Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2009, 53254-53258 [E8-21450]
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53254
Federal Register / Vol. 73, No. 179 / Monday, September 15, 2008 / Notices
estimated total annual burden for
followup reports of new medical
information is shown in row 2 of table
1 of this document.
As previously noted, section 761(e)(1)
of the act requires that responsible
persons maintain records related to
dietary supplement adverse event
reports they receive, whether or not the
adverse event is serious. Under the
statute, the records must be retained for
a period of 6 years. The draft guidance
provides FDA’s recommendations as to
what records industry should maintain
to satisfy the statutory recordkeeping
requirement.
The guidance recommends that the
responsible person document its
attempts to obtain the minimum data
elements for a serious adverse event
report. Along with these records, the
guidance recommends that the
responsible person keep the following
other records: (1) Communications
between the responsible person and the
initial reporter of the adverse event and
with any other person(s) who provided
information about the adverse event; (2)
(for serious adverse events only) the
responsible person’s serious adverse
event report to FDA on MedWatch Form
3500A, with attachments; (3) any new
medical information about the adverse
event received by the responsible
person; (4) (for serious adverse events
only) any reports to FDA of new
medical information related to the
serious adverse event report. We
estimate that assembling and filing these
records, including any necessary
photocopying, will take approximately
0.5 hours per adverse event report
received by the responsible person.
Once the documents pertaining to an
adverse event report have been
assembled and filed, FDA expects the
records retention burden to be minimal,
as the agency believes most
establishments would normally keep
this kind of record for at least several
years after receiving the report, as a
matter of usual and customary business
practice. FDA requests comment on
current adverse event recordkeeping
practices in the dietary supplement
industry, including the length of time
such records are typically kept.
According to a 2001 report by the
Office of the Inspector General, between
1994–1999 FDA received 2,547 adverse
event reports involving dietary
supplements, or about 500 reports per
year, on average. According to the
report, the actual number of adverse
events relating to dietary supplements is
likely to be at least 100 times that many,
or more than 50,000 adverse events per
year. Given that we have limited data on
how many adverse events will be
reported each year to the responsible
person, we are using the 50,000 per year
figure as an upper-bound estimate of
reporting. This is almost certainly an
overestimate of the number of reports
the firms will receive, as it is unlikely
that every adverse event that occurs will
be reported to the responsible person.
FDA requests comments on this
estimate.
We estimated in the economic impact
analysis of the Dietary Supplement
Good Manufacturing Practices final rule
(the GMP final rule) (72 FR 34752, June
25, 2007) that there are 1,460
manufacturers, packers, and holders of
dietary supplements (72 FR 34752 at
34920). We assume that the estimated
50,000 adverse event reports related to
dietary supplements will be spread
evenly among these firms. The estimate
of the number of manufacturers,
packers, and holders of dietary
supplements from the GMP final rule is
FDA’s best estimate of the number of
firms that are ‘‘responsible persons’’
who must comply with the
recordkeeping requirements of the
DSNDCPA; however, it is not a precise
estimate because the number of dietary
supplement establishments covered by
the GMP final rule is likely to be larger
than the number of ‘‘responsible
persons,’’ where a ‘‘responsible person’’
is a dietary supplement manufacturer,
packer, or distributor whose name is
listed on the label of a dietary
supplement marketed in the United
States (see section 761(b)(1) of the act).
Thus, FDA’s estimate for the number of
respondents in table 2 may be over
inclusive. FDA requests comments on
the number of firms that would be
subject to the recordkeeping
requirements of the DSNDCPA.
The estimated total annual
recordkeeping burden under the statute
and this guidance is shown in table 2 of
this document.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of
Recordkeepers
Dietary supplement adverse event
records (21 U.S.C. 379aa–
1(e)(1))
Annual Frequency
per Recordkeeping
1,460
Total Annual
Records2
4.2465
Hours per
Record
50,000
Total Hours
0.5
25,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 For purposes of estimating the number of records and hours per record, a ‘‘record’’ means all records kept for an individual adverse event report received by the responsible person.
Dated: September 8, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–21454 Filed 9–12–08; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0480]
BILLING CODE 4160–01–S
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Animal Drug User Fee Rates and
Payment Procedures for Fiscal Year
2009
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
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rates and payment procedures for fiscal
year (FY) 2009 for user fees under the
Animal Drug User Fee Act program
(ADUFA). The Federal Food, Drug, and
Cosmetic Act (the act), as amended by
the Animal Drug User Fee Act of 2003
(ADUFA I), and the Animal Drug User
Fee Amendments of 2008 (ADUFA II),
authorizes FDA to collect user fees for
certain animal drug applications, on
certain animal drug products, on certain
establishments where such products are
made, and on certain sponsors of such
animal drug applications and/or
investigational animal drug
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submissions. This notice establishes the
fee rates for FY 2009.
For FY 2009, the animal drug user fee
rates are: $246,300 for an animal drug
application; $123,150 for a
supplemental animal drug application
for which safety or effectiveness data is
required and for an animal drug
application subject to certain criteria;
$4,925 for an annual product fee;
$59,450 for an annual establishment fee;
and $52,700 for an annual sponsor fee.
FDA will issue invoices for FY 2009
product, establishment, and sponsor
fees by December 31, 2008, and these
invoices will be due and payable on or
before January 31, 2009. FDA will issue
invoices in November 2009 for any
products, establishments, and sponsors
that are subject to fees for FY 2009 but
that qualified for fees after the December
2008 billing.
The application fee rates are effective
for applications submitted on or after
October 1, 2008, and will remain in
effect through September 30, 2009.
Applications will not be accepted for
review until FDA has received full
payment of application fees and any
other animal drug user fees owed.
Visit
the FDA Web site at https://www.fda.gov/
oc/adufa or contact Roxanne
Schweitzer, Center for Veterinary
Medicine (HFV–10), Food and Drug
Administration, 7529 Standish Pl.,
Rockville, MD 20855, 240–276–9705.
For general questions, you may also e-
FOR FURTHER INFORMATION CONTACT:
mail the Center for Veterinary Medicine
at: cvmadufa@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Section 740 of the act (21 U.S.C. 379j–
12) establishes four different kinds of
user fees: (1) Fees for certain types of
animal drug applications and
supplements, (2) annual fees for certain
animal drug products, (3) annual fees
for certain establishments where such
products are made, and (4) annual fees
for certain sponsors of animal drug
applications and/or investigational
animal drug submissions (section 740(a)
of the act). When certain conditions are
met, FDA will waive or reduce fees
(section 740(d) of the act).
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,
establishments, 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
ADUFA II (Public Law 110–316
signed by the President on August 14,
2008) specifies that the aggregate
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revenue amount for FY 2009 for each of
the four animal drug user fee categories
is $3,815,000, before any adjustment for
workload is made (see section 740(b)(1)
through (b)(4) of the act).
B. Inflation Adjustment to Fee Revenue
Amount
Because the amounts established in
ADUFA II for each year for FY 2009
through FY 2013 include an inflation
adjustment, no further inflation
adjustment is required.
C. Workload Adjustment to Fee Revenue
Amount
For each FY beginning after FY 2009,
ADUFA II provides that statutory fee
revenue amounts shall be further
adjusted to reflect changes in review
workload (section 740(c)(1) of the act).
No workload adjustment is to be made
in fee revenue amounts for FY 2009.
III. Adjustment for Excess Collections
in Previous Years
Under the provisions of ADUFA I, if
the agency collects more fees than were
provided for in appropriations in any
year, FDA is required to reduce its
anticipated fee collections in a
subsequent year by that amount (section
740(g)(4) of the act). Table 1 of this
document shows the amount of
collections realized and the amount
provided in appropriations acts, and the
amount to be offset in a subsequent
year, as of the end of the latest complete
fiscal year, 2007.
TABLE 1—FEES COLLECTED, FEES APPROPRIATED, AND OFFSET FOR FUTURE COLLECTIONS AS OF SEPTEMBER 30, 2007
Fiscal Year
Collections Realized
Fees Appropriated
Amount to Offset Future Collections
2004
$5,154,700
$5,000,000
$154,700
2005
$8,519,101
$8,354,000
$165,101
2006
$10,945,866
$11,318,000
$0
2007
$12,946,515
$11,604,000
$1,342,515
Total
$1,662,316
Amount offset when fees for FY 2008 were determined
$320,000
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Remaining balance to be offset in FY 2009
$1,342,316
When ADUFA fees were established
for FY 2008, the amount of fee revenues
for FY 2008 was reduced by a total of
$320,000 of excess collections. That
leaves a total of $1,342,316 to be offset
against FY 2009 revenue collections,
lowering the net amount that would
otherwise be collected. One-fourth of
this amount, rounded to the nearest
thousand, or $336,000, rounded to the
nearest thousand dollars, will be
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subtracted from the statutory fee
revenue amounts for each of the four fee
categories in setting the FY 2009
adjusted revenue amount for each fee
category. Thus, after adjustment for
prior-year excess collections, the
adjusted FY 2009 revenue target for
each fee category is as follows:
Application Fee Revenue Amount:
$3,479,000 ($3,815,000 minus
$336,000)
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Establishment Fee Revenue Amount:
$3,479,000 ($3,815,000 minus
$336,000)
Product Fee Revenue Amount:
$3,479,000 ($3,815,000 minus
$336,000)
Sponsor Fee Revenue Amount:
$3,479,000 ($3,815,000 minus
$336,000)
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Thus, the adjusted revenue amount from
all four categories after this adjustment
totals $13,916,000.
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IV. Application Fee Calculations for FY
2009
The terms ‘‘animal drug applications’’
and ‘‘supplemental animal drug
applications’’ are defined in section
739(1) and (2) of the act (21 U.S.C. 379j–
11(1) and (2)).
A. Application Fee Revenues and
Numbers of Fee-Paying Applications
The application fee must be paid for
any animal drug application or
supplemental animal drug application
that is subject to fees under ADUFA and
that is submitted on or after September
1, 2003. The application fees are to be
set so that they will generate $3,479,000
in fee revenue for FY 2009. This is the
amount set out in the statute after it has
been adjusted for excess collections in
previous years as set out in section III
of this document. The fee for a
supplemental animal drug application
for which safety or effectiveness data are
required and for an animal drug
application subject to criteria set forth
in section 512(d)(4) of the act (21 U.S.C.
360b(d)(4)) is to be set at 50 percent of
the animal drug application fee (see
section 740(a)(1)(A)(ii) of the act, as
amended by ADUFA II).
To set animal drug application fees
and supplemental animal drug
application fees to realize $3,479,000,
FDA must first make some assumptions
about the number of fee-paying
applications and supplements it will
receive in FY 2009.
The agency knows the number of
applications that have been submitted
in previous years. That number
fluctuates significantly from year to
year. In estimating the fee revenue to be
generated by animal drug application
fees in FY 2009, FDA is assuming that
the number of applications that will pay
fees in FY 2009 will equal the average
number of submissions over the 4 most
recent years (including an estimate for
the current year). 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 5 years of
experience with this program.
Over the past 4 years, the average
number of animal drug applications that
have been subject to the full fee was 7.5,
including the number for the most
recent year, which is estimated at 4.
Over this same period, the average
number of supplemental applications
and applications subject to the criteria
set forth in section 512(d)(4) that would
have been subject to half of the full fee
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was 13.25, including the number for the
most recent year, which is estimated at
9.
Thus, for FY 2009, FDA estimates
receipt of 7.5 fee paying original
applications and 13.25 fee-paying
supplemental animal drug applications
and applications subject to the criteria
set forth is section 512(d)(4), which pay
half of the full fee.
B. Fee Rates for FY 2009
FDA must set the fee rates for FY 2009
so that the estimated 7.5 applications
that pay the full fee and the estimated
13.25 supplements and applications
subject to the criteria set forth in section
512(d)(4) that pay half of the full fee
will generate a total of $3,479,000. To
generate this amount, the fee for an
animal drug application, rounded to the
nearest hundred dollars, will have to be
$246,300, and the fee for a supplemental
animal drug application for which
safety or effectiveness data are required
and for applications subject to the
criteria set forth in section 512(d)(4) will
have to be $123,150.
V. Product Fee Calculations for FY 2009
A. Product Fee Revenues and Numbers
of Fee-Paying Products
The animal drug product fee (also
referred to as the product fee) must be
paid annually by the person named as
the applicant in an animal drug
application or supplemental animal
drug application for an animal drug
product submitted for listing under
section 510 of the act (21 U.S.C. 360),
and who had an animal drug
application or supplemental animal
drug application pending before FDA
after September 1, 2003 (see section
740(a)(2) of the act). The term ‘‘animal
drug product’’ is defined in section
739(3) of the act. The product fees are
to be set so that they will generate
$3,479,000 in fee revenue for FY 2009.
This is the amount set out in the statute
after it has been adjusted for excess
collections in previous years as set out
in section III of this document.
To set animal drug product fees to
realize $3,479,000, 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 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 had an animal
drug application or supplement pending
after September 1, 2003. As of August
2008, FDA estimates that there are a
total of 785 products submitted for
listing by persons who had an animal
drug application or supplemental
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animal drug application pending after
September 1, 2003. Based on this, FDA
estimates that a total of 785 products
will be subject to this fee in FY 2009.
In estimating the fee revenue to be
generated by animal drug product fees
in FY 2009, FDA is assuming that 10
percent of the products invoiced, or
about 78.5, 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
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 fees for a total of 706.5 products
(785 minus 78.5) will be paid in FY
2009.
B. Product Fee Rates for FY 2009
FDA must set the fee rates for FY 2009
so that the estimated 706.5 products for
which fees will be paid will generate a
total of $3,479,000. To generate this
amount will require the fee for an
animal drug product, rounded to the
nearest 5 dollars, to be $4,925.
VI. Establishment Fee Calculations for
FY 2009
A. Establishment Fee Revenues and
Numbers of Fee-Paying Establishments
The animal drug establishment fee
(also referred to as the establishment
fee) must be paid annually by the
person who: (1) Owns or operates,
directly or through an affiliate, an
animal drug establishment; (2) is named
as the applicant in an animal drug
application or supplemental animal
drug application for an animal drug
product submitted for listing under
section 510 of the act; (3) had an animal
drug application or supplemental
animal drug application pending before
FDA after September 1, 2003; and (4)
whose establishment engaged in the
manufacture of the animal drug product
during the FY (see section 740(a)(3) of
the act). An establishment subject to
animal drug establishment fees is
assessed only one such fee per FY (see
section 740(a)(3) of the act). The term
‘‘animal drug establishment’’ is defined
in section 739(4) of the act. The
establishment fees are to be set so that
they will generate $3,479,000 in fee
revenue for FY 2009. This is the amount
set out in the statute after it has been
adjusted for excess collections in
previous years as set out in section III
of this document.
To set animal drug establishment fees
to realize $3,479,000, FDA must make
some assumptions about the number of
establishments for which these fees will
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be paid in FY 2009. FDA developed data
on all animal drug establishments and
matched this to the list of all persons
who had an animal drug application or
supplement pending after September 1,
2003. As of August 2008, FDA estimates
that there are a total of 65
establishments owned or operated by
persons who had an animal drug
application or supplemental animal
drug application pending after
September 1, 2003. Based on this, FDA
believes that 65 establishments will be
subject to this fee in FY 2009.
In estimating the fee revenue to be
generated by animal drug establishment
fees in FY 2009, FDA is assuming that
10 percent of the establishments
invoiced, or 6.5, will not pay fees in FY
2009 due to fee waivers and reductions.
Based on experience with the first 5
years of ADUFA, FDA believes that this
is a reasonable basis for estimating the
number of fee-paying establishments in
FY 2009.
Accordingly, the agency estimates
that fees for a total of 58.5
establishments (65 minus 6.5) will be
paid in FY 2009.
B. Establishment Fee Rates for FY 2009
FDA must set the fee rates for FY 2009
so that the estimated 58.5
establishments for which fees will be
paid will generate a total of $3,479,000.
To generate this amount will require the
fee for an animal drug establishment,
rounded to the nearest 50 dollars, to be
$59,450.
VII. Sponsor Fee Calculations for FY
2009
A. Sponsor Fee Revenues and Numbers
of Fee-Paying Sponsors
The 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 animal
drug application that has not been
withdrawn or has submitted an
investigational animal drug submission
that has not been terminated or
otherwise rendered inactive and (2) had
an animal drug application,
supplemental animal drug application,
or investigational animal drug
submission pending before FDA after
September 1, 2003 (see sections 739(6)
and 740(a)(4) of the act). An animal drug
sponsor is subject to only one such fee
each FY (see section 740(a)(4) of the
act). The sponsor fees are to be set so
that they will generate $3,479,000 in fee
revenue for FY 2009. This is the amount
set out in the statute after it has been
adjusted for excess collections in
previous years as set out in section III
of this document.
To set animal drug sponsor fees to
realize $3,479,000, 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 as of
August 2008, FDA estimates that a total
of 140 sponsors will meet this definition
in FY 2009.
Careful review indicates that about
one-third or 33 percent of all of these
sponsors will qualify for a minor use/
minor species waiver or reduction
(section 740(d)(1)(C) of the act). Based
on the agency’s experience with sponsor
fees, FDA’s current best estimate is that
an additional 20 percent will qualify for
other waivers or reductions, for a total
of 53 percent of the sponsors invoiced,
or 74 sponsors, who will not pay fees in
FY 2009 due to fee waivers and
reductions. FDA believes that this is a
reasonable basis for estimating the
number of fee-paying sponsors in FY
2009.
Accordingly, the agency estimates
that a total of 66 sponsors (140 minus
74) will pay sponsor fees in FY 2009.
B. Sponsor Fee Rates for FY 2009
FDA must set the fee rates for FY 2009
so that the estimated 66 sponsors that
pay fees will generate a total of
$3,479,000. To generate this amount
will require the fee for an animal drug
sponsor, rounded to the nearest 50
dollars, to be $52,700.
VIII. Fee Schedule for FY 2009
The fee rates for FY 2009 are
summarized in table 2 of this document.
TABLE 2—FY 2009 FEE RATES
Animal Drug User Fee Category
Fee Rate for FY 2009
Animal Drug Application Fee
Animal drug application ....................................................................................................................................................
Supplemental animal drug application for which safety or effectiveness data are required or animal drug application
subject to the criteria set forth in section 512(d)(4) of the act .....................................................................................
Animal drug product fee ...................................................................................................................................................
Animal drug establishment fee1 ...........................................................................................................................................
Animal drug sponsor fee2 ....................................................................................................................................................
1 An
2 An
$123,150
$4,925
$59,450
$52,700
animal drug establishment is subject to only one such fee each FY.
animal drug sponsor is subject to only one such fee each FY.
IX. Procedures for Paying the FY 2009
Fees
A. Application Fees and Payment
Instructions
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$246,300
The appropriate application fee
established in the new fee schedule
must be paid for an animal drug
application or supplemental animal
drug application subject to fees under
ADUFA II that is submitted after
September 30, 2008. Payment must be
made in U.S. currency by check, bank
draft, U.S. postal money order payable
to the order of the Food and Drug
Administration, by wire transfer, or
electronically using Pay.gov (the ‘‘Pay
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Now’’ button on the cover sheet). On
your check, bank draft, or U.S. postal
money order, or wire transfer, please
write your application’s unique
Payment Identification Number,
beginning with the letters AD, from the
upper right-hand corner of your
completed Animal 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 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
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US 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 payment
is made via Pay.gov, you will first create
and submit a cover sheet for your
organization, then click on the ‘‘Pay
Now’’ button. You will then be taken to
the Pay.gov site to make your payment
electronically.
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
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953877, 1005 Convention Plaza, St.
Louis, Missouri 63101. (Note: This
address is for courier delivery only. If
you have any questions concerning
courier delivery contact the US Bank at
314–418–4821. This phone number is
only for questions about courier
delivery.)
The tax identification number of the
Food and Drug Administration is
530196965. (Note: In no case should the
check for the fee be submitted to FDA
with the application.)
It is helpful if the fee arrives at the
bank at least a day or two before the
application arrives at FDA’s Center for
Veterinary Medicine (CVM). FDA
records the official application receipt
date as the later of the following: the
date the application was received by
CVM, or the date US Bank notifies FDA
that your check in the full amount of the
payment due has been received, or
when the United States Treasury
notifies FDA of receipt of an electronic
payment. US Bank and the United
States Treasury are required to notify
FDA within 1 working day, using the
Payment Identification Number
described previously.
B. Application Cover Sheet Procedures
Step One—Create a user account and
password. Log onto the ADUFA Web
site at https://www.fda.gov/oc/adufa and,
under the ‘‘Forms’’ heading, click on the
link ‘‘User Fee Cover Sheet.’’ For
security reasons, each firm submitting
an application will be assigned an
organization identification number, and
each user will also be required to set up
a user account and password the first
time they use this site. Online
instructions will walk you through this
process.
Step Two—Create an Animal Drug
User Fee Cover Sheet, transmit it to
FDA, and print a copy. After logging
into your account with your user name
and password, complete the steps
required to create an Animal Drug User
Fee Cover Sheet. One cover sheet is
needed for each animal drug application
or supplement. Once you are satisfied
that the data on the cover sheet is
accurate and you have finalized the
Cover Sheet, you will be able to transmit
it electronically to FDA and you will be
able to print a copy of your cover sheet
showing your unique Payment
Identification Number.
Step Three—Send the payment for
your application as described in section
IX.A of this document.
Step Four—Please submit your
application and a copy of the completed
Animal Drug User Fee Cover Sheet to
the following address: Food and Drug
Administration, Center for Veterinary
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Jkt 214001
Medicine, Document Control Unit
(HFV–199), 7500 Standish Pl.,
Rockville, MD 20855.
C. Product, Establishment and Sponsor
Fees
By December 31, 2008, FDA will issue
invoices and payment instructions for
product, establishment, and sponsor
fees for FY 2009 using this fee schedule.
Payment will be due and payable on or
before January 31, 2009. FDA will issue
invoices in November 2009 for any
products, establishments, and sponsors
subject to fees for FY 2009 but that
qualified for fees after the December
2008 billing.
Dated: September 8, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–21450 Filed 9–12–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0479]
Generic New Animal Drug User Fee
Rates and Payment Procedures for
Fiscal Year 2009
Food and Drug Administration
Notice
AGENCY:
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
rates and payment procedures for fiscal
year (FY) 2009 generic new animal drug
user fees. The Federal Food, Drug, and
Cosmetic Act (the act), as amended by
the Animal Generic Drug User Fee Act
of 2008 (AGDUFA), authorizes FDA to
collect user fees for certain abbreviated
applications for a generic new animal
drug, on certain generic new animal
drug products, and on certain sponsors
of such abbreviated applications for
generic new animal drugs and/or
investigational submissions for generic
new animal drugs. This notice
establishes the fee rates for FY 2009.
For FY 2009, the generic new animal
drug user fee rates are: $41,400 for each
abbreviated application for a generic
new animal drug; $3,005 for each
generic new animal drug product;
$56,350 for each generic new animal
drug sponsor paying 100 percent of the
sponsor fee; $42,265 for each generic
new animal drug sponsor paying 75
percent of the sponsor fee; and $28,175
for a generic new animal drug sponsor
paying 50 percent of the sponsor fee.
FDA will issue invoices for FY 2009
product and sponsor fees by December
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
31, 2008, or within 30 days of
enactment of an appropriation for these
fees, whichever is later. These fees will
be due and payable within 30 days of
the issuance of the invoices.
The application fee rates are effective
for all abbreviated applications for
generic new animal drugs submitted on
or after July 1, 2008, and will remain in
effect through September 30, 2009.
However, FDA may not collect
application fees until enactment of an
appropriation for these fees. Within 30
days of enactment of an appropriation
for these fees, FDA will issue invoices
for applications received on or after July
1, 2008, and will publish a Federal
Register notice stating that for the
remainder of fiscal year 2009 FDA will
not accept any further abbreviated
applications for generic new animal
drugs for review until FDA has received
full payment of application fees and any
other generic new animal drug user fees
owed. That Federal Register notice will
also provide instructions for payment of
abbreviated applications for generic new
animal drug fees.
Visit
the FDA Web site at https://www.fda.gov/
oc/agdufa or contact Roxanne
Schweitzer, Center for Veterinary
Medicine (HFV–10), Food and Drug
Administration, 7529 Standish Place,
Rockville, MD 20855, 240–276–9705.
For general questions, you may also email the Center for Veterinary Medicine
at: cvmagdufa@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
I. Background
Section 741 of the act (21 U.S.C. 379j–
21) establishes three different kinds of
user fees: (1) Fees for certain types of
abbreviated applications for generic new
animal drugs, (2) annual fees for certain
generic new animal drug products, and
(3) annual fees for certain sponsors of
abbreviated applications for generic new
animal drugs and/or investigational
submissions for generic new animal
drugs (21 U.S.C. 379j–21(a)). When
certain conditions are met, FDA will
waive or reduce fees for generic new
animal drugs intended solely to provide
for a minor use or minor species
indication (21 U.S.C. 379j–21(d)).
For FY 2009 through FY 2013, the act
establishes aggregate yearly base
revenue amounts for each of these fee
categories. Base revenue amounts
established for years after FY 2009 are
subject to adjustment for workload. Fees
for applications, products, and sponsors
are to be established each year by FDA
so that the revenue for each fee category
will approximate the level established
E:\FR\FM\15SEN1.SGM
15SEN1
]]>Agencies
[Federal Register Volume 73, Number 179 (Monday, September 15, 2008)]
[Notices]
[Pages 53254-53258]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-21450]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0480]
Animal Drug User Fee Rates and Payment Procedures for Fiscal Year
2009
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) 2009 for user fees under
the Animal Drug User Fee Act program (ADUFA). The Federal Food, Drug,
and Cosmetic Act (the act), as amended by the Animal Drug User Fee Act
of 2003 (ADUFA I), and the Animal Drug User Fee Amendments of 2008
(ADUFA II), authorizes FDA to collect user fees for certain animal drug
applications, on certain animal drug products, on certain
establishments where such products are made, and on certain sponsors of
such animal drug applications and/or investigational animal drug
[[Page 53255]]
submissions. This notice establishes the fee rates for FY 2009.
For FY 2009, the animal drug user fee rates are: $246,300 for an
animal drug application; $123,150 for a supplemental animal drug
application for which safety or effectiveness data is required and for
an animal drug application subject to certain criteria; $4,925 for an
annual product fee; $59,450 for an annual establishment fee; and
$52,700 for an annual sponsor fee. FDA will issue invoices for FY 2009
product, establishment, and sponsor fees by December 31, 2008, and
these invoices will be due and payable on or before January 31, 2009.
FDA will issue invoices in November 2009 for any products,
establishments, and sponsors that are subject to fees for FY 2009 but
that qualified for fees after the December 2008 billing.
The application fee rates are effective for applications submitted
on or after October 1, 2008, and will remain in effect through
September 30, 2009. Applications will not be accepted for review until
FDA has received full payment of application fees and any other animal
drug user fees owed.
FOR FURTHER INFORMATION CONTACT: Visit the FDA Web site at https://
www.fda.gov/oc/adufa or contact Roxanne Schweitzer, Center for
Veterinary Medicine (HFV-10), Food and Drug Administration, 7529
Standish Pl., Rockville, MD 20855, 240-276-9705. For general questions,
you may also e-mail the Center for Veterinary Medicine at:
cvmadufa@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Section 740 of the act (21 U.S.C. 379j-12) establishes four
different kinds of user fees: (1) Fees for certain types of animal drug
applications and supplements, (2) annual fees for certain animal drug
products, (3) annual fees for certain establishments where such
products are made, and (4) annual fees for certain sponsors of animal
drug applications and/or investigational animal drug submissions
(section 740(a) of the act). When certain conditions are met, FDA will
waive or reduce fees (section 740(d) of the act).
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, establishments, 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
ADUFA II (Public Law 110-316 signed by the President on August 14,
2008) specifies that the aggregate revenue amount for FY 2009 for each
of the four animal drug user fee categories is $3,815,000, before any
adjustment for workload is made (see section 740(b)(1) through (b)(4)
of the act).
B. Inflation Adjustment to Fee Revenue Amount
Because the amounts established in ADUFA II for each year for FY
2009 through FY 2013 include an inflation adjustment, no further
inflation adjustment is required.
C. Workload Adjustment to Fee Revenue Amount
For each FY beginning after FY 2009, ADUFA II provides that
statutory fee revenue amounts shall be further adjusted to reflect
changes in review workload (section 740(c)(1) of the act). No workload
adjustment is to be made in fee revenue amounts for FY 2009.
III. Adjustment for Excess Collections in Previous Years
Under the provisions of ADUFA I, if the agency collects more fees
than were provided for in appropriations in any year, FDA is required
to reduce its anticipated fee collections in a subsequent year by that
amount (section 740(g)(4) of the act). Table 1 of this document shows
the amount of collections realized and the amount provided in
appropriations acts, and the amount to be offset in a subsequent year,
as of the end of the latest complete fiscal year, 2007.
Table 1--Fees Collected, Fees Appropriated, and Offset for Future Collections as of September 30, 2007
----------------------------------------------------------------------------------------------------------------
Amount to Offset Future
Fiscal Year Collections Realized Fees Appropriated Collections
----------------------------------------------------------------------------------------------------------------
2004 $5,154,700 $5,000,000 $154,700
----------------------------------------------------------------------------------------------------------------
2005 $8,519,101 $8,354,000 $165,101
----------------------------------------------------------------------------------------------------------------
2006 $10,945,866 $11,318,000 $0
----------------------------------------------------------------------------------------------------------------
2007 $12,946,515 $11,604,000 $1,342,515
----------------------------------------------------------------------------------------------------------------
Total $1,662,316
----------------------------------------------------------------------------------------------------------------
Amount offset when fees for FY 2008 were determined $320,000
----------------------------------------------------------------------------------------------------------------
Remaining balance to be offset in FY 2009 $1,342,316
----------------------------------------------------------------------------------------------------------------
When ADUFA fees were established for FY 2008, the amount of fee
revenues for FY 2008 was reduced by a total of $320,000 of excess
collections. That leaves a total of $1,342,316 to be offset against FY
2009 revenue collections, lowering the net amount that would otherwise
be collected. One-fourth of this amount, rounded to the nearest
thousand, or $336,000, rounded to the nearest thousand dollars, will be
subtracted from the statutory fee revenue amounts for each of the four
fee categories in setting the FY 2009 adjusted revenue amount for each
fee category. Thus, after adjustment for prior-year excess collections,
the adjusted FY 2009 revenue target for each fee category is as
follows:
Application Fee Revenue Amount: $3,479,000 ($3,815,000 minus
$336,000)
Establishment Fee Revenue Amount: $3,479,000 ($3,815,000 minus
$336,000)
Product Fee Revenue Amount: $3,479,000 ($3,815,000 minus $336,000)
Sponsor Fee Revenue Amount: $3,479,000 ($3,815,000 minus $336,000)
[[Page 53256]]
Thus, the adjusted revenue amount from all four categories after this
adjustment totals $13,916,000.
IV. Application Fee Calculations for FY 2009
The terms ``animal drug applications'' and ``supplemental animal
drug applications'' are defined in section 739(1) and (2) of the act
(21 U.S.C. 379j-11(1) and (2)).
A. Application Fee Revenues and Numbers of Fee-Paying Applications
The application fee must be paid for any animal drug application or
supplemental animal drug application that is subject to fees under
ADUFA and that is submitted on or after September 1, 2003. The
application fees are to be set so that they will generate $3,479,000 in
fee revenue for FY 2009. This is the amount set out in the statute
after it has been adjusted for excess collections in previous years as
set out in section III of this document. The fee for a supplemental
animal drug application for which safety or effectiveness data are
required and for an animal drug application subject to criteria set
forth in section 512(d)(4) of the act (21 U.S.C. 360b(d)(4)) is to be
set at 50 percent of the animal drug application fee (see section
740(a)(1)(A)(ii) of the act, as amended by ADUFA II).
To set animal drug application fees and supplemental animal drug
application fees to realize $3,479,000, FDA must first make some
assumptions about the number of fee-paying applications and supplements
it will receive in FY 2009.
The agency knows the number of applications that have been
submitted in previous years. That number fluctuates significantly from
year to year. In estimating the fee revenue to be generated by animal
drug application fees in FY 2009, FDA is assuming that the number of
applications that will pay fees in FY 2009 will equal the average
number of submissions over the 4 most recent years (including an
estimate for the current year). 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 5 years of
experience with this program.
Over the past 4 years, the average number of animal drug
applications that have been subject to the full fee was 7.5, including
the number for the most recent year, which is estimated at 4. Over this
same period, the average number of supplemental applications and
applications subject to the criteria set forth in section 512(d)(4)
that would have been subject to half of the full fee was 13.25,
including the number for the most recent year, which is estimated at 9.
Thus, for FY 2009, FDA estimates receipt of 7.5 fee paying original
applications and 13.25 fee-paying supplemental animal drug applications
and applications subject to the criteria set forth is section
512(d)(4), which pay half of the full fee.
B. Fee Rates for FY 2009
FDA must set the fee rates for FY 2009 so that the estimated 7.5
applications that pay the full fee and the estimated 13.25 supplements
and applications subject to the criteria set forth in section 512(d)(4)
that pay half of the full fee will generate a total of $3,479,000. To
generate this amount, the fee for an animal drug application, rounded
to the nearest hundred dollars, will have to be $246,300, and the fee
for a supplemental animal drug application for which safety or
effectiveness data are required and for applications subject to the
criteria set forth in section 512(d)(4) will have to be $123,150.
V. Product Fee Calculations for FY 2009
A. Product Fee Revenues and Numbers of Fee-Paying Products
The animal drug product fee (also referred to as the product fee)
must be paid annually by the person named as the applicant in an animal
drug application or supplemental animal drug application for an animal
drug product submitted for listing under section 510 of the act (21
U.S.C. 360), and who had an animal drug application or supplemental
animal drug application pending before FDA after September 1, 2003 (see
section 740(a)(2) of the act). The term ``animal drug product'' is
defined in section 739(3) of the act. The product fees are to be set so
that they will generate $3,479,000 in fee revenue for FY 2009. This is
the amount set out in the statute after it has been adjusted for excess
collections in previous years as set out in section III of this
document.
To set animal drug product fees to realize $3,479,000, 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 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 had an animal drug
application or supplement pending after September 1, 2003. As of August
2008, FDA estimates that there are a total of 785 products submitted
for listing by persons who had an animal drug application or
supplemental animal drug application pending after September 1, 2003.
Based on this, FDA estimates that a total of 785 products will be
subject to this fee in FY 2009.
In estimating the fee revenue to be generated by animal drug
product fees in FY 2009, FDA is assuming that 10 percent of the
products invoiced, or about 78.5, 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 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 fees for a total of 706.5
products (785 minus 78.5) will be paid in FY 2009.
B. Product Fee Rates for FY 2009
FDA must set the fee rates for FY 2009 so that the estimated 706.5
products for which fees will be paid will generate a total of
$3,479,000. To generate this amount will require the fee for an animal
drug product, rounded to the nearest 5 dollars, to be $4,925.
VI. Establishment Fee Calculations for FY 2009
A. Establishment Fee Revenues and Numbers of Fee-Paying Establishments
The animal drug establishment fee (also referred to as the
establishment fee) must be paid annually by the person who: (1) Owns or
operates, directly or through an affiliate, an animal drug
establishment; (2) is named as the applicant in an animal drug
application or supplemental animal drug application for an animal drug
product submitted for listing under section 510 of the act; (3) had an
animal drug application or supplemental animal drug application pending
before FDA after September 1, 2003; and (4) whose establishment engaged
in the manufacture of the animal drug product during the FY (see
section 740(a)(3) of the act). An establishment subject to animal drug
establishment fees is assessed only one such fee per FY (see section
740(a)(3) of the act). The term ``animal drug establishment'' is
defined in section 739(4) of the act. The establishment fees are to be
set so that they will generate $3,479,000 in fee revenue for FY 2009.
This is the amount set out in the statute after it has been adjusted
for excess collections in previous years as set out in section III of
this document.
To set animal drug establishment fees to realize $3,479,000, FDA
must make some assumptions about the number of establishments for which
these fees will
[[Page 53257]]
be paid in FY 2009. FDA developed data on all animal drug
establishments and matched this to the list of all persons who had an
animal drug application or supplement pending after September 1, 2003.
As of August 2008, FDA estimates that there are a total of 65
establishments owned or operated by persons who had an animal drug
application or supplemental animal drug application pending after
September 1, 2003. Based on this, FDA believes that 65 establishments
will be subject to this fee in FY 2009.
In estimating the fee revenue to be generated by animal drug
establishment fees in FY 2009, FDA is assuming that 10 percent of the
establishments invoiced, or 6.5, will not pay fees in FY 2009 due to
fee waivers and reductions. Based on experience with the first 5 years
of ADUFA, FDA believes that this is a reasonable basis for estimating
the number of fee-paying establishments in FY 2009.
Accordingly, the agency estimates that fees for a total of 58.5
establishments (65 minus 6.5) will be paid in FY 2009.
B. Establishment Fee Rates for FY 2009
FDA must set the fee rates for FY 2009 so that the estimated 58.5
establishments for which fees will be paid will generate a total of
$3,479,000. To generate this amount will require the fee for an animal
drug establishment, rounded to the nearest 50 dollars, to be $59,450.
VII. Sponsor Fee Calculations for FY 2009
A. Sponsor Fee Revenues and Numbers of Fee-Paying Sponsors
The 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 animal drug application that has not been withdrawn or has
submitted an investigational animal drug submission that has not been
terminated or otherwise rendered inactive and (2) had an animal drug
application, supplemental animal drug application, or investigational
animal drug submission pending before FDA after September 1, 2003 (see
sections 739(6) and 740(a)(4) of the act). An animal drug sponsor is
subject to only one such fee each FY (see section 740(a)(4) of the
act). The sponsor fees are to be set so that they will generate
$3,479,000 in fee revenue for FY 2009. This is the amount set out in
the statute after it has been adjusted for excess collections in
previous years as set out in section III of this document.
To set animal drug sponsor fees to realize $3,479,000, 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 as of August 2008, FDA estimates that a total of 140
sponsors will meet this definition in FY 2009.
Careful review indicates that about one-third or 33 percent of all
of these sponsors will qualify for a minor use/minor species waiver or
reduction (section 740(d)(1)(C) of the act). Based on the agency's
experience with sponsor fees, FDA's current best estimate is that an
additional 20 percent will qualify for other waivers or reductions, for
a total of 53 percent of the sponsors invoiced, or 74 sponsors, who
will not pay fees in FY 2009 due to fee waivers and reductions. FDA
believes that this is a reasonable basis for estimating the number of
fee-paying sponsors in FY 2009.
Accordingly, the agency estimates that a total of 66 sponsors (140
minus 74) will pay sponsor fees in FY 2009.
B. Sponsor Fee Rates for FY 2009
FDA must set the fee rates for FY 2009 so that the estimated 66
sponsors that pay fees will generate a total of $3,479,000. To generate
this amount will require the fee for an animal drug sponsor, rounded to
the nearest 50 dollars, to be $52,700.
VIII. Fee Schedule for FY 2009
The fee rates for FY 2009 are summarized in table 2 of this
document.
Table 2--FY 2009 Fee Rates
------------------------------------------------------------------------
Animal Drug User Fee Category Fee Rate for FY 2009
------------------------------------------------------------------------
Animal Drug Application Fee.............................................
Animal drug application...................... $246,300
Supplemental animal drug application for $123,150
which safety or effectiveness data are
required or animal drug application subject
to the criteria set forth in section
512(d)(4) of the act........................
Animal drug product fee...................... $4,925
Animal drug establishment fee\1\............... $59,450
Animal drug sponsor fee\2\..................... $52,700
------------------------------------------------------------------------
\1\ An animal drug establishment is subject to only one such fee each
FY.
\2\ An animal drug sponsor is subject to only one such fee each FY.
IX. Procedures for Paying the FY 2009 Fees
A. Application Fees and Payment Instructions
The appropriate application fee established in the new fee schedule
must be paid for an animal drug application or supplemental animal drug
application subject to fees under ADUFA II that is submitted after
September 30, 2008. Payment must be made in U.S. currency by check,
bank draft, U.S. postal money order payable to the order of the Food
and Drug Administration, by wire transfer, or electronically using
Pay.gov (the ``Pay Now'' button on the cover sheet). On your check,
bank draft, or U.S. postal money order, or wire transfer, please write
your application's unique Payment Identification Number, beginning with
the letters AD, from the upper right-hand corner of your completed
Animal 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 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 US 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 payment is made via Pay.gov, you will first
create and submit a cover sheet for your organization, then click on
the ``Pay Now'' button. You will then be taken to the Pay.gov site to
make your payment electronically.
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
[[Page 53258]]
953877, 1005 Convention Plaza, St. Louis, Missouri 63101. (Note: This
address is for courier delivery only. If you have any questions
concerning courier delivery contact the US Bank at 314-418-4821. This
phone number is only for questions about courier delivery.)
The tax identification number of the Food and Drug Administration
is 530196965. (Note: In no case should the check for the fee be
submitted to FDA with the application.)
It is helpful if the fee arrives at the bank at least a day or two
before the application arrives at FDA's Center for Veterinary Medicine
(CVM). FDA records the official application receipt date as the later
of the following: the date the application was received by CVM, or the
date US Bank notifies FDA that your check in the full amount of the
payment due has been received, or when the United States Treasury
notifies FDA of receipt of an electronic payment. US Bank and the
United States Treasury are required to notify FDA within 1 working day,
using the Payment Identification Number described previously.
B. Application Cover Sheet Procedures
Step One--Create a user account and password. Log onto the ADUFA
Web site at https://www.fda.gov/oc/adufa and, under the ``Forms''
heading, click on the link ``User Fee Cover Sheet.'' For security
reasons, each firm submitting an application will be assigned an
organization identification number, and each user will also be required
to set up a user account and password the first time they use this
site. Online instructions will walk you through this process.
Step Two--Create an Animal Drug User Fee Cover Sheet, transmit it
to FDA, and print a copy. After logging into your account with your
user name and password, complete the steps required to create an Animal
Drug User Fee Cover Sheet. One cover sheet is needed for each animal
drug application or supplement. Once you are satisfied that the data on
the cover sheet is accurate and you have finalized the Cover Sheet, you
will be able to transmit it electronically to FDA and you will be able
to print a copy of your cover sheet showing your unique Payment
Identification Number.
Step Three--Send the payment for your application as described in
section IX.A of this document.
Step Four--Please submit your application and a copy of the
completed Animal Drug User Fee Cover Sheet to the following address:
Food and Drug Administration, Center for Veterinary Medicine, Document
Control Unit (HFV-199), 7500 Standish Pl., Rockville, MD 20855.
C. Product, Establishment and Sponsor Fees
By December 31, 2008, FDA will issue invoices and payment
instructions for product, establishment, and sponsor fees for FY 2009
using this fee schedule. Payment will be due and payable on or before
January 31, 2009. FDA will issue invoices in November 2009 for any
products, establishments, and sponsors subject to fees for FY 2009 but
that qualified for fees after the December 2008 billing.
Dated: September 8, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-21450 Filed 9-12-08; 8:45 am]
BILLING CODE 4160-01-S
