[Federal Register Volume 73, Number 179 (Monday, September 15, 2008)]
[Notices]
[Pages 53258-53260]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-21453]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0479]


Generic New Animal Drug User Fee Rates and Payment Procedures for 
Fiscal Year 2009

AGENCY: Food and Drug Administration

ACTION: Notice

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SUMMARY: The Food and Drug Administration (FDA) is announcing the rates 
and payment procedures for fiscal year (FY) 2009 generic new animal 
drug user fees. The Federal Food, Drug, and Cosmetic Act (the 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 a generic new animal drug, on certain generic new 
animal drug products, and on 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 2009.
    For FY 2009, the generic new animal drug user fee rates are: 
$41,400 for each abbreviated application for a generic new animal drug; 
$3,005 for each generic new animal drug product; $56,350 for each 
generic new animal drug sponsor paying 100 percent of the sponsor fee; 
$42,265 for each generic new animal drug sponsor paying 75 percent of 
the sponsor fee; and $28,175 for a generic new animal drug sponsor 
paying 50 percent of the sponsor fee. FDA will issue invoices for FY 
2009 product and sponsor fees by December 31, 2008, or within 30 days 
of enactment of an appropriation for these fees, whichever is later. 
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 generic new animal drugs submitted on or after July 1, 
2008, and will remain in effect through September 30, 2009. However, 
FDA may not collect application fees until enactment of an 
appropriation for these fees. Within 30 days of enactment of an 
appropriation for these fees, FDA will issue invoices for applications 
received on or after July 1, 2008, and will publish a Federal Register 
notice stating that for the remainder of fiscal year 2009 FDA will not 
accept any further abbreviated applications for generic new animal 
drugs for review until FDA has received full payment of application 
fees and any other generic new animal drug user fees owed. That Federal 
Register notice will also provide instructions for payment of 
abbreviated applications for generic new animal drug fees.

FOR FURTHER INFORMATION CONTACT:  Visit the FDA Web site at http://www.fda.gov/oc/agdufa or contact Roxanne Schweitzer, Center for 
Veterinary Medicine (HFV-10), Food and Drug Administration, 7529 
Standish Place, Rockville, MD 20855, 240-276-9705. For general 
questions, you may also e-mail the Center for Veterinary Medicine at: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Section 741 of the 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 act establishes aggregate yearly 
base revenue amounts for each of these fee categories. Base revenue 
amounts established for years after FY 2009 are subject to adjustment 
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

[[Page 53259]]

in the statute, after the level has been adjusted for workload.

II. Revenue Amount for FY 2009

A. Statutory Fee Revenue Amounts

    AGDUFA (Title II of Public Law 110-316 signed by the President on 
August 14, 2008) specifies that the aggregate revenue amount for FY 
2009 for abbreviated application fees is $1,449,000, and the other two 
generic new animal drug user fee categories, annual product fees and 
annual sponsor fees, are $1,691,000 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 further 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)). No workload adjustment is to 
be made in fee revenue amounts for FY 2009.

III. Abbreviated Application Fee Calculations for FY 2009

    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 
generic new animal drugs that are subject to fees under AGDUFA and that 
are submitted on or after July 1, 2008. The application fees are to be 
set so that they will generate $1,449,000 in fee revenue for FY 2009. 
This is the amount set out in the statute and no adjustments to it are 
required for FY 2009.
    To set fees for abbreviated applications for generic new animal 
drugs to realize $1,449,000, FDA must first make some assumptions about 
the number of fee-paying abbreviated applications it will receive over 
the 15 months from July 1, 2008 through September 30, 2009.
    The agency knows the number of such applications that have been 
submitted in previous years. That number fluctuates significantly from 
year to year. FDA is assuming that the number of abbreviated 
applications that will pay fees in FY 2009 will equal the average 
number of submissions over the 4 most recent years. 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 
about 5 years of experience with other user fee programs. Further, 
because the imposition of a fee may reduce somewhat the number of 
abbreviated applications submitted, FDA will use a 12-month average 
estimate in estimating the number of abbreviated applications that will 
be subject to and pay fees in the 15-month period from July 1, 2008 
through September 30, 2009.
    Over the past 4 years, the average number of abbreviated 
applications for generic new animal drugs that would have been subject 
to the fee was 38.75, including the number for the most recent year, 
which is estimated at 40. FDA will also assume that 10 percent of these 
applications, or 3.875, may be subject to fee waivers or reduction 
based on indications solely for minor use or minor species.
    Thus, for FY 2009, FDA estimates receipt of 34.55 (38.75 minus 
3.875) fee-paying abbreviated applications.

B. Fee Rates for FY 2009

    FDA must set the fee rates for FY 2009 so that the estimated 35 
abbreviated applications that pay the fee will generate a total of 
$1,449,000. To generate this amount, the fee for an animal drug 
application, rounded to the nearest hundred dollars, will have to be 
$41,400.

IV. Generic Product Fee Calculations for FY 2009

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 application for a generic new animal drug or a 
supplemental abbreviated application for a generic new animal drug 
product submitted for listing under section 510 of the act (21 U.S.C. 
360), and who had an abbreviated application or a supplemental 
abbreviated application for a generic new animal drug product 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 $1,691,000 in 
fee revenue for FY 2009. This is the amount set out in the statute and 
no further adjustments are required for FY 2009.
    To set generic new animal drug product fees to realize $1,691,000, 
FDA must make some assumptions about the number of products for which 
these fees will be paid in FY 2009. FDA developed data on all generic 
new animal drug products that have been submitted for listing under 
section 510 of the act, and matched this to the list of all persons who 
FDA estimated would have an abbreviated application for a generic new 
animal drug or supplemental abbreviated application pending after 
September 1, 2008. FDA estimates there is a total of 626 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 626 products will be subject to this fee 
in FY 2009.
    In estimating the fee revenue to be generated by generic new animal 
drug product fees in FY 2009, FDA is assuming that 10 percent of the 
products invoiced, or 63, will not pay fees in FY 2009 due to fee 
waivers and reductions. Based on experience with other user fee 
programs and the first 5 years of the Animal Drug User Fee Act program 
(ADUFA), FDA believes that this is a reasonable basis for estimating 
the number of fee-paying products in FY 2009.
    Accordingly, the agency estimates that a total of 563 (626 minus 
63) products will be subject to product fees in FY 2009.

B. Product Fee Rates for FY 2009

    FDA must set the fee rates for FY 2009 so that the estimated 563 
products that pay fees will generate a total of $1,691,000. To generate 
this amount will require the fee for a generic new animal drug product, 
rounded to the nearest five dollars, to be $3,005.

V. Generic New Animal Drug Sponsor Fee Calculations for FY 2009

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

[[Page 53260]]

abbreviated application for a generic new animal drug, that has not 
been withdrawn by the applicant and for which approval has not been 
withdrawn by the Secretary of Health and Human Services, 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 six approved abbreviated applications will pay 100 
percent of the sponsor fee, applicants with two to six approved 
abbreviated applications will pay 75 percent of the sponsor fee, and 
applicants with one 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 $1,691,000 in fee 
revenue for FY 2009. This is the amount set out in the statute and no 
adjustments are required for FY 2009.
    To set generic new animal drug sponsor fees to realize $1,691,000, 
FDA must make some assumptions about the number of sponsors who will 
pay these fees in FY 2009. Based on the number of firms that would have 
met this definition in each of the past 5 years, FDA estimates that in 
FY 2009 11 sponsors will pay 100 percent (full) fees, 11 sponsors will 
pay 75 percent fees, and 28 sponsors will pay 50 percent fees. That 
totals the equivalent of 33.25 full sponsor fees (11 times 100 percent 
or 11, plus 11 times 75 percent or 8.25, plus 28 times 50 percent or 
14).
    FDA estimates that about 10 percent of all of these sponsors, or 
3.25, may qualify for a minor use/minor species waiver or reduction.
    Accordingly, the agency estimates that the equivalent of 30 full 
sponsor fees (33.25 minus 3.25) are likely to be paid in FY 2009.

B. Sponsor Fee Rates for FY 2009

    FDA must set the fee rates for FY 2009 so that the estimated 
equivalent of 30 full sponsor fees will generate a total of $1,691,000. 
To generate this amount will require the 100-percent fee for a generic 
new animal drug sponsor, rounded to the nearest fifty dollars, to be 
$56,350. Accordingly, the fee for those paying 75 percent of the full 
sponsor fee, rounded to the nearest five dollars, will be $42,265, and 
the fee for those paying 50 percent of the full sponsor fee will be 
$28,175.

VI. Fee Schedule for FY 2009

    The fee rates for FY 2009 are summarized in table 1 of this 
document.

                       Table 1--FY 2009 Fee Rates
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     Generic New Animal Drug User Fee Category      Fee Rate for FY 2009
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Abbreviated Application for Generic New Animal                   $41,400
 Drug Fee
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Generic New Animal Drug Product Fee                               $3,005
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100 Percent Generic New Animal Drug Sponsor Fee\*\               $56,350
75 Percent Generic New Animal Drug Sponsor Fee\*\                $42,265
50 Percent Generic New Animal Drug Sponsor Fee\*\                $28,175
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\*\ An animal drug sponsor is subject to only one such fee each fiscal
  year

VII. Procedures for Paying FY 2009 Generic New Animal Drug User Fees

    FDA may not collect user fees for abbreviated applications, for 
generic new animal drug products, and for generic new animal drug 
sponsors until an appropriation of fees is provided by Congress (see 21 
U.S.C. 379j-21(g)(1)). For this reason FDA may not begin to collect 
these fees at this time.
    Fees for generic new animal drug products and sponsors will be 
invoiced at the rates published in this notice on the later of December 
31, 2008, or 30 days after appropriation of generic new animal drug 
user fees by Congress.
    Invoices for fees for abbreviated applications for generic new 
animal drugs submitted on or after July 1, 2008, will be issued 30 days 
after appropriation of generic new animal drug user fees by Congress. 
After that time, FDA will not consider an abbreviated application for a 
generic abbreviated new animal drug complete unless the application fee 
for that application has been paid in advance. Within 30 days after 
appropriation of generic new animal drug user fees by Congress, FDA 
will publish another notice in the Federal Register providing payment 
instructions so that these fees may be paid in advance of the 
submission of such abbreviated applications from that time forward.

    Dated: September 3, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-21453 Filed 9-12-08; 8:45 am]
BILLING CODE 4160-01-S