[Federal Register Volume 74, Number 127 (Monday, July 6, 2009)]
[Rules and Regulations]
[Pages 31849-31850]
[FR Doc No: E9-15694]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2008-0940; Airspace Docket No. 08-AAL-25]
RIN 2120-AA66

Removal and Modification of VOR Federal Airways; Alaska

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action removes Federal Airway V-328, and modifies three
Federal Airways, V-319, V-333 and V-480, in Alaska. This action revises
the Instrument Flight Rules (IFR) airway and route structure in Alaska
to account for the pending decommissioning from the National Airspace
System (NAS) of the Kipnuk Very High Omni-directional Range (VOR), at
Kipnuk, AK. The FAA is taking this action to enhance safety and improve
the management of air traffic operations in the State of Alaska.

DATES: Effective Date: 0901 UTC, August 27, 2009. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Ken McElroy, Airspace and Rules Group,
Office of System Operations Airspace and AIM, Federal Aviation
Administration, 800 Independence Avenue, SW., Washington, DC 20591;
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    On December 10, 2008, the FAA published in the Federal Register a
notice of proposed rulemaking (NPRM) to remove V-328 and modify V-319,
V-333 and V-480 (73 FR 75013). Interested parties were invited to
participate in this rulemaking effort by submitting written comments on
this proposal. No comments were received in response to the NPRM.
    VOR Federal Airways are published in paragraph 6010(b) of FAA Order
7400.9S, signed October 3, 2008, and effective October 31, 2008, which
is incorporated by reference in 14 CFR 71.1. The VOR Federal Airways
listed in this document will be published subsequently in the Order.

The Rule

    The FAA is amending Title 14 Code of Federal Regulations (14 CFR
part 71) by revoking one Federal Airway V-328, and modifying three
Federal Airways, V-319, V-333, and V-480 in Alaska. The FAA is taking
this action to remove all airways off the Kipnuk, Very High Omni-
directional Range (VOR), Kipnuk, AK, in preparation for the VOR's
eventual decommissioning from the National Airspace System (NAS). The
Kipnuk VOR decommissioning proposal was publicly advertised in non-
rulemaking notice numbers 02-AAL-31NR and 06-AAL-32NR. After reviewing
public comment, the FAA decided that keeping or moving the Kipnuk VOR
was not feasible and should be decommissioned. The FAA has determined
that this regulation only involves an established body of technical
regulations for which frequent and routine amendments are necessary to
keep them operationally current. Therefore, this regulation: (1) Is not
a ``significant regulatory action'' under Executive Order 12866; (2) is
not a ``significant rule'' under Department of Transportation (DOT)
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1E, ``Environmental Impacts: Polices and
Procedures,'' paragraph 311a. This airspace action is not expected to
cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

0
In consideration of the foregoing, the Federal Aviation Administration
amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24
FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1   [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.9S,
Airspace Designations and Reporting Points, signed October 3, 2008, and
effective October 31, 2008, is amended as follows:

Paragraph 6010(b) Alaskan VOR Federal Airways.

* * * * *

V-319 [Revised]

    From Yakutat, AK, via Johnstone Point, AK, INT Johnstone Point
286[deg] and Anchorage, AK, 117[deg] radials; Anchorage, AK;
Sparrevohn, AK; Bethel, AK; Hooper Bay, AK; to Nanwak, AK NDB.
* * * * *

V-333 [Revised]

    From Hooper Bay, AK; Nome, AK; to Shishmaref, AK.
* * * * *

V-328 [Removed]

* * * * *

V-480 [Revised]

    From Mt. Moffett, AK, NDB, 20 AGL via St. Paul Island, AK, NDB,
20 AGL; Bethel, AK; McGrath, AK; Nenana, AK; to Fairbanks, AK.
* * * * *

    Issued in Washington, DC, on June 26, 2009.
Edith V. Parish,
Manager, Airspace and Rules Group.
[FR Doc. E9-15694 Filed 7-2-09; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 40 (Wednesday, March 1, 2023)]
[Notices]
[Pages 12950-12951]
[FR Doc No: 2023-04178]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2018-E-4422, FDA-2018-E-4827, and FDA-2018-E-4427]

Determination of Regulatory Review Period for Purposes of Patent
Extension; VYZULTA

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for VYZULTA and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of applications to the Director
of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human drug
product.

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect must submit either electronic
or written comments and ask for a redetermination by May 1, 2023.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by August 28, 2023. See
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of May 1, 2023. Comments received by
mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket Nos.
FDA-2018-E-4422, FDA-2018-E-4827, and FDA-2018-E-4427 for
``Determination of Regulatory Review Period for Purposes of Patent
Extension; VYZULTA.'' Received comments, those filed in a timely manner
(see ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management

Staff. If you do not wish your name and contact information to be made
publicly available, you can provide this information on the cover sheet
and not in the body of your comments and you must identify this
information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with Sec.
10.20 (21 CFR 10.20) and other applicable disclosure law. For more
information about FDA's posting of comments to public dockets, see 80
FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug or biologic product, animal drug product, medical device,
food additive, or color additive) was subject to regulatory review by
FDA before the item was marketed. Under these acts, a product's
regulatory review period forms the basis for determining the amount of
extension an applicant may receive.
    A regulatory review period consists of two periods of time: a
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product, VYZULTA
(latanoprostene bunod). VYZULTA is indicated for reduction of
intraocular pressure in patients with open-angle glaucoma or ocular
hypertension. Subsequent to this approval, the USPTO received patent
term restoration applications for VYZULTA (U.S. Patent Nos. 7,273,946;
7,629,345; and 8,058,467) from Nicox S.A., and the USPTO requested
FDA's assistance in determining the patents' eligibility for patent
term restoration. In a letter dated May 13, 2019, FDA advised the USPTO
that this human drug product had undergone a regulatory review period
and that the approval of VYZULTA represented the first permitted
commercial marketing or use of the product. Thereafter, the USPTO
requested that FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
VYZULTA is 3,879 days. Of this time, 3,043 days occurred during the
testing phase of the regulatory review period, while 836 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
March 23, 2007. FDA has verified the applicant's claim that the date
the investigational new drug application became effective was on March
23, 2007.
    2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: July 21,
2015. FDA has verified the applicant's claim that the new drug
application (NDA) for VYZULTA (NDA 207795) was initially submitted on
July 21, 2015.
    3. The date the application was approved: November 2, 2017. FDA has
verified the applicant's claim that NDA 207795 was approved on November
2, 2017.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its applications for patent extension,
this applicant seeks 1,826 days or 1,507 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: February 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-04178 Filed 2-28-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 80 (Tuesday, April 26, 2022)]
[Proposed Rules]
[Pages 24476-24479]
[FR Doc No: 2022-08822]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-0470; Project Identifier MCAI-2021-01002-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 all Bombardier, Inc., Model BD-700-1A10 and BD-700-1A11 airplanes.
This proposed AD was prompted by reports that some oxygen box
assemblies had their piston ejected during the mask deployment test.
This proposed AD would require a one-time inspection of each passenger
oxygen box dual manifold assembly to find and replace affected parts.
This proposed AD would also prohibit installing affected parts. 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 June 10,
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 https://www.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.
    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<PHONE_NUMBER>;
email [email protected]; internet https://www.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>.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2022-0470; 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.

FOR FURTHER INFORMATION CONTACT: Elizabeth Dowling, Aerospace Engineer,
Mechanical Systems and Administrative Services 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-2022-0470; Project Identifier
MCAI-2021-01002-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
https://www.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
Elizabeth Dowling, Aerospace Engineer, Mechanical Systems and
Administrative Services 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-2021-30, dated September 7,
2021 (TCCA AD CF-2021-30) (also referred to after this as the Mandatory
Continuing Airworthiness Information, or the MCAI), to correct an
unsafe condition for all Bombardier, Inc., Model BD-700-1A10 and BD-
700-1A11 airplanes. You may examine the MCAI in the AD docket at
https://www.regulations.gov by searching for and locating Docket No.
FAA-2022-0470.
    This proposed AD was prompted by reports that some passenger oxygen
box dual manifold assemblies had their piston ejected during the mask
deployment test due to a non-conformity in manufacturing. The FAA is
proposing this AD to address a possible in-service piston ejection when
used for emergency descent, smoke, or fire that may result in a high
rate of oxygen leakage, which could prematurely deplete the oxygen for
all passengers. See the MCAI for additional background information.

Related Service Information Under 1 CFR Part 51

    Bombardier, Inc., has issued the following service information.
     Service Bulletin 700-35-5004, Revision 02, dated August
27, 2021.
     Service Bulletin 700-35-5502, dated August 27, 2021.
     Service Bulletin 700-35-6004, Revision 05, dated August
27, 2021.
     Service Bulletin 700-35-6502, dated August 27, 2021.
    This service information describes procedures for inspecting each
passenger oxygen box dual manifold assembly to find affected parts, and
replacing affected parts. These documents are distinct because 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 the State of Design Authority,
the FAA has been notified of the unsafe condition described in the MCAI
and service information referenced above. The FAA is proposing this AD
because the FAA evaluated all the relevant information and determined
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 308 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.............................              $0              $85          $26,180
----------------------------------------------------------------------------------------------------------------

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

                 Estimated Costs of On-Condition Actions
------------------------------------------------------------------------
         Labor cost                Parts cost         Cost per product
------------------------------------------------------------------------
Up to 34 work-hours x $85     Up to $1,700........  Up to $4,590.
 per hour = $2,890.
------------------------------------------------------------------------

    The FAA has included all known costs in its cost estimate.
According to the manufacturer, however, some or all of the costs of
this proposed AD may be covered under warranty, thereby reducing the
cost impact on affected operators.

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-2022-0470; Project Identifier MCAI-
2021-01002-T.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by June 10, 2022.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Bombardier, Inc., Model BD-700-1A10 and
BD-700-1A11 airplanes, certificated in any category.

(d) Subject

    Air Transport Association (ATA) of America Code 35, Oxygen.

(e) Unsafe Condition

    This AD was prompted by reports that some passenger oxygen box
dual manifold had their piston ejected during the mask deployment
test due to a non-conformity in manufacturing. The FAA is issuing
this AD to address a possible in-service piston ejection when used
for emergency descent, smoke, or fire that may result in a high rate
of oxygen leakage, which could prematurely deplete the oxygen for
all passengers.

(f) Compliance

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

(g) Definition

    An affected part is a passenger oxygen box assembly having a
dual manifold assembly having part number 100-009-39 and a lot and
serial number specified in figure 1 to paragraph (g) of this AD.
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[GRAPHIC] [TIFF OMITTED] TP26AP22.058

(h) Required Actions

    Within the applicable compliance time specified in paragraph
(h)(1) or (2) of this AD: Inspect each passenger oxygen box dual
manifold assembly to determine if it is an affected part, as defined
in paragraph (g) of this AD, and replace any affected part in
accordance with paragraph 2.B. of the Accomplishment Instructions of
the applicable Bombardier service bulletin specified in figure 2 to
paragraph (h) of this AD. Replace any affected part before further
flight.
    (1) For airplanes having serial numbers 9771, 9779, 9784, 9788
through 9824 inclusive, 9853 through 9857 inclusive, and 9859
through 9876 inclusive, within 4 months after the effective date of
this AD.
    (2) For airplane having serial numbers 9877 through 9879
inclusive, and 60001 through 60042 inclusive, within 30 months after
the effective date of this AD.
[GRAPHIC] [TIFF OMITTED] TP26AP22.059

(i) Parts Installation Prohibition

    As of the effective date of this AD, no person may install an
affected part as defined in paragraph (g) of this AD, on any
airplane.

(j) Credit for Previous Actions

    This paragraph provides credit for actions required by paragraph
(h) of this AD, if those actions were performed before the effective
date of this AD using the service information specified in
paragraphs (j)(1) through (7) of this AD, as applicable.
    (1) Bombardier Service Bulletin 700-35-5004, dated December 10,
2018.
    (2) Bombardier Service Bulletin 700-35-5004, Revision 01, dated
November 29, 2019.

    (3) Bombardier Service Bulletin 700-35-6004, dated December 10,
2018.
    (4) Bombardier Service Bulletin 700-35-6004, Revision 01, dated
January 16, 2019.
    (5) Bombardier Service Bulletin 700-35-6004, Revision 02, dated
April 5, 2019.
    (6) Bombardier Service Bulletin 700-35-6004, Revision 03, dated
May 31, 2019.
    (7) Bombardier Service Bulletin 700-35-6004, Revision 04, dated
November 29, 2019.

(k) Other FAA 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 certification
office, send it to ATTN: Program Manager, Continuing Operational
Safety, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410,
Westbury, NY 11590; telephone<PHONE_NUMBER>. 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.

(l) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) TCCA AD CF-2021-30, dated September 7, 2021, for related
information. This MCAI may be found in the AD docket on the internet
at https://www.regulations.gov by searching for and locating Docket
No. FAA-2022-0470.
    (2) For more information about this AD, contact Elizabeth
Dowling, Aerospace Engineer, Mechanical Systems and Administrative
Services 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, 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 [email protected]; internet
https://www.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>.

    Issued on April 20, 2022.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2022-08822 Filed 4-25-22; 8:45 am]
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