Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2010, 38434-38437 [E9-18458]
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38434
Federal Register / Vol. 74, No. 147 / Monday, August 3, 2009 / Notices
Dated: July 28, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–18459 Filed 7–31–09; 8:45 am]
BILLING CODE 4160–01–S
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 2010
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
sroberts on DSKD5P82C1PROD with NOTICES
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
rates and payment procedures for fiscal
year (FY) 2010 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 2010.
For FY 2010, the generic animal drug
user fee rates are: $75,000 for each
abbreviated application for a generic
new animal drug; $3,255 for each
generic new animal drug product;
$54,050 for each generic new animal
drug sponsor paying 100 percent of the
sponsor fee; $40,537 for each generic
new animal drug sponsor paying 75
percent of the sponsor fee; and $27,025
for a generic new animal drug sponsor
paying 50 percent of the sponsor fee.
FDA will issue invoices for FY 2010
product and sponsor fees by December
31, 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 a
generic new animal drug submitted on
or after October 1, 2009, and will remain
in effect through September 30, 2010.
Applications will not be accepted for
review until the 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 https://www.fda.gov/
ForIndustry/UserFees/Animal
GenericDrugUserFeeActAGDUFA/
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:
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 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 2010
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 2010 for
abbreviated application fees is
$1,532,000 and each of the other two
generic new animal drug user fee
categories, annual product fees and
annual sponsor fees, is $1,787,000 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 5year period that ended on June 30, 2009.
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 11.2 percent for FY 2010. This
is the workload adjuster for FY2010.
TABLE 1.—WORKLOAD ADJUSTER CALCULATION
Column 1
5-Year Avg. (Base
Years)
Application type
Column 2
Latest 5-Year Avg.
44.20
38.00
Abbreviated New Animal Drug Applications (ANADAs)
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Column 3
Percent Change
Column 4
Weighting Factor
-14%
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59%
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Colum 5
Weighted Percent
Change
-8.3%
Federal Register / Vol. 74, No. 147 / Monday, August 3, 2009 / Notices
38435
TABLE 1.—WORKLOAD ADJUSTER CALCULATION—Continued
Column 1
5-Year Avg. (Base
Years)
Column 2
Latest 5-Year Avg.
114.80
101.20
-12%
15%
-1.8%
Generic Investigational Study Submissions
18.00
19.60
9%
10%
.9%
Generic Investigational Protocol Submissions
21.60
18.80
-13%
16%
-2.1%
Application type
Manufacturing Supplements ANADAs
Column 3
Percent Change
Column 4
Weighting Factor
FY 2010 AGDUFA Workload Adjuster
-11.2%
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 2010 would result in fees less
than the statutory amount, the workload
adjustment will not be applied in FY
2010. As a result, the statutory revenue
amount for each category of fees for FY
2010 ($1,532,000 for application fees
and $1,787,000 for both product and
sponsor fees) becomes the revenue
target for the fees in FY 2010, for a total
inflation-adjusted fee revenue target in
FY 2010 of $5,106,000 for fees from all
three categories.
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III. Abbreviated Application Fee
Calculations for FY 2010
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 $1,532,000 in fee revenue for
FY 2010. This is the amount set out in
the statute.
To set fees for abbreviated
applications for generic new animal
drugs to realize $1,532,000, FDA must
first make some assumptions about the
number of fee-paying abbreviated
applications it will receive during FY
2010.
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
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Colum 5
Weighted Percent
Change
abbreviated applications for generic new
animal drugs. Any original submissions
of abbreviated applications for generic
new animal drugs that were received by
the FDA before July 1, 2008, were not
assessed 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
the FDA (i.e. the 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 2010 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 5 original submissions of
abbreviated applications for generic new
animal drugs, compared to average
receipts of 16.2 per year over the latest
5 years, including our FY 2009 estimate.
Applying a 30-percent reduction to the
16.2 average, the estimate for original
submissions of abbreviated applications
for generic new animal drugs for FY
2010 is 11.3. (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 2011.)
Regarding reactivated submissions of
abbreviated applications for generic new
animal drugs, FDA is applying a 50percent reduction based on the FDA’s
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experience with these types of
submissions during the second 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 the 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 the 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 2009, FDA estimates
it will receive only 3 reactivated
submissions of abbreviated applications
for generic new animal drugs, compared
to average receipts of 18.2 per year over
the most recent 5 years, including our
estimate for FY 2009. Applying a 50percent reduction to the 18.2 average,
the estimate for reactivated submissions
of abbreviated applications for generic
new animal drugs for FY 2010 is 9.1.
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 6 years of
experience with a similar user fee
program.
Based on the previous assumptions,
FDA is estimating that it will receive a
total of 20.4 fee paying generic new
animal drug applications in FY 2010
(11.3 original applications and 9.1
reactivations).
B. Fee Rates for FY 2010
FDA must set the fee rates for FY 2010
so that the estimated 20.4 abbreviated
applications that pay the fee will
generate a total of $1,532,000. To
generate this amount, the fee for a
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Federal Register / Vol. 74, No. 147 / Monday, August 3, 2009 / Notices
generic new animal drug application,
rounded to the nearest hundred dollars,
will have to be $75,000.
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IV. Generic New Animal Drug Product
Fee Calculations for FY 2010
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
$1,787,000 in fee revenue for FY 2010.
This is the amount set out in the statute
and no further adjustments are required
for FY 2010.
To set generic new animal drug
product fees to realize $1,787,000, FDA
must make some assumptions about the
number of products for which these fees
will be paid in FY 2010. 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 610
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 610 products will be subject to this
fee in FY 2010.
In estimating the fee revenue to be
generated by generic new animal drug
product fees in FY 2010, FDA is
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16:05 Jul 31, 2009
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assuming that 10 percent of the
products invoiced, or 61, will not pay
fees in FY 2010 due to fee waivers and
reductions. Based on experience with
other user fee programs and the first 6
years of ADUFA, FDA believes that this
is a reasonable basis for estimating the
number of fee-paying products in FY
2010.
Accordingly, the agency estimates
that a total of 549 (610 minus 61)
products will be subject to product fees
in FY 2010.
B. Product Fee Rates for FY 2010
FDA must set the fee rates for FY 2010
so that the estimated 549 products that
pay fees will generate a total of
$1,787,000. To generate this amount
will require the fee for a generic new
animal drug product, rounded to the
nearest five dollars, to be $3,255.
V. Generic New Animal Drug Sponsor
Fee Calculations for FY 2010
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 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
$1,787,000 in fee revenue for FY 2010.
This is the amount set out in the statute
and no adjustments are required for FY
2010.
To set generic new animal drug
sponsor fees to realize $1,787,000, FDA
must make some assumptions about the
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number of sponsors who will pay these
fees in FY 2010. Based on the number
of firms that meet this definition, FDA
estimates that in FY 2010, 11 sponsors
will pay 100 percent fees, 11 sponsors
will pay 75 percent fees, and 35
sponsors will pay 50 percent fees. That
totals the equivalent of 36.75 full
sponsor fees (11 times 100 percent or
11, plus 11 times 75 percent or 8.25,
plus 35 times 50 percent or 17.5).
FDA estimates that about 10 percent
of all of these sponsors, or 3.675, may
qualify for a minor use/minor species
waiver.
Accordingly, the agency estimates
that the equivalent of 33.075 full
sponsor fees (36.75 minus 3.675) are
likely to be paid in FY 2010.
B. Sponsor Fee Rates for FY 2010
FDA must set the fee rates for FY 2010
so that the estimated equivalent of
33.075 full sponsor fees will generate a
total of $1,787,000. To generate this
amount will require the 100-percent fee
for a generic new animal drug sponsor,
rounded to the nearest $50, to be
$54,050. Accordingly, the fee for those
paying 75 percent of the full sponsor
fee, rounded to the nearest $5, will be
$40,537, and the fee for those paying 50
percent of the full sponsor fee will be
$27,025.
VI. Fee Schedule for FY 2010
The fee rates for FY 2010 are
summarized in table 2 of this document.
TABLE 2.—FY 2010 FEE RATES
Generic New Animal Drug User
Fee Category
Fee Rate
for FY 2010
Abbreviated Application Fee for
Generic New Animal Drug
Application
$75,000
Generic New Animal Drug
Product Fee
100 Percent Generic New Animal Drug Sponsor Fee(1)
75 Percent Generic New Animal Drug Sponsor Fee(1)
50 Percent Generic New Animal Drug Sponsor Fee(1)
$3,255
$54,050
$40,537
$27,025
(1) An
animal drug sponsor is subject to only
one fee each fiscal year
VII. Procedures for Paying FY 2010
Generic New Animal Drug User Fees
A. Abbreviated Application Fees and
Payment Instructions
The FY 2010 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, 2009. Payment must be made
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03AUN1
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Federal Register / Vol. 74, No. 147 / Monday, August 3, 2009 / Notices
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 righthand 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
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16:05 Jul 31, 2009
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38437
required to notify FDA within one
working day, using the Payment
Identification Number described
previously.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
B. Application Cover Sheet Procedures
[Docket No. FDA–2009–D–0347]
Step One—Create a user account and
password. Log onto the AGDUFA
website at https://www.fda.gov/
ForIndustry/UserFees/Animal
GenericDrugUserFeeActAGDUFA/
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
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.
Draft Guidance for Industry: Guide to
Minimize Microbial Food Safety
Hazards of Melons; Availability
C. Product and Sponsor Fees
By December 31, 2009, FDA will issue
invoices and payment instructions for
product and sponsor fees for FY 2010
using this fee schedule. Fees will be due
and payable 30 days after the issuance
of the invoices. FDA will issue invoices
in November 2010 for any products and
sponsors subject to fees for FY 2010 that
qualify for fees after the December 2009
billing.
Dated: July 28, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–18458 Filed 7–31–09; 8:45 am]
BILLING CODE 4160–01–S
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Food and Drug Administration
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance entitled
‘‘Guidance for Industry: Guide to
Minimize Microbial Food Safety
Hazards of Melons.’’ This draft guidance
is intended to cover the entire melon
supply chain, both domestic firms and
foreign firms exporting melons into the
United States, to enhance the safety of
melons by recommending practices to
minimize microbial food safety hazards
and to prevent microbial contamination.
This draft guidance, when finalized,
will supplement existing FDA
guidances, including the 1998
‘‘Guidance to Industry: Guide to
Minimize Microbial Food Safety
Hazards for Fresh Fruits and
Vegetables,’’ which applies to fresh
produce commodities, and the 2008
‘‘Guidance to Industry: Guide to
Minimize Microbial Food Safety
Hazards of Fresh-cut Fruits and
Vegetables,’’ which applies to fresh-cut
produce.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance by October 2, 2009.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Office of Food Safety (HFS–317), Center
for Food Safety and Applied Nutrition,
5100 Paint Branch Pkwy., College Park,
MD 20740. Send one self-addressed
adhesive label to assist that office in
processing your request, or fax your
request to 301–436–2651. Submit
written comments on the draft guidance
to the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance.
FOR FURTHER INFORMATION CONTACT:
Willette Crawford, Center for Food
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Agencies
[Federal Register Volume 74, Number 147 (Monday, August 3, 2009)]
[Notices]
[Pages 38434-38437]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-18458]
-----------------------------------------------------------------------
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 2010
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the rates
and payment procedures for fiscal year (FY) 2010 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 2010.
For FY 2010, the generic animal drug user fee rates are: $75,000
for each abbreviated application for a generic new animal drug; $3,255
for each generic new animal drug product; $54,050 for each generic new
animal drug sponsor paying 100 percent of the sponsor fee; $40,537 for
each generic new animal drug sponsor paying 75 percent of the sponsor
fee; and $27,025 for a generic new animal drug sponsor paying 50
percent of the sponsor fee. FDA will issue invoices for FY 2010 product
and sponsor fees by December 31, 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 a generic new animal drug submitted on or after
October 1, 2009, and will remain in effect through September 30, 2010.
Applications will not be accepted for review until the 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 https://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: 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 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 2010
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
2010 for abbreviated application fees is $1,532,000 and each of the
other two generic new animal drug user fee categories, annual product
fees and annual sponsor fees, is $1,787,000 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, 2009.
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 11.2 percent for FY 2010. This is the workload adjuster for
FY2010.
Table 1.--Workload Adjuster Calculation
--------------------------------------------------------------------------------------------------------------------------------------------------------
Column 1 5-Year Column 2 Latest Column 3 Percent Column 4 Colum 5 Weighted
Application type Avg. (Base Years) 5-Year Avg. Change Weighting Factor Percent Change
--------------------------------------------------------------------------------------------------------------------------------------------------------
Abbreviated New Animal Drug Applications (ANADAs) 44.20 38.00 -14% 59% -8.3%
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 38435]]
Manufacturing Supplements ANADAs 114.80 101.20 -12% 15% -1.8%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Generic Investigational Study Submissions 18.00 19.60 9% 10% .9%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Generic Investigational Protocol Submissions 21.60 18.80 -13% 16% -2.1%
--------------------------------------------------------------------------------------------------------------------------------------------------------
FY 2010 AGDUFA Workload Adjuster -11.2%
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 2010 would result in fees less than the
statutory amount, the workload adjustment will not be applied in FY
2010. As a result, the statutory revenue amount for each category of
fees for FY 2010 ($1,532,000 for application fees and $1,787,000 for
both product and sponsor fees) becomes the revenue target for the fees
in FY 2010, for a total inflation-adjusted fee revenue target in FY
2010 of $5,106,000 for fees from all three categories.
III. Abbreviated Application Fee Calculations for FY 2010
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 $1,532,000 in fee revenue for FY 2010.
This is the amount set out in the statute.
To set fees for abbreviated applications for generic new animal
drugs to realize $1,532,000, FDA must first make some assumptions about
the number of fee-paying abbreviated applications it will receive
during FY 2010.
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 the FDA before July 1,
2008, were not assessed 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 the FDA (i.e. the
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 2010 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 5 original submissions of abbreviated applications
for generic new animal drugs, compared to average receipts of 16.2 per
year over the latest 5 years, including our FY 2009 estimate. Applying
a 30-percent reduction to the 16.2 average, the estimate for original
submissions of abbreviated applications for generic new animal drugs
for FY 2010 is 11.3. (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 2011.)
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
second 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 the 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 the
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 2009, FDA estimates it will receive only
3 reactivated submissions of abbreviated applications for generic new
animal drugs, compared to average receipts of 18.2 per year over the
most recent 5 years, including our estimate for FY 2009. Applying a 50-
percent reduction to the 18.2 average, the estimate for reactivated
submissions of abbreviated applications for generic new animal drugs
for FY 2010 is 9.1. 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 6 years of
experience with a similar user fee program.
Based on the previous assumptions, FDA is estimating that it will
receive a total of 20.4 fee paying generic new animal drug applications
in FY 2010 (11.3 original applications and 9.1 reactivations).
B. Fee Rates for FY 2010
FDA must set the fee rates for FY 2010 so that the estimated 20.4
abbreviated applications that pay the fee will generate a total of
$1,532,000. To generate this amount, the fee for a
[[Page 38436]]
generic new animal drug application, rounded to the nearest hundred
dollars, will have to be $75,000.
IV. Generic New Animal Drug Product Fee Calculations for FY 2010
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 $1,787,000 in fee revenue for FY 2010. This is the amount
set out in the statute and no further adjustments are required for FY
2010.
To set generic new animal drug product fees to realize $1,787,000,
FDA must make some assumptions about the number of products for which
these fees will be paid in FY 2010. 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 610 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 610 products will be subject to this fee in FY 2010.
In estimating the fee revenue to be generated by generic new animal
drug product fees in FY 2010, FDA is assuming that 10 percent of the
products invoiced, or 61, will not pay fees in FY 2010 due to fee
waivers and reductions. Based on experience with other user fee
programs and the first 6 years of ADUFA, FDA believes that this is a
reasonable basis for estimating the number of fee-paying products in FY
2010.
Accordingly, the agency estimates that a total of 549 (610 minus
61) products will be subject to product fees in FY 2010.
B. Product Fee Rates for FY 2010
FDA must set the fee rates for FY 2010 so that the estimated 549
products that pay fees will generate a total of $1,787,000. To generate
this amount will require the fee for a generic new animal drug product,
rounded to the nearest five dollars, to be $3,255.
V. Generic New Animal Drug Sponsor Fee Calculations for FY 2010
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 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 $1,787,000 in fee revenue for
FY 2010. This is the amount set out in the statute and no adjustments
are required for FY 2010.
To set generic new animal drug sponsor fees to realize $1,787,000,
FDA must make some assumptions about the number of sponsors who will
pay these fees in FY 2010. Based on the number of firms that meet this
definition, FDA estimates that in FY 2010, 11 sponsors will pay 100
percent fees, 11 sponsors will pay 75 percent fees, and 35 sponsors
will pay 50 percent fees. That totals the equivalent of 36.75 full
sponsor fees (11 times 100 percent or 11, plus 11 times 75 percent or
8.25, plus 35 times 50 percent or 17.5).
FDA estimates that about 10 percent of all of these sponsors, or
3.675, may qualify for a minor use/minor species waiver.
Accordingly, the agency estimates that the equivalent of 33.075
full sponsor fees (36.75 minus 3.675) are likely to be paid in FY 2010.
B. Sponsor Fee Rates for FY 2010
FDA must set the fee rates for FY 2010 so that the estimated
equivalent of 33.075 full sponsor fees will generate a total of
$1,787,000. To generate this amount will require the 100-percent fee
for a generic new animal drug sponsor, rounded to the nearest $50, to
be $54,050. Accordingly, the fee for those paying 75 percent of the
full sponsor fee, rounded to the nearest $5, will be $40,537, and the
fee for those paying 50 percent of the full sponsor fee will be
$27,025.
VI. Fee Schedule for FY 2010
The fee rates for FY 2010 are summarized in table 2 of this
document.
Table 2.--FY 2010 Fee Rates
------------------------------------------------------------------------
Fee Rate
Generic New Animal Drug User Fee Category for FY 2010
------------------------------------------------------------------------
Abbreviated Application Fee for Generic New Animal Drug $75,000
Application
------------------------------------------------------------------------
Generic New Animal Drug Product Fee $3,255
------------------------------------------------------------------------
100 Percent Generic New Animal Drug Sponsor Fee\(1)\ $54,050
75 Percent Generic New Animal Drug Sponsor Fee\(1)\ $40,537
50 Percent Generic New Animal Drug Sponsor Fee\(1)\ $27,025
------------------------------------------------------------------------
\(1)\ An animal drug sponsor is subject to only one fee each fiscal year
VII. Procedures for Paying FY 2010 Generic New Animal Drug User Fees
A. Abbreviated Application Fees and Payment Instructions
The FY 2010 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, 2009. Payment must be
made
[[Page 38437]]
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 one 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
website at https://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 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, 2009, FDA will issue invoices and payment
instructions for product and sponsor fees for FY 2010 using this fee
schedule. Fees will be due and payable 30 days after the issuance of
the invoices. FDA will issue invoices in November 2010 for any products
and sponsors subject to fees for FY 2010 that qualify for fees after
the December 2009 billing.
Dated: July 28, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-18458 Filed 7-31-09; 8:45 am]
BILLING CODE 4160-01-S