Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2013, 45624-45629 [2012-18709]
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Federal Register / Vol. 77, No. 148 / Wednesday, August 1, 2012 / Notices
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.
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 https://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.
SUMMARY:
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 5year Avg.
(base years)
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Application type
New Animal Drug Applications (NADAs) .................................................
Supplemental NADAs With Safety or Efficacy Data ...............................
Manufacturing Supplements ....................................................................
Investigational Study Submissions ..........................................................
Investigational Protocol Submissions ......................................................
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Column 2
latest 5-year
avg.
28.8
23.4
366.6
336.6
292.4
11.4
11.4
394.2
224.0
148.6
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Column 3
percent
change
¥60
¥51
8
¥33
¥49
01AUN1
Column 4
weighting
factor
0.0229
0.0275
0.1222
0.6435
0.1838
Column 5
weighted
percent
change
¥1
¥1
1
¥22
¥9
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TABLE 1—WORKLOAD ADJUSTER CALCULATION (NUMBERS MAY NOT ADD DUE TO ROUNDING)—Continued
Column 1 5year Avg.
(base years)
Application type
FY 2013 Workload Adjuster .............................................................
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.
Column 2
latest 5-year
avg.
Column 3
percent
change
Column 4
weighting
factor
....................
....................
....................
....................
Column 5
weighted
percent
change
¥32
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.
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–
TABLE 2—OFFSETS REMAINING TO BE TAKEN FOR ADUFA I, FY 2004–2008
Fees
appropriated
Fiscal year
2004
2005
2006
2007
2008
Fees collected
as of
3/31/2012
Excess
collections
offset when
fees were set
Remaining
excess
collections to
be
offset
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
$5,000,000
8,354,000
11,318,000
11,604,000
13,696,000
$5,154,700
8,519,101
10,901,466
13,342,455
11,577,312
........................
........................
........................
........................
320,000
$154,700
165,101
0
1,738,455
0
Totals ........................................................................................................
Net Excess Appropriations, to be Offset Against 2013 Collections .........
........................
........................
........................
........................
........................
........................
1 2,058,256
1 See
394,256
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]
Fees
appropriated
tkelley on DSK3SPTVN1PROD with NOTICES
Fiscal year
2009
2010
2011
2012
Fees collected
Excess
collections
offset when
fees were set
Difference
.................................................................................................................
.................................................................................................................
.................................................................................................................
estimated ................................................................................................
$15,260,000
17,280,000
19,448,000
21,768,000
$12,893,721
16,609,805
18,342,199
21,768,000
$1,344,000
........................
........................
........................
($2,366,279)
(670,195)
(1,105,801)
0
Cumulative Difference Less Than Appropriations ....................................
........................
........................
........................
(4,142,275)
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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.
tkelley on DSK3SPTVN1PROD with NOTICES
TABLE 4—ESTIMATED CARRYOVER
BALANCE AT THE END OF FY 2013,
AFTER ADJUSTMENTS
Total Carryover Balance
End of FY 2011 ...............
Net Prior Year Fees Collected After 9/30/2011 (3/
31/2012) ..........................
Used for Offset in 2013 ......
Reserve for Refunds in
2012 and 2013 ................
Estimated Change to Carryover Balance at the End
of FY 2012 ......................
Estimated Change to Carryover Balance at the End
of FY 2013 ......................
Estimated 2013 End of FY
Carryover Balance ..........
$4,664,000
445,000
(394,000)
(1,400,000)
636,000
(257,000)
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.
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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
$19,652,000 amount, as derived in table 6 of this
document.
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 .......
Estimated FY 2014 Inflation
Costs at 2.01% .................
Estimated FY 2014 Funds to
Sustain FY 2013 Operations .................................
Estimated Fees Needed for
3 Months in FY 2014 ........
Estimated End-of-FY 2013
Carryover Balance ............
Additional Revenue Needed
for 3 Months in FY 2013 ...
395,000
20,047,000
5,012,000
3,694,000
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
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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 .......
Estimated FY 2014 Inflation
Costs at 2.01% .................
Estimated FY 2014 Funds to
Sustain FY 2013 Operations .................................
Estimated Fees Needed for
2 Months in FY 2014 ........
Estimated End-of-FY 2013
Carryover Balance ............
Additional Revenue Needed
for 2 Months in FY 2013 ...
$19,652,000
395,000
20,047,000
3,341,000
3,694,000
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,
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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
fees
Fee components
Establishment
fees
Product fees
Sponsor fees
Total
Amount in ADUFA II ............................................................
Reduction for Offset .............................................................
Final Year Adjustment .........................................................
$6,061,000
(98,564)
0
$6,061,000
(98,564)
0
$6,061,000
(98,564)
0
$6,061,000
(98,564)
0
$24,244,000
(394,256)
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)).
tkelley on DSK3SPTVN1PROD with NOTICES
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
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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
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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.
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V. Establishment Fee Calculations for
FY 2013
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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.
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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.
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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
Animal drug user fee category
Animal Drug Application Fees:
Animal Drug Application ...........
Supplemental Animal Drug
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 FD&C
Act ..................................
Animal Drug Product Fee .........
Animal Drug Establishment
Fee 1 ......................................
Animal Drug Sponsor Fee 2 ......
Fee rate for
FY 2013
$435,200
217,600
8,640
104,600
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
E:\FR\FM\01AUN1.SGM
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Federal Register / Vol. 77, No. 148 / Wednesday, August 1, 2012 / Notices
tkelley on DSK3SPTVN1PROD with NOTICES
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 https://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
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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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0807]
Animal Generic Drug User Fee Rates
and Payment Procedures for Fiscal
Year 2013
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
rates and payment procedures for fiscal
year (FY) 2013 generic new animal drug
user fees. The Federal Food, Drug, and
Cosmetic Act (the FD&C Act), as
amended by the Animal Generic Drug
User Fee Act of 2008 (AGDUFA),
authorizes FDA to collect user fees for
certain abbreviated applications for
generic new animal drugs, for certain
SUMMARY:
PO 00000
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45629
generic new animal drug products, and
for certain sponsors of such abbreviated
applications for generic new animal
drugs and/or investigational
submissions for generic new animal
drugs. This notice establishes the fee
rates for FY 2013.
FOR FURTHER INFORMATION CONTACT: Visit
the FDA Web site at https://www.fda.gov/
ForIndustry/UserFees/AnimalGeneric
DrugUserFeeActAGDUFA/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:
cvmagdufa@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Section 741 of the FD&C Act
(21 U.S.C. 379j–21) establishes three
different types of user fees: (1) Fees for
certain types of abbreviated applications
for generic new animal drugs, (2) annual
fees for certain generic new animal drug
products, and (3) annual fees for certain
sponsors of abbreviated applications for
generic new animal drugs and/or
investigational submissions for generic
new animal drugs (21 U.S.C. 379j–
21(a)). When certain conditions are met,
FDA will waive or reduce fees for
generic new animal drugs intended
solely to provide for a minor use or
minor species indication (21 U.S.C.
379j–21(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 may
be adjusted for workload. Fees for
applications, 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 generic new animal
drug user fee rates are: $148,300 for
each abbreviated application for a
generic new animal drug; $6,515 for
each generic new animal drug product;
$63,000 for each generic new animal
drug sponsor paying 100 percent of the
sponsor fee; $47,250 for each generic
new animal drug sponsor paying 75
percent of the sponsor fee; and $31,500
for each generic new animal drug
sponsor paying 50 percent of the
sponsor fee. FDA will issue invoices for
FY 2013 product and sponsor fees by
December 31, 2012. These fees will be
due and payable within 30 days of the
issuance of the invoices. The
E:\FR\FM\01AUN1.SGM
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]]>Agencies
[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]]
-----------------------------------------------------------------------
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 https://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 https://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
