[Federal Register Volume 69, Number 147 (Monday, August 2, 2004)]
[Notices]
[Pages 46147-46151]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-17441]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Establishment of Animal Drug User Fee Rates and Payment
Procedures for Fiscal Year 2005
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) 2005 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), Public Law 108-130,
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 2005.
For FY 2005, the animal drug user fee rates are: $119,300 for an
animal drug application; $59,650 for a supplemental animal drug
application for which safety or effectiveness data is required; $3,085
for an annual product fee; $42,600 for an annual establishment fee; and
$32,150 for an annual sponsor fee. FDA will issue invoices for FY 2005
product, establishment and sponsor fees by December 30, 2004, and these
invoices will be due and payable by January 31, 2005.
The application fee rates are effective for applications submitted
on or after October 1, 2004, and will remain in effect through
September 30, 2005. 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 FDA's Web site at: http://www.fda.gov/oc/adufa or contact Robert Miller, Center for Veterinary
Medicine (HFV-10), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 301-827-5436. 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. (See
21 U.S.C.
[[Page 46148]]
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 2005 and Adjustments for Inflation and
Workload
A. Statutory Fee Revenue Amounts
ADUFA specifies that the aggregate revenue amount for FY 2005 for
each of the four animal drug user fee categories is $2,000,000, before
any adjustments for inflation or workload are made. (See 21 U.S.C.
379j-12(b)(1)-(b)(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: (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. (See 21 U.S.C.
379j-12(c)(1).)
The inflation adjustment for FY 2005 is 4.42 percent. This is 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). No compounding is
applied to this amount because there was no inflation increase applied
in FY 2004.
The inflation-adjusted revenue amount for each category of fees for
FY 2005 is the statutory fee amount ($2,000,000) increased by 4.42
percent, the inflation adjuster for FY 2005. The inflation-adjusted
revenue amount is $2,088,400 for each category of fee, for a total
inflation-adjusted fee revenue amount of $8,353,600 for all four
categories of fees in FY 2005.
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). The agency also
calculated the average number of each of these types of applications
and submissions over the most recent 3-year period that ended May 31,
2004.
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 of this document 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 in table 1 of this
document, the sum of the values in column 5 is added, reflecting a
total change in workload of -4 percent for FY 2005. This is the
workload adjuster for FY 2005.
Table 1.--Workload Adjuster Calculation
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Column 1 3-Year Column 5
Application Type Average (Base Column 2 Latest Column 3 Percent Column 4 Weighted Percent
Years) 3-Year Average Change Weighting Factor Change
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New Animal Drug 23 20 -13% 3% -0.4%
Applications (NADAs)
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Supplemental NADAs 31 20 -35% 12% -4.2%
with Safety or
Efficacy Data
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Manufacturing 368 417 +13% 25% +3.3%
Supplements
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Investigational Study 272 270 -0.7% 46% -0.3%
Submissions
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Investigational 283 235 -17% 14% -2.4%
Protocol Submissions
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FY 2005 Workload Adjuster ................ -4.0%
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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 2005, and the inflation-adjusted revenue amount for each
category of fees for FY 2005 ($2,088,400) becomes the revenue target
for fees in FY 2005, for a total inflation-adjusted fee revenue target
in FY 2005 of $8,353,600 for fees from all four categories.
III. Application Fee Calculations for FY 2005
The terms ``animal drug applications'' and ``supplemental animal
drug applications'' are defined in section 739 of the act (21 U.S.C.
379j-11(1).
[[Page 46149]]
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 $2,088,400 in
fee revenue for FY 2005. This is the amount set out in the statute
after it has been adjusted for inflation and workload, as previously
discussed in section II 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.
(See 21 U.S.C. 379j-12(a)(1)(A)(ii).)
To set animal drug application fees and supplemental animal drug
application fees to realize $2,088,400, FDA must first make some
assumptions about the number of fee-paying applications and supplements
the agency will receive in FY 2005.
The agency knows the number of applications that have been
submitted in previous years. That number fluctuates significantly from
year to year. Further, it is possible that the user fee program will
affect the number of applications submitted, exacerbating the kinds of
fluctuation in applications that is normally experienced. In addition,
the agency does not have data on the number of waivers and reductions
that will be granted, though this number will reduce the revenues that
the agency will realize. For these reasons, in estimating the fee
revenue to be generated by animal drug application fees in FY 2005, FDA
is assuming that the number of applications that will pay fees in FY
2005 will be only 80 percent of the lower of the average number of
submissions over the past 3 years or the number in the most recent
year. This should account both for the effect of fluctuations in the
numbers of applications submitted and for the effect of fee waivers or
reductions that FDA estimates will be granted. Based on experience with
other application user fee programs and the experience with ADUFA fees
in FY 2004, FDA believes that this is a reasonable basis for estimating
the number of fee-paying applications for the second year of this
program.
Over the past 3 years, the average number of animal drug
applications that would have been subject to the full fee was 14.3, and
the number for the most recent year is 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 15.3, and the number for the
most recent year is estimated at 15.
Thus, for FY 2005, FDA estimates receipt of 11.5 fee paying
original applications (80 percent of the 3-year average of 14.3) and 12
fee-paying supplemental animal drug applications (80 percent of the 15
estimated for the most recent years).
B. Fee Rates for FY 2005
FDA must set the fee rates for FY 2005 so that the estimated 11.5
applications that pay the full fee and the estimated 12 supplements
that pay half of the full fee will generate a total of $2,088,400. To
generate this amount, the fee for an animal drug application, rounded
to the nearest $100, will have to be $119,300. The fee for a
supplemental animal drug application, for which safety or effectiveness
data, are required will have to be $59,650.
IV. Product Fee Calculations for FY 2005
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 by the person who had an animal drug application or
supplemental animal drug application pending at FDA after September 1,
2003. (See 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 $2,088,400 in fee revenue for FY 2005. This is
the amount set out in the statute after it has been adjusted for
inflation and workload, as previously discussed in section II of this
document.
To set animal drug product fees to realize $2,088,400, FDA must
make some assumptions about the number of products for which these fees
will be paid in FY 2005. 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, 2004, FDA found a total of 752 products submitted for listing by
persons who had an animal drug application or supplemental animal drug
application pending after September 1, 2003. While the number of
applications pending after September 1, 2003, could increase between
July 1, 2004, and the end of FY 2004, the number of products
potentially subject to fees that have not already qualified for fees by
April 1, 2004, is only 75. Based on experience over the past several
months, FDA is assuming that none of these remaining products will
qualify for fees because their sponsors will submit an application
between July 1, 2004, and the end of September 2004. Based on this
information, FDA believes that a total of 752 products will be subject
to this fee in FY 2005.
The agency does not have data on the number of waivers and
reductions that will be granted, though this number will reduce the
revenues that the agency will realize. In estimating the fee revenue to
be generated by animal drug product fees in FY 2005, FDA is assuming
that 10 percent of the products invoiced, or 75, will not pay fees in
FY 2005 due to fee waivers and reductions. Based on experience with
other user fee programs and the first year of ADUFA, FDA believes that
this is a reasonable basis for estimating the number of fee-paying
products in the first year of this program.
Accordingly, the agency estimates that a total of 677 products will
be subject to product fees in FY 2005 (752 minus 75).
B. Product Fee Rates for FY 2005
FDA must set the fee rates for FY 2005 so that the estimated 677
products that pay fees will generate a total of $2,088,400. To generate
this amount, the agency will require the fee for an animal drug
product, rounded to the nearest $5, to be $3,085.
V. Establishment Fee Calculations for FY 2005
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 meets the
following qualifications: (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. (See 21 U.S.C. 379j-12(a)(3).) An establishment subject
to animal drug establishment fees is assessed only one such fee per FY.
(See
[[Page 46150]]
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 $2,088,400 in fee revenue for FY 2005. This
is the amount set out in the statute after it has been adjusted for
inflation and workload, as previously discussed in section II of this
document.
To set animal drug establishment fees to realize $2,088,400, FDA
must make some assumptions about the number of establishments for which
these fees will be paid in FY 2005. 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, 2004, FDA found a total of 54 establishments owned
or operated by persons who had an animal drug application or
supplemental animal drug application pending after September 1, 2003.
While the number of applications pending after September 1, 2003, could
increase between July 1, 2004, and the end of FY 2004, the number of
establishments potentially subject to fees that have not already
qualified for fees by July 1, 2004, is only 10. Based on experience
over the last several months, FDA is assuming that none of these
remaining establishments will qualify for fees because of additional
applications submitted between July 1, 2004, and the end of FY 2004.
Based on this information, FDA believes that 54 establishments will be
subject to this fee in FY 2005.
The agency does not have data on the number of waivers and
reductions that will be granted, though this number will reduce the
revenues that the agency will realize. In estimating the fee revenue to
be generated by animal drug establishment fees in FY 2005, FDA is
assuming that 10 percent of the establishments invoiced, or five, will
not pay fees in FY 2005 due to fee waivers and reductions. Based on
experience with other user fee programs and the first year of ADUFA,
FDA believes that this is a reasonable basis for estimating the number
of fee-paying establishments in the second year of this program.
Accordingly, the agency estimates that a total of 49 establishments
will be subject to establishment fees in FY 2005 (54 minus 5).
B. Establishment Fee Rates for FY 2005
FDA must set the fee rates for FY 2005 so that the estimated 49
establishments that pay fees will generate a total of $2,088,400. To
generate this amount, the agency will require the fee for an animal
drug establishment, rounded to the nearest $50, to be $42,600.
VI. Sponsor Fee Calculations for FY 2005
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 meets the following
qualifications: (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. (See 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. (See 21 U.S.C. 379j-
12(a)(4).) The sponsor fees are to be set so that they will generate
$2,088,400 in fee revenue for FY 2005. This is the amount set out in
the statute after it has been adjusted for inflation and workload, as
previously discussed in section II of this document.
To set animal drug sponsor fees to realize $2,088,400, FDA must
make some assumptions about the number of sponsors who will pay these
fees in FY 2005. Based on the number of firms that would have met this
definition in each of the past 3 years, FDA estimates that a total of
138 sponsors will meet this definition in FY 2005.
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 with sponsor fees in FY 2004, 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 2005 due to fee waivers
and reductions. FDA believes that this is a reasonable basis for
estimating the number of fee-paying sponsors in the second year of this
program.
Accordingly, the agency estimates that a total of 65 sponsors will
be subject to sponsor fees in FY 2005 (138 minus 73).
B. Sponsor Fee Rates for FY 2005
FDA must set the fee rates for FY 2005 so that the estimated 65
sponsors that pay fees will generate a total of $2,088,400. To generate
this amount, the agency will require the fee for an animal drug
sponsor, rounded to the nearest $50, to be $32,150.
VII. Adjustment for Excess Collections
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 the adjusted aggregate revenue amount in a subsequent year by
that excess amount (21 U.S.C. 379j-12(g)(4)). No adjustment under this
provision is required for fees assessed in FY 2005 because FDA has not
collected animal drug user fees in excess of amounts provided in
appropriations in any previous year.
VIII. Fee Schedule for FY 2005
The fee rates for FY 2005 are summarized in table 2 of this
document.
Table 2.--FY 2005 Fee Rates
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Animal Drug User Fee Category Fee Rate for FY 2005
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Animal Drug Application Fee .........................................................................
Animal Drug Application $119,300
Supplemental Animal Drug $59,650
Application for which Safety or
Effectiveness Data are Required
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Animal Drug Product Fee $3,085
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Animal Drug Establishment Fee\1\ $42,600
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Animal Drug Sponsor Fee\2\ $32,150
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\1\ An animal drug establishment is subject to only one such fee each fiscal year.
\2\ An animal drug sponsor is subject to only one such fee each fiscal year.
[[Page 46151]]
IX. Procedures for Paying the FY 2005 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, 2004. 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 FDA's 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 you prefer to send a check by a courier such as Federal Express
or United Parcel Service, the courier may deliver the check and printed
copy of the cover sheet to: U.S. 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 U.S. Bank at 314-418-4821. This telephone number
is only for questions about courier delivery.)
The tax identification number of the FDA is 530 19 6965. (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 2
before the application arrives at FDA's CVM. FDA records the official
application receipt date as the later of the following: The date the
application was received by FDA's CVM, or the date U.S. Bank notifies
FDA that your check in the full amount of the payment due has been
received. U.S. 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. It may take a
day or 2 to get the organization number and have the user account and
password established.
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 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 30, 2004, FDA will issue invoices and payment
instructions for product, establishment, and sponsor fees for FY 2005
using this fee schedule. Payment will be due and payable by January 31,
2005. FDA will issue invoices in October 2005 for any products,
establishments, and sponsors subject to fees for FY 2005 that qualify
for fees after the December 2004 billing.
Dated: July 23, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-17441 Filed 7-30-04; 8:45 am]
BILLING CODE 4160-01-S