[Federal Register Volume 75, Number 148 (Tuesday, August 3, 2010)]
[Notices]
[Pages 45636-45640]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-19040]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0340]
Animal Generic Drug User Fee Rates and Payment Procedures for
Fiscal Year 2011
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) 2011 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 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
submissions for generic new animal drugs. This notice establishes the
fee rates for FY 2011.
For FY 2011, the generic animal drug user fee rates are: $92,600
for each abbreviated application for a generic new animal drug; $5,440
for each generic new animal drug product; $55,950 for each generic new
animal drug sponsor paying 100 percent of the sponsor fee; $41,963 for
each generic new animal drug sponsor paying 75 percent of the sponsor
fee; and $27,975 for a generic new animal drug sponsor paying 50
percent of the sponsor fee. FDA will issue invoices for FY 2011 product
and sponsor fees by December 31, 2010. 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, 2010, and will remain in effect through September 30, 2011.
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.
FOR FURTHER INFORMATION CONTACT: Visit the FDA Web site at http://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/default.htm 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: [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
[[Page 45637]]
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.
II. Revenue Amount for FY 2011
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
2011 for abbreviated application fees is $1,619,000 and each of the
other two generic new animal drug user fee categories, annual product
fees and annual sponsor fees, is $1,889,000 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, 2010.
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 24.47 percent for FY 2011. This is the workload adjuster
for FY 2011.
Table 1--Workload Adjuster Calculation
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Column 1 5-Year Column 2 Latest 5-
Application Avg. 2004-2008 Year Avg. (thru June Column 3 Percent Column 4 Colum 5 Weighted
Type (Base Years) 30, 2010) Change Weighting Factor Percent Change
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Abbreviated 44.2 30.2 -32% 56% -17.74%
New Animal
Drug
Application
s (ANADAs)
----------------------------------------------------------------------------------------------------------------
Manufacturin 114.6 102.6 -10% 19% -1.99%
g
Supplements
ANADAs\1\
----------------------------------------------------------------------------------------------------------------
Generic 17.4 17.4 0% 10% 0.00%
Investigati
onal Study
Submissions
\2\
----------------------------------------------------------------------------------------------------------------
Generic 21.6 15.2 -30% 16% -4.74%
Investigati
onal
Protocol
Submissions
----------------------------------------------------------------------------------------------------------------
FY 2011 AGDUFA Workload Adjuster -24.47%
----------------------------------------------------------------------------------------------------------------
\1\ This number is slightly lower than the 114.8 shown in last year's notice because FDA refused to file some
applications.
\2\ This number is slightly lower than the 18 shown in last years notice because FDA refused to accept some
submissions.
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 2011 would result in fees less than the
statutory amount, the workload adjustment will not be applied in FY
2011. As a result, the statutory revenue amount for each category of
fees for FY 2011 ($1,619,000 for application fees and $1,889,000 for
both product and sponsor fees) becomes the revenue target for the fees
in FY 2011, for a total fee revenue target in FY 2011 of $5,397,000 for
fees from all three categories.
III. Abbreviated Application Fee Calculations for FY 2011
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 $1,619,000 in fee revenue for FY 2011.
This is the amount set out in the statute.
To set fees for abbreviated applications for generic new animal
drugs to realize $1,619,000, FDA must first make some assumptions about
the number of fee-paying abbreviated applications it will receive
during FY 2011.
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
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fees (21 U.S.C. 379j-21(a)(1)(A)). Some of these nonfee 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 2011 will equal 30 percent less
than the average number of submissions over the 5 most recent years.
This 30-percent reduction is made because of the anticipated impact of
fees on the number on submissions. During FY 2010, FDA estimates it
will receive only 6 original submissions of abbreviated applications
for generic new animal drugs, compared to average receipts of 14.4 per
year over the latest 5 years, including our FY 2010 estimate. 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 2011 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
a year from now when fees are set for FY 2012.)
Regarding reactivated submissions of abbreviated applications for
generic new animal drugs, FDA is applying a 50-percent reduction based
on the FDA's experience with these types of submissions during the
third year of other user fee programs. This assumption 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, and 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. During FY 2010, FDA estimates it will receive only 9
reactivated submissions of abbreviated applications for generic new
animal drugs, compared to average receipts of 14.8 per year average
over the most recent 5 years, including our estimate for FY 2010.
Applying a 50-percent reduction to the 14.8 average, the estimate for
reactivated submissions of abbreviated applications for generic new
animal drugs for FY 2011 is 7.4. 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
about 7 years of experience with a similar user fee program.
Based on the previous assumptions, FDA is estimating that it will
receive a total of 17.5 fee paying generic new animal drug applications
in FY 2011 (10.1 original applications and 7.4 reactivations).
B. Fee Rates for FY 2011
FDA must set the fee rates for FY 2011 so that the estimated 17.5
abbreviated applications that pay the fee will generate a total of
$1,619,000. To generate this amount, the fee for a generic new animal
drug application, rounded to the nearest hundred dollars, will have to
be $92,600.
IV. Generic New Animal Drug Product Fee Calculations for FY 2011
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 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 $1,889,000 in fee revenue for FY 2011. This is the amount
set out in the statute and no further adjustments are required for FY
2011.
To set generic new animal drug product fees to realize $1,889,000,
FDA must make some assumptions about the number of products for which
these fees will be paid in FY 2011. FDA gathered 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 new animal drug application or
supplemental abbreviated application pending after September 1, 2008.
FDA estimates a total of 386 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 386 products will be subject to this fee in FY 2011. The
number of products has dropped substantially from the numbers in last
year's Federal Register fee notice because a number of products were
de-listed and are no longer subject to fee. That also causes the fee
per product to increase.
In estimating the fee revenue to be generated by generic new animal
drug product fees in FY 2011, FDA is assuming that 10 percent of the
products invoiced, or 38.6, will not pay fees in FY 2011 due to fee
waivers and reductions. Based on experience with other user fee
programs and the first 2 years of AGDUFA, FDA believes that this is a
reasonable basis for estimating the number of fee-paying products in FY
2011.
Accordingly, the agency estimates that a total of 347.4 (386 minus
38.6) products will be subject to product fees in FY 2011.
B. Product Fee Rates for FY 2011
FDA must set the fee rates for FY 2011 so that the estimated 347.4
products that pay fees will generate a total of $1,889,000. To generate
this amount will require the fee for a generic new animal drug product,
rounded to the nearest five dollars, to be $5,440.
V. Generic New Animal Drug Sponsor Fee Calculations for FY 2011
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 45639]]
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 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 $1,889,000 in fee revenue for
FY 2011. This is the amount set out in the statute and no adjustments
are required for FY 2011.
To set generic new animal drug sponsor fees to realize $1,889,000,
FDA must make some assumptions about the number of sponsors who will
pay these fees in FY 2011. Based on the number of firms that meet this
definition, FDA estimates that in FY 2011, 12 sponsors will pay 100
percent fees, 12 sponsors will pay 75 percent fees, and 33 sponsors
will pay 50 percent fees. That totals the equivalent of 37.5 full
sponsor fees (12 times 100 percent or 12, plus 12 times 75 percent or
9, plus 33 times 50 percent or 16.5).
FDA estimates that about 10 percent of all of these sponsors, or
3.75, may qualify for a minor use/minor species waiver.
Accordingly, the agency estimates that the equivalent of 33.75 full
sponsor fees (37.5 minus 3.75) are likely to be paid in FY 2011.
B. Sponsor Fee Rates for FY 2011
FDA must set the fee rates for FY 2011 so that the estimated
equivalent of 33.75 full sponsor fees will generate a total of
$1,889,000. To generate this amount will require the 100-percent fee
for a generic new animal drug sponsor, rounded to the nearest $50, to
be $55,950. Accordingly, the fee for those paying 75 percent of the
full sponsor fee will be $41,963, and the fee for those paying 50
percent of the full sponsor fee will be $27,795.
VI. Fee Schedule for FY 2011
The fee rates for FY 2011 are summarized in table 2 of this
document.
Table 2--FY 2011 Fee Rates
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Fee Rate for
Generic New Animal Drug User Fee Category FY 2011
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Abbreviated Application Fee for Generic New Animal Drug $92,600
Application
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Generic New Animal Drug Product Fee 5,440
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100 Percent Generic New Animal Drug Sponsor Fee\1\ 55,950
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75 Percent Generic New Animal Drug Sponsor Fee \1\ 41,963
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50 Percent Generic New Animal Drug Sponsor Fee \1\ 27,975
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\1\ An animal drug sponsor is subject to only one fee each fiscal year.
VII. Procedures for Paying FY 2011 Generic New Animal Drug User Fees
A. Abbreviated Application Fees and Payment Instructions
The FY 2011 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, 2010. 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. (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, U.S.
or 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 (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 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, 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 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 Center for Veterinary Medicine, or the date US
Bank notifies FDA that your payment in the full amount has been
received, or when the U.S. Department of the Treasury notifies FDA of
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 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
[[Page 45640]]
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
By December 31, 2010, FDA will issue invoices and payment
instructions for product and sponsor fees for FY 2011 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 2011 that qualify for fees after
the December 2010 billing.
Dated: July 29, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-19040 Filed 8-2-10; 8:45 am]
BILLING CODE 4160-01-S