Generic New Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2009, 53258-53260 [E8-21453]
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53258
Federal Register / Vol. 73, No. 179 / Monday, September 15, 2008 / Notices
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953877, 1005 Convention Plaza, St.
Louis, Missouri 63101. (Note: This
address is for courier delivery only. If
you have any questions concerning
courier delivery contact the US Bank at
314–418–4821. 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
check 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 Center for
Veterinary Medicine (CVM). FDA
records the official application receipt
date as the later of the following: the
date the application was received by
CVM, or the date US Bank notifies FDA
that your check in the full amount of the
payment due has been received, or
when the United States Treasury
notifies FDA of receipt of an electronic
payment. US Bank and the United
States Treasury are required to notify
FDA within 1 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 ADUFA Web
site at https://www.fda.gov/oc/adufa and,
under the ‘‘Forms’’ heading, click on the
link ‘‘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 they use this site. Online
instructions will walk you through this
process.
Step Two—Create an Animal 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 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 Payment
Identification Number.
Step Three—Send the payment for
your application as described in section
IX.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
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Medicine, Document Control Unit
(HFV–199), 7500 Standish Pl.,
Rockville, MD 20855.
C. Product, Establishment and Sponsor
Fees
By December 31, 2008, FDA will issue
invoices and payment instructions for
product, establishment, and sponsor
fees for FY 2009 using this fee schedule.
Payment will be due and payable on or
before January 31, 2009. FDA will issue
invoices in November 2009 for any
products, establishments, and sponsors
subject to fees for FY 2009 but that
qualified for fees after the December
2008 billing.
Dated: September 8, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–21450 Filed 9–12–08; 8:45 am]
BILLING CODE 4160–01–S
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
Food and Drug Administration
Notice
AGENCY:
ACTION:
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
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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.
Visit
the FDA Web site at https://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 email the Center for Veterinary Medicine
at: cvmagdufa@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
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
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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.
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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
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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) feepaying 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
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53259
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
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Federal Register / Vol. 73, No. 179 / Monday, September 15, 2008 / Notices
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
Generic New Animal Drug User Fee Category
Fee Rate for FY 2009
Abbreviated Application for Generic New Animal Drug Fee
$41,400
Generic New Animal Drug Product Fee
$3,005
100 Percent Generic New Animal Drug Sponsor Fee*
75 Percent Generic New Animal Drug Sponsor Fee*
50 Percent Generic New Animal Drug Sponsor Fee*
* 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
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$56,350
$42,265
$28,175
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
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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
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[Federal Register Volume 73, Number 179 (Monday, September 15, 2008)]
[Notices]
[Pages 53258-53260]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-21453]
-----------------------------------------------------------------------
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
-----------------------------------------------------------------------
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 https://
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:
cvmagdufa@fda.hhs.gov.
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
------------------------------------------------------------------------
Generic New Animal Drug User Fee Category Fee Rate for FY 2009
------------------------------------------------------------------------
Abbreviated Application for Generic New Animal $41,400
Drug Fee
------------------------------------------------------------------------
Generic New Animal Drug Product Fee $3,005
------------------------------------------------------------------------
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
------------------------------------------------------------------------
\*\ 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
