[Federal Register Volume 72, Number 148 (Thursday, August 2, 2007)]
[Notices]
[Pages 42415-42419]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-3782]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Animal Drug User Fee Rates and Payment Procedures for Fiscal Year
2008
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the rates
and payment procedures for fiscal year (FY) 2008 animal drug user fees.
The Federal Food, Drug, and Cosmetic Act (the act), as amended by the
Animal Drug User Fee Act of 2003 (ADUFA), 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 submissions. This notice establishes the
fee rates for FY 2008.
For FY 2008, the animal drug user fee rates are: $172,500 for an
animal drug application; $86,250 for a supplemental animal drug
application for which safety or effectiveness data is required; $4,125
for an annual product fee; $52,700 for an annual establishment fee; and
$43,900 for an annual sponsor fee. FDA will issue invoices for FY 2008
product, establishment and sponsor fees by December 30, 2007, and these
invoices will be due and payable by January 31, 2008.
The application fee rates are effective for applications submitted
on or after October 1, 2007, and will remain in effect through
September 30, 2008. Applications will not be accepted to 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 http://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 (CVM) at
[email protected].
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 (21
U.S.C. 379j-12(a)). When certain conditions are met, FDA will waive or
reduce fees (21 U.S.C. 379j-12(d)).
For FY 2004 through FY 2008, the act establishes aggregate yearly
base revenue amounts for each of these fee categories. Base revenue
amounts established for years after FY 2004 are subject to adjustment
for inflation and workload. Fees for applications, establishments,
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
inflation and workload.
II. Revenue Amount for FY 2008 and Adjustments for Inflation and
Workload
A. Statutory Fee Revenue Amounts
ADUFA (Public Law 108-130) specifies that the aggregate revenue
amount for FY 2008 for each of the four animal drug user fee categories
is $2,500,000, before any adjustments for inflation or workload are
made (21 U.S.C. 379j-12(b)(1)-(4)).
B. Inflation Adjustment to Fee Revenue Amount
ADUFA provides that fee revenue amounts for each FY after 2004
shall be adjusted for inflation (see 21 U.S.C. 379j-12(c)(1)). The
adjustment must reflect the greater of the following: (1) The total
percentage change that occurred in the Consumer Price Index (CPI) for
all urban consumers (all items; U.S. city average) during the 12-month
period ending June 30 preceding the FY for which fees are being set, or
(2) the total percentage pay change for the previous FY for Federal
employees stationed in Washington, DC. ADUFA provides for this annual
adjustment to be cumulative and compounded annually after FY 2004 (21
U.S.C. 379j-12(c)(1)).
The inflation adjustment for FY 2005 was 4.42 percent. This was the
greater of the CPI increase during the 12-month period ending June 30,
2004, (3.27 percent) or the increase in pay for FY 2004 for Federal
employees stationed in Washington, DC (4.42 percent).
The inflation adjustment for FY 2006 was 3.71 percent. This was the
greater of the CPI increase during the 12-month period ending June 30,
2005, (2.53 percent) or the increase in pay for FY 2005 for Federal
employees stationed in Washington, DC (3.71 percent).
The inflation adjustment for FY 2007 was 4.32 percent. This was the
greater of the CPI increase for the 12-month period ending June 30,
2006, (4.32 percent) or the increase in pay for FY 2006 for Federal
employees stationed in Washington, DC (3.44 percent).
The inflation adjustment for FY 2008 is 2.69 percent. This is the
greater of the CPI increase for the 12-month period ending June 30,
2007, (2.69 percent) or the increase in pay for FY 2007 for Federal
employees stationed in Washington, DC (2.64 percent).
Compounding these amounts (1.0442 times 1.0371 times 1.0432 times
1.0269) yields a total compounded inflation adjustment of 16.01 percent
for FY 2008.
[[Page 42416]]
The inflation-adjusted revenue amount for each category of fees for
FY 2008 is the statutory fee amount ($2,500,000) increased by 16.01
percent, the inflation adjuster for FY 2008. The inflation-adjusted
revenue amount is $2,900,000 for each category of fee, rounded to the
nearest thousand dollars, for a total inflation-adjusted fee revenue
amount of $11,600,000 for all four categories of fees in FY 2008.
C. Workload Adjustment to Inflation Adjusted Fee Revenue Amount
For each FY beginning in FY 2005, ADUFA provides that fee revenue
amounts, after they have been adjusted for inflation, shall be further
adjusted to reflect changes in review workload (21 U.S.C. 379j-
12(c)(2)).
FDA calculated the average number of each of the five types of
applications and submissions specified in the workload adjustment
provision (animal drug applications, supplemental animal drug
applications for which data with respect to safety or efficacy are
required, manufacturing supplemental animal drug applications,
investigational animal drug study submissions, and investigational
animal drug protocol submissions) received over the 3-year period that
ended on September 30, 2002 (the base years), and the average number of
each of these types of applications and submissions over the most
recent 3-year period that ended May 31, 2007.
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 3-year periods. Column 4 shows the
weighting factor for each type of application, reflecting how much of
the total FDA animal drug review workload was accounted for by each
type of application or submission in the table during the most recent 3
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 the table the sum of the
values in column 5 is added, reflecting a total change in workload of
negative 16.7 percent for FY 2008. This is the workload adjuster for FY
2008.
Table 1.--Workload Adjuster Calculation (Numbers may not add due to rounding)
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Column 1 3-Year Avg. Column 2 Latest Column 3 Column 4 Column 5 Weighted
Application Type (Base Years) 3-Year Avg. Percent Change Weighting Factor Percent Change
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New Animal Drug Applications (NADAs) 22 13 -39% 4% -1.5%
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Supplemental NADA's with Safety or Efficacy 31 12 -62% 2% -1.4%
Data
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Manufacturing Supplements 368 409 +11% 16% +1.8%
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Investigational Study Submissions 272 217 -20% 60% -12.1%
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Investigational Protocol Submissions 283 229 -19% 18% -3.4%
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FY 2008 Workload Adjuster -16.7%
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ADUFA specifies that the workload adjuster may not result in fees
that are less than the inflation-adjusted revenue amount (21 U.S.C.
379j-12(c)(2)(B)). For this reason, the workload adjustment will not be
applied in FY 2008, and the inflation-adjusted revenue amount for each
category of fees for FY 2008 ($2,900,000) becomes the revenue target
for fees in FY 2008, for a total inflation-adjusted fee revenue target
in FY 2008 of $11,600,000 for fees from all four categories.
III. Adjustment for Excess Collections in Previous Years
Under the provisions of ADUFA, 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 (21 U.S.C. 379j-12(g)(4)).
In FY 2004, Congress appropriated a total of $5,000,000 to FDA in
ADUFA fee revenue. As of July 1, 2007, collections for FY 2004 totaled
$5,154,700--or $154,700 in excess of the appropriation limit. Also, in
FY 2005 Congress appropriated a total of $8,354,000 to FDA in ADUFA fee
revenue, and FDA collected a total of $8,519,101 as of July 1, 2007.
This is $165,101 in excess of appropriations. The total in excess
collections for the 2 years is $319,801. These are the only fiscal
years since ADUFA began in which FDA has collected more in ADUFA fees
than Congress appropriated.
The total of $319,801 will be offset against FY 2008 revenue
collections, lowering the net amount that would otherwise be collected.
One-fourth of this amount, or $80,000, rounded to the nearest thousand
dollars, will be subtracted from the FY 2008 adjusted revenue amount
for each fee category in the previous section. Thus, after adjustment
for prior-year excess collections, the adjusted FY 2008 revenue target
for each fee category is:
Application Fee Revenue Amount: $2,820,000 ($2,900,000
minus $80,000)
Establishment Fee Revenue Amount: $2,820,000 ($2,900,000
minus $80,000)
Product Fee Revenue Amount: $2,820,000 ($2,900,000 minus
$80,000)
Sponsor Fee Revenue Amount: $2,820,000 ($2,900,000 minus
$80,000)
Thus the adjusted revenue amount from all 4 categories after this
adjustment totals $11,280,000.
IV. Final Year Adjustment
Under the provisions of ADUFA, the Secretary of Health and Human
Services may, in addition to the inflation and workload adjustments,
further increase the fees and fee revenues if such an adjustment is
necessary to provide for not more than 3 months of operating reserves
of carryover user fees for the process for the review of animal drug
applications for the first 3 months of FY
[[Page 42417]]
2009. The rational for the amount of this increase shall be contained
in the annual notice establishing fee revenues and fees for FY 2008 (21
U.S.C. 379j-12(c)(3)).
As of June 30, 2007, FDA has unallocated cash carryover balances of
$4,453,000. In addition, the agency is estimating that application fees
over the final 3 months of FY 2007 will add another $675,000 to this
balance, for an estimated cash carryover of $5,128,000 on September 30,
2007.
In FY 2008, FDA expects to collect a total of $11,280,000 after
adjustments, as noted at the end of section III of this document. To
sustain current operations in FY 2008, FDA expects to obligate a total
of $13,084,000 (compared with anticipated obligations in FY 2007 of
about $12,355,000). The anticipated obligations of $13,084,000 will be
about $1,768,000 more than anticipated collections. This will reduce
the estimated carryover balance over the course of FY 2008 from
$5,128,000 to an estimated $3,360,000 ($5,128,000 minus $1,768,000).
To sustain operations supported from user fees for the first 3
months of FY 2009, FDA estimates that it will need one-fourth of the
$13,084,000 it expects to spend in FY 2008, or $3,271,000 (rounded to
the nearest thousand). However this amount will need to be increased
for inflation by an estimated 5.9 percent (the average amount by which
FDA's costs per full-time employee have increased over the past 5
years). The amount needed to sustain operations for the first 3 months
of FY 2009 is thus estimated at $3,464,000 (rounded to the nearest
thousand), while the estimated carryover balance at the beginning of FY
2009 is estimated at only $3,360,000. Thus FDA will need an additional
$104,000 as the final year adjustment to assure sufficient operating
reserves for the first 3 months of FY 2009. One-fourth of this amount
or $26,000 will be added to the FY 2008 adjusted revenue amount for
each of the four fee categories in the previous section. Thus, after
the final-year adjustment, the adjusted FY 2008 revenue target for each
fee category is:
Application Fee Revenue Amount: $2,846,000 ($2,820,000
plus $26,000)
Establishment Fee Revenue Amount: $2,846,000 ($2,820,000
plus $26,000)
Product Fee Revenue Amount: $2,846,000 ($2,820,000 plus
$26,000)
Sponsor Fee Revenue Amount: $2,846,000 ($2,820,000 plus
$26,000)
Thus, after the final year adjustment, the adjusted FY 2008 revenue
target from all fee types combined totals $11,384,000.
V. Application Fee Calculations for FY 2008
The terms ``animal drug applications'' and ``supplemental animal
drug applications'' are defined in 21 U.S.C. 379j-11(1).
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 $2,846,000 in
fee revenue for FY 2008. This is the amount set out in the statute
after it has been adjusted for inflation and workload, as set out in
section II of this document, for excess collections in previous years
as set out in section III of this document, and for the final year
adjustment as set out in section IV of this document. The fee for a
supplemental animal drug application for which safety or effectiveness
data are required is to be set at 50 percent of the animal drug
application fee (21 U.S.C. 379j-12(a)(1)(A)(ii)).
To set animal drug application fees and supplemental animal drug
application fees to realize $2,846,000, FDA must first make some
assumptions about the number of fee-paying applications and supplements
it will receive in FY 2008.
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 2008, FDA is assuming that the number of
applications that will pay fees in FY 2008 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 nearly 4 years of
experience with this program.
Over the past 4 years, the average number of animal drug
applications that would have been subject to the full fee was 10.25,
including the number for the most recent year, estimated at 15. Over
this same period, the average number of supplemental applications that
would have been subject to half of the full fee was 12.5, including the
number for the most recent year, estimated at 13.
Thus, for FY 2008, FDA estimates receipt of 10.25 fee paying
original applications and 12.5 fee-paying supplemental animal drug
applications.
B. Fee Rates for FY 2008
FDA must set the fee rates for FY 2008 so that the estimated 10.25
applications that pay the full fee and the estimated 12.5 supplements
that pay half of the full fee will generate a total of $2,846,000. To
generate this amount, the fee for an animal drug application, rounded
to the nearest hundred dollars, will have to be $172,500, and the fee
for a supplemental animal drug application for which safety or
effectiveness data are required will have to be $86,250.
VI. Product Fee Calculations for FY 2008
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 at FDA after September 1, 2003, (21
U.S.C. 379j-12(a)(2)). The term ``animal drug product'' is defined in
21 U.S.C. 379j-11(3). The product fees are to be set so that they will
generate $2,846,000 in fee revenue for FY 2008. This is the amount set
out in the statute after it has been adjusted for inflation and
workload, as set out in section II of this document, for excess
collections in previous years as set out in section III of this
document, and for the final year adjustment as set out in section IV of
this document.
To set animal drug product fees to realize $2,846,000, FDA must
make some assumptions about the number of products for which these fees
will be paid in FY 2008. 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 July
1, 2007, FDA found a total of 767 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
believes that a total of 767 products will be subject to this fee in FY
2008.
In estimating the fee revenue to be generated by animal drug
product fees in FY 2008, FDA is assuming that 10 percent of the
products invoiced, or 77, will not pay fees in FY 2008 due to fee
waivers and reductions. Based on experience with other user fee
programs
[[Page 42418]]
and the first 4 years of ADUFA, FDA believes that this is a reasonable
basis for estimating the number of fee-paying products in FY 2008.
Accordingly, the agency estimates that a total of 690 (767 minus
77) products will be subject to product fees in FY 2008.
B. Product Fee Rates for FY 2008
FDA must set the fee rates for FY 2008 so that the estimated 690
products that pay fees will generate a total of $2,846,000. To generate
this amount will require the fee for an animal drug product, rounded to
the nearest five dollars, to be $4,125.
VII. Establishment Fee Calculations for FY 2008
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
at FDA after September 1, 2003; and (4) whose establishment engaged in
the manufacture of the animal drug product during the FY (21 U.S.C.
379j-12(a)(3)). An establishment subject to animal drug establishment
fees is assessed only one such fee per FY (21 U.S.C. 379j-12(a)(3)).
The term ``animal drug establishment'' is defined in 21 U.S.C. 379j-
11(4). The establishment fees are to be set so that they will generate
$2,846,000 in fee revenue for FY 2008. This is the amount set out in
the statute after it has been adjusted for inflation and workload, as
set out in section II of this document, for excess collections in
previous years as set out in section III of this document, and for the
final year adjustment as set out in section IV of this document.
To set animal drug establishment fees to realize $2,846,000, FDA
must make some assumptions about the number of establishments for which
these fees will be paid in FY 2008. 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 July 1, 2007, FDA found a total of 60 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 60 establishments will be subject to
this fee in FY 2008.
In estimating the fee revenue to be generated by animal drug
establishment fees in FY 2008, FDA is assuming that 10 percent of the
establishments invoiced, or six, will not pay fees in FY 2008 due to
fee waivers and reductions. Based on experience with the first 4 years
of ADUFA, FDA believes that this is a reasonable basis for estimating
the number of fee-paying establishments in FY 2008.
Accordingly, the agency estimates that a total of 54 establishments
(60 minus 6) will be subject to establishment fees in FY 2008.
B. Establishment Fee Rates for FY 2008
FDA must set the fee rates for FY 2008 so that the estimated 54
establishments that pay fees will generate a total of $2,846,000. To
generate this amount will require the fee for an animal drug
establishment, rounded to the nearest 50 dollars, to be $52,700.
VIII. Sponsor Fee Calculations for FY 2008
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, 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 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 at FDA
after September 1, 2003, (21 U.S.C. 379j-11(6) and 379j-12(a)(4)). An
animal drug sponsor is subject to only one such fee each FY (21 U.S.C.
379j-12(a)(4)). The sponsor fees are to be set so that they will
generate $2,846,000 in fee revenue for FY 2008. This is the amount set
out in the statute after it has been adjusted for inflation and
workload, as set out in section II of this document, for excess
collections in previous years as set out in section III of this
document, and for the final year adjustment as set out in section IV of
this document.
To set animal drug sponsor fees to realize $2,846,000, FDA must
make some assumptions about the number of sponsors who will pay these
fees in FY 2008. Based on the number of firms that would have met this
definition in each of the past 4 years, FDA estimates that a total of
138 sponsors will meet this definition in FY 2008.
Careful review indicates that about one third or 33 percent of all
of these sponsors will qualify for minor use/minor species exemption.
Based on the agency's experience to date 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 73, who will not pay fees in FY 2008 due to fee waivers
and reductions. FDA believes that this is a reasonable basis for
estimating the number of fee-paying sponsors in FY 2008.
Accordingly, the agency estimates that a total of 65 sponsors (138
minus 73) will be subject to sponsor fees in FY 2008.
B. Sponsor Fee Rates for FY 2008
FDA must set the fee rates for FY 2008 so that the estimated 65
sponsors that pay fees will generate a total of $$2,846,000. To
generate this amount will require the fee for an animal drug sponsor,
rounded to the nearest 50 dollars, to be $43,900.
IX. Fee Schedule for FY 2008
The fee rates for FY 2008 are summarized in table 2 of this
document.
Table 2.--FY 2008 Fee Rates
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Animal Drug User Fee Category Fee Rate for FY 2008
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Animal Drug Application Fee
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Animal Drug Application $172,500
Supplemental Animal Drug Application for which $86,250
Safety or Effectiveness Data are Required
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Animal Drug Product Fee $4,125
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[[Page 42419]]
Animal Drug Establishment Fee\1\ $52,700
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Animal Drug Sponsor Fee\2\ $43,900
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\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.
X. Procedures for Paying the FY 2008 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 supplement subject to
fees under ADUFA that is submitted after September 30, 2007. Payment
must be made in U.S. currency by check, bank draft, or U.S. postal
money order payable to the order of the Food and Drug Administration.
On your check, bank draft, or U.S. postal money order, 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 (PO 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 you prefer to send a check by a courier such as FEDEX or UPS,
the courier may deliver the check and printed copy of the cover sheet
to: US Bank, Attn: Government Lockbox 953877, 1005 Convention Plaza,
St. Louis, MO 63101. (Note: This address is for courier delivery only.
If you have any questions concerning courier delivery contact the US
Bank at 314-418-4821. This phone number is only for questions about
courier delivery.)
The tax identification number of the Food and Drug Administration
is 530196965. (Note: In no case should the check for the fee be
submitted to FDA with the application.)
It is helpful if the fee arrives at the bank at least a day or two
before the application arrives at FDA's Center for Veterinary Medicine.
FDA records the official application receipt date as the later of the
following: The date the application was received by FDA's Center for
Veterinary Medicine, or the date US Bank notifies FDA that your check
in the full amount of the payment due has been received. US Bank is
required to notify FDA within 1 working day, using the Payment
Identification Number described previously.
B. Application Cover Sheet Procedures
Step One--Create a user account and password. Log onto the ADUFA
Web site at http://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 you use this site.
Online instructions will walk you through this process.
Step Two--Create an Animal Drug User 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 X.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 30, 2007, FDA will issue invoices and payment
instructions for product, establishment, and sponsor fees for FY 2008
using this Fee Schedule. Payment will be due and payable by January 31,
2008. FDA will issue invoices in October 2008 for any products,
establishments, and sponsors subject to fees for FY 2008 that qualify
for fees after the December 2007 billing.
Dated: July 27, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. 07-3782 Filed 7-30-07; 4:29 pm]
BILLING CODE 4160-01-S