[Federal Register Volume 87, Number 218 (Monday, November 14, 2022)]
[Proposed Rules]
[Pages 68113-68116]
[FR Doc No: 2022-23911]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-1240; Project Identifier AD-2022-00683-E]
RIN 2120-AA64

Airworthiness Directives; General Electric Company Turbofan
Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for certain General Electric Company (GE) GE90-76B, GE90-85B, GE90-90B,
and GE90-94B model turbofan engines. This proposed AD was prompted by a
commanded in-flight shutdown (IFSD) due to cracking and rockback of the
high-pressure turbine (HPT) stage 2 nozzles resulting in blade
liberation, severe rotor imbalance, and liberation of the exhaust
centerbody. This proposed AD would require initial and repetitive
borescope inspections (BSIs) of the forward platforms of the HPT stage
2 blades or the leading edges of the HPT stage 2 nozzles and, depending
on the results of the inspections, removal and replacement of the HPT
stage 2 nozzles with a part eligible for installation. As a mandatory
terminating action to the repetitive BSIs of the forward platforms of
the HPT stage 2 blades or the leading edges of the HPT stage 2 nozzles,
this proposed AD would require replacement of the HPT stage 2 nozzles.
The FAA is proposing this AD to address the unsafe condition on these
products.

DATES: The FAA must receive comments on this proposed AD by December
29, 2022.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to regulations.gov. Follow
the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    AD Docket: You may examine the AD docket at regulations.gov by
searching for and locating Docket No. FAA-2022-1240; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this NPRM, any comments
received, and other information. The street address for Docket
Operations is listed above.
    Material Incorporated by Reference: For service information
identified in this NPRM, contact General Electric Company, GE Aviation,
Room 285, 1 Neumann Way, Cincinnati, OH 45215; phone:<PHONE_NUMBER>;
email: [email protected]. You may view this service
information at the FAA, Airworthiness Products Section, Operational
Safety Branch, 1200 District Avenue, Burlington, MA 01803. For
information on the availability of this material at the FAA, call (817)
222-5110.

FOR FURTHER INFORMATION CONTACT: Stephen Elwin, Aviation Safety
Engineer, ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803;
phone:<PHONE_NUMBER>; email: [email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2022-1240; Project Identifier
AD-2022-00683-E'' at the beginning of your comments. The most helpful
comments reference a specific portion of the

proposal, explain the reason for any recommended change, and include
supporting data. The FAA will consider all comments received by the
closing date and may amend this proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
regulations.gov, including any personal information you provide. The
agency will also post a report summarizing each substantive verbal
contact received about this NPRM.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to
Stephen Elwin, Aviation Safety Engineer, ECO Branch, FAA, 1200 District
Avenue, Burlington, MA 01803. Any commentary that the FAA receives
which is not specifically designated as CBI will be placed in the
public docket for this rulemaking.

Background

    The FAA received a report of a commanded IFSD of a GE90-85B model
turbofan engine installed on a Boeing Model 777-200ER airplane that
occurred on July 12, 2018. Subsequent investigation by the manufacturer
found that cracking and rockback of the HPT stage 2 nozzles, due to
thermal distress in the fillet radius of the leading edge, resulted in
rotor-stator contact with the HPT stage 2 blade platform. This
condition caused liberation of an HPT stage 2 blade and severe rotor
imbalance, leading to liberation of the exhaust centerbody from the
engine. This condition, if not addressed, could result in IFSD, failure
of the engine and exhaust centerbody, and loss of the airplane.

FAA's Determination

    The FAA is issuing this NPRM after determining that the unsafe
condition described previously is likely to exist or develop on other
products of the same type design.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed GE GE90 Service Bulletin (SB) 72-1166, Revision 3,
dated February 14, 2019. This service information specifies procedures
for BSIs of the HPT stage 2 blade forward platforms for rub marks or
evidence of contact (circumferential grooves on the HPT stage 2 blade
platforms) with the HPT stage 2 nozzle angel wings. This service
information also specifies procedures for performing a 360-degree BSI
of the HPT stage 2 nozzles leading edges and specifies procedures for
removal and replacement of HPT stage 2 nozzles.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in ADDRESSES.

Other Related Service Information

    The FAA reviewed GE GE90 SB 72-1071, Revision 1, dated January 16,
2015. This service information specifies procedures for removal and
replacement of HPT stage 2 nozzles with HPT stage 2 nozzles that
incorporate a design change.
    The FAA also reviewed GE GE90 SB 72-1216, Initial Issue, dated
August 22, 2022. This service information specifies inspection
procedures for affected HPT stage 2 nozzles.

Proposed AD Requirements in This NPRM

    This proposed AD would require initial and repetitive borescope
inspections of the forward platforms of the HPT stage 2 blades or the
leading edges of the HPT stage 2 nozzles and, depending on the results
of the inspections, removal and replacement of the HPT stage 2 nozzles
with parts eligible for installation. As a mandatory terminating action
to the repetitive BSIs of the forward platforms of the HPT stage 2
blades or the leading edges of the HPT stage 2 nozzles, this proposed
AD would require replacement of the HPT stage 2 nozzles.

Differences Between This Proposed AD and the Service Information

    GE GE90 SB 72-1166, Revision 3, dated February 14, 2019, specifies
BSIs be performed upon reaching the threshold of the analytical model
for the HPT stage 2 nozzles after GE Aviation issues a customer
notification report for any engine that reaches the analytical
threshold, while this proposed AD would require that BSIs be performed
based on the flight hours accrued on the HPT stage 2 nozzles since new
or since overhaul.

Costs of Compliance

    The FAA estimates that this AD, if adopted as proposed, would
affect 8 engines installed on airplanes of U.S. registry.
    The FAA estimates the following costs to comply with this proposed
AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
BSI of HPT stage 2 nozzles or HPT       4 work-hours x $85 per                $0            $340          $2,720
 stage 2 blade interface.                hour = $340.
----------------------------------------------------------------------------------------------------------------

    The FAA estimates the following costs to do any necessary
replacements that would be required based on the results of the
proposed inspections. The agency has no way of determining the number
of aircraft that might need these replacements.

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                    Action                                 Labor cost               Parts cost        product
----------------------------------------------------------------------------------------------------------------
Replace full set of HPT stage 2 nozzles.......  8 work-hours x $85 per hour =           $918,650        $919,330
                                                 $680.
----------------------------------------------------------------------------------------------------------------

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.
    The FAA is 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

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would 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 this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Would not affect intrastate aviation in Alaska, and
    (3) Would 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.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 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:

General Electric Company: Docket No. FAA-2022-1240; Project
Identifier AD-2022-00683-E.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by December 29, 2022.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to General Electric Company (GE) GE90-76B, GE90-
85B, GE90-90B, and GE90-94B model turbofan engines, excluding those
engines with an installed full set of high-pressure turbine (HPT)
stage 2 nozzles with part numbers 1847M47G23 and 1847M47G24.

(d) Subject

    Joint Aircraft System Component (JASC) Code 7250, Turbine
Section.

(e) Unsafe Condition

    This AD was prompted by a commanded in-flight shutdown (IFSD)
due to cracking and rockback of the HPT stage 2 nozzles resulting in
blade liberation, severe rotor imbalance, and liberation of the
exhaust centerbody. The FAA is issuing this AD to prevent failure of
the HPT stage 2 nozzles, HPT stage 2 blades, and exhaust centerbody.
The unsafe condition, if not addressed, could result in IFSD,
failure of the engine and exhaust centerbody, and loss of the
airplane.

(f) Compliance

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

(g) Required Actions

    (1) Within the compliance times specified in paragraphs
(g)(1)(i) and (ii) of this AD, perform an initial borescope
inspection (BSI) of the forward platforms of the HPT stage 2 blades,
or perform a 360 degree BSI of the leading edges of the HPT stage 2
nozzles (optional procedure) in accordance with the Accomplishment
Instructions, paragraph 3.A.(3)(a) of GE GE90 SB 72-1166, Revision
3, dated February 14, 2019 (the SB):
    (i) For engines with HPT stage 2 nozzles that have accumulated
22,000 or more flight hours since new or since last overhaul as of
the effective date of this AD, perform the initial BSI before
accumulating 250 flight cycles (FCs) after the effective date of
this AD.
    (ii) For engines with HPT stage 2 nozzles that have accumulated
less than 22,000 flight hours since new or since last overhaul as of
the effective date of this AD, perform the initial BSI before
accumulating 22,000 flight hours since new or since last overhaul,
or within 250 FCs after the effective date of this AD, whichever
occurs later.
    (2) Thereafter, at intervals not to exceed 100 FCs from
performance of the last BSI of the forward platforms of the HPT
stage 2 blades, or at intervals not to exceed 500 FCs from the last
BSI of the leading edges of the HPT stage 2 nozzles, as applicable,
perform a repetitive BSI of the forward platforms of the HPT stage 2
blades or the leading edges of the HPT stage 2 nozzles in accordance
with the Accomplishment Instructions, paragraph 3.A.(3)(a) of the
SB.
    (3) If, during any inspection required by paragraphs (g)(1) or
(g)(2) of this AD, rub marks, evidence of contact on the HPT stage 2
blade forward platform on three or more HPT stage 2 blades, or an
unserviceable HPT stage 2 nozzle is found, before further flight,
remove and replace the HPT stage 2 nozzles with a part eligible for
installation.
    Note 1 to paragraph (g)(3): Serviceability criteria can be found
in the GE90 Boeing 777 Aircraft Maintenance Manual, 72-00-00,
INSPECTION/CHECK, Subtask 72-00-00-220-074-G00.

(h) Mandatory Terminating Action

    As a mandatory terminating action to the repetitive inspections
required by paragraph (g)(2) of this AD, at the next engine shop
visit after reaching 22,000 flight hours since new or since last
overhaul, replace the HPT stage 2 nozzles with parts eligible for
installation.

(i) Definitions

    (1) For the purpose of this AD, ``parts eligible for
installation'' is a full set of HPT stage 2 nozzles with part
numbers 1847M47G23 and 1847M47G24.
    (2) For the purpose of this AD, an ``overhaul'' is the complete
refurbishment of the HPT stage 2 nozzle segments.
    (3) For the purpose of this AD, and ``engine shop visit'' is the
induction of an engine into the shop for maintenance involving
separation of pairs of major mating engine case flanges, except for
the following situations, which do not constitute an engine shop
visit:
    (i) Separation of engine flanges solely for the purposes of
transportation of the engine without subsequent maintenance; or
    (ii) Separation of engine flanges solely for the purpose of
replacing the fan or propulsor without subsequent maintenance.

(j) Credit for Previous Actions

    You may take credit for the initial inspection required by
paragraph (g)(1) of this AD if you performed the inspection before
the effective date of this AD using GE GE90 SB 72-1166, Revision 2,
dated October 13, 2017, or earlier revisions.

(k) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, ECO Branch, 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
certification office, send it to the attention of the person
identified in paragraph (l)(1) of this AD. Information may be
emailed to: [email protected].
    (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.

(l) Related Information

    (1) For more information about this AD, contact Stephen Elwin,
Aviation Safety Engineer, ECO Branch, FAA, 1200 District Avenue,
Burlington, MA 01803; phone:<PHONE_NUMBER>; email:
[email protected].
    (2) GE service information identified in this AD that is not
incorporated by reference is available at the addresses specified in
paragraph (m)(3) of this AD.

(m) 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) GE GE90 Service Bulletin (SB) 72-1166, Revision 3, dated
February 14, 2019.
    (ii) [Reserved]
    (3) For GE service information identified in this AD, contact
General Electric Company, GE Aviation, Room 285, 1 Neumann Way,
Cincinnati, OH 45215; phone:<PHONE_NUMBER>; email:
[email protected].
    (4) You may view this service information at FAA, Airworthiness
Products Section, Operational Safety Branch, 1200 District Avenue,
Burlington, MA, 01803. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.
    (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, email: [email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on September 26, 2022.
Christina Underwood,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2022-23911 Filed 11-10-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 203 (Monday, October 23, 2023)]
[Notices]
[Pages 72763-72767]
[FR Doc No: 2023-23373]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-4488]

Animal Drug User Fee Rates and Payment Procedures for Fiscal Year
2024

AGENCY: Food and Drug Administration, 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) 2024 animal
drug user fees. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as
amended by the Animal Drug User Fee Amendments of 2023 (ADUFA V),
authorizes FDA to collect user fees for certain animal drug
applications and supplemental animal drug applications, for certain
animal drug products, for certain establishments where such products
are made, and for certain sponsors of such animal drug applications
and/or investigational animal drug submissions. This notice establishes
the fee rates for FY 2024.

DATES: The application fee rates are effective for applications
submitted on or after October 1, 2023, and will remain in effect
through September 30, 2024.

FOR FURTHER INFORMATION CONTACT: Visit FDA's website at https://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/default.htm
or contact Lisa Kable, Center for Veterinary Medicine (HFV-10), Food
and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-
402-6888, [email protected]. For general questions, you may also
email FDA's Center for Veterinary Medicine (CVM) at:
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Section 740 of the FD&C Act (21 U.S.C. 379j-12), as amended by
ADUFA V, establishes four different types of user fees: (1) fees for
certain types of animal drug applications and supplemental animal drug
applications; (2) annual fees for certain animal drug products; (3)
annual fees for certain establishments where such products are made;
and (4) annual fees for certain sponsors of animal drug applications
and/or investigational animal drug submissions (21 U.S.C. 379j-12(a)).
When certain conditions are met, FDA will waive or reduce fees (21
U.S.C. 379j-12(d)).
    For FYs 2024 through 2028, the FD&C Act establishes the base
revenue amount for each fiscal year (21 U.S.C. 379j-12(b)(1)).
Beginning in FY 2025, the base revenue amount is subject to adjustment
for inflation and workload (21 U.S.C. 379j-12(c)(2) and (3)). Also
beginning in FY 2025, ADUFA V provides for an operating reserve
adjustment to allow FDA to adjust the fee revenue amount to maintain a
specified operating reserve of carryover user fees (21 U.S.C. 379j-
12(c)(4)). FDA may increase the fee revenue amount to maintain a 12-
week minimum. If FDA has an excess operating reserve, FDA will decrease
the fee revenue amount so that FDA has 22 weeks of operating reserve
for FY 2025, 20 weeks for FY 2026, 18 weeks for FY 2027, and 16 weeks
for FY 2028.
    Fees for applications, establishments, products, and sponsors are
to be established each year by FDA so that the percentages of the total
revenue that are derived from each type of user fee will be as follows:
(1) revenue from application fees shall be 20 percent of total fee
revenue; (2) revenue from product fees shall be 27 percent of total fee
revenue; (3) revenue from establishment fees shall be 26 percent of
total fee revenue; and (4) revenue from sponsor fees shall be 27
percent of total fee revenue (21 U.S.C. 379jndash;12(b)(2)). The fee
revenue amount for FY 2024 is $33,500,000 (21 U.S.C. 379j-12(b)(1)).
The target revenue amounts for each fee category for FY 2024 are as
follows: for application fees, the target revenue amount is $6,700,000;
for product fees, the target revenue amount is $9,045,000; for
establishment fees, the target revenue amount is $8,710,000; and for
sponsor fees, the target revenue amount is $9,045,000.
    For FY 2024, the animal drug user fee rates are: $683,673 for an
animal drug application; $341,837 for a supplemental animal drug
application for which safety or effectiveness data are required, for an
animal drug application subject to the criteria set forth in section
512(d)(4) of the FD&C Act (21 U.S.C. 360b(d)(4)), and for an
application for conditional approval under section 571 of the FD&C Act
(21 U.S.C. 360ccc) for which an animal drug application submitted under
section 512(b)(1) of the FD&C Act has been previously approved under
section 512(d)(1) of the FD&C Act for another intended use; $12,459 for
the annual product fee; $174,200 for the annual establishment fee; and
$153,305 for the annual sponsor fee. FDA will issue invoices for FY
2024 product, establishment, and sponsor fees by December 31, 2023, and
payment will be due by January 31, 2024. The application fee rates are
effective for applications submitted on or after October 1, 2023, and
will remain in effect through September 30, 2024.

Applications will not be accepted for review until FDA has received
full payment of application fees and any other animal drug user fees
owed under the ADUFA program.

II. Revenue Amount for FY 2024

A. Statutory Fee Revenue Amounts

    ADUFA V, Title III of Public Law 118-15, specifies that the
aggregate base fee revenue amount for FY 2024 for all animal drug user
fee categories is $33,500,000 (21 U.S.C. 379j-12(b)(1)).

B. Inflation Adjustment to Fee Revenue Amount

    ADUFA V specifies that the annual fee revenue amount is to be
adjusted for inflation increases for FY 2025 and subsequent fiscal
years (21 U.S.C. 379j-12(c)(2)). Since ADUFA V does not adjust for
inflation until FY 2025, there is no inflation adjustment for FY 2024.

C. Workload Adjustment to Inflation Adjusted Fee Revenue Amount

    The fee revenue amounts established in ADUFA V for FY 2025 and
subsequent fiscal years are also subject to adjustment to account for
changes in FDA's review workload (21 U.S.C. 379j-12(c)(3)). Since ADUFA
V does not adjust for workload until FY 2025, there is no workload
adjustment for FY 2024.

D. Operating Reserve Adjustment

    For fiscal year 2025 and each subsequent fiscal year, after the fee
revenue amount established under section 740(b) of the FD&C Act is
adjusted for inflation and workload, the Secretary shall increase the
fee revenue amount for such fiscal year, if necessary to provide an
operating reserve of not less than 12 weeks. If the operating reserve
is in excess of the number of weeks specified in section 740(c)(4)(C)
of the FD&C Act for that fiscal year, the Secretary shall decrease the
fee revenue amount to provide not more than the number of weeks
specified for that fiscal year. Since ADUFA V does not adjust for the
operating reserve until FY 2025, there is no adjustment for FY 2024.

E. FY 2024 Fee Revenue Amounts

    The fee revenue amount for FY 2024 is $33,500,000. ADUFA V
specifies that this revenue amount is to be divided as follows: 20
percent, or a total of $6,700,000, is to come from application fees; 27
percent, or a total of $9,045,000, is to come from product fees; 26
percent, or a total of $8,710,000 is to come from establishment fees;
and 27 percent, or a total of $9,045,000 is to come from sponsor fees
(21 U.S.C. 379j-12(b)).

III. Application Fee Calculations for FY 2024

A. Application Fee Revenues and Numbers of Fee-Paying Applications

    Each person that submits an animal drug application or a
supplemental animal drug application shall be subject to an application
fee, with limited exceptions (see 21 U.S.C. 379j-12(a)(1)). The term
``animal drug application'' means an application for approval of any
new animal drug submitted under section 512(b)(1) of the FD&C Act or an
application for conditional approval of a new animal drug submitted
under section 571 of the FD&C Act (see section 739(1) of the FD&C Act
(21 U.S.C. 379j-11(1)). A ``supplemental animal drug application'' is
defined as a request to FDA to approve a change in an approved animal
drug application, or a request to FDA to approve a change to an
application approved under section 512(c)(2) of the FD&C Act for which
data with respect to safety or effectiveness are required. Such
applications are subject to ADUFA fees, except those fees may be waived
if the application is intended solely to provide for a minor use or
minor species (MUMS) indication (see 21 U.S.C. 379j-12(d)(1)(D)).
    Furthermore, ADUFA V continues to provide an exception from
application fees for animal drug applications submitted under section
512(b)(1) of the FD&C Act by a sponsor who previously applied for
conditional approval under section 571 of the FD&C Act for the same
product and paid an application fee at the time they applied for
conditional approval. The purpose of this exception is to prevent
sponsors of conditionally approved products from having to pay a second
application fee at the time they apply for full approval of their
products under section 512(b)(1) of the FD&C Act, provided the
sponsor's application for full approval is filed consistent with the
timeframes established in section 571(h) of the FD&C Act (see 21 U.S.C.
379j-12(a)(1)(C)(ii)).
    The application fees are to be set so that they will generate
$6,700,000 in fee revenue for FY 2024. The fee for a supplemental
animal drug application for which safety or effectiveness data are
required, for an animal drug application subject to criteria set forth
in section 512(d)(4) of the FD&C Act, and for an application for
conditional approval under section 571 of the FD&C Act of a new animal
drug for which an animal drug application submitted under section
512(b)(1) of the FD&C Act has been previously approved under section
512(d)(1) for another intended use is to be set at 50 percent of the
animal drug application fee (21 U.S.C. 379j-12(a)(1)(A)(ii)).
    To set animal drug application fees and supplemental animal drug
application fees to realize $6,700,000, FDA must first make some
assumptions about the number of fee-paying applications and
supplemental applications the Agency will receive in FY 2024.
    The Agency knows the number of applications that have been
submitted in previous fiscal years. That number fluctuates annually. In
estimating the fee revenue to be generated by animal drug application
fees in FY 2024, FDA is assuming that the number of applications for
which fees will be paid in FY 2024 will equal the average number of
applications over the 5 most recently completed fiscal years of the
ADUFA program (FY 2018 to FY 2022).
    Over the 5 most recently completed fiscal years, the average number
of animal drug applications subject to the full fee was 5.20. Over this
same period, the average number of supplemental applications for which
safety or effectiveness data are required, applications subject to the
criteria set forth in section 512(d)(4) of the FD&C Act, and
applications for conditional approval of a new animal drug for which a
section 512(b)(1) application has been previously approved for another
intended use subject to half of the full fee was 9.20.
    Based on the previous assumptions, FDA is estimating that it will
receive a total of 9.80 fee-paying animal drug applications in FY 2024
(5.20 applications paying a full fee and 9.20 applications paying a
half fee).

B. Application Fee Rates for FY 2024

    FDA must set the fee rates for FY 2024 so that the estimated 9.80
applications that pay the fee will generate a total of $6,700,000. To
generate this amount, the fee for an animal drug application, rounded
to the nearest dollar, will have to be $683,673, and the fee for a
supplemental animal drug application for which safety or effectiveness
data are required, for applications subject to the criteria set forth
in section 512(d)(4) of the FD&C Act, and for an application for
conditional approval under section 571 of the FD&C Act of a new animal
drug for which an animal drug application submitted under section
512(b)(1) of the FD&C Act has been previously approved under section
512(d)(1) for another intended use will have to be $341,837.

IV. Animal Drug Product Fee Calculations for FY 2024

A. Product Fee Revenues and Numbers of Fee-Paying Products

    The animal drug product fee must be paid annually by the person
named as the applicant in a new animal drug application or supplemental
new animal drug application for an animal drug product submitted for
listing under section 510 of the FD&C Act (21 U.S.C. 360) and who had
an animal drug application or supplemental animal drug application
pending at FDA after September 1, 2003 (21 U.S.C. 379j-12(a)(2)). The
term ``animal drug product'' means each specific strength or potency of
a particular active ingredient or ingredients in final dosage form
marketed by a particular manufacturer or distributor, which is uniquely
identified by the labeler code and product code portions of the
National Drug Code, and for which an animal drug application or a
supplemental animal drug application has been approved (21 U.S.C. 379j-
11(3)). The product fees are to be set so that they will generate
$9,045,000 in fee revenue for FY 2024.
    To set animal drug product fees to realize $9,045,000, FDA must
make some assumptions about the number of products for which these fees
will be paid in FY 2024. FDA developed data on all animal drug products
that have been submitted for listing under section 510 of the FD&C Act
and matched this to the list of all persons who had an animal drug
application or supplemental animal drug application pending after
September 1, 2003. As of May 2023, FDA estimates that there are 733
products submitted for listing by persons who had an animal drug
application or supplemental animal drug application pending after
September 1, 2003. Based on this, FDA estimates that a total of 733
products will be subject to this fee in FY 2024.
    In estimating the fee revenue to be generated by animal drug
product fees in FY 2024, FDA is assuming that 1 percent of the products
invoiced, or seven, will not pay fees in FY 2024, due to fee waivers
and reductions. FDA has made this estimate at 1 percent this year,
based on historical data over the past 5 completed fiscal years of the
ADUFA program.
    Accordingly, the Agency estimates that a total of 726 (733 minus 7)
products will be subject to product fees in FY 2024.

B. Product Fee Rates for FY 2024

    FDA must set the fee rates for FY 2024 so that the estimated 726
products for which fees are paid will generate a total of $9,045,000.
To generate this amount will require the fee for an animal drug
product, rounded to the nearest dollar, to be $12,459.

V. Animal Establishment Fee Calculations for FY 2024

A. Establishment Fee Revenues and Numbers of Fee-Paying Establishments

    The animal drug establishment fee must be paid annually by the
person who: (1) owns or operates, directly or through an affiliate, an
animal drug establishment; (2) is named as the applicant in an animal
drug application or supplemental animal drug application for an animal
drug product submitted for listing under section 510 of the FD&C Act;
(3) had an animal drug application or supplemental animal drug
application pending at FDA after September 1, 2003; and (4) whose
establishment engaged in the manufacture of the animal drug product
during the fiscal year (see 21 U.S.C. 379j-12(a)(3)). An establishment
subject to animal drug establishment fees is assessed only one such fee
per fiscal year. The term ``animal drug establishment'' is defined as a
foreign or domestic place of business at one general physical location,
consisting of one or more buildings, all of which are within 5 miles of
each other, at which one or more animal drug products are manufactured
in final dosage form (21 U.S.C. 379j-11(4)). The establishment fees are
to be set so that they will generate $8,710,000 in fee revenue for FY
2024.
    To set animal drug establishment fees to realize $8,710,000, FDA
must make some assumptions about the number of establishments for which
these fees will be paid in FY 2024. FDA developed data on all animal
drug establishments and matched this to the list of all persons who had
an animal drug application or supplemental animal drug application
pending after September 1, 2003. As of May 2023, FDA estimates that
there are a total of 53 establishments owned or operated by persons who
had an animal drug application or supplemental animal drug application
pending after September 1, 2003. Based on this, FDA believes that 53
establishments will be subject to this fee in FY 2024.
    In estimating the fee revenue to be generated by animal drug
establishment fees in FY 2024, FDA is assuming that 6 percent of the
establishments invoiced, or three, will not pay fees in FY 2024 due to
fee waivers and reductions. FDA has made this estimate at 6 percent
this year, based on historical data over the past 5 completed fiscal
years.
    Accordingly, the Agency estimates that a total of 50 establishments
(53 minus 3) will be subject to establishment fees in FY 2024.

B. Establishment Fee Rates for FY 2024

    FDA must set the fee rates for FY 2024 so that the fees paid for
the estimated 50 establishments will generate a total of $8,710,000. To
generate this amount will require the fee for an animal drug
establishment, rounded to the nearest dollar, to be $174,200.

VI. Animal Drug Sponsor Fee Calculations for FY 2024

A. Sponsor Fee Revenues and Numbers of Fee-Paying Sponsors

    The animal drug sponsor fee must be paid annually by each person
who: (1) is named as the applicant in an animal drug application,
except for an approved application for which all subject products have
been removed from listing under section 510 of the FD&C Act, or has
submitted an investigational animal drug submission that has not been
terminated or otherwise rendered inactive and (2) had an animal drug
application, supplemental animal drug application, or investigational
animal drug submission pending at FDA after September 1, 2003 (see 21
U.S.C. 379j-11(6) and 379j-12(a)(4)). An animal drug sponsor is subject
to only one such fee each fiscal year (see 21 U.S.C. 379j-12(a)(4)).
The sponsor fees are to be set so that they will generate $9,045,000 in
fee revenue for FY 2024.
    To set animal drug sponsor fees to realize $9,045,000, FDA must
make some assumptions about the number of sponsors who will pay these
fees in FY 2024. FDA developed data on all animal drug sponsors and
matched this to the list of all sponsors who had pending submissions
and applications after September 1, 2003. As of May, 2023, FDA
estimates that a total of 179 sponsors will meet this definition in FY
2024.
    In estimating the fee revenue to be generated by animal drug
sponsor fees in FY 2024, FDA is assuming that 67 percent of the
sponsors invoiced, or 120, will not pay sponsor fees in FY 2024 due to
fee waivers and reductions. FDA has made this estimate at 67 percent
this year, based on historical data over the past 5 completed fiscal
years of the ADUFA program.
    Accordingly, the Agency estimates that a total of 59 sponsors (179
minus 120) will be subject to and pay sponsor fees in FY 2024.

B. Sponsor Fee Rates for FY 2024

    FDA must set the fee rates for FY 2024 so that the estimated 59
sponsors that pay fees will generate a total of $9,045,000. To generate
this amount will require the fee for an animal drug sponsor, rounded to
the nearest dollar, to be $153,305.

VII. Fee Schedule for FY 2024

    The fee rates for FY 2024 are summarized in table 1.

                       Table 1--FY 2024 Fee Rates
------------------------------------------------------------------------
                                                           Fee rate for
              Animal drug user fee category                   FY 2024
------------------------------------------------------------------------
Animal Drug Application Fees:
    Animal Drug Application.............................        $683,673
    Supplemental Animal Drug Application for Which               341,837
     Safety or Effectiveness Data are Required, Animal
     Drug Application Subject to the Criteria Set Forth
     in Section 512(d)(4) of the FD&C Act, or
     Application for Conditional Approval Under Section
     571 of the FD&C Act for Which an Animal Drug
     Application Submitted Under Section 512(b)(1) of
     the FD&C Act Has Been Previously Approved Under
     Section 512(d)(1) for Another Intended Use.........
Animal Drug Product Fee.................................          12,459
Animal Drug Establishment Fee \1\.......................         174,200
Animal Drug Sponsor Fee \2\.............................         153,305
------------------------------------------------------------------------
\1\ An animal drug establishment is subject to only one such fee each
  fiscal year.
\2\ An animal drug sponsor is subject to only one such fee each fiscal
  year.

VIII. Fee Waiver or Reduction; Exemption From Fees

    The types of fee waivers, fee reductions, and exemptions from fees
that applied during ADUFA IV still exist in ADUFA V, with one
exception. No longer available is the exemption for a supplemental
animal drug application relating to a new animal drug application
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 503(w) of the FD&C Act (21 U.S.C. 352(w)).
    Remaining waivers and reductions apply for the following: barriers
to innovation; where fees will exceed the cost to review the animal
drug application; if the application is related to certain free-choice
medicated feeds; if the application is solely for a MUMS indication; or
if the sponsor is a small business submitting its first animal drug
application. See section 740(d)(1) of the FD&C Act.

A. Barrier to Innovation Waivers or Fee Reductions

    Under section 740(d)(1)(A) of the FD&C Act, an animal drug
applicant may qualify for a waiver or reduction of one or more ADUFA
fees if the fee would present a significant barrier to innovation
because of limited resources available to the applicant or other
circumstances. CVM's guidance for industry (GFI) #170, entitled
``Animal Drug User Fees and Fee Waivers and Reductions,'' \1\ states
that the Agency interprets this provision to mean that a waiver or
reduction is appropriate when: (1) the product for which the waiver is
being requested is innovative, or the requestor is otherwise pursuing
innovative animal drug products or technology, and (2) the fee would be
a significant barrier to the applicant's ability to develop,
manufacture, or market the innovative product or technology. Only those
applicants that meet both of these criteria will qualify for a waiver
or reduction in user fees under this provision (see GFI #170 at pp. 6-
8). For purposes of determining whether the second criterion would be
met on the basis of limited financial resources available to the
applicant, FDA has determined an applicant with financial resources of
less than $20,000,000 (including the financial resources of the
applicant's affiliates), adjusted annually for inflation, has limited
resources available. Using the Consumer Price Index for urban consumers
(U.S. city average; not seasonally adjusted; all items; annual index),
the inflation-adjusted level for FY 2024 will be $22,796,000; this
level represents the financial resource ceiling that will be used to
determine if there are limited resources available to an applicant
requesting a Barrier to Innovation waiver on financial grounds for FY
2024. Requests for a waiver need to be submitted to FDA each fiscal
year not later than 180 days from when the fees are due. A waiver
granted on Barrier to Innovation grounds (or any of the other grounds
listed in section 740(d)(1) of the FD&C Act) is only valid for 1 fiscal
year. If a sponsor is not granted a waiver, they are liable for the
fees.
---------------------------------------------------------------------------

    \1\ CVM's GFI #170 is located at: https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052494.pdf.
---------------------------------------------------------------------------

B. Exemption or Exception From Fees

    In addition to the waivers and fee reductions described above, one
fee exemption and two exceptions still apply in ADUFA V.
    If an animal drug application, supplemental animal drug
application, or investigational submission involves the intentional
genomic alteration of an animal that is intended to produce a human
medical product, any person who is the named applicant or sponsor of
that application or submission will not be subject to sponsor, product,
or establishment fees under ADUFA based solely on that application or
submission (21 U.S.C. 379j-12(d)(4)).
    There is an exception from application fees for animal drug
applications submitted under section 512(b)(1) of the FD&C Act by a
sponsor who previously applied for conditional approval under section
571 of the FD&C Act for the same product and paid an application fee at
the time they applied for conditional approval, provided the sponsor
has submitted the application under section 512(b)(1) of the FD&C Act
within the timeframe specified in section 571(h) of the FD&C Act. There
is also an exception from application fees for previously filed
applications that were not approved or were withdrawn (without waiver
or refund). Both exceptions are detailed in section 740(a)(1)(C) of the
FD&C Act.

IX. Procedures for Paying the FY 2024 Fees

A. Application Fees and Payment Instructions

    The FY 2024 fee established in the new fee schedule must be paid
for an animal drug application or supplement subject to fees under
ADUFA V that is submitted on or after October 1, 2023. 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 electronic check (Automated Clearing House (ACH)
also known as eCheck) or credit card (Discover, VISA, MasterCard,
American Express). Secure electronic payments can be submitted using
the User Fees Payment Portal at https://userfees.fda.gov/pay, or the
Pay.gov payment option is available to you after you submit a cover
sheet. (Note: Only full payments are accepted. No partial payments can
be made online.) Once you search for and find your invoice, select
``Pay Now'' to be redirected to www.pay.gov. Electronic payment options
are based on the balance due. Payment by credit card is available only
for balances that are less than $25,000. If the balance exceeds this
amount, only the ACH option is available. Payments must be made using
U.S. bank accounts as well as U.S. credit cards.
    When paying by check, bank draft, or U.S. postal money order,
please write your application's unique Payment Identification Number
(PIN), beginning with the letters AD, on the upper right-hand corner of
your completed Animal Drug User Fee Cover Sheet. Also write the FDA'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 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, the invoice number or PIN needs to be
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 payment by
wire transfer: U.S. Department of the Treasury, TREAS NYC, 33 Liberty
St., New York, NY 10045, Account Name: Food and Drug Administration,
Account Number: 75060099, U.S. Department of the Treasury routing/
transit number: 021030004, SWIFT Number: FRNYUS33.
    To send a check by a courier such as FedEx, the courier must
deliver the check and printed copy of the cover sheet to U.S. Bank:
U.S. Bank, Attn: Government Lockbox 979033, 3180 Rider Trail S., Earth
City, MO 63045. (Note: This address is for courier delivery only. If
you have any questions concerning courier delivery, contact U.S. Bank
at<PHONE_NUMBER>. This telephone number is only for questions about
courier delivery.)
    It is important that the fee arrives at the bank at least a day or
two before the application arrives at FDA's CVM. FDA records the
official application receipt date as the later of the following: the
date the application was received by 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 receipt of an
electronic or wire transfer payment. U.S. Bank and the U.S. Department
of the 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 on to the ADUFA
website at https://www.fda.gov/industry/animal-drug-user-fee-act-adufa/animal-drug-user-fee-cover-sheet and, under Application Submission
Information, click on ``Create ADUFA User Fee Cover Sheet.'' For
security reasons, each firm submitting an application will be assigned
an organization identification number, and each user will also be
required to set up a user account and password the first time you use
this site. Online instructions will walk you through this process.
    Step Two: Create an Animal Drug User Fee Cover Sheet, transmit it
to FDA, and print a copy. After logging into your account with your
username and password, complete the steps required to create an Animal
Drug User Fee Cover Sheet. One cover sheet is needed for each animal
drug application or supplement. Once you are satisfied that the data on
the cover sheet are 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 IX.A.
    Step Four: Submit your application.

C. Product, Establishment, and Sponsor Fees

    By December 31, 2023, FDA will issue invoices and payment
instructions for product, establishment, and sponsor fees for FY 2024
using this fee schedule. Payment will be due by January 31, 2024. FDA
will issue invoices in November 2024 for any products, establishments,
and sponsors subject to fees for FY 2024 that qualify for fees after
the December 2023 billing.

    Dated: October 18, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-23373 Filed 10-20-23; 8:45 am]
BILLING CODE 4164-01-P