Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2022, 39028-39033 [2021-15642]
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Federal Register / Vol. 86, No. 139 / Friday, July 23, 2021 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
Reduction of Issuer Burden Through
Technology Grant
Centers for Medicare &
Medicaid Services (CMS), Department
of Health and Human Services (HHS).
ACTION: Notice of funding opportunity.
AGENCY:
This notice announces the
issuance of the March 10, 2021 (and
amended on April 29, 2021) singlesource funding opportunity titled
‘‘Reduction of Issuer Burden Through
Technology Grant’’ (hereafter referred to
as the ‘‘RIBTT Grant’’) available solely
to the National Association of Insurance
Commissioners (NAIC) to build a
connection between the State Electronic
Rate and Form Filing (SERFF) system,
owned and operated by the NAIC, and
the Health Insurance Oversight System
(HIOS), which is operated by the
Centers for Medicare and Medicaid
Services (CMS). This connection will
enable health insurance issuers to enter
rate justification data into the SERFF
system and then have this rate
justification data automatically transfer
to HIOS. Currently, health insurance
issuers have to enter duplicate data into
both the SERFF system and HIOS in
order to maintain compliance with
federal and state law in 49 states and the
District of Columbia.
DATES: The project period of the award,
in the amount of $250,000 to the NAIC,
will be 24 months from the date of
award. The tentative award date is July
29, 2021.
FOR FURTHER INFORMATION CONTACT: Jim
Taing, (301) 492–4182.
SUPPLEMENTARY INFORMATION:
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SUMMARY:
I. Background
The Reduction of Issuer Burden
Through Technology Grant (RIBTT
Grant) provides a funding source to
build a connection between the SERFF
system and the Unified Rate Review
(URR) module of HIOS. Forty-nine
states and the District of Columbia
currently use the SERFF system to
collect and review rate data. Building a
connection between SERFF and HIOS
will reduce burden on health insurance
issuers and decrease the potential for
data mismatches between the two
systems. It will enable health insurance
issuers to enter rate justification data
into the SERFF system and the rate
justification data will automatically
transfer to HIOS. Currently, health
insurance issuers have to enter
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duplicate data into both the SERFF
system and HIOS in order to maintain
compliance with applicable federal and
state law. Funding under the RIBTT
Grant is available to the NAIC to
complete their portion of the technical
changes needed in order to build such
a connection between the SERFF system
and HIOS.
II. Provisions of the Notice
CMS is anticipating approximately a
total of $250,000 will be available for
the RIBTT Grant, pending availability of
funds, to the NAIC to complete their
portion of the technical changes needed
in order to build such a connection
between the SERFF system and HIOS
for the transfer of rate filing information.
The NAIC may use grant funds for a
variety of planning, development,
testing, and implementation objectives
related to the technical changes needed
to build the connection between the
SERFF system and HIOS. This includes,
but is not limited to, hiring or
contracting with information technology
professionals or firms to complete the
work. Pending an acceptable application
and budget, the CMS will recommend
awarding a single source grant to the
NAIC who is uniquely qualified to
complete the work requested. The NAIC
is uniquely positioned to perform this
work as they are the only applicant
under this funding opportunity to meet
the objectives of this funding
opportunity as they own, operate, and
maintain the SERFF system and the
SERFF system is what is utilized by
health insurance issuers to submit rate
filing justification data in 49 states and
the District of Columbia. The NAIC has
built previous IT connections between
their SERFF system and HIOS for the
submission of Qualified Health Plan
certification data between SERFF and
the Plan Management module of HIOS.
Funds enable NAIC to establish this
new IT connection between the SERFF
system and the URR module of HIOS
based on the prior system architecture.
The Administrator of the Centers for
Medicare & Medicaid Services (CMS),
Chiquita Brooks-LaSure, having
reviewed and approved this document,
authorizes Lynette Wilson, who is the
Federal Register Liaison, to
electronically sign this document for
purposes of publication in the Federal
Register.
Dated: July 19, 2021.
Lynette Wilson,
Federal Register Liaison, Centers for Medicare
& Medicaid Services.
[FR Doc. 2021–15656 Filed 7–22–21; 8:45 am]
BILLING CODE 4120–01–P
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Correction
In notice document 2021–15025,
appearing on page 37337 in the issue of
Thursday, July 15, 2021 make the
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On page 37337, in the first column, in
the DATES section, on the second and
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[FR Doc. C1–2021–15025 Filed 7–22–21; 8:45 am]
BILLING CODE 0099–10–D
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0703]
Animal Generic Drug User Fee Rates
and Payment Procedures for Fiscal
Year 2022
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
The Food and Drug
Administration (FDA or Agency) is
announcing the fee rates and payment
procedures for fiscal year (FY) 2022
generic new animal drug user fees. The
Federal Food, Drug, and Cosmetic Act
(FD&C Act), as amended by the Animal
Generic Drug User Fee Amendments of
2018 (AGDUFA III), 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 2022.
FOR FURTHER INFORMATION CONTACT: Lisa
Kable, Center for Veterinary Medicine
(HFV–10), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–6888,
Lisa.Kable@fda.hhs.gov or visit FDA’s
website at https://www.fda.gov/
ForIndustry/UserFees/AnimalGeneric
DrugUserFeeActAGDUFA/default.htm.
For general questions, you may also
email the Center for Veterinary
SUMMARY:
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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 2019 through FY 2023, the
FD&C Act establishes a yearly base
revenue amount and percentages for
each of these fee categories (21 U.S.C.
379j–21(b)). Base revenue amounts are
subject to adjustment for inflation and
workload (21 U.S.C. 379j–21(c)(2) and
(3)). Beginning with FY 2021, the
annual fee revenue amounts are also
subject to adjustment to reduce
workload-based increases by the amount
of certain excess collections (21 U.S.C.
379j–21(c)(3)(B)). The target revenue
amounts for each fee category for FY
2022, are as follows: For application
fees, the target revenue amount is
$6,199,500; for product fees, the target
revenue amount is $9,299,250; and for
sponsor fees, the target revenue amount
is $9,299,250.
For FY 2022, the generic new animal
drug user fee rates are: $548,628 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)); $274,314 for each
abbreviated application for a generic
new animal drug subject to the criteria
in section 512(d)(4) of the FD&C Act;
$17,513 for each generic new animal
drug product; $234,297 for each generic
new animal drug sponsor paying 100
percent of the sponsor fee; $175,723 for
each generic new animal drug sponsor
paying 75 percent of the sponsor fee;
and $117,149 for each generic new
animal drug sponsor paying 50 percent
of the sponsor fee. FDA will issue
invoices for FY 2022 product and
sponsor fees by December 31, 2021.
These fees will be due by January 31,
2022. The application fee rates are
effective for all abbreviated applications
for a generic new animal drug submitted
on or after October 1, 2021, and will
remain in effect through September 30,
2022. 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 2022
A. Statutory Fee Revenue Amounts
AGDUFA III, Title II of Public Law
115–234, specifies that the aggregate
base fee revenue amount for FY 2022 for
all generic new animal drug user fee
categories is $18,336,340 (21 U.S.C.
379j–21(b)(1)).
B. Inflation Adjustment to Fee Revenue
Amount
AGDUFA III specifies that the annual
fee revenue amount is to be adjusted for
inflation increases for FY 2020 and
subsequent fiscal years, using two
separate adjustments—one for personnel
compensation and benefits (PC&B) and
one for non-PC&B costs (see 21 U.S.C.
379j–21(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 PC&B
paid per full-time equivalent position
(FTE) at FDA for the first 3 of the 4
preceding fiscal years of available data,
multiplied by the average proportion of
PC&B costs to total FDA costs for the
first 3 of the 4 preceding fiscal years of
available data. 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 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 2022.
The 3-year average is 2.7383 percent.
TABLE 1—FDA PERSONNEL COMPENSATION AND BENEFITS (PC&B) EACH YEAR AND PERCENT CHANGE
Fiscal year
2018
Total PC&B ........................................................................................
Total FTE ...........................................................................................
PC&B per FTE ...................................................................................
Percent Change from Previous Year ................................................
The statute specifies that this 2.7383
percent should be multiplied by the
2019
$2,690,678,000
17,023
$158,061
4.2206
$2,620,052,000
17,144
$152,826
¥3.3120
proportion of PC&B costs to total FDA
costs. Table 2 shows the amount of
3-year
average
2020
$2,875,592,000
17,535
$163,992
7.3063
....................
....................
....................
2.7383
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
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Fiscal year
2018
Total PC&B ..............................................................................
Total Costs ...............................................................................
PC&B Percent ..........................................................................
The portion of the inflation
adjustment relating to payroll cost is
2.7383 percent multiplied by 47.9915
percent, or 1.3142 percent.
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$2,690,678,000
$5,370,935,000
50.0970
2019
$2,620,052,000
$5,663,389,000
46.2630
The statute specifies that the portion
of the inflation adjustment for nonpayroll costs is the average annual
percent change that occurred in the
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2020
$2,875,592,000
$6,039,321,000
47.6145
3-year
average
..............................
..............................
47.9915
Consumer Price Index (CPI) for urban
consumers (Washington-Baltimore, DCMD-VA-WV; not seasonally adjusted; all
items less food and energy; annual
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index) for the first 3 of the preceding 4
years of available data multiplied by the
average proportion of all costs other
than PC&B costs to total FDA costs for
the first 3 of the 4 preceding fiscal years.
As a result of a geographical revision
made by the Bureau of Labor and
Statistics in January 2018,1 the
‘‘Washington-Baltimore, DC–MD-VAWV’’ index was discontinued and
in calculating the relevant adjustment
factors for FY 2020 and subsequent
years. Table 3 provides the summary
data for the percent change in the
specified CPI for the WashingtonArlington-Alexandria area. The data
from the Bureau of Labor Statistics is
shown in table 3.
replaced with two separate indices (i.e.,
‘‘Washington-Arlington-Alexandria, DCVA-MD-WV’’ and ‘‘Baltimore-ColumbiaTowson, MD’’). In order to continue
applying a CPI that best reflects the
geographic region in which FDA is
headquartered and that provides the
most current data available, FDA is
using the Washington-ArlingtonAlexandria index, less food and energy,
TABLE 3—ANNUAL AND 3-YEAR AVERAGE PERCENT CHANGE IN WASHINGTON-ARLINGTON-ALEXANDRIA AREA CPI LESS
FOOD AND ENERGY
Year
2018
Annual CPI .......................................................................................................
Annual Percent Change ..................................................................................
To calculate the inflation adjustment
for non-payroll costs, we multiply
1.4221 percent by the proportion of all
costs other than PC&B to total FDA
costs. Since 47.9915 percent was
obligated for PC&B as shown in table 2,
52.0085 percent is the portion of costs
other than PC&B (100 percent¥47.9915
percent = 52.0085 percent). The nonpayroll adjustment is 1.4221 percent
times 52.0085 percent, or 0.7396
percent.
Next, we add the payroll component
(1.3142 percent) to the non-payroll
component (0.7396 percent), for an
inflation adjustment of 2.0538 percent
for FY 2022.
AGDUFA III provides for the inflation
adjustment to be compounded each
fiscal year after FY 2020 (see 21 U.S.C.
379j–21(c)(2)). The inflation adjustment
for FY 2022 (2.0538 percent) is
compounded by adding 1 and then
multiplying by 1 plus the inflation
adjustment factor for FY 2021 (3.5847
percent), as published in the Federal
Register on August 3, 2020 (85 FR
46647 to 46651), which equals 1.057121
(rounded) (1.020538 × 1.035847) for FY
2019
272.414
2.0671
275.841
1.2580
2022. We then multiply the base
revenue amount for FY 2022
($18,336,340) by 1.057121, yielding an
inflation adjusted amount of
$19,383,730.
C. Workload Adjustment to Inflation
Adjusted Fee Revenue Amount
The fee revenue amounts established
in AGDUFA III for FY 2020 and
subsequent fiscal years are also subject
to adjustment to account for changes in
FDA’s review workload. A workload
adjustment will be applied to the
inflation adjusted fee revenue amount
(21 U.S.C. 379j–21(c)(3)).
To determine whether a workload
adjustment applies, FDA calculates the
weighted average of the change in the
total 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
2020
278.437
0.9411
3-year
average
........................
1.4221
drug protocol submissions) received
over the 5-year period that ended on
September 30, 2018 (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 May 31, 2021.
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
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 the table the sum of the values in
column 5 is calculated, reflecting a total
change in workload of 49.0190 percent
for FY 2022. This is the workload
adjuster for FY 2022.
TABLE 4—WORKLOAD ADJUSTER CALCULATION
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Application type
Column 1
Column 2
Column 3
Column 4
Column 5
5-year
average
(base years)
Latest 5-year
average
Percent
change
Weighting
factor
Weighted
percent
change
Abbreviated Application for a Generic New Animal Drug
(ANADAs) .........................................................................
Manufacturing Supplements ANADAs .................................
Generic Investigational Study Submissions ........................
Generic Investigational Protocol Submissions ....................
24.0
169.4
69.2
34.4
26.6
198.2
122.8
58.64
10.8333
17.0012
77.4566
70.3488
0.1745
0.2601
0.4121
0.1534
1.8904
4.4212
31.9161
10.7913
FY 2022 AGDUFA III Workload Adjuster .....................
........................
........................
........................
........................
49.0190
1 https://www.bls.gov/cpi/additional-resources/
geographic-revision-2018.htm.
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The statutory revenue amount after
the inflation adjustment ($19,383,730)
must now be increased by 49.0190
percent to reflect the changes in review
workload (workload adjustment), for a
workload and inflation-adjusted amount
of $28,885,441.
D. Reduction of Workload-Based
Increase by Amount of Certain Excess
Collections
Under section 741(c)(3)(B) of the
FD&C Act, for FYs 2021 through 2023,
if application of the workload
adjustment increases the amount of fee
revenues established for the fiscal year,
as adjusted for inflation, the fee revenue
increase will be reduced by the amount
of any excess collections, for the second
preceding fiscal year, up to the amount
of the fee revenue increase for workload.
The workload and inflation-adjusted
amount ($28,885,441) is subtracted by
the inflation adjusted amount
($19,383,730) to get the workload
adjustment amount ($9,501,711). Then
the excess fees collected from FY 2020
as of May 31, 2021 ($4,087,114) are
subtracted from the workload
adjustment amount ($9,501,711) to get a
reduced workload adjustment amount of
$5,414,597. Next, the reduced workload
adjustment amount ($5,414,597) is
added to the inflation-adjusted revenue
amount ($19,383,730), for a total fee
revenue target of $24,798,000 (rounded
to the nearest thousand dollars).
E. FY 2022 Fee Revenue Amounts
AGDUFA III specifies that the revenue
amount of $24,798,000 for FY 2022 is to
be divided as follows: 25 percent, or a
total of $6,199,500, is to come from
application fees; 37.5 percent, or a total
of $9,299,250, is to come from product
fees; and 37.5 percent, or a total of
$9,299,250, is to come from sponsor fees
(21 U.S.C. 379j–21(b)).
III. Abbreviated Application Fee
Calculations for FY 2022
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A. Application Fee Revenues and
Numbers of Fee-Paying Applications
Each person who 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) of the FD&C Act
(21 U.S.C. 379j–21(k)(1)). The
application fees are to be set so that they
will generate $6,199,500 in fee revenue
for FY 2022.
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To set fees for abbreviated
applications for generic new animal
drugs to realize $6,199,500 FDA must
first make some assumptions about the
number of fee-paying abbreviated
applications it will receive during FY
2022.
The Agency knows the number of
applications that have been submitted
in previous years. That number
fluctuates annually. In estimating the
fee revenue to be generated by generic
new animal drug applications in FY
2022, FDA is assuming that the number
of applications for which fees will be
paid in FY 2022 will equal the average
number of submissions over the 5 most
recently completed fiscal years of the
AGDUFA program (FY 2016–FY 2020).
Also, under AGDUFA III, 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)).
The average number of original
submissions of abbreviated applications
for generic new animal drugs over the
5 most recently completed fiscal years is
8.2 applications not subject to the
criteria in section 512(d)(4) of the FD&C
Act and 6.2 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 11.30 anticipated full fees.
Based on the previous assumptions,
FDA is estimating that it will receive a
total of 11.30 fee-paying generic new
animal drug applications in FY 2022
(8.2 original applications paying a full
fee and 6.2 applications paying a half
fee).
B. Application Fee Rates for FY 2022
FDA must set the fee rates for FY 2022
so that the estimated 11.30 abbreviated
applications that pay the fee will
generate a total of $6,199,500. To
generate this amount, the fee for a
generic new animal drug application
will have to be $548,628 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 $274,314.
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IV. Generic New Animal Drug Product
Fee Calculations for FY 2022
A. Product Fee Revenues and Numbers
of Fee-Paying Products
The generic new animal drug 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
$9,299,250 in fee revenue for FY 2022.
To set generic new animal drug
product fees to realize $9,299,250, FDA
must make some assumptions about the
number of products for which these fees
will be paid in FY 2022. 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 had a generic new animal
drug application or supplemental
abbreviated application pending after
September 1, 2008. As of May 2021,
FDA estimates a total of 536 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 536
products will be subject to this fee in FY
2022.
In estimating the fee revenue to be
generated by generic new animal drug
product fees in FY 2022, FDA is
estimating that 1 percent of the products
invoiced, or 5 products, will qualify for
minor use/minor species fee waiver (see
21 U.S.C. 379j–21(d)). FDA has made
this estimate at 1 percent this year,
based on historical data over the past 5
completed fiscal years of the AGDUFA
program.
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Accordingly, the Agency estimates
that a total of 531 (536 minus 5)
products will be subject to product fees
in FY 2022.
B. Product Fee Rates for FY 2022
FDA must set the fee rates for FY 2022
so that the estimated 531 products that
pay fees will generate a total of
$9,299,250. To generate this amount
will require the fee for a generic new
animal drug product, rounded to the
nearest dollar, to be $17,513.
V. Generic New Animal Drug Sponsor
Fee Calculations for FY 2022
A. Sponsor Fee Revenues and Numbers
of Fee-Paying Sponsors
The generic new animal drug 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
6 approved abbreviated applications
will pay 100 percent of the sponsor fee;
applicants with more than 1 and fewer
than 7 approved abbreviated
applications will pay 75 percent of the
sponsor fee; and applicants with 1 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 $9,299,250
in fee revenue for FY 2022.
To set generic new animal drug
sponsor fees to realize $9,299,250, FDA
must make some assumptions about the
number of sponsors who will pay these
fees in FY 2022. FDA estimates that in
FY 2022, 12 sponsors will pay 100
percent fees, 18 sponsors will pay 75
percent fees, and 30 sponsors will pay
50 percent fees. That totals the
equivalent of 40.5 full sponsor fees (12
× 100 percent or 12, plus 18 × 75 percent
or 13.5, plus 30 × 50 percent or 15).
FDA estimates that about 2 percent of
all of these sponsors, or 0.81, may
qualify for a minor use/minor species
fee waiver (see 21 U.S.C. 379j–21(d)).
FDA has made the estimate of the
percentage of sponsors that will not pay
fees at 2 percent this year, based on
historical data over the past 5 completed
fiscal years of the AGDUFA program.
Accordingly, the Agency estimates
that the equivalent of 39.69 full sponsor
fees (40.5¥0.81) are likely to be paid in
FY 2022.
B. Sponsor Fee Rates for FY 2022
FDA must set the fee rates for FY 2022
so that the estimated equivalent of 39.69
full sponsor fees will generate a total of
$9,299,250. To generate this amount
will require the 100 percent fee for a
generic new animal drug sponsor,
rounded to the nearest dollar, to be
$234,297. Accordingly, the fee for those
paying 75 percent of the full sponsor fee
will be $175,723, and the fee for those
paying 50 percent of the full sponsor fee
will be $117,149.
VI. Fee Schedule for FY 2022
The fee rates for FY 2022 are
summarized in table 5.
TABLE 5—FY 2022 FEE RATES
Fee rate
for FY 2022
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% Generic New Animal Drug Sponsor Fee.1 ................................................................................................................................
75% Generic New Animal Drug Sponsor Fee.1 ..................................................................................................................................
50% Generic New Animal Drug Sponsor Fee.1 ..................................................................................................................................
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1An
$548,628
274,314
17,513
234,297
175,723
117,149
animal drug sponsor is subject to only one fee each fiscal year.
VII. Fee Waiver or Reduction;
Exemption From Fees
abbreviated application (21 U.S.C. 379j–
21(d)(2)).
The types of fee waivers and
reductions that applied last fiscal year
still exist for FY 2022. In AGDUFA III
a new exemption from fees was
established, as follows:
Fees will not apply to any person who
not later than September 30, 2023,
submits to CVM a supplemental
abbreviated application relating to a
generic new animal drug approved
under section 512 of the FD&C Act,
solely to add the application number to
the labeling of the drug in the manner
specified in section 502(w)(3) of the
FD&C Act (21 U.S.C. 352(w)(3)), if that
person otherwise would be subject to
user fees under AGDUFA based only on
the submission of the supplemental
VIII. Procedures for Paying FY 2022
Generic New Animal Drug User Fees
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A. Abbreviated Application Fees and
Payment Instructions
The FY 2022 fee established in the
new fee schedule must be paid for a
generic new animal drug application
subject to fees under AGDUFA III that
is submitted on or after October 1, 2021.
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
PO 00000
Frm 00063
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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.
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Federal Register / Vol. 86, No. 139 / Friday, July 23, 2021 / Notices
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 ‘‘AG’’, on the upper
right-hand corner of your completed
Animal Generic Drug User Fee Cover
Sheet. Also write FDA’s post office box
number (P.O. Box 979033) and PIN 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. Note: In no
case should the payment for the fee be
submitted to FDA with the application.
When paying by wire transfer, it is
required that the invoice number or PIN
is included; without the invoice number
or PIN the payment may not be applied,
and 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.
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
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
PIN described previously.
The tax identification number of FDA
is 53–0196965.
website at https://www.fda.gov/
ForIndustry/UserFees/AnimalGeneric
DrugUserFeeActAGDUFA/
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
application for a generic new animal
drug. 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 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, 2021, FDA will issue
invoices and payment instructions for
product and sponsor fees for FY 2022
using this fee schedule. Fees will be due
by January 31, 2022. FDA will issue
invoices in November 2022 for any
products and sponsors subject to fees for
FY 2022 that qualify for fees after the
December 2021 billing.
Dated: July 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–15642 Filed 7–22–21; 8:45 am]
BILLING CODE 4164–01–P
B. Application Cover Sheet Procedures
Step One—Create a user account and
password. Log onto the AGDUFA
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39033
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0363]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Prescription Drug
Advertising
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: Submit written comments
(including recommendations) on the
collection of information by August 23,
2021.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0686. Also include
the FDA docket number found in
brackets in the heading of this
document.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St. North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Prescription Drug Advertising—21 CFR
Part 202
OMB Control Number 0910–0686—
Extension
This information collection supports
Agency regulations and associated
guidance. FDA protects the public
health by assuring the safety,
effectiveness, and security of a wide
range of products. We also help
consumers get accurate, science-based
information they need to use medicines
appropriately and improve their health.
E:\FR\FM\23JYN1.SGM
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]]>Agencies
[Federal Register Volume 86, Number 139 (Friday, July 23, 2021)]
[Notices]
[Pages 39028-39033]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-15642]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0703]
Animal Generic Drug User Fee Rates and Payment Procedures for
Fiscal Year 2022
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the fee rates and payment procedures for fiscal year (FY) 2022 generic
new animal drug user fees. The Federal Food, Drug, and Cosmetic Act
(FD&C Act), as amended by the Animal Generic Drug User Fee Amendments
of 2018 (AGDUFA III), 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 2022.
FOR FURTHER INFORMATION CONTACT: Lisa Kable, Center for Veterinary
Medicine (HFV-10), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240-402-6888, [email protected] or visit
FDA's website at https://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/default.htm. For general questions,
you may also email the Center for Veterinary
[[Page 39029]]
Medicine (CVM) at [email protected].
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 2019 through FY 2023, the FD&C Act establishes a yearly base
revenue amount and percentages for each of these fee categories (21
U.S.C. 379j-21(b)). Base revenue amounts are subject to adjustment for
inflation and workload (21 U.S.C. 379j-21(c)(2) and (3)). Beginning
with FY 2021, the annual fee revenue amounts are also subject to
adjustment to reduce workload-based increases by the amount of certain
excess collections (21 U.S.C. 379j-21(c)(3)(B)). The target revenue
amounts for each fee category for FY 2022, are as follows: For
application fees, the target revenue amount is $6,199,500; for product
fees, the target revenue amount is $9,299,250; and for sponsor fees,
the target revenue amount is $9,299,250.
For FY 2022, the generic new animal drug user fee rates are:
$548,628 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)); $274,314 for each abbreviated
application for a generic new animal drug subject to the criteria in
section 512(d)(4) of the FD&C Act; $17,513 for each generic new animal
drug product; $234,297 for each generic new animal drug sponsor paying
100 percent of the sponsor fee; $175,723 for each generic new animal
drug sponsor paying 75 percent of the sponsor fee; and $117,149 for
each generic new animal drug sponsor paying 50 percent of the sponsor
fee. FDA will issue invoices for FY 2022 product and sponsor fees by
December 31, 2021. These fees will be due by January 31, 2022. The
application fee rates are effective for all abbreviated applications
for a generic new animal drug submitted on or after October 1, 2021,
and will remain in effect through September 30, 2022. 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 2022
A. Statutory Fee Revenue Amounts
AGDUFA III, Title II of Public Law 115-234, specifies that the
aggregate base fee revenue amount for FY 2022 for all generic new
animal drug user fee categories is $18,336,340 (21 U.S.C. 379j-
21(b)(1)).
B. Inflation Adjustment to Fee Revenue Amount
AGDUFA III specifies that the annual fee revenue amount is to be
adjusted for inflation increases for FY 2020 and subsequent fiscal
years, using two separate adjustments--one for personnel compensation
and benefits (PC&B) and one for non-PC&B costs (see 21 U.S.C. 379j-
21(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
PC&B paid per full-time equivalent position (FTE) at FDA for the first
3 of the 4 preceding fiscal years of available data, multiplied by the
average proportion of PC&B costs to total FDA costs for the first 3 of
the 4 preceding fiscal years of available data. 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 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 2022. The 3-year average is 2.7383 percent.
Table 1--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Change
----------------------------------------------------------------------------------------------------------------
3-year
Fiscal year 2018 2019 2020 average
----------------------------------------------------------------------------------------------------------------
Total PC&B................................ $2,690,678,000 $2,620,052,000 $2,875,592,000 ...........
Total FTE................................. 17,023 17,144 17,535 ...........
PC&B per FTE.............................. $158,061 $152,826 $163,992 ...........
Percent Change from Previous Year......... 4.2206 -3.3120 7.3063 2.7383
----------------------------------------------------------------------------------------------------------------
The statute specifies that this 2.7383 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 2018 2019 2020 3-year average
----------------------------------------------------------------------------------------------------------------
Total PC&B.......................... $2,690,678,000 $2,620,052,000 $2,875,592,000 .................
Total Costs......................... $5,370,935,000 $5,663,389,000 $6,039,321,000 .................
PC&B Percent........................ 50.0970 46.2630 47.6145 47.9915
----------------------------------------------------------------------------------------------------------------
The portion of the inflation adjustment relating to payroll cost is
2.7383 percent multiplied by 47.9915 percent, or 1.3142 percent.
The statute specifies that the portion of the inflation adjustment
for non-payroll costs 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
[[Page 39030]]
index) for the first 3 of the preceding 4 years of available data
multiplied by the average proportion of all costs other than PC&B costs
to total FDA costs for the first 3 of the 4 preceding fiscal years. As
a result of a geographical revision made by the Bureau of Labor and
Statistics in January 2018,\1\ the ``Washington-Baltimore, DC-MD-VA-
WV'' index was discontinued and replaced with two separate indices
(i.e., ``Washington-Arlington-Alexandria, DC-VA-MD-WV'' and
``Baltimore-Columbia-Towson, MD''). In order to continue applying a CPI
that best reflects the geographic region in which FDA is headquartered
and that provides the most current data available, FDA is using the
Washington-Arlington-Alexandria index, less food and energy, in
calculating the relevant adjustment factors for FY 2020 and subsequent
years. Table 3 provides the summary data for the percent change in the
specified CPI for the Washington-Arlington-Alexandria area. The data
from the Bureau of Labor Statistics is shown in table 3.
---------------------------------------------------------------------------
\1\ https://www.bls.gov/cpi/additional-resources/geographic-revision-2018.htm.
Table 3--Annual and 3-Year Average Percent Change in Washington-Arlington-Alexandria Area CPI Less Food and
Energy
----------------------------------------------------------------------------------------------------------------
Year 2018 2019 2020 3-year average
----------------------------------------------------------------------------------------------------------------
Annual CPI...................................... 272.414 275.841 278.437 ..............
Annual Percent Change........................... 2.0671 1.2580 0.9411 1.4221
----------------------------------------------------------------------------------------------------------------
To calculate the inflation adjustment for non-payroll costs, we
multiply 1.4221 percent by the proportion of all costs other than PC&B
to total FDA costs. Since 47.9915 percent was obligated for PC&B as
shown in table 2, 52.0085 percent is the portion of costs other than
PC&B (100 percent-47.9915 percent = 52.0085 percent). The non-payroll
adjustment is 1.4221 percent times 52.0085 percent, or 0.7396 percent.
Next, we add the payroll component (1.3142 percent) to the non-
payroll component (0.7396 percent), for an inflation adjustment of
2.0538 percent for FY 2022.
AGDUFA III provides for the inflation adjustment to be compounded
each fiscal year after FY 2020 (see 21 U.S.C. 379j-21(c)(2)). The
inflation adjustment for FY 2022 (2.0538 percent) is compounded by
adding 1 and then multiplying by 1 plus the inflation adjustment factor
for FY 2021 (3.5847 percent), as published in the Federal Register on
August 3, 2020 (85 FR 46647 to 46651), which equals 1.057121 (rounded)
(1.020538 x 1.035847) for FY 2022. We then multiply the base revenue
amount for FY 2022 ($18,336,340) by 1.057121, yielding an inflation
adjusted amount of $19,383,730.
C. Workload Adjustment to Inflation Adjusted Fee Revenue Amount
The fee revenue amounts established in AGDUFA III for FY 2020 and
subsequent fiscal years are also subject to adjustment to account for
changes in FDA's review workload. A workload adjustment will be applied
to the inflation adjusted fee revenue amount (21 U.S.C. 379j-21(c)(3)).
To determine whether a workload adjustment applies, FDA calculates
the weighted average of the change in the total 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, 2018 (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 May 31, 2021.
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 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 the table the sum of the values in column 5 is
calculated, reflecting a total change in workload of 49.0190 percent
for FY 2022. This is the workload adjuster for FY 2022.
Table 4--Workload Adjuster Calculation
----------------------------------------------------------------------------------------------------------------
Column 1 Column 2 Column 3 Column 4 Column 5
-------------------------------------------------------------------------------
Application type 5-year average Latest 5-year Weighting Weighted
(base years) average Percent change factor percent change
----------------------------------------------------------------------------------------------------------------
Abbreviated Application for a 24.0 26.6 10.8333 0.1745 1.8904
Generic New Animal Drug
(ANADAs).......................
Manufacturing Supplements ANADAs 169.4 198.2 17.0012 0.2601 4.4212
Generic Investigational Study 69.2 122.8 77.4566 0.4121 31.9161
Submissions....................
Generic Investigational Protocol 34.4 58.64 70.3488 0.1534 10.7913
Submissions....................
-------------------------------------------------------------------------------
FY 2022 AGDUFA III Workload .............. .............. .............. .............. 49.0190
Adjuster...................
----------------------------------------------------------------------------------------------------------------
[[Page 39031]]
The statutory revenue amount after the inflation adjustment
($19,383,730) must now be increased by 49.0190 percent to reflect the
changes in review workload (workload adjustment), for a workload and
inflation-adjusted amount of $28,885,441.
D. Reduction of Workload-Based Increase by Amount of Certain Excess
Collections
Under section 741(c)(3)(B) of the FD&C Act, for FYs 2021 through
2023, if application of the workload adjustment increases the amount of
fee revenues established for the fiscal year, as adjusted for
inflation, the fee revenue increase will be reduced by the amount of
any excess collections, for the second preceding fiscal year, up to the
amount of the fee revenue increase for workload. The workload and
inflation-adjusted amount ($28,885,441) is subtracted by the inflation
adjusted amount ($19,383,730) to get the workload adjustment amount
($9,501,711). Then the excess fees collected from FY 2020 as of May 31,
2021 ($4,087,114) are subtracted from the workload adjustment amount
($9,501,711) to get a reduced workload adjustment amount of $5,414,597.
Next, the reduced workload adjustment amount ($5,414,597) is added to
the inflation-adjusted revenue amount ($19,383,730), for a total fee
revenue target of $24,798,000 (rounded to the nearest thousand
dollars).
E. FY 2022 Fee Revenue Amounts
AGDUFA III specifies that the revenue amount of $24,798,000 for FY
2022 is to be divided as follows: 25 percent, or a total of $6,199,500,
is to come from application fees; 37.5 percent, or a total of
$9,299,250, is to come from product fees; and 37.5 percent, or a total
of $9,299,250, is to come from sponsor fees (21 U.S.C. 379j-21(b)).
III. Abbreviated Application Fee Calculations for FY 2022
A. Application Fee Revenues and Numbers of Fee-Paying Applications
Each person who 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) of the FD&C Act (21 U.S.C. 379j-21(k)(1)). The
application fees are to be set so that they will generate $6,199,500 in
fee revenue for FY 2022.
To set fees for abbreviated applications for generic new animal
drugs to realize $6,199,500 FDA must first make some assumptions about
the number of fee-paying abbreviated applications it will receive
during FY 2022.
The Agency knows the number of applications that have been
submitted in previous years. That number fluctuates annually. In
estimating the fee revenue to be generated by generic new animal drug
applications in FY 2022, FDA is assuming that the number of
applications for which fees will be paid in FY 2022 will equal the
average number of submissions over the 5 most recently completed fiscal
years of the AGDUFA program (FY 2016-FY 2020).
Also, under AGDUFA III, 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)).
The average number of original submissions of abbreviated
applications for generic new animal drugs over the 5 most recently
completed fiscal years is 8.2 applications not subject to the criteria
in section 512(d)(4) of the FD&C Act and 6.2 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 11.30 anticipated full fees.
Based on the previous assumptions, FDA is estimating that it will
receive a total of 11.30 fee-paying generic new animal drug
applications in FY 2022 (8.2 original applications paying a full fee
and 6.2 applications paying a half fee).
B. Application Fee Rates for FY 2022
FDA must set the fee rates for FY 2022 so that the estimated 11.30
abbreviated applications that pay the fee will generate a total of
$6,199,500. To generate this amount, the fee for a generic new animal
drug application will have to be $548,628 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 $274,314.
IV. Generic New Animal Drug Product Fee Calculations for FY 2022
A. Product Fee Revenues and Numbers of Fee-Paying Products
The generic new animal drug 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 $9,299,250 in
fee revenue for FY 2022.
To set generic new animal drug product fees to realize $9,299,250,
FDA must make some assumptions about the number of products for which
these fees will be paid in FY 2022. 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 had a generic new animal drug application or supplemental
abbreviated application pending after September 1, 2008. As of May
2021, FDA estimates a total of 536 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 536 products will be subject to this fee in FY 2022.
In estimating the fee revenue to be generated by generic new animal
drug product fees in FY 2022, FDA is estimating that 1 percent of the
products invoiced, or 5 products, will qualify for minor use/minor
species fee waiver (see 21 U.S.C. 379j-21(d)). FDA has made this
estimate at 1 percent this year, based on historical data over the past
5 completed fiscal years of the AGDUFA program.
[[Page 39032]]
Accordingly, the Agency estimates that a total of 531 (536 minus 5)
products will be subject to product fees in FY 2022.
B. Product Fee Rates for FY 2022
FDA must set the fee rates for FY 2022 so that the estimated 531
products that pay fees will generate a total of $9,299,250. To generate
this amount will require the fee for a generic new animal drug product,
rounded to the nearest dollar, to be $17,513.
V. Generic New Animal Drug Sponsor Fee Calculations for FY 2022
A. Sponsor Fee Revenues and Numbers of Fee-Paying Sponsors
The generic new animal drug 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 6 approved abbreviated applications will pay 100 percent
of the sponsor fee; applicants with more than 1 and fewer than 7
approved abbreviated applications will pay 75 percent of the sponsor
fee; and applicants with 1 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
$9,299,250 in fee revenue for FY 2022.
To set generic new animal drug sponsor fees to realize $9,299,250,
FDA must make some assumptions about the number of sponsors who will
pay these fees in FY 2022. FDA estimates that in FY 2022, 12 sponsors
will pay 100 percent fees, 18 sponsors will pay 75 percent fees, and 30
sponsors will pay 50 percent fees. That totals the equivalent of 40.5
full sponsor fees (12 x 100 percent or 12, plus 18 x 75 percent or
13.5, plus 30 x 50 percent or 15).
FDA estimates that about 2 percent of all of these sponsors, or
0.81, may qualify for a minor use/minor species fee waiver (see 21
U.S.C. 379j-21(d)). FDA has made the estimate of the percentage of
sponsors that will not pay fees at 2 percent this year, based on
historical data over the past 5 completed fiscal years of the AGDUFA
program.
Accordingly, the Agency estimates that the equivalent of 39.69 full
sponsor fees (40.5-0.81) are likely to be paid in FY 2022.
B. Sponsor Fee Rates for FY 2022
FDA must set the fee rates for FY 2022 so that the estimated
equivalent of 39.69 full sponsor fees will generate a total of
$9,299,250. To generate this amount will require the 100 percent fee
for a generic new animal drug sponsor, rounded to the nearest dollar,
to be $234,297. Accordingly, the fee for those paying 75 percent of the
full sponsor fee will be $175,723, and the fee for those paying 50
percent of the full sponsor fee will be $117,149.
VI. Fee Schedule for FY 2022
The fee rates for FY 2022 are summarized in table 5.
Table 5--FY 2022 Fee Rates
------------------------------------------------------------------------
Fee rate for
Generic new animal drug user fee category FY 2022
------------------------------------------------------------------------
Abbreviated Application Fee for Generic New Animal Drug $548,628
except those subject to the criteria in section
512(d)(4)..............................................
Abbreviated Application Fee for Generic New Animal Drug 274,314
subject to the criteria in section 512(d)(4)...........
Generic New Animal Drug Product Fee..................... 17,513
100% Generic New Animal Drug Sponsor Fee.1.............. 234,297
75% Generic New Animal Drug Sponsor Fee.1............... 175,723
50% Generic New Animal Drug Sponsor Fee.1............... 117,149
------------------------------------------------------------------------
1An animal drug sponsor is subject to only one fee each fiscal year.
VII. Fee Waiver or Reduction; Exemption From Fees
The types of fee waivers and reductions that applied last fiscal
year still exist for FY 2022. In AGDUFA III a new exemption from fees
was established, as follows:
Fees will not apply to any person who not later than September 30,
2023, submits to CVM a supplemental abbreviated application relating to
a generic new animal drug approved under section 512 of the FD&C Act,
solely to add the application number to the labeling of the drug in the
manner specified in section 502(w)(3) of the FD&C Act (21 U.S.C.
352(w)(3)), if that person otherwise would be subject to user fees
under AGDUFA based only on the submission of the supplemental
abbreviated application (21 U.S.C. 379j-21(d)(2)).
VIII. Procedures for Paying FY 2022 Generic New Animal Drug User Fees
A. Abbreviated Application Fees and Payment Instructions
The FY 2022 fee established in the new fee schedule must be paid
for a generic new animal drug application subject to fees under AGDUFA
III that is submitted on or after October 1, 2021. 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.
[[Page 39033]]
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 ``AG'', on the upper right-hand
corner of your completed Animal Generic Drug User Fee Cover Sheet. Also
write FDA's post office box number (P.O. Box 979033) and PIN 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. Note:
In no case should the payment for the fee be submitted to FDA with the
application.
When paying by wire transfer, it is required that the invoice
number or PIN is included; without the invoice number or PIN the
payment may not be applied, and 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.
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 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 PIN described previously.
The tax identification number of FDA is 53-0196965.
B. Application Cover Sheet Procedures
Step One--Create a user account and password. Log onto the AGDUFA
website 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 application for a generic new animal drug. 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 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, 2021, FDA will issue invoices and payment
instructions for product and sponsor fees for FY 2022 using this fee
schedule. Fees will be due by January 31, 2022. FDA will issue invoices
in November 2022 for any products and sponsors subject to fees for FY
2022 that qualify for fees after the December 2021 billing.
Dated: July 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-15642 Filed 7-22-21; 8:45 am]
BILLING CODE 4164-01-P
