[Federal Register Volume 78, Number 149 (Friday, August 2, 2013)]
[Notices]
[Pages 46955-46958]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-18619]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0007]


Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 
2014

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) 2014 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, which was signed by the 
President on June 13, 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 2014.

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, 7529 Standish Pl., Rockville, MD 20855, 240-
276-9718. 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

[[Page 46956]]

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 is derived from each type of user fee will be as follows: 
Revenue from application fees will be 20 percent of total fee revenue; 
revenue from product fees will 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 2014, the animal drug user fee rates are: $396,600 for an 
animal drug application; $198,300 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)); $9,075 for an annual 
product fee; $105,800 for an annual establishment fee; and $101,150 for 
an annual sponsor fee. FDA will issue invoices for FY 2014 product, 
establishment, and sponsor fees by December 31, 2013, and payment will 
be due by January 31, 2014. The application fee rates are effective for 
applications submitted on or after October 1, 2013, and will remain in 
effect through September 30, 2014. 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 ADUFA.

II. Revenue Amount for FY 2014

A. Statutory Fee Revenue Amounts

    ADUFA III (Title I of Pub. L. 113-14) specifies that the aggregate 
revenue amount for FY 2014 for all animal drug user fee categories is 
$23,600,000. (21 U.S.C. 379j-12(b)(1)(A).)

B. Inflation Adjustment to Fee Revenue Amount

    The amount established in ADUFA III for FY 2014 includes an 
inflation adjustment; therefore, no further inflation adjustment is 
required for FY 2014. For FY 2015 and subsequent years an inflation 
adjustment will be made (21 U.S.C. 379j-12(c)(2)).

C. Workload Adjustment to Inflation Adjusted Fee Revenue Amount

    The amount established in ADUFA III for FY 2014 is not to be 
further adjusted for workload. For FY 2015 and subsequent years a 
workload adjustment will be calculated (21 U.S.C. 379j-12(c)(3)).

D. FY 2014 Fee Revenue Amounts

    ADUFA III specifies a total revenue amount of $23,600,000 for FY 
2014. Of this amount: 20 percent, or a total of $4,720,000, is to come 
from application fees; 27 percent, or a total of $6,372,000, is to come 
from product fees; 26 percent, or a total of $6,136,000, is to come 
from establishment fees; and 27 percent, or a total of $6,372,000, is 
to come from sponsor fees (21 U.S.C. 379j-12(b)).

III. Application Fee Calculations for FY 2014

    The terms ``animal drug application'' and ``supplemental animal 
drug application'' are defined in section 739 of the FD&C Act (21 
U.S.C. 379j-11(1) and (2)).

A. Application Fee Revenues and Numbers of Fee-Paying Applications

    The application fee must be paid for any animal drug application or 
supplemental animal drug application that is subject to fees under 
ADUFA and that is submitted on or after September 1, 2003. The 
application fees are to be set so that they will generate $4,720,000 in 
fee revenue for FY 2014. This is the amount derived in section II.D of 
this document. 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 $4,720,000 FDA must first make some 
assumptions about the number of fee-paying applications and supplements 
the Agency will receive in FY 2014.
    The Agency knows the number of applications that have been 
submitted in previous years. That number fluctuates significantly from 
year to year. In estimating the fee revenue to be generated by animal 
drug application fees in FY 2014, FDA is assuming that the number of 
applications that will pay fees in FY 2014 will equal the average 
number of submissions over the 5 most recent completed years (FY 2008-
FY 2012). This may not fully account for possible year to year 
fluctuations in numbers of fee-paying applications, but FDA believes 
that this is a reasonable approach after 10 years of experience with 
this program.
    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 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 9.4.

B. Fee Rates for FY 2014

    FDA must set the fee rates for FY 2014 so that the estimated 7.2 
applications that pay the full fee and the estimated 9.4 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 $4,720,000. To generate this amount, the fee for an 
animal drug application, rounded to the nearest $100, will have to be 
$396,600, 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 $198,300.

IV. Product Fee Calculations for FY 2014

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. (See 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 $6,372,000 in fee revenue for 
FY 2014. This is the amount derived in section II.D of this document.
    To set animal drug product fees to realize $6,372,000, FDA must 
make some assumptions about the number of products for which these fees 
will be paid in FY 2014. 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

[[Page 46957]]

animal drug application or supplement pending after September 1, 2003. 
As of June 2013, FDA estimates that there are a total of 747 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 747 products will be 
subject to this fee in FY 2014.
    In estimating the fee revenue to be generated by animal drug 
product fees in FY 2014, FDA is assuming that 6 percent of the products 
invoiced, or 45, will not pay fees in FY 2014 due to fee waivers and 
reductions. FDA has reduced the estimate of the percentage of products 
that will not pay fees from 10 percent to 6 percent this year, based on 
historical data over the past 5 years. Based on experience with other 
user fee programs and the first 10 years of ADUFA, FDA believes that 
this is a reasonable basis for estimating the number of fee-paying 
products in FY 2014.
    Accordingly, the Agency estimates that a total of 702 (747 minus 
45) products will be subject to product fees in FY 2014.

B. Product Fee Rates for FY 2014

    FDA must set the fee rates for FY 2014 so that the estimated 702 
products that pay fees will generate a total of $6,372,000. To generate 
this amount will require the fee for an animal drug product, rounded to 
the nearest $5, to be $9,075.

V. Establishment Fee Calculations for FY 2014

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. 
(See 21 U.S.C. 379j-12(a)(3).) The term ``animal drug establishment'' 
is defined in 21 U.S.C. 379j-11(4). The establishment fees are to be 
set so that they will generate $6,136,000 in fee revenue for FY 2014. 
This is the amount derived in section II.D of this document.
    To set animal drug establishment fees to realize $6,136,000, FDA 
must make some assumptions about the number of establishments for which 
these fees will be paid in FY 2014. 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 2013, FDA estimates that there are a total of 66 
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 66 establishments 
will be subject to this fee in FY 2014.
    In estimating the fee revenue to be generated by animal drug 
establishment fees in FY 2014, FDA is assuming that 12 percent of the 
establishments invoiced, or 8, will not pay fees in FY 2014 due to fee 
waivers and reductions. FDA has increased the estimate of the 
percentage of establishments that will not pay fees from 10 percent to 
12 percent this year, based on historical data over the past 5 years. 
Based on experience with the first 10 years of ADUFA, FDA believes that 
this is a reasonable basis for estimating the number of fee-paying 
establishments in FY 2014.
    Accordingly, the Agency estimates that a total of 58 establishments 
(66 minus 8) will be subject to establishment fees in FY 2014.

B. Establishment Fee Rates for FY 2014

    FDA must set the fee rates for FY 2014 so that the estimated 58 
establishments that pay fees will generate a total of $6,136,000. To 
generate this amount will require the fee for an animal drug 
establishment, rounded to the nearest $50, to be $105,800.

VI. Sponsor Fee Calculations for FY 2014

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 $6,372,000 in fee revenue for FY 2014. This is 
the amount derived in section II.D of this document.
    To set animal drug sponsor fees to realize $6,372,000, FDA must 
make some assumptions about the number of sponsors who will pay these 
fees in FY 2014. Based on the number of firms that would have met this 
definition in each of the past 10 years, FDA estimates that a total of 
181 sponsors will meet this definition in FY 2014.
    Careful review indicates that about one third or 33 percent of all 
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 65 percent of the sponsors invoiced, or 118, 
who will not pay fees in FY 2014 due to fee waivers and reductions. FDA 
has increased the estimate of the percentage of sponsors that will not 
pay fees from 60 percent to 65 percent this year, based on historical 
data over the past 5 years. FDA believes that this is a reasonable 
basis for estimating the number of fee-paying sponsors in FY 2014.
    Accordingly, the Agency estimates that a total of 63 sponsors (181 
minus 118) will be subject to and pay sponsor fees in FY 2014.

B. Sponsor Fee Rates for FY 2014

    FDA must set the fee rates for FY 2014 so that the estimated 63 
sponsors that pay fees will generate a total of $6,372,000. To generate 
this amount will require the fee for an animal drug sponsor, rounded to 
the nearest $50, to be $101,150.

VII. Fee Schedule for FY 2014

    The fee rates for FY 2014 are summarized in table 1 of this 
document.

                       Table 1--FY 2014 Fee Rates
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                                                           Fee rate for
              Animal drug user fee category                   FY 2014
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Animal Drug Application Fees:
  Animal Drug Application...............................        $396,600

[[Page 46958]]

 
  Supplemental Animal Drug Application for which Safety          198,300
   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.................................           9,075
Animal Drug Establishment Fee \1\.......................         105,800
Animal Drug Sponsor Fee \2\.............................         101,150
------------------------------------------------------------------------
\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.

VIII. Procedures for Paying the FY 2014 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 that is submitted after September 30, 2013. Payment 
must be made in U.S. currency by check, bank draft, or U.S. postal 
money order payable to the order of the Food and Drug Administration, 
by wire transfer, or electronically using Pay.gov. (The Pay.gov payment 
option is available to you after you submit a cover sheet. Click the 
``Pay Now'' button.) 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 953877) 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 953877, St. Louis, MO 63195-3877.
    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. 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 such as Federal Express 
or United Parcel Service, the courier may deliver the check and printed 
copy of the cover sheet to: U.S. Bank, Attn: Government Lockbox 953877, 
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.
    Step Three--Send the payment for your application as described in 
section VIII.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, 2013, FDA will issue invoices and payment 
instructions for product, establishment, and sponsor fees for FY 2014 
using this fee schedule. Payment will be due by January 31, 2014. FDA 
will issue invoices in November 2014 for any products, establishments, 
and sponsors subject to fees for FY 2014 that qualify for fees after 
the December 2013 billing.

    Dated: July 29, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-18619 Filed 8-1-13; 8:45 am]
BILLING CODE 4160-01-P