Document ID: FDA-2018-N-0007-0003
Agency: fda
Document Type: Notice
Title: Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2019
Posted Date: 2018-09-26T04:00Z

[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]]

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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.

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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 http://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
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                                                           Fee rate for
              Animal drug user fee category                   FY 2019
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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.
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    \1\ CVM's guidance for industry (GFI) #170 is located at: 
https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052494.pdf.
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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