[Federal Register Volume 70, Number 146 (Monday, August 1, 2005)]
[Notices]
[Pages 44101-44104]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-15158]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Establishment of Animal Drug User Fee Rates and Payment
Procedures for Fiscal Year 2006
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the rates
and payment procedures for fiscal year (FY) 2006 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 2006.
For FY 2006, the animal drug user fee rates are: $151,800 for an
animal drug application; $75,900 for a supplemental animal drug
application for which safety or effectiveness data is required; $3,905
for an annual product fee; $49,200 for an annual establishment fee; and
$44,400 for an annual sponsor fee. FDA will issue invoices for FY 2006
product, establishment, and sponsor fees by December 30, 2005, and
these invoices will be due and payable by January 31, 2006.
The application fee rates are effective for applications submitted
on or after October 1, 2005, and will remain in effect through
September 30, 2006. 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 Robert Miller, Center for Veterinary
Medicine (HFV-10), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240-276-9707. 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 2006 and Adjustments for Inflation and
Workload
A. Statutory Fee Revenue Amounts
ADUFA (Public Law 108-130) specifies that the aggregate revenue
amount for FY 2006 for each of the four animal drug user fee categories
is $2,500,000, before any adjustments for inflation or workload are
made (see 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: (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 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 is 3.71 percent. This is 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).
Compounding these amounts (1.0442 times 1.0371) yields a total
compounded inflation adjustment of 8.29 percent for FY 2006.
The inflation-adjusted revenue amount for each category of fees for
FY 2006 is the statutory fee amount ($2,500,000) increased by 8.29
percent, the inflation adjuster for FY 2006. The inflation-adjusted
revenue amount is $2,707,250 for each category of fee, for a total
inflation-adjusted fee revenue amount of $10,829,000 for all four
categories of fees in FY 2006.
[[Page 44102]]
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, 2005.
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 table 1 the sum of the values
in column 5 is added, reflecting a total change in workload of negative
6.4 percent for FY 2006. This is the workload adjuster for FY 2006.
Table 1.--Workload Adjuster Calculation
--------------------------------------------------------------------------------------------------------------------------------------------------------
Column 13-Year Column 2Latest 3- Column 3Percent Column 4Weighting Column 5Weighted %
Application Type Avg. (Base Years) Year Avg. Change Factor Change
--------------------------------------------------------------------------------------------------------------------------------------------------------
New Animal Drug Applications (NADAs) 22 18 -18% 3% -0.5%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Supplemental NADAs with Safety or Efficacy Data 31 13 -58% 12% -7.0%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Manufacturing Supplements 368 432 +17% 25% +4.3%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Investigational Study Submissions 272 274 +0.7% 46% +0.3%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Investigational Protocol Submissions 283 212 -25% 14% -3.5%
--------------------------------------------------------------------------------------------------------------------------------------------------------
FY 2006 Workload Adjuster -6.4%
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 2006, and the inflation-adjusted revenue amount for each
category of fees for FY 2006 ($2,707,250) becomes the revenue target
for fees in FY 2006, for a total inflation-adjusted fee revenue target
in FY 2006 of $10,829,000 for fees from all four categories.
III. Application Fee Calculations for FY 2006
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 $2,707,250 in
fee revenue for FY 2006. 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. 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 $2,707,250, FDA must first make some
assumptions about the number of fee-paying applications and supplements
it will receive in FY 2006.
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 know 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 application fees in FY 2006, FDA is assuming that the number of
applications that will pay fees in FY 2006 will equal the average
number of submissions over the 3 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 2 years of
experience with this program.
Over the past 3 years, the average number of animal drug
applications that would have been subject to the full fee was 12,
including the number for the most recent year, estimated at 8. Over
this same period, the average number of supplemental applications that
would have been subject to half of the full fee was 11.7, including the
number for the most recent year, estimated at 8.
Thus, for FY 2006, FDA estimates receipt of 12 fee paying original
applications and 11.7 fee-paying supplemental animal drug applications.
[[Page 44103]]
B. Fee Rates for FY 2006
FDA must set the fee rates for FY 2006 so that the estimated 12
applications that pay the full fee and the estimated 11.7 supplements
that pay half of the full fee will generate a total of $2,704,250. To
generate this amount, the fee for an animal drug application, rounded
to the nearest hundred dollars, will have to be $151,800, and the fee
for a supplemental animal drug application for which safety or
effectiveness data are required will have to be $75,900.
IV. Product Fee Calculations for FY 2006
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 (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 $2,707,250 in fee revenue for FY 2006. 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.
To set animal drug product fees to realize $2,707,250, FDA must
make some assumptions about the number of products for which these fees
will be paid in FY 2006. 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, 2005, FDA found a total of 770 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 770 products will be subject to this fee in FY
2006.
The agency does not know 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 2006, FDA is assuming that 10 percent of
the products invoiced, or 77, will not pay fees in FY 2006 due to fee
waivers and reductions. Based on experience with other user fee
programs and the first 2 years of ADUFA, FDA believes that this is a
reasonable basis for estimating the number of fee-paying products in
the third year of this program.
Accordingly, the agency estimates that a total of 693 (770 minus
77) products will be subject to product fees in FY 2006.
B. Product Fee Rates for FY 2006
FDA must set the fee rates for FY 2006 so that the estimated 693
products that pay fees will generate a total of $2,707,250. To generate
this amount will require the fee for an animal drug product, rounded to
the nearest $5, to be $3,905.
V. Establishment Fee Calculations for FY 2006
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 fiscal year (see
21 U.S.C. 379j-12(a)(3)). An establishment subject to animal drug
establishment fees is assessed only one such fee per fiscal year (see
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 $2,707,250 in fee revenue for FY 2006. 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.
To set animal drug establishment fees to realize $2,707,250, FDA
must make some assumptions about the number of establishments for which
these fees will be paid in FY 2006. 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, 2005, FDA found a total of 61 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 61 establishments will be subject to
this fee in FY 2006.
The agency does not know 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 2006, FDA is assuming that 10
percent of the establishments invoiced, or 6, will not pay fees in FY
2006 due to fee waivers and reductions. Based on experience with other
user fee programs and the first 2 years of ADUFA, FDA believes that
this is a reasonable basis for estimating the number of fee-paying
establishments in the third year of this program.
Accordingly, the agency estimates that a total of 55 establishments
(61 minus 6) will be subject to establishment fees in FY 2006.
B. Establishment Fee Rates for FY 2006
FDA must set the fee rates for FY 2006 so that the estimated 55
establishments that pay fees will generate a total of $2,707,250. To
generate this amount will require the fee for an animal drug
establishment, rounded to the nearest $50, to be $49,200.
VI. Sponsor Fee Calculations for FY 2006
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 (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 fiscal year
(see 21 U.S.C. 379j-12(a)(4)). The sponsor fees are to be set so that
they will generate $2,707,250 in fee revenue for FY 2006. 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.
To set animal drug sponsor fees to realize $2,707,250, FDA must
make some assumptions about the number of sponsors who will pay these
fees in FY 2006. Based on the number of firms that
[[Page 44104]]
would have met this definition in each of the past 3 years, FDA
estimates that a total of 129 sponsors will meet this definition in FY
2006.
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 and FY
2005, 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 68, who will not pay fees in FY 2006 due to
fee waivers and reductions. FDA believes that this is a reasonable
basis for estimating the number of fee-paying sponsors in the third
year of this program.
Accordingly, the agency estimates that a total of 61 sponsors (129
minus 68) will be subject to sponsor fees in FY 2006.
B. Sponsor Fee Rates for FY 2006
FDA must set the fee rates for FY 2006 so that the estimated 61
sponsors that pay fees will generate a total of $2,707,250. To generate
this amount will require the fee for an animal drug sponsor, rounded to
the nearest $50, to be $44,400.
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 2006 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 2006
The fee rates for FY 2006 are summarized in table 2.
Table 2.--FY 2006 Fee Rates
------------------------------------------------------------------------
Animal Drug User Fee Category Fee Rate for FY 2006
------------------------------------------------------------------------
Animal Drug Application Fee
Animal Drug Application $151,800
Supplemental Animal Drug Application $75,900
for which Safety or Effectiveness
Data are Required
------------------------------------------------------------------------
Animal Drug Product Fee $3,905
------------------------------------------------------------------------
Animal Drug Establishment Fee\1\ $49,200
------------------------------------------------------------------------
Animal Drug Sponsor Fee\2\ $44,400
------------------------------------------------------------------------
\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.
IX. Procedures for Paying the FY 2006 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, 2005. 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 (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 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 for 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 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. 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. It may take a
day or two 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, 2005, FDA will issue invoices and payment
instructions for product, establishment, and sponsor fees for FY 2006
using this fee schedule. Payment will be due and payable by January 31,
2006. FDA will issue invoices in October 2006 for any products,
establishments, and sponsors subject to fees for FY 2006 that qualify
for fees after the December 2005 billing.
Dated: July 22, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-15158 Filed 7-29-05; 8:45 am]
BILLING CODE 4160-01-S