[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 
<a href="/cdn-cgi/l/email-protection#096a7f64686d7c6f68496f6d68276e667f"><span class="__cf_email__" data-cfemail="c6a5b0aba7a2b3a0a786a0a2a7e8a1a9b0">[email protected]</span></a>.

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)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                               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
--------------------------------------------------------------------------------------------------------------------------------------------------------
New Animal Drug Applications (NADAs)                                22                 13             -39%                 4%                      -1.5%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Supplemental NADA's with Safety or Efficacy                         31                 12             -62%                 2%                      -1.4%
 Data
--------------------------------------------------------------------------------------------------------------------------------------------------------
Manufacturing Supplements                                          368                409             +11%                16%                      +1.8%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Investigational Study Submissions                                  272                217             -20%                60%                     -12.1%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Investigational Protocol Submissions                               283                229             -19%                18%                      -3.4%
--------------------------------------------------------------------------------------------------------------------------------------------------------
FY 2008 Workload Adjuster                                                                                                                         -16.7%
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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:
    <bullet> Application Fee Revenue Amount: $2,820,000 ($2,900,000 
minus $80,000)
    <bullet> Establishment Fee Revenue Amount: $2,820,000 ($2,900,000 
minus $80,000)
    <bullet> Product Fee Revenue Amount: $2,820,000 ($2,900,000 minus 
$80,000)
    <bullet> 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:
    <bullet> Application Fee Revenue Amount: $2,846,000 ($2,820,000 
plus $26,000)
    <bullet> Establishment Fee Revenue Amount: $2,846,000 ($2,820,000 
plus $26,000)
    <bullet> Product Fee Revenue Amount: $2,846,000 ($2,820,000 plus 
$26,000)
    <bullet> 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
------------------------------------------------------------------------
         Animal Drug User Fee Category             Fee Rate for FY 2008
------------------------------------------------------------------------
Animal Drug Application Fee
------------------------------------------------------------------------
Animal Drug Application                                         $172,500
Supplemental Animal Drug Application for which                   $86,250
 Safety or Effectiveness Data are Required
------------------------------------------------------------------------
Animal Drug Product Fee                                           $4,125
------------------------------------------------------------------------

[[Page 42419]]

 
Animal Drug Establishment Fee\1\                                 $52,700
------------------------------------------------------------------------
Animal Drug Sponsor Fee\2\                                       $43,900
------------------------------------------------------------------------
\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


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