Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2015, 44787-44792 [2014-18110]
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Federal Register / Vol. 79, No. 148 / Friday, August 1, 2014 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
21 CFR 189.5(c) and 700.27(c)
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average burden per recordkeeper
Total hours
Domestic facilities .............................
Foreign facilities ................................
697
916
52
52
36,244
47,632
0.25 (15 minutes) .............................
0.25 (15 minutes) .............................
9,061
11,908
Total ...........................................
........................
........................
........................
...........................................................
20,969
1 There
are no capital or operating and maintenance costs associated with this collection of information.
Except where otherwise noted, this
estimate is based on FDA’s estimate of
the number of facilities affected by the
final rule entitled, ‘‘Recordkeeping
Requirements for Human Food and
Cosmetics Manufactured From,
Processed With, or Otherwise
Containing Material From Cattle,’’
published in the Federal Register of
October 11, 2006 (71 FR 59653).
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Reporting
FDA’s regulations in §§ 189.5(c)(6)
and 700.27(c)(6) impose a reporting
burden on importers of human food and
cosmetics manufactured from,
processed with, or otherwise containing
cattle material. Importers of these
products must affirm that the human
food or cosmetics are not manufactured
from, processed with, or otherwise
contain prohibited cattle materials and
must affirm that the human food or
cosmetics were manufactured in
accordance with the applicable
requirements of §§ 189.5 or 700.27. The
affirmation is made by the importer of
record to the FDA through FDA’s
Operational and Administrative System
for Import Support. Affirmation by
importers is expected to take
approximately 2 minutes per entry line.
Table 2 shows 54,825 lines of human
food and cosmetics likely to contain
cattle materials are imported annually.
The reporting burden of affirming
whether import entry lines contain
cattle-derived materials is estimated to
take 1,809 hours annually (54,825 lines
multiplied by 2 minutes per line).
FDA’s estimate of the reporting
burden for designation under §§ 189.5
and 700.27 is based on its experience
and the average number of requests for
designation received in the past 3 years.
In the last 3 years, FDA has not received
any requests for designation. Thus, FDA
estimates that one or fewer will be
received annually in the future. Based
on this experience, FDA estimates the
annual number of new requests for
designation will be one. FDA estimates
that preparing the information required
by §§ 189.5 and 700.27 and submitting
it to FDA in the form of a written
request to the CFSAN Director will
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require a burden of approximately 80
hours per request. Thus, the burden for
new requests for designation is
estimated to be 80 hours annually, as
shown in Table 1, row 1.
Under §§ 189.5(e) and 700.27(e),
designated countries are subject to
future review by FDA and may respond
to periodic FDA requests by submitting
information to confirm their
designations remain appropriate. In the
last 3 years, FDA has not requested any
reviews. Thus, FDA estimates that one
or fewer will occur annually in the
future. FDA estimates that the
designated country undergoing a review
in the future will need one-third of the
time it took preparing its request for
designation to respond to FDA’s request
for review, or 26 hours (80 hours × 0.33
= 26.4 hours, rounded to 26). The
annual burden for reviews is estimated
to be 26 hours, as shown in Table 1, row
2. The total reporting burden for this
information collection is estimated to be
1,915 hours annually.
Recordkeeping
FDA estimates that there are 697
domestic facility relationships and 916
foreign facility relationships consisting
of the following facilities: An input
supplier of cattle-derived materials that
requires records (the upstream facility)
and a purchaser of cattle-derived
materials requiring documentation (this
may be a human food or cosmetics
manufacturer or processor). The
recordkeeping burden of FDA’s
regulations in §§ 189.5(c) and 700.27(c)
is the burden of sending, verifying, and
storing documents regarding shipments
of cattle material that is to be used in
human food and cosmetics.
In this estimate of the recordkeeping
burden, FDA treats these recordkeeping
activities as shared activities between
the upstream and downstream facilities.
It is in the best interests of both facilities
in the relationship to share the burden
necessary to comply with the
regulations; therefore, FDA estimates
the time burden of developing these
records as a joint task between the two
facilities. Thus, FDA estimates that this
recordkeeping burden will be about 15
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minutes per week, or 13 hours per year,
and FDA assumes that the
recordkeeping burden will be shared
between 2 entities (i.e., the ingredient
supplier and the manufacturer of
finished products). Therefore, the total
recordkeeping burden for domestic
facilities is estimated to be 9,061 hours
(13 hours multiplied by 697), and the
total recordkeeping burden for foreign
facilities is estimated to be 11,908 hours
(13 hours multiplied by 916), as shown
in Table 1.
Dated: July 28, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–18109 Filed 7–31–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0007]
Animal Drug User Fee Rates and
Payment Procedures for Fiscal Year
2015
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) 2015 animal drug user fees.
The Federal Food, Drug, and Cosmetic
Act (the FD&C Act), as amended by the
Animal Drug User Fee Amendments of
2013 (ADUFA III), 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 document establishes
the fee rates for FY 2015.
FOR FURTHER INFORMATION CONTACT: Visit
FDA’s Web site at https://www.fda.gov/
ForIndustry/UserFees/
AnimalDrugUserFeeActADUFA/
default.htm or contact Lisa Kable,
SUMMARY:
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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 2014 through FY 2018, the
FD&C Act establishes aggregate yearly
base revenue amounts for each fiscal
year (21 U.S.C. 379j–12(b)(1)). Base
revenue amounts established for years
after FY 2014 are subject to adjustment
for inflation and workload (21 U.S.C.
379j–12(c)). Fees for applications,
establishments, products, and sponsors
are to be established each year by FDA
so that the percentages of the total
revenue that is derived from each type
of user fee will be as follows: Revenue
from application fees shall be 20 percent
of total fee revenue; revenue from
product fees shall be 27 percent of total
fee revenue; revenue from establishment
fees shall be 26 percent of total fee
revenue; and revenue from sponsor fees
shall be 27 percent of total fee revenue
(21 U.S.C. 379j–12(b)(2)).
For FY 2015, the animal drug user fee
rates are: $400,600 for an animal drug
application; $200,300 for a
supplemental animal drug application
for which safety or effectiveness data are
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)); $8,075 for an
annual product fee; $104,150 for an
annual establishment fee; and $94,450
for an annual sponsor fee. FDA will
issue invoices for FY 2015 product,
establishment, and sponsor fees by
December 31, 2014, and payment will
be due by January 31, 2015. The
application fee rates are effective for
applications submitted on or after
October 1, 2014, and will remain in
effect through September 30, 2015.
Applications will not be accepted for
review until FDA has received full
payment of application fees and any
other animal drug user fees owed under
ADUFA.
II. Revenue Amount for FY 2015
A. Statutory Fee Revenue Amounts
ADUFA III (Title I of Pub. L. 113–14)
specifies that the aggregate fee revenue
amount for FY 2015 for all animal drug
user fee categories is $21,600,000. (21
U.S.C. 379j–12(b)(1)(B).)
B. Inflation Adjustment to Fee Revenue
Amount
The fee revenue amount established
in ADUFA III for FY 2015 and
subsequent years are subject to an
inflation adjustment (21 U.S.C. 379j–
12(c)(2)).
The component of the inflation
adjustment for payroll costs shall be 1
plus the average annual percent change
in the cost of all personnel
compensation and benefits (PC&B) paid
per full-time equivalent position (FTE)
at FDA for the first three of the four
preceding fiscal years, multiplied by the
proportion of PC&B costs to total FDA
costs for the first three of the preceding
four fiscal years (see 21 U.S.C. 379j–
12(c)(2)(B)). The data on total PC&B
paid and numbers of FTE paid, from
which the average cost per FTE can be
derived, are published in FDA’s
Justification of Estimates for
Appropriations Committees.
Table 1 summarizes that actual cost
and FTE data for the specified fiscal
years, and provides the percent change
from the previous fiscal year and the
average percent change over the first
three of the four fiscal years preceding
FY 2015. The 3-year average is 1.8829
percent.
TABLE 1—FDA PERSONNEL COMPENSATION AND BENEFITS (PC&B) EACH YEAR AND PERCENT CHANGE
Fiscal year
2011
Total PC&B ..............................................................................
Total FTE .................................................................................
PC&B per FTE .........................................................................
Percent Change from Previous Year ......................................
The statute specifies that this 1.8829
percent should be multiplied by the
$1,761,655,000
13,331
$132,147
1.2954%
2012
2013
$1,824,703,000
13,382
$136,355
3.1843%
proportion of PC&B costs to total FDA
costs. Table 2 shows the amount of
3-Year average
(percent)
$1,927,703,000
13,974
$137,949
1.169%
1.8829
PC&B and the total amount obligated by
FDA for the same three fiscal years.
TABLE 2—PERSONNEL COMPENSATION AND BENEFITS (PC&B) AS A PERCENT OF TOTAL COSTS AT FDA
Fiscal year
2011
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Total PC&B ......................................................................
Total Costs .......................................................................
PC&B Percent ..................................................................
The payroll adjustment is 1.8829
percent multiplied by 50.2257 percent
(or .9457 percent).
The statute specifies that the portion
of the inflation adjustment for nonpayroll costs for FY 2015 is the average
annual percent change that occurred in
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2012
$1,761,655,000
$3,333,407,000
52.8485%
$1,824,703,000
$3,550,496,000
51.3929%
the Consumer Price Index (CPI) for
urban consumers (WashingtonBaltimore, DC-MD-VA-WV; not
seasonally adjusted; all items less food
and energy; annual index) for the first
3 of the preceding 4 years of available
data multiplied by the proportion of all
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2013
$1,927,703,000
$4,151,343,000
46.4356%
3-Year average
50.2257%
costs other than PC&B costs to total FDA
costs (see 21 U.S.C. 379j–12(c)(2)(C)).
Table 3 provides the summary data for
the percent change in the specified CPI
for the Baltimore-Washington area. The
data from the Bureau of Labor Statistics
is shown in Table 3.
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TABLE 3—ANNUAL AND 3-YEAR AVERAGE PERCENT CHANGE IN BALTIMORE-WASHINGTON AREA CPI LESS FOOD AND
ENERGY
Year
2011
Annual CPI .......................................................................
Annual Percent Change ..................................................
To calculate the inflation adjustment
for non-pay costs, we multiply the
2.1586 percent by the proportion of all
costs other than PC&B to total FDA
costs. Since 50.2257 percent was
obligated for PC&B as shown in Table 2,
49.7743 percent is the portion of costs
other than PC&B (100%¥50.2257& =
49.7743 percent). The non-payroll
adjustment is 2.1586 percent times
49.7743 percent, or 1.0744 percent.
To complete the inflation adjustment,
we add the payroll component (0.9457
percent) to the non-pay component
(1.0744 percent), for a total inflation
adjustment of 2.0201 percent, and then
add one, making 1.020201. We then
multiply the base revenue amount for
FY 2015 ($21,600,000) by 1.020201,
yielding an inflation adjusted amount of
$22,036,000 (rounded to the nearest
thousand dollars).
2012
140.963
2.2694%
2013
144.413
2.4475%
C. Workload Adjustment to Inflation
Adjusted Fee Revenue Amount
A workload adjustment will be
calculated to the inflation adjusted fee
revenue amount established in ADUFA
III for FY 2015 and subsequent fiscal
years (21 U.S.C. 379j–12(c)(3)).
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,
2013 (the base years), and the average
number of each of these types of
applications and submissions over the
3-Year average
146.953
1.7588%
2.1586%
most recent 5-year period that ended
June 30, 2014.
The results of these calculations are
presented in the first two columns of
Table 4. 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 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
¥0.47 percent for FY 2015. This is the
workload adjuster for FY 2015.
TABLE 4—WORKLOAD ADJUSTER CALCULATION
[Numbers may not add due to rounding]
Column 2
latest 5-year
avg.
New Animal Drug Applications (NADAs) ...............................................
Supplemental NADAs with Safety or Efficacy Data ..............................
Manufacturing Supplements ..................................................................
Investigational Study Submissions ........................................................
Investigational Protocol Submissions ....................................................
9.80
9.6
361.0
216.4
133.6
13.2
11.4
349.6
211.6
133.4
35
19
¥3
¥2
0
0.0214
0.0349
0.1385
0.6334
0.1718
0.74
0.65
¥0.44
¥1.41
¥0.03
FY 2015 Workload Adjuster ...................................................................
......................
....................
....................
....................
¥0.47
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ADUFA specifies that the workload
adjuster may not result in fees that are
less than the fee revenue amount in the
statute (21 U.S.C. 379j–12(c)(3)(C)).
Because applying the FY 2015 workload
adjuster would result in fees less than
the statutory amount, the workload
adjustment will not be applied in FY
2015. As a result, the statutory revenue
target amount for fees in FY 2015
remains at the inflation adjusted fee
revenue amount of $22,036,000.
from application fees; 27 percent, or a
total of $5,950,000 (rounded to the
nearest thousand dollars), is to come
from product fees; 26 percent, or a total
of $5,729,000 (rounded to the nearest
thousand dollars), is to come from
establishment fees; and 27 percent, or a
total of $5,950,000 (rounded to the
nearest thousand dollars), is to come
from sponsor fees (21 U.S.C. 379j–
12(b)).
D. FY 2015 Fee Revenue Amounts
III. Application Fee Calculations for FY
2015
ADUFA III specifies that the revenue
amount of $22,036,000 for FY 2015 is to
be divided as follows: 20 percent, or a
total of $4,407,000 (rounded to the
nearest thousand dollars), is to come
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)).
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Column 3
percent
change
Column 4
weighting
factor
Column 5
weighted
percent
change
Column 1
5-year avg.
(base years)
Application type
A. Application Fee Revenues and
Numbers of Fee-Paying Applications
The application fee must be paid for
any animal drug application or
supplemental animal drug application
that is subject to fees under ADUFA and
that is submitted on or after September
1, 2003. The application fees are to be
set so that they will generate $4,407,000
in fee revenue for FY 2015. This is the
amount derived in section II.D. 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 (21
U.S.C. 379j–12(a)(1)(A)(ii)).
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To set animal drug application fees
and supplemental animal drug
application fees to realize $4,407,000
FDA must first make some assumptions
about the number of fee-paying
applications and supplements the
Agency will receive in FY 2015.
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 2015, FDA is assuming that
the number of applications that will pay
fees in FY 2015 will equal the average
number of submissions over the five
most recent completed years (FY 2009–
FY 2013). 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 10 years of experience
with this program.
Over the five most recent completed
years, the average number of animal
drug applications that would have been
subject to the full fee was 6.2. 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 9.6.
B. Fee Rates for FY 2015
FDA must set the fee rates for FY 2015
so that the estimated 6.2 applications
that pay the full fee and the estimated
9.6 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 $4,407,000. To
generate this amount, the fee for an
animal drug application, rounded to the
nearest $100, will have to be $400,600,
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 $200,300.
IV. Product Fee Calculations for FY
2015
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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
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drug application pending at FDA after
September 1, 2003. (See 21 U.S.C. 379j–
12(a)(2).) The term ‘‘animal drug
product’’ means each specific strength
or potency of a particular active
ingredient or ingredients in final dosage
form marketed by a particular
manufacturer or distributor, which is
uniquely identified by the labeler code
and product code portions of the
national drug code, and for which an
animal drug application or a
supplemental animal drug application
has been approved (21 U.S.C. 379j–
11(3)). The product fees are to be set so
that they will generate $5,950,000 in fee
revenue for FY 2015. This is the amount
derived in section II.D.
To set animal drug product fees to
realize $5,950,000, FDA must make
some assumptions about the number of
products for which these fees will be
paid in FY 2015. 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 2014, FDA estimates that there are
a total of 768 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 768 products
will be subject to this fee in FY 2015.
In estimating the fee revenue to be
generated by animal drug product fees
in FY 2015, FDA is assuming that 4
percent of the products invoiced, or 31,
will not pay fees in FY 2015 due to fee
waivers and reductions. FDA has
reduced the estimate of the percentage
of products that will not pay fees from
6 percent to 4 percent this year, based
on historical data over the past 5 years.
Based on experience with other user fee
programs and the first 10 years of
ADUFA, FDA believes that this is a
reasonable basis for estimating the
number of fee-paying products in FY
2015.
Accordingly, the Agency estimates
that a total of 737 (768 minus 31)
products will be subject to product fees
in FY 2015.
B. Product Fee Rates for FY 2015
FDA must set the fee rates for FY 2015
so that the estimated 737 products that
pay fees will generate a total of
$5,950,000. To generate this amount
will require the fee for an animal drug
product, rounded to the nearest $5, to be
$8,075.
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V. Establishment Fee Calculations for
FY 2015
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 $5,729,000 in fee
revenue for FY 2015. This is the amount
derived in section II.D.
To set animal drug establishment fees
to realize $5,729,000, FDA must make
some assumptions about the number of
establishments for which these fees will
be paid in FY 2015. 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 2014, FDA estimates
that there are a total of 62
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 62 establishments will be
subject to this fee in FY 2015.
In estimating the fee revenue to be
generated by animal drug establishment
fees in FY 2015, FDA is assuming that
12 percent of the establishments
invoiced, or 7, will not pay fees in FY
2015 due to fee waivers and reductions.
FDA has kept this estimate at 12 percent
this year, based on historical data over
the past 5 years. Based on experience
with the first 10 years of ADUFA, FDA
believes that this is a reasonable basis
for estimating the number of fee-paying
establishments in FY 2015.
Accordingly, the Agency estimates
that a total of 55 establishments (62
minus 7) will be subject to
establishment fees in FY 2015.
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B. Establishment Fee Rates for FY 2015
FDA must set the fee rates for FY 2015
so that the estimated 55 establishments
that pay fees will generate a total of
$5,729,000. To generate this amount
will require the fee for an animal drug
establishment, rounded to the nearest
$50, to be $104,150.
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VI. Sponsor Fee Calculations for FY
2015
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 $5,950,000 in
fee revenue for FY 2015. This is the
amount derived in section II.D.
To set animal drug sponsor fees to
realize $5,950,000, FDA must make
some assumptions about the number of
sponsors who will pay these fees in FY
2015. Based on the number of firms that
would have met this definition in each
of the past 10 years, FDA estimates that
a total of 179 sponsors will meet this
definition in FY 2015.
Careful review indicates that 33
percent 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 32
percent will qualify for other waivers or
reductions, for a total of 65 percent of
the sponsors invoiced, or 116, who will
not pay fees in FY 2015 due to fee
waivers and reductions. FDA has kept
this estimate at 65 percent this year,
based on historical data over the past 5
years. FDA believes that this is a
reasonable basis for estimating the
number of fee-paying sponsors in FY
2015.
Accordingly, the Agency estimates
that a total of 63 sponsors (179 minus
116) will be subject to and pay sponsor
fees in FY 2015.
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B. Sponsor Fee Rates for FY 2015
FDA must set the fee rates for FY 2015
so that the estimated 63 sponsors that
pay fees will generate a total of
$5,950,000. To generate this amount
will require the fee for an animal drug
sponsor, rounded to the nearest $50, to
be $94,450.
44791
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, Beneficiary: FDA, 8455
Colesville Rd., Silver Spring, MD
VII. Fee Schedule for FY 2015
20993–0002. You are responsible for
any administrative costs associated with
The fee rates for FY 2015 are
the processing of a wire transfer.
summarized in Table 5.
Contact your bank or financial
institution about the fee and add it to
TABLE 5—FY 2015 FEE RATES
your payment to ensure that your fee is
Fee rate fully paid.
Animal drug user fee category
for FY
If you prefer to send a check by a
2015
courier, the courier may deliver the
check and printed copy of the cover
Animal Drug Application Fees:
sheet to: U.S. Bank, Attn: Government
Animal Drug Application ........ $400,600
Lockbox 979033, 1005 Convention
Supplemental Animal Drug
Plaza, St. Louis, MO 63101. (Note: This
Application for which Safeaddress is for courier delivery only. If
ty or Effectiveness Data
you have any questions concerning
are Required or Animal
Drug Application Subject to
courier delivery contact the U.S. Bank at
the Criteria Set Forth in
314–418–4013. This telephone number
Section 512(d)(4) of the
is only for questions about courier
FD&C Act ...........................
200,300 delivery.)
Animal Drug Product Fee .............
8,075
The tax identification number of FDA
Animal Drug Establishment Fee 1
104,150
is 53–0196965. (Note: In no case should
2 ..........
Animal Drug Sponsor Fee
94,450
the payment for the fee be submitted to
1 An animal drug establishment is subject to
FDA with the application.)
only one such fee each fiscal year.
It is helpful if the fee arrives at the
2 An animal drug sponsor is subject to only
bank at least a day or two before the
one such fee each fiscal year.
application arrives at FDA’s CVM. FDA
VIII. Procedures for Paying the FY 2015 records the official application receipt
Fees
date as the later of the following: The
date the application was received by
A. Application Fees and Payment
FDA’s CVM, or the date U.S. Bank
Instructions
notifies FDA that your payment in the
The appropriate application fee
full amount has been received, or when
established in the new fee schedule
the U.S. Treasury notifies FDA of
must be paid for an animal drug
receipt of an electronic or wire transfer
application or supplement subject to
payment. U.S. Bank and the U.S.
fees under ADUFA that is submitted on
Treasury are required to notify FDA
or after October 1, 2014. Payment must
within 1 working day, using the PIN
be made in U.S. currency by check,
described previously.
bank draft, or U.S. postal money order
B. Application Cover Sheet Procedures
payable to the order of the Food and
Drug Administration, by wire transfer,
Step One—Create a user account and
or electronically using https://
password. Log on to the ADUFA Web
www.pay.gov. (The Pay.gov payment
site at https://www.fda.gov/ForIndustry/
option is available to you after you
UserFees/
submit a cover sheet. Click the ‘‘Pay
AnimalDrugUserFeeActADUFA/
Now’’ button.) On your check, bank
default.htm and, under Tools and
draft, or U.S. postal money order, please Resources, click ‘‘The Animal Drug User
write your application’s unique
Fee Cover Sheet’’ and then click ‘‘Create
Payment Identification Number (PIN),
ADUFA User Fee Cover Sheet.’’ For
beginning with the letters ‘‘AD’’, from
security reasons, each firm submitting
the upper right-hand corner of your
an application will be assigned an
completed Animal Drug User Fee Cover organization identification number, and
Sheet. Also write the FDA post office
each user will also be required to set up
box number (P.O. Box 979033) on the
a user account and password the first
enclosed check, bank draft, or money
time you use this site. Online
order. Your payment and a copy of the
instructions will walk you through this
completed Animal Drug User Fee Cover process.
Sheet can be mailed to: Food and Drug
Step Two—Create an Animal Drug
Administration, P.O. Box 979033, St.
User Cover Sheet, transmit it to FDA,
Louis, MO 63197–9000.
and print a copy. After logging into your
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E:\FR\FM\01AUN1.SGM
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Federal Register / Vol. 79, No. 148 / Friday, August 1, 2014 / Notices
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.
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, 2014, FDA will issue
invoices and payment instructions for
product, establishment, and sponsor
fees for FY 2015 using this fee schedule.
Payment will be due by January 31,
2015. FDA will issue invoices in
November 2015 for any products,
establishments, and sponsors subject to
fees for FY 2015 that qualify for fees
after the December 2014 billing.
Dated: July 28, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–18110 Filed 7–31–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0007]
Animal Generic Drug User Fee Rates
and Payment Procedures for Fiscal
Year 2015
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
fee rates and payment procedures for
fiscal year (FY) 2015 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 Amendments of
2013 (AGDUFA II), authorizes FDA to
collect user fees for certain abbreviated
applications for generic new animal
drugs, for certain generic new animal
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
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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 2015.
FOR FURTHER INFORMATION CONTACT: Visit
FDA’s 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 2014 through FY 2018, the
FD&C Act establishes aggregate yearly
base revenue amounts for each of these
fee categories. Base revenue amounts
established for fiscal years after FY 2014
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 2015, the generic new animal
drug user fee rates are: $189,200 for
each abbreviated application for a
generic new animal drug other than
those subject to the criteria in section
512(d)(4) of the FD&C Act (21 U.S.C.
360b(d)(4)); $94,600 for each
abbreviated application for a generic
new animal drug subject to the criteria
in section 512(d)(4); $8,500 for each
generic new animal drug product;
$80,900 for each generic new animal
drug sponsor paying 100 percent of the
sponsor fee; $60,675 for each generic
new animal drug sponsor paying 75
percent of the sponsor fee; and $40,450
for each generic new animal drug
sponsor paying 50 percent of the
PO 00000
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sponsor fee. FDA will issue invoices for
FY 2015 product and sponsor fees by
December 31, 2014. These fees will be
due by January 31, 2015. The
application fee rates are effective for all
abbreviated applications for a generic
new animal drug submitted on or after
October 1, 2014, and will remain in
effect through September 30, 2015.
Applications will not be accepted for
review until FDA has received full
payment of related application fees and
any other fees owed under the Animal
Generic Drug User Fee program.
II. Revenue Amount for FY 2015
A. Statutory Fee Revenue Amounts
AGDUFA II, Title II of Public Law
113–14, specifies that the aggregate
revenue amount for FY 2015 for
abbreviated application fees is
$1,736,000 and each of the other two
generic new animal drug user fee
categories, annual product fees and
annual sponsor fees, is $2,604,000 each
(see 21 U.S.C. 379j–21(b)).
B. Inflation Adjustment to Fee Revenue
Amount
The amounts established in AGDUFA
II for each year for FY 2014 through FY
2018 include an inflation adjustment;
therefore, no further inflation
adjustment is required.
C. Workload Adjustment Fee Revenue
Amount
For each FY beginning after FY 2014,
AGDUFA provides that statutory fee
revenue amounts shall be further
adjusted to reflect changes in review
workload. (See 21 U.S.C. 379j–21(c)(2).)
FDA calculated the average number of
each of the four types of applications
and submissions specified in the
workload adjustment provision
(abbreviated applications for generic
new animal drugs, manufacturing
supplemental abbreviated applications
for generic new animal drugs,
investigational generic new animal drug
study submissions, and investigational
generic new animal drug protocol
submissions) received over the 5-year
period that ended on September 30,
2013 (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 on
June 30, 2014.
The results of these calculations are
presented in the first two columns in
Table 1. 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
generic new animal drug review
E:\FR\FM\01AUN1.SGM
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]]>Agencies
[Federal Register Volume 79, Number 148 (Friday, August 1, 2014)]
[Notices]
[Pages 44787-44792]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-18110]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0007]
Animal Drug User Fee Rates and Payment Procedures for Fiscal Year
2015
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) 2015 animal drug user fees.
The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by
the Animal Drug User Fee Amendments of 2013 (ADUFA III), 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 document establishes the fee rates for FY 2015.
FOR FURTHER INFORMATION CONTACT: Visit FDA's Web site at https://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/default.htm
or contact Lisa Kable,
[[Page 44788]]
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 2014 through FY 2018, the FD&C Act establishes aggregate
yearly base revenue amounts for each fiscal year (21 U.S.C. 379j-
12(b)(1)). Base revenue amounts established for years after FY 2014 are
subject to adjustment for inflation and workload (21 U.S.C. 379j-
12(c)). Fees for applications, establishments, products, and sponsors
are to be established each year by FDA so that the percentages of the
total revenue that is derived from each type of user fee will be as
follows: Revenue from application fees shall be 20 percent of total fee
revenue; revenue from product fees shall be 27 percent of total fee
revenue; revenue from establishment fees shall be 26 percent of total
fee revenue; and revenue from sponsor fees shall be 27 percent of total
fee revenue (21 U.S.C. 379j-12(b)(2)).
For FY 2015, the animal drug user fee rates are: $400,600 for an
animal drug application; $200,300 for a supplemental animal drug
application for which safety or effectiveness data are 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)); $8,075 for an annual
product fee; $104,150 for an annual establishment fee; and $94,450 for
an annual sponsor fee. FDA will issue invoices for FY 2015 product,
establishment, and sponsor fees by December 31, 2014, and payment will
be due by January 31, 2015. The application fee rates are effective for
applications submitted on or after October 1, 2014, and will remain in
effect through September 30, 2015. Applications will not be accepted
for review until FDA has received full payment of application fees and
any other animal drug user fees owed under ADUFA.
II. Revenue Amount for FY 2015
A. Statutory Fee Revenue Amounts
ADUFA III (Title I of Pub. L. 113-14) specifies that the aggregate
fee revenue amount for FY 2015 for all animal drug user fee categories
is $21,600,000. (21 U.S.C. 379j-12(b)(1)(B).)
B. Inflation Adjustment to Fee Revenue Amount
The fee revenue amount established in ADUFA III for FY 2015 and
subsequent years are subject to an inflation adjustment (21 U.S.C.
379j-12(c)(2)).
The component of the inflation adjustment for payroll costs shall
be 1 plus the average annual percent change in the cost of all
personnel compensation and benefits (PC&B) paid per full-time
equivalent position (FTE) at FDA for the first three of the four
preceding fiscal years, multiplied by the proportion of PC&B costs to
total FDA costs for the first three of the preceding four fiscal years
(see 21 U.S.C. 379j-12(c)(2)(B)). The data on total PC&B paid and
numbers of FTE paid, from which the average cost per FTE can be
derived, are published in FDA's Justification of Estimates for
Appropriations Committees.
Table 1 summarizes that actual cost and FTE data for the specified
fiscal years, and provides the percent change from the previous fiscal
year and the average percent change over the first three of the four
fiscal years preceding FY 2015. The 3-year average is 1.8829 percent.
Table 1--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Change
----------------------------------------------------------------------------------------------------------------
3-Year average
Fiscal year 2011 2012 2013 (percent)
----------------------------------------------------------------------------------------------------------------
Total PC&B.......................... $1,761,655,000 $1,824,703,000 $1,927,703,000
Total FTE........................... 13,331 13,382 13,974
PC&B per FTE........................ $132,147 $136,355 $137,949
Percent Change from Previous Year... 1.2954% 3.1843% 1.169% 1.8829
----------------------------------------------------------------------------------------------------------------
The statute specifies that this 1.8829 percent should be multiplied
by the proportion of PC&B costs to total FDA costs. Table 2 shows the
amount of PC&B and the total amount obligated by FDA for the same three
fiscal years.
Table 2--Personnel Compensation and Benefits (PC&B) as a Percent of Total Costs at FDA
----------------------------------------------------------------------------------------------------------------
Fiscal year 2011 2012 2013 3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B...................... $1,761,655,000 $1,824,703,000 $1,927,703,000
Total Costs..................... $3,333,407,000 $3,550,496,000 $4,151,343,000
PC&B Percent.................... 52.8485% 51.3929% 46.4356% 50.2257%
----------------------------------------------------------------------------------------------------------------
The payroll adjustment is 1.8829 percent multiplied by 50.2257
percent (or .9457 percent).
The statute specifies that the portion of the inflation adjustment
for non-payroll costs for FY 2015 is the average annual percent change
that occurred in the Consumer Price Index (CPI) for urban consumers
(Washington-Baltimore, DC-MD-VA-WV; not seasonally adjusted; all items
less food and energy; annual index) for the first 3 of the preceding 4
years of available data multiplied by the proportion of all costs other
than PC&B costs to total FDA costs (see 21 U.S.C. 379j-12(c)(2)(C)).
Table 3 provides the summary data for the percent change in the
specified CPI for the Baltimore-Washington area. The data from the
Bureau of Labor Statistics is shown in Table 3.
[[Page 44789]]
Table 3--Annual and 3-Year Average Percent Change in Baltimore-Washington Area CPI Less Food and Energy
----------------------------------------------------------------------------------------------------------------
Year 2011 2012 2013 3-Year average
----------------------------------------------------------------------------------------------------------------
Annual CPI...................... 140.963 144.413 146.953
Annual Percent Change........... 2.2694% 2.4475% 1.7588% 2.1586%
----------------------------------------------------------------------------------------------------------------
To calculate the inflation adjustment for non-pay costs, we
multiply the 2.1586 percent by the proportion of all costs other than
PC&B to total FDA costs. Since 50.2257 percent was obligated for PC&B
as shown in Table 2, 49.7743 percent is the portion of costs other than
PC&B (100%-50.2257& = 49.7743 percent). The non-payroll adjustment is
2.1586 percent times 49.7743 percent, or 1.0744 percent.
To complete the inflation adjustment, we add the payroll component
(0.9457 percent) to the non-pay component (1.0744 percent), for a total
inflation adjustment of 2.0201 percent, and then add one, making
1.020201. We then multiply the base revenue amount for FY 2015
($21,600,000) by 1.020201, yielding an inflation adjusted amount of
$22,036,000 (rounded to the nearest thousand dollars).
C. Workload Adjustment to Inflation Adjusted Fee Revenue Amount
A workload adjustment will be calculated to the inflation adjusted
fee revenue amount established in ADUFA III for FY 2015 and subsequent
fiscal years (21 U.S.C. 379j-12(c)(3)).
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, 2013 (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, 2014.
The results of these calculations are presented in the first two
columns of Table 4. 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 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 -0.47 percent for FY 2015. This is the
workload adjuster for FY 2015.
Table 4--Workload Adjuster Calculation
[Numbers may not add due to rounding]
----------------------------------------------------------------------------------------------------------------
Column 5
Column 1 5- Column 2 Column 3 Column 4 weighted
Application type year avg. latest 5- percent weighting percent
(base years) year avg. change factor change
----------------------------------------------------------------------------------------------------------------
New Animal Drug Applications (NADAs).......... 9.80 13.2 35 0.0214 0.74
Supplemental NADAs with Safety or Efficacy 9.6 11.4 19 0.0349 0.65
Data.........................................
Manufacturing Supplements..................... 361.0 349.6 -3 0.1385 -0.44
Investigational Study Submissions............. 216.4 211.6 -2 0.6334 -1.41
Investigational Protocol Submissions.......... 133.6 133.4 0 0.1718 -0.03
-----------------------------------------------------------------
FY 2015 Workload Adjuster..................... ............ ........... ........... ........... -0.47
----------------------------------------------------------------------------------------------------------------
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)(3)(C)). Because applying the FY 2015 workload adjuster would
result in fees less than the statutory amount, the workload adjustment
will not be applied in FY 2015. As a result, the statutory revenue
target amount for fees in FY 2015 remains at the inflation adjusted fee
revenue amount of $22,036,000.
D. FY 2015 Fee Revenue Amounts
ADUFA III specifies that the revenue amount of $22,036,000 for FY
2015 is to be divided as follows: 20 percent, or a total of $4,407,000
(rounded to the nearest thousand dollars), is to come from application
fees; 27 percent, or a total of $5,950,000 (rounded to the nearest
thousand dollars), is to come from product fees; 26 percent, or a total
of $5,729,000 (rounded to the nearest thousand dollars), is to come
from establishment fees; and 27 percent, or a total of $5,950,000
(rounded to the nearest thousand dollars), is to come from sponsor fees
(21 U.S.C. 379j-12(b)).
III. Application Fee Calculations for FY 2015
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 $4,407,000 in
fee revenue for FY 2015. This is the amount derived in section II.D.
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 (21 U.S.C.
379j-12(a)(1)(A)(ii)).
[[Page 44790]]
To set animal drug application fees and supplemental animal drug
application fees to realize $4,407,000 FDA must first make some
assumptions about the number of fee-paying applications and supplements
the Agency will receive in FY 2015.
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 2015, FDA is assuming that the number of
applications that will pay fees in FY 2015 will equal the average
number of submissions over the five most recent completed years (FY
2009-FY 2013). 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 10 years of experience with
this program.
Over the five most recent completed years, the average number of
animal drug applications that would have been subject to the full fee
was 6.2. 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 9.6.
B. Fee Rates for FY 2015
FDA must set the fee rates for FY 2015 so that the estimated 6.2
applications that pay the full fee and the estimated 9.6 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 $4,407,000. To generate this amount, the fee for an
animal drug application, rounded to the nearest $100, will have to be
$400,600, 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 $200,300.
IV. Product Fee Calculations for FY 2015
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''
means each specific strength or potency of a particular active
ingredient or ingredients in final dosage form marketed by a particular
manufacturer or distributor, which is uniquely identified by the
labeler code and product code portions of the national drug code, and
for which an animal drug application or a supplemental animal drug
application has been approved (21 U.S.C. 379j-11(3)). The product fees
are to be set so that they will generate $5,950,000 in fee revenue for
FY 2015. This is the amount derived in section II.D.
To set animal drug product fees to realize $5,950,000, FDA must
make some assumptions about the number of products for which these fees
will be paid in FY 2015. 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
2014, FDA estimates that there are a total of 768 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 768 products will be
subject to this fee in FY 2015.
In estimating the fee revenue to be generated by animal drug
product fees in FY 2015, FDA is assuming that 4 percent of the products
invoiced, or 31, will not pay fees in FY 2015 due to fee waivers and
reductions. FDA has reduced the estimate of the percentage of products
that will not pay fees from 6 percent to 4 percent this year, based on
historical data over the past 5 years. Based on experience with other
user fee programs and the first 10 years of ADUFA, FDA believes that
this is a reasonable basis for estimating the number of fee-paying
products in FY 2015.
Accordingly, the Agency estimates that a total of 737 (768 minus
31) products will be subject to product fees in FY 2015.
B. Product Fee Rates for FY 2015
FDA must set the fee rates for FY 2015 so that the estimated 737
products that pay fees will generate a total of $5,950,000. To generate
this amount will require the fee for an animal drug product, rounded to
the nearest $5, to be $8,075.
V. Establishment Fee Calculations for FY 2015
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 $5,729,000 in fee revenue for FY 2015.
This is the amount derived in section II.D.
To set animal drug establishment fees to realize $5,729,000, FDA
must make some assumptions about the number of establishments for which
these fees will be paid in FY 2015. 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 2014, FDA estimates that there are a total of 62
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 62 establishments
will be subject to this fee in FY 2015.
In estimating the fee revenue to be generated by animal drug
establishment fees in FY 2015, FDA is assuming that 12 percent of the
establishments invoiced, or 7, will not pay fees in FY 2015 due to fee
waivers and reductions. FDA has kept this estimate at 12 percent this
year, based on historical data over the past 5 years. Based on
experience with the first 10 years of ADUFA, FDA believes that this is
a reasonable basis for estimating the number of fee-paying
establishments in FY 2015.
Accordingly, the Agency estimates that a total of 55 establishments
(62 minus 7) will be subject to establishment fees in FY 2015.
[[Page 44791]]
B. Establishment Fee Rates for FY 2015
FDA must set the fee rates for FY 2015 so that the estimated 55
establishments that pay fees will generate a total of $5,729,000. To
generate this amount will require the fee for an animal drug
establishment, rounded to the nearest $50, to be $104,150.
VI. Sponsor Fee Calculations for FY 2015
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 $5,950,000 in fee revenue for FY 2015. This is
the amount derived in section II.D.
To set animal drug sponsor fees to realize $5,950,000, FDA must
make some assumptions about the number of sponsors who will pay these
fees in FY 2015. Based on the number of firms that would have met this
definition in each of the past 10 years, FDA estimates that a total of
179 sponsors will meet this definition in FY 2015.
Careful review indicates that 33 percent 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 32
percent will qualify for other waivers or reductions, for a total of 65
percent of the sponsors invoiced, or 116, who will not pay fees in FY
2015 due to fee waivers and reductions. FDA has kept this estimate at
65 percent this year, based on historical data over the past 5 years.
FDA believes that this is a reasonable basis for estimating the number
of fee-paying sponsors in FY 2015.
Accordingly, the Agency estimates that a total of 63 sponsors (179
minus 116) will be subject to and pay sponsor fees in FY 2015.
B. Sponsor Fee Rates for FY 2015
FDA must set the fee rates for FY 2015 so that the estimated 63
sponsors that pay fees will generate a total of $5,950,000. To generate
this amount will require the fee for an animal drug sponsor, rounded to
the nearest $50, to be $94,450.
VII. Fee Schedule for FY 2015
The fee rates for FY 2015 are summarized in Table 5.
Table 5--FY 2015 Fee Rates
------------------------------------------------------------------------
Fee rate
Animal drug user fee category for FY
2015
------------------------------------------------------------------------
Animal Drug Application Fees:
Animal Drug Application.................................. $400,600
Supplemental Animal Drug Application for which Safety or 200,300
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...................................... 8,075
Animal Drug Establishment Fee \1\............................ 104,150
Animal Drug Sponsor Fee \2\.................................. 94,450
------------------------------------------------------------------------
\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 2015 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 on or after October 1, 2014. 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 https://www.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
979033) on the enclosed check, bank draft, or money order. Your payment
and a copy of the completed Animal Drug User Fee Cover Sheet can be
mailed to: Food and Drug Administration, P.O. Box 979033, St. Louis, MO
63197-9000.
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, Beneficiary:
FDA, 8455 Colesville Rd., Silver Spring, MD 20993-0002. You are
responsible for any administrative costs associated with the processing
of a wire transfer. Contact your bank or financial institution about
the fee and add it to your payment to ensure that your fee is fully
paid.
If you prefer to send a check by a courier, the courier may deliver
the check and printed copy of the cover sheet to: U.S. Bank, Attn:
Government Lockbox 979033, 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 FDA is 53-0196965. (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
[[Page 44792]]
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.
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, 2014, FDA will issue invoices and payment
instructions for product, establishment, and sponsor fees for FY 2015
using this fee schedule. Payment will be due by January 31, 2015. FDA
will issue invoices in November 2015 for any products, establishments,
and sponsors subject to fees for FY 2015 that qualify for fees after
the December 2014 billing.
Dated: July 28, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-18110 Filed 7-31-14; 8:45 am]
BILLING CODE 4164-01-P
