[Federal Register: August 3, 2009 (Volume 74, Number 147)]
[Notices]
[Page 38429-38434]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03au09-70]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0336]
Animal Drug User Fee Rates and Payment Procedures for Fiscal Year
2010
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) 2010 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) and the Animal Drug User Fee
Amendments of 2008 (ADUFA II), authorizes FDA to collect user fees for
certain animal drug applications and supplements, 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 2010.
FOR FURTHER INFORMATION CONTACT: Visit FDA's Web site at http://
www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/default.htm
or contact Lisa Kable, Center for Veterinary Medicine (HFV-10), Food
and Drug Administration, 7529 Standish Pl., Rockville, MD 20855, 240-
276-9718. For general questions, you may also e-mail the Center for
Veterinary Medicine (CVM) at: cvmadufa@fda.hhs.gov.
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 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, 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 workload.
For FY 2010, the animal drug user fee rates are: $209,400 for an
animal drug application; $145,200 for a supplemental animal drug
application for which safety or effectiveness data is required and for
an animal drug application subject to the criteria set forth in section
512(d)(4) of the act (21 U.S.C. 360b(d)(4)); $6,185 for an annual
[[Page 38430]]
product fee; $73,850 for an annual establishment fee; and $57,100 for
an annual sponsor fee. FDA will issue invoices for FY 2010 product,
establishment, and sponsor fees by December 31, 2009, and these
invoices will be due and payable within 30 days of issuance of the
invoice.
The application fee rates are effective for applications submitted
on or after October 1, 2009, and will remain in effect through
September 30, 2010. Applications will not be accepted for review until
FDA has received full payment of application fees and any other animal
drug user fees owed.
II. Revenue Amount for FY 2010
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 2010 for each
of the 4 animal drug user fee categories is $4,320,000, before any
adjustment for workload is made. (See 21 U.S.C. 379j-12(b)(1) through
(b)(4).)
B. Inflation Adjustment to Fee Revenue Amount
The amounts established in ADUFA II for each year for FY 2009
through FY 2013 include an inflation adjustment; so, no further
inflation adjustment is required.
C. Workload Adjustment to Inflation Adjusted Fee Revenue Amount
For each FY beginning in FY 2010, ADUFA provides that fee revenue
amounts shall be further adjusted to reflect changes in review workload
(21 U.S.C. 379j-12(c)(1)).
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 5-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 5-year period that ended June 30, 2009.
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 5-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 5
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 of the table the sum of
the values in column 5 is added, reflecting a total change in workload
of -22% percent for FY 2010. This is the workload adjuster for FY 2010.
Table 1.--Workload Adjuster Calculation (Numbers may not add due to rounding)
----------------------------------------------------------------------------------------------------------------
Column 1 5-Year
Application Average (Base Column 2 Latest 5- Column 3 Percent Column 4 Column 5
Type Years) Year Average Change Weighting Factor Weighted % Change
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New Animal 28.80 12.40 -57% 0.0319 -2%
Drug
Applications
(NADAs)
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Supplemental 23.40 13.60 -42% 0.0233 -1%
NADAs With
Safety or
Efficacy
Data
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Manufacturing 366.6 435.20 19% 0.1605 3%
Supplements
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Investigation 336.60 242.80 -28% 0.5930 -17%
al Study
Submissions
----------------------------------------------------------------------------------------------------------------
Investigation 292.40 204.80 -30% 0.1913 -6%
al Protocol
Submissions
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FY 2010 Workload Adjuster -22%
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ADUFA specifies that the workload adjuster may not result in fees
that are less than the fee revenue amount in the statute (21 U.S.C.
379j-12(c)(1)(B)). Because applying the FY 2010 workload adjuster would
result in fees less than the statutory amount, the workload adjustment
will not be applied in FY 2010. As a result, the statutory revenue
target amount for each of the 4 categories of fees stand at $4,320,000
with the new total revenue target for fees in FY 2010 being
$17,280,000.
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 fiscal year
by that amount (21 U.S.C. 379j-12(g)(4)) prior to its amendment under
ADUFA II). Table 2 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, 2008, which is the final year of ADUFA.
Table 2.--Fees Collected, Fees Appropriated, and Offset for Future Collections--as of September 30, 2008
----------------------------------------------------------------------------------------------------------------
Fiscal Year
Cohort Fees Collected Fees Appropriated Amount to Offset Future Collections
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2004 $5,154,700 $5,000,000 $154,700
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[[Page 38431]]
2005 $8,519,101 $8,354,000 $165,101
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2006 $10,945,866 $11,318,000 $0
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2007 $13,189,060 $11,604,000 $1,585,060\1\
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2008 $11,177,600 $13,696,000 $0
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Total $1,904,861
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Amount Offset When Fees for FY 2008 Were Determined $320,000
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Amount Offset When Fees for FY 2009 Were Determined $1,344,000\2\
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Remaining Balance to Be Offset When FY 2013 Fees Are Set $240,861
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\1\ Some fees for FY 2007 were collected at the end of FY 2008 and were therefore not reflected in the Federal
Register document announcing animal drug user fee rates and payment procedures for FY 2009 (September 15,
2008; 73 FR 53254). These additional fees amount to $240,861 and represent the remaining balance to be offset.
\2\ The amount shown in the corresponding chart last year was $1,342,316 (73 FR 53254). When the reduction was
taken this amount was divided by 4, so it could be distributed among the 4 categories of fees (application
fees, establishment fees, product fees and sponsor fees) and then it was rounded to the nearest thousand
dollars, which amounted to $336,000, for each of these categories. Thus, the total reduction actually taken in
FY 2009 was $336,000 times 4, or a total of $1,344,000.
When ADUFA fees were established for FY 2008 and FY 2009, the
amount of fee revenues for each year was reduced by $320,000 and
$1,344,000 of collections in excess of appropriations, respectively.
That leaves a total of $240,861 collected under ADUFA I remaining to be
offset. ADUFA II amended the annual offset provision of ADUFA I to
require one offset when FY 2013 fees are set in August of 2012, if
aggregate collections from FY 2009 through 2011 plus the amount of fees
estimated to be collected for FY 2012 exceed aggregate appropriations
over the same period (21 U.S.C. 379j-12(g)(4), as amended by ADUFA II).
FDA will include the remaining $240,861 in excess collections from FY
2004 through FY 2008 in the calculations when it determines whether or
not there will be an offset in FY 2013, the final year of ADUFA II. FDA
is not offsetting for excess collections at this time.
IV. Application Fee Calculations for FY 2010
The terms ``animal drug application'' and ``supplemental animal
drug application'' are defined in section 739 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 $4,320,000 in
fee revenue for FY 2010. This is the amount set out in the statute and
no adjustments are required for FY 2010. 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) is to be set at 50 percent of the animal
drug application fee. (See 21 U.S.C. 379j-12(a)(1)(A)(ii), as amended
by ADUFA II.)
To set animal drug application fees and supplemental animal drug
application fees to realize $4,320,000, FDA must first make some
assumptions about the number of fee-paying applications and supplements
the agency will receive in FY 2010.
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 2010, FDA is assuming that the number of
applications that will pay fees in FY 2010 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 6 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 8.25,
including the number for the most recent year, estimated at 6. Over
this same period, the average number of supplemental applications and
applications subject to the criteria set forth in section 512(d)(4) of
the act that would have been subject to half of the full fee was 13.25,
including the number for the most recent year, estimated at 9.
Thus, for FY 2010, FDA estimates receipt of 8.25 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) of the act which pay half of the full fee.
B. Fee Rates for FY 2010
FDA must set the fee rates for FY 2010 so that the estimated 8.25
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)
of the act that pay half of the full fee will generate a total of
$4,320,000. To generate this amount, the fee for an animal drug
application, rounded to the nearest hundred dollars, will have to be
$290,400, 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) of the act will
have to be $145,200.
V. Product Fee Calculations for FY 2010
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 a new
animal drug application or supplemental new animal drug application for
an animal drug product submitted for listing under
[[Page 38432]]
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 $4,320,000 in fee revenue
for FY 2010. This is the amount set out in the statute and no
adjustments are required for FY 2010.
To set animal drug product fees to realize $4,320,000, FDA must
make some assumptions about the number of products for which these fees
will be paid in FY 2010. 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
2009, FDA estimates that there are a total of 776 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 776 products will be
subject to this fee in FY 2010.
In estimating the fee revenue to be generated by animal drug
product fees in FY 2010, FDA is assuming that 10 percent of the
products invoiced, or about 77.6, will not pay fees in FY 2010 due to
fee waivers and reductions. Based on experience with other user fee
programs and the first 6 years of ADUFA, FDA believes that this is a
reasonable basis for estimating the number of fee-paying products in FY
2010.
Accordingly, the agency estimates that a total of 698.4 (776 minus
77.6) products will be subject to product fees in FY 2010.
B. Product Fee Rates for FY 2010
FDA must set the fee rates for FY 2010 so that the estimated 698.4
products that pay fees will generate a total of $4,320,000. To generate
this amount will require the fee for an animal drug product, rounded to
the nearest 5 dollars, to be $6,185.
VI. Establishment Fee Calculations for FY 2010
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 1 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 $4,320,000 in fee revenue for FY 2010. This
is the amount set out in the statute and no adjustments are required
for FY 2010.
To set animal drug establishment fees to realize $4,320,000, FDA
must make some assumptions about the number of establishments for which
these fees will be paid in FY 2010. 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 2009, 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 2010.
In estimating the fee revenue to be generated by animal drug
establishment fees in FY 2010, FDA is assuming that 10 percent of the
establishments invoiced, or 6.5, will not pay fees in FY 2010 due to
fee waivers and reductions. Based on experience with the first 6 years
of ADUFA, FDA believes that this is a reasonable basis for estimating
the number of fee-paying establishments in FY 2010.
Accordingly, the agency estimates that a total of 58.5
establishments (65 minus 6.5) will be subject to establishment fees in
FY 2010.
B. Establishment Fee Rates for FY 2010
FDA must set the fee rates for FY 2010 so that the estimated 58.5
establishments that pay fees will generate a total of $4,320,000. To
generate this amount will require the fee for an animal drug
establishment, rounded to the nearest 50 dollars, to be $73,850.
VII. Sponsor Fee Calculations for FY 2010
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 $4,320,000 in fee revenue for FY 2010. This is
the amount set out in the statute, and no adjustments are required for
FY 2010.
To set animal drug sponsor fees to realize $4,320,000, FDA must
make some assumptions about the number of sponsors who will pay these
fees in FY 2010. Based on the number of firms that would have met this
definition in each of the past 6 years, FDA estimates that a total of
161 sponsors will meet this definition in FY 2010.
Careful review indicates that about one third or 33 percent of all
of these sponsors will qualify for minor use/minor species waiver or
reduction (21 U.S.C. 379j-12(d)(1)(C)). 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
85.3, who will not pay fees in FY 2010 due to fee waivers and
reductions. FDA believes that this is a reasonable basis for estimating
the number of fee-paying sponsors in FY 2010.
Accordingly, the agency estimates that a total of 75.7 sponsors
(161 minus 85.3) will be subject to and pay sponsor fees in FY 2010.
B. Sponsor Fee Rates for FY 2010
FDA must set the fee rates for FY 2010 so that the estimated 75.7
sponsors that pay fees will generate a total of $4,320,000. To generate
this amount will require the fee for an animal drug sponsor, rounded to
the nearest 50 dollars, to be $57,100.
[[Page 38433]]
VIII. Fee Schedule for FY 2010
The fee rates for FY 2010 are summarized in table 3 of this
document.
Table 3.--FY 2010 Fee Rates
------------------------------------------------------------------------
Animal Drug User Fee Category Fee Rate for FY 2010
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Animal Drug Application Fees ..................................
Animal Drug Application $290,400
Supplemental Animal Drug $145,200
Application for 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 $6,185
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Animal Drug Establishment Fee\1\ $73,850
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Animal Drug Sponsor Fee\2\ $57,100
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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.
IX. Procedures for Paying the FY 2010 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, 2009. 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,
by wire transfer, or electronically using Pay.gov. (The Pay.gov payment
option is available to you after you submit a cover sheet. Click the
``Pay Now'' button.) On your check, bank draft, or U.S. postal money
order, please write your application's unique Payment Identification
Number (PIN), 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 by wire transfer, send payment to: U.S.
Department of Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045,
FDA Deposit Account Number: 75060099, U.S. Department of Treasury
routing/transit number: 021030004, SWIFT Number: FRNYUS33. You are
responsible for any administrative costs associated with the processing
of a wire transfer. Contact your bank or financial institution
regarding additional fees.
If you prefer to send a check by a courier such as Federal Express
(FEDEX) or United Parcel Service (UPS), 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 Food and Drug Administration
is 530196965. (Note: In no case should the payment 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 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 payment in the full amount has been received, or when the
U.S. Treasury notifies FDA of receipt of an electronic or wire transfer
payment. U.S. Bank and the U.S. Treasury are required to notify FDA
within 1 working day, using the PIN described previously.
B. Application Cover Sheet Procedures
Step One--Create a user account and password. Log on to the ADUFA
Web site at http://www.fda.gov/ForIndustry/UserFees/
AnimalDrugUserFeeActADUFA/default.htm and, under Tools and Resources
click ``The Animal Drug User Fee Cover Sheet'' and then click ``Create
ADUFA 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 PIN.
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, 2009, FDA will issue invoices and payment
instructions for product, establishment, and sponsor fees for FY 2010
using this Fee Schedule. Payment will be due and payable within 30 days
of issuance of the invoice. FDA will issue invoices in November 2010
for any products, establishments, and sponsors subject to fees for FY
2010 that qualify for fees after the December 2009 billing.
[[Page 38434]]
Dated: July 28, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-18459 Filed 7-31-09; 8:45 am]
BILLING CODE 4160-01-S