[Federal Register Volume 75, Number 244 (Tuesday, December 21, 2010)]
[Proposed Rules]
[Pages 80011-80013]
[FR Doc No: 2010-31888]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 58

[Docket No. FDA-2010-N-0548]

Good Laboratory Practice for Nonclinical Laboratory Studies

AGENCY: Food and Drug Administration, HHS.

ACTION: Advance notice of proposed rulemaking.

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SUMMARY: The Food and Drug Administration (FDA) is seeking comment on
whether to amend the regulations governing good laboratory practices
(GLPs). The Agency decided that to require a GLP quality system for all
facilities/laboratories, as well as to more completely address
nonclinical studies as they are presently conducted, the Agency would
need to modify the existing regulations.

DATES: Submit either electronic or written comments by February 22,
2011.

ADDRESSES: You may submit comments, identified by the Docket No. FDA-
2010-N-0548, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Fax:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name
and docket number for this rulemaking. All comments received may be
posted without change to http://www.regulations.gov, including any
personal information provided. For additional information on submitting
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION
section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number, found in the brackets in the heading of this document,
into the ``Search'' box and follow the prompts

and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: C. T. Viswanathan, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 5346, Silver Spring, MD 20993-0002, 301-
796-3394.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA's GLP regulations, part 58 (21 CFR part 58), were finalized on
December 22, 1978 (43 FR 60013). As stated in its scope (Sec.  58.1),
this regulation prescribes good laboratory practices for conducting
nonclinical laboratory studies that support or are intended to support
applications for research or marketing permits for products regulated
by FDA, including food and color additives, animal food additives,
human and animal drugs, medical devices for human use, biological
products, and electronic products. A nonclinical laboratory study, as
defined in Sec.  58.3(d), is an * * * in vivo or in vitro experiment in
which test articles are studied prospectively in test systems under
laboratory conditions to determine their safety. The term does not
include studies utilizing human subjects or clinical studies or field
trials in animals. [It also] does not include basic exploratory studies
carried out to determine whether a test article has any potential
utility or to determine physical or chemical characteristics of a test
article.
    The conduct of nonclinical laboratory studies has changed markedly
since issuance of this regulation in 1978. For example, it is presently
common for nonclinical laboratory studies to be conducted across
multiple testing facilities, or sites (multisite studies). When the
regulation was originally finalized, however, most studies were
conducted within a single facility. In addition, laboratories have
expanded the use of electronic technology, both for laboratory
instrumentation and as a means for collecting, storing, and reporting
study data. Current part 58 does not specifically describe these modern
arrangements and advances.
    In 2006, FDA announced its Human Subject Protection/Bioresearch
Monitoring (HSP/BIMO) initiative aimed at modernizing the Agency's
regulations and policies governing the conduct of studies used to
support submissions to FDA. In response to the announcement of the HSP/
BIMO initiative, FDA received stakeholder recommendations that included
suggestions for the revision of part 58. In 2007, FDA established an
Agency-wide GLP working group (WG) to evaluate the existing regulation
and determine if regulatory revision and/or guidance should be pursued.
The WG gathered information as to the needs of each FDA center with
regard to nonclinical laboratory studies, reviewed suggestions from
external sources, conferred with the Environmental Protection Agency
(EPA) which has a similar regulation, and performed a thorough
evaluation of the existing regulations. The WG concluded that to ensure
the integrity of the data in all nonclinical laboratory studies
submitted to FDA, nonclinical laboratory facilities that conduct these
studies need to follow a GLP quality system approach. Currently, the
regulations governing nonclinical laboratory studies do not use such an
approach consistently throughout part 58. A GLP quality system would
allow nonclinical laboratories to develop standard operating procedures
consistent with their specific operational needs as long as they
satisfy regulatory requirements aimed at ensuring data integrity. The
WG decided that to require a GLP quality system for all facilities/
laboratories, as well as to more completely address nonclinical studies
as they are presently conducted, the Agency would need to modify the
existing regulations.

II. Agency Request for Information

    FDA is soliciting public comments about whether to modify the
existing regulations, and in particular about the areas FDA has
identified as potentially appropriate for revision, as follows:

1. GLP Quality System

    While many of the requirements of the existing regulation are
consistent with a GLP quality system, FDA believes that modifications
may be necessary to incorporate all basic elements needed for a
comprehensive GLP quality system, such as that set forth in the
internationally recognized standard, Quality management systems--
Requirements ISO 9001, available from the International Organization
for Standardization (ISO) at: http://www.iso.org/iso/home.html.
Ultimately, any GLP quality system proposed for a facility must be
capable of ensuring the integrity of resulting data. FDA is considering
whether to include in the regulations a core set of essential elements
for such a GLP quality system, including specifically mentioning
management responsibility for all activities at the facility and
specifying a requirement for standard operating procedures for all
essential functions.

2. Multisite Studies

    It is currently common practice for nonclinical laboratory studies
to be performed across multiple sites (multisite studies), rather than
for a single facility to conduct all aspects/phases of a study. FDA is
considering revising the GLP regulations to specifically address the
use of multisite studies through the addition of specific definitions
to describe personnel and study aspects specific to multisite studies,
e.g., by requiring that an individual be designated as the responsible
person for each site of a multisite study. Such an individual would be
responsible for any phase(s) of the study conducted at the site and
would report to the study director.

3. Electronic/Computerized Systems

    Since the regulation was finalized, many laboratory systems have
become fully automated. In addition, many facilities now employ
computerized systems for managing general laboratory functions as well
as for instrumentation in which such systems are integral components.
While the present regulation does not preclude such electronic systems,
several of the current regulatory requirements are more consistent with
paper-based systems (e.g., an individual as archivist Sec.  58.190(c));
maintenance of copies of study protocols and the Master Schedule by the
quality assurance unit (Sec.  58.35(b)(1) and (b)(2))). FDA is
considering updating the regulation to reflect the use of electronic
and computerized systems. FDA believes that any modifications to the
regulation to reference electronic/computerized systems should be
general, to accommodate changes and advances in technology.

4. Sponsor Responsibilities

    Whether nonclinical laboratory studies are conducted by a sponsor
or at a contracted facility, FDA believes that the study sponsor should
clearly have responsibilities that the present regulation does not
specifically mention, such as development and/or approval of study
protocols. FDA is therefore considering amending the regulations to
include additional specific responsibilities of sponsors of nonclinical
laboratory studies.

5. Animal Welfare

    In the United States, the Animal Welfare Act (7 U.S.C 2131-2159)
governs the treatment and use of

animals, including their use for research purposes. FDA is soliciting
comments regarding whether and how to receive documentation of
compliance with these existing statutory provisions or comparable
international standards governing the ethical and humane use of
laboratory animals in nonclinical laboratory studies. This issue is not
specifically addressed in the present regulation.

6. Information on Quality Assurance Inspectional Findings

    When an FDA bioresearch monitoring (BIMO) inspection of a
nonclinical study identifies problems, FDA often finds it difficult to
determine whether the quality assurance unit (QAU) failed to adequately
inspect the study, or whether the QAU made recommendations for
corrective actions and management did not adequately respond. FDA is
considering the addition of a requirement that the QAU prepare a yearly
summary of general inspectional findings that would reveal problems
that are not necessarily study-specific and that includes the
recommendations made to management to resolve those problems. Such a
report would be maintained at the facility and be made available to FDA
upon request, usually during the course of a BIMO inspection.

7. Process-Based Systems Inspections

    A number of procedures used in conducting a particular nonclinical
laboratory study are common across many or even most studies conducted
at the facility. Facilities often find it more resourceful to
periodically inspect such procedures during systems inspections rather
than repetitively as part of each study-specific inspection, as
currently required in Sec.  58.35(b). For example, it may be
appropriate to periodically inspect procedures such as slide
preparation for pathology studies as part of a facility's process-based
systems inspections rather than for each study. FDA therefore is
considering permitting a combination of systems inspections and study-
specific inspections. The results of the appropriate systems
inspection(s) would be referenced in the study-specific inspection
reports relevant to those aspects of the procedures for the study under
inspection.

8. Test and Control Article Information

    When reviewing and inspecting nonclinical laboratory studies,
particularly those submitted for new drugs (human and animal), basic
information about the test article, such as strength, purity,
stability, and for mixtures thereof, concentration and uniformity, is
often absent from the laboratory's records, therefore precluding
appropriate interpretation of the study results. Although the current
regulations require that these parameters be determined (Sec.
58.105(a) and (b) and Sec.  58.113(a)), the regulations do not specify
who is to receive this information or include a timeframe for delivery
of the information to the facility performing the nonclinical testing.
FDA is therefore considering additional requirements under the sections
in the regulations discussing test and control characterization (Sec.
58.105) and mixtures of articles with carriers (Sec.  58.113),
including timeframes for provision of this information to the study
director.
    In addition, sponsors have requested the ability to cite compliance
with the applicable good manufacturing requirements (i.e, parts 210 and
211, etc. as relevant) regarding the specifications, quality, and
integrity of the test article. FDA is considering whether to accept
compliance with either the specifics that would be required under a
revised part 58, subpart F or the relevant good manufacturing
requirements.

9. Sample Storage Container Retention

    FDA's regulations currently require that facilities maintain test
article storage containers for the duration of the study (21 CFR
58.105(c)). FDA believes that compliance with the regulatory
requirements for the handling of test and control articles, which
include documentation of receipt, distribution, and use of each batch
(Sec.  58.107(d)) provides adequate information about the use and
integrity of study samples. Therefore, FDA is considering eliminating
the requirement at Sec.  58.105(c).
    FDA welcomes comments from all interested persons on these issues
and any other concerns related to the current GLP regulations,
including recommendations as to the best method(s) for addressing such
concerns.

III. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. Identify comments with the docket number found in brackets in
the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
    This advance notice of proposed rulemaking is issued under section
201 et al. of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321
et al.) and under authority of the Commissioner of Food and Drugs.

    Dated: December 15, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-31888 Filed 12-20-10; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 88, Number 249 (Friday, December 29, 2023)]
[Proposed Rules]
[Pages 90134-90137]
[FR Doc No: 2023-28721]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2023-2403; Project Identifier AD-2023-00888-T]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

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 The Boeing Company Model MD-11 and MD-11F airplanes
equipped with General Electric (GE) CF6-80C2D1F high-bypass turbofan
engines. This proposed AD was prompted by a report of a Model MD-11F
airplane experiencing an uncommanded deployment of a thrust reverser
in-flight at low altitude. This proposed AD would require a one-time
detailed inspection of the engine pylon thrust reverser control system
wire harnesses and applicable on-condition actions. The proposed AD
would also require repetitive detailed inspections and wire integrity
tests of the engine thrust reverser control system wire harnesses (in
the pylon), junction box and junction box cover, left side and right
side thrust reverser electrical harnesses, core (engine compartment)
miscellaneous wire harness assembly, and 30 degree bulkhead wire
harness assembly; and applicable on-condition actions. This AD also
requires reporting. 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 February
12, 2024.

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 under
Docket No. FAA-2023-2403; 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
Boeing Commercial Airplanes, Attention: Contractual & Data Services
(C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600;
telephone<PHONE_NUMBER>; website myboeingfleet.com.
     You may view this service information at the 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>. It is also
available at regulations.gov under Docket No. FAA-2023-2403.

FOR FURTHER INFORMATION CONTACT: Kevin Nguyen, Aviation Safety
Engineer, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone
206-231-3555; 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-2023-2403; Project Identifier
AD-2023-00888-T'' 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 Kevin
Nguyen, Aviation Safety Engineer, FAA, 2200 South 216th St., Des
Moines, WA 98198; telephone<PHONE_NUMBER>; email [email protected].
Any commentary that the FAA receives that is not specifically
designated as CBI will be placed in the public docket for this
rulemaking.

Background

    The FAA has received a report of an MD-11F airplane equipped with
three GE CF6-80C2D1F high-bypass turbofan engines experiencing an in-
flight deployment of the (left) engine 1 thrust reverser at
approximately 500 feet above ground level. Both left and right
translating cowls of the thrust reverser deployed. In the Engine 1
pylon, damaged wiring was found, which could have caused or contributed
to the deployment of the two transcowls.
    The FAA is issuing this AD to address uncommanded deployment of a
thrust reverser in flight at low altitude, which could result in loss
of control of the airplane and loss of continued safe flight and
landing.

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 Boeing Alert Service Bulletin MD11-78A017, dated
December 4, 2023. This service information specifies work package 1
inspection procedures to do an initial detailed inspection of the
engine 1, engine 2, and engine 3 pylon thrust reverser control system
wire harnesses. The service information also specifies work package 2
procedures to do repetitive detailed inspections and wire integrity
tests at the following locations: engine 1, engine 2, and engine 3
thrust reverser control system wire harnesses (in the pylon); junction
box and junction box cover (only detailed inspection); left side and
right side thrust reverser electrical harnesses; core (engine
compartment) miscellaneous wire harness assembly; and 30 degree
bulkhead wire harness assembly. The service information also specifies
applicable on-condition actions (includes repairs, replacements,
installations, post-replacement inspections and tests, and return to
service tests). The service information also specifies that
accomplishing the initial inspections and tests by doing Action 1
through Action 3 in work package 2 terminates the need to do the
inspection in accordance with Part 2 as required in work package 1.
However, this substitution of actions does not change the compliance
time of work package 1 as specified in Table 1 of paragraph 1.E.,
``Compliance,'' of Boeing Alert Service Bulletin MD11-78A017, dated
December 4, 2023.
    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.

Proposed AD Requirements in This NPRM

    This proposed AD would require accomplishing the actions identified
as ``RC'' (required for compliance) in the Accomplishment Instructions
of Boeing Alert Service Bulletin MD11-78A017, dated December 4, 2023,
already described and except for any differences identified as
exceptions in the regulatory text of this proposed AD. This proposed AD
also requires reporting findings to Boeing. For information on the
procedures and compliance times, see this service information at
regulations.gov under Docket No. FAA-2023-2403.

Interim Action

    The FAA considers this proposed AD to be an interim action. The
reports that are required by this proposed AD will enable the
manufacturer to obtain better insight into the nature, cause, and
extent of the unsafe condition, and eventually to develop final action
to address the unsafe condition. If final action is later identified,
the FAA might consider further rulemaking.

Costs of Compliance

    The FAA estimates that this AD, if adopted as proposed, would
affect 79 airplanes of U.S. registry. The FAA estimates the following
costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
              Action                    Labor cost        Parts cost    Cost per product          operators
----------------------------------------------------------------------------------------------------------------
Inspections and Tests............  Up to 78 work-hours            $0  Up to $6,630 per      Up to $523,770 per
                                    x $85 per hour = Up                inspection/test       inspection/test
                                    to $6,630 per                      cycle.                cycle.
                                    inspection/test
                                    cycle.

Reporting........................  1 work-hour x $85               0  85 per inspection/    6,715 per inspection/
                                    per hour = $85 per                 test cycle.           test cycle.
                                    inspection/test
                                    cycle.
----------------------------------------------------------------------------------------------------------------

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

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                  Action                            Labor cost           Parts cost        Cost per product
----------------------------------------------------------------------------------------------------------------
Repairs/Replacements/Tests...............  Up to 120 work-hours x $85          * $0  Up to $10,200.
                                            per hour = up to $10,200.
----------------------------------------------------------------------------------------------------------------
* The FAA has received no definitive data that would enable the FAA to provide a parts cost estimate for the on-
  condition repairs/replacements specified in this proposed AD.

Paperwork Reduction Act

    A federal agency may not conduct or sponsor, and a person is not
required to respond to, nor shall a person be subject to penalty for
failure to comply with a collection of information subject to the
requirements of the Paperwork Reduction Act unless that collection of
information displays a currently valid OMB Control Number. The OMB
Control Number for this information collection is 2120-0056. Public
reporting for this collection of information is estimated to take
approximately 1 hour per response, including the time for reviewing
instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the
collection of information. All responses to this collection of
information are mandatory. Send comments regarding this burden estimate
or any other aspect of this collection of information, including
suggestions for reducing this burden, to Information Collection
Clearance Officer, Federal Aviation Administration, 10101 Hillwood
Parkway, Fort Worth, TX 76177-1524.

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:

The Boeing Company: Docket No. FAA-2023-2403; Project Identifier AD-
2023-00888-T.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by February 12, 2024.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to The Boeing Company Model MD-11 and MD-11F
airplanes, certificated in any category, equipped with General
Electric (GE) CF6-80C2D1F high-bypass turbofan engines.

(d) Subject

    Air Transport Association (ATA) of America Code 78, Engine
Exhaust.

(e) Unsafe Condition

    This AD was prompted by a report of a Model MD-11F airplane
experiencing an uncommanded deployment of a thrust reverser at
approximately 500 feet above ground level. The FAA is issuing this
AD to address uncommanded deployment of a thrust reverser in-flight
at low altitude, which could result in loss of flight control of the
airplane and loss of continued safe flight and landing.

(f) Compliance

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

(g) Required Actions

    Except as specified in paragraph (h) of this AD: At the
applicable times specified in paragraph 1.E., ``Compliance,'' of
Boeing Alert Service Bulletin MD11-78A017, dated December 4, 2023,
do all applicable actions identified as ``RC'' (required for
compliance)

in, and in accordance with, the Accomplishment Instructions of
Boeing Alert Service Bulletin MD11-78A017, dated December 4, 2023.

(h) Exceptions to Service Information Specifications

    (1) Where the Compliance Time columns of the tables in the
``Compliance'' paragraph of Boeing Alert Service Bulletin MD11-
78A017, dated December 4, 2023, use the phrase ``the original issue
date of this service bulletin,'' this AD requires using ``the
effective date of this AD.''
    (2) Where step 6.c.(2)(a), ``CONDITION 14 OPTION 1 (ACTION 1)''
and step 6.c.(2)(b)4)d), ``CONDITION 14.4 OPTION 2 (ACTION 1)'' of
the Accomplishment Instructions of Boeing Service Bulletin MD11-
78017, dated December 4, 2023, specify to replace the junction box,
that replacement must be accomplished in accordance with ``PART 12:
JUNCTION BOX REPLACEMENT'' of the Accomplishment Instructions of
Boeing Service Bulletin MD11-78017, dated December 4, 2023.

(i) Reporting

    At the applicable time specified in paragraph (i)(1) or (2) of
this AD, submit a report to The Boeing Company via the Boeing
Communication System (BCS) and include the information specified in
Appendix C of Boeing Alert Service Bulletin MD11-78A017, dated
December 4, 2023.
    (1) If the inspection or test was done on or after the effective
date of this AD: Submit the report within 30 days after the
inspection or test.
    (2) If the inspection or test was done before the effective date
of this AD: Submit the report within 30 days after the effective
date of this AD.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, AIR-520, Continued Operational Safety 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 manager of AIR-520, Continued
Operational Safety Branch, send it to the attention of the person
identified in paragraph (k) of this AD. Information may be emailed
to [email protected].[FEDREG][VOL]*[/VOL][NO]*[/
NO][DATE]*[/DATE][PRORULES][PRORULE][PREAMB][AGENCY]*[/
AGENCY][SUBJECT]*[/SUBJECT][/PREAMB][SUPLINF][HED]*[/
HED][EXTRACT][P]*[/P]
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the responsible Flight Standards Office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair, modification, or alteration required by this AD
if it is approved by The Boeing Company Organization Designation
Authorization (ODA) that has been authorized by the Manager, AIR-
520, Continued Operational Safety Branch, FAA, to make those
findings. To be approved, the repair method, modification deviation,
or alteration deviation must meet the certification basis of the
airplane, and the approval must specifically refer to this AD.
    (4) Except as specified by paragraph (g) of this AD: For service
information that contains steps that are labeled as Required for
Compliance (RC), the provisions of paragraphs (j)(4)(i) and (ii) of
this AD apply.
    (i) The steps labeled as RC, including substeps under an RC step
and any figures identified in an RC step, must be done to comply
with the AD. If a step or substep is labeled ``RC Exempt,'' then the
RC requirement is removed from that step or substep. An AMOC is
required for any deviations to RC steps, including substeps and
identified figures.
    (ii) Steps not labeled as RC may be deviated from using accepted
methods in accordance with the operator's maintenance or inspection
program without obtaining approval of an AMOC, provided the RC
steps, including substeps and identified figures, can still be done
as specified, and the airplane can be put back in an airworthy
condition.

(k) Related Information

    For more information about this AD, contact Kevin Nguyen,
Aviation Safety Engineer, FAA, 2200 South 216th St., Des Moines, WA
98198; telephone<PHONE_NUMBER>; email [email protected].

(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 Alert Service Bulletin MD11-78A017, dated December 4,
2023.
    (ii) [Reserved]
    (3) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Contractual & Data Services
(C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-
5600; telephone<PHONE_NUMBER>; website myboeingfleet.com.
    (4) You may view this service information at the 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>.
    (5) You may view this material at the National Archives and
Records Administration (NARA). For information on the availability
of this material at NARA, visit www.archives.gov/federal-register/cfr/ibr-locations or email [email protected].

    Issued on December 22, 2023.
Caitlin Locke,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2023-28721 Filed 12-28-23; 8:45 am]
BILLING CODE 4910-13-P