Document ID: FDA-2012-N-0806-0001
Agency: fda
Document Type: Notice
Title: Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2013
Posted Date: 2012-08-01T04:00Z

[Federal Register Volume 77, Number 148 (Wednesday, August 1, 2012)]
[Notices]
[Pages 45624-45629]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-18709]

[[Page 45624]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0806]

Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 
2013

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) 2013 animal drug user fees. 
The Federal Food, Drug, and Cosmetic Act (the FD&C 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, for certain 
animal drug products, for certain establishments where such products 
are made, and for certain sponsors of such animal drug applications 
and/or investigational animal drug submissions. This notice establishes 
the fee rates for FY 2013.

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 email the Center for 
Veterinary Medicine (CVM) at: cvmadufa@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 740 of the FD&C Act (21 U.S.C. 379j-12) establishes four 
different types 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 FD&C 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 2013, the animal drug user fee rates are: $435,200 for an 
animal drug application; $217,600 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 FD&C Act (21 U.S.C. 360b(d)(4)); $8,640 for an annual 
product fee; $104,600 for an annual establishment fee; and $87,700 for 
an annual sponsor fee. FDA will issue invoices for FY 2013 product, 
establishment, and sponsor fees by December 31, 2012, 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, 2012, and will remain in effect 
through September 30, 2013. 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 2013

A. Statutory Fee Revenue Amounts

    ADUFA II (Pub. L. 110-316 signed by the President on August 14, 
2008) specifies that the aggregate revenue amount for FY 2013 for each 
of the four animal drug user fee categories is $6,061,000 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; therefore, 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, 2012.
    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 -32% percent for FY 2013. This is the workload adjuster for FY 2013.

                  Table 1--Workload Adjuster Calculation (Numbers May Not Add Due to Rounding)
----------------------------------------------------------------------------------------------------------------
                                                 Column 1 5-                                           Column 5
                                                  year Avg.     Column 2     Column 3     Column 4     weighted
                Application type                    (base      latest 5-     percent     weighting     percent
                                                    years)     year avg.      change       factor       change
----------------------------------------------------------------------------------------------------------------
New Animal Drug Applications (NADAs)...........         28.8         11.4          -60       0.0229           -1
Supplemental NADAs With Safety or Efficacy Data         23.4         11.4          -51       0.0275           -1
Manufacturing Supplements......................        366.6        394.2            8       0.1222            1
Investigational Study Submissions..............        336.6        224.0          -33       0.6435          -22
Investigational Protocol Submissions...........        292.4        148.6          -49       0.1838           -9

[[Page 45625]]

 
    FY 2013 Workload Adjuster..................  ...........  ...........  ...........  ...........          -32
----------------------------------------------------------------------------------------------------------------

    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 2013 workload adjuster would 
result in fees less than the statutory amount, the workload adjustment 
will not be applied in FY 2013. As a result, the statutory revenue 
target amount for each of the four categories of fees remains at 
$6,061,000 with the new total revenue target for fees in FY 2013 being 
$24,244,000.

D. Offset for Excess Collections Through FY 2012

    Under the provisions of ADUFA I, which apply to fees collected for 
FY 2004 through FY 2008, if the amount of fees collected for a FY 
exceeds the amount of fees specified in appropriation acts for that FY, 
the excess amount shall be credited to FDA's appropriation account and 
shall be subtracted from the amount of fees that would otherwise be 
authorized to be collected in a subsequent FY. (See section 740(g)(4) 
of the FD&C Act as originally enacted in Public Law 108-130 on November 
18, 2003.) In setting ADUFA fees for FY 2008 and FY 2009, offsets 
totaling $1,664,000 were made under these provisions ($320,000 when FY 
2008 fees were set and another $1,344,000 when fees for FY 2009 were 
set), but offsets totaling $394,256 for this period still need to be 
made. Table 2 shows the amount of fees specified in FDA's annual 
appropriation for each year from 2004 through 2008, the amounts FDA has 
collected for each year; the amount of offset previously taken, and the 
cumulative difference. FDA will take this difference as an offset 
against FY 2013 fee collections.

                        Table 2--Offsets Remaining To Be Taken for ADUFA I, FY 2004-2008
----------------------------------------------------------------------------------------------------------------
                                                                                      Excess         Remaining
                                                       Fees       Fees collected    collections       excess
                   Fiscal year                     appropriated     as of 3/31/     offset when   collections to
                                                                       2012        fees were set     be offset
----------------------------------------------------------------------------------------------------------------
2004............................................      $5,000,000      $5,154,700  ..............        $154,700
2005............................................       8,354,000       8,519,101  ..............         165,101
2006............................................      11,318,000      10,901,466  ..............               0
2007............................................      11,604,000      13,342,455  ..............       1,738,455
2008............................................      13,696,000      11,577,312         320,000               0
                                                 ---------------------------------------------------------------
    Totals......................................  ..............  ..............  ..............   \1\ 2,058,256
    Net Excess Appropriations, to be Offset       ..............  ..............  ..............         394,256
     Against 2013 Collections...................
----------------------------------------------------------------------------------------------------------------
\1\ See table 3 of this document for information on additional offset taken in FY 2009.

    In addition, under the provisions of ADUFA, as amended by ADUFA II, 
if the cumulative amount of the fees collected for fiscal years 2009 
through 2011, and the amount of fees estimated to be collected under 
this section for FY 2012, exceeds the cumulative amount appropriated 
for fees for fiscal years 2009 through 2012, the excess will be 
subtracted from the amount of fees that FDA would otherwise be 
authorized to collect for FY 2013 under the FD&C Act (21 U.S.C. 379j-
12(g)(4) as amended by ADUFA II).
    Table 3 shows the amounts appropriated for each year from FY 2009 
through FY 2012, and the amounts FDA has collected for fiscal years 
2009, 2010, and 2011 as of March 31, 2012, and the amount that FDA 
estimated it would collect in FY 2012 when it published the notice of 
FY 2012 fees in the Federal Register on August 1, 2011 (76 FR 45811). 
The bottom line of Table 3 shows the estimated cumulative amount by 
which fees collected fell below amounts appropriated for FY 2009 
through FY 2012.

                  Table 3--Offsets To Be Taken for the ADUFA II Period, Fiscal Years 2009-2012
       [for FY 2009-2011, fees collected through March 31, 2012; for FY 2012, estimate as August 1, 2011]
----------------------------------------------------------------------------------------------------------------
                                                                                      Excess
                                                       Fees                         collections
                   Fiscal year                     appropriated   Fees collected    offset when     Difference
                                                                                   fees were set
----------------------------------------------------------------------------------------------------------------
2009............................................     $15,260,000     $12,893,721      $1,344,000    ($2,366,279)
2010............................................      17,280,000      16,609,805  ..............       (670,195)
2011............................................      19,448,000      18,342,199  ..............     (1,105,801)
2012 estimated..................................      21,768,000      21,768,000  ..............               0
                                                 ---------------------------------------------------------------
    Cumulative Difference Less Than               ..............  ..............  ..............     (4,142,275)
     Appropriations.............................
----------------------------------------------------------------------------------------------------------------

[[Page 45626]]

    As can be seen from table 3, no further offset is required for the 
period 2009 through 2012 since collections have fallen substantially 
below the amounts appropriated each year and in aggregate. The only 
offset required at this time is the $394,256 from the ADUFA I period.

E. Final Year Adjustment

    Under the provisions of ADUFA, as amended, the Secretary may, in 
addition to the workload adjustment and offset, further increase the 
fees and fee revenues if such an adjustment is necessary to provide up 
to 3 months of operating reserves of carryover user fees for the 
process for the review of animal drug applications for the first 3 
months of FY 2014. (See 21 U.S.C. 379j-12(c)(2).) The rationale for the 
amount of this increase shall be contained in the annual notice 
establishing fee revenues and fees for FY 2013 (See section 740(c)(2) 
of the FD&C Act.) Table 4 in this document estimates the amount of 
carryover reserve FDA currently estimates to have available at the end 
of FY 2013. It begins with the balance available at the end of FY 2011, 
rounded to the nearest thousand dollars, adds the net prior year 
collections for the 6 months ending March 31, 2012, and subtracts the 
amount it will have to use to cover the offset it will make when 2013 
fees are set. In addition, FDA is keeping aside a reserve of $1,400,000 
for potential refunds, and a net of $379,000 for the last 2 years of 
ADUFA II. The amount of carry-over balance FDA expects to have 
available for obligation at the end of FY 2013 is $3,694,000, as shown 
in the last line of table 4.

    Table 4--Estimated Carryover Balance at the End of FY 2013, After
                               Adjustments
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Total Carryover Balance End of FY 2011.................       $4,664,000
Net Prior Year Fees Collected After 9/30/2011 (3/31/             445,000
 2012).................................................
Used for Offset in 2013................................        (394,000)
Reserve for Refunds in 2012 and 2013...................      (1,400,000)
Estimated Change to Carryover Balance at the End of FY           636,000
 2012..................................................
Estimated Change to Carryover Balance at the End of FY         (257,000)
 2013..................................................
Estimated 2013 End of FY Carryover Balance.............        3,694,000
------------------------------------------------------------------------

    Table 5 estimates the amount of funds FDA anticipates that it will 
need from animal drug user fees in order to operate for the first 3 
months of FY 2014.

 Table 5--Estimated Fee Revenue Needed To Sustain FY 2013 Operations for
                      the First 3 Months of FY 2014
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Estimated Total Spending from Fees in FY 2013...........     $19,652,000
Estimated FY 2014 Inflation Costs at 2.01%..............         395,000
Estimated FY 2014 Funds to Sustain FY 2013 Operations...      20,047,000
Estimated Fees Needed for 3 Months in FY 2014...........       5,012,000
Estimated End-of-FY 2013 Carryover Balance..............       3,694,000
Additional Revenue Needed for 3 Months in FY 2013.......       1,318,000
------------------------------------------------------------------------

    FDA expects to collect and spend a total of $19,652,000 in FY 2013, 
rounding to the nearest thousand dollars, after making adjustments for 
the offset of $394,256 and for likely revenue shortfalls below the 
$24,244,000 amount authorized for collection from ADUFA fee in that 
year. To maintain FY 2013 operations in FY 2014, FDA is applying an 
anticipated inflation rate of 2.01 percent to the amount of fee 
revenues FDA expects to obligate in FY 2013. This 2.01 percent is the 
statutory inflation adjustment to be applied to PDUFA and several other 
user fee programs in FY 2013, and the only statutory inflation 
adjustment for FDA available at this time; its derivation is published 
elsewhere in this issue of the Federal Register where the FY 2013 fees 
for the PDUFA user fee program is published. FDA expects to obligate a 
total of $20,047,000 in FY 2014--or a total of about $5,012,000 during 
the first 3 months of FY 2014, rounded to the nearest thousand dollars. 
The available carryover balance at the beginning of FY 2013 is 
estimated at $3,694,000 (rounded to the nearest thousand dollars). Thus 
FDA would need an additional $1,318,000 ($5,012,000 minus $3,694,000 
rounded to the nearest thousand dollars) as the final year adjustment 
to assure sufficient operating reserves for the first 3 months of FY 
2014.
    FDA recognizes that adding $1,318,000 to the fee revenue costs in 
FY 2013 poses a substantial burden on the regulated industry at a time 
when it is undergoing financial strain. In light of this, and in light 
of the fact that the legislative language authorizing the final year 
adjustment allows FDA discretion in whether to make this adjustment for 
a full 3 months of operating reserves or for a shorter period, FDA has 
decided to balance its own risks with the amount of burden the final 
year adjustment would place on the industry. In making this decision, 
FDA has decided to assume more risk, making the final year adjustment 
to allow for only 2 months of operating reserves instead of 3 months. 
Accordingly FDA will make the final year adjustment for a lesser 
amount, as derived in table 6 of this document.

 Table 6--Estimated Fee Revenue Needed To Sustain FY 2013 Operations for
                      the First 2 Months of FY 2014
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Estimated Total Spending from Fees in FY 2013...........     $19,652,000
Estimated FY 2014 Inflation Costs at 2.01%..............         395,000
Estimated FY 2014 Funds to Sustain FY 2013 Operations...      20,047,000
Estimated Fees Needed for 2 Months in FY 2014...........       3,341,000
Estimated End-of-FY 2013 Carryover Balance..............       3,694,000
Additional Revenue Needed for 2 Months in FY 2013.......               0
------------------------------------------------------------------------

    Accordingly FDA will make no final year adjustment in the ADUFA fee 
revenue amount. In making this decision, FDA is assuming that it will 
have the revenues to operate in FY 2013 as proposed in the President's 
budget request for FDA. Should a significant reduction below that 
amount occur, FDA will have to make larger expenditures of user fee 
reserves to sustain the animal drug review program in FY 2013, to make 
up for appropriation reductions, and will have less carryover balance 
at the end of FY 2013 than estimated in this document. If such a 
reduction in appropriated funds should occur, FDA is reserving the 
right to revise the fees it is setting for FY 2013, due to the need to 
assess a final year adjustment in such circumstances. If that fact only 
becomes known after the start of FY 2013, FDA may publish a revised fee 
schedule with increased FY 2013 fees, and advise any who have paid fees 
at the lower rate that they will have to make another payment to make 
up the difference between the fees published in this document and the 
higher fees necessitated by the need to impose a final year adjustment.

F. FY 2013 Fee Revenue Amounts

    The final estimate of fee revenue for ADUFA fees for FY 2013 is 
shown in table 7 in this document. The statutory amount of $6,061,000 
for each of the fee components is reduced by a total of $98,564--one 
fourth of the total offset amount of $394,256. No final year adjustment 
is made. The total is then rounded to the nearest thousand dollars,

[[Page 45627]]

for a total of $5,962,000 to come from each fee component.

                            Table 7--Estimate of Total ADUFA Fee Revenue for FY 2013
----------------------------------------------------------------------------------------------------------------
                                    Application    Establishment
         Fee components                fees            fees        Product fees    Sponsor fees        Total
----------------------------------------------------------------------------------------------------------------
Amount in ADUFA II..............      $6,061,000      $6,061,000      $6,061,000      $6,061,000     $24,244,000
Reduction for Offset............        (98,564)        (98,564)        (98,564)        (98,564)       (394,256)
Final Year Adjustment...........               0               0               0               0               0
                                 -------------------------------------------------------------------------------
    Total.......................       5,962,436       5,962,436       5,962,436       5,962,436      23,849,744
                                 -------------------------------------------------------------------------------
    Total Rounded...............       5,962,000       5,962,000       5,962,000       5,962,000      23,848,000
----------------------------------------------------------------------------------------------------------------

III. Application Fee Calculations for FY 2013

    The terms ``animal drug application'' and ``supplemental animal 
drug application'' are defined in section 739 of the FD&C 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 $5,962,000 in 
fee revenue for FY 2013. This is the amount set out in the statute and 
adjusted for the offset with no final year adjustment. 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 FD&C Act 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 $5,962,000, FDA must first make some 
assumptions about the number of fee-paying applications and supplements 
the Agency will receive in FY 2013.
    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 2013, FDA is assuming that the number of 
applications that will pay fees in FY 2013 will equal the average 
number of submissions over the 5 most recent completed years (FY 2007-
FY 2011). 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 9 years of experience with 
this program.
    Over the 5 most recent completed years, the average number of 
animal drug applications that would have been subject to the full fee 
was 8.2. 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 FD&C Act that would have been subject to half 
of the full fee was 11.0.

B. Fee Rates for FY 2013

    FDA must set the fee rates for FY 2013 so that the estimated 8.2 
applications that pay the full fee and the estimated 11.0 supplemental 
applications and applications subject to the criteria set forth in 
section 512(d)(4) of the FD&C Act that pay half of the full fee will 
generate a total of $5,962,000. To generate this amount, the fee for an 
animal drug application, rounded to the nearest hundred dollars, will 
have to be $435,200, 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 FD&C Act will have to be $217,600.

IV. Product Fee Calculations for FY 2013

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 section 510 of the 
FD&C 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 $5,962,000 in fee revenue for FY 2013. This is 
the amount set out in the statute and adjusted for the offset with no 
final year adjustment.
    To set animal drug product fees to realize $5,962,000, FDA must 
make some assumptions about the number of products for which these fees 
will be paid in FY 2013. FDA developed data on all animal drug products 
that have been submitted for listing under section 510 of the FD&C 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 June 
2012, FDA estimates that there are a total of 767 products submitted 
for listing by persons who had an animal drug application or 
supplemental animal drug application pending after September 1, 2003. 
Based on this, FDA estimates that a total of 767 products will be 
subject to this fee in FY 2013.
    In estimating the fee revenue to be generated by animal drug 
product fees in FY 2013, FDA is again assuming that 10 percent of the 
products invoiced, or 77, will not pay fees in FY 2013 due to fee 
waivers and reductions. Based on experience with other user fee 
programs and the first 9 years of ADUFA, FDA believes that this is a 
reasonable basis for estimating the number of fee-paying products in FY 
2013.
    Accordingly, the Agency estimates that a total of 690 (767 minus 
77) products will be subject to product fees in FY 2013.

B. Product Fee Rates for FY 2013

    FDA must set the fee rates for FY 2013 so that the estimated 690 
products that pay fees will generate a total of $5,962,000. To generate 
this amount will require the fee for an animal drug product, rounded to 
the nearest 5 dollars, to be $8,640.

[[Page 45628]]

V. Establishment Fee Calculations for FY 2013

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 FD&C 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 $5,962,000 in fee revenue for FY 2013. 
This is the amount set out in the statute and adjusted for the offset 
with no final year adjustment.
    To set animal drug establishment fees to realize $5,962,000, FDA 
must make some assumptions about the number of establishments for which 
these fees will be paid in FY 2013. 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 June 2012, FDA estimates that there are a total of 63 
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 63 establishments 
will be subject to this fee in FY 2013.
    In estimating the fee revenue to be generated by animal drug 
establishment fees in FY 2013, FDA is assuming that 10 percent of the 
establishments invoiced, or 6, will not pay fees in FY 2013 due to fee 
waivers and reductions. Based on experience with the first 9 years of 
ADUFA, FDA believes that this is a reasonable basis for estimating the 
number of fee-paying establishments in FY 2013.
    Accordingly, the Agency estimates that a total of 57 establishments 
(63 minus 6) will be subject to establishment fees in FY 2013.

B. Establishment Fee Rates for FY 2013

    FDA must set the fee rates for FY 2013 so that the estimated 57 
establishments that pay fees will generate a total of $5,962,000. To 
generate this amount will require the fee for an animal drug 
establishment, rounded to the nearest 50 dollars, to be $104,600.

VI. Sponsor Fee Calculations for FY 2013

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 FD&C 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 $5,962,000 in fee revenue for FY 2013. This is 
the amount set out in the statute and adjusted for the offset with no 
final year adjustment.
    To set animal drug sponsor fees to realize $5,962,000, FDA must 
make some assumptions about the number of sponsors who will pay these 
fees in FY 2013. Based on the number of firms that would have met this 
definition in each of the past 9 years, FDA estimates that a total of 
171 sponsors will meet this definition in FY 2013.
    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)(D)). Based on the Agency's 
experience to date with sponsor fees, FDA's current best estimate is 
that an additional 27 percent will qualify for other waivers or 
reductions, for a total of 60 percent of the sponsors invoiced, or 103, 
who will not pay fees in FY 2013 due to fee waivers and reductions. FDA 
believes that this is a reasonable basis for estimating the number of 
fee-paying sponsors in FY 2013.
    Accordingly, the Agency estimates that a total of 68 sponsors (171 
minus 103) will be subject to and pay sponsor fees in FY 2013.

B. Sponsor Fee Rates for FY 2013

    FDA must set the fee rates for FY 2013 so that the estimated 68 
sponsors that pay fees will generate a total of $5,962,000. To generate 
this amount will require the fee for an animal drug sponsor, rounded to 
the nearest 50 dollars, to be $87,700.

VII. Fee Schedule for FY 2013

    The fee rates for FY 2013 are summarized in table 8 of this 
document.

                       Table 8--FY 2013 Fee Rates
------------------------------------------------------------------------
                                                               Fee rate
               Animal drug user fee category                 for FY 2013
------------------------------------------------------------------------
Animal Drug Application Fees:
Animal Drug Application....................................     $435,200
    Supplemental Animal Drug Application for which Safety        217,600
     or Effectiveness Data are Required or Animal Drug
     Application Subject to the Criteria Set Forth in
     Section 512(d)(4) of the FD&C Act.....................
Animal Drug Product Fee....................................        8,640
Animal Drug Establishment Fee \1\..........................      104,600
Animal Drug Sponsor Fee \2\................................       87,700
------------------------------------------------------------------------
\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.

VIII. Procedures for Paying the FY 2013 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, 2012. 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

[[Page 45629]]

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 
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 314-418-4013. 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 VIII.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, 2012, FDA will issue invoices and payment 
instructions for product, establishment, and sponsor fees for FY 2013 
using this Fee Schedule. Payment will be due and payable within 30 days 
of issuance of the invoice. FDA will issue invoices in November 2013 
for any products, establishments, and sponsors subject to fees for FY 
2013 that qualify for fees after the December 2012 billing.

    Dated: July 26, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-18709 Filed 7-31-12; 8:45 am]
BILLING CODE 4160-01-P