[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