[Federal Register Volume 77, Number 88 (Monday, May 7, 2012)]
[Notices]
[Pages 26769-26770]
[FR Doc No: 2012-10893]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]

Educational Forum on Medical Device Reporting, Complaint Files,
and Recalls, Corrections, and Removals; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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    The Food and Drug Administration (FDA), Office of Regulatory
Affairs (ORA), Southwest Region (SWR), Dallas District Office (DALDO),
in collaboration with the FDA Medical Device Industry Coalition
(FMDIC), is announcing a public workshop entitled ``Educational Forum
on Medical Device Reporting, Complaint Files, and Recalls, Corrections,
and Removals.'' The purpose of the public workshop is to provide
information about FDA's Medical Device Quality Systems Regulation (QSR)
to the regulated industry, particularly small businesses.

DATES:  Date and Time: The public workshop will be held on June 15,
2012, from 8 a.m. to 5 p.m.
    Location: The public workshop will be held at the Renaissance
Dallas Hotel, 2222 Stemmons Freeway, Dallas, TX 75207. Directions and
lodging information are available at the FMDIC Web site at http://www.fmdic.org/.
    Contact Person: David Arvelo, Food and Drug Administration, 4040
North Central Expressway, Suite 900, Dallas, TX 75204,<PHONE_NUMBER>,
FAX:<PHONE_NUMBER>, email<EMAIL_ADDRESS>    Registration: FMDIC has a $250 early registration fee. Discounts
for full-time students and government employees with valid
identification are available. Early registration ends June 1, 2012.
Registration is $300 thereafter. For more information on fees and/or to
register online, please visit http://www.fmdic.org/. As an alternative,
you may send registration information including name, title, firm name,
address, telephone and fax numbers, and email, along with a check or
money order for the appropriate amount payable to the FMDIC, to FMDIC
Registrar, 4447 N. Central Expressway, Suite 110 PMB197, Dallas, TX
75205.

Registration on site will be accepted on a space available basis on the
day of the public workshop beginning at 7:30 a.m. Please note that due
to popularity, similar past events have reached maximum capacity well
before the day of the event. The cost of registration at the site is
$300 payable to the FMDIC. The registration fee will be used to offset
expenses of hosting the event including continental breakfast, lunch,
refreshments, venue, materials, audiovisual equipment, and other
logistics associated with this event.
    If you need special accommodations due to a disability, please
contact David Arvelo (see Contact Person) at least 21 days in advance.

SUPPLEMENTARY INFORMATION: The workshop is being held in response to
the interest in the topics discussed from small medical device
manufacturers in the Dallas District area. This workshop helps achieve
objectives set forth in section 406 of the Food and Drug Administration
Modernization Act of 1997 (21 U.S.C. 393), which include working
closely with stakeholders and maximizing the availability and clarity
of information to stakeholders and the public. This is also consistent
with the purposes of FDA's Regional Small Business Program, which are
in part to respond to industry inquiries, develop educational
materials, sponsor workshops and conferences to provide firms,
particularly small businesses, with firsthand working knowledge of
FDA's requirements and compliance policies. This workshop is also
consistent with the Small Business Regulatory Enforcement Fairness Act
of 1996 (Pub. L. 104-121), as an outreach activity by Government
agencies to small businesses.
    The goal of the workshop is to present information that will enable
manufacturers and regulated industry to better comply with the Medical
Device QSR. The following topics will be discussed at the workshop: (1)
The role of complaint files, (2) medical device reporting, (3) medical
device recalls, corrections, and removals, and (4) Corrective and
Preventive Actions as They Relate to Complaints.
    Transcripts: Transcripts of this event will not be available due to
the format of this workshop. Handouts will be posted online at http://www.fmdic.org/ or may be requested in writing from David Arvelo (see
Contact Person), after the public workshop.

    Dated: May 1, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-10893 Filed 5-4-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 88, Number 28 (Friday, February 10, 2023)]
[Rules and Regulations]
[Pages 8747-8750]
[FR Doc No: 2023-02783]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-1313; Project Identifier MCAI-2021-01418-T;
Amendment 39-22317; AD 2023-02-10]
RIN 2120-AA64

Airworthiness Directives; BAE Systems (Operations) Limited
Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is superseding Airworthiness Directive (AD) 99-25-11
for certain BAE Systems (Operations) Limited Model BAe 146 and Avro
146-RJ series airplanes. AD 99-25-11 required repetitive inspections
for cracks along the face of the retraction attachment boss in the nose
landing gear (NLG) sidewall; and corrective action, if necessary. This
AD was prompted by a report of a crack found on the left-hand sidewall
well on the NLG, and by the determination that additional airplanes are
subject to the identified unsafe condition. This AD continues to
require the actions in AD 99-25-11, and expands the applicability. The
FAA is issuing this AD to address the unsafe condition on these
products.

DATES: This AD is effective March 17, 2023.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of March 17,
2023.
    The Director of the Federal Register approved the incorporation by
reference of a certain other publication listed in this AD as of
February 1, 2000 (64 FR 72522, December 28, 1999).

ADDRESSES:
    AD Docket: You may examine the AD docket at regulations.gov under
Docket No. FAA-2022-1313; 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 final rule, the mandatory continuing airworthiness
information (MCAI), any comments received, and other information. The
address for Docket Operations is U.S. Department of Transportation,
Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200
New Jersey Avenue SE, Washington, DC 20590.
    Material Incorporated by Reference:
     For service information identified in this final rule,
contact BAE Systems (Operations) Limited, Customer Information
Department, Prestwick International Airport, Ayrshire, KA9 2RW,
Scotland, United Kingdom; phone: +44 1292 675207; fax: +44 1292 675704;
email: [email protected]; website: regional-services.com.
     You may view this service information at the Airworthiness
Products Section, Operational Safety Branch, FAA, 2200 South 216th St.,
Des Moines, WA. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>. It is also available at regulations.gov
under Docket No. FAA-2022-1313.

FOR FURTHER INFORMATION CONTACT: Todd Thompson, Aerospace Engineer,
Large Aircraft Section, International Validation Branch, FAA, 2200
South 216th St., Des Moines, WA 98198; phone:<PHONE_NUMBER>; email:
[email protected].

SUPPLEMENTARY INFORMATION:

Background

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 to supersede AD 99-25-11, Amendment 39-11454 (64 FR 72522,
December 28, 1999) (AD 99-25-11). AD 99-25-11 applied to certain BAE
Systems (Operations) Limited Model BAe 146 and Avro 146-RJ series
airplanes. AD 99-25-11 required repetitive eddy current inspections for
cracks along the face of the retraction attachment boss in the NLG
sidewall; and corrective action, if necessary. AD 99-25-11 was prompted
by issuance of MCAI by a foreign civil aviation authority. The FAA
issued AD 99-25-11 to address cracking along the face of the retraction
attachment boss in the NLG sidewall, which could result in premature
extension of the NLG or result in depressurization of the airplane.
    FAA AD 99-25-11 corresponds to British AD 015-10-98.
    The NPRM published in the Federal Register on October 31, 2022 (87
FR 65541). The NPRM was prompted by AD G-2021-0016R1, dated February
18, 2022 (U.K. CAA AD G-2021-0016R1) (also referred as the MCAI),
issued by the Civil Aviation Authority, which is the aviation authority
for the United Kingdom. U.K. CAA AD G-2021-0016R1 superseded European
Union

Aviation Safety Agency (EASA) AD 2007-0305, dated December 20, 2007,
which superseded British AD 015-10-98. The FAA did not issue an AD
corresponding to EASA AD 2007-0305. The MCAI states that evidence of
cracking was found on several in-service airplanes in the bore and
along the face of the retraction jack attachment boss on the left-hand
NLG sidewall. Undetected cracking of the NLG sidewall could lead to
explosive decompression of the fuselage near to the flightcrew (since
the NLG sidewall forms part of the nose fuselage pressure shell),
leading to significant structural damage to the airframe and/or
incapacitation of the flightcrew.
    The effectivity of each revision of Inspection Service Bulletin
ISB.53-152 before Revision 8 was limited to airplanes that were not
modified by torque tightening modification HCM01641A in production. BAE
Systems (Operations) Limited has received reports of two airplanes with
cracks at the NLG retraction jack attachment boss; those airplanes were
post-modification HCM01641A and as such were not subject to the
requirements of FAA AD 99-25-11. As a result of new findings and
further analysis, BAE Systems (Operations) Limited issued Revision 8 of
ISB.53-152, dated February 19, 2018, which extends the effectivity to
all BAe 146 and Avro 146-RJ airplanes, except for airplanes post-
modification HCM20011A, HCM20012A, HCM20013A, HCM20313A, HCM20314A, or
HMC20315A.
    Revisions prior to Revision 8 of ISB.53-152 included provisions for
continued operation with certain crack conditions, which was also
allowed in FAA AD 99-25-11 if approved as specified in paragraph (h)(1)
of this AD. The U.K. CAA and the FAA have determined that continued
operation with known cracks is not acceptable. Therefore, this AD does
not allow flight with cracks.
    You may examine the MCAI in the AD docket at regulations.gov under
Docket No. FAA-2022-1313.
    In the NPRM, the FAA proposed to continue to require the actions in
AD 99-25-11 and expand the applicability.

Discussion of Final Airworthiness Directive

Comments

    The FAA received no comments on the NPRM or on the determination of
the costs.

Conclusion

    This product has been approved by the aviation authority of another
country and is approved for operation in the United States. Pursuant to
the FAA's bilateral agreement with this State of Design Authority, it
has notified the FAA of the unsafe condition described in the MCAI
referenced above. The FAA reviewed the relevant data and determined
that air safety requires adopting this AD as proposed. Accordingly, the
FAA is issuing this AD to address the unsafe condition on this product.
Except for minor editorial changes, this AD is adopted as proposed in
the NPRM. None of the changes will increase the economic burden on any
operator.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed BAE Systems (Operations) Limited Inspection
Service Bulletin ISB.53-152, Revision 8, dated February 19, 2018. This
service information describes procedures for repetitive eddy current
inspections for cracking in the bore and along the face of the
retraction attachment boss in the left-hand NLG sidewall, and repair or
replacement of a cracked sidewall.
    The FAA also reviewed British Aerospace Service Bulletin SB.53-152,
dated October 8, 1998, which the Director of the Federal Register
approved for incorporation by reference as of February 1, 2000 (64 FR
72522, December 28, 1999).
    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.

Costs of Compliance

    The FAA estimates that this AD affects 20 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
              Action                    Labor cost        Parts cost      Cost per product        operators
----------------------------------------------------------------------------------------------------------------
Retained actions from AD 99-25-11  1 work-hour x $85                $0  $85 per inspection   $1,700 per
                                    per hour = $85 per                   cycle.               inspection cycle.
                                    inspection cycle.
New proposed actions.............  2 work-hours x $85                0  170 per inspection   3,400 per
                                    per hour = $170.                     cycle.               inspection cycle.
----------------------------------------------------------------------------------------------------------------

    The FAA has received no definitive data on which to base the cost
estimates for the on-condition actions specified in this AD.

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 has determined that 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) Will not affect intrastate aviation in Alaska, and
    (3) 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.

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:
0
a. Removing Airworthiness Directive 99-25-11, Amendment 39-11454 (64 FR
72522, December 28, 1999); and
0
b. Adding the following new airworthiness directive:

2023-02-10 BAE Systems (Operations) Limited: Amendment 39-22317;
Docket No. FAA-2022-1313; Project Identifier MCAI-2021-01418-T.

(a) Effective Date

    This airworthiness directive (AD) is effective March 17, 2023.

(b) Affected ADs

    This AD replaces AD 99-25-11, Amendment 39-11454 (64 FR 72522,
December 28, 1999) (AD 99-25-11).

(c) Applicability

    This AD applies to BAE Systems (Operations) Limited Model BAe
146-100A, -200A, and -300A airplanes; and Model Avro 146-RJ70A, 146-
RJ85A, and 146-RJ100A airplanes; certificated in any category,
without modification HCM20011A, HCM20012A, HCM20013A, HCM20313A,
HCM20314A, or HMC20315A.

(d) Subject

    Air Transport Association (ATA) of America Code 53, Fuselage.

(e) Reason

    This AD was prompted by a report of a crack found on the left-
hand sidewall well on the nose landing gear (NLG), and by the
determination that additional airplanes are subject to the
identified unsafe condition. We are issuing this AD to address
cracking along the face of the retraction attachment boss in the NLG
sidewall, which could result in premature extension of the NLG or
result in depressurization of the airplane.

(f) Compliance

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

(g) Retained Repetitive Inspections, With New Terminating Action

    This paragraph restates the requirements of paragraph (a) of AD
99-25-11, with new terminating action. For airplanes listed in
British Aerospace Service Bulletin SB.53-152, dated October 8, 1998:
Prior to the accumulation of 8,000 total flight cycles, or within
200 flight cycles after February 1, 2000 (the effective date of AD
99-25-11), whichever occurs later, perform an eddy current
inspection to detect cracking along the face of the retraction
attachment boss in the NLG sidewall, in accordance with British
Aerospace Service Bulletin SB.53-152, dated October 8, 1998.
Thereafter, repeat the eddy current inspection at intervals not to
exceed 2,600 flight cycles, except as provided in paragraph (j) of
this AD.

(h) Retained Repair, With Revised Repair Approval

    This paragraph restates the requirements of paragraph (b) of AD
99-25-11, with revised repair approval.
    (1) If any crack is detected before the effective date of this
AD, during any inspection required by paragraph (g) of this AD,
prior to further flight, repair or re-inspect in accordance with a
method approved by either the Manager, International Branch, ANM-
116, FAA, Transport Airplane Directorate; or the Civil Aviation
Authority (or its delegated agent). For a repair method to be
approved by the Manager, International Branch, as required by this
paragraph, the Manager's approval letter must specifically reference
this AD.
    (2) If any crack is detected on or after the effective date of
this AD during any inspection required by paragraph (g) of this AD:
Before further flight, either repair using a method approved by the
Manager, International Validation Branch, FAA; or the U.K. Civil
Aviation Authority (U.K. CAA); or BAE Systems (Operations) Limited's
U.K. CAA Design Organization Approval (DOA); or do the replacement
specified in paragraph (i) of this AD. If approved by the DOA, the
approval must include the DOA-authorized signature.

(i) New Requirements: Repetitive Inspections and Corrective Actions

    (1) For all airplanes: Before the accumulation of 7,375 total
flight cycles, or within 625 flight cycles after the effective date
of this AD, or within 2,600 flight cycles since the most recent
inspection required by paragraph (g) of this AD, whichever occurs
latest, do an eddy current inspection for cracking in the bore and
along the face of the retraction jack attachment boss in the left-
hand NLG sidewall, in accordance with the Accomplishment
Instructions of BAE Systems (Operations) Limited Inspection Service
Bulletin ISB.53-152, Revision 8, dated February 19, 2018. Before
further flight, repair or replace any cracked sidewall, as
applicable, in accordance with BAE Systems (Operations) Limited
Inspection Service Bulletin ISB.53-152, Revision 8, dated February
19, 2018. Repeat the inspection thereafter at intervals not to
exceed 6,700 flight cycles, except as provided in paragraphs
(i)(1)(i) and (ii) of this AD.
    (i) For airplanes on which a repair identified for Option A, D,
or E in Table 1 of BAE Systems (Operations) Limited Inspection
Service Bulletin ISB.53-152, Revision 8, dated February 19, 2018,
has been done: Inspect within 20,000 flight cycles after the repair,
and repeat thereafter at intervals not to exceed 4,000 flight
cycles.
    (ii) For airplanes on which the replacement with part number
HC537L0002-000, -002, or -004 identified in Option F in Table 1 of
BAE Systems (Operations) Limited Inspection Service Bulletin ISB.53-
52, Revision 8, dated February 19, 2018, has been done: Inspect
within 20,000 flight cycles after the repair, and repeat thereafter
at intervals not to exceed 4,000 flight cycles.
    (2) For airplanes on which re-inspection of cracks was allowed
as specified in paragraph (h)(1) of this AD: Within 2,600 flight
cycles after the most recent inspection required by paragraph (g) of
this AD, repair or replace any cracked sidewall, as applicable, in
accordance with BAE Systems (Operations) Limited Inspection Service
Bulletin ISB.53-152, Revision 8, dated February 19, 2018.

(j) Terminating Action

    (1) Accomplishment of the initial inspection and applicable
corrective actions required by paragraph (i) of this AD terminates
the repetitive inspection requirements of paragraph (g) of this AD.
    (2) Accomplishment of the action identified for Option B or C in
Table 1 of BAE Systems (Operations) Limited Inspection Service
Bulletin ISB.53-152, Revision 8, dated February 19, 2018, terminates
the repetitive inspection requirements of paragraphs (g) and (i)(1)
of this AD.
    (3) Accomplishment of the replacement with part number
HC537L0002-006 identified for Option F in Table 1 of BAE Systems
(Operations) Limited Inspection Service Bulletin ISB.53-152,
Revision 8, dated February 19, 2018, terminates the repetitive
inspection requirements of paragraphs (g) and (i)(1) of this AD.

(k) Credit for Previous Actions

    (1) This paragraph provides credit for actions required by
paragraphs (i) and (j)(2) of this AD, if those actions were
performed before the effective date of this AD using the service
information identified in paragraphs (k)(1)(i) and (ii) of this AD.
    (i) BAE Systems (Operations) Limited Inspection Service Bulletin
ISB.53-152, Revision 6, dated March 5, 2014.
    (ii) BAE Systems (Operations) Limited Inspection Service
Bulletin ISB.53-152, Revision 7, dated May 7, 2014.
    (2) This paragraph provides credit for the actions required by
paragraph (j)(3) of this AD, if those actions were performed before
the effective date of this AD using the service information
identified in paragraphs (k)(2)(i) and (ii) of this AD, provided the
sidewall replacement for Option F was part number HC537L0002-006.
    (i) BAE Systems (Operations) Limited Inspection Service Bulletin
ISB.53-152, Revision 6, dated March 5, 2014.
    (ii) BAE Systems (Operations) Limited Inspection Service
Bulletin ISB.53-152, Revision 7, dated May 7, 2014.

(l) No Reporting Requirement

    Although BAE Systems (Operations) Limited Inspection Service
Bulletin ISB.53-152, Revision 8, dated February 19, 2018, specifies
to submit certain information to the manufacturer, this AD does not
include that requirement.

(m) Other FAA AD Provisions

    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Validation 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 responsible Flight Standards Office, as
appropriate. If sending information directly to the International
Validation Branch, send it to the attention of the person identified
in paragraph (n)(2) of this AD. Information may be emailed to: [email protected]. Before using any approved AMOC, notify
your appropriate principal inspector, or lacking a principal
inspector, the manager of the responsible Flight Standards Office.
    (2) Contacting the Manufacturer: As of the effective date of
this AD, for any requirement in this AD to obtain instructions from
a manufacturer, the instructions must be accomplished using a method
approved by the Manager, International Validation Branch, FAA; or
the U.K. CAA; or BAE Systems (Operations) Limited's U.K. CAA DOA. If
approved by the DOA, the approval must include the DOA-authorized
signature.

(n) Additional Information

    (1) Refer to Civil Aviation Authority (United Kingdom) AD G-
2021-0016, dated December 17, 2021, for related information. This
U.K. CAA AD may be found in the AD docket at regulations.gov under
Docket No. FAA-2022-1313.
    (2) For more information about this AD, contact Todd Thompson,
Aerospace Engineer, Large Aircraft Section, International Validation
Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; phone:
(206) 231-3228; email: [email protected].
    (3) Service information identified in this AD that is not
incorporated by reference is available at the addresses specified in
paragraphs (o)(5) and (6) of this AD.

(o) 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.
    (3) The following service information was approved for IBR on
March 17, 2023.
    (i) BAE Systems (Operations) Limited Inspection Service Bulletin
ISB.53-152, Revision 8, dated February 19, 2018.
    (ii) [Reserved]
    (4) The following service information was approved for IBR on
February 1, 2000 (64 FR 72522, December 28, 1999).
    (i) British Aerospace Service Bulletin SB.53-152, dated October
8, 1998.
    (ii) [Reserved]
    (5) For service information identified in this AD, contact BAE
Systems (Operations) Limited, Customer Information Department,
Prestwick International Airport, Ayrshire, KA9 2RW, Scotland, United
Kingdom; phone: +44 1292 675207; fax: +44 1292 675704; email:
[email protected]; website regional-services.com.
    (6) You may view this service information at FAA, Airworthiness
Products Section, Operational Safety Branch, 2200 South 216th St.,
Des Moines, WA. For information on the availability of this material
at the FAA, call<PHONE_NUMBER>.
    (7) 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 January 24, 2023.
Christina Underwood,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2023-02783 Filed 2-9-23; 8:45 am]
BILLING CODE 4910-13-P