[Federal Register Volume 81, Number 145 (Thursday, July 28, 2016)]
[Notices]
[Pages 49664-49669]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-17848]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0007]


Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 
2017

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) 2017 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 2017.

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, 7519 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 2017, the animal drug user fee rates are: $350,700 for an 
animal drug application; $175,350 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)); $8,195 for an annual 
product fee; $111,900 for an annual establishment fee; and $103,100 for 
an annual sponsor fee. FDA will issue invoices for FY 2017 product, 
establishment, and sponsor fees by December 31, 2016, and payment will 
be due by January 31, 2017. The application fee rates are effective for 
applications submitted on or after October 1, 2016, and will remain in 
effect through September 30, 2017. 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 2017

A. Statutory Fee Revenue Amounts

    ADUFA III, Title I of Public Law 113-14, specifies that the 
aggregate fee revenue amount for FY 2017 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 three of the four 
fiscal years preceding FY 2017. The 3-year average is 1.8759 percent.

[[Page 49665]]



                                  Table 1--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Change
--------------------------------------------------------------------------------------------------------------------------------------------------------
                         Fiscal year                                     2013                     2014                     2015           3-year average
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total PC&B...................................................           $1,927,703,000           $2,054,937,000           $2,232,304,000  ..............
Total FTE....................................................                   13,974                   14,555                   15,484  ..............
PC&B per FTE.................................................                  137,949                  141,184                  144,168  ..............
Percent Change from Previous Year............................                  1.1690%                  2.3451%                  2.1136%         1.8759%
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The statute specifies that this 1.8759 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                         Fiscal year                                     2013                     2014                     2015           3-year average
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total PC&B...................................................           $1,927,703,000           $2,054,937,000           $2,232,304,000  ..............
Total Costs..................................................            4,151,343,000            4,298,476,000            4,510,565,000  ..............
PC&B Percent.................................................                 46.4356%                 47.8062%                 49.4906%        47.9108%
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The payroll adjustment is 1.8759 percent multiplied by 47.9108 
percent (or 0.8988 percent).
    The statute specifies that the portion of the inflation adjustment 
for non-payroll costs for FY 2017 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                                        2013                     2014                     2015           3-year average
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual CPI...................................................                  146.953                  149.581                  152.242  ..............
Annual Percent Change........................................                  1.7588%                  1.7883%                  1.7790%         1.7754%
--------------------------------------------------------------------------------------------------------------------------------------------------------

    To calculate the inflation adjustment for non-pay costs, we 
multiply the 1.7754 percent by the proportion of all costs other than 
PC&B to total FDA costs. Since 47.9108 percent was obligated for PC&B 
as shown in table 2, 52.0892 percent is the portion of costs other than 
PC&B (100 percent minus 47.9108 percent equals 52.0892 percent). The 
non-payroll adjustment is 1.7754 percent times 52.0892 percent, or 
0.9248 percent.
    Next, we add the payroll component (0.8988 percent) to the non-pay 
component (0.9248 percent), for a total inflation adjustment of 1.8236 
percent for FY 2017.
    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 2017 (1.8236 percent) is compounded by adding 1 and then 
multiplying by 1 plus the inflation adjustment factor for FY 2016 
(2.1121 percent), as published in the Federal Register of August 3, 
2015 (80 FR 45993 to 45998), which equals 1.060746 (rounded) (1.018236 
times 1.041749) for FY 2017. We then multiply the base revenue amount 
for FY 2017 ($21,600,000) by 1.060746, yielding an inflation adjusted 
amount of $22,912,114.

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, 2016.
    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 3.3206 percent for FY 2017. This is the 
workload adjuster for FY 2017.

[[Page 49666]]



                                     Table 4--Workload Adjuster Calculation
                                      [Numbers may not add due to rounding]
----------------------------------------------------------------------------------------------------------------
                                     Column 1        Column 2        Column 3        Column 4        Column 5
                                 -------------------------------------------------------------------------------
        Application type          5-year average   Latest 5-year                     Weighting       Weighted
                                   (base years)       average     Percent change      factor      percent change
----------------------------------------------------------------------------------------------------------------
New Animal Drug Applications              9.8000         13.4000         36.7347          0.0250          0.9168
 (NADAs)........................
Supplemental NADAs with Safety            9.6000         12.4000         29.1667          0.0342          0.9971
 or Efficacy Data...............
Manufacturing Supplements.......        361.0000        324.6000        -10.0831          0.1565         -1.5783
Investigational Study                   216.4000        204.6000         -5.4529          0.6002         -3.2727
 Submissions....................
Investigational Protocol                133.6000        179.0000         33.9820          0.1841          6.2577
 Submissions....................
                                 -------------------------------------------------------------------------------
    FY 2017 Workload Adjuster...  ..............  ..............  ..............  ..............          3.3206
----------------------------------------------------------------------------------------------------------------

    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 have 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. 
As a result, the statutory revenue amount after the inflation 
adjustment ($22,912,114) must now be increased by 3.3206 percent to 
reflect the changes in review workload (workload adjustment), for a 
total fee revenue target of $23,673,000 (rounded to the nearest 
thousand dollars).

D. FY 2017 Fee Revenue Amounts

    ADUFA III specifies that the revenue amount of $23,673,000 for FY 
2017 is to be divided as follows: 20 percent, or a total of $4,734,000 
(rounded to the nearest thousand dollars), is to come from application 
fees; 27 percent, or a total of $6,392,000 (rounded to the nearest 
thousand dollars), is to come from product fees; 26 percent, or a total 
of $6,155,000 (rounded to the nearest thousand dollars), is to come 
from establishment fees; and 27 percent, or a total of $6,392,000 
(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 2017

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) (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) 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 $4,734,000 in fee revenue for FY 2017. 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 $4,734,000 FDA must first make some 
assumptions about the number of fee-paying applications and supplements 
the Agency will receive in FY 2017.
    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 2017, FDA is assuming that the number of 
applications that will pay fees in FY 2017 will equal the average 
number of submissions over the five most recent completed years of the 
ADUFA program (FY 2011 to FY 2015). FDA believes that this is a 
reasonable approach after 12 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 7.2. Over this same period, the average number of supplemental 
applications 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 2017

    FDA must set the fee rates for FY 2017 so that the estimated 7.2 
applications that pay the full fee and the estimated 12.6 supplemental 
applications 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 $4,734,000. To generate this amount, the fee for an 
animal drug application, rounded to the nearest $100, will have to be 
$350,700, 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 $175,350.

IV. Product Fee Calculations for FY 2017

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

[[Page 49667]]

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 $6,392,000 in fee revenue for FY 2017.
    To set animal drug product fees to realize $6,392,000, FDA must 
make some assumptions about the number of products for which these fees 
will be paid in FY 2017. 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 
2016, FDA estimates that there are a total of 804 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 804 products will be 
subject to this fee in FY 2017.
    In estimating the fee revenue to be generated by animal drug 
product fees in FY 2017, FDA is assuming that 3 percent of the products 
invoiced, or 24, will not pay fees in FY 2017 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. 
Based on experience over the first 12 completed years of the ADUFA 
program, FDA believes that this is a reasonable basis for estimating 
the number of fee-paying products in FY 2017.
    Accordingly, the Agency estimates that a total of 780 (804 minus 
24) products will be subject to product fees in FY 2017.

B. Product Fee Rates for FY 2017

    FDA must set the fee rates for FY 2017 so that the estimated 780 
products that pay fees will generate a total of $6,392,000. To generate 
this amount will require the fee for an animal drug product, rounded to 
the nearest $5, to be $8,195.

V. Establishment Fee Calculations for FY 2017

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 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 $6,155,000 in fee revenue for FY 
2017.
    To set animal drug establishment fees to realize $6,155,000, FDA 
must make some assumptions about the number of establishments for which 
these fees will be paid in FY 2017. 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 2016, FDA estimates that there are a total of 62 
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 62 establishments 
will be subject to this fee in FY 2017.
    In estimating the fee revenue to be generated by animal drug 
establishment fees in FY 2017, FDA is assuming that 11 percent of the 
establishments invoiced, or seven, will not pay fees in FY 2017 due to 
fee waivers and reductions. FDA has reduced this estimate from 12 
percent to 11 percent this year, based on historical data over the past 
5 completed years. Based on experience over the past 12 completed years 
of the ADUFA program, FDA believes that this is a reasonable basis for 
estimating the number of fee-paying establishments in FY 2017.
    Accordingly, the Agency estimates that a total of 55 establishments 
(62 minus 7) will be subject to establishment fees in FY 2017.

B. Establishment Fee Rates for FY 2017

    FDA must set the fee rates for FY 2017 so that the estimated 55 
establishments that pay fees will generate a total of $6,155,000. To 
generate this amount will require the fee for an animal drug 
establishment, rounded to the nearest $50, to be $111,900.

VI. Sponsor Fee Calculations for FY 2017

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 $6,392,000 in fee revenue for FY 2017.
    To set animal drug sponsor fees to realize $6,392,000, FDA must 
make some assumptions about the number of sponsors who will pay these 
fees in FY 2017. Based on the number of firms that would have met this 
definition in each of the past 12 completed years of the ADUFA program, 
FDA estimates that a total of 189 sponsors will meet this definition in 
FY 2017.
    Careful review indicates that 35 percent of these sponsors will 
qualify for minor use/minor species 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 127, who will not pay fees in FY 
2017 due to fee waivers and reductions. FDA has increased this estimate 
from 65 percent

[[Page 49668]]

to 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 
2017.
    Accordingly, the Agency estimates that a total of 62 sponsors (189 
minus 127) will be subject to and pay sponsor fees in FY 2017.

B. Sponsor Fee Rates for FY 2017

    FDA must set the fee rates for FY 2017 so that the estimated 62 
sponsors that pay fees will generate a total of $6,392,000. To generate 
this amount will require the fee for an animal drug sponsor, rounded to 
the nearest $50, to be $103,100.

VII. Fee Schedule for FY 2017

    The fee rates for FY 2017 are summarized in Table 5.

                       Table 5--FY 2017 Fee Rates
------------------------------------------------------------------------
                                                           Fee rate for
              Animal drug user fee category                 FY 2017 ($)
------------------------------------------------------------------------
Animal Drug Application Fees:
    Animal Drug Application.............................         350,700
    Supplemental Animal Drug Application for Which               175,350
     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.............................           8,195
    Animal Drug Establishment Fee \1\...................         111,900
    Animal Drug Sponsor Fee \2\.........................         103,100
------------------------------------------------------------------------
\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. Procedures for Paying the FY 2017 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, 2016. 
Payment must be made in U.S. currency by check, bank draft, U.S. postal 
money order payable to the order of the Food and Drug Administration, 
wire transfer, or electronically using Pay.gov. 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. Once you search for your invoice, click ``Pay Now'' to be 
redirected to Pay.gov. Note that electronic payment options are based 
on the balance due. Payment by credit card is available for balances 
less than $25,000. If the balance exceeds this amount, only the ACH 
option is available. Payments must be drawn on U.S bank accounts as 
well as U.S. credit cards.
    On your check, bank draft, or U.S. postal money order, please write 
your application's unique Payment Identification Number (PIN), 
beginning with the letters AD, from 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. Your payment and a copy of the completed Animal Drug 
User Fee Cover Sheet can be mailed to: Food and Drug Administration, 
P.O. Box 979033, St. Louis, MO 63197-9000.
    If payment is made by wire transfer, send payment to: 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. You 
are responsible for any administrative costs associated with the 
processing of a wire transfer. Contact your bank or financial 
institution about the fee and add it to your payment to ensure that 
your fee is fully paid.
    If you prefer to send a check by a courier, the courier may 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 the U.S. Bank at 314-418-
4013. This telephone number is only for questions about courier 
delivery.)
    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.)
    It is helpful if 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.

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 click ``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.

[[Page 49669]]

    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, 2016, FDA will issue invoices and payment 
instructions for product, establishment, and sponsor fees for FY 2017 
using this fee schedule. Payment will be due by January 31, 2017. FDA 
will issue invoices in November 2017 for any products, establishments, 
and sponsors subject to fees for FY 2017 that qualify for fees after 
the December 2016 billing.

    Dated: July 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-17848 Filed 7-27-16; 8:45 am]
 BILLING CODE 4164-01-P