[Federal Register: May 12, 2010 (Volume 75, Number 91)]
[Notices]
[Page 26825-26827]
[DOCID:fr12my10-125]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-62038; File No. SR-NYSE-2010-22]

Self-Regulatory Organizations; New York Stock Exchange, LLC;
Order Approving Proposed Rule Change To Make Permanent a Unit-of-Count
Metric Alternative for NYSE OpenBook Products

May 5, 2010.

I. Introduction

    On March 11, 2010, the New York Stock Exchange, LLC (``NYSE'' or
the ``Exchange'') filed with the Securities

and Exchange Commission (``Commission''), pursuant to Section 19(b)(1)
of the Securities Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4
thereunder,\2\ a proposed rule change to make the unit-of-count metric
a permanent alternative to the traditional device fee. The proposed
rule change was published for comment in the Federal Register on April
1, 2010.\3\ The Commission received one comment letter on the
proposal.\4\ This order approves the proposed rule change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 61779 (March 25,
2010), 75 FR 16537 (``Notice'').
    \4\ Letter to Elizabeth M. Murphy, Secretary, Commission, from
Melissa MacGregor, Managing Director and Associate General Counsel,
SIFMA, dated May 5, 2010.
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II. Description of the Proposal

A. Unit-of-Count

    The Exchange proposes to permanently implement the ``Subscriber
Entitlement'' unit-of-count methodology in accordance with the terms
set forth in the Pilot Program.\5\ Under the Pilot Program, instead of
defining the Vendor-subscriber relationship based on how the Data Feed
Recipient or subscriber receives data (i.e., through controlled
displays or through data feeds), the Exchange proposed to adopt a more
objective billing criteria. The following basic principles underlie
this proposal.
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    \5\ See Securities Exchange Act Release No. 59544 (March 9,
2009), 74 FR 11162 (March 16, 2009) (SR-NYSE-2008-131) (approving
the one-year pilot program that revises the unit-of-count
methodology to determine the device fees payable by data recipients
(``Pilot Program'')). The Commission subsequently approved an
extension of the Pilot Program. See Securities Exchange Act Release
No. 61780 (March 25, 2010), 75 FR 16535 (April 1, 2010) (SR-NYSE-
2010-21).
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    i. Vendors.
     ``Vendors'' are market data vendors, broker-dealers,
private network providers and other entities that control Subscribers'
access to data through Subscriber Entitlement Controls.
    ii. Subscribers.
     ``Subscribers'' are unique individual persons or devices
to which a Vendor provides data. Any individual or device that receives
data from a Vendor is a Subscriber, whether the individual or device
works for or belongs to the Vendor, or works for or belongs to an
entity other than the Vendor.
     Only a Vendor may control Subscriber access to data.
     Subscribers may not redistribute data in any manner.
    iii. Subscriber Entitlements.
     A Subscriber Entitlement is a Vendor's permitting a
Subscriber to receive access to data through an Exchange-approved
Subscriber Entitlement Control.
     A Vendor may not provide data access to a Subscriber
except through a unique Subscriber Entitlement.
     The Exchange will require each Vendor to provide a unique
Subscriber Entitlement to each unique Subscriber.
     At prescribed intervals (normally monthly), the Exchange
will require each Vendor to report each unique Subscriber Entitlement.
    iv. Subscriber Entitlement Controls.
     A Subscriber Entitlement Control is the Vendor's process
of permitting Subscribers' access to data.
     Prior to using any Subscriber Entitlement Control or
changing a previously approved Subscriber Entitlement Control, a Vendor
must provide the Exchange with a demonstration and a detailed written
description of the control or change and the Exchange must have
approved it in writing.
     The Exchange will approve a Subscriber Entitlement Control
if it allows only authorized, unique end-users or devices to access
data or monitors access to data by each unique end-user or device.
     Vendors must design Subscriber Entitlement Controls to
produce an audit report and make each audit report available to the
Exchange upon request. The audit report must identify:
    A. each entitlement update to the Subscriber Entitlement Control;
    B. the status of the Subscriber Entitlement Control; and
    C. any other changes to the Subscriber Entitlement Control over a
given period.
     Only the Vendor may have access to Subscriber Entitlement
Controls.
    The proposal does not restrict how Vendors use NYSE OpenBook data
in their display services. In fact, the Exchange believes that proposal
could encourage Vendors to create and promote innovative uses of NYSE
OpenBook information. For instance, a Vendor may use NYSE OpenBook data
to create derived information displays, such as displays that aggregate
NYSE OpenBook data with data from other markets.\6\ In addition, the
proposal's unit-of-count concepts would apply equally to all data
recipients and users.
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    \6\ In the case of derived displays, the Vendor is required to:
(1) Pay the Exchange's device fees (described below); (2) include
derived displays in its reports of NYSE OpenBook usage; and (3) use
reasonable efforts to assure that any person viewing a display of
derived data understands what the display represents and the manner
in which it was derived.
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    Under the proposed rule change, the Exchange would require Vendors
to count every Subscriber Entitlement, whether it be an individual
person or a device. Thus, the Vendor's count would include every person
and device that accesses the data regardless of the purpose for which
the individual or device uses the data. The proposal is designed to
subject the count to a more objective process and simplify the
reporting obligation for Vendors by eliminating current exceptions to
the device-reporting obligation. For instance, the Exchange noted that
Vendors were not previously required to report certain programmers and
other individuals who receive access to data for certain specific, non-
trading purposes but that these exceptions required the Exchange to
monitor the manner end-users consume data, which adds cost for both the
Exchange and customers.
    To simplify the process, the Exchange proposes that Vendors would
be required to report all entitlements in accordance with the
following:
    i. In connection with a Vendor's external distribution of NYSE
OpenBook data, the Vendor should count as one Subscriber Entitlement
each unique Subscriber that the Vendor has entitled to have access to
the Exchange's market data. However, where a device is dedicated
specifically to a single individual, the Vendor should count only the
individual and need not count the device.
    ii. In connection with a Vendor's internal distribution of NYSE
OpenBook data, the Vendor should count as one Subscriber Entitlement
each unique individual (but not devices) that the Vendor has entitled
to have access to the Exchange's market data.
    iii. The Vendor should identify and report each unique Subscriber.
If a Subscriber uses the same unique Subscriber Entitlement to gain
access to multiple market data services, the Vendor should count that
as one Subscriber Entitlement. However, if a unique Subscriber uses
multiple Subscriber Entitlements to gain access to one or more market
data services (e.g., a single Subscriber has multiple passwords and
user identifications), the Vendor should report all of those Subscriber
Entitlements.
    iv. Vendors should report each unique individual person who
receives access through multiple devices as one Subscriber Entitlement
so long as each device is dedicated specifically to that individual.
    v. The Vendor should include in the count as one Subscriber
Entitlement devices serving no entitled individuals. However, if the
Vendor entitles one or more individuals to use the same

device, the Vendor should include only the entitled individuals, and
not the device, in the count.

III. Discussion

    After careful consideration, the Commission finds that the proposed
rule change is consistent with the requirements of the Act and the
rules and regulations thereunder applicable to a national securities
exchange.\7\ In particular, it is consistent with Section 6(b)(4) of
the Act,\8\ which requires that the rules of a national securities
exchange provide for the equitable allocation of reasonable dues, fees,
and other charges among its members and issuers and other parties using
its facilities, and Section 6(b)(5) of the Act,\9\ which requires,
among other things, that the rules of a national securities exchange be
designed to promote just and equitable principles of trade, to remove
impediments to and perfect the mechanism of a free and open market and
a national market system and, in general, to protect investors and the
public interest, and not be designed to permit unfair discrimination
between customers, issuers, brokers, or dealers.
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    \7\ In approving this proposed rule change, the Commission notes
that it has considered the proposed rule's impact on efficiency,
competition, and capital formation. 15 U.S.C. 78c(f).
    \8\ 15 U.S.C. 78f(b)(4).
    \9\ 15 U.S.C. 78f(b)(5).
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    The Commission also finds that the proposed rule change is
consistent with the provisions of Section 6(b)(8) of the Act,\10\ which
requires that the rules of an exchange not impose any burden on
competition not necessary or appropriate in furtherance of the purposes
of the Act. Finally, the Commission finds that the proposed rule change
is consistent with Rule 603(a) of Regulation NMS,\11\ adopted under
Section 11A(c)(1) of the Act, which requires an exclusive processor
that distributes information with respect to quotations for or
transactions in an NMS stock to do so on terms that are fair and
reasonable and that are not unreasonably discriminatory.\12\
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    \10\ 15 U.S.C. 78f(b)(8).
    \11\ 17 CFR 242.603(a).
    \12\ NYSE is an exclusive processor of NYSE depth-of-book data
under Section 3(a)(22)(B) of the Act, 15 U.S.C. 78c(a)(22)(B), which
defines an exclusive processor as, among other things, an exchange
that distributes information with respect to quotations or
transactions on an exclusive basis on its own behalf.
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    The Exchange proposes to permanently implement the Subscriber
Entitlement unit-of-count methodology in accordance with the terms set
forth in the Pilot Program. According to the Exchange, the proposed
rule change would simplify the way it charges for NYSE OpenBook by
changing the methodology for the unit-of-count, and this change should
reduce the fees and administrative costs related to the receipt and
distribution of NYSE OpenBook packages. The Exchange has indicated that
its experience with the Pilot Program has been successful. The
Commission has reviewed the proposal using the approach set forth in
the NYSE Arca Order for non-core market data fees.\13\ The Commission
has previously found that NYSE was subject to significant competitive
forces in setting fees for its depth-of-book order data in the proposed
rule changes that established and extended the Pilot Program's revised
unit-of-count methodology.\14\ There are a variety of alternative
sources of information that impose significant competitive pressures on
the NYSE in setting the terms for distributing its depth-of-book order
data. The Commission believes that the availability of those
alternatives, as well as the NYSE's compelling need to attract order
flow, imposed significant competitive pressure on the NYSE to act
equitably, fairly, and reasonably in setting the terms of its proposal.
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    \13\ Securities Exchange Act Release No. 59039 (December 2,
2008), 73 FR 74770 (December 9, 2008) (SR-NYSEArca-2006-21) (``NYSE
Arca Order''). In the NYSE Arca Order, the Commission describes in
great detail the competitive factors that apply to non-core market
data products. The Commission hereby incorporates by reference the
data and analysis from the NYSE Arca Order into this order.
    \14\ See note 5, supra.
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    Because the NYSE was subject to significant competitive forces in
setting the terms of the proposal, the Commission will approve the
proposal in the absence of a substantial countervailing basis to find
that its terms nevertheless fail to meet an applicable requirement of
the Act or the rules thereunder. An analysis of the proposal does not
provide such a basis.

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\15\ that the proposed rule change (SR-NYSE-2010-22) be, and hereby
is, approved.
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    \15\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
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    \16\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-11258 Filed 5-11-10; 8:45 am]
BILLING CODE 8010-01-P


[Federal Register Volume 87, Number 28 (Thursday, February 10, 2022)]
[Rules and Regulations]
[Pages 7708-7710]
[FR Doc No: 2022-02716]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0952; Project Identifier 2019-CE-039-AD; Amendment
39-21918; AD 2022-03-01]
RIN 2120-AA64

Airworthiness Directives; Diamond Aircraft Industries GmbH
Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain Diamond Aircraft Industries GmbH (DAI) Model DA 42, DA 42 M-NG,
and DA 42 NG airplanes. This AD was prompted by mandatory continuing
airworthiness information (MCAI) issued by the aviation authority of
another country to identify and correct an unsafe condition on an
aviation product. The MCAI describes the unsafe condition as dissolved
or detached fuel tank hose material entering the main fuel tank
chambers, which could result in restricted fuel flow with consequent
fuel starvation. This AD requires removing the fuel tank connection
hoses from service and inspecting the fuel tank connection hoses for
damage and detached rubber material. The FAA is issuing this AD to
address the unsafe condition on these products.

DATES: This AD is effective March 17, 2022.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of March 17,
2022.

ADDRESSES: For service information identified in this final rule,
contact Diamond Aircraft Industries GmbH, N.A. Otto-Stra[szlig]e 5, A-
2700 Wiener Neustadt, Austria; phone: +43 2622 26700; fax: +43 2622
26780; email: [email protected]; website: https://www.diamondaircraft.com. You may view this service information at the
FAA, Airworthiness Products Section, Operational Safety Branch, 901
Locust, Kansas City, MO 64106. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>. It is also available at
https://www.regulations.gov by searching for and locating Docket No.
FAA-2021-0952.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-0952; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this final rule, the
MCAI, any comments received, and other information. The address for
Docket Operations is U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Penelope Trease, Aviation Safety
Engineer, General Aviation & Rotorcraft Section, International
Validation Branch, FAA, 26805 E. 68th Avenue, Denver, CO 80249; phone:
(303) 342-1094; fax:<PHONE_NUMBER>; email: [email protected].

SUPPLEMENTARY INFORMATION:

Background

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to DAI Model DA 42, DA 42
M-NG, and DA 42 NG airplanes with a certain fuel tank connection hose
installed. The NPRM published in the Federal Register on November 3,
2021 (86 FR 60600). The NPRM was prompted by MCAI originated by the
European Union Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union. EASA issued EASA AD
2019-0218, dated September 3, 2019 (referred to after this as ``the
MCAI''), to address an unsafe condition on certain DAI Model DA 42, DA
42M, DA 42 M-NG, and DA 42 NG airplanes. The MCAI states:

    Reports were received of dissolved fuel tank connections hoses.
Rubber parts were found within the fuel tank. The investigation
results showed that the affected parts are limited to 2 isolated
batches, some of which were installed on the production line. Other
affected parts have been supplied as spare for in-service
replacement.
    This condition, if not corrected, could lead to restricted fuel
flow from the tank, possibly resulting in fuel starvation and
consequent reduced control of the aeroplane.
    To address this potential unsafe condition, DAI issued the
applicable MSB [Mandatory Service Bulletin], providing instructions
to identify and replace the affected parts. The applicable MSB
identifies the MSN [manufacturer serial numbers] of the aeroplanes
on which affected parts were installed during aeroplane production.
The applicable MSB also indicates that any other aeroplane may be
affected, if an affected part supplied as spare was installed.
    For the reason described above, this [EASA] AD requires removal
and replacement of the affected parts, and, if a removed affected
part is found damaged, inspection of the fuel tank chambers and
removal of any detached rubber material. This [EASA] AD also
prohibits (re)installation of any affected parts.

    You may examine the MCAI in the AD docket at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-
0952.

Discussion of Final Airworthiness Directive

Comments

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

Conclusion

    This product has been approved by the aviation authority of another
country and is approved for operation in the United States. Pursuant to
the FAA's bilateral agreement with this State of Design Authority, it
has notified the FAA of the unsafe condition described in the MCAI and
service information referenced above. The FAA reviewed the relevant
data and determined that air safety requires adopting this AD as
proposed. Accordingly, the FAA is issuing this AD to address the unsafe
condition on these products. This AD is adopted as proposed in the
NPRM, except for an editorial correction to the Applicability section.
Paragraph (c)(1) states the AD applies to the airplanes in paragraph
(c)(1) ``or'' paragraph (c)(2) when it should state the AD applies to
airplanes identified in both paragraphs.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Diamond Aircraft Mandatory Service Bulletin MSB
42-138/MSB 42NG-080, dated July 1, 2019 (issued as one document)
published with Diamond Aircraft Work Instruction WI MSB 42-138/WI-MSB
42NG-080, Revision 0, dated July 1, 2019 (issued as one document)
attached. This service information identifies the list of affected fuel
tank connection hoses and also contains procedures for replacing the

fuel tank connection hose and inspecting the main fuel tank chambers.
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.

Differences Between This AD and the MCAI or Service Information

    The MCAI applies to the Model DA 42 M airplane and this AD does not
because it does not have an FAA type certificate.
    The service information specifies reporting information to DAI, and
this AD does not require reporting.

Costs of Compliance

    The FAA estimates that this AD affects 192 airplanes of U.S.
registry. The FAA estimates that it would take about 30 work-hours to
do the actions of this AD and require a part costing $188. The average
labor rate is $85 per work-hour. Based on these figures, the FAA
estimates the cost to do the actions of this AD on U.S. operators to be
$525,696 or $2,738 per airplane.
    The FAA has included all known costs in its cost estimate.
According to the manufacturer, however, some of the costs of this 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

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government. For the reasons discussed above, I certify that
this AD. For the reasons discussed above, I certify this AD.
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive:

2022-03-01 Diamond Aircraft Industries GmbH: Amendment 39-21918;
Docket No. FAA-2021-0952; Project Identifier 2019-CE-039-AD.

(a) Effective Date

    This AD is effective March 17, 2022.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to:
    (1) Diamond Aircraft Industries GmbH (DAI) Model DA 42 NG
airplanes, serial numbers (S/N) 42.N303 through 42.N314, 42.N319,
and 42.N320, certificated in any category, with a fuel tank
connection hose part number (P/N) D4D-2817-10-70 installed; and
    (2) DAI Models DA 42, DA 42 NG, and DA 42 M-NG airplanes, all
serial numbers, certificated in any category, with a fuel tank
connection hose P/N D4D-2817-10-70 identified in the Technical
Details, section I.11, of Diamond Aircraft Mandatory Service
Bulletin MSB 42-138/MSB 42NG-080, dated July 1, 2019 (issued as one
document) (Diamond MSB 42-138/42NG-080), installed.

(d) Subject

    Joint Aircraft System Component (JASC) Code 2810, Fuel Storage.

(e) Unsafe Condition

    This AD was prompted by mandatory continuing airworthiness
information (MCAI) issued by the aviation authority of another
country to identify and correct an unsafe condition on an aviation
product. The MCAI describes the unsafe condition as dissolved or
detached fuel tank hose material entering the main fuel tank
chambers. The FAA is issuing this AD to prevent restricted fuel
flow, which could result in fuel starvation. The unsafe condition,
if not addressed, could result in fuel starvation and reduced
control of the airplane.

(f) Compliance

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

(g) Required Actions

    (1) Within 100 hours time-in-service (TIS) after the effective
date of this AD or within 4 months after the effective date of this
AD, whichever occurs first, replace the main fuel tank connection
hoses in accordance with the Instructions, sections III.1 and III.2,
in DAI Work Instruction WI-MSB 42-138/WI-MSB 42NG-080, Revision 0,
dated July 1, 2019, (issued as one document) attached to Diamond MSB
42-138/42NG-080. Instead of P/N D4D-2817-10-70_01, you may also
replace a fuel tank connection hose with P/N D4D-2817-10-70 that is
not identified in paragraph (c) of this AD.
    (2) As of the effective date of this AD, do not install a fuel
tank connection hose P/N D4D-2817-10-70 identified in paragraph (c)
of this AD on any airplane.

(h) No Reporting Requirement

    This AD does not require you to report information as specified
in the Instructions, step III.1.12, in DAI Work Instruction WI-MSB
42-138/WI-MSB 42NG-080, Revision 0, dated July 1, 2019, (issued as
one document) attached to Diamond MSB 42-138/42NG-080.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, International Validation Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the manager of the certification office, send it to the
attention of the person identified in paragraph (j)(1) of this AD
and email to: [email protected].
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(j) Related Information

    (1) For more information about this AD, contact Penelope Trease,
Aviation Safety Engineer, General Aviation & Rotorcraft Section,
International Validation Branch, FAA, 26805 E. 68th Avenue, Denver,
CO 80249; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
[email protected].

    (2) Refer to European Union Aviation Safety Agency (EASA) AD
2019-0218, dated September 3, 2019, for more information. You may
examine the EASA AD in the AD docket at https://www.regulations.gov
by searching for and locating Docket No. FAA-2021-0952.

(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference 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) Diamond Aircraft Mandatory Service Bulletin MSB 42-138/MSB
42NG-080, dated July 1, 2019 (issued as one document) published with
Diamond Aircraft Work Instruction WI MSB 42-138/WI-MSB 42NG-080,
Revision 0, dated July 1, 2019 (issued as one document) attached.
    (ii) [Reserved]
    (3) For service information identified in this AD, contact
Diamond Aircraft Industries GmbH, N.A. Otto-Stra[szlig]e 5, A-2700
Wiener Neustadt, Austria; phone: +43 2622 26700; fax: +43 2622
26780; email: [email protected]; website: https://www.diamondaircraft.com.
    (4) You may view this service information at FAA, Airworthiness
Products Section, Operational Safety Branch, 901 Locust, Kansas
City, MO 64106. 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: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on January 18, 2022.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2022-02716 Filed 2-9-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 174 (Monday, September 13, 2021)]
[Notices]
[Pages 50949-50951]
[FR Doc No: 2021-19626]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2020-0092; Notice 1]

Michelin North America, Inc., Receipt of Petition for Decision of
Inconsequential Noncompliance

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Receipt of petition.

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SUMMARY: Michelin North America, Inc. (MNA) has determined that certain
Michelin CrossClimate SUV

replacement tires do not fully comply with Federal Motor Vehicle Safety
Standard (FMVSS) No. 139, New Pneumatic Radial Tires for Light
Vehicles. MNA filed a noncompliance report dated July 31, 2020, and
subsequently petitioned NHTSA on August 21, 2020, for a decision that
the subject noncompliance is inconsequential as it relates to motor
vehicle safety. This notice announces receipt of MNA's petition.

DATES: Send comments on or before October 13, 2021.

ADDRESSES: Interested persons are invited to submit written data,
views, and arguments on this petition. Comments must refer to the
docket and notice number cited in the title of this notice and
submitted by any of the following methods:
     Mail: Send comments by mail addressed to the 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 comments by hand to the U.S.
Department of Transportation, Docket Operations, M-30, West Building
Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC
20590. The Docket Section is open on weekdays from 10 a.m. to 5 p.m.
except for Federal holidays.
     Electronically: Submit comments electronically by logging
onto the Federal Docket Management System (FDMS) website at https://www.regulations.gov/. Follow the online instructions for submitting
comments.
     Comments may also be faxed to<PHONE_NUMBER>.
    Comments must be written in the English language, and be no greater
than 15 pages in length, although there is no limit to the length of
necessary attachments to the comments. If comments are submitted in
hard copy form, please ensure that two copies are provided. If you wish
to receive confirmation that comments you have submitted by mail were
received, please enclose a stamped, self-addressed postcard with the
comments. Note that all comments received will be posted without change
to https://www.regulations.gov, including any personal information
provided.
    All comments and supporting materials received before the close of
business on the closing date indicated above will be filed in the
docket and will be considered. All comments and supporting materials
received after the closing date will also be filed and will be
considered to the fullest extent possible.
    When the petition is granted or denied, notice of the decision will
also be published in the Federal Register pursuant to the authority
indicated at the end of this notice.
    All comments, background documentation, and supporting materials
submitted to the docket may be viewed by anyone at the address and
times given above. The documents may also be viewed on the internet at
https://www.regulations.gov by following the online instructions for
accessing the docket. The docket ID number for this petition is shown
in the heading of this notice.
    DOT's complete Privacy Act Statement is available for review in a
Federal Register notice published on April 11, 2000 (65 FR 19477-78).

SUPPLEMENTARY INFORMATION:

I. Overview

    MNA has determined that certain Michelin CrossClimate SUV
replacement tires do not fully comply with the requirements of
paragraphs S5.5(e) and (f) of FMVSS No. 139, New Pneumatic Radial Tires
for Light Vehicles (49 CFR 571.139). MNA filed a noncompliance report
dated July 31, 2020, pursuant to 49 CFR part 573, Defect and
Noncompliance Responsibility and Reports. MNA subsequently petitioned
NHTSA on August 21, 2020, for an exemption from the notification and
remedy requirements of 49 U.S.C. Chapter 301 on the basis that this
noncompliance is inconsequential as it relates to motor vehicle safety,
pursuant to 49 U.S.C. 30118(d) and 30120(h) and 49 CFR part 556,
Exemption for Inconsequential Defect or Noncompliance.
    This notice of receipt of MNA's petition is published under 49
U.S.C. 30118 and 30120 and does not represent any Agency decision or
other exercise of judgment concerning the merits of the petition.

II. Tires Involved

    Approximately 884 Michelin CrossClimate SUV replacement tires, size
235/55R17 99V, manufactured between October 20, 2019, and November 30,
2019, are potentially involved.

III. Noncompliance

    MNA explains that the noncompliance is due to a mold error and that
as a result, the number of tread plies indicated on the sidewall of the
subject tires does not match the actual number of plies in the tire
construction as required by paragraphs S5.5(e) and (f) of FMVSS No.
139. Specifically, the tires were marked ``Tread Plies: 2 Polyester + 2
Steel + 1 Polyamide; Sidewall: 2 Polyester'' when they should have been
marked ``Tread Plies: 1 Polyester + 2 Steel + 1 Polyamide; Sidewall: 1
Polyester.''

IV. Rule Requirements

    Paragraphs S5.5(e) and (f) of FMVSS No. 139 include the
requirements relevant to this petition. Each tire must be marked on
each sidewall with the information specified in paragraphs S5.5(a)
through (d) and on one sidewall with the information specified in
paragraphs S5.5(e) through (i) according to the phase-in schedule
specified in paragraph S7 of FMVSS No. 139. Specifically, each tire
should be marked with the generic name of each cord material used in
the plies (both sidewall and tread area) of the tire and the actual
number of plies in the sidewall, and the actual number of plies in the
tread area, if different.

V. Summary of MNA's Petition

    The following views and arguments presented in this section, ``V.
Summary of MNA's Petition,'' are the views and arguments provided by
MNA. They have not been evaluated by the Agency and do not reflect the
views of the Agency. MNA describes the subject noncompliance and
contends that the noncompliance is inconsequential as it relates to
motor vehicle safety.
    In support of its petition, MNA submitted the following reasoning:

1. Operational Safety

    a. Tire performance--MNA says that the subject tires have been
designed as a single ply construction. The mismarked tires have been
manufactured according to the design specification. These tires fully
comply with MNA performance requirements as well as with all applicable
FMVSS tire safety performance standards and related requirements.
    b. Tire application--MNA claims that the mismarked ply information
has no direct impact on tire application. The tires are properly marked
with all other FMVSS required information including the tire size
designation, maximum load, and maximum inflation pressure. These
markings provide both dealers and consumers with the necessary
information to ensure proper selection and application of the tires.
    c. Tire repair and retread--MNA also says that concerns related to
the safety of tire repair and retread personnel have been previously
raised for filings involving steel carcass ply tires. The CrossClimate
SUV is a passenger car, sport utility, and light truck tire line with a
polyester carcass. The tire is not

intended for retreading. The concern for service personnel related to
steel carcass construction is not relevant for this tire line.

2. Corrective Measures

    a. Upon identification of the mismarking, MNA instituted a block on
the affected sku. A total of 782 tires were captured and retained in
MNA inventory. These tires will be repaired to display the correct
single ply marking, or they will be scrapped.
    b. The tire specification drawing has been corrected and the mold
plate has been updated to show the correct single ply marking. All
tires currently being produced have the correct marking.

3. Prior NHTSA Decisions

    MNA states that NHTSA has concluded in other petitions related to
the number of plies marking that this type of noncompliance is
inconsequential to safety. Examples of prior decisions include:

 Sumitomo Rubber Industries, Ltd., 83 FR 13002 (March 26, 2018)
 Continental Tire the Americas, LLC, 83 FR 36668 (July 30,
2018)
 Cooper Tire & Rubber Company, 82 FR 17075 (April 7, 2017)
 Hankook Tire America Corp., 79 FR 30688 (May 28, 2014)
 Bridgestone Americas Tire Operations, LLC, 78 FR 47049 (August
2, 2013).

    MNA concludes by again contending that the subject noncompliance is
inconsequential as it relates to motor vehicle safety, and that its
petition to be exempted from providing notification of the
noncompliance, as required by 49 U.S.C. 30118, and a remedy for the
noncompliance, as required by 49 U.S.C. 30120, be granted.
    NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and
30120(h)) that permit manufacturers to file petitions for a
determination of inconsequentiality allow NHTSA to exempt manufacturers
only from the duties found in sections 30118 and 30120, respectively,
to notify owners, purchasers, and dealers of a defect or noncompliance
and to remedy the defect or noncompliance. Therefore, any decision on
this petition only applies to the subject tires that MNA no longer
controlled at the time it determined that the noncompliance existed.
However, any decision on this petition does not relieve equipment
distributors and dealers of the prohibitions on the sale, offer for
sale, or introduction or delivery for introduction into interstate
commerce of the noncompliant tires under their control after MNA
notified them that the subject noncompliance existed.

(Authority: 49 U.S.C. 30118, 30120: delegations of authority at 49
CFR 1.95 and 501.8)

Otto G. Matheke III,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2021-19626 Filed 9-10-21; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register: March 11, 2010 (Volume 75, Number 47)]
[Notices]
[Page 11549-11551]
[DOCID:fr11mr10-61]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0109]

Determination That PRO-BANTHINE (Propantheline Bromide) Tablets
and 14 Other Drug Products Were Not Withdrawn From Sale for Reasons of
Safety or Effectiveness

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

-----------------------------------------------------------------------

SUMMARY:  The Food and Drug Administration (FDA) has determined that
the 15 drug products listed in this document were not withdrawn from
sale for reasons of safety or effectiveness. This determination means
that FDA will not begin procedures to withdraw approval of abbreviated
new drug applications (ANDAs) that refer to these drug products, and it
will allow FDA to continue to approve ANDAs that refer to the products
as long as they meet relevant legal and regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Olivia Pritzlaff, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6308, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Public Law 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products approved under an ANDA procedure. ANDA
sponsors must, with certain exceptions, show that the drug for which
they are seeking approval contains the same active ingredient in the
same strength and dosage form as the ``listed drug,'' which is a
version of the drug that was previously approved. Sponsors of ANDAs do
not have to repeat the extensive clinical testing otherwise necessary
to gain approval of a new drug application (NDA). The only clinical
data required in an ANDA are data to show that the drug that is the
subject of the ANDA is bioequivalent to the listed drug.
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(j)(7)),
which requires FDA to publish a list of all approved drugs. FDA
publishes this list as part of the ``Approved Drug Products With
Therapeutic Equivalence Evaluations,'' which is generally known as the
``Orange Book.'' Under FDA regulations, a drug is withdrawn from the
list if the agency withdraws or suspends approval of the drug's NDA or
ANDA for reasons of safety or effectiveness, or if FDA determines that
the listed drug was withdrawn from sale for reasons of safety or
effectiveness (21 CFR 314.162).

    Under Sec.  314.161(a) (21 CFR 314.161(a)), the agency must
determine whether a listed drug was withdrawn from sale for reasons of
safety or effectiveness: (1) Before an ANDA that refers to that listed
drug may be approved; (2) whenever a listed drug is voluntarily
withdrawn from sale and ANDAs that refer to the listed drug have been
approved; and (3) when a person petitions for such a determination
under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if
FDA determines that a listed drug was withdrawn from sale for reasons
of safety or effectiveness, the agency will initiate proceedings that
could result in the withdrawal of approval of the ANDAs that refer to
the listed drug.
    FDA has become aware that the drug products listed in the table in
this document are no longer being marketed. (As requested by the
applicant, FDA withdrew approval of NDA 12-097 for KENALOG IN ORABASE
(triamcinolone acetonide) Dental Paste in the Federal Register of
February 11, 2009 (74 FR 6896).)

------------------------------------------------------------------------
    Application No.                Drug                  Applicant
------------------------------------------------------------------------
NDA 8-732                PRO-BANTHINE             Shire Pharmaceuticals,
                          (propantheline           Inc.,725 Chesterbrook
                          bromide) Tablets, 7.5    Blvd., Wayne, PA
                          milligrams (mg) and 15   19087)
                          mg
------------------------------------------------------------------------
NDA 12-097               KENALOG IN ORABASE       Apothecon, Inc., c/o
                          (triamcinolone           Bristol-Myers Squibb,
                          acetonide) Dental        P.O. Box 4500,
                          Paste, 0.1%              Princeton, NJ 08543-
                                                   4500
------------------------------------------------------------------------
NDA 12-141               CYTOXAN                  Baxter Healthcare
                          (cyclophosphamide)       Corp., 1620 Waukegan
                          Tablets, 25 mg and 50    Rd. MPGR-AL, McGaw
                          mg                       Park, IL 60085
------------------------------------------------------------------------
NDA 17-498               MICRONASE (glyburide)    Pharmacia and Upjohn
                          Tablets, 1.25 mg, 2.5    Co., 7171 Portage
                          mg, and 5 mg             Rd., Kalamazoo, MI
                                                   49001
------------------------------------------------------------------------
NDA 17-924               TAGAMET (cimetidine      GlaxoSmithKline, 5
                          HCl) Oral Solution,      Moore Dr., P.O. Box
                          Equivalent to (EQ) 300   13398, Research
                          mg base/5 mL             Triangle Park, NC
                                                   27709-3398
------------------------------------------------------------------------
NDA 18-207               DESYREL (trazodone HCl)  Apothecon, Inc.
                          Tablets, 50 mg, 100
                          mg, 150 mg, and 300 mg
------------------------------------------------------------------------
NDA 19-425               TRANDATE (labetalol      Prometheus
                          HCl) Injection, 5 mg/    Laboratories, Inc.,
                          mL                       9410 Carroll Park
                                                   Dr., San Diego, CA
                                                   92121
------------------------------------------------------------------------
NDA 20-101               PROZAC (fluoxetine HCl)  Eli Lilly and Co.,
                          Oral Solution, EQ 20     Lilly Corporate
                          mg base/5 mL             Center, Indianapolis,
                                                   IN 46285
------------------------------------------------------------------------
NDA 20-286               MONOPRIL-HCT             Bristol-Myers Squibb
                          (fosinopril sodium;      Co., P.O. Box 4000,
                          hydrochlorothiazide)     Princeton, NJ 08543-
                          Tablets, 10 mg/12.5      4000
                          mg, 20 mg/12.5 mg
------------------------------------------------------------------------
NDA 20-664               DOSTINEX (cabergoline)   Pharmacia and Upjohn
                          Tablet, 0.5 mg           Co.
------------------------------------------------------------------------
NDA 20-683               ALESSE (ethinyl          Wyeth Pharmaceuticals
                          estradiol;               Inc., P.O. Box 8299,
                          levonorgestrel)          Philadelphia, PA
                          Tablets (21 Tablets      19101-8299
                          and 28 Tablets), 0.02
                          mg; 0.1 mg
------------------------------------------------------------------------
NDA 20-801               PEPCID AC (famotidine)   Merck Research
                          Chewable Tablet, 10 mg   Laboratories,
                                                   Sumneytown Pike BLA
                                                   20, P.O. Box 4, West
                                                   Point, PA 19486-0004
------------------------------------------------------------------------
NDA 20-860               LEVLITE (ethinyl         Bayer Healthcare
                          estradiol;               Pharmaceuticals,
                          levonorgestrel)          Inc., 340
                          Tablets (21 Tablets      Changebridge Rd.,
                          and 28 Tablets), 0.02    P.O. Box 1000,
                          mg; 0.1 mg               Montville, NJ 07045-
                                                   1000
------------------------------------------------------------------------
NDA 21-455               BONIVA (ibandronate      Hoffmann LaRoche,
                          sodium) Tablet, EQ 2.5   Inc., 340 Kingsland
                          mg base                  St., Bldg. 719/4,
                                                   Nutley, NJ 07110-1199
------------------------------------------------------------------------
NDA 50-517               MEFOXIN (cefoxitin       Merck and Co., Inc.,
                          sodium) Injection, EQ    Sumneytown Pike BLA
                          1 gram (g) base/vial     20, P.O. Box 4, West
                          and EQ 2 g base/vial     Point, PA 19486-0004
------------------------------------------------------------------------

    FDA has reviewed its records and, under Sec.  314.161, has
determined that the drug products listed in this document were not
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the agency will continue to list the drug products listed
in this document in the ``Discontinued Drug Product List'' section of
the Orange Book. The ``Discontinued Drug Product List'' identifies,
among other items, drug products that have been discontinued from
marketing for reasons other than safety or effectiveness.
    Approved ANDAs that refer to the NDAs listed in this document are
unaffected by the discontinued marketing of the products subject to
those NDAs. Additional ANDAs that refer to these products may also be
approved by the agency if they comply with relevant legal and
regulatory requirements. If FDA determines that labeling for these drug
products should be revised to meet current standards, the agency will
advise ANDA applicants to submit such labeling.

    Dated: March 8, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-5275 Filed 3-10-10; 8:45 am]
BILLING CODE 4160-01-S