[Federal Register Volume 76, Number 119 (Tuesday, June 21, 2011)]
[Notices]
[Page 36142]
[FR Doc No: 2011-15322]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-1979-DR; Docket ID FEMA-2011-0001]

Tennessee; Amendment No. 3 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Tennessee (FEMA-1979-DR), dated May 9, 2011, and
related determinations.

DATES: Effective Date: June 7, 2011.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that the incident
period for this disaster is closed effective June 7, 2011.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households in Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2011-15322 Filed 6-20-11; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 76, Number 220 (Tuesday, November 15, 2011)]
[Rules and Regulations]
[Pages 70647-70649]
[FR Doc No: 2011-29409]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2011-0976]
RIN 1625-AA00

Safety Zone; Fireworks Display, Potomac River, National Harbor
Access Channel, MD

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a safety zone upon specified
waters of the Potomac River. This action is necessary to provide for
the safety of life on navigable waters during a fireworks display
launched from a floating platform located within the National Harbor
Access Channel, in Prince Georges County, Maryland. This safety zone is
intended to protect the maritime public in a portion of the Potomac
River.

DATES: This rule is effective from 6 p.m. on November 19, 2011 through
8 p.m. on November 20, 2011.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2011-0976 and are available online
by going to http://www.regulations.gov, inserting USCG-2011-0976 in the
``Keyword'' box, and then clicking ``Search.'' They are also available
for inspection or copying at 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.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call or email Mr. Ronald L. Houck, Sector Baltimore
Waterways Management Division, Coast Guard; telephone<PHONE_NUMBER>,
email<EMAIL_ADDRESS>If you have questions on viewing the
docket, call Renee V. Wright, Program Manager, Docket Operations,
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because it is contrary to public interest to
delay the effective date of this rule. Delaying the effective date by
first publishing an NPRM would be contrary to the safety zone's
intended objectives because immediate action is needed to protect
persons and vessels against the hazards associated with a fireworks
display on navigable waters. Such hazards include premature
detonations, dangerous projectiles and falling or burning debris.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Due to the need for immediate
action, the restriction of vessel traffic is necessary to protect life,
property and the environment; therefore, a 30-day notice is
impracticable. Delaying the effective date would be contrary to the
safety zone's intended objectives of protecting persons and vessels
involved in the event, and enhancing public and maritime safety.

Basis and Purpose

    Fireworks displays are frequently held from locations on or near
the navigable waters of the United States. The potential hazards
associated with fireworks displays are a safety concern during such
events. The purpose of this rule is to promote public and maritime
safety during a fireworks display, and to protect mariners transiting
the area from the potential hazards associated with a fireworks
display, such as the accidental discharge of fireworks, dangerous
projectiles, and falling hot embers or other debris. This rule is
needed to ensure safety on the waterway during the scheduled event.

Discussion of Rule

    Pyrotecnico, of New Castle, Pennsylvania, will conduct a fireworks
display launched from a floating platform located on the Potomac River
at National Harbor, Maryland scheduled on November 19, 2011 at
approximately 6:45 p.m. If necessary, due to inclement weather, the
fireworks display may be scheduled on November 20, 2011 at
approximately 6:45 p.m.
    The Coast Guard is establishing a temporary safety zone on certain
waters of the Potomac River, National Harbor Access Channel, within a
50 yards radius of a fireworks discharge platform in approximate
position latitude 38[deg]47'01'' N, longitude 077[deg]01'15'' W,
located at National Harbor, Maryland (NAD 1983). The temporary safety
zone will be enforced from 6 p.m. through 8 p.m. on and November 19,
2011, and if necessary due to inclement weather, from 6 p.m. through 8
p.m. on November 20, 2011. The effect of this temporary safety zone
will be to restrict navigation in the regulated area during the
fireworks display. No person or vessel may enter or remain in the
safety zone. Vessels will be allowed to transit the waters of the
Potomac River outside the safety zone. Notification of the temporary
safety zone will be provided to the public via marine information
broadcasts.

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, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of that Order or under section
1 of Executive Order 13563. The Office of Management and Budget has not
reviewed it under that Order. It is not ``significant'' under the
regulatory policies and procedures of the Department of Homeland
Security (DHS). Although this safety zone will restrict some vessel
traffic, there is little vessel traffic associated with commercial
fishing in the area, and recreational boating in the area can transit
waters outside the safety zone. In addition, the effect of this rule
will not be significant because the safety zone is

of limited duration and limited size. For the above reasons, the Coast
Guard does not anticipate any significant economic impact.

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
operate, transit, or anchor in a portion of the Potomac River, National
Harbor Access Channel, located at National Harbor, MD, from 6 p.m.
through 8 p.m. on November 19, 2011, and if necessary due to inclement
weather, from 6 p.m. through 8 p.m. on November 20, 2011. This safety
zone will not have a significant economic impact on a substantial
number of small entities for the following reasons. The safety zone is
of limited size and duration. In addition, before the effective
periods, the Coast Guard will issue maritime advisories widely
available to users of the waterway to allow mariners to make
alternative plans for transiting the affected area.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small
entities in understanding the rule so that they can 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 (adjusted for
inflation) 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 cause 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, as supplemented by
Executive Order 13563, Improving Regulation and Regulatory Review, 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 023-01 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
this action is one of a category of actions that 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. This rule involves establishing a temporary safety
zone.

    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.

    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. 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 Sec.  165.T05-0976 to read as follows:

Sec.  165.T05-0976  Safety Zone; Fireworks Display, Potomac River,
National Harbor Access Channel, MD.

    (a) Regulated Area. The following area is a safety zone: All waters
of the Potomac River, National Harbor Access Channel, within a 50 yards
radius of a fireworks discharge platform in approximate position
latitude 38[deg]47'01'' N, longitude 077[deg]01'15'' W, located at
National Harbor, Maryland (NAD 1983).
    (b) Regulations. The general safety zone regulations found in 33
CFR 165.23 apply to the safety zone created by this temporary section,
Sec.  165.T05.0976.
    (1) All vessels and persons are prohibited from entering this zone,
except as authorized by the Coast Guard Captain of the Port Baltimore.
    (2) Persons or vessels requiring entry into or passage within the
zone must request authorization from the Captain of the Port Baltimore
or his designated representative by telephone at<PHONE_NUMBER> or on
VHF-FM marine band radio channel 16.
    (3) All Coast Guard assets enforcing this safety zone can be
contacted on VHF-FM marine band radio channels 13 and 16.
    (4) The operator of any vessel within or in the immediate vicinity
of this safety zone shall:
    (i) Stop the vessel immediately upon being directed to do so by any
commissioned, warrant or petty officer on board a vessel displaying a
Coast Guard Ensign, and
    (ii) Proceed as directed by any commissioned, warrant or petty
officer on board a vessel displaying a Coast Guard Ensign.
    (c) Definitions. Captain of the Port Baltimore means the Commander,
Coast Guard Sector Baltimore or any Coast Guard commissioned, warrant
or petty officer who has been authorized by the Captain of the Port to
act on his behalf.
    Designated representative means any Coast Guard commissioned,
warrant, or petty officer who has been authorized by the Captain of the
Port Baltimore to assist in enforcing the safety zone described in
paragraph (a) of this section.
    (d) Enforcement. The U.S. Coast Guard may be assisted by Federal,
State and local agencies in the patrol and enforcement of the zone.
    (e) Enforcement period. This section will be enforced from 6 p.m.
through 8 p.m. on November 19, 2011 and, if necessary due to inclement
weather, from 6 p.m. through 8 p.m. on November 20, 2011.

    Dated: October 20, 2011.
Mark P. O'Malley,
Captain, U.S. Coast Guard, Captain of the Port Baltimore.
[FR Doc. 2011-29409 Filed 11-14-11; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 78, Number 23 (Monday, February 4, 2013)]
[Notices]
[Pages 7844-7848]
[FR Doc No: 2013-02302]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-68760; File No. SR-ISE-2013-05]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change To Amend Certain Market Maker Fees

January 29, 2013.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on January 17, 2013, the International Securities Exchange, LLC
(the ``Exchange'' or the ``ISE'') filed with the Securities and
Exchange Commission the proposed rule change, as described in Items I,
II, and III below, which items have been prepared by the self-
regulatory organization. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
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    \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 ISE proposes to amend its Schedule of Fees. The text of the
proposed rule change is available on the Exchange's Web site (http://www.ise.com), at the principal office of the Exchange, and at the
Commission's Public Reference Room.

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 self-regulatory organization
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 self-regulatory organization
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
    The Exchange currently assesses per contract transaction fees and
provides rebates to market participants that add or remove liquidity
from the Exchange (``maker/taker fees and rebates'') in a number of
options classes (the ``Select Symbols'').\3\ The Exchange's maker/taker
fees and rebates are applicable to regular and complex orders executed
in the Select Symbols. The Exchange also currently assesses maker/taker
fees and rebates for complex orders in symbols that are in the Penny
Pilot program but are not a Select Symbol (``Non-Select Penny Pilot
Symbols'') \4\ and for complex orders in all symbols that are not in
the Penny Pilot Program (``Non-Penny Pilot Symbols'').\5\
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    \3\ Options classes subject to maker/taker fees and rebates are
identified by their ticker symbol on the Exchange's Schedule of
Fees.
    \4\ See Exchange Act Release Nos. 65724 (November 10, 2011), 76
FR 71413 (November 17, 2011) (SR-ISE-2011-72); and 66961 (May 10,
2012), 77 FR 28914 (May 16, 2012) (SR-ISE-2012-38).
    \5\ See Exchange Act Release Nos. 66084 (January 3, 2012), 77 FR
1103 (January 9, 2012) (SR-ISE-2011-84); 66392 (February 14, 2012),
77 FR 10016 (February 21, 2012) (SR-ISE-2012-06); 66961 (May 10,
2012), 77 FR 28914 (May 16, 2012) (SR-ISE-2012-38); and 67400 (July
11, 2012), 77 FR 42036 (July 17, 2012) (SR-ISE-2012-63).
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    The purpose of this proposed rule change is to increase the
discount for Market Makers \6\ when they trade against Priority
Customer \7\ orders that are preferenced to them to $0.05 per contract
from the fee charged to Market Makers who trade against Priority
Customer orders that are not preferenced to them. This discount is
currently set at $0.02 per contract and is applicable when Market
Makers add or remove liquidity in the Select Symbols (excluding SPY),
in SPY, in the Non-Select Penny Pilot Symbols and in the Non-Penny
Pilot Symbols from the complex order book.\8\ Accordingly, Market
Makers that add or remove liquidity from the complex order book by
trading against Priority Customer complex orders that are preferenced
to them will be charged: (i) $0.34 per contract in the Select Symbols
(including SPY) and in the Non-Select Penny Pilot Symbols; and (ii)
$0.77 per contract in the Non-Penny Pilot Symbols.
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    \6\ The term ``Market Makers'' refers to ``Competitive Market
Makers'' and ``Primary Market Makers'' collectively. See ISE Rule
100(a)(25).
    \7\ A Priority Customer is defined in ISE Rule 100(a)(37A) as a
person or entity that is not a broker/dealer in securities, and does
not place more than 390 orders in listed options per day on average
during a calendar month for its own beneficial account(s).
    \8\ The current $0.02 per contract discount also applies to a
group of symbols in which Market Makers can enter quotes in the
complex order book (``Complex Quoting Symbols''). The discount
applicable to the Complex Quoting Symbols is found on the Exchange's
Schedule of Fees. See Section II. Complex Order Fees and Rebates,
footnote 4. This proposed rule change also applies to the Complex
Quoting Symbols.

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    The Exchange notes that NASDAQ OMX PHLX, Inc. (``PHLX'') currently
has a $0.05 per contract differential between the fee it charges market
makers for complex orders in certain symbols and the fee it charges
directed (i.e., preferenced) market makers for the same
transactions.\9\ With this proposed rule change, ISE seeks to adopt the
$0.05 differential currently in place at PHLX.
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    \9\ See Section I, Rebates and Fees for Adding and Removing
Liquidity in Select Symbols, Part B. Complex Order at http://nasdaqomxphlx.cchwallstreet.com/NASDAQOMXPHLXTools/PlatformViewer.asp?selectednode=chp%5F1%5F4&manual=%2Fnasdaqomxphlx%2Fphlx%2Fphlx%2Drulesbrd%2F. see also Securities Exchange Act Release
No. 68202 (November 9, 2012), 77 FR 68856 (November 16, 2012) (the
``PHLX Approval Order'').
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    The Exchange notes that the fee differential currently between
Market Makers and preferenced Market Makers on ISE is $0.02 per
contract where a preferenced Market Maker is assessed the lower fee.
The Exchange is now proposing to increase the differential from $0.02
per contract to $0.05 per contract for complex order transactions to
reflect the increased costs that are incurred by such Market Makers
that enter into order flow arrangements at a cost and without the
benefit of a guaranteed allocation.\10\ The Exchange believes that in
order to attract Priority Customer complex orders in an intensely
competitive environment it must continue to adjust its fees and
rebates, which ultimately benefit all market participants.
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    \10\ The Exchange notes that under ISE Rule 722(b)(3), the
Exchange has the ability to provide Market Makers with a guaranteed
allocation and the Exchange may do so by designating on a class
basis where such guaranteed allocations would apply. The Exchange,
however, has not designated any class as such. In the event the
Exchange designates certain classes to provide Market Makers the
benefit of a guaranteed allocation in those classes, the discount
proposed in this filing will not apply to those preferenced Market
Makers in those classes of options designated by the Exchange.
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    Market Makers may be categorized as preferenced Market Makers when
such Market Makers execute against a Priority Customer order
preferenced to them for execution by an order flow provider. For
example, Market Maker ABCD is assessed the preferenced Market Maker fee
for trading against a Priority Customer order preferenced to it for
execution by an order flow provider. Market Maker ABCD is not assessed
the discounted preferenced Market Maker fee for executing a Priority
Customer order that is not preferenced to Market Maker ABCD, but rather
is assessed the full Market Maker fee.
    The Exchange notes that all Market Makers have the ability to
incentivize an order flow provider to preference an order if they
desire to enter into, for example, a payment for order flow arrangement
with an order flow provider. While all market participants enjoy the
benefits of the liquidity that such order flow brings to the market,
not all market participants incur the additional expense of paying an
order flow provider for such order flow. The Exchange believes that
this additional expense should be considered in assessing fees to
Market Makers that attract such order flow to the Exchange for the
benefit of all market participants.
    The Exchange proposes to implement this proposed rule change on a
pilot basis set to expire one (1) year from the date the proposed fees
become operative. In support of this proposed rule change, the Exchange
agrees to submit to the Commission on a monthly basis during the pilot
period certain summary data as the Commission may request regarding
this proposed fee change and make this data publicly available. The
data would include information with respect to rates of order
interaction of Priority Customer complex orders and rates of price
improvement, and an analysis of the effect of the fee differential upon
inter-market and intra-market competition. In addition, the Exchange
also agrees to submit data, and make it publicly available, on (1) the
rate of interaction with preferenced Priority Customer complex orders
by both preferenced Market Makers and non-preferenced Market Makers,
(2) the rates of price improvement for preferenced Priority Customer
complex orders that received price improvement by both preferenced
Market Makers and non-preferenced Market Makers, and (3) the percentage
of preferenced and non-preferenced Priority Customer complex orders
that received price improvement, and the average price improvement for
such orders, for the six months prior to the time that this proposed
fee became operative (i.e., July 2012 through December 2012) to allow
the Commission to analyze the impact of the proposed fee change.
    The Exchange represents that the proposed fee change will apply
only to equity options that are able to be listed and traded on more
than one options exchange. There will be no discount for Singly Listed
Symbols and FX Options Symbols.\11\ The Exchange further represents
that, prior to and at the time of a complex order transaction, Market
Makers, including preferenced Market Makers, are unaware of the
identity of the contra-party to the transaction and moreover, ISE Rule
400 titled ``Just and Equitable Principles of Trade'' is intended to
prohibit coordinated actions between preferenced Market Makers and
order flow providers, and that the Exchange proactively conducts
surveillance for, and enforces against, such violations.
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    \11\ Singly Listed Symbols and FX Options Symbols are identified
by their ticker symbol on the Exchange's Schedule of Fees. The
Exchange is not providing this fee discount to Singly Listed Symbols
and FX Options Symbols because these symbols are traded only on ISE
and therefore, the Exchange does not need to provide an incentive to
attract order flow in them.
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    The Exchange also proposes to make one non-substantive amendment to
the Exchange's Schedule of Fees. Specifically, the Exchange proposes to
remove footnote 7 under Section I, Regular Order Fees and Rebates, as
that footnote is no longer applicable. Footnote 7 was previously
applicable to Special Non-Select Penny Pilot Symbols (``SNS Symbols''),
a group of symbols that were a part of Section I of the Schedule of
Fees. The Exchange recently removed the SNS Symbols from the Schedule
of Fees in its entirety and moved them into the Select Symbols
category.\12\ The Exchange inadvertently failed to remove footnote 7
when it filed to remove the SNS Symbols and proposes to do so now.
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    \12\ See Securities Exchange Act Release No. 68240 (November 15,
2012), 77 FR 69905 (November 21, 2012) (SR-ISE-2012-88).
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    The Exchange is not proposing any other changes in this filing.
2. Statutory Basis
    The Exchange believes that its proposal to amend its Schedule of
Fees is consistent with Section 6(b) of the Securities and Exchange Act
of 1934 (the ``Act'') \13\ in general, and furthers the objectives of
Section 6(b)(4) of the Act \14\ in particular, in that it is an
equitable allocation of reasonable dues, fees and other charges among
Exchange members and other persons using its facilities.
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    \13\ 15 U.S.C. 78f(b).
    \14\ 15 U.S.C. 78f(b)(4).
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    The Exchange believes that it is reasonable, equitable and not
unfairly discriminatory to assess lower fees to preferenced market
makers that add or remove liquidity from the complex order book by
trading against Priority Customer orders that are preferenced to them
in the Select Symbols (excluding SPY), in SPY, in the Non-Select Penny
Pilot Symbols and in the Non-Penny Pilot Symbols, than the fee charged
to Market Makers because of the requisite quoting obligations
applicable to preferenced Market Makers. Preferenced Market Makers have
heightened and burdensome quoting obligations to the market which do
not apply to the non-

preferenced Market Makers or to other market participants and therefore
are assessed a lower fee when they transact with a Priority Customer
complex order that was preferenced to them for execution.\15\ Firm
Proprietary/Broker-Dealer, Non-ISE Market Maker \16\ and Professional
Customer \17\ orders are currently assessed a higher fee than Market
Makers while Priority Customers are not assessed a fee for removing
liquidity from the complex order book, as is the case on competing
exchanges.\18\
---------------------------------------------------------------------------

    \15\ Preferenced market makers are required to continuously
quote at least 90% of the series of an options class, whereas non-
preferenced market makers are required to quote only 60% of the
series of an options class. See ISE Rule 804(e).
    \16\ A Non-ISE Market Maker, or Far Away Market Maker
(``FARMM''), is a market maker as defined in Section 3(a)(38) of the
Securities Exchange Act of 1934, registered in the same options
class on another options exchange.
    \17\ A Professional Customer is a person who is not a broker/
dealer and is not a Priority Customer.
    \18\ Firm Proprietary/Broker-Dealer, Non-ISE Market Maker and
Professional Customer orders are currently charged $0.40 per
contract for removing liquidity in the Select Symbols (excluding
SPY) and in the Non-Select Penny Pilot Symbols, $0.41 per contract
for removing liquidity in SPY and $0.84 per contract for removing
liquidity in the Non-Penny Pilot Symbols whereas Market Maker orders
are currently charged $0.39 per contract for removing liquidity in
the Select Symbols (excluding SPY), in the Non-Select Penny Pilot
Symbols and in SPY and $0.82 per contract for removing liquidity in
the Non-Penny Pilot Symbols. see also PHLX Pricing Schedule at
http://nasdaqomxphlx.cchwallstreet.com/NASDAQOMXPHLXTools/PlatformViewer.asp?selectednode=chp%5F1%5F4&manual=%2Fnasdaqomxphlx%2Fphlx%2Fphlx%2Drulesbrd%2F.
---------------------------------------------------------------------------

    The Exchange operates in a highly competitive market in which
market participants can easily and readily direct order flow to
competing venues if they deem fee levels at a particular venue to be
excessive. ISE and the other options exchanges are engaged in an
intense competition on price (and other dimensions of competition) to
attract order flow from order flow providers. Accordingly, the fees
assessed by the Exchange must remain competitive with fees charged by
other venues and therefore must continue to be reasonable and equitably
allocated to those members that opt to send orders to the Exchange
rather than to a competing venue.
    In the PHLX Approval Order, the Commission employed a two part test
to evaluate whether PHLX's proposal to adopt a $0.05 per contract
differential was consistent with the Act. First, the Commission
examined whether the exchange making the proposal was subject to
significant competitive forces in setting the terms of its proposal.
The Commission noted that if the exchange making the proposal was
subject to significant competitive forces in setting the terms of its
proposal, the Commission will approve the proposal unless it determines
that there is a substantial countervailing basis to find that the terms
nevertheless fail to meet an applicable requirement of the Act or the
rules thereunder.
    With respect to the first part of the analysis, ISE notes that it
is subject to significant competitive forces in setting the terms of
any fee proposals, including this proposed fee change. The Commission
has previously found that there is significant competition for order
flow in the options markets.\19\ There currently are eleven registered
national securities exchanges that trade listed options. Competition in
the options market is evidenced by data PHLX provided in support of its
filing to adopt a $0.05 differential, noting that market share, based
on contract volume, among the options exchanges, as of 2012, ranged
from approximately less than 1% to 22% for equity options.\20\ Further,
six of the eleven options exchanges have rules that provide for the
trading of complex orders.\21\ Further, data regarding market share
among the options exchanges for complex orders also shows that there is
significant competition for order flow. For example, for June 1, 2012,
the market share for complex orders ranged from 3.39% for NYSE Arca,
which had 74,486 complex order trades, to 43.79% for ISE, which had
961,040 complex order trades.\22\ Moreover, the volume for complex
orders has been increasing over the past few years.\23\ Additionally,
the proposed fees will apply only to equity options that are able to be
listed and traded on more than one options exchange, and are therefore
subject to competition among the markets for order flow.\24\
---------------------------------------------------------------------------

    \19\ See Securities Exchange Act Release No. 61317 (January 8,
2010), 75 FR 2915 (January 19, 2010) (SR-ISE-2009-103) (finding that
the exchange was subject to significant competitive forces in
setting the terms of its proposal, including fees, and noting that
``the Exchange has a compelling need to attract order flow to
maintain its share of trading volume, imposing pressure on the
Exchange to act reasonably in establishing fees for these data
offerings'').
    \20\ See Letter from Joan C. Conley, Senior Vice President and
Corporate Secretary, NASDAQ OMX, dated July 26, 2012 (``PHLX
Letter'').
    \21\ See C2 Rule 6.13; CBOE Rules 6.42, 6.45, 6.53C; PHLX Rule
1080; NYSE Arca Rules 6.62(e), 6.91; NYSE MKT Rules 900.3NY(e),
963NY, 980NY.
    \22\ See PHLX Supporting Data, at http://www.sec.gov/comments/sr-phlx-2012-27/phlx201227-2.pdf.
    \23\ See Complex Orders Surge, Traders Magazine, March 2012
(noting increase in use of customer orders by customers at one
broker-dealer in 2011); see also BATS February 2012 Options Market
Update, at http://www.batstrading.com/resources/fee_schedule/2012/BATS-February-2012-USMarket-Update.pdf (noting that more volume is
being done through complex strategies, and that volume in the
complex order book has increased).
    \24\ There will be no discount for Singly Listed Symbols and FX
Options Symbols because these symbols are traded only on ISE and
therefore they are not subject to competition for order flow.
---------------------------------------------------------------------------

    With respect to second part of the analysis, the Exchange does not
believe that there is a substantial countervailing basis to find that
the proposed rule change fails to meet the requirements of the Act or
the rules thereunder. The Exchange notes that the fees for adding or
removing liquidity as proposed distinguish between preferenced Market
Makers and non-preferenced Market Makers, and would provide the
preferenced Market Makers a lower fee than non-preferenced Market
Makers when the preferenced Market Maker interacts with order flow that
has been preferenced to them. The Exchange notes in part that
preferenced Market Makers that execute against order flow in the
complex order book that has been preferenced to them do not have a
guaranteed allocation,\25\ unlike in the leg market, and that the
reduced fee for preferenced Market Makers is an attempt to confer an
additional benefit on preferenced Market Makers for the value they
provide in bringing order flow to the Exchange.
---------------------------------------------------------------------------

    \25\ See supra note 10.
---------------------------------------------------------------------------

    The Exchange further notes that increased order flow provides
better execution quality on the Exchange because customers enjoy
greater price transparency and executions at lower prices, and that
Market Makers to whom order flow is preferenced still must compete with
other Exchange participants to interact with that order flow to receive
the benefits of such arrangements. This increased order flow, and
corresponding greater execution quality, benefits all market
participants.
    The Commission has previously approved as consistent with the Act
rules of exchanges that provide preferenced Market Makers a guaranteed
allocation when they interact with preferenced order flow, based upon
their status as preferenced market makers.\26\ Likewise, preferenced
Market Makers on ISE would be charged a lower fee when they interact
with order flow preferenced to them, based on their status as
preferenced Market Makers.
---------------------------------------------------------------------------

    \26\ See Securities Exchange Act Release No. 51759 (May 27,
2005), 70 FR 32860 (June 6, 2005) (Order Approving SR-PHLX-2004-91).
---------------------------------------------------------------------------

    When approving the proposals that provided a guaranteed allocation
to preferenced market makers, the Commission found that the guaranteed
allocation for preferenced market makers would not affect the
incentives

of the trading crowd to compete aggressively for orders based on
price.\27\ The Exchange believes that the potential impact of a
guaranteed allocation on competition may be distinguished from the
potential impact of the reduced transaction fee on competition.
Specifically, the guaranteed allocation does not provide preferenced
market makers an explicit subsidy--in the form of lesser per contract
fees--over other market makers that are competing to execute against
the same order flow. Rather, the guaranteed allocation scheme allocates
portions of orders to other market makers who are at the same price as
the preferenced market maker, thus protecting the incentive of other
market makers to compete with preferenced market makers on price. In
contrast, assessing a lesser transaction fee on preferenced market
makers than other market makers when the preferenced market makers
interact with order flow preferenced to them may allow preferenced
market makers to execute against complex orders at more aggressive
prices than other market makers, which may reduce the incentive and
ability of such other market makers to compete with preferenced market
makers on price.
---------------------------------------------------------------------------

    \27\ Id.
---------------------------------------------------------------------------

    The Exchange has considered the potential impact of the fees for
adding and removing liquidity on preferenced Market Makers and the
$0.05 fee differential on competition between preferenced Market Makers
and other Market Makers that are competing to execute against the same
order flow. In the PHLX Approval Order, the Commission noted that for
the two months during which the PHLX $0.05 price differential was in
effect, there was no statistically significant adverse impact on the
competitiveness of the PHLX market for directed (i.e., preferenced)
customer complex orders. Given that the Exchange is proposing to
implement the same $0.05 cent differential for preferenced Priority
Customer complex orders, the Exchange believes there will not be any
statistical significant adverse impact of the proposed fee differential
on the competitiveness of the ISE market for preferenced Priority
Customer complex orders, or the extent of price improvement for
preferenced Priority Customer complex orders on the ISE. Nevertheless,
like PHLX, ISE is proposing to adopt the $0.05 discount for preferenced
Priority Customer complex orders on a pilot basis and will provide data
to the Commission to further evaluate whether there is any adverse
impact.\28\
---------------------------------------------------------------------------

    \28\ For purposes of studying the competitive impact of the
proposed fee change, ISE agrees to provide data on the rate of
interaction with preferenced Priority Customer complex orders by
both preferenced Market Makers and non-preferenced Market Makers.
This data will cover the six months prior to the time the proposed
fee was in effect. For the same time period, ISE also agrees to
provide data on rates of price improvement for preferenced Priority
Customer complex orders that received price improvement by both
preferenced Market Makers and non-preferenced Market Makers. For the
same time period, ISE also agrees to provide data on the percentage
of preferenced and non-preferenced Priority Customer complex orders
that received price improvement, and the average price improvement
for such orders.
---------------------------------------------------------------------------

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

    ISE does not believe that the proposed rule change will impose any
burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act. The Exchange believes this
proposal, which seeks to adopt a fee discount applicable to Market
Makers for executing orders that are preferenced to them, will enhance
competition because the Exchange is seeking to adopt a fee discount
that is already in place at one other exchange. The Exchange believes
that the proposed rule change will promote competition, as it is
designed to allow ISE to better compete for order flow and allow Market
Makers to execute more of their transactions on the Exchange and
therefore, improve the Exchange's competitive position. ISE also does
not believe that the proposed rule change will impose any burden on
competition among market participants on ISE that is not necessary or
appropriate in furtherance of the purposes of the Act because, as noted
above, preferenced Market Makers have heightened and burdensome quoting
obligations to the market that non-preferenced Market Makers or other
market participants do not have and therefore preferenced Market Makers
may be assessed a lower fee when they transact with Priority Customer
complex orders that are preferenced to them for execution.

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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act \29\ and subparagraph (f)(2) of Rule 19b-4
thereunder,\30\ because it establishes a due, fee, or other charge
imposed by ISE.
---------------------------------------------------------------------------

    \29\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \30\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

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-ISE-2013-05 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-ISE-2013-05. 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, 20549-1090, 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-ISE-
2013-05, and should be submitted on or before February 25, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\31\
---------------------------------------------------------------------------

    \31\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-02302 Filed 2-1-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 152 (Thursday, August 7, 2014)]
[Notices]
[Pages 46272-46274]
[FR Doc No: 2014-18662]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1088]

Center for Devices and Radiological Health: Experiential Learning
Program; General Training Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA), Center for Devices and
Radiological Health (CDRH or Center) is announcing a new component of
the Experiential Learning Program (ELP) identified as the ELP General
Training Program. This training component is intended to provide CDRH
staff with an opportunity to understand the policies, laboratory
practices, and challenges faced in broader disciplines that impact the
device development life cycle. The purpose of this document is to
invite medical device industry, academia, and health care facilities to
apply to participate in this formal training program for FDA's medical
device review staff, or to contact CDRH for more information regarding
the ELP General Training Program.

DATES: Submit either an electronic or written request for participation
in the ELP General Training Program by September 8, 2014.

ADDRESSES: Submit either electronic requests to http://www.regulations.gov or written requests to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify proposals with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Latonya Powell, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4448, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
FAX:<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    CDRH is responsible for ensuring the safety and effectiveness of
medical devices marketed in the United States. Furthermore, CDRH
assures that patients and providers have timely and continued access to
high-quality, safe, and effective medical devices and safe radiation-
emitting products. In support of this mission, the Center launched
various training and development initiatives to enhance performance of
its staff involved in regulatory review and

in the premarket review process. One of these initiatives, the ELP
Pilot, was launched in 2012 and fully implemented on April 2, 2013 (see
78 FR 19711).
    CDRH is committed to advancing regulatory science; providing
industry with predictable, consistent, transparent, and efficient
regulatory pathways; and helping to ensure consumer confidence in
medical devices marketed in the United States and throughout the world.
The ELP General Training Program component is intended to provide CDRH
staff with an opportunity to understand the policies, laboratory
practices, and challenges faced in broader disciplines that impact the
device development life cycle. This component is a collaborative effort
to enhance communication and facilitate the premarket review process.
Furthermore, CDRH is committed to understanding current industry
practices, innovative technologies, regulatory impacts, and regulatory
needs.
    These formal training visits are not a mechanism for FDA to
inspect, assess, judge, or perform a regulatory function (e.g.,
compliance inspection), but rather they are an opportunity to provide
CDRH review staff a better understanding of the products they review.
Through this notice, CDRH is formally requesting participation from
companies, academia, and clinical facilities, including those that have
previously participated in the ELP or other FDA site visit programs.

II. ELP General Training Program

A. ELP General Training Component

    In this training program, groups of CDRH staff will observe
operations at research, manufacturing, academia, and health care
facilities. The focus areas and specific areas of interest for visits
may include the following:

         Table 1--Areas of Interest: Office of Device Evaluation
------------------------------------------------------------------------
               Focus area                   Specific areas of interest
------------------------------------------------------------------------
Biocompatibility testing...............  Decisionmaking process for
                                          biocompatibility test
                                          selection; considerations for
                                          use of animal testing vs. in
                                          vitro testing; sample
                                          preparation of nanoscale,
                                          bioabsorbable, and in situ
                                          polymerized materials;
                                          evaluation of color additives.
Combination products...................  Devices coated with drug(s);
                                          drug delivery products.
Emerging manufacturing methods.........  3-D printing; additive
                                          manufacturing; additional or
                                          unique validation and
                                          verification activities.
Management of clinical trials for        Understanding clinical trial
 medical devices.                         infrastructure, roles,
                                          responsibilities, and
                                          relationships with other
                                          organizations involved in the
                                          management and conduct of
                                          clinical trials; challenges
                                          encountered in obtaining
                                          regulatory approval and
                                          successfully executing a
                                          clinical trial; issues related
                                          to early feasibility studies;
                                          institutional review boards;
                                          clinical research
                                          organizations.
Reprocessing and sterilization.........  Reprocessing challenges in the
                                          manufacturing or clinical
                                          environment; validation of
                                          reprocessing or sterilization
                                          instructions; simulated use
                                          testing; unique sterilization
                                          methods (e.g., use of flexible
                                          bags, sound waves, ultraviolet
                                          light, microwave radiation.)
------------------------------------------------------------------------

  Table 2--Areas of Interest: Office of In Vitro Diagnostic Devices and
                           Radiological Health
------------------------------------------------------------------------
               Focus area                   Specific areas of interest
------------------------------------------------------------------------
Manufacturing of in vitro diagnostic     Preanalytical devices (i.e.
 devices.                                 blood tubes), pathogen
                                          collection devices, micro
                                          collection/transport devices;
                                          general reagents, manual
                                          reagents; general assays,
                                          common point-of-care devices.
Instrument training of medical devices   Hands-on instrument and system
 (manufacturer or clinical laboratory).   training; clinical implication
                                          of common laboratory testing.
Quality system in manufacturing          Observation of implemented
 environments based on 21 CFR part 820.   quality systems practices
                                          based on current good
                                          manufacturing practices.
------------------------------------------------------------------------

B. Site Selection

    The Center will be responsible for CDRH staff travel expenses
associated with the site visits. CDRH will not provide funds to support
the training provided by the site to the ELP General Training Program.
Selection of potential facilities will be based on CDRH's priorities
for staff training and resources available to fund this program. In
addition to logistical and other resource factors, all sites must have
a successful compliance record with FDA or another Agency with which
FDA has a memorandum of understanding. If a site visit involves a visit
to a separate physical location of another firm under contract with the
site, that firm must agree to participate in the ELP General Training
program and must also have a satisfactory compliance history.

III. Request for Participation

    Submit proposals for participation with the docket number found in
the brackets in the heading of this document. Received requests 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.
    The proposal should include a description of your facility relative
to focus areas described in table 1or 2. Please include the Area of
Interest (see table 1or 2) that the site visit will demonstrate to CDRH
staff, a contact person, site visit location(s), length of site visit,
proposed dates, and maximum number of CDRH staff that can be
accommodated during a site visit. Proposals submitted without this
minimum information will not be considered. In addition, please include
an agenda outlining the proposed training for the site visit. A sample
request and agenda are available on the ELP Web site at http://www.fda.gov/downloads/ScienceResearch/ScienceCareerOpportunities/UCM392988.pdf and http://

www.fda.gov/scienceresearch/sciencecareeropportunities/ucm380676.htm.

    Dated: July 31, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-18662 Filed 8-6-14; 8:45 am]
BILLING CODE 4164-01-P


% Predict blood CPY and urine TCPY levels
% Drinking water concentrations from Orestimba Creek Site 3 120 days.xlsx
% Infants
% Cecilia Tan
% Jan 21, 2016

% Setting model parameters
use human_parameters_MRP
use preg_female_parameters
BWSW=1;		% Set BW to a fixed value
BWST=4.8;	% Set BW to 4.8 kg
PREG=0;		% Not pregnant
DT(1) = 0.0;
TSTOP=2880; 	% Exposure duration in hrs

%TO READ IN DOSES FROM AN EXCEL SPREADSHEET. must be saved as .xls
VOLUME=0.68557  % Water consumption volume in L/DAY
EVENTS=6        % Drinking frequency per day
DT = xlsRead("Drinkingwater.xls", "Creek", "D2:D722") ; % Dosing Times
AMTCDOSE=xlsRead("Drinkingwater.xls", "Creek", "E2:E722")*VOLUME/EVENTS; % Dose in ug/l
prepare time rbcce cv urinetcpy cvo
start@nocallback

%Output RBC AChE, Urine TCPy, venous blood conc of CPF, venous blood conc of oxon
mytable = [_time _rbcce _urinetcpy _cv*350.6 _cvo*334.5]; % Output unit ug/L for concentrations
save mytable @file='orestimba_infant_01222016.txt' @format=ascii


[Federal Register Volume 80, Number 110 (Tuesday, June 9, 2015)]
[Proposed Rules]
[Pages 32522-32523]
[FR Doc No: 2015-13946]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2015-0311; FRL-9928-67-Region 3]

Approval and Promulgation of Air Quality Implementation Plans;
Pennsylvania; 2011 Lead Base Year Emissions Inventory

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) proposes to approve
the State Implementation Plan (SIP) revision submitted by the
Commonwealth of Pennsylvania regarding the 2011 lead base year
emissions inventory. The base year emissions inventory SIP revision was
submitted to meet the requirements of the Clean Air Act (CAA) for the
Lyons 2008 lead National Ambient Air Quality Standards (NAAQS)
nonattainment area (hereafter referred to as the ``Lyons Area'' or
``Area''). In the Rules and Regulations section of this Federal
Register, EPA is approving the Commonwealth's SIP submittal as a direct
final rule without prior proposal because the Agency views this as a
noncontroversial submittal and anticipates no adverse comments. A more
detailed description of the SIP submittal and EPA's evaluation is
included in a Technical Support Document (TSD) prepared in support of
this rulemaking action. A copy of the TSD is available, upon request,
from the EPA Regional Office listed in the ADDRESSES section of this
document or is also available electronically within the Docket for this
rulemaking action. If no adverse comments are received in response to
this action, no further activity is contemplated. If EPA receives
adverse comments, the direct final rule will be withdrawn and all
public comments received will be addressed in a subsequent final rule
based on this proposed rule. EPA will not institute a second comment
period. Any parties interested in commenting on this action should do
so at this time.

DATES: Comments must be received in writing by July 9, 2015.

ADDRESSES: Submit your comments, identified by Docket ID Number EPA-
R03-OAR-2015-0311 by one of the following methods:
    A. www.regulations.gov. Follow the on-line instructions for
submitting comments.
    B. Email<EMAIL_ADDRESS>    C. Mail: EPA-R03-OAR-2015-0311, Cristina Fernandez, Associate
Director, Office of Air Program Planning, Mailcode 3AP30, U.S.
Environmental Protection Agency, Region III, 1650 Arch Street,
Philadelphia, Pennsylvania 19103.
    D. Hand Delivery: At the previously-listed EPA Region III address.
Such deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-R03-OAR-
2015-0311. EPA's policy is that all comments received will be included
in the public docket without change, and may be made available online
at www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through www.regulations.gov or email. The
www.regulations.gov Web site is an ``anonymous access'' system, which
means EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an email comment
directly to EPA without going through www.regulations.gov, your email
address will be automatically captured and included as part of the
comment that is placed in the public docket and made available on the

Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the electronic docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI 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 in www.regulations.gov or
in hard copy during normal business hours at the Air Protection
Division, U.S. Environmental Protection Agency, Region III, 1650 Arch
Street, Philadelphia, Pennsylvania 19103. Copies of the submittal are
available at the Pennsylvania Department of Environmental Protection,
Bureau of Air Quality Control, P.O. Box 8468, 400 Market Street,
Harrisburg, Pennsylvania 17105.

FOR FURTHER INFORMATION CONTACT: Ellen Schmitt,<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: For further information, please see the
information provided in the direct final action with the same title,
``Approval and Promulgation of Air Quality Implementation Plans;
Pennsylvania; 2011 Lead Base Year Emissions Inventory,'' that is
located in the ``Rules and Regulations'' section of this Federal
Register publication.

    Dated: May 20, 2015.
William C. Early,
Acting Regional Administrator, Region III.
[FR Doc. 2015-13946 Filed 6-8-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: June 12, 2009 (Volume 74, Number 112)]
[Rules and Regulations]
[Page 27932-27934]
[DOCID:fr12jn09-10]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2008-1261]
RIN 1625-AA00

Safety Zone; AVI July Fireworks Display; Laughlin, NV

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a safety zone on the navigable
waters of the lower Colorado River, Laughlin, NV, in support of a
fireworks display near the AVI Resort and Casino. This 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 through, or anchoring within this safety zone unless
authorized by the Captain of the Port, or his designated
representative.

DATES: This rule is effective from 8:15 p.m. to 9:15 p.m. on July 4,
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-2008-1261 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-2008-1261 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
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.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call or e-mail Petty Officer Shane Jackson, Waterways
Management, Coast Guard; telephone<PHONE_NUMBER>, e-mail
<EMAIL_ADDRESS>If you have questions on viewing the docket,
call Renee V. Wright, Program Manager, Docket Operations, telephone
202-366-9826.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    On April 20, 2009 we published a notice of proposed rulemaking
(NPRM) entitled ``Safety zone; AVI July Fireworks Display; Laughlin,
Nevada,'' in the Federal Register (74 FR 17931). We received no
comments on the proposed rule. No public meeting was requested, and
none was held.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register because delaying the effective date
would be contrary to the public interest, since immediate action is
needed to ensure the public's safety.

Background and Purpose

    The AVI Resort and Casino is sponsoring the AVI July fireworks
display, which is to be held at the AVI Resort and Casino on the Lower
Colorado River in Laughlin, Nevada. The Coast Guard is establishing a
temporary safety zone on the navigable waters of the Lower Colorado
River, Laughlin, NV in support of the AVI July fireworks display. The
safety zone is set as a 1000 foot radius around the firing site in
approximate position: 35[deg]00'45'' N, 114[deg]38'18'' W. This
temporary safety zone is necessary to provide for the safety of the
show's crew, spectators, participants of the event, participating
vessels, and other vessels and users of the waterway.

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.
    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
designated safety zone during the specified times.

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 Colorado River from 8:15 p.m. to
9:15 p.m. on July 4, 2009. This safety zone will not have a significant
economic impact on a substantial number of small entities for the
following reasons. The safety zone will only be in effect for one hour
late in the evening when vessel traffic is low. Before the effective
period, we 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 023-01 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
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. This rule involves establishment of a
safety zone.
    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, and 160.5;
Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

0
2. Add new temporary zone Sec.  165.T11-167 to read as follows:

Sec.  165.T11-167  Safety zone; AVI July Fireworks Display; Laughlin,
Nevada.

    (a) Location. The following area is a safety zone: the navigable
waters extending out 1000 feet from the firing site located at
approximately 35[deg]00'45'' N, 114[deg]38'18'' W.
    (b) Enforcement Period. This rule will be enforced from 8:15 p.m.
to 9:15 p.m. on July 4, 2009. If the need for the safety zone ends
before the scheduled termination time, the Captain of the Port will
cease enforcement of this safety zone.
    (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 16.
    (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: May 27, 2009.
T.H. Farris,
Captain, U.S. Coast Guard, Captain of the Port San Diego.
[FR Doc. E9-13776 Filed 6-11-09; 8:45 am]

BILLING CODE 4910-15-P