[Federal Register Volume 81, Number 43 (Friday, March 4, 2016)]
[Proposed Rules]
[Pages 11469-11471]
[FR Doc No: 2016-04677]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2016-4256; Directorate Identifier 2016-CE-002-AD]
RIN 2120-AA64

Airworthiness Directives; M7 Aerospace LLC

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for all
M7 Aerospace LLC Models SA226-AT, SA226-T, SA226-T(B), SA226-TC, SA227-
AC (C-26A), SA227-AT, SA227-BC (C-26A), SA227-CC, SA227-DC (C-26B), and
SA227-TT airplanes. This proposed AD was prompted by reports of failed
elevator control rod ends due to corrosion and lack of lubrication.
This proposed AD would require initial and repetitive inspections and
lubrication of the elevator control rod ends and bearings with
replacement as necessary. We are proposing this AD to correct the
unsafe condition on these products.

DATES: We must receive comments on this proposed AD by April 18, 2016.

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 http://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 proposed AD, contact M7
Aerospace LLC, 10823 NE Entrance Road, San Antonio, Texas 78216; phone:
(210) 824-9421; fax:<PHONE_NUMBER>; Internet: http://www.elbitsystems-us.com; email<EMAIL_ADDRESS>You may view this referenced
service information at the FAA, Small Airplane Directorate, 901 Locust,
Kansas City, Missouri 64106. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
4256; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Office (phone:<PHONE_NUMBER>) is in the ADDRESSES section. Comments will
be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Andrew McAnaul, Aerospace Engineer,
FAA, ASW-143 (c/o San Antonio MIDO), 10100 Reunion Place, Suite 650,
San Antonio, Texas 78216; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2016-4256;
Directorate Identifier 2016-CE-002-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The FAA received reports of broken elevator control rod link
assemblies between the elevator torque tube and the elevator quadrant
due to corrosion and lack of lubrication on M7 Aerospace SA26, SA226,
and SA227 airplanes.
    This condition, if not corrected, could result in increased
friction and partial or complete loss of elevator control resulting in
loss of pitch control.

Relevant Service Information Under 1 CFR Part 51

    We reviewed M7 Aerospace LLC Service Bulletin (SB) 226-27-080 R1,
M7 Aerospace LLC SB 227-27-060 R1, and M7 Aerospace LLC SB CC7-27-032
R1, all Issued: November 5, 2015 and Revised: February 23, 2016. The
service information describes procedures for inspection of the elevator
control link assemblies between the elevator torque tubes and the
elevator quadrant for frozen (stiff, hard to move) bearings or broken/
cracked links (rod ends) with instructions for lubrication and
replacement if necessary. All of the related 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 of this NPRM.

FAA's Determination

    We are proposing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

Proposed AD Requirements

    This proposed AD would require initial and repetitive inspections
of the elevator control rod ends and bearings with replacement as
necessary.

Costs of Compliance

    We estimate that this proposed AD affects 350 airplanes of U.S.
registry.
    We estimate the following costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
               Action                        Labor cost           Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
Inspection and lubrication..........  2 work-hours x $85 per              *NA             $170          $59,500
                                       hour = $170.
----------------------------------------------------------------------------------------------------------------
* Not applicable

    We estimate the following costs to do any necessary repairs/
replacements that would be required based on the results of the
proposed inspection. We have no way of determining the number of
airplanes that might need these repairs/replacements:

                                               On-condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                    Action                                Labor cost               Parts cost        product
----------------------------------------------------------------------------------------------------------------
Replace Rod End..............................  4 work-hours x $85 per hour =               $30             $370
                                                $340.
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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.
    We are 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

    We 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) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) 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 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:

M7 Aerospace LLC: Docket No. FAA-2016-4256; Directorate Identifier
2016-CE-002-AD.

(a) Comments Due Date

    We must receive comments by April 18, 2016.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to M7 Aerospace LLC Models SA226-AT, SA226-T,
SA226-T(B), SA226-TC, SA227-AC (C-26A), SA227-AT, SA227-BC (C-26A),
SA227-CC, SA227-DC (C-26B), and SA227-TT airplanes, all serial
numbers, certificated in any category.

 (d) Subject

    Joint Aircraft System Component (JASC)/Air Transport Association
(ATA) of America Code 2730, Elevator Control System.

(e) Unsafe Condition

    This AD was prompted by reports of failed elevator control rod
ends due to corrosion and lack of lubrication. We are issuing this
AD to require initial and repetitive inspections and lubrication of
the elevator control rod ends and bearings with replacement as
necessary. We are proposing this AD to correct the unsafe condition
on these products.

(f) Compliance

    Comply with paragraphs (g)(1) through (g)(5) of this AD using
the following service bulletins within the compliance times
specified, unless already done:
    (1) For Models SA226-AT, SA226-T, SA226-T(B), and SA226-TC: M7
Aerospace LLC Service Bulletin (SB) 226-27-080 R1, Issued: November
5, 2015 and Revised: February 23, 2016;
    (2) For Models SA227-AC (C-26A), SA227-AT, SA227-BC (C-26A), and
SA227-TT: M7 Aerospace LLC SB 227-27-060 R1, Issued: November 5,
2015 and Revised: February 23, 2016; or
    (3) For Models SA227-CC and SA227-DC (C-26B): M7 Aerospace LLC
SB CC7-27-032 R1, Issued: November 5, 2015 and Revised: February 23,
2016.

(g) Actions

    (1) If abnormally high resistance is reported when operating the
elevators, before further flight after the effective date of this
AD, inspect and lubricate installed elevator control links following
paragraph 2.A. of the Accomplishment Instructions of the service
bulletins identified in paragraphs (f)(1), (f)(2), or (f)(3) of this
AD, as applicable.
    (2) Remove the elevator control links and inspect following
paragraph 2.B. (and 2.C. when applicable) and lubricate the bearings
following paragraph 2.E. of the Accomplishment Instructions of the
service bulletins identified in paragraphs (f)(1), (f)(2), or (f)(3)
of this AD, as applicable, at whichever of the following occurs
first:
    (i) At the next Zone related Phase or Letter Check inspection
after the effective date of this AD or within the next 600 hours
time-in-service after the effective date of this AD, whichever
occurs later; or

    (ii) Within the next 6 months after the effective date of this
AD.
    (3) Repetitively remove and inspect the elevator control links
not to exceed every 12 months following any inspection required in
paragraph (g)(1) or (g)(2) of this AD following paragraph 2.B. (and
2.C. when applicable) and lubricate the bearings following paragraph
2.E. of the Accomplishment Instructions of the service bulletins
identified in paragraphs (f)(1), (f)(2), or (f)(3) of this AD, as
applicable.
    (4) If during any inspection required in paragraphs (g)(1),
(g)(2) or (g)(3) of this AD, any link assemblies between the
elevator torque tubes and the elevator quadrant are found to have
frozen (stiff, hard to move) bearings or broken/cracked links (rod
ends), before further flight, replace the rod ends following
paragraph 2.D. and lubricate the bearings following with paragraph
2.E. of the Accomplishment Instructions of the service bulletins
identified in paragraphs (f)(1), (f)(2), or (f)(3) of this AD, as
applicable.
    (5) Repetitively lubricate the rod end bearings (male and
female) on both elevator control link assemblies following the time
limits in paragraph 1.D.4) of the applicable SB, but not to exceed
every 6 months, and following the procedures in paragraph 2.E. of
the Accomplishment Instructions of the service bulletins identified
in paragraphs (f)(1), (f)(2), or (f)(3) of this AD, as applicable.

(h) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Fort Worth Airplane Certification Office, 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 ACO, send it to the attention of the
person identified in paragraph (i) of this AD.
    (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.

(i) Related Information

    (1) For more information about this AD, contact Andrew McAnaul,
Aerospace Engineer, FAA, ASW-143 (c/o San Antonio MIDO), 10100
Reunion Place, Suite 650, San Antonio, Texas 78216; phone: (210)
308-3365; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>    (2) For service information identified in this AD, contact M7
Aerospace LLC, 10823 NE Entrance Road, San Antonio, Texas 78216;
phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; Internet: http://www.elbitsystems-us.com; email<EMAIL_ADDRESS>You may
view this referenced service information at the FAA, Small Airplane
Directorate, 901 Locust, Kansas City, Missouri 64106. For
information on the availability of this material at the FAA, call
816-329-4148.

    Issued in Kansas City, Missouri, on February 25, 2016.
Robert P. Busto,
Acting Manager, Small Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2016-04677 Filed 3-3-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 225 (Monday, November 23, 2015)]
[Notices]
[Pages 73029-73031]
[FR Doc No: 2015-29728]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-76462; File No. SR-NSCC-2015-004]

Self-Regulatory Organizations; National Securities Clearing
Corporation; Order Approving Proposed Rule Change To Require Real-Time
Trade Submission and To Prohibit Pre-Netting Practices Through NSCC's
Correspondent Clearing Service

November 17, 2015.
    On September 30, 2015, National Securities Clearing Corporation
(``NSCC'') filed with the Securities and Exchange Commission
(``Commission'') proposed rule change SR-NSCC-2015-004 pursuant to
section 19(b)(1) of the Securities Exchange Act of 1934 (``Act''),\1\
and Rule 19b-4 thereunder,\2\ to require correspondent clearing trades
to be submitted in real-time. The proposed rule change was published
for comment in the Federal Register on October 14, 2015.\3\ The
Commission did not receive comment letters regarding the proposed
change. For the reasons discussed below, the Commission is granting
approval of 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. 76099 (October 7,
2015), 80 FR 61860 (October 14, 2015) (SR-NSCC-2015-004).
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I. Description of the Proposed Rule Change

    The following is a description of the proposed rule change, as
provided by NSCC:
    The proposed rule change consists of amendments to NSCC's Rules &
Procedures (``Rules'') in order to require that trade data submitted to
NSCC through its Correspondent Clearing service, other than position
movements between NSCC Members that are Affiliates and Client Custody
Movements, as described further below, be submitted in real-time, and
to prohibit pre-netting and other practices that prevent real-time
trade submission.\4\
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    \4\ Terms not defined herein are defined in the Rules, available
at http://dtcc.com/~/media/Files/Downloads/legal/rules/
nscc_rules.pdf.
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Background

    Requiring trades to be submitted in real-time facilitates efficient
risk management for both NSCC and its Members, enables same-day
bookkeeping and reconciliation, and, therefore, significantly reduces
risk to the industry. Receipt of trade data on a real-time basis
permits NSCC's risk management processes to monitor trades closer to
trade execution on an intra-day basis, and to identify and risk manage
any issues relating to exposures earlier in the day. Contract
information is currently reported out to submitting firms by NSCC's
Universal Trade Capture (``UTC'') system upon trade comparison and
validation, and receipt of trade data in real-time enables NSCC to
report to Members trade data as it is received, thereby promoting
intra-day reconciliation of transactions at the Member level. The
majority of trades submitted to NSCC for clearing are currently being
submitted in real-time on a trade-by-trade basis, and NSCC is
operationally capable of managing trade volumes that are multiple times
larger than the historical peak volumes.
    NSCC will require that trade data submitted through its
Correspondent Clearing service, as described below, be submitted in
real-time and to prohibit pre-netting and other practices that prevent
real-time trade submission (``pre-netting practices''). NSCC will
exclude from this requirement position movements between NSCC Members
that are Affiliates and Client Custody Movements, as described below.
The term ``real-time,'' when used with respect to trade submission, is
defined in Procedure XIII (Definitions) of the Rules as the submission
of trade data on a trade-by-trade basis promptly after trade execution,
in any format and by any communication method acceptable to NSCC.
    NSCC's UTC system receives and validates transactions that are
submitted to it, reports trade details back out to the submitting firm,
and prepares those transactions for netting and settlement by routing
transactions to netting and settlement systems, such as Continuous Net
Settlement Accounting Operation, the Balance Order Accounting
Operation, or the Foreign Security Accounting Operation, as applicable.
Transactions are submitted to UTC

either on a locked-in basis by self-regulatory organizations (including
national and regional exchanges and marketplaces) (``SROs'') and
Qualified Special Representatives (``QSRs''),\5\ or are submitted to
UTC as a part of NSCC's Correspondent Clearing service, which allows
for post-execution position movements between two clearing firms.
Currently all transactions submitted to NSCC on a locked-in basis by
SROs and QSRs, which constitute approximately 95% of all transactions
processed at NSCC,\6\ are required to be submitted in real-time and may
not be pre-netted or batched prior to submission.\7\
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    \5\ QSRs are defined in section 3 of Rule 7 as NSCC Members that
have applied to NSCC to be a Special Representative, and either (i)
operate an automated execution system where they are always the
contra side of every trade, (ii) are the parent or affiliate of an
entity operating such an automated system, where they are the contra
side of every trade, or (iii) clear for a broker/dealer that
operates such a system and the subscribers to the system acknowledge
the clearing Member's role in the clearance and settlement of these
trades. Rules, supra note 4.
    \6\ Based on data from the second quarter of 2015, which show an
approximate daily average of 41 million transactions processed at
NSCC, with an approximate total daily value of an average of $455
billion; and an approximate average of 1.1 million submissions
through Correspondent Clearing, with an approximate total daily
value of an average of $57 billion. The average daily volume of
submissions through Correspondent Clearing is less than 5% of NSCC's
overall daily volume.
    \7\ Securities Exchange Act Release No. 69890 (June 28, 2013),
78 FR 40538 (July 5, 2013) (File No. SR-NSCC-2013-05). See also Rule
7 (Comparison and Trade Recording Operation), Procedure II (Trade
Comparison and Recording Service), and Procedure IV (Special
Representative Service), supra note 4.
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    NSCC's Correspondent Clearing service is designed to provide an
automated method by which a Member, acting as a Special Representative,
may move a position that has been submitted to NSCC for clearing to the
account of another Member (the submitting Member's correspondent) on
whose behalf the original trade was executed.\8\ Members participating
in the Correspondent Clearing service for post-execution position
movements and those participating as a QSR for submission of original,
locked-in trades are required to apply for status as a Special
Representative or as a QSR, and to establish relationships with other
NSCC Members that will be designated as their correspondents. While
NSCC encourages Special Representatives to submit Correspondent
Clearing submissions to NSCC as soon as possible following execution,
currently these position movements may be sent to NSCC either in real-
time, intraday, or at the end of the day.
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    \8\ The term ``original trade'' is used within the Rules
describing the Correspondent Clearing service solely to distinguish
between trades executed in the marketplace by the Special
Representative, and transactions booked for accounting purposes to
accommodate the movement of positions between Members as provided
for in Section C of Procedure IV. Original trades may not be
submitted through NSCC's Correspondent Clearing service. Rules,
supra note 4.
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    NSCC has continued to engage widely with its Members about the
benefits of expanding the requirements to submit transactions in real-
time and, as a result of these continuing discussions, will modify its
Rules to require that trade data submitted through its Correspondent
Clearing service also be submitted in real-time. The proposed rule
change will also prohibit pre-netting practices that prevent real-time
trade submission through Correspondent Clearing.
    NSCC's Rules currently prohibit pre-netting practices that preclude
real-time submission with respect to submissions by QSRs and SROs. Pre-
netting practices that are currently prohibited include
``summarization'' (a technique in which the clearing broker nets all
trades in a single CUSIP by the same correspondent broker into fewer
submitted trades), ``compression'' (a technique to combine submissions
of data for multiple trades to the point where the identity of the
party actually responsible for the trades is masked), netting, or any
other practice that combines two or more trades prior to their
submission to NSCC.
    NSCC will extend the prohibition against pre-netting practices to
submissions through Correspondent Clearing because pre-netting
practices prevent the submission to NSCC of transactions on a trade-by-
trade basis, and cause Special Representatives to delay submission of
their trades, thereby undermining the risk mitigation benefits of real-
time trade submission. Pre-netting practices disrupt NSCC's ability to
accurately monitor market and credit risks as they evolve during the
trading day.
    NSCC will exclude from the requirements of this proposal any
position movements between Members that are Affiliates, as identified
within NSCC's membership management records. As defined in Rule 4A,
``Affiliate'' means a person that controls or is controlled by or is
under common control with another person.\9\ Position movements between
Affiliates do not introduce the risk management concerns that are
mitigated by real-time trade submission. As such, Members will not be
required to submit these position movements in real-time, but will
continue to be encouraged to do so. Positions movements between
Affiliates represent fewer than 5% of trade data submitted through
Correspondent Clearing to NSCC.\10\
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    \9\ Control of a person means the direct or indirect ownership
or power to vote more than 50% of any class of the voting securities
or other voting interests of any person. Rule 4A, supra note 4.
    \10\ Based on data from the second quarter of 2015, which show
an approximate daily average of 1.1 million submissions through
Correspondent Clearing at NSCC, with an approximate total daily
value of an average of $57 billion; and an approximate average of
52,000 position movements through Correspondent Clearing between
Affiliates, with an approximate total daily value of an average of
$13 billion. The average daily volume of position movements through
Correspondent Clearing between Affiliates is less than 1% of NSCC's
overall daily volume.
---------------------------------------------------------------------------

    In order to submit trade data through Correspondent Clearing
outside of the real-time trade submission requirements, Special
Representatives will need to identify a transaction as an Affiliate
position movement. NSCC will validate the Affiliates' relationship
between the counterparties by a check against the information within
NSCC's membership management records as of the time of the trade
submission. Members continue to be required to provide NSCC with
current information regarding their corporate ownership structure. If
an Affiliate relationship is not reflected on NSCC's records at the
time of the trade submission, the transaction will be rejected.
    NSCC will also exclude from the requirements of this proposal
position movements that occur between two unaffiliated clearing
brokers, typically at the end of the day, on behalf of a common
customer for custody purposes (``Client Custody Movements''). These
movements, which today represent approximately 1% of submissions
through Correspondent Clearing, will be exempt from the requirement
because they necessarily take place at the end of the day, after the
common client has reviewed its end of day positions and has instructed
the clearing brokers as to which positions it will move for custody
purposes.
    NSCC will amend Rule 7 (Comparison and Trade Recording Operation),
Procedure II (Trade Comparison and Recording Service), and Procedure IV
(Special Representative Service) to require that trades submitted by
Special Representatives for trade recording through NSCC's
Correspondent Clearing service be submitted on a real-time basis and to
make clear that trade data submitted to NSCC through Correspondent
Clearing service must be submitted on a trade-by-trade basis, in the
original form executed, and that pre-netting practices are prohibited.
The proposed rule change will also make clear that these requirements
will not

apply to position movements between NSCC Members that are Affiliates or
to Client Custody Movements.

Implementation

    The effective date of the proposed rule change will be announced
via a NSCC Important Notice. The proposed rule change will not be
implemented earlier than ten business days from the date of Commission
approval.

II. Discussion and Commission Findings

    Section 19(b)(2)(C) of the Act \11\ directs the Commission to
approve a proposed rule change of a self-regulatory organization if it
finds that such proposed rule change is consistent with the
requirements of the Act and rules and regulations thereunder applicable
to such organization. The Commission believes the proposal is
consistent with section 17A(b)(3)(F) of the Act \12\ and Rule 17Ad-
22(d)(4) \13\ under the Act, as described in detail below.
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    \11\ 15 U.S.C. 78s(b)(2)(C).
    \12\ 15 U.S.C. 78q-1(b)(3)(F).
    \13\ 17 CFR 240.17Ad-22(d)(4).
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    Consistency with Section 17A(b)(3)(F) of the Act. Section
17A(b)(3)(F) of the Act requires, among other things, that the rules of
a clearing agency be designed to promote the prompt and accurate
clearance and settlement of securities transactions, as well as, in
general, protect investors and the public interest.\14\ The Commission
believes that the receipt of locked-in trade data on a real-time basis
through NSCC's Correspondent Clearing service will enable NSCC's risk
management processes to monitor such trades closer to trade execution
and, thus, better identify and manage related risk exposure on an
intra-day basis. Further, receiving such transactions in real-time will
promote intra-day reconciliation and, in return, more timely reporting
of Member transactions back to Members, thereby enabling Members to
manage their exposure to certain operational, market, and credit risks,
all of which helps facilitate the prompt and accurate clearance and
settlement of securities transactions. As such, the Commission believes
that the proposal is consistent with section 17A(b)(3)(F) of the
Act.\15\
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    \14\ 15 U.S.C. 78q-1(b)(3)(F).
    \15\ Id.
---------------------------------------------------------------------------

    Consistency with Rule 17Ad-22(d)(4). Rule 17Ad-22(d)(4) under the
Act requires a central counterparty, such as NSCC, to ``establish,
implement, maintain and enforce written policies and procedures
reasonably designed to . . . [i]dentify sources of operational risk and
minimize them through the development of appropriate systems, controls,
and procedures . . . .'' \16\ As stated above, the Commission believes
that the receipt of locked-in trade data on a real-time basis through
NSCC's Correspondent Clearing service will enable NSCC's risk
management processes to monitor such trades closer to trade execution,
on an intra-day basis, and, thus, identify and manage related risk
exposure earlier, thereby potentially minimizing a source of
operational risk. As such, the Commission believes that the proposal is
consistent with Rule 17Ad-22(d)(4).\17\
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    \16\ 17 CFR 240.17Ad-22(d)(4).
    \17\ Id.
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III. Conclusion

    On the basis of the foregoing, the Commission finds that the
proposal is consistent with the requirements of the Act and in
particular with the requirements of section 17A of the Act \18\ and the
rules and regulations thereunder.
---------------------------------------------------------------------------

    \18\ 15 U.S.C. 78q-1.
---------------------------------------------------------------------------

    It is therefore ordered, pursuant to section 19(b)(2) of the Act,
that proposed rule change SR-NSCC-2015-004 be, and hereby is,
Approved.\19\
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    \19\ In approving the proposed rule change, the Commission
considered the proposal's impact on efficiency, competition, and
capital formation. 15 U.S.C. 78c(f).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\20\
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    \20\ 17 CFR 200.30-3(a)(12).
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Robert W. Errett,
Deputy Secretary.
[FR Doc. 2015-29728 Filed 11-20-15; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 118 (Monday, June 20, 2011)]
[Proposed Rules]
[Pages 35799-35801]
[FR Doc No: 2011-15110]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2011-0280; Airspace Docket No. 11-ASO-16]

Proposed Amendment of Class E Airspace; Shelby, NC

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to amend Class E Airspace at Shelby, NC,
as new Standard Instrument Approach Procedures have been developed at
Shelby-Cleveland County Regional

Airport. This action would enhance the safety and airspace management
of Instrument Flight Rules (IFR) operations at the airport. This action
also would recognize the airport name change to Shelby-Cleveland County
Regional Airport.

DATES: Effective 0901 UTC, Comments must be received on or before
August 4, 2011. The Director of the Federal Register approves this
incorporation by reference action under title 1, Code of Federal
Regulations, part 51, subject to the annual revision of FAA, Order
7400.9 and publication of conforming amendments.

ADDRESSES: Send comments on this rule to: U.S. Department of
Transportation, Docket Operations, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590-0001;
Telephone: 1-800-647-5527; Fax:<PHONE_NUMBER>. You must identify the
Docket Number FAA-2011-0280; Airspace Docket No. 11-ASO-16, at the
beginning of your comments. You may also submit and review received
comments through the Internet at http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, P.O.
Box 20636, Atlanta, Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested persons are invited to comment on this rule by
submitting such written data, views, or arguments, as they may desire.
Comments that provide the factual basis supporting the views and
suggestions presented are particularly helpful in developing reasoned
regulatory decisions on the proposal. Comments are specifically invited
on the overall regulatory, aeronautical, economic, environmental, and
energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA-2011-0280; Airspace Docket No. 11-ASO-16) and be submitted in
triplicate to the Docket Management System (see ADDRESSES section for
address and phone number). You may also submit comments through the
Internet at http://www.regulations.gov.
    Annotators wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed stamped
postcard on which the following statement is made: ``Comments to Docket
No. FAA-2011-0280; Airspace Docket No. 11-ASO-16.'' The postcard will
be date/time stamped and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this notice may be changed in light of the
comments received. A report summarizing each substantive public contact
with FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded from and
comments submitted through http://www.regulations.gov. Recently
published rulemaking documents can also be accessed through the FAA's
Web page at http://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Office (see the ADDRESSES section for address and phone number) between
9 a.m. and 5 p.m., Monday through Friday, except Federal Holidays. An
informal docket may also be examined during normal business hours at
the office of the Eastern Service Center, Federal Aviation
Administration, Room 210, 1701 Columbia Avenue, College Park, Georgia
30337.
    Persons interested in being placed on a mailing list for future
NPRM's should contact the FAA's Office of Rulemaking,<PHONE_NUMBER>,
to request a copy of Advisory circular No. 11-2A, Notice of Proposed
Rulemaking Distribution System, which describes the application
procedure.

The Proposal

    The FAA is considering an amendment to Title 14, Code of Federal
Regulations (14 CFR) part 71 to amend Class E airspace extending upward
from 700 feet above the surface to support new standard instrument
approach procedures developed at Shelby-Cleveland County Regional
Airport, Shelby, NC. Airspace reconfiguration is necessary for
continued safety and management of IFR operations at the airport. Also,
the airport name would be changed from Shelby Municipal Airport to
Shelby-Cleveland County Regional Airport.
    Class E airspace designations are published in Paragraph 6005 of
FAA Order 7400.9U, dated August 18, 2010, and effective September 15,
2010, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designation listed in this document will be published
subsequently in the Order.
    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore, (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under 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 proposed rule, when promulgated, would not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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. This proposed rulemaking is promulgated under the authority
described in Subtitle VII, Part, A, Subpart I, Section 40103. Under
that section, the FAA is charged with prescribing regulations to assign
the use of airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This proposed regulation is within the scope
of that authority as it would amend Class E airspace at Shelby-
Cleveland County Regional Airport, Shelby, NC.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (Air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 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

    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]

    2. The incorporation by reference in 14 CFR 71.1 of Federal
Aviation Administration Order 7400.9U,

Airspace Designations and Reporting Points, dated August 18, 2010,
effective September 15, 2010, is amended as follows:

Paragraph 6005 Class E airspace areas extending upward from 700
feet or more above the surface of the earth.

* * * * *

ASO NC E5 Shelby, NC [AMENDED]

Shelby-Cleveland County Regional Airport, NC
    (Lat. 35[deg]15'21'' N., long. 81[deg]36'02'' W.)

    That airspace extending upward from 700 feet above the surface
within a 7.8-mile radius of Shelby-Cleveland County Regional
Airport.

    Issued in College Park, Georgia, on June 1, 2011.
Mark D. Ward,
Manager, Operations Support Group, Eastern Service Center, Air Traffic
Organization.
[FR Doc. 2011-15110 Filed 6-17-11; 8:45 am]
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[Federal Register Volume 84, Number 173 (Friday, September 6, 2019)]
[Notices]
[Pages 46953-46955]
[FR Doc No: 2019-19205]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-E-1391]

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

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 SHINGRIX and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of an application 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
biological product.

DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by
November 5, 2019. 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 March 4,
2020. 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. Electronic comments
must be submitted on or before November 5, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 5, 2019. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is 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 No.
FDA-2018-E-1391 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; SHINGRIX.'' 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.
     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.gpo.gov/fdsys/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.

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 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 biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological product becomes effective and runs
until the approval phase begins. The approval phase starts with the
initial submission of an application to market the human biological
product and continues until FDA grants permission to market the
biological 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 biological 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 biologic product SHINGRIX
(Zoster Vaccine Recombinant, Adjuvanted). SHINGRIX is a vaccine
indicated for prevention of herpes zoster (shingles) in adults aged 50
years and older. Subsequent to this approval, the USPTO received a
patent term restoration application for SHINGRIX (U.S. Patent No.
7,939,084) from GlaxoSmithKline Biologicals SA, and the USPTO requested
FDA's assistance in determining this patent's eligibility for patent
term restoration. In a letter dated September 18, 2018, FDA advised the
USPTO that this human biological product had undergone a regulatory
review period and that the approval of SHINGRIX 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
SHINGRIX is 3,257 days. Of this time, 2,892 days occurred during the
testing phase of the regulatory review period, while 365 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 (21 U.S.C. 355(i)) became effective: November
21, 2008. The applicant claims November 24, 2008, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was November 21, 2008,
which was the first date after receipt of the IND that the

investigational studies were allowed to proceed.
    2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): October 21, 2016. FDA has verified the
applicant's claim that the biologics license application (BLA) for
SHINGRIX (BLA 125614) was initially submitted on October 21, 2016.
    3. The date the application was approved: October 20, 2017. FDA has
verified the applicant's claim that BLA 125614 was approved on October
20, 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 application for patent extension,
this applicant seeks 1,361 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: August 28, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-19205 Filed 9-5-19; 8:45 am]
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