[Federal Register Volume 87, Number 21 (Tuesday, February 1, 2022)]
[Rules and Regulations]
[Pages 5391-5393]
[FR Doc No: 2022-01954]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0945; Project Identifier MCAI-2021-01033-T;
Amendment 39-21895; AD 2022-01-07]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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SUMMARY: The FAA is superseding Airworthiness Directive (AD) 2021-11-
23, which applied to certain Airbus SAS Model A350-941 and -1041
airplanes. AD 2021-11-23 required revising the existing maintenance or
inspection program, as applicable, to incorporate new or more
restrictive airworthiness limitations, and, for certain airplanes,
updating the hydraulic monitoring system to include additional
redundancy. Since the FAA issued AD 2021-11-23, the FAA has determined
that new or more restrictive airworthiness limitations are necessary.
This AD requires revising the existing maintenance or inspection
program, as applicable, to incorporate new or more restrictive
airworthiness limitations; as specified in a European Union Aviation
Safety Agency (EASA) AD, which is incorporated by reference. This AD
also revises the applicability to include different airplanes. The FAA
is issuing this AD to address the unsafe condition on these products.

DATES: This AD is effective March 8, 2022.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of March 8,
2022.

ADDRESSES: For EASA material incorporated by reference (IBR) in this
AD, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany;
telephone +49 221 8999 000; email [email protected]; internet
www.easa.europa.eu. You may find this IBR material on the EASA website
at https://ad.easa.europa.eu. You may view this material at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200 South
216th St., Des Moines, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available in the AD
docket at https://www.regulations.gov by

searching for and locating Docket No. FAA-2021-0945.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-0945; 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
mandatory continuing airworthiness information (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: Dan Rodina, Aerospace Engineer, Large
Aircraft Section, International Validation Branch, FAA, 2200 South
216th St., Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>; email
[email protected].

SUPPLEMENTARY INFORMATION:

Background

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2021-0209, dated September 15, 2021
(EASA AD 2021-0209) (also referred to as the Mandatory Continuing
Airworthiness Information, or the MCAI), to correct an unsafe condition
for all Airbus SAS Model A350-941 and -1041 airplanes.
    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 to supersede AD 2021-11-23, Amendment 39-21585 (86 FR
40932, July 30, 2021) (AD 2021-11-23). AD 2021-11-23 applied to certain
Airbus SAS Model A350-941 and -1041 airplanes. The NPRM published in
the Federal Register on October 29, 2021 (86 FR 59896). The NPRM was
prompted by the FAA's determination that new or more restrictive
airworthiness limitations are necessary. The NPRM proposed to require
revising the existing maintenance or inspection program, as applicable,
to incorporate new or more restrictive airworthiness limitations, as
specified in EASA AD 2021-0209. The airworthiness limitations include
updating the hydraulic monitoring system to include additional
redundancy, which was a separate action in AD 2021-11-23. The NPRM also
proposed to revise the applicability to include different airplanes.
    The FAA is issuing this AD to address the potential of ignition
sources inside fuel tanks, which, in combination with flammable fuel
vapors, could result in a fuel tank explosion and consequent loss of
the airplane. See the MCAI for additional background information.

Discussion of Final Airworthiness Directive

Comments

    The FAA received a comment from the Air Line Pilots Association,
International (ALPA), who supported the NPRM without change.

Conclusion

    The FAA reviewed the relevant data, considered the comment
received, and determined that air safety requires adopting this AD as
proposed. Except for minor editorial changes, this AD is adopted as
proposed in the NPRM. None of the changes will increase the economic
burden on any operator. Accordingly, the FAA is issuing this AD to
address the unsafe condition on these products.

Related Service Information Under 1 CFR Part 51

    EASA AD 2021-0209 describes new or more restrictive airworthiness
limitations related to fuel tank ignition prevention and fuel tank
flammability reduction. This material 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.

Costs of Compliance

    The FAA estimates that this AD affects 24 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD:
    The FAA has determined that revising the existing maintenance or
inspection program takes an average of 90 work-hours per operator,
although the agency recognizes that this number may vary from operator
to operator. Since operators incorporate maintenance or inspection
program changes for their affected fleet(s), the FAA has determined
that a per-operator estimate is more accurate than a per-airplane
estimate.
    The FAA estimates the total cost per operator for the maintenance
or inspection program revision to be $7,650 (90 work-hours x $85 per
work-hour).

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:
    (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:
0
a. Removing Airworthiness Directive (AD) 2021-11-23, Amendment 39-21585
(86 FR 40932, July 30, 2021); and
0
b. Adding the following new AD:

2022-01-07 Airbus SAS: Amendment 39-21895; Docket No. FAA-2021-0945;
Project Identifier MCAI-2021-01033-T.

(a) Effective Date

    This airworthiness directive (AD) is effective March 8, 2022.

(b) Affected ADs

    This AD replaces AD 2021-11-23, Amendment 39-21585 (86 FR 40932,
July 30, 2021) (AD 2021-11-23).

(c) Applicability

    This AD applies Airbus SAS Model A350-941 and -1041 airplanes,
certificated in any category; with an original airworthiness
certificate or original export certificate of airworthiness issued
on or before June 30, 2021.

(d) Subject

    Air Transport Association (ATA) of America Code 05, Time Limits/
Maintenance Checks.

(e) Reason

    This AD was prompted by a determination that new or more
restrictive airworthiness limitations are necessary. The FAA is
issuing this AD to address the potential of ignition sources inside
fuel tanks, which, in combination with flammable fuel vapors, could
result in a fuel tank explosion and consequent loss of the airplane.

(f) Compliance

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

(g) Maintenance or Inspection Program Revision

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, European Union Aviation Safety Agency (EASA) AD
2021-0209, dated September 15, 2021 (EASA AD 2021-0209).

(h) Exceptions to EASA AD 2021-0209

    (1) The requirements specified in paragraphs (1) and (2) of EASA
AD 2021-0209 do not apply to this AD.
    (2) Paragraph (3) of EASA AD 2021-0209 specifies revising ``the
AMP [aircraft maintenance program]'' within 12 months after its
effective date, but this AD requires revising the existing
maintenance or inspection program, as applicable, to incorporate the
``limitations, tasks and associated thresholds and intervals''
specified in paragraph (3) of EASA AD 2021-0209 within 90 days after
the effective date of this AD.
    (3) The initial compliance time for doing the tasks specified in
paragraph (3) of EASA AD 2021-0209 is at the applicable ``associated
thresholds'' specified in paragraph (3) of EASA AD 2021-0209, or
within 90 days after the effective date of this AD, whichever occurs
later.
    (4) The provisions specified in paragraphs (4) and (5) of EASA
AD 2021-0209 do not apply to this AD.
    (5) The ``Remarks'' section of EASA AD 2021-0209 does not apply
to this AD.

(i) Provisions for Alternative Actions, Intervals, and CDCCLs

    After the maintenance or inspection program has been revised as
required by paragraph (g) of this AD, no alternative actions (e.g.,
inspections), intervals, and critical design configuration control
limitations (CDCCLs) are allowed unless they are approved as
specified in the provisions of the ``Ref. Publications'' section of
EASA AD 2021-0209.

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Large Aircraft Section, 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 responsible Flight
Standards Office, as appropriate. If sending information directly to
the Large Aircraft Section, International Validation Branch, send it
to the attention of the person identified in paragraph (k) of this
AD. Information may be emailed to: [email protected].
Before using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
responsible Flight Standards Office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, Large Aircraft
Section, International Validation Branch, FAA; or EASA; or Airbus
SAS's EASA Design Organization Approval (DOA). If approved by the
DOA, the approval must include the DOA-authorized signature.
    (3) Required for Compliance (RC): Except as required by
paragraph (j)(2) of this AD, if any service information contains
procedures or tests that are identified as RC, those procedures and
tests must be done to comply with this AD; any procedures or tests
that are not identified as RC are recommended. Those procedures and
tests that are not identified as RC may be deviated from using
accepted methods in accordance with the operator's maintenance or
inspection program without obtaining approval of an AMOC, provided
the procedures and tests identified as RC can be done and the
airplane can be put back in an airworthy condition. Any
substitutions or changes to procedures or tests identified as RC
require approval of an AMOC.

(k) Related Information

    For more information about this AD, contact Dan Rodina,
Aerospace Engineer, Large Aircraft Section, International Validation
Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone
and fax<PHONE_NUMBER>; email [email protected].

(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) European Union Aviation Safety Agency (EASA) AD 2021-0209,
dated September 15, 2021.
    (ii) [Reserved]
    (3) For EASA AD 2021-0209, contact EASA, Konrad-Adenauer-Ufer 3,
50668 Cologne, Germany; telephone +49 221 8999 000; email
[email protected]; internet www.easa.europa.eu. You may find this
EASA AD on the EASA website at https://ad.easa.europa.eu.
    (4) You may view this material at the FAA, Airworthiness
Products Section, Operational Safety Branch, 2200 South 216th St.,
Des Moines, WA. For information on the availability of this material
at the FAA, call<PHONE_NUMBER>.
    (5) You may view this material 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 December 23, 2021.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2022-01954 Filed 1-31-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 246 (Thursday, December 22, 2016)]
[Rules and Regulations]
[Pages 93822-93824]
[FR Doc No: 2016-30641]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2016-0421; FRL-9957-09-Region 4]

Air Plan Approval; Mississippi; Interstate Transport (Prongs 1
and 2) for the 2010 1-Hour NO2 Standard

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving a
revision to the Mississippi State Implementation Plan (SIP), submitted
by the Mississippi Department of Environmental Quality, on May 23,
2016, addressing the Clean Air Act (CAA or Act) interstate transport
(prongs 1 and 2) infrastructure SIP requirements for the 2010 1-hour
Nitrogen Dioxide (NO2) National Ambient Air Quality Standard
(NAAQS). The CAA requires that each state adopt and submit a SIP for
the implementation, maintenance, and enforcement of each NAAQS
promulgated by EPA, commonly referred to as an ``infrastructure SIP.''
Specifically, EPA is approving Mississippi's May 23, 2016, SIP
submission addressing prongs 1 and 2,

to ensure that air emissions in the State do not significantly
contribute to nonattainment or interfere with maintenance of the 2010
1-hour NO2 NAAQS in any other state.

DATES: This rule is effective January 23, 2017.

ADDRESSES: EPA has established a docket for these actions under Docket
Identification No EPA-R04-OAR-2016-0421. All documents in the docket
are listed on the www.regulations.gov Web site. Although listed in the
index, some information may not be publicly available, i.e.,
Confidential Business Information or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through www.regulations.gov or in hard
copy at the Air Regulatory Management Section, Air Planning and
Implementation Branch, Air, Pesticides and Toxics Management Division,
U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW.,
Atlanta, Georgia 30303-8960. EPA requests that if at all possible, you
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section to schedule your inspection. The Regional Office's official
hours of business are Monday through Friday 8:30 a.m. to 4:30 p.m.,
excluding federal holidays.

FOR FURTHER INFORMATION CONTACT: Nacosta C. Ward of the Air Regulatory
Management Section, Air Planning and Implementation Branch, Air,
Pesticides and Toxics Management Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia
30303-8960. Ms. Ward can be reached by telephone at<PHONE_NUMBER> or
via electronic mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    By statute, SIPs meeting the requirements of sections 110(a)(1) and
(2) of the CAA are to be submitted by states within three years after
promulgation of a new or revised NAAQS to provide for the
implementation, maintenance, and enforcement of the new or revised
NAAQS. EPA has historically referred to these SIP submissions made for
the purpose of satisfying the requirements of sections 110(a)(1) and
110(a)(2) as ``infrastructure SIP'' submissions. Sections 110(a)(1) and
(2) require states to address basic SIP elements such as requirements
for monitoring, basic program requirements, and legal authority that
are designed to assure attainment and maintenance of the newly
established or revised NAAQS. More specifically, section 110(a)(1)
provides the procedural and timing requirements for infrastructure
SIPs. Section 110(a)(2) lists specific elements that states must meet
for the infrastructure SIP requirements related to a newly established
or revised NAAQS. The contents of an infrastructure SIP submission may
vary depending upon the data and analytical tools available to the
state, as well as the provisions already contained in the state's
implementation plan at the time in which the state develops and submits
the submission for a new or revised NAAQS.
    Section 110(a)(2)(D) has two components: 110(a)(2)(D)(i) and
110(a)(2)(D)(ii). Section 110(a)(2)(D)(i) includes four distinct
components, commonly referred to as ``prongs,'' that must be addressed
in infrastructure SIP submissions. The first two prongs, which are
codified in section 110(a)(2)(D)(i)(I), are provisions that prohibit
any source or other type of emissions activity in one state from
contributing significantly to nonattainment of the NAAQS in another
state (prong 1) and from interfering with maintenance of the NAAQS in
another state (prong 2). The third and fourth prongs, which are
codified in section 110(a)(2)(D)(i)(II), are provisions that prohibit
emissions activity in one state from interfering with measures required
to prevent significant deterioration of air quality in another state
(prong 3) and from interfering with measures to protect visibility in
another state (prong 4). Section 110(a)(2)(D)(ii) requires SIPs to
include provisions ensuring compliance with sections 115 and 126 of the
Act, relating to interstate and international pollution abatement.
    Through this action, EPA is approving Mississippi's May 23, 2016,
SIP submission addressing prong 1 and prong 2 requirements for the 2010
1-hour NO2 NAAQS. All other applicable infrastructure SIP
requirements for Mississippi for the 2010 1-hour NO2 NAAQS
have been addressed in separate rulemakings. See 80 FR 14019 (March 18,
2015), 81 FR 32707 (May 24, 2016), and 81 FR 33139 (May 25, 2016).
    In a notice of proposed rulemaking (NPRM) published on September
28, 2016 (81 FR 66591), EPA proposed to approve Mississippi's May 23,
2016, SIP revision addressing the interstate transport requirements for
the 2010 NO2 NAAQS. The NPRM provides additional detail
regarding the rationale for EPA's actions, including further discussion
of the requirements for prongs 1 and 2. Comments on the proposed
rulemaking were due on or before October 28, 2016. EPA received no
adverse comments on the proposed action.

II. Final Action

    As described previously, EPA is approving approve Mississippi's May
23, 2016, SIP submission addressing prongs 1 and 2 of CAA section
110(a)(2)(D)(i) for the 2010 1-hour NO2 NAAQS.

III. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     does not provide EPA with the discretionary authority to
address, as

appropriate, disproportionate human health or environmental effects,
using practicable and legally permissible methods, under Executive
Order 12898 (59 FR 7629, February 16, 1994).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where EPA or an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of Indian country, the rules do
not have tribal implications as specified by Executive Order 13175 (65
FR 67249, November 9, 2000), nor will they impose substantial direct
costs on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing these actions and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. These actions are not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of these actions must be filed in the United States Court of Appeals
for the appropriate circuit by February 21, 2017. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of these actions for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. These actions may not be challenged later in proceedings to
enforce its requirements. See section 307(b)(2).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Ozone,
Reporting and recordkeeping requirements.

    Dated: December 6, 2016.
Heather McTeer Toney,
Regional Administrator, Region 4.

    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart Z--Mississippi

0
2. Section 52.1270(e) is amended by adding a new entry ``Good Neighbor
Provisions (Section 110(a)(2)(D)(i)(I)) for the 2010 1-hour
NO2 NAAQS'' at the end of the table to read as follows:

Sec.  52.1270  Identification of plan.

* * * * *
    (e) * * *

                               EPA Approved Mississippi Non-Regulatory Provisions
----------------------------------------------------------------------------------------------------------------
                                                             State submittal
  Name of non-regulatory SIP     Applicable geographic or     date/effective     EPA approval      Explanation
           provision                nonattainment area             date              date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Good Neighbor Provisions        Mississippi...............          5/23/2016  12/22/16,         ...............
 (Section 110(a)(2)(D)(i)(I)                                                    [Insert Federal
 for the 2010 1-hour NO2 NAAQS.                                                 Register
                                                                                citation].
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[FR Doc. 2016-30641 Filed 12-21-16; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 90 (Monday, May 11, 2015)]
[Notices]
[Pages 26960-26962]
[FR Doc No: 2015-11273]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-74874; File No. SR-Phlx-2015-37]

Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Amend
Exchange Rules To Describe How All-or-None Orders Are Handled by Its
New Options Floor Broker Management System

May 5, 2015.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\, and Rule 19b-4 thereunder,\2\ notice is hereby given
that on April 22, 2015, NASDAQ OMX PHLX LLC (``Phlx'' or ``Exchange'')
filed with the Securities and Exchange Commission (``SEC'' or
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the Exchange. The Commission
is publishing this notice to solicit comments on the proposed rule
change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The Exchange proposes to amend Exchange rules to describe how All-
or-None (``AON'') orders are handled by its new Options Floor Broker
Management System (``FBMS'').
    The text of the proposed rule change is below; proposed new
language is italicized; proposed deletions are in brackets.
* * * * *

A-9 All-or-None Option Orders

    An all-or-none option order is a limit order which is to be
executed in its entirety, or not at all. Unlike a fill-or-kill
order, an all-or-none order is not cancelled if it is not executed
as soon as it is represented in the trading crowd. An all-or-none
order has no standing respecting executions in the crowd except with
respect to other all-or-none orders.
    When represented in the crowd, [A]all-or-none orders are not
included as part of the bid or offer. [However, an all-or-none order
entrusted to a Specialist should be disclosed to the trading crowd
if such order falls within or upon the bid or offer for the
particular option series.
    For example, if the market in XYZ Oct 30 calls is 4-4.25, 10x15,
and there is an all-or-none order on the Specialist's book to sell
10 XYZ Oct 30 calls at 4.25 all-or-none, the Specialist, in response
to a request for the market in XYZ Oct 30 calls, should respond:
    ``The market is 4-4.25, 10x15, 10 (to sell) at 4.25 all-or-
none.''
    Accordingly, under this policy, all-or-none option orders should
be announced to the trading crowd as part of the quoted market, but
not as part of the bid or offer.]
    When entered electronically pursuant to Rule 1080 or into
Options Floor Broker Management System pursuant to Rule 1063, an
all-or-none order has standing and is eligible for execution in time
priority with all other customer orders and all-or-none professional
orders (as specified in Rule 1000(b)(14)) at that price if the all-
or-none contingency can be met.

FINE SCHEDULE

    Fine not applicable
* * * * *

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
Background
    Today, the Exchange is operating two versions of FBMS as part of an
implementation period for the new FBMS. The old FBMS enabled Floor
Brokers and/or their employees to enter, route, and report transactions
stemming from options orders executed manually (verbally) in open
outcry on the Exchange. It also established an electronic audit trail
for options orders represented by Floor Brokers on the Exchange. Floor
Brokers can use old FBMS to submit orders to the PHLX XL II System
(``System'') pursuant to Rule 1063, rather than executing the orders in
the trading crowd.
    With the new FBMS, all options transactions on the Exchange
involving at least one Floor Broker can continue to be represented in
open outcry in the trading crowd but are now required to be executed by
and through the new FBMS. In connection with order execution, the
Exchange allows FBMS to execute two-sided orders entered by Floor
Brokers, including multi-leg orders up to 15 legs, after the Floor
Broker has represented the orders in the trading crowd. FBMS also
provides Floor Brokers with an enhanced functionality called the
complex calculator that calculates and displays a suggested price of
each individual component of a multi-leg order, up to 15 legs,
submitted on a net debit or credit basis. The Exchange deployed the new
FBMS in March 2014. Despite the initial intent to phase out the old
FBMS after an implementation period involving the old and new FBMS
operating concurrently, the Exchange has determined to operate the old
FBMS until November 3, 2015 and is planning to implement a new, third
FBMS, the details of which will be filed as a proposed rule change.\3\
In the event that the Floor Broker is utilizing the new FBMS and the
new FBMS malfunctions or is otherwise not available after a Floor
Broker has entered an order, the Floor Broker can re-enter that order
into the old FBMS.
---------------------------------------------------------------------------

    \3\ Securities Exchange Act Release No. 73586 (November 13,
2014), 79 FR 68931 (November 19, 2014) (SR-Phlx-2014-71).
---------------------------------------------------------------------------

Proposal
    The purpose of the proposal is to address the way AON orders on the
book are handled electronically by the new FBMS.\4\ In its filing for
approval of the new FBMS, the Exchange addressed AON orders merely by
referring to Advice A-9, which provides, in pertinent part, that an AON
option order is a limit order which is to be executed in its entirety,
or not at all.\5\ Advice A-9 further provides that an AON order has no
standing in the crowd except with respect to other AON orders.
Accordingly, when a Floor Broker using

the old FBMS executes an order in the trading crowd today where there
is an AON order executable against the Floor Broker's order on the
contra-side, the Floor Broker can skip that AON order and trade with
another quote or order at that price, because the AON order has no
standing. This would continue to be the case for verbal executions,
which occur when the old FBMS is used, when the new FBMS malfunctions
\6\ and where there is no Floor Broker involved.\7\ The Exchange is not
proposing to change this, other than to make a slight language change
to clarify that the execution is occurring in the trading crowd.
---------------------------------------------------------------------------

    \4\ Only customers and professionals can submit AON orders. See
Rules 1000(b)(14) and Rule 1080(b).
    \5\ See also Rule 1066(c)(4).
    \6\ Rule 1063(e)(ii).
    \7\ Rule 1000(f)(ii).
---------------------------------------------------------------------------

    Although this is how AON orders are treated on the trading floor
today when executed manually in the trading crowd, AON orders are
treated differently when the new FBMS is used because the System
performs the execution. Specifically, in the new FBMS, AON orders that
can trade against any eligible interest, not just other AON orders, and
they are not skipped. When a Floor Broker seeks to execute an order
using the new FBMS where there is an AON order at a price equal to or
better than the Floor Broker's order on the contra-side, the Floor
Broker must enter his order into the new FBMS and execute against the
full size of the AON order electronically. If the Floor Broker does not
fulfill the full size of the AON order, the Floor Broker's order will
be returned with no execution occurring.
    This is the same way that AON orders are treated by the System;
they are subject to the normal price and time priority principles of
Rule 1014, except that the AON contingency must be met for the AON
order to trade. An AON order with time priority will trade in time
priority before another customer order if its size contingency can be
met. If the size contingency order cannot be met, the AON order will be
skipped and a customer order behind it in time priority may execute.
Because the new FBMS executes orders electronically and generally
provides more electronic functionality, the Exchange believes it is
appropriate to address AON orders executed against orders submitted
through the new FBMS in the same way.
    Accordingly, Advice A-9 is proposed to be amended to expressly
state that how AON orders are handled when executed manually (verbally)
as well as when executed electronically. With respect to electronic AON
orders, the Exchange proposes to expressly state that an AON order has
standing and is eligible for execution in time priority with all other
customer orders and AON professional orders (as specified in Rule
1000(b)(14)) at that price if the AON contingency can be met. The
Exchange is not changing what types of orders a professional can submit
nor the priority of those orders. Rule 1000(b)(14) will continue to
state that the term ``professional'' means any person or entity that
(i) is not a broker or dealer in securities, and (ii) places more than
390 orders in listed options per day on average during a calendar month
for its own beneficial account(s). It will also continue to state that
a professional will be treated in the same manner as an off-floor
broker-dealer for purposes of Rules 1014(g)(except with respect to AON
orders, which will be treated like customer orders, except that orders
submitted pursuant to Rule 1080(n) for the beneficial account(s) of
professionals with an AON designation will be treated in the same
manner as off-floor broker-dealer orders), 1033(e), 1064.02 (except
professional orders will be considered customer orders subject to
facilitation), 1080(n) and 1080.08 as well as Options Floor Procedure
Advices B-6, B-11 and F-5.
    The Exchange also proposes to delete the example at the end of
Advice A-9. It is obsolete for several reasons; it refers to the
``Specialist's book,'' which is now generally considered the Exchange's
book, the limit order book or just the book; and announcing AON orders
on the book to the crowd does not occur where there is a remote
specialist. For similar reasons, the Exchange proposes to delete
reference to an AON order being ``entrusted to a Specialist.'' This
process is no longer performed.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \8\ in general, and furthers the objectives of Section
6(b)(5) of the Act \9\ in particular, in that it is designed to promote
just and equitable principles of trade and to protect investors and the
public interest, by specifically providing how an AON order executes
against orders submitted through the new FBMS and by improving the
treatment of such AON orders as opposed to AON orders handled manually.
Specifically, the proposal results in improving the treatment of
electronic AON orders by increasing their interaction with other orders
on the Exchange, because AON orders are electronically executed against
contra-side orders entered into the new FBMS. More specifically, such
orders have standing and time priority, as explained above. The
Exchange is not changing the priority of afforded to electronic AON
orders, but rather is codifying such treatment in its rules.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. This treatment of AON orders
should help the Exchange compete with other floor-based exchanges for
AON orders. More importantly, the proposal should result in more
interaction between AON orders and all other orders, as explained
above, thereby promoting a more competitive marketplace.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were either solicited or received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \10\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\11\
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) normally does
not become operative for 30 days after the date of filing.\12\ However,
Rule 19b-4(f)(6)(iii) permits the Commission to designate a shorter
time if such action is consistent with the protection of investors and
the public interest.\13\ The Exchange has asked the Commission to waive
the 30-day operative delay so that the proposed rule change may become
operative immediately upon filing. The Commission notes that the
proposal is designed to provide Exchange members with more specificity
regarding how the Exchange handles AON orders in the

new FBMS system. The Commission also notes that the Exchange represents
that the proposal does not affect the priority of electronic AON
orders. Accordingly, the Commission hereby waives the 30-day operative
delay and designates the proposal operative upon filing.\14\
---------------------------------------------------------------------------

    \12\ 17 CFR 240.19b-4(f)(6)(iii).
    \13\ Id.
    \14\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is: (i)
Necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) otherwise in furtherance of the
purposes of the Act.\15\ If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule change should be approved or disapproved.\16\
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78s(b)(3)(C).
    \16\ Id.
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-Phlx-2015-37 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-Phlx-2015-37. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal offices of the Exchange.
All comments received will be posted without change; the Commission
does not edit personal identifying information from submissions. You
should submit only information that you wish to make available
publicly. All submissions should refer to File Number SR-Phlx-2015-37,
and should be submitted on or before June 1, 2015.
---------------------------------------------------------------------------

    \17\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2015-11273 Filed 5-8-15; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: April 29, 2009 (Volume 74, Number 81)]
[Rules and Regulations]
[Page 19422-19424]
[DOCID:fr29ap09-8]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2008-1220]
RIN 1625-AA00

Safety Zone; Blue Water Resort and Casino APBA National Tour
Rounds 1 & 2; Colorado River, Parker, AZ

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a temporary safety zone within
the Lake Moolvalya region of the navigable waters of the Colorado River
in Parker, Arizona for the Blue Water Resort and Casino APBA National
Tour Rounds 1 & 2. This temporary safety zone is necessary to provide
for the safety of the participants, crew, spectators, participating
vessels, and other vessels and users of the waterway. Persons and
vessels are prohibited from entering into, transiting though, or
anchoring within this safety zone unless authorized by the Captain of
the Port or his designated representative.

DATES: This rule is effective from 6 a.m. on May 1, 2009 through 6 p.m.
on May 3, 2009.

ADDRESSES: Comments and material received from the public, as well as
documents mentioned in this preamble as being available in the docket,
are part of docket USCG-2008-1220 and are available online by going to
http://www.regulations.gov, selecting the Advanced Docket Search option
on the right side of the screen, inserting USCG-2008-1220 in the Docket
ID box, pressing Enter, and then clicking on the item in the Docket ID
column. This material is also available for inspection or copying at
two locations: the Docket Management Facility (M-30), U.S. Department
of Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays and the U.S. Coast Guard
Sector San Diego, 2710 N. Harbor Drive, San Diego, CA 92101 between 8
a.m. and 3 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call Petty Officer Kristen Beer, USCG, Waterways
Management, U.S. Coast Guard Sector San Diego at<PHONE_NUMBER>. If you
have questions on viewing the docket, call Renee V. Wright, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    On February 26, 2009, we published a notice of proposed rulemaking
(NPRM) entitled Safety Zone; Blue Water Resort and Casino APBA National
Tour Rounds 1 & 2 in the Federal Register (74 FR 8761). We received no
letters commenting on the proposed rule. No public meeting was
requested, and none was held.

Background and Purpose

    The RPM Racing Enterprises is sponsoring the Blue Water Resort and
Casino APBA National Tour Rounds 1 & 2, which is held on the Lake
Moolvalya region on the Colorado River in Parker, Arizona. This
temporary safety zone is necessary to provide for the safety of the
participants, crew, spectators, sponsor vessels, and other users and
vessels of the waterway. This event involves powerboats racing along a
circular course. The size of the boats varies from ten to 16 feet in
length. Approximately 90 to 130 boats will be participating in this
event. The sponsor will provide two patrol and rescue boats and two
river closure boats.

Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, and does not
require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order.
    We expect the economic impact of this rule to be so minimal that a
full Regulatory Evaluation is unnecessary. This determination is based
on the size and location of the safety zone. Commercial vessels will
not be hindered by the safety zone. Recreational vessels will not be
allowed to transit through the established safety zone during the
specified times unless authorized to do so by the Captain of the Port
or his designated representative.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities.
    This rule will affect the following entities, some of which may be
small entities: The owners or operators of vessels intending to transit
or anchor in a portion of the lower Colorado River from 6 a.m. to 6
p.m. on May 1, 2009 through May 3, 2009.
    This safety zone will not have a significant economic impact on a
substantial number of small entities for the following reasons. This
rule will be in effect for only 3 days. Although the safety zone will
apply to the entire width of the river, traffic will be allowed to pass
through the zone with the permission of the Coast Guard patrol
commander. Before the effective period, the Coast Guard will publish a
local notice to mariners (LNM).

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), in the NPRM we offered to
assist small entities in understanding the rule so that they could
better evaluate its effects on them and participate in the rulemaking
process.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520.

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 or more in any
one year. Though this rule will not result in such an expenditure, we
do discuss the effects of this rule elsewhere in this preamble.

Taking of Private Property

    This rule will not effect a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 0023-01 and Commandant Instruction M16475.lD,
which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and
have concluded that this action is one of a category of actions which
do not individually or cumulatively have a significant effect on the
human environment. This rule is categorically excluded, under figure 2-
1, paragraph (34)(g), of the Instruction from further environmental
documentation.
    An environmental analysis checklist and a categorical exclusion
determination are available in the docket where indicated under
ADDRESSES.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

0
For the reasons discussed in the preamble, the Coast Guard amends 33
CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701, 3306,
3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Pub.
L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

0
2. Add a new temporary zone Sec.  165.T11-138 to read as follows:

Sec.  165.T11-138   Safety Zone; Blue Water Resort and Casino APBA
National Tour Rounds 1 & 2; Colorado River, Parker, AZ.

    (a) Location. The limits of this temporary safety zone are the
portion of the Colorado River from Headgate Dam to 0.5 miles north of
the Bluewater Marine in Parker, Arizona.
    (b) Enforcement Period. This section will be enforced from 6 a.m.
to 6 p.m. on May 1, 2009 through May 3, 2009. If the event concludes
prior to the scheduled termination time, the Captain of the Port will
cease enforcement of this safety zone and will announce that fact via
Broadcast Notice to Mariners.
    (c) Definitions. The following definition applies to this section:
designated representative, means any commissioned, warrant, and petty
officers of the Coast Guard on board Coast Guard, Coast Guard
Auxiliary, and local, state, and federal law enforcement vessels who
have been authorized to act on the behalf of the Captain of the Port.
    (d) Regulations. (1) Entry into, transit through or anchoring
within this safety zone is prohibited unless authorized by the Captain
of the Port of San Diego or his designated on-scene representative.
    (2) Mariners requesting permission to transit through the safety
zone may request authorization to do so from the Patrol Commander
(PATCOM). The PATCOM may be contacted on VHF-FM Channel 83.
    (3) All persons and vessels shall comply with the instructions of
the Coast Guard Captain of the Port or the designated representative.
    (4) Upon being hailed by U.S. Coast Guard patrol personnel by
siren, radio, flashing light, or other means, the operator of a vessel
shall proceed as directed.
    (5) The Coast Guard may be assisted by other federal, state, or
local agencies.

    Dated: April 14, 2009.
T.H. Farris,
Captain, U.S. Coast Guard, Captain of the Port, San Diego.
[FR Doc. E9-9718 Filed 4-28-09; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register Volume 78, Number 215 (Wednesday, November 6, 2013)]
[Notices]
[Pages 66748-66750]
[FR Doc No: 2013-26491]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1285]

Smith Miller and Patch Inc. et al.; Proposal to Withdraw Approval
of 14 New Drug Applications; Opportunity for a Hearing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity to request a hearing on the Agency's proposal to withdraw
approval of 14 new drug applications (NDAs) from multiple sponsors. The
basis for the proposal is that the sponsors have repeatedly failed to
file required annual reports for these applications.

DATES: Submit written requests for a hearing by December 6, 2013;
submit data and information in support of the hearing request by
January 6, 2014.

ADDRESSES: Identify your requests for a hearing, supporting data, and
other comments with Docket No. FDA-2013-N-1285, and submit this
information to the Division of Dockets Management (HFA-305), Food and
Drug

Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6366, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: The holders of approved applications to
market new drugs for human use are required to submit annual reports to
FDA concerning each of their approved applications in accordance with
Sec.  314.81 (21 CFR 314.81). The holders of the approved applications
listed in table 1 have failed to submit the required annual reports and
have not responded to the Agency's request by certified mail for
submission of the reports.

  Table 1--Approved NDAs for Which Required Reports Have Not Been Made
------------------------------------------------------------------------
       Application No.                Drug                Applicant
------------------------------------------------------------------------
NDA 004979..................  Multi-Vitamin         Smith Miller and
                               Tablets.              Patch Inc., P.O.
                                                     Box 367, San
                                                     German, PR 00753.
NDA 008176..................  Methostan             Do.
                               (methandriol)
                               Tablets.
NDA 008326..................  Methischol (inositol/ USV Pharmaceutical
                               vitamin B12/          Corp., 500 Virginia
                               racemethionine/       Dr., Fort
                               choline chloride)     Washington, PA
                               Injection.            19034-2779.
NDA 008362..................  Corticotropin         Vitarine
                               Injection.            Pharmaceuticals
                                                     Inc., 227-15 North
                                                     Conduit Ave.,
                                                     Springfield
                                                     Gardens, NY 11413.
NDA 009346..................  ACTH (corticotropin)  Parke-Davis, 201
                               Injection.            Tabor Rd., Morris
                                                     Plains, NJ 07950.
NDA 009515..................  Hyrye (riboflavin 5'- S.F. Durst and Co.,
                               phosphate sodium)     Inc., 5317-21 North
                               Injection.            Third St.,
                                                     Philadelphia, PA
                                                     19120.
NDA 010415..................  Flamotide             Philadelphia Ampoule
                               (riboflavin 5'-       Laboratories, 400
                               phosphate sodium)     Green St.,
                               Injection.            Philadelphia, PA
                                                     19123.
NDA 010565..................  Duracton              Nordic Biochemicals
                               (corticotropin)       Inc., 45 Bay State
                               Injection.            Rd., Boston, MA
                                                     02215.
NDA 010791..................  Rubivite              Bel Mar
                               (cyanocobalamin)      Laboratories, Inc.,
                               Injection.            6-10 Nassau Ave.,
                                                     Inwood, NY 11696.
NDA 010831..................  Corticotropin         Organics/LaGrange,
                               Injection.            Inc., 1935 Techny
                                                     Rd., Suite 14,
                                                     Northbrook, IL
                                                     60062.
NDA 011015..................  RU-B-12-1000          Dow Pharmaceutical
                               (cyanocobalamin)      Corp., 9550 North
                               Injection.            Zionsville Rd.,
                                                     Indianapolis, IN
                                                     46268.
NDA 011578..................  Efacin (niacin)       Person and Covey,
                               Tablet.               Inc., 616 Allen
                                                     Ave., Glendale, CA
                                                     91201.
NDA 017861..................  Acthar Gel Synthetic  Armour
                               (seractide acetate)   Pharmaceutical Co.,
                               Injection.            P.O. Box 511,
                                                     Kankakee, IL 60901.
NDA 018087..................  Thyrel TRH            Ferring
                               (protirelin)          Pharmaceuticals,
                               Injection.            Inc., 400 Rella
                                                     Blvd., Suite 300,
                                                     Suffern, NY 10901.
------------------------------------------------------------------------

    Therefore, notice is given to the holders of the approved
applications listed in table 1 and to all other interested persons that
the Director of the Center for Drug Evaluation and Research proposes to
issue an order under section 505(e) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 355(e)) withdrawing approval of the
applications and all amendments and supplements thereto on the ground
that the applicants have failed to submit reports required under Sec.
314.81.
    In accordance with section 505 of the FD&C Act and part 314 (21 CFR
part 314), the applicants are hereby provided an opportunity for a
hearing to show why the applications listed previously should not be
withdrawn and an opportunity to raise, for administrative
determination, all issues relating to the legal status of the drug
products covered by these applications.
    An applicant who decides to seek a hearing must file the following:
(1) A written notice of participation and request for a hearing (see
DATES) and (2) the data, information, and analyses relied on to
demonstrate that there is a genuine and substantial issue of fact that
requires a hearing (see DATES). Any other interested person may also
submit comments on this notice. The procedures and requirements
governing this notice of opportunity for a hearing, notice of
participation and request for a hearing, information and analyses to
justify a hearing, other comments, and a grant or denial of a hearing
are contained in Sec.  314.200 and in 21 CFR part 12.
    The failure of an applicant to file a timely written notice of
participation and request for a hearing, as required by Sec.  314.200,
constitutes an election by that applicant not to avail itself of the
opportunity for a hearing concerning the proposal to withdraw approval
of the applications and constitutes a waiver of any contentions
concerning the legal status of the drug products. FDA will then
withdraw approval of the applications and the drug products may not
thereafter lawfully be marketed, and FDA will begin appropriate
regulatory action to remove the products from the market. Any new drug
product marketed without an approved new drug application is subject to
regulatory action at any time.
    A request for a hearing may not rest upon mere allegations or
denials, but must present specific facts showing that there is a
genuine and substantial issue of fact that requires a hearing. Reports
submitted to remedy the deficiencies must be complete in all respects
in accordance with Sec.  314.81. If the submission is not complete or
if a request for a hearing is not made in the required format or with
the required reports, the Commissioner of Food and Drugs will enter
summary judgment against the person who requests the hearing, making
findings and conclusions, and denying a hearing.
    All submissions under this notice of opportunity for a hearing must
be filed in four copies. Except for data and information prohibited
from public disclosure under 21 U.S.C. 331(j) or 18 U.S.C. 1905, the
submissions may be seen in the Division of Dockets Management (see
ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday, and will
be posted to the docket at http://www.regulations.gov.
    This notice is issued under the Federal Food, Drug, and Cosmetic
Act (section 505 (21 U.S.C. 355)) and under authority delegated to the
Director,

Center for Drug Evaluation and Research, by the Commissioner of Food
and Drugs.

    Dated: October 30, 2013.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 2013-26491 Filed 11-5-13; 8:45 am]
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[Federal Register Volume 80, Number 164 (Tuesday, August 25, 2015)]
[Notices]
[Pages 51558-51560]
[FR Doc No: 2015-21040]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2014-0766; FRL-9931-05]

Final Test Guidelines; Endocrine Disruptor Screening Program Test
Guidelines (Series 890); Three Tier 2 Non-Mammalian Tests; Notice of
Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: EPA is announcing the availability of three Office of Chemical
Safety and Pollution Prevention (OCSPP) final test guidelines: Medaka
Extended One-generation Reproduction Test (MEOGRT), OCSPP Test
Guideline 890.2200; Larval Amphibian Growth and Development Assay
(LAGDA), OCSPP Test Guideline 890.2300; and Avian Two-generation
Toxicity Test in the Japanese Quail (JQTT), OCSPP Test Guideline
890.2100. These test guidelines are part of a series of test guidelines
established by OCSPP for use in testing pesticides and chemical
substances. The test guidelines serve as a compendium of accepted
scientific methodologies and protocols that are intended to provide
data to inform regulatory decisions. The test guidelines provide
guidance for conducting the test and are also used by EPA, the public,
and companies that submit data to EPA.

FOR FURTHER INFORMATION CONTACT: Sharlene Matten, telephone number:
(202) 564-0130, email address<EMAIL_ADDRESS>or Jane Robbins,
telephone number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
Office of Science Coordination and Policy (7201M), Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001.

SUPPLEMENTARY INFORMATION:

I. Introduction

    EPA is announcing the availability of three final test guidelines:
Medaka Extended One-generation Reproduction Test (MEOGRT), OCSPP Test
Guideline 890.2200; Larval Amphibian Growth and Development Assay
(LAGDA), OCSPP Test Guideline 890.2300; and Avian Two-generation
Toxicity Test in the Japanese Quail (JQTT), OCSPP Test Guideline
890.2100. These test guidelines are part of a series of test guidelines
established by OCSPP for use in testing pesticides and chemical
substances to develop data for submission to the Agency under the
Federal Food, Drug, and Cosmetic Act (FFDCA) section 408 (21 U.S.C.
346a), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
(7 U.S.C. 136 et seq.), and the Toxic Substances Control Act (TSCA) (15
U.S.C. 2601 et seq.). The test guidelines serve as a compendium of
accepted scientific methodologies and protocols that are intended to
provide data to inform regulatory decisions under TSCA, FIFRA, and/or
FFDCA.
    The test guidelines provide guidance for conducting the test and
are also used by EPA, the public, and companies that are subject to
data submission requirements under TSCA, FIFRA, and/or FFDCA. As
guidance documents, the test guidelines are not binding on either EPA
or any outside parties and EPA may depart from the test guidelines
where circumstances warrant and without prior notice. At places in this
guidance, the Agency uses the word ``should.'' In this guidance, use of
``should'' with regard to an action means that the action is
recommended rather than mandatory. The procedures contained in the test
guidelines are recommended for generating the data that are the subject
of the test guideline, but EPA recognizes that departures may be
appropriate in specific situations. You may propose alternatives to the
recommendations described in the test guidelines and the Agency will
assess them for appropriateness on a case-by-case basis.

II. General Information

A. Does this action apply to me?

    This action is directed to the public in general. Although this
action may be of particular interest to those persons who are or may be
required to conduct testing of pesticides and chemical substances for
submission to EPA under TSCA, FIFRA, and/or FFDCA, the Agency has not
attempted to describe all the specific entities that may be affected by
this action.

B. How can I get copies of this document and other related information?

    1. Docket for this document. The docket for this action, identified
by docket identification (ID) number EPA-HQ-OPPT-2014-0766 is available
at http://www.regulations.gov or at the Office of Pollution Prevention
and Toxics Docket (OPPT Docket), Environmental Protection Agency Docket
Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution Ave. NW.,
Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Public Reading Room is<PHONE_NUMBER> and the telephone
number for the OPPT Docket is<PHONE_NUMBER>. Please review the visitor
instructions and additional information about the docket available at
http://www.epa.gov/dockets.
    2. Electronic access to the OCSPP test guidelines. To access OCSPP
test guidelines electronically, please go to http://www.epa.gov/ocspp/pubs/frs/home/testmeth.htm. You may also access the test guidelines in
http://www.regulations.gov, grouped by series under docket ID numbers:
EPA-HQ-OPPT-2009-0150 through EPA-HQ-OPPT-2009-0159 and EPA-HQ-OPPT-
2009-0576.

III. Overview

A. What action is EPA taking?

    EPA is announcing the availability of three final test guidelines
that are being added to its 890 Series, entitled ``Endocrine Disruptor
Screening Program Test Guidelines'' and identified as follows:
    1. OCSPP Test Guideline 890.2200, entitled Endocrine Disruptor
Screening Program Test Guidelines; Medaka Extended One-generation
Reproduction Test.
    2. OCSPP Test Guideline 890.2300, entitled Endocrine Disruptor
Screening Program Test Guidelines; Larval Amphibian Growth and
Development Assay.
    3. OCSPP Test Guideline 890.2100, entitled Endocrine Disruptor
Screening

Program Test Guidelines; Avian Two-generation Toxicity Test in the
Japanese Quail.

B. How Were These Final Test Guidelines Developed?

    On January 30, 2015, the Agency released three draft non-mammalian
test guidelines for public review and comment as described in a Federal
Register notice (80 FR 5107) (FRL-9919-43) (Ref. 1). These three draft
test guidelines were subsequently revised based on public comments,
existing EPA test guidelines, and concurrent Organisation for Economic
Co-operation and Development (OECD) test guidelines for MEOGRT (Ref. 2)
and LAGDA (Ref. 3).
    Comments were submitted by representatives from the following
organizations: Endocrine Policy Forum, SynTech Research Laboratory
Services, American Petroleum Institute, Wildlife International, People
for Ethical Treatment of Animals, the Physicians Committee for
Responsible Medicine, and the Humane Society of the United States.
Comments were grouped according to each test guidelines: JQTT
(890.2100), MEOGRT (890.2200) and LAGDA (890.2300).
    EPA worked with the OECD to harmonize test guidelines for MEOGRT
(Ref. 2) and LAGDA (Ref. 3). The OECD test guidelines were approved at
the Working Group of National Coordinators of the Test Guidelines
Programme (WNT) and endorsed by the Joint Meeting of the Chemicals
Committee and the Working Party on Chemicals, Pesticides and
Biotechnology in June 2015 prior to EPA finalizing the U.S. MEOGRT and
LAGDA test guidelines. EPA revised the terminology, procedures, and
statistical practices to harmonize the MEOGRT and LAGDA test guidelines
with analogous OECD's test guidelines and at the same time incorporated
public comments received that were not already addressed in the
harmonization.
    A summary of the substantive changes reflected in the final U.S.
MEOGRT and LAGDA test guidelines is provided:
    1. The option for extending the MEOGRT through F2 generation
reproduction has been removed from the final test guideline pending
additional data. The test will end following hatching of the F2
offspring. This is consistent with the decision made in the draft OECD
test guideline for MEOGRT. This test guideline may be updated as new
information and data are considered. For example, guidance on extending
the F2 generation through reproduction may be potentially useful under
certain circumstances (e.g., chemicals with high bioconcentration
potential or indications of trans-generational effects in other taxa).
    2. The mean water temperature over the duration of the MEOGRT has
been changed to 25  2 [deg]C to be consistent with the
analogous OECD test guideline.
    3. The LAGDA developmental stage terminology has been clarified to
avoid confusion with what is meant by complete metamorphosis.
    4. Clarified the conduct of liver and kidney histopathology in the
MEOGRT and LAGDA test guidelines for overt toxicity. An effort was made
to clarify and provide more explicit guidance as to what specific
histopathology is appropriate based on the results of the study.
    5. The rationale for use of solvent control only, dilution water
control only, or pooled controls in the statistical analyses for the
MEOGRT and LAGDA was clarified.
    6. The guidelines have been modified to address commenters'
concerns that they be more flexible and less prescriptive. Examples
have been provided as appropriate to add clarity.
    The JQTT draft test guideline (OCSPP 890.2100) was revised to
address comments provided by the public, the draft OECD test guideline
for the avian two-generation toxicity test in the Japanese quail (Ref.
4), as well as the existing EPA and OECD test guidelines for avian one-
generation toxicity tests (Refs. 5 and 6). EPA revised the terminology,
procedures, endpoints measured, figures, tables, and appendices in the
JQTT test guideline to clarify specific points raised by public
commenters as follows:
    1. The revised test guidelines include fewer endpoints. For
example, the revisions eliminated behavioral endpoints to reduce the
overall numbers of birds required for the study; eliminated endpoints
that are difficult to obtain (i.e., hormone levels measured in embryo
blood samples); eliminated redundant endpoints; and statistical
analyses.
    2. For clarity, the test termination point is following measurement
of the 14-day survival of filial 2 (F2) generation chicks. This is the
minimum length of the study necessary to evaluate and measure a
chemical's effect on the F1 generation's reproductive performance. If
delayed reproduction is observed in F1 birds, a decision to extend the
F2 generation may be made. If extended, the test should be terminated
when F2 birds are approximately 6 weeks old when 90% of control animals
have reached sexual maturity. The decision to limit the length of the
JQTT is consistent with EPA's efforts to move to extended one-
generation reproduction test protocols for Tier 2 tests rather than
multigenerational studies (Ref. 7). Extended one-generation
reproduction tests are technically sound, save animals, and reduce
costs.
    3. The guidelines have been modified to address commenters'
concerns that they be more flexible and less prescriptive. Examples
have been provided as appropriate to add clarity.

IV. References

    The following is a listing of the documents that are specifically
referenced in this document. The docket includes these documents and
other information considered by EPA, including documents that are
referenced within the documents that are in the docket, even if the
referenced document is not physically located in the docket. For
assistance in locating these other documents, please consult the
persons listed under FOR FURTHER INFORMATION CONTACT.
    1. EPA Draft Test Guidelines; Endocrine Disruptor Screening Program
Test Guidelines (Series 890); Three Tier 2 Non-Mammalian Tests; Notice
of Availability and Public Comment, Federal Register (80 FR 5107,
January 30, 2015). It is available at http://www.gpo.gov/fdsys/pkg/FR-2015-01-30/pdf/2015-01836.pdf.
    2. OECD, Test No. 240: Medaka Extended One-Generation Reproduction
Test, OECD Guidelines for the Testing of Chemicals, section 2 (2015).
It is available at http://www.oecd-ilibrary.org/environment/oecd-guidelines-for-the-testing-of-chemicals-section-2-effects-on-biotic-systems_20745761.
    3. OECD, Test No. 241: Larval Amphibian Growth and Development
Test, OECD Guidelines for the Testing of Chemicals, section 2 (2015).
It is available at http://www.oecd-ilibrary.org/environment/oecd-guidelines-for-the-testing-of-chemicals-section-2-effects-on-biotic-systems_20745761.
    4. OECD Guidelines for Testing of Chemicals. Proposal for a new
test guideline: Avian Two-generation Toxicity Test in the Japanese
Quail, Draft November 2005. It is available at http://www.epa.gov/endo/pubs/edmvac/2gen_guide_gd_draft1.pdf.
    5. U.S. EPA Ecological Effects Test Guidelines; OCSPP 850.2300,
Avian Reproduction Test. January 2012. EPA 712C-023. It is available at
http://www.epa.gov/ocspp/pubs/frs/publications/Test_Guidelines/series850.htm.

    6. OECD, Test No. 206: Avian Reproduction Test. OECD Guidelines for
the Testing of Chemicals, section 2--Effect on Biotic Systems (adopted
1984). OECD Publishing, Paris (1993) DOI: It is available at http://dx.doi.org/10.1787/9789264070028-en.
    7. OECD, Test No. 443: Extended One-Generation Reproductive
Toxicity Study, OECD Guidelines for the Testing of Chemicals, section
4, 28 July 2011, DOI. It is available at http://dx.doi.org/10.1787/9789264122550-en.

    Authority: 7 U.S.C. 136 et seq.; 15 U.S.C. 2601 et seq.; 21
U.S.C. 301 et seq.

    Dated: August 18, 2015.
Louise P. Wise,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2015-21040 Filed 8-24-15; 8:45 am]
BILLING CODE 6560-50-P