[Federal Register Volume 74, Number 65 (Tuesday, April 7, 2009)]
[Notices]
[Pages 15736-15738]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-7786]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0148]
Generic New Animal Drug User Fee Rates and Payment Procedures for
Fiscal Year 2009
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) 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. AGDUFA required FDA to 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. The appropriations were enacted on March 11, 2009.
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.
FOR FURTHER INFORMATION CONTACT: Visit the FDA Web site at http://www.fda.gov/oc/adufa/agdufamain.html or contact Bryan Walsh, Center for
Veterinary Medicine (HFV-10), Food and Drug Administration, 7529
Standish Pl., Rockville, MD 20855, 240-276-9730. For general questions,
you may also e-mail the Center for Veterinary Medicine (CVM) 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 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
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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 $5, 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 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, 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 $1,691,000 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
[[Page 15738]]
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 $50, to be $56,350. Accordingly, the
fee for those paying 75 percent of the full sponsor fee, rounded to the
nearest $5, 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 Drug Fee $41,400
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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 the FY 2009 Abbreviated New Animal Drug
Application Fees
A. Abbreviated Application Fees and Payment Instructions
The appropriate application fee established in the new fee schedule
must be paid for an abbreviated new animal drug application subject to
fees under AGDUFA that was submitted on or after July 1, 2008. For
those sponsors who have submitted an abbreviated new animal drug
application between July 1, 2008, and the publication date of this
Federal Register notice, a cover sheet is not necessary, as the Food
and Drug Administration will complete a cover sheet for you and invoice
you accordingly. Payment must be made in U.S. currency by check, bank
draft, or U.S. postal money order payable to the order of the Food and
Drug Administration, by wire transfer, or by automatic clearing house
(ACH) using Pay.gov. On your check, bank draft, or U.S. postal money
order, please write your application's unique Payment Identification
Number, beginning with the letters ``AG'', from the upper right-hand
corner of your completed Animal Generic Drug User Fee Cover Sheet. Also
write the FDA post office box number (P.O. Box 953877) on the enclosed
check, bank draft, or money order. Your payment and a copy of the
completed Animal Generic Drug User Fee Cover Sheet can be mailed to:
Food and Drug Administration, P.O. Box 953877, St. Louis, MO, 63195-
3877. If payment is made by wire transfer, send payment to U.S.
Department of 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.
If you prefer to send a check by a courier such as FEDEX or UPS,
the courier may deliver the check and printed copy of the cover sheet
to: US 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 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 abbreviated application arrives at FDA's Center for
Veterinary Medicine. FDA records the official abbreviated application
receipt date as the later of the following: The date the application
was received by FDA's Center for Veterinary Medicine, or the date US
Bank notifies FDA that your check in the full amount of the payment due
has been received or when the U.S. Department of Treasury notifies FDA
of payment. US Bank is 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 AGDUFA
Web site at http://www.fda.gov/oc/adufa/agdufamain.html 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 you use
this site. Online instructions will walk you through this process.
Step Two--Create an Animal Generic Drug User Fee Cover Sheet,
transmit it to FDA, and print a copy. After logging into your account
with your user name and password, complete the steps required to create
an Animal Generic Drug User Fee Cover Sheet. One cover sheet is needed
for each abbreviated animal drug application. Once you are satisfied
that the data on the cover sheet is accurate and you have finalized the
cover sheet, you will be able to transmit it electronically to FDA and
you will be able to print a copy of your cover sheet showing your
unique Payment Identification Number.
Step Three--Send the payment for your application as described in
section VII.A of this document.
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
Thirty days after the March 11, 2009, enactment of appropriations
for generic animal drug user fees, FDA will issue invoices and payment
instructions for product and sponsor fees for FY 2009 using this fee
schedule. Fees will be due and payable 30 days after the date the
invoice is issued. FDA will issue invoices in November 2009 for any
qualifying products and sponsors subject to fees received after this
initial FY 2009 billing.
Dated: April 1, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-7786 Filed 4-6-09; 8:45 am]
BILLING CODE 4160-01-S