Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2018, 35966-35971 [2017-16180]
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Federal Register / Vol. 82, No. 147 / Wednesday, August 2, 2017 / Notices
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Dated July 27, 2017.
Anna K. Abram,
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Legislation, and Analysis.
[FR Doc. 2017–16229 Filed 8–1–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–0007]
Animal Drug User Fee Rates and
Payment Procedures for Fiscal Year
2018
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) 2018 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 2018.
FOR FURTHER INFORMATION CONTACT: Visit
FDA’s Web site at https://www.fda.gov/
ForIndustry/UserFees/AnimalDrugUser
FeeActADUFA/default.htm or contact
Lisa Kable, Center for Veterinary
Medicine (HFV–10), Food and Drug
SUMMARY:
Administration, 7500 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 2018, the animal drug user fee
rates are: $238,100 for an animal drug
application; $119,050 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)); $6,175 for an
annual product fee; $88,750 for an
annual establishment fee; and $75,150
for an annual sponsor fee. FDA will
issue invoices for FY 2018 product,
establishment, and sponsor fees by
December 31, 2017, and payment will
be due by January 31, 2018. The
application fee rates are effective for
applications submitted on or after
October 1, 2017, and will remain in
effect through September 30, 2018.
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 2018
A. Statutory Fee Revenue Amounts
ADUFA III, Title I of Public Law 113–
14, specifies that the aggregate fee
revenue amount for FY 2018 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 of
the 4 fiscal years preceding FY 2018.
The 3-year average is 2.2354 percent.
TABLE 1—FDA PERSONNEL COMPENSATION AND BENEFITS (PC&B) EACH YEAR AND PERCENT CHANGE
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Fiscal year
2014
Total PC&B ..............................................................................
Total FTE .................................................................................
PC&B per FTE .........................................................................
Percent Change from Previous Year ......................................
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$2,054,937,000
14,555
$141,184
2.3451%
Fmt 4703
Sfmt 4703
2015
$2,232,304,000
15,484
$144,168
2.1136%
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2016
$2,414,728,159
16,381
$147,408
2.2474%
02AUN1
3-Year average
..............................
..............................
..............................
2.2354%
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The statute specifies that this 2.2354
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
2014
Total PC&B ..............................................................................
Total Costs ...............................................................................
PC&B Percent ..........................................................................
The payroll adjustment is 2.2354
percent multiplied by 49.6819 percent
(or 1.1106 percent).
The statute specifies that the portion
of the inflation adjustment for nonpayroll costs for FY 2018 is the average
annual percent change that occurred in
2015
$2,054,937,000
$4,298,476,000
47.8062%
2016
$2,232,304,000
$4,510,565,000
49.4906%
3-Year average
$2,414,728,159
$4,666,236,000
51.7490
..............................
..............................
49.6819%
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.
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
TABLE 3—ANNUAL AND 3-YEAR AVERAGE PERCENT CHANGE IN BALTIMORE-WASHINGTON AREA CPI LESS FOOD AND
ENERGY
Year
2014
Annual CPI ...............................................................................
Annual Percent Change ..........................................................
To calculate the inflation adjustment
for non-pay costs, we multiply the
1.7277 percent by the proportion of all
costs other than PC&B to total FDA
costs. Since 49.6819 percent was
obligated for PC&B as shown in table 2,
50.3181 percent is the portion of costs
other than PC&B (100 percent ¥49.6819
percent = 50.3181 percent). The nonpayroll adjustment is 1.7277 percent
times 50.3181 percent, or 0.8693
percent.
Next, we add the payroll component
(1.1106 percent) to the non-pay
component (0.8693 percent), for a total
inflation adjustment of 1.9799 percent
for FY 2018.
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 2018
(1.9799 percent) is compounded by
adding 1 and then multiplying by 1 plus
the inflation adjustment factor for FY
2017 (6.0746 percent), as published in
the Federal Register of July 28, 2016 (81
FR 49664 to 49669), which equals
2015
149.581
1.7883%
2016
152.242
1.7790%
1.081748 (rounded) (1.019799 ×
1.060746) for FY 2018. We then
multiply the base revenue amount for
FY 2018 ($21,600,000) by 1.081748,
yielding an inflation adjusted amount of
$23,365,757.
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,
3-Year average
154.702
1.6158%
..............................
1.7277%
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, 2017.
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 5.4599 percent
for FY 2018. This is the workload
adjuster for FY 2018.
TABLE 4—WORKLOAD ADJUSTER CALCULATION
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[Numbers may not add due to rounding]
Column 1
5-year
average
(base years)
Application type
New Animal Drug Applications (NADAs) .............................
Supplemental NADAs with Safety or Efficacy Data ............
Manufacturing Supplements ................................................
Investigational Study Submissions ......................................
Investigational Protocol Submissions ..................................
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Column 2
latest
5-year
average
9.8000
9.6000
361.0000
216.4000
133.6000
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16.0
10.6
334.6
189.8
210.4
Column 3
percent
change
63.2653
10.4167
¥7.3130
¥12.2921
57.4850
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Column 4
weighting
factor
0.030373
0.026491
0.162018
0.579781
0.201337
Column 5
weighted
percent
change
1.9216
0.2759
¥1.1848
¥7.1267
11.5739
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TABLE 4—WORKLOAD ADJUSTER CALCULATION—Continued
[Numbers may not add due to rounding]
Application type
Column 1
5-year
average
(base years)
Column 2
latest
5-year
average
Column 3
percent
change
Column 4
weighting
factor
FY 2018 Workload Adjuster .................................................
........................
........................
........................
........................
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 has 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. The
increases in these submissions are
consistent with an overall increase in
workload including all submissions and
communications with sponsors. In
addition, CVM is not seeing a
corresponding decrease in any of the
other submission types that might have
served to offset workload. As a result,
the statutory revenue amount after the
inflation adjustment ($23,365,757) must
now be increased by 5.4599 percent to
reflect the changes in review workload
(workload adjustment), for a total fee
revenue target of $24,641,504.
D. Offset for Excess Collections Through
FY 2017
Under section 740(g)(4) of the FD&C
Act, if the sum of the cumulative
Column 5
weighted
percent
change
5.4599
amount of the fees collected for FY 2014
through FY 2016, and the amount of
fees estimated to be collected for FY
2017, exceeds the cumulative amount
appropriated for fees for FY 2014
through FY 2017, the excess shall be
credited to FDA’s appropriation account
and subtracted from the amount of fees
that FDA would otherwise be
authorized to collect for FY 2018 under
the FD&C Act. (21 U.S.C. 379j–12(g)(4)).
Table 5 shows the amounts specified
in appropriation acts for each year from
FY 2014 through FY 2017, and the
amounts FDA has collected for FY 2014,
FY 2015, FY 2016, and FY 2017 as of
June 30, 2017, and an additional
$21,941,000 (rounded to the nearest
thousand dollars) that FDA estimates it
will collect in FY 2017 based on
historical data. Table 5 shows the
estimated cumulative difference
between ADUFA fee amounts specified
in appropriation acts for FY 2014
through FY 2017 and ADUFA fee
amounts collected.
TABLE 5—OFFSETS TO BE TAKEN FOR ADUFA III
Collections
realized
Fiscal year
2014
2015
2016
2017
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
$27,184,831
24,535,338
25,442,477
21,941,000
Collection
amount
specified in
appropriation
acts
Amount in
excess of
collection
amount
specified in
appropriation
acts
$23,600,000
22,464,000
22,818,000
23,673,000
$3,584,831
2,071,338
2,624,477
¥1,732,000
Net Balance to be Offset When Fees are Set for FY 2018 .........................................................................................................
6,548,646
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Note: FY 2017 ‘Collections Realized’ is the amount FDA estimates it will collect in FY 2017 based on historical data.
The cumulative fees collected for FY
2014 through FY 2017 are estimated to
be $6,548,646 greater than the
cumulative fee amounts specified in
appropriation acts during this same
period. Reducing the inflation and
workload adjusted amount of
$24,641,504 by the ADUFA III offset of
$6,548,646 results in an amount of
$18,093,000 (rounded to the nearest
thousand), before the final year
adjustment.
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E. Final Year Adjustment
Under section 740(c)(4) of the FD&C
Act, for FY 2018 the Secretary of Health
and Human Services (the Secretary)
may, in addition to the inflation and
workload adjustments, further increase
the fees if such an adjustment is
necessary to provide for not more than
3 months of operating reserves of
carryover user fees for the process for
the review of animal drug applications
for the first 3 months of FY 2019. If such
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an adjustment is necessary, the rationale
for the amount of this increase must be
included in the annual notice
establishing fees for FY 2018 (21 U.S.C.
379j–12(c)(4)).
After calculating the operating
reserves and estimating the balance as of
the beginning of FY 2019, FDA
estimates that the ADUFA program will
have sufficient funds for the operating
reserves, thus FDA will not be
performing a final year adjustment for
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FY 2019 because FDA has determined
such an adjustment to be unnecessary.
F. FY 2018 Fee Revenue Amounts
ADUFA III specifies that the revenue
amount of $18,093,000 for FY 2018 is to
be divided as follows: 20 percent, or a
total of $3,619,000 (rounded to the
nearest thousand dollars), is to come
from application fees; 27 percent, or a
total of $4,885,000 (rounded to the
nearest thousand dollars), is to come
from product fees; 26 percent, or a total
of $4,704,000 (rounded to the nearest
thousand dollars), is to come from
establishment fees; and 27 percent, or a
total of $4,885,000 (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
2018
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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) of the FD&C Act (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) of the FD&C Act 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
$3,619,000 in fee revenue for FY 2018.
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 $3,619,000
FDA must first make some assumptions
about the number of fee-paying
applications and supplements the
Agency will receive in FY 2018.
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
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fees in FY 2018, FDA is assuming that
the number of applications that will pay
fees in FY 2018 will equal the average
number of submissions over the five
most recent completed years of the
ADUFA program (FY 2012 to FY 2016).
FDA believes that this is a reasonable
approach after 13 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 8.2. Over this
same period, the average number of
supplemental applications for which
safety or effectiveness data are required
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 14.0.
B. Application Fee Rates for FY 2018
FDA must set the fee rates for FY 2018
so that the estimated 8.2 applications
that pay the full fee and the estimated
14.0 supplemental applications for
which safety or effectiveness data are
required 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 $3,619,000.
To generate this amount, the fee for an
animal drug application, rounded to the
nearest $100, will have to be $238,100,
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 $119,050.
IV. Product Fee Calculations for FY
2018
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 (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
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35969
has been approved (21 U.S.C. 379j–
11(3)). The product fees are to be set so
that they will generate $4,885,000 in fee
revenue for FY 2018.
To set animal drug product fees to
realize $4,885,000, FDA must make
some assumptions about the number of
products for which these fees will be
paid in FY 2018. 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 2017, FDA estimates that there are
a total of 815 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 815 products
will be subject to this fee in FY 2018.
In estimating the fee revenue to be
generated by animal drug product fees
in FY 2018, FDA is assuming that 3
percent of the products invoiced, or 24,
will not pay fees in FY 2018 due to fee
waivers and reductions. FDA has kept
this estimate at 3 percent this year,
based on historical data over the past
five completed years of the ADUFA
program. Based on experience over the
first 13 completed years of the ADUFA
program, FDA believes that this is a
reasonable basis for estimating the
number of fee-paying products in FY
2018.
Accordingly, the Agency estimates
that a total of 791 (815 minus 24)
products will be subject to product fees
in FY 2018.
B. Product Fee Rates for FY 2018
FDA must set the fee rates for FY 2018
so that the estimated 791 products that
pay fees will generate a total of
$4,885,000. To generate this amount
will require the fee for an animal drug
product, rounded to the nearest $5, to be
$6,175.
V. Establishment Fee Calculations for
FY 2018
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
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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 $4,704,000 in fee
revenue for FY 2018.
To set animal drug establishment fees
to realize $4,704,000, FDA must make
some assumptions about the number of
establishments for which these fees will
be paid in FY 2018. 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 2017, FDA estimates
that there are a total of 60
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 60 establishments will be
subject to this fee in FY 2018.
In estimating the fee revenue to be
generated by animal drug establishment
fees in FY 2018, FDA is assuming that
11 percent of the establishments
invoiced, or seven, will not pay fees in
FY 2018 due to fee waivers and
reductions. FDA has kept this estimate
at 11 percent this year, based on
historical data over the past 5 completed
years. Based on experience over the past
13 completed years of the ADUFA
program, FDA believes that this is a
reasonable basis for estimating the
number of fee-paying establishments in
FY 2018.
Accordingly, the Agency estimates
that a total of 53 establishments (60
minus 7) will be subject to
establishment fees in FY 2018.
B. Establishment Fee Rates for FY 2018
FDA must set the fee rates for FY 2018
so that the estimated 53 establishments
that pay fees will generate a total of
$4,704,000. To generate this amount
will require the fee for an animal drug
establishment, rounded to the nearest
$50, to be $88,750.
VI. Sponsor Fee Calculations for FY
2018
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 $4,885,000 in
fee revenue for FY 2018.
To set animal drug sponsor fees to
realize $4,885,000, FDA must make
some assumptions about the number of
sponsors who will pay these fees in FY
2018. Based on the number of firms that
would have met this definition in each
of the past 13 completed years of the
ADUFA program, FDA estimates that a
total of 198 sponsors will meet this
definition in FY 2018.
A review of our records indicates that
35 percent of these sponsors will qualify
for a minor use/minor species fee
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 133, who will not pay fees in FY 2018
due to fee waivers and reductions. FDA
has kept this estimate at 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
2018.
Accordingly, the Agency estimates
that a total of 65 sponsors (198 minus
133) will be subject to and pay sponsor
fees in FY 2018.
B. Sponsor Fee Rates for FY 2018
FDA must set the fee rates for FY 2018
so that the estimated 65 sponsors that
pay fees will generate a total of
$4,885,000. To generate this amount
will require the fee for an animal drug
sponsor, rounded to the nearest $50, to
be $75,150.
VII. Fee Schedule for FY 2018
The fee rates for FY 2018 are
summarized in Table 6.
TABLE 6—FY 2018 FEE RATES
Fee rate for
FY 2018
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 Fee1 ........................................................................................................................................................
Animal Drug Sponsor Fee2 .................................................................................................................................................................
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1 An
2 An
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.
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119,050
6,175
88,750
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Federal Register / Vol. 82, No. 147 / Wednesday, August 2, 2017 / Notices
sradovich on DSKBCFCHB2PROD with NOTICES
VIII. Procedures for Paying the FY 2018
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, 2017. The
payment must be made in U.S. currency
by one of the following methods: Wire
transfer, electronically, check, bank
draft, or U.S. postal money order made
payable to the Food and Drug
Administration. 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. (Note: only
full payments are accepted. No partial
payments can be made online.) Once
you search for and find your invoice,
select ‘‘Pay Now’’ to be redirected to
Pay.gov. Electronic payment options are
based on the balance due. Payment by
credit card is available only for balances
that are less than $25,000. If the balance
exceeds this amount, only the ACH
option is available. Payments must be
made using U.S. bank accounts as well
as U.S. credit cards.
When paying by check, bank draft, or
U.S. postal money order, please write
your application’s unique Payment
Identification Number (PIN), beginning
with the letters AD, on the upper righthand 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. Mail the
payment and a copy of the completed
Animal Drug User Fee Cover Sheet to:
Food and Drug Administration, P.O.
Box 979033, St. Louis, MO 63197–9000.
When paying by wire transfer, the
invoice number needs to be included;
without the invoice number, the
payment may not be applied. If the
payment amount is not applied, the
invoice amount would be referred to
collections. The originating financial
institution may charge a wire transfer
fee. If the financial institution charges a
wire transfer fee, it is required to add
that amount to the payment to ensure
that the invoice is paid in full.
Use the following account
information when sending a payment by
wire transfer: U.S. Department of
Treasury, TREAS NYC, 33 Liberty St.,
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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.
To send a check by a courier such as
Federal Express, the courier must
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 U.S.
Bank at 314–418–4013. This telephone
number is only for questions about
courier delivery.)
It is important that 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.
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.)
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/AnimalDrugUser
FeeActADUFA/default.htm and, under
Tools and Resources, click ‘‘The Animal
Drug User Fee Cover Sheet’’ and then
select ‘‘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
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35971
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, 2017, FDA will issue
invoices and payment instructions for
product, establishment, and sponsor
fees for FY 2018 using this fee schedule.
Payment will be due by January 31,
2018. FDA will issue invoices in
November 2018 for any products,
establishments, and sponsors subject to
fees for FY 2018 that qualify for fees
after the December 2017 billing.
Dated: July 26, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–16180 Filed 8–1–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0689]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; De Novo
Classification Process (Evaluation of
Automatic Class III Designation)
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by September
1, 2017.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
SUMMARY:
E:\FR\FM\02AUN1.SGM
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Agencies
[Federal Register Volume 82, Number 147 (Wednesday, August 2, 2017)]
[Notices]
[Pages 35966-35971]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16180]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-0007]
Animal Drug User Fee Rates and Payment Procedures for Fiscal Year
2018
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) 2018 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 2018.
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, 7500 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 2018, the animal drug user fee rates are: $238,100 for an
animal drug application; $119,050 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)); $6,175 for an annual
product fee; $88,750 for an annual establishment fee; and $75,150 for
an annual sponsor fee. FDA will issue invoices for FY 2018 product,
establishment, and sponsor fees by December 31, 2017, and payment will
be due by January 31, 2018. The application fee rates are effective for
applications submitted on or after October 1, 2017, and will remain in
effect through September 30, 2018. 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 2018
A. Statutory Fee Revenue Amounts
ADUFA III, Title I of Public Law 113-14, specifies that the
aggregate fee revenue amount for FY 2018 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 of the 4 fiscal
years preceding FY 2018. The 3-year average is 2.2354 percent.
Table 1--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Change
----------------------------------------------------------------------------------------------------------------
Fiscal year 2014 2015 2016 3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B.......................... $2,054,937,000 $2,232,304,000 $2,414,728,159 .................
Total FTE........................... 14,555 15,484 16,381 .................
PC&B per FTE........................ $141,184 $144,168 $147,408 .................
Percent Change from Previous Year... 2.3451% 2.1136% 2.2474% 2.2354%
----------------------------------------------------------------------------------------------------------------
[[Page 35967]]
The statute specifies that this 2.2354 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 2014 2015 2016 3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B.......................... $2,054,937,000 $2,232,304,000 $2,414,728,159 .................
Total Costs......................... $4,298,476,000 $4,510,565,000 $4,666,236,000 .................
PC&B Percent........................ 47.8062% 49.4906% 51.7490 49.6819%
----------------------------------------------------------------------------------------------------------------
The payroll adjustment is 2.2354 percent multiplied by 49.6819
percent (or 1.1106 percent).
The statute specifies that the portion of the inflation adjustment
for non-payroll costs for FY 2018 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 2014 2015 2016 3-Year average
----------------------------------------------------------------------------------------------------------------
Annual CPI.......................... 149.581 152.242 154.702 .................
Annual Percent Change............... 1.7883% 1.7790% 1.6158% 1.7277%
----------------------------------------------------------------------------------------------------------------
To calculate the inflation adjustment for non-pay costs, we
multiply the 1.7277 percent by the proportion of all costs other than
PC&B to total FDA costs. Since 49.6819 percent was obligated for PC&B
as shown in table 2, 50.3181 percent is the portion of costs other than
PC&B (100 percent -49.6819 percent = 50.3181 percent). The non-payroll
adjustment is 1.7277 percent times 50.3181 percent, or 0.8693 percent.
Next, we add the payroll component (1.1106 percent) to the non-pay
component (0.8693 percent), for a total inflation adjustment of 1.9799
percent for FY 2018.
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 2018 (1.9799 percent) is compounded by adding 1 and then
multiplying by 1 plus the inflation adjustment factor for FY 2017
(6.0746 percent), as published in the Federal Register of July 28, 2016
(81 FR 49664 to 49669), which equals 1.081748 (rounded) (1.019799 x
1.060746) for FY 2018. We then multiply the base revenue amount for FY
2018 ($21,600,000) by 1.081748, yielding an inflation adjusted amount
of $23,365,757.
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, 2017.
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 5.4599 percent for FY 2018. This is the
workload adjuster for FY 2018.
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 average latest 5-year percent weighting percent
(base years) average change factor change
----------------------------------------------------------------------------------------------------------------
New Animal Drug Applications 9.8000 16.0 63.2653 0.030373 1.9216
(NADAs)........................
Supplemental NADAs with Safety 9.6000 10.6 10.4167 0.026491 0.2759
or Efficacy Data...............
Manufacturing Supplements....... 361.0000 334.6 -7.3130 0.162018 -1.1848
Investigational Study 216.4000 189.8 -12.2921 0.579781 -7.1267
Submissions....................
Investigational Protocol 133.6000 210.4 57.4850 0.201337 11.5739
Submissions....................
[[Page 35968]]
FY 2018 Workload Adjuster....... .............. .............. .............. .............. 5.4599
----------------------------------------------------------------------------------------------------------------
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 has 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.
The increases in these submissions are consistent with an overall
increase in workload including all submissions and communications with
sponsors. In addition, CVM is not seeing a corresponding decrease in
any of the other submission types that might have served to offset
workload. As a result, the statutory revenue amount after the inflation
adjustment ($23,365,757) must now be increased by 5.4599 percent to
reflect the changes in review workload (workload adjustment), for a
total fee revenue target of $24,641,504.
D. Offset for Excess Collections Through FY 2017
Under section 740(g)(4) of the FD&C Act, if the sum of the
cumulative amount of the fees collected for FY 2014 through FY 2016,
and the amount of fees estimated to be collected for FY 2017, exceeds
the cumulative amount appropriated for fees for FY 2014 through FY
2017, the excess shall be credited to FDA's appropriation account and
subtracted from the amount of fees that FDA would otherwise be
authorized to collect for FY 2018 under the FD&C Act. (21 U.S.C. 379j-
12(g)(4)).
Table 5 shows the amounts specified in appropriation acts for each
year from FY 2014 through FY 2017, and the amounts FDA has collected
for FY 2014, FY 2015, FY 2016, and FY 2017 as of June 30, 2017, and an
additional $21,941,000 (rounded to the nearest thousand dollars) that
FDA estimates it will collect in FY 2017 based on historical data.
Table 5 shows the estimated cumulative difference between ADUFA fee
amounts specified in appropriation acts for FY 2014 through FY 2017 and
ADUFA fee amounts collected.
Table 5--Offsets To Be Taken for ADUFA III
----------------------------------------------------------------------------------------------------------------
Amount in
Collection excess of
amount collection
Fiscal year Collections specified in amount
realized appropriation specified in
acts appropriation
acts
----------------------------------------------------------------------------------------------------------------
2014............................................................ $27,184,831 $23,600,000 $3,584,831
2015............................................................ 24,535,338 22,464,000 2,071,338
2016............................................................ 25,442,477 22,818,000 2,624,477
2017............................................................ 21,941,000 23,673,000 -1,732,000
-----------------------------------------------
Net Balance to be Offset When Fees are Set for FY 2018...................................... 6,548,646
----------------------------------------------------------------------------------------------------------------
Note: FY 2017 `Collections Realized' is the amount FDA estimates it will collect in FY 2017 based on historical
data.
The cumulative fees collected for FY 2014 through FY 2017 are
estimated to be $6,548,646 greater than the cumulative fee amounts
specified in appropriation acts during this same period. Reducing the
inflation and workload adjusted amount of $24,641,504 by the ADUFA III
offset of $6,548,646 results in an amount of $18,093,000 (rounded to
the nearest thousand), before the final year adjustment.
E. Final Year Adjustment
Under section 740(c)(4) of the FD&C Act, for FY 2018 the Secretary
of Health and Human Services (the Secretary) may, in addition to the
inflation and workload adjustments, further increase the fees if such
an adjustment is necessary to provide for not more than 3 months of
operating reserves of carryover user fees for the process for the
review of animal drug applications for the first 3 months of FY 2019.
If such an adjustment is necessary, the rationale for the amount of
this increase must be included in the annual notice establishing fees
for FY 2018 (21 U.S.C. 379j-12(c)(4)).
After calculating the operating reserves and estimating the balance
as of the beginning of FY 2019, FDA estimates that the ADUFA program
will have sufficient funds for the operating reserves, thus FDA will
not be performing a final year adjustment for
[[Page 35969]]
FY 2019 because FDA has determined such an adjustment to be
unnecessary.
F. FY 2018 Fee Revenue Amounts
ADUFA III specifies that the revenue amount of $18,093,000 for FY
2018 is to be divided as follows: 20 percent, or a total of $3,619,000
(rounded to the nearest thousand dollars), is to come from application
fees; 27 percent, or a total of $4,885,000 (rounded to the nearest
thousand dollars), is to come from product fees; 26 percent, or a total
of $4,704,000 (rounded to the nearest thousand dollars), is to come
from establishment fees; and 27 percent, or a total of $4,885,000
(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 2018
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) of the FD&C Act (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)
of the FD&C Act 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 $3,619,000 in fee revenue for FY 2018. 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 $3,619,000 FDA must first make some
assumptions about the number of fee-paying applications and supplements
the Agency will receive in FY 2018.
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 2018, FDA is assuming that the number of
applications that will pay fees in FY 2018 will equal the average
number of submissions over the five most recent completed years of the
ADUFA program (FY 2012 to FY 2016). FDA believes that this is a
reasonable approach after 13 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 8.2. Over this same period, the average number of supplemental
applications for which safety or effectiveness data are required 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
14.0.
B. Application Fee Rates for FY 2018
FDA must set the fee rates for FY 2018 so that the estimated 8.2
applications that pay the full fee and the estimated 14.0 supplemental
applications for which safety or effectiveness data are required 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
$3,619,000. To generate this amount, the fee for an animal drug
application, rounded to the nearest $100, will have to be $238,100, 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
$119,050.
IV. Product Fee Calculations for FY 2018
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 (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 $4,885,000 in fee revenue for FY 2018.
To set animal drug product fees to realize $4,885,000, FDA must
make some assumptions about the number of products for which these fees
will be paid in FY 2018. 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
2017, FDA estimates that there are a total of 815 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 815 products will be
subject to this fee in FY 2018.
In estimating the fee revenue to be generated by animal drug
product fees in FY 2018, FDA is assuming that 3 percent of the products
invoiced, or 24, will not pay fees in FY 2018 due to fee waivers and
reductions. FDA has kept this estimate at 3 percent this year, based on
historical data over the past five completed years of the ADUFA
program. Based on experience over the first 13 completed years of the
ADUFA program, FDA believes that this is a reasonable basis for
estimating the number of fee-paying products in FY 2018.
Accordingly, the Agency estimates that a total of 791 (815 minus
24) products will be subject to product fees in FY 2018.
B. Product Fee Rates for FY 2018
FDA must set the fee rates for FY 2018 so that the estimated 791
products that pay fees will generate a total of $4,885,000. To generate
this amount will require the fee for an animal drug product, rounded to
the nearest $5, to be $6,175.
V. Establishment Fee Calculations for FY 2018
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
[[Page 35970]]
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 $4,704,000 in fee revenue for FY 2018.
To set animal drug establishment fees to realize $4,704,000, FDA
must make some assumptions about the number of establishments for which
these fees will be paid in FY 2018. 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 2017, FDA estimates that there are a total of 60
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 60 establishments
will be subject to this fee in FY 2018.
In estimating the fee revenue to be generated by animal drug
establishment fees in FY 2018, FDA is assuming that 11 percent of the
establishments invoiced, or seven, will not pay fees in FY 2018 due to
fee waivers and reductions. FDA has kept this estimate at 11 percent
this year, based on historical data over the past 5 completed years.
Based on experience over the past 13 completed years of the ADUFA
program, FDA believes that this is a reasonable basis for estimating
the number of fee-paying establishments in FY 2018.
Accordingly, the Agency estimates that a total of 53 establishments
(60 minus 7) will be subject to establishment fees in FY 2018.
B. Establishment Fee Rates for FY 2018
FDA must set the fee rates for FY 2018 so that the estimated 53
establishments that pay fees will generate a total of $4,704,000. To
generate this amount will require the fee for an animal drug
establishment, rounded to the nearest $50, to be $88,750.
VI. Sponsor Fee Calculations for FY 2018
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 $4,885,000 in fee revenue for FY 2018.
To set animal drug sponsor fees to realize $4,885,000, FDA must
make some assumptions about the number of sponsors who will pay these
fees in FY 2018. Based on the number of firms that would have met this
definition in each of the past 13 completed years of the ADUFA program,
FDA estimates that a total of 198 sponsors will meet this definition in
FY 2018.
A review of our records indicates that 35 percent of these sponsors
will qualify for a minor use/minor species fee 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 133, who will not pay fees in FY
2018 due to fee waivers and reductions. FDA has kept this estimate at
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
2018.
Accordingly, the Agency estimates that a total of 65 sponsors (198
minus 133) will be subject to and pay sponsor fees in FY 2018.
B. Sponsor Fee Rates for FY 2018
FDA must set the fee rates for FY 2018 so that the estimated 65
sponsors that pay fees will generate a total of $4,885,000. To generate
this amount will require the fee for an animal drug sponsor, rounded to
the nearest $50, to be $75,150.
VII. Fee Schedule for FY 2018
The fee rates for FY 2018 are summarized in Table 6.
Table 6--FY 2018 Fee Rates
------------------------------------------------------------------------
Fee rate for
Animal drug user fee category FY 2018
------------------------------------------------------------------------
Animal Drug Application Fees:
Animal Drug Application............................. $238,100
Supplemental Animal Drug Application for Which 119,050
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................................. 6,175
Animal Drug Establishment Fee\1\........................ 88,750
Animal Drug Sponsor Fee\2\.............................. 75,150
------------------------------------------------------------------------
\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.
[[Page 35971]]
VIII. Procedures for Paying the FY 2018 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, 2017. The
payment must be made in U.S. currency by one of the following methods:
Wire transfer, electronically, check, bank draft, or U.S. postal money
order made payable to the Food and Drug Administration. 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. (Note: only full payments are accepted.
No partial payments can be made online.) Once you search for and find
your invoice, select ``Pay Now'' to be redirected to Pay.gov.
Electronic payment options are based on the balance due. Payment by
credit card is available only for balances that are less than $25,000.
If the balance exceeds this amount, only the ACH option is available.
Payments must be made using U.S. bank accounts as well as U.S. credit
cards.
When paying by check, bank draft, or U.S. postal money order,
please write your application's unique Payment Identification Number
(PIN), beginning with the letters AD, on 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. Mail the payment and a copy of the completed
Animal Drug User Fee Cover Sheet to: Food and Drug Administration, P.O.
Box 979033, St. Louis, MO 63197-9000. When paying by wire transfer, the
invoice number needs to be included; without the invoice number, the
payment may not be applied. If the payment amount is not applied, the
invoice amount would be referred to collections. The originating
financial institution may charge a wire transfer fee. If the financial
institution charges a wire transfer fee, it is required to add that
amount to the payment to ensure that the invoice is paid in full.
Use the following account information when sending a payment by
wire transfer: 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.
To send a check by a courier such as Federal Express, the courier
must 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 U.S. Bank at
314-418-4013. This telephone number is only for questions about courier
delivery.)
It is important that 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.
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.)
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 select ``Create
ADUFA User Fee Cover Sheet.'' For security reasons, each firm
submitting an application will be assigned an organization
identification number, and each user will also be required to set up a
user account and password the first time you use this site. Online
instructions will walk you through this process.
Step Two--Create an Animal Drug User Cover Sheet, transmit it to
FDA, and print a copy. After logging into your account with your user
name and password, complete the steps required to create an Animal Drug
User Fee Cover Sheet. One cover sheet is needed for each animal drug
application or supplement. Once you are satisfied that the data on the
cover sheet is accurate and you have finalized the cover sheet, you
will be able to transmit it electronically to FDA and you will be able
to print a copy of your cover sheet showing your unique PIN.
Step Three--Send the payment for your application as described in
section VIII.A.
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, 2017, FDA will issue invoices and payment
instructions for product, establishment, and sponsor fees for FY 2018
using this fee schedule. Payment will be due by January 31, 2018. FDA
will issue invoices in November 2018 for any products, establishments,
and sponsors subject to fees for FY 2018 that qualify for fees after
the December 2017 billing.
Dated: July 26, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-16180 Filed 8-1-17; 8:45 am]
BILLING CODE 4164-01-P