Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2017, 49664-49669 [2016-17848]
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Federal Register / Vol. 81, No. 145 / Thursday, July 28, 2016 / Notices
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[FR Doc. 2016–17928 Filed 7–27–16; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0007]
Animal Drug User Fee Rates and
Payment Procedures for Fiscal Year
2017
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AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
rates and payment procedures for fiscal
SUMMARY:
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year (FY) 2017 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 notice establishes the
fee rates for FY 2017.
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,
7519 Standish Pl., Rockville, MD 20855,
240–402–6888. For general questions,
you may also email the Center for
Veterinary Medicine (CVM) at:
cvmadufa@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
application; $175,350 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)); $8,195 for an
annual product fee; $111,900 for an
annual establishment fee; and $103,100
for an annual sponsor fee. FDA will
issue invoices for FY 2017 product,
establishment, and sponsor fees by
December 31, 2016, and payment will
be due by January 31, 2017. The
application fee rates are effective for
applications submitted on or after
October 1, 2016, and will remain in
effect through September 30, 2017.
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
the Animal Drug User Fee program
(ADUFA program).
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 are 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 2017, the animal drug user fee
rates are: $350,700 for an animal drug
ADUFA III, Title I of Public Law 113–
14, specifies that the aggregate fee
revenue amount for FY 2017 for all
animal drug user fee categories is
$21,600,000 (21 U.S.C. 379j–
12(b)(1)(B).).
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Sfmt 4703
II. Revenue Amount for FY 2017
A. Statutory Fee Revenue Amounts
B. Inflation Adjustment to Fee Revenue
Amount
The fee revenue amount established
in ADUFA III for FY 2015 and
subsequent fiscal 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 one
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 four
preceding fiscal years (see 21 U.S.C.
379j–12(c)(2)(A) and (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 2017. The 3-year average is 1.8759
percent.
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TABLE 1—FDA PERSONNEL COMPENSATION AND BENEFITS (PC&B) EACH YEAR AND PERCENT CHANGE
Fiscal year
3-year
average
2013
The statute specifies that this 1.8759
percent should be multiplied by the
2015
$1,927,703,000
13,974
137,949
1.1690%
Total PC&B ......................................................
Total FTE .........................................................
PC&B per FTE .................................................
Percent Change from Previous Year ..............
2014
$2,054,937,000
14,555
141,184
2.3451%
$2,232,304,000
15,484
144,168
2.1136%
proportion of PC&B costs to total FDA
costs. Table 2 shows the amount of
........................
........................
........................
1.8759%
PC&B and the total amount obligated by
FDA for the same 3 FYs.
TABLE 2—PC&B AS A PERCENT OF TOTAL COSTS AT FDA
Fiscal year
3-year
average
2013
The payroll adjustment is 1.8759
percent multiplied by 47.9108 percent
(or 0.8988 percent).
The statute specifies that the portion
of the inflation adjustment for nonpayroll costs for FY 2017 is the average
annual percent change that occurred in
2015
$1,927,703,000
4,151,343,000
46.4356%
Total PC&B ......................................................
Total Costs .......................................................
PC&B Percent ..................................................
2014
$2,054,937,000
4,298,476,000
47.8062%
$2,232,304,000
4,510,565,000
49.4906%
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
........................
........................
47.9108%
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.
TABLE 3—ANNUAL AND 3-YEAR AVERAGE PERCENT CHANGE IN BALTIMORE-WASHINGTON AREA CPI LESS FOOD AND
ENERGY
Year
2013
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Annual CPI .......................................................
Annual Percent Change ..................................
To calculate the inflation adjustment
for non-pay costs, we multiply the
1.7754 percent by the proportion of all
costs other than PC&B to total FDA
costs. Since 47.9108 percent was
obligated for PC&B as shown in table 2,
52.0892 percent is the portion of costs
other than PC&B (100 percent minus
47.9108 percent equals 52.0892
percent). The non-payroll adjustment is
1.7754 percent times 52.0892 percent, or
0.9248 percent.
Next, we add the payroll component
(0.8988 percent) to the non-pay
component (0.9248 percent), for a total
inflation adjustment of 1.8236 percent
for FY 2017.
ADUFA III provides for the inflation
adjustment to be compounded each
fiscal year after FY 2014 (see 21 U.S.C.
379j–12(c)(2)). The factor for FY 2017
(1.8236 percent) is compounded by
adding 1 and then multiplying by 1 plus
the inflation adjustment factor for FY
2016 (2.1121 percent), as published in
the Federal Register of August 3, 2015
(80 FR 45993 to 45998), which equals
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2014
146.953
1.7588%
149.581
1.7883%
1.060746 (rounded) (1.018236 times
1.041749) for FY 2017. We then
multiply the base revenue amount for
FY 2017 ($21,600,000) by 1.060746,
yielding an inflation adjusted amount of
$22,912,114.
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,
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3-year
average
2015
152.242
1.7790%
........................
1.7754%
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, 2016.
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 five 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 table 4 the sum of the values in
column 5 is added, reflecting a total
change in workload of 3.3206 percent
for FY 2017. This is the workload
adjuster for FY 2017.
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TABLE 4—WORKLOAD ADJUSTER CALCULATION
[Numbers may not add due to rounding]
Column 1
Column 3
Column 4
Column 5
5-year
average
(base years)
Application type
Column 2
Latest
5-year
average
Percent
change
Weighting
factor
Weighted
percent
change
New Animal Drug Applications (NADAs) .............................
Supplemental NADAs with Safety or Efficacy Data ............
Manufacturing Supplements ................................................
Investigational Study Submissions ......................................
Investigational Protocol Submissions ..................................
9.8000
9.6000
361.0000
216.4000
133.6000
13.4000
12.4000
324.6000
204.6000
179.0000
36.7347
29.1667
¥10.0831
¥5.4529
33.9820
0.0250
0.0342
0.1565
0.6002
0.1841
0.9168
0.9971
¥1.5783
¥3.2727
6.2577
FY 2017 Workload Adjuster .........................................
........................
........................
........................
........................
3.3206
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FDA experienced an increase in the
number of new animal drug
applications (NADAs) and supplemental
NADAs with safety or effectiveness
data. Over the last several years FDA
has seen an increase in the number of
animal drug products brought by animal
drug sponsors for review in the drug
evaluation process. These new animal
drug products come from both existing
animal drug sponsors as well as
sponsors new to the animal drug
market. The increase in new animal
drug products have contributed to an
increase in the number of protocol
submissions and NADAs submitted for
many novel drug classes and novel
indications for both food-producing
animals and companion animals. FDA
can expect that the increases in
reviewed protocols will lead in the near
future to an increase in the number of
Investigational Study Submissions and
NADAs or supplemental NADAs as
sponsors work their products through
the regulatory review process.
Additionally, FDA has seen an increase
in the number of animal drug sponsors
pursuing multiple changes to their
existing NADAs (e.g., new indications,
new species, changes in dosage). For
this reason we are seeing an increase in
the number of supplemental NADAs
with safety or effectiveness data. As a
result, the statutory revenue amount
after the inflation adjustment
($22,912,114) must now be increased by
3.3206 percent to reflect the changes in
review workload (workload adjustment),
for a total fee revenue target of
$23,673,000 (rounded to the nearest
thousand dollars).
D. FY 2017 Fee Revenue Amounts
ADUFA III specifies that the revenue
amount of $23,673,000 for FY 2017 is to
be divided as follows: 20 percent, or a
total of $4,734,000 (rounded to the
nearest thousand dollars), is to come
from application fees; 27 percent, or a
total of $6,392,000 (rounded to the
nearest thousand dollars), is to come
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from product fees; 26 percent, or a total
of $6,155,000 (rounded to the nearest
thousand dollars), is to come from
establishment fees; and 27 percent, or a
total of $6,392,000 (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
2017
A. Application Fee Revenues and
Numbers of Fee-Paying Applications
Each person that submits an animal
drug application or a supplemental
animal drug application shall be subject
to an application fee, with limited
exceptions (see 21 U.S.C. 379j–12
(a)(1)). The term ‘‘animal drug
application’’ means an application for
approval of any new animal drug
submitted under section 512(b)(1) (21
U.S.C. 379j–11(1)). A ‘‘supplemental
animal drug application’’ is defined as
a request to the Secretary to approve a
change in an animal drug application
which has been approved, or a request
to the Secretary to approve a change to
an application approved under section
512(c)(2) for which data with respect to
safety or effectiveness are required (21
U.S.C. 379j–11(2)). The application fees
are to be set so that they will generate
$4,734,000 in fee revenue for FY 2017.
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)).
To set animal drug application fees
and supplemental animal drug
application fees to realize $4,734,000
FDA must first make some assumptions
about the number of fee-paying
applications and supplements the
Agency will receive in FY 2017.
The Agency knows the number of
applications that have been submitted
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in previous years. That number
fluctuates from year to year. In
estimating the fee revenue to be
generated by animal drug application
fees in FY 2017, FDA is assuming that
the number of applications that will pay
fees in FY 2017 will equal the average
number of submissions over the five
most recent completed years of the
ADUFA program (FY 2011 to FY 2015).
FDA believes that this is a reasonable
approach after 12 completed 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 7.2. 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 12.6.
B. Application Fee Rates for FY 2017
FDA must set the fee rates for FY 2017
so that the estimated 7.2 applications
that pay the full fee and the estimated
12.6 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 $4,734,000. To
generate this amount, the fee for an
animal drug application, rounded to the
nearest $100, will have to be $350,700,
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 $175,350.
IV. Product Fee Calculations for FY
2017
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
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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 (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 $6,392,000 in fee
revenue for FY 2017.
To set animal drug product fees to
realize $6,392,000, FDA must make
some assumptions about the number of
products for which these fees will be
paid in FY 2017. 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 2016, FDA estimates that there are
a total of 804 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 804 products
will be subject to this fee in FY 2017.
In estimating the fee revenue to be
generated by animal drug product fees
in FY 2017, FDA is assuming that 3
percent of the products invoiced, or 24,
will not pay fees in FY 2017 due to fee
waivers and reductions. FDA has kept
this estimate at 3 percent this year,
based on historical data over the past 5
completed years of the ADUFA
program. Based on experience over the
first 12 completed years of the ADUFA
program, FDA believes that this is a
reasonable basis for estimating the
number of fee-paying products in FY
2017.
Accordingly, the Agency estimates
that a total of 780 (804 minus 24)
products will be subject to product fees
in FY 2017.
B. Product Fee Rates for FY 2017
FDA must set the fee rates for FY 2017
so that the estimated 780 products that
pay fees will generate a total of
$6,392,000. To generate this amount
will require the fee for an animal drug
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product, rounded to the nearest $5, to be
$8,195.
V. Establishment Fee Calculations for
FY 2017
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. The term ‘‘animal drug
establishment’’ is defined as a foreign or
domestic place of business which is at
one general physical location consisting
of one or more buildings all of which
are within 5 miles of each other, at
which one or more animal drug
products are manufactured in final
dosage form (21 U.S.C. 379j–11(4)). The
establishment fees are to be set so that
they will generate $6,155,000 in fee
revenue for FY 2017.
To set animal drug establishment fees
to realize $6,155,000, FDA must make
some assumptions about the number of
establishments for which these fees will
be paid in FY 2017. 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 2016, 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 2017.
In estimating the fee revenue to be
generated by animal drug establishment
fees in FY 2017, FDA is assuming that
11 percent of the establishments
invoiced, or seven, will not pay fees in
FY 2017 due to fee waivers and
reductions. FDA has reduced this
estimate from 12 percent to 11 percent
this year, based on historical data over
the past 5 completed years. Based on
experience over the past 12 completed
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49667
years of the ADUFA program, FDA
believes that this is a reasonable basis
for estimating the number of fee-paying
establishments in FY 2017.
Accordingly, the Agency estimates
that a total of 55 establishments (62
minus 7) will be subject to
establishment fees in FY 2017.
B. Establishment Fee Rates for FY 2017
FDA must set the fee rates for FY 2017
so that the estimated 55 establishments
that pay fees will generate a total of
$6,155,000. To generate this amount
will require the fee for an animal drug
establishment, rounded to the nearest
$50, to be $111,900.
VI. Sponsor Fee Calculations for FY
2017
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 $6,392,000 in
fee revenue for FY 2017.
To set animal drug sponsor fees to
realize $6,392,000, FDA must make
some assumptions about the number of
sponsors who will pay these fees in FY
2017. Based on the number of firms that
would have met this definition in each
of the past 12 completed years of the
ADUFA program, FDA estimates that a
total of 189 sponsors will meet this
definition in FY 2017.
Careful review indicates that 35
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 67 percent of
the sponsors invoiced, or 127, who will
not pay fees in FY 2017 due to fee
waivers and reductions. FDA has
increased this estimate from 65 percent
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to 67 percent this year, based on
historical data over the past 5 completed
years of the ADUFA program. FDA
believes that this is a reasonable basis
for estimating the number of fee-paying
sponsors in FY 2017.
Accordingly, the Agency estimates
that a total of 62 sponsors (189 minus
127) will be subject to and pay sponsor
fees in FY 2017.
B. Sponsor Fee Rates for FY 2017
FDA must set the fee rates for FY 2017
so that the estimated 62 sponsors that
pay fees will generate a total of
$6,392,000. To generate this amount
will require the fee for an animal drug
sponsor, rounded to the nearest $50, to
be $103,100.
VII. Fee Schedule for FY 2017
The fee rates for FY 2017 are
summarized in Table 5.
TABLE 5—FY 2017 FEE RATES
Fee rate for
FY 2017
($)
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 ..........................................................................................................................................................
1 An
2 An
175,350
8,195
111,900
103,100
animal drug establishment is subject to only one such fee each fiscal year.
animal drug sponsor is subject to only one such fee each fiscal year.
VIII. Procedures for Paying the FY 2017
Fees
A. Application Fees and Payment
Instructions
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350,700
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 III that is submitted
on or after October 1, 2016. Payment
must be made in U.S. currency by
check, bank draft, U.S. postal money
order payable to the order of the Food
and Drug Administration, wire transfer,
or electronically using Pay.gov. The
preferred payment method is online
using electronic check (Automated
Clearing House (ACH) also known as
eCheck) or credit card (Discover, VISA,
MasterCard, American Express). Secure
electronic payments can be submitted
using the User Fees Payment Portal at
https://userfees.fda.gov/pay or the
Pay.gov payment option is available to
you after you submit a cover sheet. Once
you search for your invoice, click ‘‘Pay
Now’’ to be redirected to Pay.gov. Note
that electronic payment options are
based on the balance due. Payment by
credit card is available for balances less
than $25,000. If the balance exceeds this
amount, only the ACH option is
available. Payments must be drawn on
U.S bank accounts as well as U.S. credit
cards.
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
VerDate Sep<11>2014
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(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., 14th Floor, 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
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Sfmt 4703
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.
E:\FR\FM\28JYN1.SGM
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Federal Register / Vol. 81, No. 145 / Thursday, July 28, 2016 / Notices
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, 2016, FDA will issue
invoices and payment instructions for
product, establishment, and sponsor
fees for FY 2017 using this fee schedule.
Payment will be due by January 31,
2017. FDA will issue invoices in
November 2017 for any products,
establishments, and sponsors subject to
fees for FY 2017 that qualify for fees
after the December 2016 billing.
Dated: July 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–17848 Filed 7–27–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0007]
Animal Generic Drug User Fee Rates
and Payment Procedures for Fiscal
Year 2017
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) 2017 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
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 2017.
FOR FURTHER INFORMATION CONTACT: Visit
FDA’s Web site at https://www.fda.gov/
ForIndustry/UserFees/
AnimalGenericDrugUser
FeeActAGDUFA/default.htm, or contact
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SUMMARY:
VerDate Sep<11>2014
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Jkt 238001
49669
Lisa Kable, Center for Veterinary
Medicine (HFV–10), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–402–6888.
For general questions, you may also
email the Center for Veterinary
Medicine (CVM) at cvmagdufa@
fda.hhs.gov.
October 1, 2016, and will remain in
effect through September 30, 2017.
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
(AGDUFA program).
SUPPLEMENTARY INFORMATION:
II. Revenue Amount for FY 2017
I. Background
A. Statutory Fee Revenue Amounts
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 (21 U.S.C. 379j–21(b)).
Base revenue amounts established for
fiscal years after FY 2014 are subject to
adjustment for workload (21 U.S.C.
379j–21(c)). The target revenue amounts
for each fee category for FY 2017, after
the adjustment for workload, are as
follows: For application fees the target
revenue amount is $2,835,000; for
product fees the target revenue amount
is $4,253,000; and for sponsor fees the
target revenue amount is $4,253,000.
For FY 2017, the generic new animal
drug user fee rates are: $232,400 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)); $116,200 for each
abbreviated application for a generic
new animal drug subject to the criteria
in section 512(d)(4); $10,200 for each
generic new animal drug product;
$96,350 for each generic new animal
drug sponsor paying 100 percent of the
sponsor fee; $72,263 for each generic
new animal drug sponsor paying 75
percent of the sponsor fee; and $48,175
for each generic new animal drug
sponsor paying 50 percent of the
sponsor fee. FDA will issue invoices for
FY 2017 product and sponsor fees by
December 31, 2016. These fees will be
due by January 31, 2017. The
application fee rates are effective for all
abbreviated applications for a generic
new animal drug submitted on or after
AGDUFA II, Title II of Public Law
113–14, specifies that the aggregate
revenue amount for FY 2017 for
abbreviated application fees is
$1,984,000 and each of the other two
generic new animal drug user fee
categories, annual product fees and
annual sponsor fees, is $2,976,000 each
(see 21 U.S.C. 379j–21(b)).
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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 II 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, 2016.
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
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
E:\FR\FM\28JYN1.SGM
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]]>Agencies
[Federal Register Volume 81, Number 145 (Thursday, July 28, 2016)]
[Notices]
[Pages 49664-49669]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-17848]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0007]
Animal Drug User Fee Rates and Payment Procedures for Fiscal Year
2017
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) 2017 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 notice establishes the fee rates for FY 2017.
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, 7519 Standish Pl., Rockville, MD 20855, 240-
402-6888. 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 are 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 2017, the animal drug user fee rates are: $350,700 for an
animal drug application; $175,350 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)); $8,195 for an annual
product fee; $111,900 for an annual establishment fee; and $103,100 for
an annual sponsor fee. FDA will issue invoices for FY 2017 product,
establishment, and sponsor fees by December 31, 2016, and payment will
be due by January 31, 2017. The application fee rates are effective for
applications submitted on or after October 1, 2016, and will remain in
effect through September 30, 2017. 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 the Animal Drug User Fee
program (ADUFA program).
II. Revenue Amount for FY 2017
A. Statutory Fee Revenue Amounts
ADUFA III, Title I of Public Law 113-14, specifies that the
aggregate fee revenue amount for FY 2017 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 fiscal 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 one 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 four preceding fiscal years
(see 21 U.S.C. 379j-12(c)(2)(A) and (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 2017. The 3-year average is 1.8759 percent.
[[Page 49665]]
Table 1--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Change
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fiscal year 2013 2014 2015 3-year average
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total PC&B................................................... $1,927,703,000 $2,054,937,000 $2,232,304,000 ..............
Total FTE.................................................... 13,974 14,555 15,484 ..............
PC&B per FTE................................................. 137,949 141,184 144,168 ..............
Percent Change from Previous Year............................ 1.1690% 2.3451% 2.1136% 1.8759%
--------------------------------------------------------------------------------------------------------------------------------------------------------
The statute specifies that this 1.8759 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 3
FYs.
Table 2--PC&B as a Percent of Total Costs at FDA
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fiscal year 2013 2014 2015 3-year average
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total PC&B................................................... $1,927,703,000 $2,054,937,000 $2,232,304,000 ..............
Total Costs.................................................. 4,151,343,000 4,298,476,000 4,510,565,000 ..............
PC&B Percent................................................. 46.4356% 47.8062% 49.4906% 47.9108%
--------------------------------------------------------------------------------------------------------------------------------------------------------
The payroll adjustment is 1.8759 percent multiplied by 47.9108
percent (or 0.8988 percent).
The statute specifies that the portion of the inflation adjustment
for non-payroll costs for FY 2017 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.
Table 3--Annual and 3-Year Average Percent Change in Baltimore-Washington Area CPI Less Food and Energy
--------------------------------------------------------------------------------------------------------------------------------------------------------
Year 2013 2014 2015 3-year average
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual CPI................................................... 146.953 149.581 152.242 ..............
Annual Percent Change........................................ 1.7588% 1.7883% 1.7790% 1.7754%
--------------------------------------------------------------------------------------------------------------------------------------------------------
To calculate the inflation adjustment for non-pay costs, we
multiply the 1.7754 percent by the proportion of all costs other than
PC&B to total FDA costs. Since 47.9108 percent was obligated for PC&B
as shown in table 2, 52.0892 percent is the portion of costs other than
PC&B (100 percent minus 47.9108 percent equals 52.0892 percent). The
non-payroll adjustment is 1.7754 percent times 52.0892 percent, or
0.9248 percent.
Next, we add the payroll component (0.8988 percent) to the non-pay
component (0.9248 percent), for a total inflation adjustment of 1.8236
percent for FY 2017.
ADUFA III provides for the inflation adjustment to be compounded
each fiscal year after FY 2014 (see 21 U.S.C. 379j-12(c)(2)). The
factor for FY 2017 (1.8236 percent) is compounded by adding 1 and then
multiplying by 1 plus the inflation adjustment factor for FY 2016
(2.1121 percent), as published in the Federal Register of August 3,
2015 (80 FR 45993 to 45998), which equals 1.060746 (rounded) (1.018236
times 1.041749) for FY 2017. We then multiply the base revenue amount
for FY 2017 ($21,600,000) by 1.060746, yielding an inflation adjusted
amount of $22,912,114.
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, 2016.
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 five 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 table 4 the sum of the values in column 5 is added, reflecting a
total change in workload of 3.3206 percent for FY 2017. This is the
workload adjuster for FY 2017.
[[Page 49666]]
Table 4--Workload Adjuster Calculation
[Numbers may not add due to rounding]
----------------------------------------------------------------------------------------------------------------
Column 1 Column 2 Column 3 Column 4 Column 5
-------------------------------------------------------------------------------
Application type 5-year average Latest 5-year Weighting Weighted
(base years) average Percent change factor percent change
----------------------------------------------------------------------------------------------------------------
New Animal Drug Applications 9.8000 13.4000 36.7347 0.0250 0.9168
(NADAs)........................
Supplemental NADAs with Safety 9.6000 12.4000 29.1667 0.0342 0.9971
or Efficacy Data...............
Manufacturing Supplements....... 361.0000 324.6000 -10.0831 0.1565 -1.5783
Investigational Study 216.4000 204.6000 -5.4529 0.6002 -3.2727
Submissions....................
Investigational Protocol 133.6000 179.0000 33.9820 0.1841 6.2577
Submissions....................
-------------------------------------------------------------------------------
FY 2017 Workload Adjuster... .............. .............. .............. .............. 3.3206
----------------------------------------------------------------------------------------------------------------
FDA experienced an increase in the number of new animal drug
applications (NADAs) and supplemental NADAs with safety or
effectiveness data. Over the last several years FDA has seen an
increase in the number of animal drug products brought by animal drug
sponsors for review in the drug evaluation process. These new animal
drug products come from both existing animal drug sponsors as well as
sponsors new to the animal drug market. The increase in new animal drug
products have contributed to an increase in the number of protocol
submissions and NADAs submitted for many novel drug classes and novel
indications for both food-producing animals and companion animals. FDA
can expect that the increases in reviewed protocols will lead in the
near future to an increase in the number of Investigational Study
Submissions and NADAs or supplemental NADAs as sponsors work their
products through the regulatory review process. Additionally, FDA has
seen an increase in the number of animal drug sponsors pursuing
multiple changes to their existing NADAs (e.g., new indications, new
species, changes in dosage). For this reason we are seeing an increase
in the number of supplemental NADAs with safety or effectiveness data.
As a result, the statutory revenue amount after the inflation
adjustment ($22,912,114) must now be increased by 3.3206 percent to
reflect the changes in review workload (workload adjustment), for a
total fee revenue target of $23,673,000 (rounded to the nearest
thousand dollars).
D. FY 2017 Fee Revenue Amounts
ADUFA III specifies that the revenue amount of $23,673,000 for FY
2017 is to be divided as follows: 20 percent, or a total of $4,734,000
(rounded to the nearest thousand dollars), is to come from application
fees; 27 percent, or a total of $6,392,000 (rounded to the nearest
thousand dollars), is to come from product fees; 26 percent, or a total
of $6,155,000 (rounded to the nearest thousand dollars), is to come
from establishment fees; and 27 percent, or a total of $6,392,000
(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 2017
A. Application Fee Revenues and Numbers of Fee-Paying Applications
Each person that submits an animal drug application or a
supplemental animal drug application shall be subject to an application
fee, with limited exceptions (see 21 U.S.C. 379j-12 (a)(1)). The term
``animal drug application'' means an application for approval of any
new animal drug submitted under section 512(b)(1) (21 U.S.C. 379j-
11(1)). A ``supplemental animal drug application'' is defined as a
request to the Secretary to approve a change in an animal drug
application which has been approved, or a request to the Secretary to
approve a change to an application approved under section 512(c)(2) for
which data with respect to safety or effectiveness are required (21
U.S.C. 379j-11(2)). The application fees are to be set so that they
will generate $4,734,000 in fee revenue for FY 2017. 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)).
To set animal drug application fees and supplemental animal drug
application fees to realize $4,734,000 FDA must first make some
assumptions about the number of fee-paying applications and supplements
the Agency will receive in FY 2017.
The Agency knows the number of applications that have been
submitted in previous years. That number fluctuates from year to year.
In estimating the fee revenue to be generated by animal drug
application fees in FY 2017, FDA is assuming that the number of
applications that will pay fees in FY 2017 will equal the average
number of submissions over the five most recent completed years of the
ADUFA program (FY 2011 to FY 2015). FDA believes that this is a
reasonable approach after 12 completed 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 7.2. 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 12.6.
B. Application Fee Rates for FY 2017
FDA must set the fee rates for FY 2017 so that the estimated 7.2
applications that pay the full fee and the estimated 12.6 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 $4,734,000. To generate this amount, the fee for an
animal drug application, rounded to the nearest $100, will have to be
$350,700, 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 $175,350.
IV. Product Fee Calculations for FY 2017
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
[[Page 49667]]
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 (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 $6,392,000 in fee revenue for FY 2017.
To set animal drug product fees to realize $6,392,000, FDA must
make some assumptions about the number of products for which these fees
will be paid in FY 2017. 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
2016, FDA estimates that there are a total of 804 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 804 products will be
subject to this fee in FY 2017.
In estimating the fee revenue to be generated by animal drug
product fees in FY 2017, FDA is assuming that 3 percent of the products
invoiced, or 24, will not pay fees in FY 2017 due to fee waivers and
reductions. FDA has kept this estimate at 3 percent this year, based on
historical data over the past 5 completed years of the ADUFA program.
Based on experience over the first 12 completed years of the ADUFA
program, FDA believes that this is a reasonable basis for estimating
the number of fee-paying products in FY 2017.
Accordingly, the Agency estimates that a total of 780 (804 minus
24) products will be subject to product fees in FY 2017.
B. Product Fee Rates for FY 2017
FDA must set the fee rates for FY 2017 so that the estimated 780
products that pay fees will generate a total of $6,392,000. To generate
this amount will require the fee for an animal drug product, rounded to
the nearest $5, to be $8,195.
V. Establishment Fee Calculations for FY 2017
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.
The term ``animal drug establishment'' is defined as a foreign or
domestic place of business which is at one general physical location
consisting of one or more buildings all of which are within 5 miles of
each other, at which one or more animal drug products are manufactured
in final dosage form (21 U.S.C. 379j-11(4)). The establishment fees are
to be set so that they will generate $6,155,000 in fee revenue for FY
2017.
To set animal drug establishment fees to realize $6,155,000, FDA
must make some assumptions about the number of establishments for which
these fees will be paid in FY 2017. 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 2016, 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 2017.
In estimating the fee revenue to be generated by animal drug
establishment fees in FY 2017, FDA is assuming that 11 percent of the
establishments invoiced, or seven, will not pay fees in FY 2017 due to
fee waivers and reductions. FDA has reduced this estimate from 12
percent to 11 percent this year, based on historical data over the past
5 completed years. Based on experience over the past 12 completed years
of the ADUFA program, FDA believes that this is a reasonable basis for
estimating the number of fee-paying establishments in FY 2017.
Accordingly, the Agency estimates that a total of 55 establishments
(62 minus 7) will be subject to establishment fees in FY 2017.
B. Establishment Fee Rates for FY 2017
FDA must set the fee rates for FY 2017 so that the estimated 55
establishments that pay fees will generate a total of $6,155,000. To
generate this amount will require the fee for an animal drug
establishment, rounded to the nearest $50, to be $111,900.
VI. Sponsor Fee Calculations for FY 2017
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 $6,392,000 in fee revenue for FY 2017.
To set animal drug sponsor fees to realize $6,392,000, FDA must
make some assumptions about the number of sponsors who will pay these
fees in FY 2017. Based on the number of firms that would have met this
definition in each of the past 12 completed years of the ADUFA program,
FDA estimates that a total of 189 sponsors will meet this definition in
FY 2017.
Careful review indicates that 35 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 67
percent of the sponsors invoiced, or 127, who will not pay fees in FY
2017 due to fee waivers and reductions. FDA has increased this estimate
from 65 percent
[[Page 49668]]
to 67 percent this year, based on historical data over the past 5
completed years of the ADUFA program. FDA believes that this is a
reasonable basis for estimating the number of fee-paying sponsors in FY
2017.
Accordingly, the Agency estimates that a total of 62 sponsors (189
minus 127) will be subject to and pay sponsor fees in FY 2017.
B. Sponsor Fee Rates for FY 2017
FDA must set the fee rates for FY 2017 so that the estimated 62
sponsors that pay fees will generate a total of $6,392,000. To generate
this amount will require the fee for an animal drug sponsor, rounded to
the nearest $50, to be $103,100.
VII. Fee Schedule for FY 2017
The fee rates for FY 2017 are summarized in Table 5.
Table 5--FY 2017 Fee Rates
------------------------------------------------------------------------
Fee rate for
Animal drug user fee category FY 2017 ($)
------------------------------------------------------------------------
Animal Drug Application Fees:
Animal Drug Application............................. 350,700
Supplemental Animal Drug Application for Which 175,350
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............................. 8,195
Animal Drug Establishment Fee \1\................... 111,900
Animal Drug Sponsor Fee \2\......................... 103,100
------------------------------------------------------------------------
\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 2017 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 III that is submitted on or after October 1, 2016.
Payment must be made in U.S. currency by check, bank draft, U.S. postal
money order payable to the order of the Food and Drug Administration,
wire transfer, or electronically using Pay.gov. The preferred payment
method is online using electronic check (Automated Clearing House (ACH)
also known as eCheck) or credit card (Discover, VISA, MasterCard,
American Express). Secure electronic payments can be submitted using
the User Fees Payment Portal at https://userfees.fda.gov/pay or the
Pay.gov payment option is available to you after you submit a cover
sheet. Once you search for your invoice, click ``Pay Now'' to be
redirected to Pay.gov. Note that electronic payment options are based
on the balance due. Payment by credit card is available for balances
less than $25,000. If the balance exceeds this amount, only the ACH
option is available. Payments must be drawn on U.S bank accounts as
well as U.S. credit cards.
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., 14th Floor, 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 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.
[[Page 49669]]
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, 2016, FDA will issue invoices and payment
instructions for product, establishment, and sponsor fees for FY 2017
using this fee schedule. Payment will be due by January 31, 2017. FDA
will issue invoices in November 2017 for any products, establishments,
and sponsors subject to fees for FY 2017 that qualify for fees after
the December 2016 billing.
Dated: July 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-17848 Filed 7-27-16; 8:45 am]
BILLING CODE 4164-01-P
