[Federal Register Volume 82, Number 147 (Wednesday, August 2, 2017)]
[Notices]
[Pages 35966-35971]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16180]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 
2018

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) 2018 animal drug user fees. 
The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by 
the Animal Drug User Fee Amendments of 2013 (ADUFA III), 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 2018.

FOR FURTHER INFORMATION CONTACT: Visit FDA's Web site 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. 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 2014 through FY 2018, 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 2014 are 
subject to adjustment for inflation and workload (21 U.S.C. 379j-
12(c)). 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 2018, the animal drug user fee rates are: $238,100 for an 
animal drug application; $119,050 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)); $6,175 for an annual 
product fee; $88,750 for an annual establishment fee; and $75,150 for 
an annual sponsor fee. FDA will issue invoices for FY 2018 product, 
establishment, and sponsor fees by December 31, 2017, and payment will 
be due by January 31, 2018. The application fee rates are effective for 
applications submitted on or after October 1, 2017, and will remain in 
effect through September 30, 2018. 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 2018

A. Statutory Fee Revenue Amounts

    ADUFA III, Title I of Public Law 113-14, specifies that the 
aggregate fee revenue amount for FY 2018 for all animal drug user fee 
categories is $21,600,000 (21 U.S.C. 379j-12(b)(1)(B)).

B. Inflation Adjustment to Fee Revenue Amount

    The fee revenue amount established in ADUFA III for FY 2015 and 
subsequent fiscal years are subject to an inflation adjustment (21 
U.S.C. 379j-12(c)(2)).
    The component of the inflation adjustment for payroll costs shall 
be one plus the average annual percent change in the cost of all 
personnel compensation and benefits (PC&B) paid per full-time 
equivalent position (FTE) at FDA for the first three of the four 
preceding fiscal years, multiplied by the proportion of PC&B costs to 
total FDA costs for the first three of the four preceding fiscal years 
(see 21 U.S.C. 379j-12(c)(2)(A) and (B)). The data on total PC&B paid 
and numbers of FTE paid, from which the average cost per FTE can be 
derived, are published in FDA's Justification of Estimates for 
Appropriations Committees.
    Table 1 summarizes that actual cost and FTE data for the specified 
fiscal years, and provides the percent change from the previous fiscal 
year and the average percent change over the first of the 4 fiscal 
years preceding FY 2018. The 3-year average is 2.2354 percent.

              Table 1--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Change
----------------------------------------------------------------------------------------------------------------
             Fiscal year                     2014               2015               2016          3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B..........................     $2,054,937,000     $2,232,304,000     $2,414,728,159  .................
Total FTE...........................             14,555             15,484             16,381  .................
PC&B per FTE........................           $141,184           $144,168           $147,408  .................
Percent Change from Previous Year...            2.3451%            2.1136%            2.2474%            2.2354%
----------------------------------------------------------------------------------------------------------------


[[Page 35967]]

    The statute specifies that this 2.2354 percent should be multiplied 
by the proportion of PC&B costs to total FDA costs. Table 2 shows the 
amount of PC&B and the total amount obligated by FDA for the same 3 
FYs.

                                Table 2--PC&B as a Percent of Total Costs at FDA
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             Fiscal year                     2014               2015               2016          3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B..........................     $2,054,937,000     $2,232,304,000     $2,414,728,159  .................
Total Costs.........................     $4,298,476,000     $4,510,565,000     $4,666,236,000  .................
PC&B Percent........................           47.8062%           49.4906%            51.7490           49.6819%
----------------------------------------------------------------------------------------------------------------

    The payroll adjustment is 2.2354 percent multiplied by 49.6819 
percent (or 1.1106 percent).
    The statute specifies that the portion of the inflation adjustment 
for non-payroll costs for FY 2018 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 (see 21 U.S.C. 379j-12(c)(2)(C)). 
Table 3 provides the summary data for the percent change in the 
specified CPI for the Baltimore-Washington area. The data from the 
Bureau of Labor Statistics is shown in table 3.

     Table 3--Annual and 3-Year Average Percent Change in Baltimore-Washington Area CPI Less Food and Energy
----------------------------------------------------------------------------------------------------------------
                Year                         2014               2015               2016          3-Year average
----------------------------------------------------------------------------------------------------------------
Annual CPI..........................            149.581            152.242            154.702  .................
Annual Percent Change...............            1.7883%            1.7790%            1.6158%            1.7277%
----------------------------------------------------------------------------------------------------------------

    To calculate the inflation adjustment for non-pay costs, we 
multiply the 1.7277 percent by the proportion of all costs other than 
PC&B to total FDA costs. Since 49.6819 percent was obligated for PC&B 
as shown in table 2, 50.3181 percent is the portion of costs other than 
PC&B (100 percent -49.6819 percent = 50.3181 percent). The non-payroll 
adjustment is 1.7277 percent times 50.3181 percent, or 0.8693 percent.
    Next, we add the payroll component (1.1106 percent) to the non-pay 
component (0.8693 percent), for a total inflation adjustment of 1.9799 
percent for FY 2018.
    ADUFA III provides for the inflation adjustment to be compounded 
each fiscal year after FY 2014 (see 21 U.S.C. 379j-12(c)(2)). The 
factor for FY 2018 (1.9799 percent) is compounded by adding 1 and then 
multiplying by 1 plus the inflation adjustment factor for FY 2017 
(6.0746 percent), as published in the Federal Register of July 28, 2016 
(81 FR 49664 to 49669), which equals 1.081748 (rounded) (1.019799 x 
1.060746) for FY 2018. We then multiply the base revenue amount for FY 
2018 ($21,600,000) by 1.081748, yielding an inflation adjusted amount 
of $23,365,757.

C. Workload Adjustment to Inflation Adjusted Fee Revenue Amount

    A workload adjustment will be calculated to the inflation adjusted 
fee revenue amount established in ADUFA III for FY 2015 and subsequent 
fiscal years (21 U.S.C. 379j-12(c)(3)).
    FDA calculated the average 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) received over the 5-year period that 
ended on September 30, 2013 (the base years), and the average number of 
each of these types of applications and submissions over the most 
recent 5-year period that ended June 30, 2017.
    The results of these calculations are presented in the first two 
columns of table 4. Column 3 reflects the percent change in workload 
over the two 5-year periods. Column 4 shows the weighting factor for 
each type of application, reflecting how much of the total FDA animal 
drug review workload was accounted for by each type of application or 
submission in the table during the most recent five years. Column 5 is 
the weighted percent change in each category of workload, and was 
derived by multiplying the weighting factor in each line in column 4 by 
the percent change from the base years in column 3. At the bottom right 
of table 4 the sum of the values in column 5 is added, reflecting a 
total change in workload of 5.4599 percent for FY 2018. This is the 
workload adjuster for FY 2018.

                                     Table 4--Workload Adjuster Calculation
                                      [Numbers may not add due to rounding]
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                                                                                                     Column 5
                                   Column 1  5-      Column 2        Column 3        Column 4        weighted
        Application type           year  average  latest  5-year      percent        weighting        percent
                                   (base years)       average         change          factor          change
----------------------------------------------------------------------------------------------------------------
New Animal Drug Applications              9.8000            16.0         63.2653        0.030373          1.9216
 (NADAs)........................
Supplemental NADAs with Safety            9.6000            10.6         10.4167        0.026491          0.2759
 or Efficacy Data...............
Manufacturing Supplements.......        361.0000           334.6         -7.3130        0.162018         -1.1848
Investigational Study                   216.4000           189.8        -12.2921        0.579781         -7.1267
 Submissions....................
Investigational Protocol                133.6000           210.4         57.4850        0.201337         11.5739
 Submissions....................

[[Page 35968]]

 
FY 2018 Workload Adjuster.......  ..............  ..............  ..............  ..............          5.4599
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    FDA experienced an increase in the number of new animal drug 
applications (NADAs) and supplemental NADAs with safety or 
effectiveness data. Over the last several years FDA has seen an 
increase in the number of animal drug products brought by animal drug 
sponsors for review in the drug evaluation process. These new animal 
drug products come from both existing animal drug sponsors as well as 
sponsors new to the animal drug market. The increase in new animal drug 
products has contributed to an increase in the number of protocol 
submissions and NADAs submitted for many novel drug classes and novel 
indications for both food-producing animals and companion animals. FDA 
can expect that the increases in reviewed protocols will lead in the 
near future to an increase in the number of Investigational Study 
Submissions and NADAs or supplemental NADAs as sponsors work their 
products through the regulatory review process. Additionally, FDA has 
seen an increase in the number of animal drug sponsors pursuing 
multiple changes to their existing NADAs (e.g., new indications, new 
species, changes in dosage). For this reason we are seeing an increase 
in the number of supplemental NADAs with safety or effectiveness data. 
The increases in these submissions are consistent with an overall 
increase in workload including all submissions and communications with 
sponsors. In addition, CVM is not seeing a corresponding decrease in 
any of the other submission types that might have served to offset 
workload. As a result, the statutory revenue amount after the inflation 
adjustment ($23,365,757) must now be increased by 5.4599 percent to 
reflect the changes in review workload (workload adjustment), for a 
total fee revenue target of $24,641,504.

D. Offset for Excess Collections Through FY 2017

    Under section 740(g)(4) of the FD&C Act, if the sum of the 
cumulative amount of the fees collected for FY 2014 through FY 2016, 
and the amount of fees estimated to be collected for FY 2017, exceeds 
the cumulative amount appropriated for fees for FY 2014 through FY 
2017, the excess shall be credited to FDA's appropriation account and 
subtracted from the amount of fees that FDA would otherwise be 
authorized to collect for FY 2018 under the FD&C Act. (21 U.S.C. 379j-
12(g)(4)).
    Table 5 shows the amounts specified in appropriation acts for each 
year from FY 2014 through FY 2017, and the amounts FDA has collected 
for FY 2014, FY 2015, FY 2016, and FY 2017 as of June 30, 2017, and an 
additional $21,941,000 (rounded to the nearest thousand dollars) that 
FDA estimates it will collect in FY 2017 based on historical data. 
Table 5 shows the estimated cumulative difference between ADUFA fee 
amounts specified in appropriation acts for FY 2014 through FY 2017 and 
ADUFA fee amounts collected.

                                   Table 5--Offsets To Be Taken for ADUFA III
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                                                                                                     Amount in
                                                                                    Collection       excess of
                                                                                      amount        collection
                           Fiscal year                              Collections    specified in       amount
                                                                     realized      appropriation   specified in
                                                                                       acts        appropriation
                                                                                                       acts
----------------------------------------------------------------------------------------------------------------
2014............................................................     $27,184,831     $23,600,000      $3,584,831
2015............................................................      24,535,338      22,464,000       2,071,338
2016............................................................      25,442,477      22,818,000       2,624,477
2017............................................................      21,941,000      23,673,000      -1,732,000
                                                                 -----------------------------------------------
    Net Balance to be Offset When Fees are Set for FY 2018......................................       6,548,646
----------------------------------------------------------------------------------------------------------------
Note: FY 2017 `Collections Realized' is the amount FDA estimates it will collect in FY 2017 based on historical
  data.

    The cumulative fees collected for FY 2014 through FY 2017 are 
estimated to be $6,548,646 greater than the cumulative fee amounts 
specified in appropriation acts during this same period. Reducing the 
inflation and workload adjusted amount of $24,641,504 by the ADUFA III 
offset of $6,548,646 results in an amount of $18,093,000 (rounded to 
the nearest thousand), before the final year adjustment.

E. Final Year Adjustment

    Under section 740(c)(4) of the FD&C Act, for FY 2018 the Secretary 
of Health and Human Services (the Secretary) may, in addition to the 
inflation and workload adjustments, further increase the fees if such 
an adjustment is necessary to provide for not more than 3 months of 
operating reserves of carryover user fees for the process for the 
review of animal drug applications for the first 3 months of FY 2019. 
If such an adjustment is necessary, the rationale for the amount of 
this increase must be included in the annual notice establishing fees 
for FY 2018 (21 U.S.C. 379j-12(c)(4)).
    After calculating the operating reserves and estimating the balance 
as of the beginning of FY 2019, FDA estimates that the ADUFA program 
will have sufficient funds for the operating reserves, thus FDA will 
not be performing a final year adjustment for

[[Page 35969]]

FY 2019 because FDA has determined such an adjustment to be 
unnecessary.

F. FY 2018 Fee Revenue Amounts

    ADUFA III specifies that the revenue amount of $18,093,000 for FY 
2018 is to be divided as follows: 20 percent, or a total of $3,619,000 
(rounded to the nearest thousand dollars), is to come from application 
fees; 27 percent, or a total of $4,885,000 (rounded to the nearest 
thousand dollars), is to come from product fees; 26 percent, or a total 
of $4,704,000 (rounded to the nearest thousand dollars), is to come 
from establishment fees; and 27 percent, or a total of $4,885,000 
(rounded to the nearest thousand dollars), is to come from sponsor fees 
(21 U.S.C. 379j-12(b)).

III. Application Fee Calculations for FY 2018

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) of the FD&C Act (21 
U.S.C. 379j-11(1)). A ``supplemental animal drug application'' is 
defined as a request to the Secretary to approve a change in an animal 
drug application which 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 $3,619,000 in fee revenue for FY 2018. 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 $3,619,000 FDA must first make some 
assumptions about the number of fee-paying applications and supplements 
the Agency will receive in FY 2018.
    The Agency knows the number of applications that have been 
submitted in previous years. That number fluctuates from year to year. 
In estimating the fee revenue to be generated by animal drug 
application fees in FY 2018, FDA is assuming that the number of 
applications that will pay fees in FY 2018 will equal the average 
number of submissions over the five most recent completed years of the 
ADUFA program (FY 2012 to FY 2016). FDA believes that this is a 
reasonable approach after 13 completed years of experience with this 
program.
    Over the five most recent completed years, the average number of 
animal drug applications that would have been subject to the full fee 
was 8.2. 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 
14.0.

B. Application Fee Rates for FY 2018

    FDA must set the fee rates for FY 2018 so that the estimated 8.2 
applications that pay the full fee and the estimated 14.0 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 pay half of the full fee will generate a total of 
$3,619,000. To generate this amount, the fee for an animal drug 
application, rounded to the nearest $100, will have to be $238,100, 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 
$119,050.

IV. Product Fee Calculations for FY 2018

A. Product Fee Revenues and Numbers of Fee-Paying Products

    The animal drug product fee (also referred to as the 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 $4,885,000 in fee revenue for FY 2018.
    To set animal drug product fees to realize $4,885,000, FDA must 
make some assumptions about the number of products for which these fees 
will be paid in FY 2018. 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 
2017, FDA estimates that there are a total of 815 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 815 products will be 
subject to this fee in FY 2018.
    In estimating the fee revenue to be generated by animal drug 
product fees in FY 2018, FDA is assuming that 3 percent of the products 
invoiced, or 24, will not pay fees in FY 2018 due to fee waivers and 
reductions. FDA has kept this estimate at 3 percent this year, based on 
historical data over the past five completed years of the ADUFA 
program. Based on experience over the first 13 completed years of the 
ADUFA program, FDA believes that this is a reasonable basis for 
estimating the number of fee-paying products in FY 2018.
    Accordingly, the Agency estimates that a total of 791 (815 minus 
24) products will be subject to product fees in FY 2018.

B. Product Fee Rates for FY 2018

    FDA must set the fee rates for FY 2018 so that the estimated 791 
products that pay fees will generate a total of $4,885,000. To generate 
this amount will require the fee for an animal drug product, rounded to 
the nearest $5, to be $6,175.

V. Establishment Fee Calculations for FY 2018

A. Establishment Fee Revenues and Numbers of Fee-Paying Establishments

    The animal drug establishment fee (also referred to as the 
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

[[Page 35970]]

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 
which is 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 $4,704,000 in fee revenue for FY 2018.
    To set animal drug establishment fees to realize $4,704,000, FDA 
must make some assumptions about the number of establishments for which 
these fees will be paid in FY 2018. 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 2017, 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 2018.
    In estimating the fee revenue to be generated by animal drug 
establishment fees in FY 2018, FDA is assuming that 11 percent of the 
establishments invoiced, or seven, will not pay fees in FY 2018 due to 
fee waivers and reductions. FDA has kept this estimate at 11 percent 
this year, based on historical data over the past 5 completed years. 
Based on experience over the past 13 completed years of the ADUFA 
program, FDA believes that this is a reasonable basis for estimating 
the number of fee-paying establishments in FY 2018.
    Accordingly, the Agency estimates that a total of 53 establishments 
(60 minus 7) will be subject to establishment fees in FY 2018.

B. Establishment Fee Rates for FY 2018

    FDA must set the fee rates for FY 2018 so that the estimated 53 
establishments that pay fees will generate a total of $4,704,000. To 
generate this amount will require the fee for an animal drug 
establishment, rounded to the nearest $50, to be $88,750.

VI. Sponsor Fee Calculations for FY 2018

A. Sponsor Fee Revenues and Numbers of Fee-Paying Sponsors

    The animal drug sponsor fee (also referred to as the 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 $4,885,000 in fee revenue for FY 2018.
    To set animal drug sponsor fees to realize $4,885,000, FDA must 
make some assumptions about the number of sponsors who will pay these 
fees in FY 2018. Based on the number of firms that would have met this 
definition in each of the past 13 completed years of the ADUFA program, 
FDA estimates that a total of 198 sponsors will meet this definition in 
FY 2018.
    A review of our records indicates that 35 percent of these sponsors 
will qualify for a minor use/minor species fee waiver or reduction (21 
U.S.C. 379j-12(d)(1)(D)). Based on the Agency's experience to date with 
sponsor fees, FDA's current best estimate is that an additional 32 
percent will qualify for other waivers or reductions, for a total of 67 
percent of the sponsors invoiced, or 133, who will not pay fees in FY 
2018 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 
2018.
    Accordingly, the Agency estimates that a total of 65 sponsors (198 
minus 133) will be subject to and pay sponsor fees in FY 2018.

B. Sponsor Fee Rates for FY 2018

    FDA must set the fee rates for FY 2018 so that the estimated 65 
sponsors that pay fees will generate a total of $4,885,000. To generate 
this amount will require the fee for an animal drug sponsor, rounded to 
the nearest $50, to be $75,150.

VII. Fee Schedule for FY 2018

    The fee rates for FY 2018 are summarized in Table 6.

                       Table 6--FY 2018 Fee Rates
------------------------------------------------------------------------
                                                           Fee rate for
              Animal drug user fee category                   FY 2018
------------------------------------------------------------------------
Animal Drug Application Fees:
    Animal Drug Application.............................        $238,100
    Supplemental Animal Drug Application for Which               119,050
     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.................................           6,175
Animal Drug Establishment Fee\1\........................          88,750
Animal Drug Sponsor Fee\2\..............................          75,150
------------------------------------------------------------------------
\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.


[[Page 35971]]

VIII. Procedures for Paying the FY 2018 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 III that is submitted on or after October 1, 2017. 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 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 number: 021030004, SWIFT Number: 
FRNYUS33, Beneficiary: FDA, 8455 Colesville Rd., 14th Floor, Silver 
Spring, MD 20993-0002.
    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 
Web site at http://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 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 is 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 VIII.A.
    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, 2017, FDA will issue invoices and payment 
instructions for product, establishment, and sponsor fees for FY 2018 
using this fee schedule. Payment will be due by January 31, 2018. FDA 
will issue invoices in November 2018 for any products, establishments, 
and sponsors subject to fees for FY 2018 that qualify for fees after 
the December 2017 billing.

    Dated: July 26, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-16180 Filed 8-1-17; 8:45 am]
 BILLING CODE 4164-01-P