[Federal Register Volume 76, Number 147 (Monday, August 1, 2011)]
[Notices]
[Pages 45814-45818]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-19334]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0547]


Animal Generic Drug User Fee Rates and Payment Procedures for 
Fiscal Year 2012

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) 2012 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, on certain generic new 
animal drug products, and on certain sponsors of such abbreviated 
applications for generic new animal drugs and/or investigational

[[Page 45815]]

submissions for generic new animal drugs. This notice establishes the 
fee rates for FY 2012.

FOR FURTHER INFORMATION CONTACT: Visit FDA's 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 kinds 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 2012, the generic new animal drug user fee rates are: 
$124,900 for each abbreviated application for a generic new animal 
drug; $6,200 for each generic new animal drug product; $54,350 for each 
generic new animal drug sponsor paying 100 percent of the sponsor fee; 
$40,763 for each generic new animal drug sponsor paying 75 percent of 
the sponsor fee; and $27,175 for each generic new animal drug sponsor 
paying 50 percent of the sponsor fee. FDA will issue invoices for FY 
2012 product and sponsor fees by December 31, 2011. These fees will be 
due and payable within 30 days of the issuance of the invoices. The 
application fee rates are effective for all abbreviated applications 
for a generic new animal drug submitted on or after October 1, 2011, 
and will remain in effect through September 30, 2012. 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 2012

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 
2012 for abbreviated application fees is $1,712,000 and each of the 
other two generic new animal drug user fee categories, annual product 
fees and annual sponsor fees, is $1,997,000 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; so, no inflation adjustment is 
required.

C. Workload Adjustment to Inflation Adjusted 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 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, 2011.
    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 25.7 percent for FY 2012. This is the workload adjuster for 
FY 2012.

                                     Table 1--Workload Adjuster Calculation
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                                                 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
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Abbreviated New Animal Drug Applications                44.2         25.4          -43          50%        -21.3
 (ANADAs)......................................
Manufacturing Supplements ANADAs...............        114.6        118.4            3          22%          0.7
Generic Investigational Study Submissions......         17.4         17.0           -2          10%         -0.2
Generic Investigational Protocol Submissions...         21.6         15.6          -28          17%         -4.8
                                                ----------------------------------------------------------------
    FY 2012 AGDUFA Workload Adjuster...........  ...........  ...........  ...........  ...........        -25.7
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    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 2012 would result in fees less than the 
statutory amount, the workload adjustment will not be applied in FY 
2012. As a result, the statutory revenue amount for each category of 
fees for FY 2012 ($1,712,000 for application fees and $1,997,000 for 
both product and sponsor fees) becomes the revenue target for the fees 
in FY 2012, for a total

[[Page 45816]]

fee revenue target in FY 2012 of $5,706,000 for fees from all three 
categories.

III. Abbreviated Application Fee Calculations for FY 2012

    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 $1,712,000 in fee revenue for FY 2012. 
This is the amount set out in the statute.
    To set fees for abbreviated applications for generic new animal 
drugs to realize $1,712,000, FDA must first make some assumptions about 
the number of fee-paying abbreviated applications it will receive 
during FY 2012.
    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 FDA before July 1, 2008, 
were not 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 FDA (i.e., FDA marked the 
submission as incomplete and requested additional nonadministrative 
information) or because the original submission was withdrawn by the 
sponsor. Because these abbreviated applications for generic new animal 
drugs are resubmitted after July 1, 2008, they are assessed 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 2012 will equal 30 percent less 
than the average number of submissions over the 5 most recent completed 
years (2006-2010). This 30-percent reduction is made because of the 
anticipated impact of fees on the number of submissions. The average 
number of original submissions of abbreviated applications for generic 
new animal drugs over the 5 most recent completed years is 14.4. 
Applying a 30-percent reduction to the 14.4 average, the estimate for 
original submissions of abbreviated applications for generic new animal 
drugs for FY 2012 is 10.1. (If the number of original submissions of 
abbreviated applications for generic new animal drugs does not increase 
over the next year, a higher percent reduction will have to be applied 
next year when fees are set for FY 2013.)
    Regarding reactivated submissions of abbreviated applications for 
generic new animal drugs, FDA is applying a 75-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 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 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 submissions of 
abbreviated applications for generic new animal drugs is 14.5 per year, 
which is the average of the 5 most recent completed years. Applying a 
75-percent reduction to the 14.5 average, the estimate for reactivated 
submissions of abbreviated applications for generic new animal drugs 
for FY 2012 is 3.6. 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 13.7 fee-paying generic new animal drug applications 
in FY 2012 (10.1 original applications and 3.6 reactivations).

B. Fee Rates for FY 2012

    FDA must set the fee rates for FY 2012 so that the estimated 13.7 
abbreviated applications that pay the fee will generate a total of 
$1,712,000. To generate this amount, the fee for a generic new animal 
drug application, rounded to the nearest hundred dollars, will have to 
be $124,900.

IV. Generic New Animal Drug Product Fee Calculations for FY 2012

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 $1,997,000 in fee revenue for FY 2012. This is the amount 
set out in the statute and no further adjustments are required for FY 
2012.
    To set generic new animal drug product fees to realize $1,997,000, 
FDA must make some assumptions about the number of products for which 
these fees will be paid in FY 2012. 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 358 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 358 products will be subject to this fee in FY 2012.
    In estimating the fee revenue to be generated by generic new animal 
drug product fees in FY 2012, FDA is assuming that approximately 10 
percent of the products invoiced, or 36, will not pay fees in FY 2012 
due to fee waivers

[[Page 45817]]

and reductions. Based on experience with other user fee programs and 
the first 3 years of AGDUFA, FDA believes that this is a reasonable 
basis for estimating the number of fee-paying products in FY 2012.
    Accordingly, the Agency estimates that a total of 322 (358 minus 
36) products will be subject to product fees in FY 2012.

B. Product Fee Rates for FY 2012

    FDA must set the fee rates for FY 2012 so that the estimated 322 
products that pay fees will generate a total of $1,997,000. To generate 
this amount will require the fee for a generic new animal drug product, 
rounded to the nearest 5 dollars, to be $6,200.

V. Generic New Animal Drug Sponsor Fee Calculations for FY 2012

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 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 $1,997,000 in fee revenue for 
FY 2012. This is the amount set out in the statute and no adjustments 
are required for FY 2012.
    To set generic new animal drug sponsor fees to realize $1,997,000, 
FDA must make some assumptions about the number of sponsors who will 
pay these fees in FY 2012. Based on the number of firms that meet this 
definition, FDA estimates that in FY 2012, 12 sponsors will pay 100 
percent fees, 13 sponsors will pay 75 percent fees, and 38 sponsors 
will pay 50 percent fees. That totals the equivalent of 40.75 full 
sponsor fees (12 times 100 percent or 12, plus 13 times 75 percent or 
9.75, plus 38 times 50 percent or 19).
    FDA estimates that about 10 percent of all of these sponsors, or 4, 
may qualify for a minor use/minor species waiver.
    Accordingly, the Agency estimates that the equivalent of 36.75 full 
sponsor fees (40.75 minus 4) are likely to be paid in FY 2012.

B. Sponsor Fee Rates for FY 2012

    FDA must set the fee rates for FY 2012 so that the estimated 
equivalent of 36.75 full sponsor fees will generate a total of 
$1,997,000. To generate this amount will require the 100-percent fee 
for a generic new animal drug sponsor, rounded to the nearest $50, to 
be $54,350. Accordingly, the fee for those paying 75 percent of the 
full sponsor fee will be $40,763, and the fee for those paying 50 
percent of the full sponsor fee will be $27,175.

VI. Fee Schedule for FY 2012

    The fee rates for FY 2012 are summarized in table 2 of this 
document.

                       Table 2--FY 2012 Fee Rates
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                                                           Fee rate for
        Generic new animal drug user fee category             FY 2012
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Abbreviated Application Fee for Generic New Animal Drug         $124,900
 Application............................................
Generic New Animal Drug Product Fee.....................           6,200
100 Percent Generic New Animal Drug Sponsor Fee\1\......          54,350
75 Percent Generic New Animal Drug Sponsor Fee\1\.......          40,763
50 Percent Generic New Animal Drug Sponsor Fee\1\.......          27,175
------------------------------------------------------------------------
\1\ An animal drug sponsor is subject to only one such fee each fiscal
  year.

VII. Procedures for Paying FY 2012 Generic New Animal Drug User Fees

A. Abbreviated Application Fees and Payment Instructions

    The FY 2012 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, 2011. 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 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 ``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 (PO 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 
(FEDEX) or United Parcel Service (UPS), 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 
314-418-4821. This telephone 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 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 payment. U.S. Bank and the U.S. Treasury are required 
to notify FDA within 1 working day, using the PIN described previously.

[[Page 45818]]

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 PIN.
    Step Three--Send the payment for your application as described in 
section VII.A of this document.
    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, 2011, FDA will issue invoices and payment 
instructions for product and sponsor fees for FY 2012 using this fee 
schedule. Fees will be due and payable 30 days after the issuance of 
the invoices. FDA will issue invoices in November 2012 for any products 
and sponsors subject to fees for FY 2012 that qualify for fees after 
the December 2011 billing.

    Dated: July 26, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-19334 Filed 7-29-11; 8:45 am]
BILLING CODE 4160-01-P