[Federal Register Volume 73, Number 179 (Monday, September 15, 2008)]
[Notices]
[Pages 53254-53258]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-21450]


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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.

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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 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 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 
(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
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         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 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 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