[Federal Register Volume 77, Number 148 (Wednesday, August 1, 2012)]
[Notices]
[Pages 45629-45634]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-18710]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0807]


Animal Generic Drug User Fee Rates and Payment Procedures for 
Fiscal Year 2013

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) 2013 generic new animal 
drug user fees. The Federal Food, Drug, and Cosmetic Act (the FD&C 
Act), as amended by the Animal Generic Drug User Fee Act of 2008 
(AGDUFA), authorizes FDA to collect user fees for certain abbreviated 
applications for generic new animal drugs, for certain generic new 
animal drug products, and for certain sponsors of such abbreviated 
applications for generic new animal drugs and/or investigational 
submissions for generic new animal drugs. This notice establishes the 
fee rates for FY 2013.

FOR FURTHER INFORMATION CONTACT:  Visit the FDA Web site at http://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/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 741 of the FD&C Act (21 U.S.C. 379j-21) establishes three 
different types of user fees: (1) Fees for certain types of abbreviated 
applications for generic new animal drugs, (2) annual fees for certain 
generic new animal drug products, and (3) annual fees for certain 
sponsors of abbreviated applications for generic new animal drugs and/
or investigational submissions for generic new animal drugs (21 U.S.C. 
379j-21(a)). When certain conditions are met, FDA will waive or reduce 
fees for generic new animal drugs intended solely to provide for a 
minor use or minor species indication (21 U.S.C. 379j-21(d)).
    For FY 2009 through FY 2013, the FD&C Act establishes aggregate 
yearly base revenue amounts for each of these fee categories. Base 
revenue amounts established for years after FY 2009 may be adjusted for 
workload. Fees for applications, products, and sponsors are to be 
established each year by FDA so that the revenue for each fee category 
will approximate the level established in the statute, after the level 
has been adjusted for workload.
    For FY 2013, the generic new animal drug user fee rates are: 
$148,300 for each abbreviated application for a generic new animal 
drug; $6,515 for each generic new animal drug product; $63,000 for each 
generic new animal drug sponsor paying 100 percent of the sponsor fee; 
$47,250 for each generic new animal drug sponsor paying 75 percent of 
the sponsor fee; and $31,500 for each generic new animal drug sponsor 
paying 50 percent of the sponsor fee. FDA will issue invoices for FY 
2013 product and sponsor fees by December 31, 2012. These fees will be 
due and payable within 30 days of the issuance of the invoices. The

[[Page 45630]]

application fee rates are effective for all abbreviated applications 
for a generic new animal drug submitted on or after October 1, 2012, 
and will remain in effect through September 30, 2013. Applications will 
not be accepted for review until FDA has received full payment of 
related application fees and any other fees owed under the Animal 
Generic Drug User Fee program.

II. Revenue Amount for FY 2013

A. Statutory Fee Revenue Amounts

    AGDUFA (Title II of Pub. L. 110-316 signed by the President on 
August 14, 2008) specifies that the aggregate revenue amount for FY 
2013 for abbreviated application fees is $1,809,000 and each of the 
other two generic new animal drug user fee categories, annual product 
fees and annual sponsor fees, is $2,111,000 each, before any adjustment 
for workload is made (see 21 U.S.C. 379j-21(b)).

B. Inflation Adjustment to Fee Revenue Amount

    The amounts established in AGDUFA for each year for FY 2009 through 
FY 2013 include an inflation adjustment; therefore, no inflation 
adjustment is required.

C. Workload Adjustment Fee Revenue Amount

    For each FY beginning after FY 2009, AGDUFA provides that statutory 
fee revenue amounts shall be further adjusted to reflect changes in 
review workload (21 U.S.C. 379j-21(c)(1)).
    FDA calculated the average number of each of the four types of 
applications and submissions specified in the workload adjustment 
provision (abbreviated applications for generic new animal drugs, 
manufacturing supplemental abbreviated applications for generic new 
animal drugs, investigational generic new animal drug study 
submissions, and investigational generic new animal drug protocol 
submissions) received over the 5-year period that ended on September 
30, 2008 (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 on June 30, 2012.
    The results of these calculations are presented in the first two 
columns of table 1 of this document. 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 generic new animal drug review workload was accounted for 
by each type of application or submission in the table during the most 
recent 5 years. Column 5 of table 1 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 1, the sum of the 
values in column 5 is calculated, reflecting a total change in workload 
of negative 17 percent for FY 2013. This is the workload adjuster for 
FY 2013.

                                     Table 1--Workload Adjuster Calculation
----------------------------------------------------------------------------------------------------------------
                                                 Column 1 5-
                                                     year       Column 2     Column 3     Column 4     Column 5
                Application type                   average     latest 5-     percent     weighting     weighted
                                                    (base         year        change       factor      percent
                                                    years)      average                                 change
----------------------------------------------------------------------------------------------------------------
Abbreviated New Animal Drug Applications                44.2         24.6          -44       0.4608          -20
 (ANADAs)......................................
Manufacturing Supplements ANADAs...............        114.6        123.6            8       0.2490            2
Generic Investigational Study Submissions......         17.4         21.8           25       0.1921            5
Generic Investigational Protocol Submissions...         21.6         13.2          -39       0.0980           -4
FY 2013 AGDUFA Workload Adjuster...............  ...........  ...........  ...........  ...........          -17
----------------------------------------------------------------------------------------------------------------

    AGDUFA specifies that the workload adjuster may not result in fees 
for a fiscal year that are less than the statutory revenue amount (21 
U.S.C. 379j-21(c)(1)(B)) for that fiscal year. Because applying the 
workload adjuster for FY 2013 would result in fees less than the 
statutory amount, the workload adjustment will not be applied in FY 
2013. As a result, the statutory revenue amount for each category of 
fees for FY 2013 ($1,809,000 for application fees and $2,111,000 for 
both product and sponsor fees) becomes the revenue target for the fees 
in FY 2013, for a total fee revenue target in FY 2013 of $6,031,000 for 
fees from all three categories.

D. Offset for Excess Collections Through FY 2012

    Under the provisions of the FD&C Act, if the cumulative amount of 
the fees collected for fiscal years 2009 through 2011, and the amount 
of fees estimated to be collected under this section for FY 2012, 
exceeds the cumulative amount appropriated for fees for fiscal years 
2009 through 2012, the excess will be subtracted from the amount of 
fees that FDA would otherwise be authorized to collect for FY 2013 
pursuant to the FD&C Act (21 U.S.C. 379j-21(g)(4)).
    Table 2 shows the amounts appropriated for each year from FY 2009 
through FY 2012, and the amounts FDA has collected for FY 2009, FY 
2010, and FY 2011 as of March 31, 2012, and the amount that FDA 
estimated it would collect in FY 2012 when it published the notice of 
FY 2012 fees in the Federal Register on August 1, 2011 (76 FR45814). 
The bottom line of Table 2 shows the estimated cumulative amount by 
which fees collected fell below amounts appropriated for FY 2009 
through FY 2012.

    Table 2--Offsets To Be Taken in FY 2013--For FY 2009-2011, Fees Collected Through 3/31/2012; For FY 2012,
                                             Estimate as of 8/1/2011
----------------------------------------------------------------------------------------------------------------
                                                                       Fees
                           Fiscal year                             appropriated   Fees collected    Difference
----------------------------------------------------------------------------------------------------------------
2009............................................................      $4,831,000      $5,099,084        $268,084
2010............................................................       5,106,000       4,392,209       (713,791)
2011............................................................       5,397,000       4,942,876       (454,124)

[[Page 45631]]

 
2012 estimate...................................................       5,706,000       5,706,000               0
                                                                 -----------------------------------------------
    Cumulative Difference Less than Appropriations..............  ..............  ..............       (899,831)
Balance to be Offset in a Subsequent Fiscal Year................  ..............  ..............               0
----------------------------------------------------------------------------------------------------------------

    As can be seen from the above table, no offset is required for the 
period FY 2009 through FY 2012 since collections have fallen below the 
amounts appropriated in aggregate.

E. Final Year Adjustment

    Under the provisions of the FD&C Act, as amended, the Secretary 
may, in addition to the workload adjustment and offset, further 
increase the fees and fee revenues if such an adjustment is necessary 
to provide for up to 3 months of operating reserves of carryover user 
fees for the process for the review of abbreviated applications for 
generic new animal drugs for the first 3 months of FY 2014. The 
rationale for the amount of this increase shall be contained in the 
annual notice establishing fee revenues and fees for FY 2013 (See the 
FD&C Act, section 741(c)(2)[21U.S.C. 379j-21(c)(2)]). Table 3 below 
estimates the amount of carryover reserve FDA currently estimates to 
have available at the end of FY 2013. It begins with the balance 
available at the end of FY 2011, rounded to the nearest thousand 
dollars, and adds the net prior year collections for the 6 months 
ending March 31, 2012. In addition, FDA is keeping aside a reserve of 
$200,000 for potential refunds, and a net of $955,000 for the last 2 
years of AGDUFA. The amount of carryover balance FDA expects to be 
available for obligation at the end of FY 2013 is $3,694,000, as shown 
in the last line of Table 3.

    Table 3--Estimated Carryover Balance at the End of FY 2013, After
                               Adjustments
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Total Carryover Balance End of FY 2011............            $2,727,000
Net Prior Year Fees Collected After 9/30/2011 (3/                212,000
 31/2012).........................................
Reserve for Refunds for FY 2012 and FY 2013.......             (200,000)
Estimated Change to Carryover Balance at the End               1,327,000
 of FY 2012.......................................
Estimated Change to Carryover Balance at the End               (372,000)
 of FY 2013.......................................
Estimated 2013 End of FY Carryover Balance........             3,694,000
------------------------------------------------------------------------

    In FY 2013, FDA expects to spend a total of $6,031,000, the amount 
authorized for collection from AGDUFA fees in that year, as shown in 
table 4 below. To maintain FY 2013 operations in FY 2014, FDA is 
applying an anticipated inflation rate of 2.01 percent to the amount of 
fee revenues FDA expects to obligate in FY 2013. This 2.01 percent is 
the statutory inflation adjustment to be applied to PDUFA and several 
other user fee programs in FY 2013, and the only statutory inflation 
adjustment for FDA available at this time; its derivation is published 
elsewhere in this issue of the Federal Register where the FY 2013 fees 
for the PDUFA user fee program is published. FDA expects to obligate a 
total of $6,152,000 in FY 2014--or a total of about $1,538,000 during 
the first 3 months of FY 2014, rounded to the nearest thousand dollars. 
The available carryover balance at the beginning of FY 2013 is 
estimated at $3,694,000, rounded to the nearest thousand dollars. Since 
the estimated carryover balance is greater than the amount FDA will 
need to operate for the first 3 months of FY 2014, no final year 
adjustment is needed.

 Table 4--Estimated Fee Revenue Needed to Sustain FY 2013 Operations for
                      the First 3 Months of FY 2014
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Estimated Total Spending from Fees in FY 2013...........      $6,031,000
Estimated FY 2014 Inflation Costs at 2.01%..............         121,000
Estimated FY 2014 Funds to Sustain FY 2013 Operations...       6,152,000
Estimated Fees Needed for 3 Months in FY 2014...........       1,538,000
Estimated End-of-FY 2013 Carryover Balance..............       3,694,000
Final Year Adjustment Needed............................               0
------------------------------------------------------------------------

    Since there is no offset nor final year adjustment to be applied in 
FY 2013, the AGDUFA revenue targets for FY 2013 remain as set in the 
statute: $1,809,000 for application fees and $2,111,000 each for both 
product and sponsor fees. The final revenue target for the fees in FY 
2013 is $6,031,000 for fees from all three categories.

III. Abbreviated Application Fee Calculations for FY 2013

    The term ``abbreviated application for a generic new animal drug'' 
is defined in 21 U.S.C. 379j-21(k)(1).

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

    The application fee must be paid for abbreviated applications for a 
generic new animal drug that is subject to fees under AGDUFA and that 
is submitted on or after July 1, 2008. The application fees are to be 
set so that they will generate $1,809,000 in fee revenue for FY 2013. 
This is the amount set out in the statute.
    To set fees for abbreviated applications for generic new animal 
drugs to realize $1,809,000, FDA must first make some assumptions about 
the number of fee-paying abbreviated applications it will receive 
during FY 2013.
    The Agency knows the number of applications that have been 
submitted in previous years. That number fluctuates significantly from 
year to year. FDA is making estimates and applying different 
assumptions for two types of submissions: Original submissions of 
abbreviated applications for generic new animal drugs and 
``reactivated'' submissions of abbreviated applications for generic new 
animal drugs. Any original submissions of abbreviated applications for 
generic new animal drugs that were received by the FDA before July 1, 
2008, were not

[[Page 45632]]

assessed fees (21 U.S.C. 379j-21(a)(1)(A)). Some of these non-fee-
paying submissions were later resubmitted after July 1 because the 
initial submission was not approved by the FDA (i.e. the FDA marked the 
submission as incomplete and requested additional non-administrative 
information) or because the original submission was withdrawn by the 
sponsor. Abbreviated applications for generic new animal drugs 
resubmitted after July 1, 2008, are subject to user fees. In this 
notice, FDA refers to these resubmitted applications as ``reactivated'' 
applications.
    Regarding original submissions of abbreviated applications for 
generic new animal drugs, FDA is assuming that the number of 
applications that will pay fees in FY 2013 will equal 15 percent less 
than the average number of submissions over the 5 most recent completed 
years (2007-2011). This 15 percent reduction is made because of the 
anticipated impact of fees on the number on submissions. The average 
number of original submissions of abbreviated applications for generic 
new animal drugs over the 5 most recently completed years is 13.2. 
Applying a 15 percent reduction to the 13.2 average, the estimate for 
original submissions of abbreviated applications for generic new animal 
drugs for FY 2013 is 11.2.
    Regarding reactivated submissions of abbreviated applications for 
generic new animal drugs, FDA is applying a 90 percent reduction. This 
is based on the fact that there were a limited number of original 
submissions of abbreviated applications for generic new animal drugs 
received by FDA before July 1, 2008, which were not assessed fees. For 
these original submissions that were not approved before July 1, 2008, 
resubmission to the FDA would trigger an application fee (21 U.S.C. 
379j-21(a)(1)(A)). Once these initial original submissions of 
abbreviated applications for generic new animal drugs received by the 
FDA before July 1, 2008, have either been withdrawn or resubmitted, 
``reactivation submissions'' will cease completely. This reduction is 
consistent with estimates made when this user fee program was in the 
development process. The average number of receipts for reactivated 
submission of abbreviated applications for generic new animal drugs 
over the 5 most recently completed fiscal years is 10.2. Applying a 90 
percent reduction to the 10.2 average, the estimate for reactivated 
submissions of abbreviated applications for generic new animal drugs 
for FY 2013 is 1. These reductions 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 years of 
experience with other user fee programs.
    Based on the previous assumptions, FDA is estimating that it will 
receive a total of 12.2 fee paying generic new animal drug applications 
in FY 2013 (11.2 original applications and 1 reactivation).

B. Fee Rates for FY 2013

    FDA must set the fee rates for FY 2013 so that the estimated 12.2 
abbreviated applications that pay the fee will generate a total of 
$1,809,000. To generate this amount, the fee for a generic new animal 
drug application, rounded to the nearest hundred dollars, will have to 
be $148,300.

IV. Generic New Animal Drug Product Fee Calculations for FY 2013

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

    The generic new animal drug product fee (also referred to as the 
product fee) must be paid annually by the person named as the applicant 
in an abbreviated new animal drug application or supplemental 
abbreviated application for generic new animal drugs 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 abbreviated application for a generic new 
animal drug or supplemental abbreviated application for a generic new 
animal drug pending at FDA after September 1, 2008 (see 21 U.S.C. 379j-
21(a)(2)). The term ``generic new 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 
abbreviated application for a generic new animal drug or supplemental 
abbreviated application for a generic new animal drug has been approved 
(21 U.S.C. 379j-21(k)(6)). The product fees are to be set so that they 
will generate $2,111,000 in fee revenue for FY 2013. This is the amount 
set out in the statute and no further adjustments are required for FY 
2013.
    To set generic new animal drug product fees to realize $2,111,000, 
FDA must make some assumptions about the number of products for which 
these fees will be paid in FY 2013. FDA gathered data on all generic 
new 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 FDA estimated would have an abbreviated new animal drug 
application or supplemental abbreviated application pending after 
September 1, 2008. FDA estimates a total of 360 products submitted for 
listing by persons who had an abbreviated application for a generic new 
animal drug or supplemental abbreviated application for a generic new 
animal drug pending after September 1, 2008. Based on this, FDA 
believes that a total of 360 products will be subject to this fee in FY 
2013.
    In estimating the fee revenue to be generated by generic new animal 
drug product fees in FY 2013, FDA is assuming that 10 percent of the 
products invoiced, or 36, will not pay fees in FY 2013 due to fee 
waivers and reductions. Based on experience with other user fee 
programs and the first 4 years of AGDUFA, FDA believes that this is a 
reasonable basis for estimating the number of fee-paying products in FY 
2013.
    Accordingly, the Agency estimates that a total of 324 (360 minus 
36) products will be subject to product fees in FY 2013.

B. Product Fee Rates for FY 2013

    FDA must set the fee rates for FY 2013 so that the estimated 324 
products that pay fees will generate a total of $2,111,000. To generate 
this amount will require the fee for a generic new animal drug product, 
rounded to the nearest 5 dollars, to be $6,515.

V. Generic New Animal Drug Sponsor Fee Calculations for FY 2013

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

    The generic new 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 abbreviated application for a new generic animal 
drug, 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 submission for a generic new animal 
drug that has not been terminated or otherwise rendered inactive and 
(2) had an abbreviated application for a generic new animal drug, 
supplemental abbreviated application for a generic new animal drug, or 
investigational submission for a generic new animal drug pending at FDA 
after September 1, 2008 (see 21 U.S.C. 379j-21(k)(7) and 379j-
21(a)(3)). A generic new animal drug sponsor is subject to only one 
such fee each fiscal

[[Page 45633]]

year (see 21 U.S.C. 379j-21(a)(3)(B)). Applicants with more than 6 
approved abbreviated applications will pay 100 percent of the sponsor 
fee; applicants with 2 to 6 approved abbreviated applications will pay 
75 percent of the sponsor fee; and applicants with 1 or fewer approved 
abbreviated applications will pay 50 percent of the sponsor fee (see 21 
U.S.C. 379j-21(a)(3)(B)). The sponsor fees are to be set so that they 
will generate $2,111,000 in fee revenue for FY 2013. This is the amount 
set out in the statute and no adjustments are required for FY 2013.
    To set generic new animal drug sponsor fees to realize $2,111,000, 
FDA must make some assumptions about the number of sponsors who will 
pay these fees in FY 2013. FDA now has 3 complete years of experience 
with collecting these sponsor fees. Based on the number of firms that 
meet this definition, and the average number of firms paying fees at 
each level over the 3 completed years of AGDUFA (FY 2009-FY 2011) FDA 
estimates that in FY 2013, 11 sponsors will pay 100 percent fees, 13 
sponsors will pay 75 percent fees, and 33 sponsors will pay 50 percent 
fees. That totals the equivalent of 37.25 full sponsor fees (11 times 
100 percent or 11, plus 13 times 75 percent or 9.75, plus 33 times 50 
percent or 16.5).
    FDA estimates that about 10 percent of all of these sponsors, or 
3.73, may qualify for a minor use/minor species waiver.
    Accordingly, the Agency estimates that the equivalent of 33.52 full 
sponsor fees (37.25 minus 3.73) are likely to be paid in FY 2013.

B. Sponsor Fee Rates for FY 2013

    FDA must set the fee rates for FY 2013 so that the estimated 
equivalent of 33.52 full sponsor fees will generate a total of 
$2,111,000. To generate this amount will require the 100 percent fee 
for a generic new animal drug sponsor, rounded to the nearest $50, to 
be $63,000. Accordingly, the fee for those paying 75 percent of the 
full sponsor fee will be $47,250, and the fee for those paying 50 
percent of the full sponsor fee will be $31,500.

VI. Fee Schedule for FY 2013

    The fee rates for FY 2013 are summarized in table 5 of this 
document.

                       Table 5--FY 2013 Fee Rates
------------------------------------------------------------------------
                                                               Fee rate
         Generic new animal drug user fee category           for FY 2013
------------------------------------------------------------------------
Abbreviated Application Fee for Generic New Animal Drug         $148,300
 Application...............................................
Generic New Animal Drug Product Fee........................        6,515
\1\ 100 Percent Generic New Animal Drug Sponsor Fee........       63,000
\1\ 75 Percent Generic New Animal Drug Sponsor Fee.........       47,250
\1\ 50 Percent Generic New Animal Drug Sponsor Fee.........       31,500
------------------------------------------------------------------------
\(1)\ An animal drug sponsor is subject to only one fee each fiscal
  year.

VII. Procedures for Paying FY 2013 Generic New Animal Drug User Fees

A. Abbreviated Application Fees and Payment Instructions

    The FY 2013 fee established in the new fee schedule must be paid 
for an abbreviated new animal drug application subject to fees under 
AGDUFA that is submitted on or after October 1, 2012. 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 by automatic clearing house (ACH) using www.Pay.gov. (The 
www.Pay.gov payment option is available to you after you submit a cover 
sheet. Click the ``Pay Now'' button). On your check, bank draft, U.S. 
or postal money order, please write your application's unique Payment 
Identification Number, beginning with the letters ``AG'', from the 
upper right-hand corner of your completed Animal Generic 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 Generic 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 via wire transfer, send payment to U. S. 
Department of the Treasury, TREAS NYC, 33 Liberty St., New York, NY 
10045, Account Name: Food and Drug Administration, Account Number: 
75060099, Routing 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 
regarding the amount of the fees that need to be paid in addition to 
the wire transfer amount.
    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 phone number is 
only for questions about courier delivery.)
    The tax identification number of the Food and Drug Administration 
is 530196965. (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 abbreviated application arrives at FDA's Center for 
Veterinary Medicine. FDA records the official abbreviated application 
receipt date as the later of the following: The date the application 
was received by FDA's Center for Veterinary Medicine, or the date U.S. 
Bank notifies FDA that your payment in the full amount has been 
received, or when the U.S. Department of the Treasury notifies FDA of 
payment. U.S. Bank and the United States Treasury are required to 
notify FDA within one working day, using the Payment Identification 
Number described previously.

B. Application Cover Sheet Procedures

    Step One--Create a user account and password. Log onto the AGDUFA 
Web site at http://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/ucm137049.htm and scroll down the 
page until you find the link ``Create AGDUFA User Fee Cover Sheet.'' 
Click on that link and follow the directions. 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 Generic Drug User Fee Cover Sheet, 
transmit it to FDA, and print a copy. After logging into your account 
with your user name and password, complete the steps required to create 
an Animal Generic Drug User Fee Cover Sheet. One cover sheet is needed 
for each abbreviated animal drug application. 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 Payment Identification Number.
    Step Three--Send the Payment for your application as described in 
Section VII.A of this document.

[[Page 45634]]

    Step Four--Please submit your application and a copy of the 
completed Animal Generic 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 and Sponsor Fees

    By December 31, 2012, FDA will issue invoices and payment 
instructions for product and sponsor fees for FY 2013 using this fee 
schedule. Fees will be due and payable 30 days after the issuance of 
the invoices. FDA will issue invoices in November 2013 for any products 
and sponsors subject to fees for FY 2013 that qualify for fees after 
the December 2012 billing.

    Dated: July 26, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-18710 Filed 7-31-12; 8:45 am]
BILLING CODE 4160-01-P