[Federal Register Volume 86, Number 139 (Friday, July 23, 2021)]
[Notices]
[Pages 39028-39033]
[FR Doc No: 2021-15642]

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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.

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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,<PHONE_NUMBER><EMAIL_ADDRESS>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

Medicine (CVM) at<EMAIL_ADDRESS>
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
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             Fiscal year                     2018               2019               2020          3-year average
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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
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    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

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
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Annual CPI......................................         272.414         275.841         278.437  ..............
Annual Percent Change...........................          2.0671          1.2580          0.9411          1.4221
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    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
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                                     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
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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...................
----------------------------------------------------------------------------------------------------------------

    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.

    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
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                                                           Fee rate for
        Generic new animal drug user fee category             FY 2022
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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.

    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<PHONE_NUMBER>. 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


[Federal Register Volume 83, Number 172 (Wednesday, September 5, 2018)]
[Rules and Regulations]
[Page 45047]
[FR Doc No: 2018-19176]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket No. USCG-2018-0834]

Special Local Regulation; Annual OPA World Championships, Gulf of
Mexico; Englewood Beach, FL

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce special local regulations for the
OPA World Championships from November 16, 2018 through November 18,
2018, to provide for the safety of life on navigable waterways during
this event. Our regulation for Annual OPA World Championships
identifies the regulated area for this event in Englewood, FL. During
the enforcement periods, the operator of any vessel in the regulated
area must comply with directions from the Patrol Commander or any
Official Patrol displaying a Coast Guard ensign.

DATES: The regulations in 33 CFR 100.735 will be enforced from 9 a.m.
until 5 p.m., each day from November 16, 2018, through November 18,
2018.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notice of enforcement, call or email Marine Science Technician First
Class Michael D. Shackleford, Sector St. Petersburg Prevention
Department, Coast Guard; telephone<PHONE_NUMBER>, email
[email protected].

SUPPLEMENTARY INFORMATION: The Coast Guard will enforce special local
regulations in 33 CFR 100.735 for the OPA World Championships regulated
area from 9 a.m. to 5 p.m. on November 16, 2018 through November 18,
2018. This action is being taken to provide for the safety of life on
navigable waterways during this 3-day event. Our regulation for Annual
OPA World Championships, Sec.  100.735, specifies the location of the
regulated area for the OPA World Championships which encompasses
portions of the Gulf of Mexico near Englewood, FL. During the
enforcement periods, as reflected in Sec.  100.735, if you are the
operator of a vessel in the regulated area you must comply with
directions from the Patrol Commander or any Official Patrol displaying
a Coast Guard ensign.
    In addition to this notice of enforcement in the Federal Register,
the Coast Guard will provide notification of this enforcement period
via the Broadcast Notice to Mariners.

Holly L. Najarian,
Captain, U.S. Coast Guard, Captain of the Port Saint Petersburg.
[FR Doc. 2018-19176 Filed 9-4-18; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 81, Number 109 (Tuesday, June 7, 2016)]
[Notices]
[Pages 36531-36532]
[FR Doc No: 2016-13355]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13563-003-Alaska]

Juneau Hydropower, Inc.; Notice of Availability of the Final
Environmental Impact Statement for the Sweetheart Lake Hydroelectric
Project

    In accordance with the National Environmental Policy Act of 1969
and the Federal Energy Regulatory Commission (Commission or FERC)
regulations contained in the Code of Federal Regulations (CFR)(18 CFR
part 380 [FERC Order No. 486, 52 FR 47897]), the Office of Energy
Projects has reviewed the application for an original license for the
Sweetheart Lake Hydroelectric Project (FERC No. 13563) and prepared a
final environmental impact statement (EIS) for the project.
    The proposed project would be located on Sweetheart Lake and
Sweetheart Creek in the City and

Borough of Juneau, Alaska. The proposed project, if licensed, would
occupy 2,058.24 acres of federal lands within the Tongass National
Forest, administered by the U.S. Department of Agriculture, Forest
Service.
    The final EIS contains staff's analysis of the applicant's proposal
and the alternatives for licensing the Sweetheart Lake Hydroelectric
Project. The final EIS documents the views of governmental agencies,
non-governmental organizations, affected Indian tribes, the public, the
license applicant, and Commission staff.
    A copy of the final EIS is available for review at the Commission
or may be viewed on the Commission's Web site at http://www.ferc.gov,
using the ``e-Library'' link. Enter the docket number, excluding the
last three digits, to access the document. For assistance, contact FERC
Online Support at<EMAIL_ADDRESS>or toll free at (866) 208-
3676, or for TTY, contact<PHONE_NUMBER>.
    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    For further information, contact John Matkowski at<PHONE_NUMBER>
or at<EMAIL_ADDRESS>
    Dated: May 31, 2016.
Kimberly D. Bose,
 Secretary.
[FR Doc. 2016-13355 Filed 6-6-16; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 211 (Thursday, October 31, 2013)]
[Rules and Regulations]
[Pages 65193-65195]
[FR Doc No: 2013-25132]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-0666; Directorate Identifier 2013-NM-060-AD;
Amendment 39-17635; AD 2013-22-03]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for all The
Boeing Company Model 727 airplanes. This AD was prompted by reports
indicating that a standard fuel tank access door was located where an
impact-resistant access door was required, and stencils were missing
from some impact-resistant access doors. This AD requires an inspection
of the left- and right-hand wing fuel tank access doors to determine
that impact-resistant access doors are installed in the correct
locations, and to replace any door with an impact-resistant access door
if necessary. This AD also requires an inspection for stencils and
index markers on impact-resistant access doors, and application of new
stencils or index markers if necessary. This AD also requires revising
the maintenance program to incorporate changes to the airworthiness
limitations section. We are issuing this AD to prevent foreign object
penetration of the fuel tank, which could cause a fuel leak near an
ignition source (e.g., hot brakes), consequently leading to a fuel-fed
fire.

DATES: This AD is effective December 5, 2013.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of December 5,
2013.

ADDRESSES: For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-
5000, extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com. You may review this referenced service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The address for the
Docket Office (phone:<PHONE_NUMBER>) is Document Management Facility,
U.S. Department of Transportation, Docket Operations, M-30, West
Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE.,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Suzanne Lucier, Aerospace Engineer,
Propulsion Branch, ANM-140S, FAA, Seattle Aircraft Certification
Office, 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-
6438; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to the specified products. The
NPRM published in the Federal Register on August 1, 2013 (78 FR 46538).
The NPRM proposed to require an inspection of the left- and right-hand
wing fuel tank access doors to determine that impact-resistant access
doors are installed in the correct locations, and to replace any door
with an impact-resistant access door if necessary. The NPRM also
proposed to require an inspection for stencils and index markers on
impact-resistant access doors, and application of new stencils or index
markers if necessary. The NPRM also proposed to require revising the
maintenance program to incorporate changes to the airworthiness
limitations section.

Comments

    We gave the public the opportunity to participate in developing
this AD. We have considered the comment received. The Boeing Company
supported the NPRM (78 FR 46538, August 1, 2013).

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
this AD as proposed--except for minor editorial changes. We have
determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM (78 FR 46538, August 1, 2013) for correcting the unsafe condition;
and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (78 FR 46538, August 1, 2013).

Costs of Compliance

    We estimate that this AD affects 139 airplanes of U.S. registry. We
estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per    Cost on U.S.
                  Action                            Labor cost           Parts cost    product       operators
----------------------------------------------------------------------------------------------------------------
Inspection...............................  Up to 3 work-hours x $85              $0         $255         $35,445
                                            per hour = $255.
Maintenance program revision.............  1 work-hour x $85 per hour             0           85          11,815
                                            = $85.
----------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do any necessary replacements
that would be required based on the results of the inspection. We have
no way of determining the number of aircraft that might need these
replacements:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                    Action                                 Labor cost               Parts cost        product
----------------------------------------------------------------------------------------------------------------
Replacement per door..........................  3 work-hours x $85 per hour =             $8,000          $8,255
                                                 $255.
Stencil and index marker......................  Up to 2 work-hours x $85 per                   0             170
                                                 hour = $170.
----------------------------------------------------------------------------------------------------------------

    According to the manufacturer, some of the costs of this AD may be
covered under warranty, thereby reducing the cost impact on affected
individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all costs in our cost
estimate.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2013-22-03 The Boeing Company: Amendment 39-17635; Docket No. FAA-
2013-0666; Directorate Identifier 2013-NM-060-AD.

(a) Effective Date

    This AD is effective December 5, 2013.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all The Boeing Company Model 727, 727C, 727-
100, 727-100C, 727-200, and 727-200F series airplanes; certificated
in any category.

(d) Subject

    Joint Aircraft System Component (JASC)/Air Transport Association
(ATA) of America Code 28, Fuel.

(e) Unsafe Condition

    This AD was prompted by reports indicating that a standard fuel
tank access door was located where an impact-resistant access door
was required, and stencils were missing from some impact-resistant
access doors. We are issuing this AD to prevent foreign object
penetration of the fuel tank, which could cause a fuel leak near an
ignition source (e.g., hot brakes), consequently leading to a fuel-
fed fire.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Inspections

    Within 72 months after the effective date of this AD, do the
actions specified in paragraphs (g)(1) and (g)(2) of this AD, in
accordance with the Accomplishment Instructions of Boeing Service
Bulletin 727-28-0134, dated January 12, 2012.
    (1) Do either a general visual inspection or ultrasonic non-
destructive test of the left- and right-hand wing fuel tank access
doors to determine whether impact-resistant access doors are
installed in the correct locations. If any standard access door is
found, before further flight, replace with an impact-resistant
access door, in accordance with the Accomplishment Instructions of
Boeing Service Bulletin 727-28-0134, dated January 12, 2012.
    (2) Do a general visual inspection of the left- and right-hand
wing fuel tank impact-resistant access doors to verify stencils and
index markers are applied. If a stencil or index marker is missing,
before further flight, apply stencil or index marker, as applicable,
in accordance with the Accomplishment Instructions of Boeing Service
Bulletin 727-28-0134, dated January 12, 2012.

(h) Maintenance Program Revision

    Within 60 days after the effective date of this AD, revise the
maintenance program to incorporate Critical Design Configuration
Control Limitation (CDCCL) Task 57-AWL-01, ``Impact-Resistant Fuel
Tank Access Door,'' of Section 1, Airworthiness Limitations (AWLs)
of Boeing 727-100/200 Airworthiness Limitations (AWLs) Document D6-
8766-AWL, Revision September 2012.

(i) No Alternative CDCCLs

    After accomplishing the revision required by paragraph (h) of
this AD, no alternative CDCCLs may be used unless the CDCCLs are
approved as an alternative method of compliance in accordance with
the procedures specified in paragraph (j) of this AD.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. In accordance with 14
CFR 39.19, send your request to your principal inspector or local
Flight Standards District Office, as appropriate. If sending
information directly to the manager of the ACO, send it to the
attention of the person identified in paragraph (k) of this AD.
Information may be emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair

required by this AD if it is approved by the Boeing Commercial
Airplanes Organization Designation Authorization (ODA) that has been
authorized by the Manager, Seattle ACO to make those findings. For a
repair method to be approved, the repair must meet the certification
basis of the airplane, and the approval must specifically refer to
this AD.

(k) Related Information

    For more information about this AD, contact Suzanne Lucier,
Aerospace Engineer, Propulsion Branch, ANM-140S, FAA, Seattle
Aircraft Certification Office, 1601 Lind Avenue SW., Renton, WA
98057-3356; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Boeing Service Bulletin 727-28-0134, dated January 12, 2012.
    (ii) Critical Design Configuration Control Limitation (CDCCL)
Task 57-AWL-01, ``Impact-Resistant Fuel Tank Access Door,'' of
Section 1, Airworthiness Limitations (AWLs) of Boeing 727-100/200
Airworthiness Limitations (AWLs) Document D6-8766-AWL, Revision
September 2012.
    (3) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-
5000, extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com.
    (4) You may view this service information at FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call
425-227-1221.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on October 15, 2013.
Jeffrey E. Duven,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2013-25132 Filed 10-30-13; 8:45 am]
BILLING CODE 4910-13-P