[Federal Register Volume 87, Number 222 (Friday, November 18, 2022)]
[Proposed Rules]
[Pages 69225-69228]
[FR Doc No: 2022-25113]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-1480; Project Identifier MCAI-2022-00548-T]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc., 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 Bombardier, Inc., Model BD-100-1A10 airplanes. This
proposed AD was prompted by reports of cracks found in the tailcone
upper firewall where the auxiliary power unit (APU) muffler electrical
bonding strap is attached. This proposed AD would require a detailed
visual inspection of the tailcone upper firewall for defects, rework by
replacement of the APU electrical bonding strap, and repair if
necessary. 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 January 3,
2023.

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-2022-1480; 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, the mandatory continuing airworthiness
information (MCAI), 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
Bombardier Business Aircraft Customer Response Center, 400 C[ocirc]te-
Vertu Road West, Dorval, Qu[eacute]bec H4S 1Y9, Canada; telephone 514-
855-2999; email bombardier.com">[email protected]bombardier.com; website bombardier.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>.

FOR FURTHER INFORMATION CONTACT: Yaser Osman, Aerospace Engineer,
Airframe and Propulsion Section, FAA, New York ACO Branch, 1600 Stewart
Avenue, Suite 410, Westbury, NY 11590; telephone<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-2022-1480; Project Identifier
MCAI-2022-00548-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
the 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 Yaser
Osman, Aerospace Engineer, Airframe and Propulsion Section, FAA, New
York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590;
telephone<PHONE_NUMBER>; email [email protected]. Any commentary
that the FAA receives which is not specifically designated as CBI will
be placed in the public docket for this rulemaking.

Background

    Transport Canada Civil Aviation (TCCA), which is the aviation
authority for Canada, has issued TCCA AD CF-2022-19, dated April 19,
2022 (TCCA AD CF-2022-19) (also referred to after this as the MCAI), to
correct an unsafe condition on certain Bombardier, Inc., Model BD-100-
1A10 airplanes. The MCAI states that cracks were found in the tailcone
upper firewall where the APU muffler electrical bonding strap is
attached. Crack initiation is related to the rigid electrical bonding
strap. A crack in this area, if not addressed, could result in a breach
of the firewall, which could allow a fire to propagate; reduced
lightning strike protection, which could affect the airplane's
grounding and potentially cause a fire; and increased radio
interference during flight, which could reduce the ability of the
flightcrew to maintain the safe flight and landing of the airplane.
    You may examine the MCAI in the AD docket at regulations.gov under
Docket No. FAA-2022-1480.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Bombardier Service Bulletin 100-53-35, dated
December 6, 2021; and Service Bulletin 350-53-004, dated December 6,
2021. This service information specifies procedures for doing a
detailed visual inspection of the tailcone upper firewall for defects
including cracking, reworking the APU electrical bonding strap by
replacing it with a new flexible APU muffler jumper cable assembly, and
repairing the tailcone upper firewall. These documents are distinct
since they apply to different airplane configurations.
    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 the ADDRESSES section.

FAA's Determination

    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
and service information described above. 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.

Proposed AD Requirements in This NPRM

    This proposed AD would require accomplishing the actions specified
in the service information already described.

Costs of Compliance

    The FAA estimates that this AD, if adopted as proposed, would
affect 691 airplanes of U.S. registry. The FAA estimates the following
costs to comply with this proposed AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
                          Labor cost                              Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
1 work-hour x $85 per hour = $85.............................             $36             $121          $83,611
----------------------------------------------------------------------------------------------------------------

    The FAA estimates the following costs to do any necessary on-
condition actions that would be required based on the results of any
required action. The FAA has no way of determining the number of
aircraft that might need these on-condition actions:

                 Estimated Costs of On-Condition Actions
------------------------------------------------------------------------
                                                             Cost per
              Labor cost                   Parts cost        product
------------------------------------------------------------------------
24 work-hours x $85 per hour = $2,040.            * $0           $2,040
------------------------------------------------------------------------
* The FAA has received no definitive data on which to base the cost
  estimates for the parts specified in this proposed 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 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:

Bombardier, Inc.: Docket No. FAA-2022-1480; Project Identifier MCAI-
2022-00548-T.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by January 3, 2023.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Bombardier, Inc., Model BD-100-1A10
airplanes, certificated in any category, serial numbers 20003
through 20500 inclusive and 20501 through 20916 inclusive.

(d) Subject

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

(e) Unsafe Condition

    This AD was prompted by reports of cracks found in the tailcone
upper firewall where the auxiliary power unit (APU) muffler
electrical bonding strap is attached. The FAA is issuing this AD to
address cracking in the tailcone upper firewall. The unsafe
condition, if not addressed, could result in a breach of the
firewall, which could allow a fire to propagate; reduced lightning
strike protection, which could affect the airplane's grounding and
potentially cause a fire; and increased radio interference during
flight, which could reduce the ability of the flightcrew to maintain
the safe flight and landing of the airplane.

(f) Compliance

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

(g) Inspection, Replacement, and Corrective Actions

    Within 48 months after the effective date of this AD: Do a
detailed visual inspection of the tailcone upper firewall for
defects including cracking, rework the APU electrical bonding strap
by replacing with a new flexible APU muffler jumper cable assembly,
and repair the tail cone upper firewall, as applicable, in
accordance with paragraphs 2.B., 2.C., and 2.D., of the
Accomplishment Instructions of the applicable service information
specified in figure 1 to paragraph (g) of this AD. Do all applicable
repairs before further flight.
[GRAPHIC] [TIFF OMITTED] TP18NO22.707

(h) Additional AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York ACO 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 the New York ACO
Branch, mail it to ATTN: Program Manager, Continuing Operational
Safety, at the address identified in paragraph (i)(2) of this AD or
email to: [email protected]. If mailing information, also
submit information by email. 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: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, New York ACO
Branch, FAA; or Transport Canada Civil Aviation (TCCA); or
Bombardier, Inc's TCCA Design Approval Organization (DAO). If
approved by the DAO, the approval must include the DAO-authorized
signature.

(i) Additional Information

    (1) Refer to TCCA AD CF-2022-19, dated April 19, 2022, for
related information. This TCCA AD may be found in the AD docket at
regulations.gov under Docket No. FAA-2022-1480.
    (2) For more information about this AD, contact Yaser Osman,
Aerospace Engineer, Airframe and Propulsion Section, FAA, New York
ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590;
telephone<PHONE_NUMBER>; email [email protected].
    (3) For service information identified in this AD that is not
incorporated by reference, contact Bombardier Business Aircraft
Customer Response Center, 400 C[ocirc]te-Vertu Road West, Dorval,
Qu[eacute]bec H4S 1Y9, Canada; telephone<PHONE_NUMBER>; email
bombardier.com">[email protected]bombardier.com; website bombardier.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
206-231-3195.

(j) 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 this AD specifies otherwise.
    (i) Bombardier Service Bulletin 100-53-35, dated December 6,
2021.
    (ii) Bombardier Service Bulletin 350-53-004, dated December 6,
2021.
    (3) For service information identified in this AD, contact
Bombardier Business Aircraft Customer Response Center, 400
C[ocirc]te-Vertu Road West, Dorval, Qu[eacute]bec H4S 1Y9, Canada;
telephone<PHONE_NUMBER>; email bombardier.com">[email protected]bombardier.com; website
bombardier.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 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 November 10, 2022.
Christina Underwood,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2022-25113 Filed 11-17-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 179 (Thursday, September 15, 2011)]
[Notices]
[Pages 57060-57061]
[FR Doc No: 2011-23605]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0588]

International Cooperation on Harmonisation of Technical
Requirements for Registration of Veterinary Medicinal Products; Draft
Guidance for Industry on Pharmacovigilance of Veterinary Medicinal
Products: Electronic Standards for Transfer of Data; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry (214) entitled
``Draft Guidance for Industry, Pharmacovigilance of Veterinary
Medicinal Products: Electronic Standards for Transfer of Data'' (VICH
GL35). This draft guidance has been developed for veterinary use by the
International Cooperation on Harmonisation of Technical Requirements
for Registration of Veterinary Medicinal Products (VICH). This draft
VICH guidance document is intended to provide recommended standards to
construct a single electronic message to transmit data elements for
submission of adverse event reports (AERs) to all member regions.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by November 14, 2011.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Communications Staff (HFV-12), Center for Veterinary
Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville,
MD 20855. Send one self-addressed adhesive label to assist that office
in processing your request. See the SUPPLEMENTARY INFORMATION section
for electronic access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments on the draft guidance to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Margarita Brown, Center for Veterinary
Medicine (HFV-240), Food and Drug Administration, 7519 Standish Place,
Rockville, MD 20855,<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
(214) entitled ``Draft Guidance for Industry,
Pharmacovigilance of Veterinary Medicinal Products: Electronic
Standards for Transfer of Data (VICH GL35).'' In recent years, many
important initiatives have been undertaken by regulatory authorities
and industry associations to promote the international harmonization of
regulatory requirements. FDA has participated in efforts to enhance
harmonization and has expressed its commitment to seek scientifically
based harmonized technical procedures for the development of
pharmaceutical products. One of the goals of harmonization is to
identify and then reduce differences in technical requirements for drug
development among regulatory agencies in different countries.
    FDA has actively participated in the International Conference on
Harmonisation of Technical Requirements for Approval of Pharmaceuticals
for Human Use for several years to develop harmonized technical
requirements for the approval of human pharmaceutical and biological
products among the European Union, Japan, and the United States. The
VICH is a parallel initiative for veterinary medicinal products. The
VICH is concerned with developing harmonized technical requirements for
the approval of veterinary medicinal products in the European Union,
Japan, and the United States, and includes input from both regulatory
and industry representatives.
    The VICH Steering Committee is composed of member representatives
from the European Commission, European Medicines Evaluation Agency,
European Federation of Animal Health, Committee on Veterinary Medicinal
Products, U.S. FDA, U.S. Department of Agriculture, the Animal Health
Institute, the Japanese Veterinary Pharmaceutical Association, the
Japanese Association of Veterinary Biologics, and the Japanese Ministry
of Agriculture, Forestry, and Fisheries.
    Four observers are eligible to participate in the VICH Steering
Committee: One representative from the government of Australia/New
Zealand, one representative from the industry in Australia/New Zealand,
one representative from the government of Canada, and one
representative from the industry of Canada. The VICH Secretariat, which
coordinates the preparation of documentation, is provided by the
International Federation for Animal Health (IFAH). An IFAH
representative also participates in the VICH Steering Committee
meetings.

II. Draft Guidance on Electronic Standards for Transfer of Data

    The VICH Steering Committee held a meeting in June 2010, and agreed
that the draft guidance document entitled ``Draft Guidance for Industry
on Pharmacovigilance of Veterinary Medicinal Products: Electronic
Standards for Transfer of Data'' (VICH GL35) should be made available
for public comment. This draft VICH guidance document is intended to
provide recommended standards to construct a single electronic message
to transmit data elements for submission of AERs to all member regions.
    The need to transfer and disseminate information quickly,
accurately and easily between Regulatory Authorities (RA) and Marketing
Authorization Holders (MAH) on a worldwide scope is especially
pertinent to the notification and assimilation of information for
pharmacovigilance. Whereas the recommended definition of the
pharmacovigilance information has

been set forth within the draft guidances entitled, ``Pharmacovigilance
of Veterinary Medicinal Products: Management of Adverse Event Reports
(AER's)'' (VICH GL24), ``Pharmacovigilance of Veterinary Medicinal
Products: Controlled Lists of Terms'' (VICH GL30) and
``Pharmacovigilance of Veterinary Medicinal Products: Data Elements for
Submission of Adverse Event Reports'' (VICH GL42), this draft guidance
defines recommended electronic standards for transfer of data.
    In order to allow for electronic exchange of this information
between stakeholders, further specification of the field descriptors
and their relationships, including agreement on format of the
electronic message is essential.
    FDA and the VICH Expert Working Group will consider comments about
the draft guidance document.

III. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in this guidance have been approved under
OMB Control No. 0910-0284.

IV. Significance of Guidance

    This draft guidance, developed under the VICH process, has been
revised to conform to FDA's good guidance practices regulation (21 CFR
10.115). For example, the document has been designated ``guidance''
rather than ``guideline.'' In addition, guidance documents must not
include mandatory language such as ``shall,'' ``must,'' ``require,'' or
``requirement,'' unless FDA is using these words to describe a
statutory or regulatory requirement.
    The draft guidance, when finalized, will represent the agency's
current thinking on this topic. It does not create or confer any rights
for or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of applicable statutes and regulations.

V. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
It is only necessary to send one set of comments. It is no longer
necessary to send two copies of mailed comments. 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.

VI. Electronic Access

    Persons with access to the Internet may obtain the draft guidance
at either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov.

    Dated: September 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-23605 Filed 9-14-11; 8:45 am]
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