S.C. 379j-11(6) and 379j-12(a)(4)). An animal drug sponsor is subject
to only one such fee each fiscal year (see 21 U.S.C. 379j-12(a)(4)).
The sponsor fees are to be set so that they will generate $8,189,370 in
fee revenue for FY 2019.
To set animal drug sponsor fees to realize $8,189,370, FDA must
make some assumptions about the number of sponsors who will pay these
fees in FY 2019. FDA estimates that a total of 196 sponsors will meet
this definition in FY 2019.
In estimating the fee revenue to be generated by animal drug
sponsor fees in FY 2019, FDA is assuming that 67 percent of the
sponsors invoiced, or 131, will not pay sponsor fees in FY 2019 due to
fee waivers and reductions. FDA has kept this estimate at 67 percent
this year, based on historical data over the past 5 completed years of
the ADUFA program. FDA believes that this is a reasonable basis for
estimating the number of fee-paying sponsors in FY 2019.
Accordingly, the Agency estimates that a total of 65 sponsors (196
minus 131) will be subject to and pay sponsor fees in FY 2019.
B. Sponsor Fee Rates for FY 2019
FDA must set the fee rates for FY 2019 so that the estimated 65
sponsors that
[[Page 48624]]
pay fees will generate a total of $8,189,370. To generate this amount
will require the fee for an animal drug sponsor, rounded to the nearest
dollar, to be $125,990.
VII. Fee Schedule for FY 2019
The fee rates for FY 2019 are summarized in table 1.
Table 1--FY 2019 Fee Rates
------------------------------------------------------------------------
Fee rate for
Animal drug user fee category FY 2019
------------------------------------------------------------------------
Animal Drug Application Fees:
Animal Drug Application............................. $449,348
Supplemental Animal Drug Application for Which 224,674
Safety or Effectiveness Data are Required or Animal
Drug Application Subject to the Criteria Set Forth
in Section 512(d)(4) of the FD&C Act...............
Animal Drug Product Fee................................. 10,747
Animal Drug Establishment Fee \1\....................... 146,038
Animal Drug Sponsor Fee \2\............................. 125,990
------------------------------------------------------------------------
\1\ An animal drug establishment is subject to only one such fee each
fiscal year.
\2\ An animal drug sponsor is subject to only one such fee each fiscal
year.
VIII. Fee Waiver or Reduction; Exemption From Fees
A. Barrier to Innovation Waivers
Under section 740(d)(1)(A) of the FD&C Act, an animal drug
applicant may qualify for a waiver or reduction of one or more ADUFA
fees if the fee would present a significant barrier to innovation
because of limited resources available to the applicant or due to other
circumstances. FDA CVM's guidance for industry (GFI) #170, entitled
``Animal Drug User Fees and Fee Waivers and Reductions \1\,'' states
that for purposes of determining whether to grant a barrier to
innovation waiver or reduction of ADUFA fees on financial grounds, FDA
has determined an applicant with financial resources of less than
$20,000,000 (including the financial resources of the applicant's
affiliates), adjusted annually for inflation, has limited resources
available. Using the CPI for urban consumers (U.S. city average; not
seasonally adjusted; all items; annual index), the inflation-adjusted
level for FY 2019 will be $20,742,100; this level represents the
financial resource ceiling that will be used to determine if there are
limited resources available to an applicant requesting a Barrier to
Innovation waiver on financial grounds for FY 2019 in addition to the
criteria requiring the product to be innovative.
---------------------------------------------------------------------------
\1\ CVM's guidance for industry (GFI) #170 is located at:
https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052494.pdf.
---------------------------------------------------------------------------
B. Exemptions From Fees
The types of fee waivers and reductions that applied last fiscal
year still exist for FY 2019. However, two new exemptions from fees
were established by ADUFA IV, as follows:
If an animal drug application, supplemental animal drug
application, or investigational submission involves the intentional
genomic alteration of an animal that is intended to produce a human
medical product, any person who is the named applicant or sponsor of
that application or submission will not be subject to sponsor, product,
or establishment fees under ADUFA based solely on that application or
submission (21 U.S.C. 379j-12(d)(4)(B)).
Fees will not apply to any person who not later than September 30,
2023, submits to CVM a supplemental animal drug application relating to
a new animal drug application approved under section 512 of the FD&C
Act, solely to add the application number to the labeling of the drug
in the manner specified in section 502(w)(3) of the FD&C Act (21 U.S.C.
352(w)(3)), if that person otherwise would be subject to user fees
under ADUFA based only on the submission of the supplemental
application (21 U.S.C. 379j-12(d)(4)(A)).
IX. Procedures for Paying the FY 2019 Fees
A. Application Fees and Payment Instructions
The appropriate application fee established in the new fee schedule
must be paid for an animal drug application or supplement subject to
fees under ADUFA IV that is submitted on or after October 1, 2018. The
payment must be made in U.S. currency by one of the following methods:
Wire transfer, electronically, check, bank draft, or U.S. postal money
order made payable to 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). Secure electronic payments can be
submitted using the User Fees Payment Portal at https://userfees.fda.gov/pay, or the Pay.gov payment option is available to you
after you submit a cover sheet. (Note: only full payments are accepted.
No partial payments can be made online.) Once you search for and find
your invoice, select ``Pay Now'' to be redirected to https://www.pay.gov/. Electronic payment options are based on the balance due.
Payment by credit card is available only 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.
When paying by check, bank draft, or U.S. postal money order,
please write your application's unique Payment Identification Number
(PIN), beginning with the letters AD, on the upper right-hand corner of
your completed Animal Drug User Fee Cover Sheet. Also write the FDA
post office box number (P.O. Box 979033) on the enclosed check, bank
draft, or money order. Mail the payment and a copy of the completed
Animal Drug User Fee Cover Sheet to: Food and Drug Administration, P.O.
Box 979033, St. Louis, MO 63197-9000. When paying by wire transfer, the
invoice number needs to be included; without the invoice number, the
payment may not be applied. If the payment amount is not applied, the
invoice amount would be referred to collections. The originating
financial institution may charge a wire transfer fee. If the financial
institution charges a wire transfer fee, it is required to add that
amount to the payment to ensure that the invoice is paid in full.
Use the following account information when sending a payment by
wire transfer: U.S. Department of Treasury, TREAS NYC, 33 Liberty St.,
New York, NY 10045, FDA Deposit Account Number: 75060099, U.S.
Department of Treasury routing/transit
[[Page 48625]]
number: 021030004, SWIFT Number: FRNYUS33.
To send a check by a courier such as Federal Express, the courier
must deliver the check and printed copy of the cover sheet to: U.S.
Bank, Attn: Government Lockbox 979033, 1005 Convention Plaza, St.
Louis, MO 63101. (Note: This address is for courier delivery only. If
you have any questions concerning courier delivery, contact U.S. Bank
at 314-418-4013. This telephone number is only for questions about
courier delivery.)
It is important that the fee arrives at the bank at least a day or
two before the application arrives at FDA's CVM. FDA records the
official application receipt date as the later of the following: The
date the application was received by FDA's CVM, or the date U.S. Bank
notifies FDA that your payment in the full amount has been received, or
when the U.S. Treasury notifies FDA of receipt of an electronic or wire
transfer payment. U.S. Bank and the U.S. Treasury are required to
notify FDA within 1 working day, using the PIN described previously.
The tax identification number of FDA is 53-0196965. (Note: In no
case should the payment for the fee be submitted to FDA with the
application.)
B. Application Cover Sheet Procedures
Step One--Create a user account and password. Log on to the ADUFA
website at https://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/default.htm and, under Tools and Resources,
click ``The Animal Drug User Fee Cover Sheet'' and then select ``Create
ADUFA User Fee Cover Sheet.'' For security reasons, each firm
submitting an application will be assigned an organization
identification number, and each user will also be required to set up a
user account and password the first time you use this site. Online
instructions will walk you through this process.
Step Two--Create an Animal Drug User Fee Cover Sheet, transmit it
to FDA, and print a copy. After logging into your account with your
user name and password, complete the steps required to create an Animal
Drug User Fee Cover Sheet. One cover sheet is needed for each animal
drug application or supplement. Once you are satisfied that the data on
the cover sheet are accurate and you have finalized the cover sheet,
you will be able to transmit it electronically to FDA and you will be
able to print a copy of your cover sheet showing your unique PIN.
Step Three--Send the payment for your application as described in
section IX.A of this document.
Step Four--Please submit your application and a copy of the
completed Animal Drug User Fee Cover Sheet to the following address:
Food and Drug Administration, Center for Veterinary Medicine, Document
Control Unit (HFV-199), 7500 Standish Pl., Rockville, MD 20855.
C. Product, Establishment, and Sponsor Fees
By December 31, 2018, FDA will issue invoices and payment
instructions for product, establishment, and sponsor fees for FY 2019
using this fee schedule. Payment will be due by January 31, 2019. FDA
will issue invoices in November 2019 for any products, establishments,
and sponsors subject to fees for FY 2019 that qualify for fees after
the December 2018 billing.
Dated: September 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20911 Filed 9-25-18; 8:45 am]
BILLING CODE 4164-01-P
