Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2018, 35957-35962 [2017-16181]
Download as PDF
<![CDATA[
Federal Register / Vol. 82, No. 147 / Wednesday, August 2, 2017 / Notices
domestic facility (as defined in section
415(b) of the FD&C Act) and by the U.S.
agent for each foreign facility (section
743(a)(1)(A) of the FD&C Act). This is
the party to whom FDA will send the
invoice for any fees that are assessed
under this section.
C. How much will this fee be?
The fee is based on the number of
direct hours spent on such
reinspections, including time spent
conducting the physical surveillance
and/or compliance reinspection at the
facility, or whatever components of
such an inspection are deemed
necessary, making preparations and
arrangements for the reinspection,
traveling to and from the facility,
preparing any reports, analyzing any
samples or examining any labels if
required, and performing other activities
as part of the OAI reinspection until the
facility is again determined to be in
compliance. The direct hours spent on
each such reinspection will be billed at
the appropriate hourly rate shown in
table 2.
IV. Fees for Non-Compliance With a
Recall Order Under Section 743(a)(1)(B)
sradovich on DSKBCFCHB2PROD with NOTICES
A. What will cause this fee to be
assessed?
The fee will be assessed for not
complying with a recall order under
section 423(d) (21 U.S.C. 350l(d)) or
section 412(f) of the FD&C Act (21
U.S.C. 350a(f)) to cover food recall
activities associated with such order
performed by the Secretary (and by
delegation, FDA) (section 743(a)(1)(B) of
the FD&C Act). Non-compliance may
include the following: (1) Not initiating
a recall as ordered by FDA; (2) not
conducting the recall in the manner
specified by FDA in the recall order; or
(3) not providing FDA with requested
information regarding the recall, as
ordered by FDA.
B. Who will be responsible for paying
this fee?
Section 743(a)(1)(B) of the FD&C Act
states that the fee is to be paid by the
responsible party for a domestic facility
(as defined in section 415(b) of the
FD&C Act) and an importer who does
not comply with a recall order under
section 423 or under section 412(f) of
the FD&C Act. In other words, the party
paying the fee would be the party that
received the recall order.
C. How much will this fee be?
The fee is based on the number of
direct hours spent on taking action in
response to the firm’s failure to comply
with a recall order. Types of activities
could include conducting recall audit
VerDate Sep<11>2014
19:43 Aug 01, 2017
Jkt 241001
checks, reviewing periodic status
reports, analyzing the status reports and
the results of the audit checks,
conducting inspections, traveling to and
from locations, and monitoring product
disposition. The direct hours spent on
each such recall will be billed at the
appropriate hourly rate shown in table
2.
V. How must the fees be paid?
An invoice will be sent to the
responsible party for paying the fee after
FDA completes the work on which the
invoice is based. Payment must be made
within 90 days of the invoice date in
U.S. currency by check, bank draft, or
U.S. postal money order payable to the
order of the Food and Drug
Administration. Detailed payment
information will be included with the
invoice when it is issued.
VI. What are the consequences of not
paying these fees?
Under section 743(e)(2) of the FD&C
Act, any fee that is not paid within 30
days after it is due shall be treated as a
claim of the U.S. Government subject to
provisions of subchapter II of chapter 37
of title 31, United States Code.
Dated: July 25, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–16184 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 Generic 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
fee rates and payment procedures for
fiscal year (FY) 2018 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
SUMMARY:
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
35957
new animal drugs. 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/AnimalGeneric
DrugUserFeeActAGDUFA/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 cvmagdufa@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Section 741 of the FD&C Act (21
U.S.C. 379j–21) establishes three
different types of user fees: (1) Fees for
certain types of abbreviated applications
for generic new animal drugs; (2) annual
fees for certain generic new animal drug
products; and (3) annual fees for certain
sponsors of abbreviated applications for
generic new animal drugs and/or
investigational submissions for generic
new animal drugs (21 U.S.C. 379j–
21(a)). When certain conditions are met,
FDA will waive or reduce fees for
generic new animal drugs intended
solely to provide for a minor use or
minor species indication (21 U.S.C.
379j–21(d)).
For FY 2014 through FY 2018, the
FD&C Act establishes aggregate yearly
base revenue amounts for each of these
fee categories (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 2018, after
the adjustment for workload, are as
follows: For application fees, the target
revenue amount is $2,355,000; for
product fees, the target revenue amount
is $3,532,000; and for sponsor fees, the
target revenue amount is $3,532,000.
For FY 2018, the generic new animal
drug user fee rates are: $193,000 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)); $96,500 for each
abbreviated application for a generic
new animal drug subject to the criteria
in section 512(d)(4); $8,195 for each
generic new animal drug product;
$76,250 for each generic new animal
drug sponsor paying 100 percent of the
sponsor fee; $57,188 for each generic
new animal drug sponsor paying 75
percent of the sponsor fee; and $38,125
for each generic new animal drug
sponsor paying 50 percent of the
sponsor fee. FDA will issue invoices for
E:\FR\FM\02AUN1.SGM
02AUN1
35958
Federal Register / Vol. 82, No. 147 / Wednesday, August 2, 2017 / Notices
FY 2018 product and sponsor fees by
December 31, 2017. These fees will be
due by January 31, 2018. The
application fee rates are effective for all
abbreviated applications for a generic
new animal drug 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 related application fees and
any other fees owed under the Animal
Generic Drug User Fee program
(AGDUFA program).
II. Revenue Amount for FY 2018
A. Statutory Fee Revenue Amounts
AGDUFA II, Title II of Public Law
113–14, specifies that the aggregate
revenue amount for FY 2018 for
abbreviated application fees is
$2,117,000 and each of the other two
generic new animal drug user fee
categories, annual product fees and
annual sponsor fees, is $3,175,000 each
(see 21 U.S.C. 379j–21(b)).
B. Inflation Adjustment to Fee Revenue
Amount
The amounts established in AGDUFA
II for each year for FY 2014 through FY
2018 include an inflation adjustment;
therefore, no further inflation
adjustment is required.
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, 2017.
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
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 1, the sum of the values in
column 5 is calculated, reflecting a total
change in workload of 51.4457 percent
for FY 2018. This is the workload
adjuster for FY 2018.
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,
TABLE 1—WORKLOAD ADJUSTER CALCULATION
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
25.0
128.0
23.0
17.2
28.00
155.40
51.40
31.60
12.0
21.4
123.5
83.7
0.342876
0.275337
0.238287
0.143501
4.1145
5.8939
29.4233
12.0140
FY 2018 AGDUFA II Workload Adjuster ......................
sradovich on DSKBCFCHB2PROD with NOTICES
Abbreviated New Animal Drug Applications (ANADAs) ......
Manufacturing Supplements ANADAs .................................
Generic Investigational Study Submissions ........................
Generic Investigational Protocol Submissions ....................
........................
........................
........................
........................
51.4457
Over the last year FDA has continued
to see more sponsors getting involved in
the generic animal drug approval
process, including pioneer sponsors.
This has contributed to sustained
increases in the number of ANADAs,
manufacturing supplements, and
protocols submitted. Additionally, more
sponsors continue to pursue drug
approvals that do not qualify for a
waiver from the requirement to conduct
an in vivo bioequivalence study. For
this reason we are seeing a large
sustained increase in the number of
generic investigational new animal drug
study submissions.
As a result, the statutory revenue
amount for each category of fees for FY
2018 ($2,117,000 for application fees
and $3,175,000 for both product and
sponsor fees) must now be increased by
51.4457 percent, for a total fee revenue
target in FY 2018 of $12,822,907 for fees
VerDate Sep<11>2014
19:43 Aug 01, 2017
Jkt 241001
from all three categories before the offset
for excess collections through FY 2018.
The target for application fee revenue
before the offset is $2,117,000 ×
151.4457 percent, for a total of
$3,206,105, rounded to the nearest
dollar. The target for product fee
revenue before the offset is $3,175,000
× 151.4457 percent, for a total of
$4,808,401, rounded to the nearest
dollar, and the target for sponsor fee
revenue before the offset is the same as
for product fees ($4,808,401, rounded to
the nearest dollar).
D. Offset for Excess Collections Through
FY 2017
Under the provisions 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
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
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 (see
section 741(g)(4) of the FD&C Act).
Table 2 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
$11,810,000 (rounded to the nearest
thousand dollars) that FDA estimates it
will collect in FY 2017 based on
historical data. Table 2 shows the
estimated cumulative difference
between AGDUFA II fee amounts
specified in appropriation acts for FY
2014 through FY 2017 and AGDUFA II
fee amounts collected.
E:\FR\FM\02AUN1.SGM
02AUN1
Federal Register / Vol. 82, No. 147 / Wednesday, August 2, 2017 / Notices
35959
TABLE 2—OFFSETS TO BE TAKEN FOR AGDUFA II
Collections
realized
Fiscal year
2014
2015
2016
2017
Collection
amount
specified in
appropriation
acts
Amount in
excess of
collection
amount
specified in
appropriation
acts
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
$8,388,928
9,982,041
8,541,304
11,810,000
$7,328,000
6,944,000
9,705,000
11,341,000
$1,060,928
3,038,041
¥1,163,696
469,000
Net Balance to be Offset When Fees are Set for FY 2018 .................................................
........................
........................
3,404,273
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 $3,404,273 greater than the
cumulative fee amounts specified in
appropriation acts during this same
period. Reducing the workload adjusted
amount of $12,822,907 by the AGDUFA
II offset of $3,404,273 results in an
amount of $9,419,000 (rounded to the
nearest thousand dollars), before the
final year adjustment.
Reducing the fees to achieve the
offset-adjusted target revenue (as a
percentage of workload-adjusted target
revenue) yields the following revenue
by fee type: The target for application
fee revenue after the offset is $9,419,000
× 25 percent, for a total of $2,355,000,
rounded to the nearest thousand. The
target for product fee revenue after the
offset is $9,419,000 × 37.5 percent, for
a total of $3,532,000, rounded to the
nearest thousand, and the target for
sponsor fee revenue after the offset is
the same as for product fees ($3,532,000,
rounded to the nearest thousand).
sradovich on DSKBCFCHB2PROD with NOTICES
E. Final Year Adjustment
Under the provisions of the FD&C
Act, for FY 2018 the Secretary of Health
and Human Services may, in addition to
the workload adjustment, 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 abbreviated applications
for generic new animal drugs for the
first 3 months of FY 2019. If such an
adjustment is necessary, the rationale
for the amount of this increase shall be
contained in the annual notice
establishing fees for FY 2018 (see
section 741(c)(3) of the FD&C Act).
After calculating the operating
reserves and estimating the balance as of
the beginning of FY 2019, FDA
estimates that the AGDUFA program
will have sufficient funds for the
operating reserves; thus, FDA will not
be performing a final year adjustment
VerDate Sep<11>2014
19:43 Aug 01, 2017
Jkt 241001
for FY 2019 because FDA has
determined such an adjustment to be
unnecessary.
III. Abbreviated Application Fee
Calculations for FY 2018
A. Application Fee Revenues and
Numbers of Fee-Paying Applications
Each person that submits an
abbreviated application for a generic
new animal drug shall be subject to an
application fee, with limited exceptions
(21 U.S.C. 379j–21(a)(1)). The term
‘‘abbreviated application for a generic
new animal drug’’ means an abbreviated
application for the approval of any
generic new animal drug submitted
under section 512(b)(2) (21 U.S.C. 379j–
21(k)(1)). The application fees are to be
set so that they will generate $2,355,000
in fee revenue for FY 2018.
To set fees for abbreviated
applications for generic new animal
drugs to realize $2,355,000, FDA must
first make some assumptions about the
number of fee-paying abbreviated
applications it will receive during FY
2018.
The Agency knows the number of
applications that have been submitted
in previous years. That number
fluctuates from year to year. FDA is
making estimates and applying different
assumptions for two types of full fee
submissions: Original submissions of
abbreviated applications for generic new
animal drugs and ‘‘reactivated’’
submissions of abbreviated applications
for generic new animal drugs. Any
original submissions of abbreviated
applications for generic new animal
drugs that were received by FDA before
July 1, 2008, were not assessed fees (21
U.S.C. 379j–21(a)(1)(A)). Some of these
non-fee-paying submissions were later
resubmitted on or after July 1 because
the initial submission was not approved
by FDA (i.e., FDA marked the
submission as incomplete and requested
additional non-administrative
information) or because the original
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
submission was withdrawn by the
sponsor. Abbreviated applications for
generic new animal drugs resubmitted
on or after July 1, 2008, are subject to
user fees. In this notice, FDA refers to
these resubmitted applications as
‘‘reactivated’’ applications.
Also, under AGDUFA II, an
abbreviated application for an animal
generic drug subject to the criteria in
section 512(d)(4) of the FD&C Act and
submitted on or after October 1, 2013,
shall be subject to 50 percent of the fee
applicable to all other abbreviated
applications for a generic new animal
drug (21 U.S.C. 379j–21(a)(1)(C)(ii)).
Regarding original submissions of
abbreviated applications for generic new
animal drugs, FDA is assuming that the
number of applications that will pay
fees in FY 2018 will equal the average
number of submissions over the 5 most
recently completed years of the
AGDUFA program (FY 2012–FY 2016).
FDA believes that this is a reasonable
approach after 8 complete years of
experience with this program.
The average number of original
submissions of abbreviated applications
for generic new animal drugs over the
5 most recently completed years is 10
applications not subject to the criteria in
section 512(d)(4) of the FD&C Act and
4.4 submissions subject to the criteria in
section 512(d)(4). Each of the
submissions described under section
512(d)(4) of the FD&C Act pays 50
percent of the fee paid by the other
applications and will be counted as one
half of a fee. Adding all of the
applications not subject to the criteria in
section 512(d)(4) of the FD&C Act and
50 percent of the number that are
subject to such criteria results in a total
of 12.2 anticipated full fees.
In prior years, FDA had estimated the
number of reactivations of abbreviated
applications for generic new animal
drugs that had been originally submitted
prior to July 1, 2008. Over the years, that
number has decreased to the point that
E:\FR\FM\02AUN1.SGM
02AUN1
35960
Federal Register / Vol. 82, No. 147 / Wednesday, August 2, 2017 / Notices
FDA no longer expects to receive any
reactivations of applications initially
submitted prior to July 1, 2008, and will
include no provision for them in its fee
estimates. Should such a submission be
made, the submitter will be expected to
pay the appropriate fee.
Based on the previous assumptions,
FDA is estimating that it will receive a
total of 12.2 fee-paying generic new
animal drug applications in FY 2018 (10
original applications paying a full fee
and 4.4 applications paying a half fee).
B. Application Fee Rates for FY 2018
FDA must set the fee rates for FY 2018
so that the estimated 12.2 abbreviated
applications that pay the fee will
generate a total of $2,355,000. To
generate this amount, the fee for a
generic new animal drug application,
rounded to the nearest hundred dollars,
will have to be $193,000, and for those
applications that are subject to the
criteria set forth in section 512(d)(4) of
the FD&C Act, 50 percent of that
amount, or $96,500.
sradovich on DSKBCFCHB2PROD with NOTICES
IV. Generic New Animal Drug Product
Fee Calculations for FY 2018
A. Product Fee Revenues and Numbers
of Fee-Paying Products
The generic new animal drug product
fee (also referred to as the product fee)
must be paid annually by the person
named as the applicant in an
abbreviated application or supplemental
abbreviated application for a generic
new animal drug product submitted for
listing under section 510 of the FD&C
Act (21 U.S.C. 360), and who had an
abbreviated application or supplemental
abbreviated application for a generic
new animal drug product pending at
FDA after September 1, 2008 (see 21
U.S.C. 379j–21(a)(2)). The term ‘‘generic
new 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 abbreviated
application for a generic new animal
drug or supplemental abbreviated
application for a generic new animal
drug has been approved (21 U.S.C. 379j–
21(k)(6)). The product fees are to be set
so that they will generate $3,532,000 in
fee revenue for FY 2018.
To set generic new animal drug
product fees to realize $3,532,000, FDA
must make some assumptions about the
number of products for which these fees
will be paid in FY 2018. FDA gathered
VerDate Sep<11>2014
19:43 Aug 01, 2017
Jkt 241001
data on all generic new 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 FDA estimated would have
an abbreviated new animal drug
application or supplemental abbreviated
application pending after September 1,
2008. As of June 2017, FDA estimates a
total of 431 products submitted for
listing by persons who had an
abbreviated application for a generic
new animal drug or supplemental
abbreviated application for a generic
new animal drug pending after
September 1, 2008. Based on this, FDA
believes that a total of 431 products will
be subject to this fee in FY 2018.
In estimating the fee revenue to be
generated by generic new animal drug
product fees in FY 2018, FDA is
assuming that less than two products
invoiced will qualify for minor use/
minor species fee waiver (see 21 U.S.C.
379j–21(d)). FDA has kept this estimate
at zero percent this year, based on
historical data over the past 5 completed
years of the AGDUFA program.
Accordingly, the Agency estimates
that a total of 431 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 431 products that
pay fees will generate a total of
$3,532,000. To generate this amount
will require the fee for a generic new
animal drug product, rounded to the
nearest $5, to be $8,195.
V. Generic New Animal Drug Sponsor
Fee Calculations for FY 2018
A. Sponsor Fee Revenues and Numbers
of Fee-Paying Sponsors
The generic new 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
abbreviated application for a generic
new animal drug, 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 submission for a generic
new animal drug that has not been
terminated or otherwise rendered
inactive and (2) had an abbreviated
application for a generic new animal
drug, supplemental abbreviated
application for a generic new animal
drug, or investigational submission for a
generic new animal drug pending at
FDA after September 1, 2008 (see 21
U.S.C. 379j–21(k)(7) and 379j–21(a)(3),
respectively). A generic new animal
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
drug sponsor is subject to only one such
fee each fiscal year (see 21 U.S.C. 379j–
21(a)(3)(C)). Applicants with more than
six approved abbreviated applications
will pay 100 percent of the sponsor fee;
applicants with more than one and
fewer than seven approved abbreviated
applications will pay 75 percent of the
sponsor fee; and applicants with one or
fewer approved abbreviated
applications will pay 50 percent of the
sponsor fee (see 21 U.S.C. 379j–
21(a)(3)(C)). The sponsor fees are to be
set so that they will generate $3,532,000
in fee revenue for FY 2018.
To set generic new animal drug
sponsor fees to realize $3,532,000, FDA
must make some assumptions about the
number of sponsors who will pay these
fees in FY 2018. FDA now has 8
complete years of experience collecting
these sponsor fees. Based on the number
of firms that meet this definition and the
average number of firms paying fees at
each level over the 5 most recently
completed years of the AGDUFA
program (FY 2012 through FY 2016),
FDA estimates that in FY 2018, 14
sponsors will pay 100 percent fees, 17
sponsors will pay 75 percent fees, and
42 sponsors will pay 50 percent fees.
That totals the equivalent of 47.75 full
sponsor fees (14 × 100 percent or 14,
plus 17 × 75 percent or 12.75, plus 42
× 50 percent or 21).
FDA estimates that about 3 percent of
all of these sponsors, or 1.43, may
qualify for a minor use/minor species
fee waiver (see 21 U.S.C. 379j–21(d)).
FDA has kept the estimate of the
percentage of sponsors that will not pay
fees at 3 percent this year, based on
historical data over the past 5 completed
years of the AGDUFA program.
Accordingly, the Agency estimates
that the equivalent of 46.32 full sponsor
fees (47.75 minus 1.43) are likely to be
paid in FY 2018.
B. Sponsor Fee Rates for FY 2018
FDA must set the fee rates for FY 2018
so that the estimated equivalent of 46.32
full sponsor fees will generate a total of
$3,532,000. To generate this amount
will require the 100 percent fee for a
generic new animal drug sponsor,
rounded to the nearest $50, to be
$76,250. Accordingly, the fee for those
paying 75 percent of the full sponsor fee
will be $57,188, and the fee for those
paying 50 percent of the full sponsor fee
will be $38,125.
VI. Fee Schedule for FY 2018
The fee rates for FY 2018 are
summarized in table 3.
E:\FR\FM\02AUN1.SGM
02AUN1
Federal Register / Vol. 82, No. 147 / Wednesday, August 2, 2017 / Notices
35961
TABLE 3—FY 2018 FEE RATES
Fee rate for
FY 2018
Generic new animal drug user fee category
Abbreviated Application Fee for Generic New Animal Drug except those subject to the criteria in section 512(d)(4) .....................
Abbreviated Application Fee for Generic New Animal Drug subject to the criteria in section 512(d)(4) ...........................................
Generic New Animal Drug Product Fee ..............................................................................................................................................
100 Percent Generic New Animal Drug Sponsor Fee 1 ......................................................................................................................
75 Percent Generic New Animal Drug Sponsor Fee 1 ........................................................................................................................
50 Percent Generic New Animal Drug Sponsor Fee 1 ........................................................................................................................
1 An
animal drug sponsor is subject to only one fee each fiscal year.
VII. Procedures for Paying FY 2018
Generic New Animal Drug User Fees
A. Abbreviated Application Fees and
Payment Instructions
sradovich on DSKBCFCHB2PROD with NOTICES
$193,000
96,500
8,195
76,250
57,188
38,125
The FY 2018 fee established in the
new fee schedule must be paid for an
abbreviated new animal drug
application subject to fees under
AGDUFA II that is submitted on or after
October 1, 2017. The payment must be
made in U.S. currency from a U.S. bank
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 an 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 have found 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 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, beginning with
the letters ‘‘AG’’, on the upper righthand corner of your completed Animal
Generic 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 Generic Drug
User Fee Cover Sheet to: Food and Drug
Administration, P.O. Box 979033, St.
Louis, MO 63197–9000.
VerDate Sep<11>2014
19:43 Aug 01, 2017
Jkt 241001
When paying by wire transfer, it is
required that the invoice number is
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 wire transfer: U.S. Department
of the Treasury, TREAS NYC, 33 Liberty
St., New York, NY 10045, Account
Name: Food and Drug Administration,
Account No.: 75060099, Routing No.:
021030004, Swift No.: 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 phone
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
abbreviated application arrives at FDA’s
Center for Veterinary Medicine (CVM).
FDA records the official abbreviated
application receipt date as the later of
the following: The date the application
was received by CVM, or the date U.S.
Bank notifies FDA that your payment in
the full amount has been received, or
when the U.S. Department of the
Treasury notifies FDA of payment. U.S.
Bank and the United States Treasury are
required to notify FDA within 1 working
day, using the Payment Identification
Number 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.)
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
B. Application Cover Sheet Procedures
Step One—Create a user account and
password. Log onto the AGDUFA Web
site at https://www.fda.gov/ForIndustry/
UserFees/AnimalGenericDrug
UserFeeActAGDUFA/ucm137049.htm
and scroll down the page until you find
the link ‘‘Create AGDUFA User Fee
Cover Sheet.’’ Select that link and
follow the directions. 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 Generic
Drug User Fee 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 Generic
Drug User Fee Cover Sheet. One cover
sheet is needed for each abbreviated
animal drug application. 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 Payment
Identification Number.
Step Three—Send the payment for
your application as described in section
VII.A of this document.
Step Four—Please submit your
application and a copy of the completed
Animal Generic 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 and Sponsor Fees
By December 31, 2017, FDA will issue
invoices and payment instructions for
product and sponsor fees for FY 2018
using this fee schedule. Fees will be due
by January 31, 2018. FDA will issue
invoices in November 2018 for any
products and sponsors subject to fees for
E:\FR\FM\02AUN1.SGM
02AUN1
35962
Federal Register / Vol. 82, No. 147 / Wednesday, August 2, 2017 / Notices
For questions relating to this notice:
Rachel Richter, Office of Financial
Management, Food and Drug
Administration, 8455 Colesville Rd.,
COLE–14216, Silver Spring, MD 20993–
0002, 301–796–7111.
SUPPLEMENTARY INFORMATION:
FY 2018 that qualify for fees after the
December 2017 billing.
Dated: July 26, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–16181 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]
Outsourcing Facility Fee Rates for
Fiscal Year 2018
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
fiscal year (FY) 2018 rates for the
establishment and re-inspection fees
related to entities that compound
human drugs and elect to register as
outsourcing facilities under the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act). The FD&C Act authorizes
FDA to assess and collect an annual
establishment fee from outsourcing
facilities, as well as a re-inspection fee
for each re-inspection of an outsourcing
facility. This document establishes the
FY 2018 rates for the small business
establishment fee ($5,364), the nonsmall business establishment fee
($17,364), and the re-inspection fee
($16,093) for outsourcing facilities;
provides information on how the fees
for FY 2018 were determined; and
describes the payment procedures
outsourcing facilities should follow.
These fee rates are effective October 1,
2017, and will remain in effect through
September 30, 2018.
FOR FURTHER INFORMATION CONTACT: For
more information on human drug
compounding and outsourcing facility
fees, visit FDA’s Web site at: https://
www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/
PharmacyCompounding/default.htm.
SUMMARY:
I. Background
The Drug Quality and Security Act
(DQSA) contains important provisions
relating to the oversight of
compounding human drugs. Title I of
this law, the Compounding Quality Act,
created a new section 503B in the FD&C
Act (21 U.S.C. 353b). Under section
503B of the FD&C Act, a human drug
compounder can become an
‘‘outsourcing facility.’’
Outsourcing facilities, as defined in
section 503B(d)(4) of the FD&C Act, are
facilities that meet all of the conditions
described in section 503B(a), including
registering with FDA as an outsourcing
facility and paying an annual
establishment fee. If the conditions of
section 503B are met, a drug
compounded by or under the direct
supervision of a licensed pharmacist in
an outsourcing facility is exempt from
three sections of the FD&C Act: (1)
Section 502(f)(1) (21 U.S.C. 352(f)(1))
concerning the labeling of drugs with
adequate directions for use; (2) section
505 (21 U.S.C. 355) concerning the
approval of human drug products under
new drug applications (NDAs) or
abbreviated new drug applications
(ANDAs); and (3) section 582 (21 U.S.C.
360eee-1) concerning drug supply chain
security requirements. Drugs
compounded in outsourcing facilities
are not exempt from the requirements of
section 501(a)(2)(B) of the FD&C Act (21
U.S.C. 351(a)(2)(B)) concerning current
good manufacturing practice
requirements for drugs.
Section 744K of the FD&C Act (21
U.S.C. 379j–62) authorizes FDA to
assess and collect the following fees
associated with outsourcing facilities:
(1) An annual establishment fee from
each outsourcing facility and (2) a reinspection fee from each outsourcing
facility subject to a re-inspection (see
section 744K(a)(1) of the FD&C Act).
Under statutorily defined conditions, a
qualified applicant may pay a reduced
small business establishment fee (see
section 744K(c)(4) of the FD&C Act).
FDA announced in the Federal
Register of November 24, 2014 (79 FR
69856), the availability of a final
guidance for industry entitled ‘‘Fees for
Human Drug Compounding Outsourcing
Facilities Under Sections 503B and
744K of the FD&C Act.’’ The guidance
provides additional information on the
annual fees for outsourcing facilities
and adjustments required by law, reinspection fees, how to submit payment,
the effect of failure to pay fees, and how
to qualify as a small business to obtain
a reduction of the annual establishment
fee. This guidance can be accessed on
FDA’s Web site at: https://www.fda.gov/
downloads/Drugs/GuidanceCompliance
RegulatoryInformation/Guidances/
UCM391102.pdf.
II. Fees for FY 2018
A. Methodology for Calculating FY 2018
Adjustment Factors
1. Inflation Adjustment Factor
Section 744K(c)(2) of the FD&C Act
specifies the annual inflation
adjustment for outsourcing facility fees.
The inflation adjustment has two
components: One based on FDA’s
payroll costs and one based on FDA’s
non-payroll costs for the first 3 of the 4
previous fiscal years. The payroll
component of the annual inflation
adjustment is calculated by taking the
average change in FDA’s per-full time
equivalent (FTE) personnel
compensation and benefits (PC&B) in
the first 3 of the 4 previous fiscal years
(see section 744K(c)(2)(A)(ii) of the
FD&C Act). FDA’s total annual spending
on PC&B is divided by the total number
of FTEs per fiscal year to determine the
average PC&B per FTE.
Table 1 summarizes the 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 3
of the 4 fiscal years preceding FY 2018.
The 3-year average is 2.2354 percent.
TABLE 1—FDA PC&BS EACH YEAR AND PERCENT CHANGE
sradovich on DSKBCFCHB2PROD with NOTICES
Fiscal year
2014
Total PC&B ..............................................................................
Total FTE .................................................................................
PC&B per FTE .........................................................................
Percent change from previous year ........................................
Section 744K(c)(2)(A)(ii) of the FD&C
Act specifies that this 2.2354 percent
should be multiplied by the proportion
VerDate Sep<11>2014
19:43 Aug 01, 2017
Jkt 241001
$2,054,937,000
14,555
$141,184
2.3451%
2015
$2,232,304,000
15,484
$144,168
2.1136%
2016
$2,414,728,159
16,381
$147,408
2.2474%
of PC&B to total costs of an average FDA
FTE for the same 3 fiscal years.
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
E:\FR\FM\02AUN1.SGM
02AUN1
3-Year average
..............................
..............................
..............................
2.2354%
]]>Agencies
[Federal Register Volume 82, Number 147 (Wednesday, August 2, 2017)]
[Notices]
[Pages 35957-35962]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16181]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-0007]
Animal Generic 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 fee
rates and payment procedures for fiscal year (FY) 2018 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 2018.
FOR FURTHER INFORMATION CONTACT: Visit FDA's Web site at https://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/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 cvmagdufa@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Section 741 of the FD&C Act (21 U.S.C. 379j-21) establishes three
different types of user fees: (1) Fees for certain types of abbreviated
applications for generic new animal drugs; (2) annual fees for certain
generic new animal drug products; and (3) annual fees for certain
sponsors of abbreviated applications for generic new animal drugs and/
or investigational submissions for generic new animal drugs (21 U.S.C.
379j-21(a)). When certain conditions are met, FDA will waive or reduce
fees for generic new animal drugs intended solely to provide for a
minor use or minor species indication (21 U.S.C. 379j-21(d)).
For FY 2014 through FY 2018, the FD&C Act establishes aggregate
yearly base revenue amounts for each of these fee categories (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 2018, after the
adjustment for workload, are as follows: For application fees, the
target revenue amount is $2,355,000; for product fees, the target
revenue amount is $3,532,000; and for sponsor fees, the target revenue
amount is $3,532,000.
For FY 2018, the generic new animal drug user fee rates are:
$193,000 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)); $96,500 for each abbreviated
application for a generic new animal drug subject to the criteria in
section 512(d)(4); $8,195 for each generic new animal drug product;
$76,250 for each generic new animal drug sponsor paying 100 percent of
the sponsor fee; $57,188 for each generic new animal drug sponsor
paying 75 percent of the sponsor fee; and $38,125 for each generic new
animal drug sponsor paying 50 percent of the sponsor fee. FDA will
issue invoices for
[[Page 35958]]
FY 2018 product and sponsor fees by December 31, 2017. These fees will
be due by January 31, 2018. The application fee rates are effective for
all abbreviated applications for a generic new animal drug 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 related application fees and any other fees
owed under the Animal Generic Drug User Fee program (AGDUFA program).
II. Revenue Amount for FY 2018
A. Statutory Fee Revenue Amounts
AGDUFA II, Title II of Public Law 113-14, specifies that the
aggregate revenue amount for FY 2018 for abbreviated application fees
is $2,117,000 and each of the other two generic new animal drug user
fee categories, annual product fees and annual sponsor fees, is
$3,175,000 each (see 21 U.S.C. 379j-21(b)).
B. Inflation Adjustment to Fee Revenue Amount
The amounts established in AGDUFA II for each year for FY 2014
through FY 2018 include an inflation adjustment; therefore, no further
inflation adjustment is required.
C. Workload Adjustment Fee Revenue Amount
For each FY beginning after FY 2014, AGDUFA 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, 2017.
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 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 1, the sum of the values in column 5 is
calculated, reflecting a total change in workload of 51.4457 percent
for FY 2018. This is the workload adjuster for FY 2018.
Table 1--Workload Adjuster Calculation
----------------------------------------------------------------------------------------------------------------
Column 1 Column 2 Column 3 Column 4 Column 5
-------------------------------------------------------------------------------
Application Type 5-Year Weighted
average (base Latest 5-Year Percent Weighting percent
years) average change factor change
----------------------------------------------------------------------------------------------------------------
Abbreviated New Animal Drug 25.0 28.00 12.0 0.342876 4.1145
Applications (ANADAs)..........
Manufacturing Supplements ANADAs 128.0 155.40 21.4 0.275337 5.8939
Generic Investigational Study 23.0 51.40 123.5 0.238287 29.4233
Submissions....................
Generic Investigational Protocol 17.2 31.60 83.7 0.143501 12.0140
Submissions....................
-------------------------------------------------------------------------------
FY 2018 AGDUFA II Workload .............. .............. .............. .............. 51.4457
Adjuster...................
----------------------------------------------------------------------------------------------------------------
Over the last year FDA has continued to see more sponsors getting
involved in the generic animal drug approval process, including pioneer
sponsors. This has contributed to sustained increases in the number of
ANADAs, manufacturing supplements, and protocols submitted.
Additionally, more sponsors continue to pursue drug approvals that do
not qualify for a waiver from the requirement to conduct an in vivo
bioequivalence study. For this reason we are seeing a large sustained
increase in the number of generic investigational new animal drug study
submissions.
As a result, the statutory revenue amount for each category of fees
for FY 2018 ($2,117,000 for application fees and $3,175,000 for both
product and sponsor fees) must now be increased by 51.4457 percent, for
a total fee revenue target in FY 2018 of $12,822,907 for fees from all
three categories before the offset for excess collections through FY
2018. The target for application fee revenue before the offset is
$2,117,000 x 151.4457 percent, for a total of $3,206,105, rounded to
the nearest dollar. The target for product fee revenue before the
offset is $3,175,000 x 151.4457 percent, for a total of $4,808,401,
rounded to the nearest dollar, and the target for sponsor fee revenue
before the offset is the same as for product fees ($4,808,401, rounded
to the nearest dollar).
D. Offset for Excess Collections Through FY 2017
Under the provisions 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 (see section 741(g)(4) of the FD&C
Act).
Table 2 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 $11,810,000 (rounded to the nearest thousand dollars) that
FDA estimates it will collect in FY 2017 based on historical data.
Table 2 shows the estimated cumulative difference between AGDUFA II fee
amounts specified in appropriation acts for FY 2014 through FY 2017 and
AGDUFA II fee amounts collected.
[[Page 35959]]
Table 2--Offsets To Be Taken for AGDUFA II
----------------------------------------------------------------------------------------------------------------
Amount in
Collection excess of
amount collection
Fiscal year Collections specified in amount
realized appropriation specified in
acts appropriation
acts
----------------------------------------------------------------------------------------------------------------
2014............................................................ $8,388,928 $7,328,000 $1,060,928
2015............................................................ 9,982,041 6,944,000 3,038,041
2016............................................................ 8,541,304 9,705,000 -1,163,696
2017............................................................ 11,810,000 11,341,000 469,000
-----------------------------------------------
Net Balance to be Offset When Fees are Set for FY 2018...... .............. .............. 3,404,273
----------------------------------------------------------------------------------------------------------------
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 $3,404,273 greater than the cumulative fee amounts
specified in appropriation acts during this same period. Reducing the
workload adjusted amount of $12,822,907 by the AGDUFA II offset of
$3,404,273 results in an amount of $9,419,000 (rounded to the nearest
thousand dollars), before the final year adjustment.
Reducing the fees to achieve the offset-adjusted target revenue (as
a percentage of workload-adjusted target revenue) yields the following
revenue by fee type: The target for application fee revenue after the
offset is $9,419,000 x 25 percent, for a total of $2,355,000, rounded
to the nearest thousand. The target for product fee revenue after the
offset is $9,419,000 x 37.5 percent, for a total of $3,532,000, rounded
to the nearest thousand, and the target for sponsor fee revenue after
the offset is the same as for product fees ($3,532,000, rounded to the
nearest thousand).
E. Final Year Adjustment
Under the provisions of the FD&C Act, for FY 2018 the Secretary of
Health and Human Services may, in addition to the workload adjustment,
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 abbreviated applications for generic
new animal drugs for the first 3 months of FY 2019. If such an
adjustment is necessary, the rationale for the amount of this increase
shall be contained in the annual notice establishing fees for FY 2018
(see section 741(c)(3) of the FD&C Act).
After calculating the operating reserves and estimating the balance
as of the beginning of FY 2019, FDA estimates that the AGDUFA program
will have sufficient funds for the operating reserves; thus, FDA will
not be performing a final year adjustment for FY 2019 because FDA has
determined such an adjustment to be unnecessary.
III. Abbreviated Application Fee Calculations for FY 2018
A. Application Fee Revenues and Numbers of Fee-Paying Applications
Each person that submits an abbreviated application for a generic
new animal drug shall be subject to an application fee, with limited
exceptions (21 U.S.C. 379j-21(a)(1)). The term ``abbreviated
application for a generic new animal drug'' means an abbreviated
application for the approval of any generic new animal drug submitted
under section 512(b)(2) (21 U.S.C. 379j-21(k)(1)). The application fees
are to be set so that they will generate $2,355,000 in fee revenue for
FY 2018.
To set fees for abbreviated applications for generic new animal
drugs to realize $2,355,000, FDA must first make some assumptions about
the number of fee-paying abbreviated applications it will receive
during FY 2018.
The Agency knows the number of applications that have been
submitted in previous years. That number fluctuates from year to year.
FDA is making estimates and applying different assumptions for two
types of full fee submissions: Original submissions of abbreviated
applications for generic new animal drugs and ``reactivated''
submissions of abbreviated applications for generic new animal drugs.
Any original submissions of abbreviated applications for generic new
animal drugs that were received by FDA before July 1, 2008, were not
assessed fees (21 U.S.C. 379j-21(a)(1)(A)). Some of these non-fee-
paying submissions were later resubmitted on or after July 1 because
the initial submission was not approved by FDA (i.e., FDA marked the
submission as incomplete and requested additional non-administrative
information) or because the original submission was withdrawn by the
sponsor. Abbreviated applications for generic new animal drugs
resubmitted on or after July 1, 2008, are subject to user fees. In this
notice, FDA refers to these resubmitted applications as ``reactivated''
applications.
Also, under AGDUFA II, an abbreviated application for an animal
generic drug subject to the criteria in section 512(d)(4) of the FD&C
Act and submitted on or after October 1, 2013, shall be subject to 50
percent of the fee applicable to all other abbreviated applications for
a generic new animal drug (21 U.S.C. 379j-21(a)(1)(C)(ii)).
Regarding original submissions of abbreviated applications for
generic new animal drugs, FDA is assuming that the number of
applications that will pay fees in FY 2018 will equal the average
number of submissions over the 5 most recently completed years of the
AGDUFA program (FY 2012-FY 2016). FDA believes that this is a
reasonable approach after 8 complete years of experience with this
program.
The average number of original submissions of abbreviated
applications for generic new animal drugs over the 5 most recently
completed years is 10 applications not subject to the criteria in
section 512(d)(4) of the FD&C Act and 4.4 submissions subject to the
criteria in section 512(d)(4). Each of the submissions described under
section 512(d)(4) of the FD&C Act pays 50 percent of the fee paid by
the other applications and will be counted as one half of a fee. Adding
all of the applications not subject to the criteria in section
512(d)(4) of the FD&C Act and 50 percent of the number that are subject
to such criteria results in a total of 12.2 anticipated full fees.
In prior years, FDA had estimated the number of reactivations of
abbreviated applications for generic new animal drugs that had been
originally submitted prior to July 1, 2008. Over the years, that number
has decreased to the point that
[[Page 35960]]
FDA no longer expects to receive any reactivations of applications
initially submitted prior to July 1, 2008, and will include no
provision for them in its fee estimates. Should such a submission be
made, the submitter will be expected to pay the appropriate fee.
Based on the previous assumptions, FDA is estimating that it will
receive a total of 12.2 fee-paying generic new animal drug applications
in FY 2018 (10 original applications paying a full fee and 4.4
applications paying a half fee).
B. Application Fee Rates for FY 2018
FDA must set the fee rates for FY 2018 so that the estimated 12.2
abbreviated applications that pay the fee will generate a total of
$2,355,000. To generate this amount, the fee for a generic new animal
drug application, rounded to the nearest hundred dollars, will have to
be $193,000, and for those applications that are subject to the
criteria set forth in section 512(d)(4) of the FD&C Act, 50 percent of
that amount, or $96,500.
IV. Generic New Animal Drug Product Fee Calculations for FY 2018
A. Product Fee Revenues and Numbers of Fee-Paying Products
The generic new animal drug product fee (also referred to as the
product fee) must be paid annually by the person named as the applicant
in an abbreviated application or supplemental abbreviated application
for a generic new animal drug product submitted for listing under
section 510 of the FD&C Act (21 U.S.C. 360), and who had an abbreviated
application or supplemental abbreviated application for a generic new
animal drug product pending at FDA after September 1, 2008 (see 21
U.S.C. 379j-21(a)(2)). The term ``generic new 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 abbreviated application for a generic new animal drug or
supplemental abbreviated application for a generic new animal drug has
been approved (21 U.S.C. 379j-21(k)(6)). The product fees are to be set
so that they will generate $3,532,000 in fee revenue for FY 2018.
To set generic new animal drug product fees to realize $3,532,000,
FDA must make some assumptions about the number of products for which
these fees will be paid in FY 2018. FDA gathered data on all generic
new 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 FDA estimated would have an abbreviated new animal drug application
or supplemental abbreviated application pending after September 1,
2008. As of June 2017, FDA estimates a total of 431 products submitted
for listing by persons who had an abbreviated application for a generic
new animal drug or supplemental abbreviated application for a generic
new animal drug pending after September 1, 2008. Based on this, FDA
believes that a total of 431 products will be subject to this fee in FY
2018.
In estimating the fee revenue to be generated by generic new animal
drug product fees in FY 2018, FDA is assuming that less than two
products invoiced will qualify for minor use/minor species fee waiver
(see 21 U.S.C. 379j-21(d)). FDA has kept this estimate at zero percent
this year, based on historical data over the past 5 completed years of
the AGDUFA program.
Accordingly, the Agency estimates that a total of 431 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 431
products that pay fees will generate a total of $3,532,000. To generate
this amount will require the fee for a generic new animal drug product,
rounded to the nearest $5, to be $8,195.
V. Generic New Animal Drug Sponsor Fee Calculations for FY 2018
A. Sponsor Fee Revenues and Numbers of Fee-Paying Sponsors
The generic new 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 abbreviated application for a generic new animal
drug, 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 submission for a generic new animal
drug that has not been terminated or otherwise rendered inactive and
(2) had an abbreviated application for a generic new animal drug,
supplemental abbreviated application for a generic new animal drug, or
investigational submission for a generic new animal drug pending at FDA
after September 1, 2008 (see 21 U.S.C. 379j-21(k)(7) and 379j-21(a)(3),
respectively). A generic new animal drug sponsor is subject to only one
such fee each fiscal year (see 21 U.S.C. 379j-21(a)(3)(C)). Applicants
with more than six approved abbreviated applications will pay 100
percent of the sponsor fee; applicants with more than one and fewer
than seven approved abbreviated applications will pay 75 percent of the
sponsor fee; and applicants with one or fewer approved abbreviated
applications will pay 50 percent of the sponsor fee (see 21 U.S.C.
379j-21(a)(3)(C)). The sponsor fees are to be set so that they will
generate $3,532,000 in fee revenue for FY 2018.
To set generic new animal drug sponsor fees to realize $3,532,000,
FDA must make some assumptions about the number of sponsors who will
pay these fees in FY 2018. FDA now has 8 complete years of experience
collecting these sponsor fees. Based on the number of firms that meet
this definition and the average number of firms paying fees at each
level over the 5 most recently completed years of the AGDUFA program
(FY 2012 through FY 2016), FDA estimates that in FY 2018, 14 sponsors
will pay 100 percent fees, 17 sponsors will pay 75 percent fees, and 42
sponsors will pay 50 percent fees. That totals the equivalent of 47.75
full sponsor fees (14 x 100 percent or 14, plus 17 x 75 percent or
12.75, plus 42 x 50 percent or 21).
FDA estimates that about 3 percent of all of these sponsors, or
1.43, may qualify for a minor use/minor species fee waiver (see 21
U.S.C. 379j-21(d)). FDA has kept the estimate of the percentage of
sponsors that will not pay fees at 3 percent this year, based on
historical data over the past 5 completed years of the AGDUFA program.
Accordingly, the Agency estimates that the equivalent of 46.32 full
sponsor fees (47.75 minus 1.43) are likely to be paid in FY 2018.
B. Sponsor Fee Rates for FY 2018
FDA must set the fee rates for FY 2018 so that the estimated
equivalent of 46.32 full sponsor fees will generate a total of
$3,532,000. To generate this amount will require the 100 percent fee
for a generic new animal drug sponsor, rounded to the nearest $50, to
be $76,250. Accordingly, the fee for those paying 75 percent of the
full sponsor fee will be $57,188, and the fee for those paying 50
percent of the full sponsor fee will be $38,125.
VI. Fee Schedule for FY 2018
The fee rates for FY 2018 are summarized in table 3.
[[Page 35961]]
Table 3--FY 2018 Fee Rates
------------------------------------------------------------------------
Fee rate for
Generic new animal drug user fee category FY 2018
------------------------------------------------------------------------
Abbreviated Application Fee for Generic New Animal Drug $193,000
except those subject to the criteria in section
512(d)(4)..............................................
Abbreviated Application Fee for Generic New Animal Drug 96,500
subject to the criteria in section 512(d)(4)...........
Generic New Animal Drug Product Fee..................... 8,195
100 Percent Generic New Animal Drug Sponsor Fee \1\..... 76,250
75 Percent Generic New Animal Drug Sponsor Fee \1\...... 57,188
50 Percent Generic New Animal Drug Sponsor Fee \1\...... 38,125
------------------------------------------------------------------------
\1\ An animal drug sponsor is subject to only one fee each fiscal year.
VII. Procedures for Paying FY 2018 Generic New Animal Drug User Fees
A. Abbreviated Application Fees and Payment Instructions
The FY 2018 fee established in the new fee schedule must be paid
for an abbreviated new animal drug application subject to fees under
AGDUFA II that is submitted on or after October 1, 2017. The payment
must be made in U.S. currency from a U.S. bank 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 an 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 have found 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 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,
beginning with the letters ``AG'', on the upper right-hand corner of
your completed Animal Generic 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 Generic Drug User Fee Cover Sheet to: Food and Drug
Administration, P.O. Box 979033, St. Louis, MO 63197-9000.
When paying by wire transfer, it is required that the invoice
number is 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 wire transfer: U.S. Department of the
Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045, Account Name:
Food and Drug Administration, Account No.: 75060099, Routing No.:
021030004, Swift No.: 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 phone 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 abbreviated application arrives at FDA's Center for
Veterinary Medicine (CVM). FDA records the official abbreviated
application receipt date as the later of the following: The date the
application was received by CVM, or the date U.S. Bank notifies FDA
that your payment in the full amount has been received, or when the
U.S. Department of the Treasury notifies FDA of payment. U.S. Bank and
the United States Treasury are required to notify FDA within 1 working
day, using the Payment Identification Number 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 onto the AGDUFA
Web site at https://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/ucm137049.htm and scroll down the
page until you find the link ``Create AGDUFA User Fee Cover Sheet.''
Select that link and follow the directions. 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 Generic Drug User Fee 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 Generic Drug User Fee Cover Sheet. One cover sheet is needed
for each abbreviated animal drug application. 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 Payment Identification Number.
Step Three--Send the payment for your application as described in
section VII.A of this document.
Step Four--Please submit your application and a copy of the
completed Animal Generic 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 and Sponsor Fees
By December 31, 2017, FDA will issue invoices and payment
instructions for product and sponsor fees for FY 2018 using this fee
schedule. Fees will be due by January 31, 2018. FDA will issue invoices
in November 2018 for any products and sponsors subject to fees for
[[Page 35962]]
FY 2018 that qualify for fees after the December 2017 billing.
Dated: July 26, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-16181 Filed 8-1-17; 8:45 am]
BILLING CODE 4164-01-P
