[Federal Register Volume 81, Number 109 (Tuesday, June 7, 2016)]
[Proposed Rules]
[Pages 36488-36490]
[FR Doc No: 2016-13323]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR part 165

[Docket Number USCG-2016-0347]
RIN 1625-AA00

Safety Zone; Fourth of July Fireworks Murrells Inlet, SC

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard proposes to establish a temporary safety zone
in the navigable waters of Murrells Inlet, SC. This safety zone is
necessary to protect the public from hazards associated with launching
fireworks over navigable waters of the United States. This proposed
rulemaking would prohibit persons and vessels from being in the safety
zone unless authorized by the Captain of the Port Charleston or a
designated representative. We invite your comments on this proposed
rulemaking.

DATES: Comments and related material must be received by the Coast
Guard on or before June 22, 2016.

ADDRESSES: You may submit comments identified by docket number USCG-
2016-0347 using the Federal eRulemaking Portal at http://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
proposed rulemaking, call or email Lieutenant John Downing, Sector
Charleston Office of Waterways Management, Coast Guard; telephone (843)
740-3184, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background, Purpose, and Legal Basis

    On April 22, 2016, The Marsh Walk Group notified the Coast Guard
that it will be conducting a fireworks display from 9:30 p.m. to 9:50
p.m. on July 4, 2016. The fireworks are to be launched from the end of
the Veterans Fishing Pier in Murrells Inlet, SC. Hazards from firework
displays include accidental discharge of fireworks, dangerous
projectiles, and falling hot embers or other debris. The Captain of the
Port Charleston (COTP) has determined that potential hazards associated
with the fireworks to be used in this display would be a safety concern
for anyone within a 500-yard radius of the pier.
    The purpose of this rulemaking is to ensure the safety of vessels
and the navigable waters within a 500-yard radius of the fireworks
barge before, during, and after the scheduled event. The Coast Guard
proposes this rulemaking under authority in 33 U.S.C. 1231.

III. Discussion of Proposed Rule

    The COTP proposes to establish a safety zone from 9:15 p.m. to 10
p.m. on July 4, 2016. The safety zone would cover all navigable waters
within 500 yards of the Veterans pier located on the Atlantic Ocean.
The duration of the zone is intended to ensure the safety of vessels
and these navigable waters before, during, and after the scheduled 9:30
to 9:50 p.m. fireworks display. No vessel or person would be permitted
to enter the safety zone without obtaining permission from the COTP or
a designated representative. The regulatory text we are proposing
appears at the end of this document.

IV. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and Executive orders related to rulemaking. Below we summarize our
analyses based on a number of these statutes and Executive orders and
we discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13563 emphasizes the importance of
quantifying both costs and benefits, of reducing costs, of harmonizing
rules, and of promoting flexibility. This NPRM has not been designated
a ``significant regulatory action,'' under Executive Order 12866.
Accordingly, the NPRM has not been reviewed by the Office of Management
and Budget.
    This regulatory action determination is based on the size,
location, duration, and time-of-day of the safety zone. Vessel traffic
would be able to safely transit around this safety zone which would
impact a small designated area of the Atlantic Ocean for less than 1
hour during the evening when vessel traffic is normally low. Moreover,
the Coast Guard would issue a Broadcast Notice to Mariners via VHF-FM
marine channel 16 about the zone, and the rule would allow vessels to
seek permission to enter the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. 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
proposed rule would not have a significant economic impact on a
substantial number of small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
IV.A above this proposed rule would not have a significant economic
impact on any vessel owner or operator.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the rule would affect
your small business, organization, or governmental jurisdiction and you
have questions concerning its provisions or options for compliance,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section. The Coast Guard will not retaliate against small entities that
question or complain about this proposed rule or any policy or action
of the Coast Guard.

C. Collection of Information

    This proposed rule would not call for a new collection of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has 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. We have analyzed this proposed rule under that Order and
have determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would 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. If
you believe this proposed rule has implications for federalism or
Indian tribes, please contact the person listed in the FOR FURTHER
INFORMATION CONTACT section.

E. 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 proposed rule would not
result in such an expenditure, we do discuss the effects of this rule
elsewhere in this preamble.

F. Environment

    We have analyzed this proposed 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 (42 U.S.C. 4321-4370f), and have made
a preliminary determination that this action is one of a category of
actions that do not individually or cumulatively have a significant
effect on the human environment. This proposed rule involves a safety
zone lasting less than 1 hour that would prohibit entry within 500
yards of the Veterans Pier. Normally such actions are categorically
excluded from further review under paragraph 34(g) of Figure 2-1 of
Commandant Instruction M16475.lD. A preliminary environmental analysis
checklist and Categorical Exclusion Determination are available in the
docket where indicated under ADDRESSES. We seek any comments or
information that may lead to the discovery of a significant
environmental impact from this proposed rule.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places, or vessels.

V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, you may review a Privacy Act notice regarding the Federal
Docket Management System in the March 24, 2005, issue of the Federal
Register (70 FR 15086).
    Documents mentioned in this NPRM as being available in the docket,
and all public comments, will be in our online docket at http://www.regulations.gov and can be viewed by following that Web site's
instructions. Additionally, if you go to the online docket and sign up
for email alerts, you will be notified when comments are posted or a
final rule is published.

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 proposes
to amend 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; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1,
6.04-6, and Department of Homeland Security Delegation No. 0170.1.

0
2. Add a temporary Sec.  165.T07-0347 under the undesignated center
heading Seventh Coast Guard District to read as follows:

Sec.  165.T07-0347  Safety Zone; Fourth of July Fireworks Murrells
Inlet, SC.

    (a) This rule establishes a safety zone on all Atlantic Ocean
waters within a 500 yard radius of Veterans Pier, from which fireworks
will be launched.
    (b) Definition. The term ``designated representative'' means Coast
Guard Patrol Commanders, including Coast Guard coxswains, petty
officers, and other officers operating Coast Guard vessels, and
Federal, state, and local officers designated by or assisting the
Captain of the Port Charleston in the enforcement of the regulated
areas.
    (c) Regulations. (1) All persons and vessels are prohibited from
entering, transiting through, anchoring in, or remaining within the
regulated area unless authorized by the Captain of the Port Charleston
or a designated representative.
    (2) Persons and vessels desiring to enter, transit through, or
remain within the regulated area may contact the Captain of the Port
Charleston by telephone at<PHONE_NUMBER>, or a designated representative
via VHF radio on channel 16, to request authorization. If authorization
to enter, transit through, or remain within the regulated area is
granted by the Captain of the Port Charleston or a designated
representative, all persons and vessels receiving such authorization
must comply with the instructions of the Captain of the Port Charleston
or a designated representative.
    (3) The Coast Guard will provide notice of the regulated area by
Local Notice to Mariners, Broadcast Notice to Mariners, and on-scene
designated representatives.
    (d) Enforcement Period. This rule will be enforced on July 4, 2016
from 9:15 p.m. until 10 p.m.

    Dated: May 31, 2016.
G.L. Tomasulo,
Captain, U.S. Coast Guard Captain of the Port Charleston.
[FR Doc. 2016-13323 Filed 6-6-16; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: November 9, 2007 (Volume 72, Number 217)]
[Notices]
[Page 63643-63646]
[DOCID:fr09no07-107]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

Environmental Impact Statement for the Expanded Moynihan/Penn
Station Redevelopment Project, New York, NY

AGENCY: Federal Railroad Administration (FRA), U.S. Department of
Transportation (DOT).

ACTION: Notice of intent to prepare an Environmental Impact Statement.

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SUMMARY: FRA is issuing this notice to advise the public that it will
jointly prepare an environmental impact statement (EIS) with the New
York State Urban Development Corporation d/b/a Empire State Development
Corporation (ESDC) to assess the proposed Expanded Moynihan/Penn
Station Redevelopment Project (the project) in New York City. The
project is a comprehensive public/private development initiative to
adaptively reuse the historic James A. Farley Building and the Western
Annex (collectively referred to as the Farley Complex) as a new train
station (Moynihan West) and relocated Madison Square Garden, to
reconstruct critical station and circulation elements at the existing
Pennsylvania Station (Penn Station) referred to herein as Moynihan
East, and to implement transit-oriented private development.
    FRA is issuing this notice to solicit public and agency input into
the development of the scope of the EIS and to advise the public that
outreach activities conducted by ESDC and its representatives will be
considered in the preparation of the EIS. The EIS will be prepared in
accordance the National Environmental Policy Act of 1969 (NEPA, 42
U.S.C. 4321 et seq.) and the applicable regulations implementing NEPA
as set forth in 40 CFR 1500-1508, FRA's Procedures for Considering
Environmental Impacts found at 64 FR 28545 (May 26, 1999), and the New
York State Environmental Quality Review Act (SEQRA) and its
implementing regulations found at 6 New York Code of Rules and
Regulations Part 617. The EIS will also address as necessary Section
106 of the National Historic Preservation Act, Section 4(f) of the U.S.
Department of Transportation Act of 1966 (49 U.S.C. 303) (DOT Act) and
other applicable federal and state laws and regulations.
    The EIS will evaluate a ``Preferred Alternative,'' a ``No Action
Alternative'' and various build alternatives that modify elements of
the Preferred Alternative. There are two options under consideration
for the Preferred Alternative. Under either of these options, the
development of the Project would occur at the Farley Complex (Block
755) owned by ESDC and bounded by Ninth Avenue to the west, Eighth
Avenue to the east, West 31st Street to the south and West 33rd Street
to the north; the Penn Station Block (Block 781) bounded by Eighth
Avenue to the west, Seventh Avenue to the east, West 31st Street to the
south and West 33rd Street to the north; the Railroad Service Building
(Block 780, Lot 60) located mid-block on West 31st Street across the
street from Penn Station; the eastern and western portions of the One
Penn Plaza Block (Block 783) bounded by Eighth and Seventh Avenues and
West 33rd to West 34th Streets; and the United States Postal Service
(USPS) Morgan Facility and Annex located on two full blocks (Blocks 726
and 727) bounded by Tenth Avenue to the west, Ninth Avenue to the east
and between West 28th and West 30th Streets ESDC may also acquire
properties on one or more blocks immediately adjacent to the Penn
Station Block to facilitate the construction of a loading dock and
other support facilities for Moynihan Station, and to otherwise further
the goals of the project.
    In addition, under one of the two options being considered, the
City of New York would establish a new zoning subdistrict (the
Subdistrict Option). This Subdistrict Option would allow development
rights from the Penn Station Block to be transferred under certain
specified conditions to receiving sites located within the subdistrict
and at prescribed maximum floor areas. It is anticipated that the
boundaries of the proposed subdistrict would include approximately 20
city blocks surrounding the Penn Station Block, extending as far south
as West 28th Street, as far north as West 36th Street, as far east as
within 200 feet west of Fifth Avenue, and as far west as 200 feet west
of Ninth Avenue.
    In a related zoning action to be examined in the EIS, the City, in
connection with the Subdistrict Option only, has proposed to change the
underlying zoning classifications for a number of lots or blocks within
the proposed subdistrict from manufacturing and commercial uses (M1-5,
M1-6, C6-3X, C6-4X and C6-4M) to C6-4. This zoning change, if adopted
by the City, would allow residential uses in certain areas where such
uses are not currently permitted by zoning.

DATES: A public scoping meeting will be held on December 6, 2007 in the
Farley Building, 380 West 33rd Street, Room 4500, New York, NY from 4
to 8 p.m. A presentation will be made at 4:30 p.m. followed by the
opportunity for the public to comment on the scope of the EIS. Those
wishing to speak are required to register at the meeting location. At
the meeting, comments may also be submitted in written form.
    Persons interested in providing written comments on the scope of
the EIS should do so by December 17, 2007. Comments should be sent to
Rebecca Pellegrini, Moynihan Station Development Corporation, 633 Third
Avenue, 36th Floor, New York, NY 1017 or Mr. John Winkle, FRA at the
address identified below.

FOR FURTHER INFORMATION CONTACT: For further information regarding the
environmental review, please contact: Arnold J. Carter, Sr. Vice
President, Communications, Empire State Development Corporation, 633
Third Avenue, New York, NY 10017,<PHONE_NUMBER>, or Mr. John Winkle,
Transportation Industry Analyst, Federal Railroad Administration, 1120
Vermont Avenue, NW., Mail Stop 20, Washington DC 20590, telephone (202)
493-6067.

SUPPLEMENTARY INFORMATION
    I. Description of Project. The proposed Expanded Moynihan Project/
Penn Station Redevelopment Project is a comprehensive initiative,
conceived to address and fulfill the following specific needs and
purposes: to create a modern, iconic, and efficient major
transportation hub that improves circulation and passenger and
pedestrian capacity of the Penn Station complex and expands railroad
capacity and throughput; to create a financially viable and dynamic
mixed-use rail- and transit-oriented development; to restore and
preserve an important historic resource; and to provide a unique
opportunity to build a modern and efficient Madison Square Garden arena
at a major transit hub.
    The development program at full build-out would include:
redevelopment of the Farley Complex with a new Moynihan West train
station and a new, relocated Madison Square Garden arena; the
construction of a rebuilt rail station (the Moynihan East train
station) with improved circulation and train halls to replace the
existing the Penn Station; the construction of up to 5.4 million square
feet in mixed-use development allowed by the zoning of the Penn Station
Block (accommodated through on-site development at the Penn Station
block or, alternatively, in the subdistrict option, through a
combination of 1.1 million square feet at the Penn Station Block and
4.3 million square feet of development in the proposed subdistrict);
the construction of an up to approximately 2 million square foot
commercial building on the eastern portion of the One Penn Plaza Block
at the Penn East site; the construction of a 125,000 square foot retail
building on the western portion of the One Penn Plaza Block at the Penn
West Site (and under the Subdistrict Option, a larger commercial and
retail building at the Penn West Site using 875,000 square feet of
development rights from the Penn Station Block); renovation of the
Railroad Service

building for railroad service, administration or other uses; possible
expansion of the Morgan Annex to accommodate the transfer of USPS
operations from the Farley Complex (it is assumed that USPS retail
services, however, would be located elsewhere in the project area if
they do not remain in the Farley Complex); in one potential
configuration, the construction of a loading dock and other station-
related support facilities on one or more blocks immediately adjacent
to the Penn Station Block; and other new commercial and residential
development within the proposed subdistrict as a result of a related
zoning action by the City of New York and the transfer of development
rights from the Farley Complex.
    II. Previous Environmental Reviews. The development of plans for
improved New York City passenger facilities has been underway since as
early as 1991 when the National Railroad Passenger Corporation (Amtrak)
began planning for a new intermodal transportation facility. The
potential availability of the Farley Complex led to additional efforts
to devise plans that incorporated passenger rail facilities in the
Farley Complex. A series of environmental reviews have accompanied the
various proposals for improvements to the Penn Station facilities and
site, including most recently draft and final environmental impact
statements that were issued by ESDC under SEQRA in January 31, 2005 and
April 27, 2006 respectively. While FRA and the USPS participated with
ESDC in the preparation of these SEQRA documents, they were not NEPA
documents and did not attempt to specifically satisfy NEPA
requirements. The EIS that is the subject of this notice of intent will
completely evaluate all of the environmental impacts of the currently
proposed actions under NEPA and SEQRA and serve as an original EIS for
the FRA but as a supplemental EIS for ESDC given its prior efforts
under the 2005/2006 state SEQRA EIS process.
    III. Problem Identification/Purpose and Need. The principal public
purpose of the project is the improvement of transportation facilities
above the existing Penn Station tracks and platforms. The Penn Station
complex is America's busiest passenger transportation facility,
handling over 550,000 people daily, which is more than Kennedy,
LaGuardia and Newark Liberty airports combined. Yet the present
station--a three-level, largely subterranean complex designed to handle
200,000 passengers per day--is inadequate to meet the needs of today's
passengers. The station is already operating above its design capacity
and is expected to experience a rapidly growing passenger load due to,
among other factors, the growth of the Midtown business district and
the development expected as a result of the Hudson Yards Rezoning.
    By rebuilding Penn Station and expanding it within the Farley
Complex, the project aims to improve the functionality and capacity of
station facilities, increase the reliability and sustainability of the
station, and create an architecturally distinctive and welcoming
facility that is easily navigable and understood both within the
facility and at street level. Further, the project would resolve
existing deficiencies in Penn Station that include pedestrian crowding,
insufficient passenger waiting areas, confusing circulation,
insufficient and outmoded employee facilities, and poor station
identification and visibility within the surrounding area. By
significantly increasing the amount of public space in the train
station, the combination of both the east and west station elements
creates an opportunity to establish wider concourses and improved
connections to a renovated and expanded Penn Station, grand entrances
from Eighth Avenue, and sky-lit train halls.
    Another primary goal of the proposed project is the preservation of
major portions of the historic Farley Complex, including the exterior,
notably the Eighth Avenue entrance and monumental stairs, and certain
interior spaces, such as the USPS retail lobby and the New York
Postmaster's office. The adaptive reuse of the historic Farley Complex
would reflect the original Pennsylvania Station's role as a
transportation resource and civic gateway, while preserving and
restoring a designated local landmark and National Register property.
    The project includes major private sector components as well. Based
on an extensive ESDC Developer Selection Process, ESDC conditionally
designated a joint venture of the Related Companies and Vornado Realty
Trust (the Venture) as project developers in July 2005. The Venture has
proposed a revised development program that includes relocating Madison
Square Garden to the Western Annex of the Farley Building and rail- and
transit-oriented development at Penn Station and nearby development
sites. The relocation of Madison Square Garden to the Farley Complex
will enable Madison Square Garden to retain its status as an important
civic facility that hosts sporting events, political conventions,
memorial services, and related activities.
    The proposed project would include mixed-use high-rise development
constructed above and around the new Moynihan Station with up to 5.4
million square feet of zoning floor area on the Penn Station block (or,
in the Subdistrict Option, 1.1 million square feet of new retail
development at the Penn Station block and 4.3 million square feet of
zoning floor of development in the surrounding area) and approximately
2.125 million square feet on an adjacent block (the Penn East and West
development sites). This development takes advantage of its unique
location at a large transportation hub and is consistent with New York
State and City public policy that promotes transit-oriented
development. Additional transit-oriented development may result from a
rezoning that has been proposed by the City of New York in connection
with the subdistrict option and by the utilization of unused
development rights from the Farley Complex at other sites within the
subdistrict.
    As a high-profile and large-scale public and private development
initiative, the proposed project is intended to be a leader in
incorporating sustainable development principles in its design and
construction. While the planning, design, and construction techniques
are still being developed, it is anticipated that buildings located at
the Farley Complex, at Penn East and Penn West and on the Penn Station
Block will seek to achieve recognition under the Leadership in Energy
and Environmental Design (LEED) standards as established by the U.S.
Green Building Council and in conformance with city, state, and federal
agency initiatives to integrate sustainable design standards in public
development projects.
    The principal identified federal government roles at this stage of
project development that trigger the application of NEPA (and related
environmental and historic preservation statutes and regulations)
involve the availability of federal funds appropriated by Congress to
the FRA and other Department of Transportation operating
administrations for improvements to Penn Station incorporating the
James A. Farley Building, and FRA's statutory oversight
responsibilities with respect to Amtrak. FRA does not have a role in
the relocation of Madison Square Garden to the Western Annex or the
development of the mixed-use high rise components of the project, both
as proposed by the Venture. Other federal agencies, including but not
limited to USPS, may

participate, as cooperating agencies in the environmental review to the
extent other federal actions subject to NEPA are identified.
    IV. Alternatives to be Considered. The EIS will consider the
Preferred Alternative as established by ESDC, a No Action Alternative
and a number of different build alternatives that would modify elements
of the Preferred Alternative. These alternatives will consider ways to
accommodate truck loading facilities at or near the new station and
private development, as well as different sizes and configurations of
the proposed development.
    V. Probable Effects. The FRA and ESDC will evaluate both project-
specific and cumulative changes to the social, economic and physical
environment--including land use and socioeconomic conditions, community
facilities and services, open space, shadows, water resources, historic
and archaeological resources, visual character and aesthetics,
contaminated and hazardous materials, transportation, air quality,
noise and vibration, infrastructure, environmental justice, and
cumulative and secondary effects. The analysis will be undertaken
consistent with NEPA, the Council on Environmental Quality regulations,
Section 106 of the National Historic Preservation Act, Section 4(f) of
the DOT Act and SEQRA, along with other applicable federal and state
regulations.
    VI. Scoping Process. FRA invites all interested individuals,
organizations, and federal, state, and local agencies to comment on the
scope of the EIS. Comments are encouraged on specific social, economic,
or environmental issues to be evaluated, on the purpose and need for
the project, and on reasonable alternatives that may be less costly,
more cost effective or have fewer environmental impacts while achieving
similar transportation and other objectives. ESDC has also prepared a
detailed draft scope of analysis as required under SEQRA and the draft
scope may be obtained from ESDC's Web site: http://www.empire.state.ny.us/default.asp
 or from the contacts identified

above.
    ESDC will be leading the outreach activities during the public
scoping process, beginning with the scoping meeting identified under
DATES above. Additional opportunities for public participation will be
announced through mailings, notices, advertisements and press releases.

    Issued in Washington, DC, on October 31, 2007.
Mark Yachmetz,
Associate Administration for Railroad Development.
[FR Doc. E7-22069 Filed 11-8-07; 8:45 am]

BILLING CODE 4910-06-P


[Federal Register Volume 87, Number 86 (Wednesday, May 4, 2022)]
[Rules and Regulations]
[Pages 26273-26276]
[FR Doc No: 2022-09577]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2022-0291]
RIN 1625-AA00

Safety Zones; Pensacola, Panama City, and Tallahassee, Florida

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing three temporary safety zones
for the reentry of a capsule launched by Space Exploration Technologies
Corporation (Space X) in support of the National Aeronautics and Space
Administration (NASA) Crew-3 capsule recovery mission. These three
temporary safety zones are located within the Coast Guard Sector Mobile
area of responsibility offshore of Pensacola, Panama City, and
Tallahassee, Florida. The purpose of this rule is to ensure the safety
of vessels, mariners, and the navigable waters in the safety zones
during a period when reentry is expected. This action is necessary to
provide for the safe recovery of this capsule and astronauts in the
U.S. Exclusive Economic Zone and implements a special activities
provision of the William M. (Mac) Thornberry National Defense
Authorization Act for Fiscal Year 2021. This rule prohibits U.S.
flagged vessels from entering the safety zones unless authorized by the
Captain of the Port Mobile or a designated representative.

DATES: This rule is effective without actual notice from May 4, 2022
until May 15, 2022. For the purposes of enforcement, actual notice will
be used from May 1, 2022 until May 4, 2022.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2022-0291 in the search box and click ``Search.'' Next, in the Document
Type column, select ``Supporting & Related Material.''

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Lieutenant Andrew Anderson, Sector Mobile Chief of
Waterways (spw), U.S. Coast Guard; telephone<PHONE_NUMBER>, email
[email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port
DHS Department of Homeland Security
EEZ Exclusive Economic Zone
FR Federal Register
NASA National Aeronautics and Space Administration
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code
Space X Space Exploration Technologies Corporation

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary 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 impracticable and contrary to
the public interest. The National Aeronautics and Space Administration
(NASA) Crew-3 capsule recovery mission was approved and scheduled less
than 30 days before the need for the three safety zones to be in place
starting on May 1, 2022. Publishing an NPRM would be impracticable and
contrary to the public interest since the missions would begin before
completion of the rulemaking process, thereby inhibiting the Coast
Guard's ability to protect against the hazards associated with the
recovery missions.
    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. Delaying the effective date of
this rule would be impracticable and contrary to the public interest
because

the temporary safety zones must be established by May 1, 2022, to
mitigate safety concerns during the capsule recovery missions.

III. Legal Authority and Need for Rule

    On January 1, 2021, the William M. (Mac) Thornberry National
Defense Authorization Act for Fiscal Year 2021 (Pub. L. 116-283)
(Authorization Act) was enacted. Its section 8343 (134 Stat. 4710)
calls for the Coast Guard to conduct a 2-year pilot program to
establish and implement a process to establish safety zones to address
special activities in the Exclusive Economic Zone (EEZ).\1\ These
special activities include space activities carried out by United
States citizens. Terms used to describe space activities, including
reentry site, and reentry vehicle, are defined in 51 U.S.C. 50902.
---------------------------------------------------------------------------

    \1\ The Coast Guard defines the Exclusive Economic Zone in 33
CFR 2.30.
---------------------------------------------------------------------------

    The Captain of the Port Mobile has determined that potential
hazards associated with the NASA Crew-3 capsule recovery mission
presents a safety concern for anyone within the perimeter of the three
safety zones. The safety zones will only be activated when a reentry
vehicle is approaching a reentry site and will be deactivated once the
reentry vehicle is removed from the reentry site. The purpose of this
rule is to ensure the safety of astronauts, vessels, mariners, and the
navigable waters in the safety zones before, during, and after the
scheduled event. The Coast Guard is issuing this rule under authority
of section 8343 of the Authorization Act and 46 U.S.C. 70034.

IV. Discussion of the Rule

    The Coast Guard is establishing special activity temporary safety
zones for reentry vehicles within any of the three reentry sites
described in this rule. The Crew-3 recovery mission may occur within
any of the following reentry sites in the Gulf of Mexico: Pensacola,
Panama City, and Tallahassee, Florida.
    Approximately one day before capsule reentry and recovery, Space X
and NASA will determine which of the sites will be used. This
determination is based on mission and environmental factors. After the
determination is made, the respective COTP will use Local Notice to
Mariners and Broadcast Notice to Mariners on VHF-FM channel 16 to
inform the public of which safety zone is expected to be used.
    The three temporary reentry sites in the EEZ are listed below and
include all waters within the coordinates from surface to bottom. The
coordinates are based on the projected reentry locations as determined
from telemetry data and modeling by Space X.
    (1) Pensacola site:

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

------------------------------------------------------------------------
Point 1.......................  29.930[deg] N        -087.643[deg] W
Point 2.......................  29.930[deg] N        -087.357[deg] W
Point 3.......................  29.670[deg] N        -087.357[deg] W
Point 4.......................  29.670[deg] N        -087.[deg] W
------------------------------------------------------------------------

    (2) Panama City site:

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

------------------------------------------------------------------------
Point 1.......................  29.846[deg] N        -086.326[deg] W
Point 2.......................  29.846[deg] N        -086.040[deg] W
Point 3.......................  29.586[deg] N        -086.040[deg] W
Point 4.......................  29.586[deg] N        -086.326[deg] W
------------------------------------------------------------------------

    (3) Tallahassee site:

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

------------------------------------------------------------------------
Point 1.......................  29.413[deg] N        -084.342[deg] W
Point 2.......................  29.413[deg] N        -084.058[deg] W
Point 3.......................  29.153[deg] N        -084.058[deg] W
Point 4.......................  29.153[deg] N        -084.342[deg] W
------------------------------------------------------------------------

    When the reentry site is activated as a safety zone, the COTP or a
designated representative will be able to restrict vessel movement
including but not limited to transiting, anchoring, or mooring within
the safety zone to protect vessels from hazards associated with rocket
and capsule recovery missions. Active restrictions are based on mission
specific recovery exclusion areas provided by Space X and NASA, are
temporary in nature, and would only be enacted and enforced at a
reasonable time prior to and after a recovery. Because the safety zones
are located in the EEZ, only United States flagged vessels are subject
to safety zone enforcement. Other vessels are encouraged to remain
outside the safety zone.
    The COTP will inform the public of the activation or status of the
safety zones by Local Notice to Mariners and Broadcast Notice to
Mariners on VHF-FM channel 16.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This rule has not been designated a ``significant
regulatory action'' under Executive Order 12866. Accordingly, this rule
has not been reviewed by the Office of Management and Budget (OMB).
    This regulatory action determination is based on the size,
location, duration, and scope of the safety zones. The safety zones are
limited in size and location to only those areas where capsule re-entry
is reasonably occurs. The safety zones are limited in scope, as vessel
traffic will be able to safely transit around the safety zones which
will impact a small part of the United States exclusive economic zone
(EEZ) within the Gulf of Mexico.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. 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.
    The safety zone activation and thus restriction to the public is
expected to be approximately two hours per capsule recovery, and we
anticipate one splash down during the effective period of this rule.
Vessels would be able to transit around the activated safety zone
location during this recovery. We do not anticipate any significant
economic impact resulting from activation of the safety zones.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
call or email the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    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.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has 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. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, 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.

E. 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.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01, Rev. 1, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), which guide the Coast
Guard in complying with the National Environmental Policy Act of 1969
(42 U.S.C. 4321-4370f), and have determined that 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 involves the
establishing of three temporary safety zones, one of which may be
activated on one occasion for approximately two hours between May 1,
2022 and May 15, 2022 for a Space X and NASA mission. It is
categorically excluded from further review under paragraph L60(a) of
Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A
Record of Environmental Consideration supporting this determination is
available in the docket. For instructions on locating the docket, see
the ADDRESSES section of this preamble.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section to coordinate protest activities so
that your message can be received without jeopardizing the safety or
security of people, places or vessels.

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:  46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No.
00170.1, Revision No. 01.2.

0
2. Add Sec.  165.T07-0233 to read as follows:

Sec.  165.T08-0291  Safety Zones; Pensacola, Panama City, and
Tallahassee, Florida.

    (a) Location. The following areas are safety zones:
    (1) Pensacola site. All waters from surface to bottom encompassed
within the following coordinates connecting a line from Point 1, thence
to Point 2, and thence to Point 3, connecting back to Point 4:

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

------------------------------------------------------------------------
Point 1.......................  29.930[deg] N        -087.643[deg] W
Point 2.......................  29.930[deg] N        -087.357[deg] W
Point 3.......................  29.670[deg] N        -087.357[deg] W
Point 4.......................  29.670[deg] N        -087.643[deg] W
------------------------------------------------------------------------

    (2) Panama City site. All waters from surface to bottom encompassed
within the following coordinates connecting a line from Point 1, thence
to Point 2, and thence to Point 3, connecting back to Point 4:

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

------------------------------------------------------------------------
Point 1.......................  29.846[deg] N        -086.326[deg] W
Point 2.......................  29.846[deg] N        -086.040[deg] W
Point 3.......................  29.586[deg] N        -086.040[deg] W
Point 4.......................  29.586[deg] N        -086.326[deg] W
------------------------------------------------------------------------

    (3) Tallahassee site. All waters from surface to bottom encompassed
within the following coordinates connecting a line from Point 1, thence
to Point 2, and thence to Point 3, connecting back to Point 4:

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

------------------------------------------------------------------------
Point 1.......................  29.413[deg] N        -084.342[deg] W
Point 2.......................  29.413[deg] N        -084.058[deg] W
Point 3.......................  29.153[deg] N        -084.058[deg] W
Point 4.......................  29.153[deg] N        -084.342[deg] W
------------------------------------------------------------------------

    (b) Definitions. As used in this section--
    Designated representative means Coast Guard Patrol Commanders
including Coast Guard coxswains, petty officers and other officers
designated by or assisting the COTP Mobile in the enforcement of the
safety zones.
    Reentry Vehicle means a vehicle designed to return from Earth orbit
or outer space to Earth, or a reusable launch vehicle designed to
return from Earth orbit or outer space to Earth, substantially intact.
    (c) Regulations. (1) Under the general safety zone regulations in
subpart C of this part, you may not enter the safety zone described in
paragraph (a) of this section unless authorized by the COTP or the
COTP's designated representative.
    (2) The COTP Mobile or other designated representative may restrict
vessel movement including but not limited to transiting, anchoring, or
mooring within these safety zones to protect vessels from hazards
associated with rocket recoveries. These restrictions are temporary in
nature and will only be enacted and enforced prior to and just after
the recovery missions.
    (3) Because the safety zones are within the United States Exclusive
Economic Zone, only United States flagged vessels are subject to safety
zone enforcement. Other vessels are encouraged to remain outside the
safety zone.
    (d) Enforcement periods. This rule will be enforced between May 1,
2022 and May 15, 2022, beginning a reasonable time before splashdown of
a reentry vehicle in one of the areas described above, and will be
deactivated once the area is no longer hazardous. The COTP will inform
the public of which safety zone will be activated by Broadcast Notice
to Mariners on VHF-FM channel 16.

    Dated: April 29, 2022
LaDonn A. Allen,
Captain, Commander, Coast Guard Sector Mobile, Captain of the Port
Mobile.
[FR Doc. 2022-09577 Filed 5-3-22; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 81, Number 192 (Tuesday, October 4, 2016)]
[Rules and Regulations]
[Pages 68295-68297]
[FR Doc No: 2016-23901]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 862

[Docket No. FDA-2016-P-0159]

Medical Devices; Exemption From Premarket Notification; Method,
Metallic Reduction, Glucose (Urinary, Nonquantitative) Test System in a
Reagent Tablet Format

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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

SUMMARY: The Food and Drug Administration (FDA) is publishing an order
denying a petition requesting exemption from the premarket notification
requirements for method, metallic reduction, glucose (urinary,
nonquantitative) devices that are in a reagent tablet format and are
classified as class II devices as urinary glucose (nonquantitative)
test system (hereinafter referred to as ''copper reduction tablet
test''). Urinary glucose (nonquantitative) measurements are used in the
diagnosis and treatment of carbohydrate metabolism disorders including
diabetes mellitus, hypoglycemia, and hyperglycemia. FDA is publishing
this order in accordance with procedures established by the Food and
Drug Administration Modernization Act of 1997 (FDAMA).

DATES: This order is effective October 4, 2016.

FOR FURTHER INFORMATION CONTACT: Sheila Connors, Center for Devices and
Radiological Health (CDRH), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 4620, Silver Spring, MD 20993-0002, 301-
796-6181<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Statutory Background

    Under section 513 of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 360c), FDA must classify devices into one of three
regulatory classes: Class I, class II, or class III. FDA classification
of a device is determined by the amount of regulation necessary to
provide a reasonable assurance of the safety and effectiveness of the
device. Under the Medical Device Amendments of 1976 (1976 amendments)
(Pub. L. 94-295), as amended by the Safe Medical Devices Act of 1990
(Pub. L. 101-629), devices are to be classified into class I (general
controls) if there is information showing that the general controls of
the FD&C Act are sufficient to assure safety and effectiveness; into
class II (special controls) if general controls, by themselves, are
insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls to provide such assurance; and into class III (premarket
approval) if there is insufficient information to support classifying a
device into class I or class II and the device is a life-sustaining or
life-supporting device, or is for a use which is of substantial
importance in preventing impairment of human health, or presents a
potential unreasonable risk of illness or injury.
    Section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and the
implementing regulations (21 CFR part 807) require persons who intend
to market a device intended for human use to submit a premarket
notification (510(k)) to FDA containing information that allows FDA to
determine whether the device is ``substantially equivalent'' within the
meaning of section 513(i) of the FD&C Act to a legally marketed device
that does not require premarket approval.
    On November 21, 1997, the President signed into law FDAMA (Pub. L.
105-115). Section 206 of FDAMA, in part, added section 510(m) to the
FD&C Act. Section 510(m)(1) of the FD&C Act requires FDA, within 60
days after enactment of FDAMA, to publish in the Federal Register a
list of each type of class II device that does not require a report
under section 510(k) of the FD&C Act to provide reasonable assurance of
safety and effectiveness. Section 510(m) of the FD&C Act further
provides that a 510(k) will no longer be required for these devices
upon the date of publication of the list in the Federal Register. FDA
published that list in the Federal Register of January 21, 1998 (63 FR
3142).
    Section 510(m)(2) of the FD&C Act provides that 1 day after the
date of publication of the list under section 510(m)(1), FDA may exempt
a class II device on its own initiative or upon petition of an
interested person, if FDA determines that a 510(k) is not necessary to
provide reasonable assurance of the safety and effectiveness of the
device.

This section requires FDA to publish in the Federal Register a notice
of intent to exempt a device, or of the petition, and to provide a 30-
day comment period. Within 120 days of publication of this document,
FDA must publish in the Federal Register its final determination
regarding the exemption of the device that was the subject of the
notice. If FDA fails to respond to a petition under this section within
180 days of receiving it, the petition shall be deemed granted.
    FDA classified the urinary glucose (nonquantitative) test system
into class II effective July 30, 1987 (52 FR 16102 at 16122, May 1,
1987). The classification for urinary glucose (nonquantitative) test
system is at Sec.  862.1340 (21 CFR 862.1340). The urinary glucose
(nonquantitative) test system is identified as a device that is
intended to measure glucosuria (glucose in urine). Urinary glucose
(nonquantitative) measurements are used in the diagnosis and treatment
of carbohydrate metabolism disorders including diabetes mellitus,
hypoglycemia, and hyperglycemia. Devices under this classification
regulation require premarket notification under section 510(k) of the
FD&C Act.

II. Criteria for Exemption

    There are a number of factors FDA may consider to determine whether
a 510(k) is necessary to provide reasonable assurance of the safety and
effectiveness of a class II device. These factors are discussed in the
guidance the Agency issued on February 19, 1998, entitled ``Procedures
for Class II Device Exemptions from Premarket Notification, Guidance
for Industry and CDRH Staff'' (Ref. 1). Accordingly, FDA generally
considers the following factors to determine whether premarket
notification is necessary: (1) The device does not have a significant
history of false or misleading claims or risks associated with inherent
characteristics of the device; (2) characteristics of the device
necessary for its safe and effective performance are well established;
(3) changes in the device that could affect safety and effectiveness
will either (a) be readily detectable by users by visual examination or
other means such as routine testing, before causing harm, or (b) not
materially increase the risk of injury, incorrect diagnosis, or
ineffective treatment; and (4) any changes to the device would not be
likely to result in a change in the device's classification. FDA may
also consider that, even when exempting devices, these devices would
still be subject to the limitations on exemptions.

III. Petition

    On January 7, 2016, FDA received a petition requesting an exemption
from premarket notification requirements for copper reduction tablet
tests that are classified as class II devices under Sec.  862.1340,
urinary glucose (nonquantitative) test system, from Evelyn Mirza,
Biorex Labs, LLC. (See Docket No. FDA-2016-P-0159).
    On March 24, 2016 (81 FR 15728), FDA published a notice in the
Federal Register announcing that this petition had been received and
provided an opportunity for interested persons to submit comments on
the petition by April 25, 2016, in accordance with section 510(m)(2) of
the FD&C Act. FDA received no comments regarding this petition.
    FDA has completed review of the previously referenced petition and
assessed the need for 510(k) clearance for copper reduction tablet test
against the criteria laid out in section II. For the reasons described
in section IV, FDA has determined that premarket notification is
necessary to provide a reasonable assurance of the safety and
effectiveness of the copper reduction tablet tests classified under
Sec.  862.1340 and assigned the classification product code JIM.
Accordingly, FDA responded to the petition by letter dated July 1,
2016, denying the petition within the 180-day timeframe under section
510(m)(2) of the FD&C Act. (See Docket No. FDA-2016-P-0159.)

IV. Order

    After reviewing the petition, FDA has determined that the petition
failed to provide information to demonstrate that premarket
notification is not necessary to provide reasonable assurance of the
safety and effectiveness of the device. Accordingly, FDA is denying the
previously referenced petition for exemption from the premarket
notification requirements.
    With regard to the first factor (section II, Criteria for
Exemption), although there have been no medical device reports reported
to the Agency in recent years, there have been numerous reports to the
Agency \1\ and in medical literature of risks associated with the
inherent characteristics of this device, including possible device-
associated deaths, serious injuries, and malfunctions such as burns,
explosions of the product bottle due to heat, and consumption of the
device. For instance, there have been reports in the medical literature
of patients consuming the tablets because of their similarity to pills,
which has led to poisoning and one report of a death. Therefore, FDA
does not agree with the petitioner that the use of the device is well
established without any reports of patient or user injury, or that the
device does not have a significant history of risks associated with
inherent characteristics of the device.
---------------------------------------------------------------------------

    \1\ For more information, see Medical Device Reporting (MDR)
database at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM.
---------------------------------------------------------------------------

    Additionally, failure to observe the reaction at all times after
the tablet has been added to the sample is another risk associated with
the inherent characteristics of the device. This can lead to a false-
negative result and result in improper patient management, which can
lead to serious injury or possibly death. The petition failed to
demonstrate how the device's inherent risks can be mitigated or
controlled without premarket notification to provide a reasonable
assurance of the safety and effectiveness of the device.
    With regard to the second factor, the petition stated that a copper
reduction tablet test can be used to evaluate pediatric patients for
possible hereditary metabolic disorders through detection of reducing
substances. For example, although all States require mandatory newborn
screening for genetic metabolic defects, clinical laboratories may
still use this device as a screening test on pediatric urine samples if
there are any suspicions of metabolic disease prior to receiving
newborn screening results or if the newborn screening results do not
match the clinical state of the newborn. Although further diagnostic
testing may be performed to confirm the result(s), physicians may
immediately treat the newborn relying solely on the result of this test
while awaiting the results for any followup diagnostic tests. False
negative results also present a safety and effectiveness concern
because followup diagnostic testing may not be performed, leading to
the failure to start needed treatment for the newborn. The petition
also stated that this device is used in the diagnosis, monitoring, and
treatment of metabolic disorders such as diabetes mellitus. However,
the petition failed to demonstrate that a premarket submission is not
necessary to provide a reasonable assurance of the safety and
effectiveness of the device for such uses, and FDA does not agree that
the characteristics of the device necessary for its safe and effective
use are well established.
    With regard to the third factor, FDA also does not agree that
changes in the device that could affect safety and effectiveness will
either be readily detectable or not materially increase

risks. For example, available quality control materials may contain
glucose but do not contain other reducing sugars (e.g., galactose,
lactose). Therefore, such materials might not readily detect an issue
with the device's safety or effectiveness in detecting other reducing
sugars, before causing harm. The petition provided insufficient
information to support the position that changes in the device that
could affect safety and effectiveness will either be readily detectable
or not materially increase risks. Moreover, changes in the device that
could affect safety and effectiveness might materially increase the
risk of injury, incorrect diagnosis, or ineffective treatment given the
device type's intended uses. The petition also did not provide
information to the contrary. The petition did not provide any
information regarding the fourth factor.
    In addition to these four factors, FDA considers the ``limitations
on exemption.'' Manufacturers of any commercially distributed device
for which FDA has granted an exemption from the requirement of
premarket notification must still submit a premarket notification to
FDA prior to marketing the device when any of the limitations of
exemption are exceeded. The general limitations of exemption from
premarket notification contained in Sec.  862.9 (21 CFR 862.9) are
broadly applicable to in vitro diagnostic (IVD) devices classified
under part 862 (21 CFR part 862). Under Sec.  862.9, the exemption from
the premarket notification requirements applies, in the case of IVD
devices, only to those devices under part 862 for which misdiagnosis,
as a result of using the device, would not be associated with high
morbidity or mortality. FDA has previously assessed that this
limitation is exceeded, and a premarket notification is necessary to
provide a reasonable assurance of the safety and effectiveness of an
IVD device, when such device is intended for use in screening or
diagnosis of familial or acquired genetic disorders, including inborn
errors of metabolism (Sec.  862.9(c)(2)) or intended for use in
diabetes management (Sec.  862.9(c)(5)). The copper reduction tablet
test described in the petition is intended for such uses and would
likely exceed the limitations just described.
    Accordingly, for all of the foregoing reasons, the petition failed
to demonstrate that a premarket submission is not necessary to provide
a reasonable assurance of the safety and effectiveness of the device
intended for such uses. Therefore, FDA is issuing this order denying
the petition requesting exemption for a method, metallic reduction,
glucose (urinary, nonquantitative) test system in a reagent tablet
format that is intended to measure glucosuria (glucose in urine) from
the premarket notification requirements. Manufacturers of this device
type must continue to submit and receive FDA clearance of a 510(k)
before marketing their device, as well as comply with all other
applicable requirements under the FD&C Act.

V. Reference

    The following reference is on display in the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, and is available for viewing by
interested persons between 9 a.m. and 4 p.m., Monday through Friday; it
is also available electronically at http://www.regulations.gov. FDA has
verified the Web site address, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.

1. ``Procedures for Class II Device Exemptions from Premarket
Notification, Guidance for Industry and CDRH Staff,'' February 1998,
available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080199.pdf.

    Dated: September 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-23901 Filed 10-3-16; 8:45 am]
 BILLING CODE 4164-01-P


123456789 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 A B C D E F G H I J K L M N O Economic values used for northern California region.

first prepared by make. econ. template. ssc 12/ 10/ 02 dcacela note: humboldt set may need updates due to uncertain lumping routine all facilities may need updates depending on revised species naming conventions ( e. g., herrings1, herrings2)

first prepared by Marca Hagenstad and Megan Harrod, 12/ 12/ 02 Commercial values are 9 year ( 1993 2001) averages of annual landings from the NMFS commercial landings database for the state of CA.

The Commercial and Recreational splits were obtained by dividing each of the average annual landings ( 1993 2001) by the sum of the commercial and recreational average annual landings. All landings data were obtained from NMFS for the state of CA.

The recreational landings were obtained from http:// www. st. nmfs. gov/ recreational/ queries/ index. html and the commercial landings were obtained from http:// www. st. nmfs. gov/ commercial/ landings/ annual_ landings. html.

It should be noted that no annual recreational data is available for invetebrates in the state of CA. Also, dungeness crab recreational fishing is not allowed in San Francisco Bay.

For the rec values: I used values when possible from Rowe, R., Morey, E., Ross D., and A. D. Shaw. 1985. Valuing Marine Recreation Fishing on the Pacific Coast. Prepared for NMFS.

March. For the species that I could not use Rowe et al, I used values from the East Coast case studies.

 For low and high missing values I used the lowest value reported and the highest value reported in studies used in the East Coast case studies.

 For only one of the low or high missing, I used an average of the values reported in studies used in the East Coast case studies.

For cabezon and silverside ( which are listed in the species class " other" on Table 1. California Recreational Species Groups and Catch" that I obtained from Tom), I was uncertain which recreational values to apply and simply used the average of the values used for the other species in this case study.

There are additional California and Pacific Coast studies which may be used in the future if time allows and improvements desired. I have a list of possible studies.

make. econ. template. ssc 12/ 10/ 02 dcacela note: humboldt set may need updates due to uncertain lumping routine all facilities may need updates depending on revised species naming conventions ( e. g., herrings1, herrings2) Page 1 of 4 5 2348  readme 123456789 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 A B C D E F G H I facility species perc. impact. to. rec. fishery perc. impact. to. com. fishery perc. impact. to. forage rec. val. lo. dlr. fish rec. val. hi. dlr. fish com. val. dlr. lb forage. val. dlr. lb all. facilities all. species  1  99  99  99  99  99 0.34 contracosta american. shad 0 1 0 0 0 1.55 NA pittsburg american. shad 0 1 0 0 0 1.55 NA diablo anchovies1 0 1 0 0 0 0.08 0 humboldt anchovies1 0 1 0 0 0 0.08 0 morrobay anchovies1 0 1 0 0 0 0.08 0 mosslanding anchovies1 0 1 0 0 0 0.08 0 potrero anchovies1 0 1 0 0 0 0.08 0 diablo anchovies2 0 1 0 0 0 0.08 0 humboldt anchovies2 0 1 0 0 0 0.08 0 morrobay anchovies2 0 1 0 0 0 0.08 0 mosslanding anchovies2 0 1 0 0 0 0.08 0 potrero anchovies2 0 1 0 0 0 0.08 0 hunterspoint anchovies2 0 1 0 0 0 0.08 0 hunterspoint anchovies3 0 1 0 0 0 0.08 0 morrobay bay. shrimps 0 0 1 0 0 0 0.34 mosslanding bay. shrimps 0 0 1 0 0 0 0.34 potrero bay. shrimps 0 0 1 0 0 0 0.34 humboldt bay. shrimps 0 0 1 0 0 0 0.34 hunterspoint bay. shrimps 0 0 1 0 0 0 0.34 diablo cabezon 0.46 0.54 0 2.53 3.35 3.32 0 morrobay cabezon 0.46 0.54 0 2.53 3.35 3.32 0 potrero cabezon 0.46 0.54 0 2.53 3.35 3.32 0 hunterspoint cabezon 0.46 0.54 0 2.53 3.35 3.32 0 diablo california. halibut 0.856468695 0.143531305 0 3.92 5.35 2.51 0 morrobay california. halibut 0.856468695 0.143531305 0 3.92 5.35 2.51 0 potrero california. halibut 0.856468695 0.143531305 0 3.92 5.35 2.51 0 hunterspoint california. halibut 0.856468695 0.143531305 0 3.92 5.35 2.51 0 contracosta chinook. salmon 0 0 0 0 0 0 0 pittsburg chinook. salmon 0 0 0 0 0 0 0 diablo croakers 0.751546884 0.248453116 0 2.26 3.29 0.57 0 morrobay croakers 0.751546884 0.248453116 0 2.26 3.29 0.57 0 potrero croakers 0.751546884 0.248453116 0 2.26 3.29 0.57 0 hunterspoint croakers 0.751546884 0.248453116 0 2.26 3.29 0.57 0 contracosta delta. smelt 0 0 0 0 0 0 0 pittsburg delta. smelt 0 0 0 0 0 0 0 humboldt dungeness1 0 1 0 0 0 1.54 0 morrobay dungeness1 0 1 0 0 0 1.54 0 mosslanding dungeness1 0 1 0 0 0 1.54 0 humboldt dungeness2 0 1 0 0 0 1.54 0 morrobay dungeness2 0 1 0 0 0 1.54 0 mosslanding dungeness2 0 1 0 0 0 1.54 0 diablo flounders 0.01 0.99 0 3.92 5.35 0.31 0 morrobay flounders 0.01 0.99 0 3.92 5.35 0.31 0 mosslanding flounders 0.01 0.99 0 3.92 5.35 0.31 0 potrero flounders 0.01 0.99 0 3.92 5.35 0.31 0 humboldt flounders 0.01 0.99 0 3.92 5.35 0.31 0 hunterspoint flounders 0.01 0.99 0 3.92 5.35 0.31 0 diablo gobies 0 0 1 0 0 0 0.34 humboldt gobies 0 0 1 0 0 0 0.34 morrobay gobies 0 0 1 0 0 0 0.34 mosslanding gobies 0 0 1 0 0 0 0.34 potrero gobies 0 0 1 0 0 0 0.34 hunterspoint gobies 0 0 1 0 0 0 0.34 Page 2 of 4 5 2348  calif. econvalues 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 A B C D E F G H I contracosta green. sturgeon 0 0 0 0 0 0 0 pittsburg green. sturgeon 0 0 0 0 0 0 0 diablo herrings1 0 1 0 0 0 0.21 0 morrobay herrings1 0 1 0 0 0 0.21 0 mosslanding herrings1 0 1 0 0 0 0.21 0 potrero herrings1 0 1 0 0 0 0.21 0 humboldt herrings1 0 1 0 0 0 0.21 0 diablo herrings2 0 1 0 0 0 0.21 0 morrobay herrings2 0 1 0 0 0 0.21 0 mosslanding herrings2 0 1 0 0 0 0.21 0 potrero herrings2 0 1 0 0 0 0.21 0 humboldt herrings2 0 1 0 0 0 0.21 0 hunterspoint herrings2 0 1 0 0 0 0.21 0 hunterspoint herrings3 0 1 0 0 0 0.21 0 contracosta junk. species 0 0 1 0 0 0 NA pittsburg junk. species 0 0 1 0 0 0 NA contracosta longfin. smelt 0 0 0 0 0 0 0 pittsburg longfin. smelt 0 0 0 0 0 0 0 contracosta northern. anchovy 0 1 0 0 0 0.07 NA pittsburg northern. anchovy 0 1 0 0 0 0.07 NA contracosta osmeridae 0 0 0 0 0 0 0 pittsburg osmeridae 0 0 0 0 0 0 0 contracosta pacific. herring 0 1 0 0 0 0.59 NA pittsburg pacific. herring 0 1 0 0 0 0.59 NA diablo rock. crabs1 0 1 0 0 0 1.14 0 morrobay rock. crabs1 0 1 0 0 0 1.14 0 mosslanding rock. crabs1 0 1 0 0 0 1.14 0 potrero rock. crabs1 0 1 0 0 0 1.14 0 humboldt rock. crabs1 0 1 0 0 0 1.14 0 hunterspoint rock. crabs1 0 1 0 0 0 1.14 0 diablo rock. crabs2 0 1 0 0 0 1.14 0 morrobay rock. crabs2 0 1 0 0 0 1.14 0 mosslanding rock. crabs2 0 1 0 0 0 1.14 0 potrero rock. crabs2 0 1 0 0 0 1.14 0 humboldt rock. crabs2 0 1 0 0 0 1.14 0 hunterspoint rock. crabs2 0 1 0 0 0 1.14 0 diablo rockfishes 0.376572523 0.623427477 0 2.26 3.29 0.55 0 humboldt rockfishes 0.376572523 0.623427477 0 2.26 3.29 0.55 0 morrobay rockfishes 0.376572523 0.623427477 0 2.26 3.29 0.55 0 mosslanding rockfishes 0.376572523 0.623427477 0 2.26 3.29 0.55 0 potrero rockfishes 0.376572523 0.623427477 0 2.26 3.29 0.55 0 hunterspoint rockfishes 0.376572523 0.623427477 0 2.26 3.29 0.55 0 contracostaacramento. splittail 0 0 0 0 0 0 0 pittsburgacramento. splittail 0 0 0 0 0 0 0 diablo sculpins 0.89 0.11 0 2.26 3.29 2.62 0 humboldt sculpins 0.89 0.11 0 2.26 3.29 2.62 0 morrobay sculpins 0.89 0.11 0 2.26 3.29 2.62 0 mosslanding sculpins 0.89 0.11 0 2.26 3.29 2.62 0 potrero sculpins 0.89 0.11 0 2.26 3.29 2.62 0 hunterspoint sculpins 0.89 0.11 0 2.26 3.29 2.62 0 morrobay silversides 1 0 0 2.53 3.35 0 0 mosslanding silversides 1 0 0 2.53 3.35 0 0 potrero silversides 1 0 0 2.53 3.35 0 0 humboldt silversides 1 0 0 2.53 3.35 0 0 hunterspoint silversides 1 0 0 2.53 3.35 0 0 Page 3 of 4 5 2348  calif. econvalues 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 A B C D E F G H I humboldt smelts 0.06 0.94 0 1.41 1.41 0.26 0 morrobay smelts 0.06 0.94 0 1.41 1.41 0.26 0 mosslanding smelts 0.06 0.94 0 1.41 1.41 0.26 0 potrero smelts 0.06 0.94 0 1.41 1.41 0.26 0 hunterspoint smelts 0.06 0.94 0 1.41 1.41 0.26 0 contracosta starry. flounder 0 1 0 0 0 0.47 NA pittsburg starry. flounder 0 1 0 0 0 0.47 NA contracosta steelhead 0 0 0 0 0 0 0 pittsburg steelhead 0 0 0 0 0 0 0 contracosta striped. bass 1 0 0 9.11 14.14 0 0 pittsburg striped. bass 1 0 0 9.11 14.14 0 0 hunterspoint striped. bass2 1.00 0.00 0.00 9.11 14.14 0.00 0.00 morrobay surfperches 0.930071259 0.069928741 0 2.26 3.29 1.57 0 mosslanding surfperches 0.930071259 0.069928741 0 2.26 3.29 1.57 0 potrero surfperches 0.930071259 0.069928741 0 2.26 3.29 1.57 0 humboldt surfperches 0.930071259 0.069928741 0 2.26 3.29 1.57 0 hunterspoint surfperches 0.930071259 0.069928741 0 2.26 3.29 1.57 0 Page 4 of 4 5 2348  calif. econvalues


[Federal Register Volume 76, Number 197 (Wednesday, October 12, 2011)]
[Notices]
[Pages 63339-63341]
[FR Doc No: 2011-26271]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-65489; File No. SR-CME-2011-08]

Self-Regulatory Organizations; Chicago Mercantile Exchange, Inc.;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
and Amendment To Add One Additional Series of Credit Default Index
Swaps Available for Clearing

October 5, 2011.
    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 September 26, 2011, Chicago Mercantile Exchange Inc. (``CME'') filed
with the Securities and Exchange Commission (``Commission'') the
proposed rule change described in Items I, II and III below, and an
amendment thereto on the same day,\3\ which items have been prepared
primarily by CME. CME filed the proposed rule change pursuant to
Section 19(b)(3)(A) \4\ of the Act and Rule 19b-4(f)(4)(i) \5\
thereunder.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ The amendment was technical in nature.
    \4\ 15 U.S.C. 78s(b)(3)(A).
    \5\ 17 CFR 240.19b-4(f)(4)(i).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of Terms of Substance of
the Proposed Rule Change

    The text of the proposed rule change is below. Italicized text
indicates additions; bracketed text indicates deletions.
* * * * *

Chicago Mercantile Exchange Inc. Rulebook

Rule 100--80203--No Change.

* * * * *

CME Chapter 802 Rules: Appendix 1

Appendix 1

CDX Indices

----------------------------------------------------------------------------------------------------------------
                   CDX Index                        Series          Termination dat. (scheduled termination)
----------------------------------------------------------------------------------------------------------------
CDX North American Investment Grade                          9  20 Dec 2012.
 (CDX.NA.IG).                                                   20 Dec 2014.
                                                ..............  20 Dec 2017.
CDX North American Investment Grade                         10  20 Jun 2013.
 (CDX.NA.IG).                                                   20 Jun 2015.
                                                ..............  20 Jun 2018.
CDX North American Investment Grade                         11  20 Dec 2011.
 (CDX.NA.IG).                                                   20 Dec 2013.
                                                ..............  20 Dec 2015.
                                                ..............  20 Dec 2018.
CDX North American Investment Grade                         12  20 Jun 2012.
 (CDX.NA.IG).                                                   20 Jun 2014.
                                                ..............  20 Jun 2016.
                                                ..............  20 Jun 2019.
CDX North American Investment Grade                         13  20 Dec 2012.
 (CDX.NA.IG).                                                   20 Dec 2014.
                                                ..............  20 Dec 2016.

                                                ..............  20 Dec 2019.
CDX North American Investment Grade                         14  20 Jun 2013.
 (CDX.NA.IG).                                                   20 Jun 2015.
                                                ..............  20 Jun 2017.
                                                ..............  20 Jun 2020.
CDX North American Investment Grade                         15  20 Dec 2013.
 (CDX.NA.IG).                                                   20 Dec 2015.
                                                ..............  20 Dec 2017.
                                                ..............  20 Dec 2020.
CDX North American Investment Grade                         16  20 Jun 2014.
 (CDX.NA.IG).                                                   20 Jun 2016.
                                                ..............  20 Jun 2018.
                                                ..............  20 Jun 2021.
CDX North American Investment Grade                         17  20 Dec 2014.
 (CDX.NA.IG).                                                   20 Dec 2016.
                                                ..............  20 Dec 2018.
                                                ..............  20 Dec 2021.
----------------------------------------------------------------------------------------------------------------

* * * * *

Rule 80301--End--No change

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

    In its filing with the Commission, CME included statements
concerning the purpose 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. CME 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 Purpose of, and
Statutory Basis for, the Proposed Rule Change

    CME offers clearing services for certain credit default swap index
products. Currently, CME offers clearing of the Markit CDX North
American Investment Grade Index Series 10, 11, 12, 13, 14, 15, 16 and
17. The proposed rule changes that are the subject of this filing are
intended to expand CME's Markit Investment Grade Index product offering
by incorporating one additional series for the existing products. More
specifically, the proposed rule changes would add the Markit CDX North
American Investment Grade Index Series 9 (with 5, 7 and 10 year
maturities).
    In addition, the filing would amend certain typographical errors in
CME Chapter 802 Rules: Appendix 1. The products are currently listed as
``CDX North America Investment Grade'' and the changes would correctly
list them as ``CDX North American Investment Grade''.
    The proposed rule changes that are the subject of this filing will
become immediately effective.\6\ CME notes that it has also certified
the proposed rule changes that are the subject of this filing to its
primary regulator, the Commodity Futures Trading Commission (``CFTC'').
The text of the CME proposed rule amendments is in Section I of this
notice, with additions italicized and deletions in brackets.
---------------------------------------------------------------------------

    \6\ The Commission notes that the rule change became effective
upon filing with the Commission.
---------------------------------------------------------------------------

    The proposed CME rule amendments merely incorporate one additional
series to CME's existing offering of broad-based Markit Investment
Grade index credit default swaps. As such, the proposed amendments
simply effect changes to an existing service of a registered clearing
agency that (1) Do not adversely affect the safeguarding of securities
or funds in the custody or control of the clearing agency or for which
it is responsible and (2) do not significantly affect the respective
rights or obligations of the clearing agency or persons using its
clearing agency services. Therefore, the proposed rule change is
therefore properly filed under Section 19(b)(3)(A) and Rule 19b-
4(f)(4)(i) thereunder.

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

    CME does not believe that the proposed rule change will have any
impact, or impose any burden, on competition.

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

    CME has not solicited, and does not intend to solicit, comments
regarding this proposed rule change. CME has not received any
unsolicited written comments from interested parties.

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

    The foregoing rule change was filed pursuant to Section 19(b)(3)(A)
of the Act and paragraph (f)(4)(i) of Rule 19b-4 and became effective
on filing. At any time within sixty days of the filing of such 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.

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 may be submitted by using the
Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml), or send an e-mail to<EMAIL_ADDRESS>Please include
File No. SR-CME-2011-08 on the subject line.
     Paper comments should be sent 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-CME-2011-08. This
file number should be included on the subject line if e-mail 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 a.m. and 3 p.m. Copies of such
filing also will be available for inspection and copying at the
principal office of CME. 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-CME-2011-08 and
should be submitted on or before November 2, 2011.

    For the Commission by the Division of Trading and Markets,
pursuant to delegated authority.\7\
---------------------------------------------------------------------------

    \7\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-26271 Filed 10-11-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 218 (Wednesday, November 12, 2014)]
[Notices]
[Pages 67180-67181]
[FR Doc No: 2014-26750]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2014-0937]

Announcement of Public Meetings Regarding the Florida East Coast
Railroad Bridges, St. Lucie River, Stuart; Loxahatchee River, Jupiter;
and New River, Fort Lauderdale, FL

AGENCY: Coast Guard, DHS.

ACTION: Notice of public meeting.

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

SUMMARY: The Coast Guard will hold three public meetings for citizens
to provide oral and written comments relating to the current and future
operations of the Florida East Coast Railroad Bridges across the St.
Lucie River in Stuart, Florida, the Loxahatchee River, Jupiter,
Florida, and the New River in Fort Lauderdale, Florida. The Coast Guard
is soliciting public comment relating to navigation through these
bridges. Specific interests include the current and future impact of
bridge closings on navigation. These meetings will be open to the
public.

DATES: A public meeting will be held on November 12, 2014 from 6:30
p.m. to 9 p.m., at the Anne Kolb Nature Center at West Lake Park, 751
Sheridan Street, Hollywood, Florida to provide an opportunity for oral
and written comments regarding navigation on the New River, Fort
Lauderdale, Florida. A public meeting will be held on November 13, 2014
from 5:30 p.m. to 8:00 p.m. at the John F. Armstrong Wing Auditorium of
the Blake Library, 2351 SE Monterey Rd., Stuart, Florida to provide an
opportunity for oral and written comments regarding navigation on the
Saint Lucie River, Stuart, Florida. A public meeting will be held on
November 14, 2014 from 5:30 p.m. to 8:30 p.m. at the Town of Jupiter
Council Chambers, 210 Military Trail, Jupiter, Florida to provide an
opportunity for oral and written comments regarding navigation on the
Loxahatchee River, Jupiter, Florida.
    If you would like to submit written materials, please send comments
to the Coast Guard's Seventh District Bridge Branch no later than
December 1, 2014 using any of the four methods listed below. If you
request to make an oral presentation at the meeting please provide your
name and contact information to the Coast Guard's Seventh District
Bridge Branch no later than November 7, 2014 using any one of the four
methods listed below. Requests to make oral comments, written comments
and related material may also be submitted to Coast Guard personnel
specified at the meeting.
    You may submit comments, materials, or requests to make oral
presentation to using any one of the following methods:
    (1) Fax:<PHONE_NUMBER>.
    (2) Mail: Brickell Federal Building C/O Seventh Coast Guard
District Bridge Branch, 909 SE 1ST AVE, Miami, FL, 33131-3050.
    (3) Hand delivery: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.
    (4) Email<EMAIL_ADDRESS>    See the ``Public Participation and Request for Comments'' portion
of the SUPPLEMENTARY INFORMATION section below for instructions on
submitting comments. To avoid duplication, please use only one of these
methods.

FOR FURTHER INFORMATION CONTACT: If you have questions regarding this
meeting, call or email Mr. Gene Stratton, Coast Guard Bridge Branch;
telephone at<PHONE_NUMBER> or email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

A. Public Participation and Request for Comments

    We encourage you to participate in this public meeting by
submitting comments and related materials.

1. Submitting Comments

    If you submit a comment, please include the docket number for these
public meeting (USCG-2014-0937), indicate the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. You may submit your comments and material
by email, or by fax, mail or hand delivery, but please use only one of
these means. If you submit a comment by email, it will be considered
received by the Coast Guard when you successfully transmit the comment.
If you fax, hand deliver, or mail your comment, it will be considered
as having been received by the Coast Guard when it is received at the
Seventh Coast Guard District Bridge Branch. We recommend that you
include your name and a mailing address, an email address, or a phone
number in the body of your document so that we can contact you if we
have questions regarding your submission.
    If you submit your comments by mail or hand delivery, submit them
in an unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit them by mail and would
like to know that they reached the Facility, please enclose a stamped,
self-addressed postcard or envelope. We will consider all comments and
material received during the comment period.

2. Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available call<PHONE_NUMBER> to arrange a visit to the
Brickell Federal Building Suite 432, 909 SE 1ST AVE, Miami, FL, 33131-
3050, between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays.

3. Privacy Act

    Anyone can view comments received by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review a
Privacy Act notice regarding our public dockets in the January 17, 2008
issue of the Federal Register (73 FR 3316).

B. Basis and Purpose

    The Coast Guard will hold three public meetings for citizens to
provide oral and written comments relating to the current and future
operations of the Florida East Coast Railroad Bridges across the St.
Lucie River in Stuart, Florida; the Loxahatchee River, Jupiter,
Florida; and the New River in Fort Lauderdale, Florida. The Coast Guard
is soliciting public comment relating to navigation through these
bridges. Specific interests include the current impact to navigation
through these bridges related to bridge closings for rail traffic and
comments related to future navigation impacts from proposed increases
of rail traffic.
    It is the intent of the Seventh Coast Guard District Bridge
Administration Branch to collect comments from these public meetings
along with navigation surveys and other information to establish and
preserve the reasonable needs of navigation on these three rivers.

C. Procedural

    The meetings are open to the public. Attendees at the meetings, who
wish to present testimony and have not previously made a request to do
so, will follow those having submitted a request, as time permits. If a
large number of persons wish to speak, the presiding officer may limit
the time allotted to each speaker. Conversely, the public meetings may
end early if all present wishing to speak have done so.

D. Information on Services for Individuals With Disabilities

    For information on facilities or services for individuals with
disabilities or to request special assistance at the meeting, contact
the individual listed in the FOR FURTHER INFORMATION CONTACT section as
soon as possible.

    Dated: October 27, 2014.
J.H. Korn,
Rear Admiral, U.S. Coast Guard, Commander, Seventh Coast Guard
District.
[FR Doc. 2014-26750 Filed 11-10-14; 8:45 am]
BILLING CODE 9110-04-P