<!DOCTYPE HTML PUBLIC "-//-//W3C//DTD HTML 3.2//EN">

<META name="generator" content="PDFCreactiveX HTML Export">
<META name="creation-date" content="07/07/2008 11:48:32 ">
<TITLE></TITLE>


[Federal Register: October 26, 2010 (Volume 75, Number 206)]
[Notices]
[Page 65703]
[DOCID:fr26oc10-145]

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

DEPARTMENT OF TRANSPORTATION

Office of the Secretary

Notice of Applications for Certificates of Public Convenience and
Necessity and Foreign Air Carrier Permits Filed Under Subpart B
(Formerly Subpart Q) During the Week Ending October 2, 2010

    The following Applications for Certificates of Public Convenience
and Necessity and Foreign Air Carrier Permits were filed under Subpart
B (formerly Subpart Q) of the Department of Transportation's Procedural
Regulations(See 14 CFR 301.201 et seq.).
    The due date for Answers, Conforming Applications, or Motions to
ModifyScope are set forth below for each application. Following the
Answer periodDOT may process the application by expedited procedures.
Such proceduresmay consist of the adoption of a show-cause order, a
tentative order, or inappropriate cases a final order without further
proceedings.
    Docket Number: DOT-OST-2010-0242.
    Date Filed: September 28, 2010.
    Due Date for Answers, Conforming Applications, or Motion To Modify
Scope:October 19, 2010.
    Description:
    Application of Compass Airlines, Inc. (``Compass'') requesting the
Department ofTransportation disclaim jurisdiction over the corporate
reorganization of Compass inwhich Compass will be converted from a
Delaware corporation to a Delaware limitedliability company bearing the
name Compass Airlines, LLC, and immediately thereaftertransfer
Compass's certificate of public convenience and necessity, exemptions,
designations,and any related operating authorities to Compass Airlines
LLC, a Delaware Limited LiabilityCompany.

Renee V. Wright,
Program Manager, Docket Operations,Federal Register Liaison.
[FR Doc. 2010-27022 Filed 10-25-10; 8:45 am]
BILLING CODE 4910-9X-P


[Federal Register: October 29, 2010 (Volume 75, Number 209)]
[Notices]
[Page 66752]
[DOCID:fr29oc10-61]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. AD10-7-000]

ILP Effectiveness Evaluation 2010; Additional Notice of Multi-
Stakeholder Technical Conference on the Integrated Licensing Process

October 21, 2010.
    As announced in the May 18, 2010, ``Notice of Interviews,
Teleconferences, Regional Workshops And Multi-Stakeholder Technical
Conference On The Integrated Licensing Process,'' a technical
conference will be held on November 3, 2010, from 11 a.m. (EST) to 3
p.m. (EST) in the Commission Meeting Room at the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426.
While we encourage interested parties to attend the technical
conference in person, a limited number of phone lines will be available
on a first-come-first-serve basis for interested parties to participate
via teleconference. If you would like to participate via
teleconference, e-mail Stephanie Obadia at<EMAIL_ADDRESS>by
October 29, 2010 to receive the toll-free telephone number and password
to join the teleconference. Also, please register to attend the
technical conference by e-mailing Stephanie Obadia at
<EMAIL_ADDRESS>by October 29, 2010.
    For more information about this conference, please contact David
Turner at<PHONE_NUMBER> or<EMAIL_ADDRESS>
Kimberly D. Bose,
Secretary.
[FR Doc. 2010-27399 Filed 10-28-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 29 (Monday, February 13, 2012)]
[Notices]
[Pages 7589-7590]
[FR Doc No: 2012-3243]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]

Neurological Devices Panel of the Medical Devices Advisory
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Neurological Devices Panel of the Medical
Devices Advisory Committee.
    General Function of the Committee: To provide advice and

recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on March 23, 2012, from 8
a.m. to 7 p.m.
    Location: Hilton Washington, DC North/Gaithersburg, Grand Ballroom,
620 Perry Pkwy., Gaithersburg, MD 20877. The hotel telephone number is
301-977-8900.
    Contact Person: Avena Russell, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 1535, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>or FDA Advisory Committee Information Line,
1-800-741-8138<PHONE_NUMBER> in the Washington, DC area), and follow
the prompts to the desired center or product area. Please call the
Information Line for up-to-date information on this meeting. A notice
in the Federal Register about last minute modifications that impact a
previously announced advisory committee meeting cannot always be
published quickly enough to provide timely notice. Therefore, you
should always check the Agency's Web site and call the appropriate
advisory committee hot line/phone line to learn about possible
modifications before coming to the meeting.
    Agenda: On March 23, 2012, the committee will discuss current
knowledge about the safety and effectiveness of the Wingspan Stent
System with Gateway PTA Balloon Catheter for the treatment of
intracranial arterial stenosis. FDA is convening this committee to seek
expert scientific and clinical opinion on the risks and benefits of
this device based on the available premarket and postmarket data. The
Wingspan Stent System with Gateway PTA Balloon Catheter is a
neurovascular stent, balloon catheter, and delivery system consisting
of the following components:
    1. Wingspan Stent--This is a self-expanding, nitinol stent with a
tubular mesh design.
    2. Gateway PTA Balloon Catheter--This balloon catheter is used to
predilate the lesion prior to introduction of the Wingspan Stent System
into the patient.
    3. Wingspan Delivery System--This delivery system is a single
lumen, over-the-wire, coaxial microcatheter that is used to deliver the
stent to the treatment site within the patient's artery.
    The Wingspan Stent System with Gateway PTA Balloon Catheter has
been approved under a humanitarian device exemption (HDE) (H050001) for
the following indications: ``The Wingspan Stent System with Gateway PTA
Balloon Catheter is indicated for use in improving cerebral artery
lumen diameter in patients with intracranial atherosclerotic disease,
refractory to medical therapy, in intracranial vessels with >= 50%
stenosis that are accessible to the system.''
    Interim results and analyses of data from an ongoing randomized
clinical trial, ``Stenting and Aggressive Medical Management for
Preventing Recurrent Stroke in Intracranial Stenosis'' (SAMMPRIS),
published in the New England Journal of Medicine (2011;365:993-1003),
will be presented for the Wingspan Stent with Gateway PTA Balloon
catheter. The committee will be asked to discuss the comparability of
the patient populations for the approved HDE and SAMMPRIS trial and the
relevance of the SAMMPRIS trial results to the assessment of safety and
probable benefit for the Wingspan Stent System with Gateway PTA Balloon
Catheter HDE.
    FDA recently received a citizen's petition seeking withdrawal of
the HDE approval and recall of Wingspan stents currently on the market.
The petitions are available for public review and comment at
www.regulations.gov under docket number FDA-2011-P-0923.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
    Procedure: FDA will work with affected industry and professional
organizations that have an interest in the Wingspan Stent System and
who wish to make a presentation separate from the general Open Public
Hearing; time slots between 2 p.m. and 3 p.m. are provided.
Representatives from industry and professionals organizations
interested in making formal presentations to the committee should
notify the contact person on or before March 1, 2012.
    Interested persons may present data, information, or views, orally
or in writing, on issues pending before the committee. Written
submissions may be made to the contact person on or before March 9,
2012. Oral presentations from the public will be scheduled between
approximately 11 a.m. and 12 p.m. Those individuals interested in
making formal oral presentations should notify the contact person and
submit a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation on or before March 1, 2012. Time allotted for
each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a
lottery to determine the speakers for the scheduled open public hearing
session. The contact person will notify interested persons regarding
their request to speak by March 2, 2012.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact James Clark,
<EMAIL_ADDRESS>or<PHONE_NUMBER> at least 7 days in advance of
the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: February 8, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-3243 Filed 2-10-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: September 25, 2009 (Volume 74, Number 185)]
[Notices]
[Page 49069-49071]
[DOCID:fr25se09-161]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2001-9561; FMCSA-2003-15268; FMCSA-2005-21254; FMCSA-
2005-21711; FMCSA-2006-26066; FMCSA-2007-26653; FMCSA-2007-27897;
FMCSA-2007-28695]

Qualification of Drivers; Exemption Applications; Vision

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of renewal of exemptions; request for comments.

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

SUMMARY: FMCSA announces its decision to renew the exemptions from the
vision requirement in the Federal Motor Carrier Safety Regulations for
26 individuals. FMCSA has statutory authority to exempt individuals
from the vision requirement if the exemptions granted will not
compromise safety. The Agency has concluded that granting these
exemption renewals will provide a level of safety that is equivalent
to, or greater than, the level of safety maintained without the
exemptions for these commercial motor vehicle (CMV) drivers.

DATES: This decision is effective October 24, 2009. Comments must be
received on or before October 26, 2009.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket ID FMCSA-2001-9561; FMCSA-2003-15268;
FMCSA-2005-21254; FMCSA-2005-21711; FMCSA-2006-26066; FMCSA-2007-26653;
FMCSA-2007-27897; FMCSA-2007-28695, using any of the following methods.
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the on-line instructions for submitting
comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., West Building Ground
Floor, Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC, between 9 a.m.
and 5

p.m., Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    Each submission must include the Agency name and the docket number
for this Notice. Note that DOT posts all comments received without
change to http://www.regulations.gov, including any personal
information included in a comment. Please see the Privacy Act heading
below.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue, SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The FDMS is available 24 hours each day, 365
days each year. If you want acknowledgment that we received your
comments, please include a self-addressed, stamped envelope or postcard
or print the acknowledgement page that appears after submitting
comments on-line.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, etc.).
You may review the DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000 (65 FR 19476). This information is
also available at http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Dr. Mary D. Gunnels, Director, Medical
Programs,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA, Department of
Transportation, 1200 New Jersey Avenue, SE., Room W64-224, Washington,
DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m. Monday through
Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may renew an exemption
from the vision requirements in 49 CFR 391.41(b)(10), which applies to
drivers of CMVs in interstate commerce, for a two-year period if it
finds ``such exemption would likely achieve a level of safety that is
equivalent to, or greater than, the level that would be achieved absent
such exemption.'' The procedures for requesting an exemption (including
renewals) are set out in 49 CFR part 381.

Exemption Decision

    This notice addresses 26 individuals who have requested a renewal
of their exemption in accordance with FMCSA procedures. FMCSA has
evaluated these 26 applications for renewal on their merits and decided
to extend each exemption for a renewable two-year period. They are:
    Calvin D. Atwood, Gregory W. Babington, George L. Cannon, William
P. Doolittle, Steven C. Durst, Kenneth J. Fisk, Jonathan M. Gentry,
Danny R. Gray, Benny D. Hatton, Jr., Robert W. Healey, Jr., Nathaniel
H. Herbert, Jr., Jason E. Mallette, Thomas W. Markham, Raul Martinez,
Joseph L. Mast, Kevin L. Moody, Terry W. Moore, Charles W. Mullenix,
Robert M. Pickett, II, Donald F. Plouf, John N. Poland, Brent L. Seaux,
Humberto A. Valles, Gary M. Wolff, John C. Young, George R. Zenor.
    These exemptions are extended subject to the following conditions:
(1) That each individual have a physical examination every year (a) By
an ophthalmologist or optometrist who attests that the vision in the
better eye continues to meet the standard in 49 CFR 391.41(b)(10), and
(b) by a medical examiner who attests that the individual is otherwise
physically qualified under 49 CFR 391.41; (2) that each individual
provide a copy of the ophthalmologist's or optometrist's report to the
medical examiner at the time of the annual medical examination; and (3)
that each individual provide a copy of the annual medical certification
to the employer for retention in the driver's qualification file and
retain a copy of the certification on his/her person while driving for
presentation to a duly authorized Federal, State, or local enforcement
official. Each exemption will be valid for two years unless rescinded
earlier by FMCSA. The exemption will be rescinded if: (1) The person
fails to comply with the terms and conditions of the exemption; (2) the
exemption has resulted in a lower level of safety than was maintained
before it was granted; or (3) continuation of the exemption would not
be consistent with the goals and objectives of 49 U.S.C. 31136(e) and
31315.

Basis for Renewing Exemptions

    Under 49 U.S.C. 31315(b)(1), an exemption may be granted for no
longer than two years from its approval date and may be renewed upon
application for additional two year periods. In accordance with 49
U.S.C. 31136(e) and 31315, each of the 26 applicants has satisfied the
entry conditions for obtaining an exemption from the vision
requirements (66 FR 30502; 66 FR 41654; 68 FR 44837; 70 FR 41811; 72 FR
64273; 68 FR 37197; 68 FR 48989; 70 FR 42615; 72 FR 40360; 70 FR 30999;
70 FR 46567; 72 FR 40359; 70 FR 48797; 70 FR 61493; 72 FR 64273; 71 FR
63379; 72 FR 1050; 72 FR 8417; 72 FR 36099; 72 FR 39879; 72 FR 52419;
72 FR 46261; 72 FR 54972). Each of these 26 applicants has requested
renewal of the exemption and has submitted evidence showing that the
vision in the better eye continues to meet the standard specified at 49
CFR 391.41(b)(10) and that the vision impairment is stable. In
addition, a review of each record of safety while driving with the
respective vision deficiencies over the past two years indicates each
applicant continues to meet the vision exemption standards. These
factors provide an adequate basis for predicting each driver's ability
to continue to drive safely in interstate commerce. Therefore, FMCSA
concludes that extending the exemption for each renewal applicant for a
period of two years is likely to achieve a level of safety equal to
that existing without the exemption.

Request for Comments

    FMCSA will review comments received at any time concerning a
particular driver's safety record and determine if the continuation of
the exemption is consistent with the requirements at 49 U.S.C. 31136(e)
and 31315. However, FMCSA requests that interested parties with
specific data concerning the safety records of these drivers submit
comments by October 26, 2009.
    FMCSA believes that the requirements for a renewal of an exemption
under 49 U.S.C. 31136(e) and 31315 can be satisfied by initially
granting the renewal and then requesting and evaluating, if needed,
subsequent comments submitted by interested parties. As indicated
above, the Agency previously published notices of final disposition
announcing its decision to exempt these 26 individuals from the vision
requirement in 49 CFR 391.41(b)(10). The final decision to grant an
exemption to each of these individuals was based on the merits of each
case and only after careful consideration of the comments received to
its notices of applications. The notices of applications stated in
detail the qualifications, experience, and medical condition of each
applicant for an exemption from the vision requirements. That
information is available by consulting the above cited Federal Register
publications.
    Interested parties or organizations possessing information that
would otherwise show that any, or all of these

drivers, are not currently achieving the statutory level of safety
should immediately notify FMCSA. The Agency will evaluate any adverse
evidence submitted and, if safety is being compromised or if
continuation of the exemption would not be consistent with the goals
and objectives of 49 U.S.C. 31136(e) and 31315, FMCSA will take
immediate steps to revoke the exemption of a driver.

    Issued on September 17, 2009.
Larry W. Minor,
Associate Administrator for Policy and Program Development.
[FR Doc. E9-23198 Filed 9-24-09; 8:45 am]

BILLING CODE 4910-EX-P


[Federal Register Volume 76, Number 209 (Friday, October 28, 2011)]
[Notices]
[Page 67018]
[FR Doc No: 2011-26791]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice to Manufacturers of Airport In-Pavement Stationary Runway
Weather Information Systems

AGENCY: Federal Aviation Administration (FAA), U.S. DOT.

ACTION: Notice to Manufacturers of In-Pavement Stationary Runway
Weather Information Systems.

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

SUMMARY: Projects funded under the Airport Improvement Program (AIP)
must meet the requirements of 49 U.S.C. 50101, Buy American
Preferences. The Federal Aviation Administration (FAA) is considering
issuing waivers to foreign manufacturers of Active or Passive In-
Pavement Stationary Runway Weather Information Systems that meet the
requirements of FAA Advisory Circular (AC) 150/5220-30, Airport Winter
Safety and Operations. This notice requests information from
manufacturers of systems meeting the technical requirements to
determine whether a waiver to the Buy American Preferences should be
issued.

FOR FURTHER INFORMATION CONTACT:  Ms. Nancy S. Williams, Airports
Financial Assistance, APP 501, Room 619, FAA, 800 Independence Avenue
SW., Washington, DC 20591, Telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Federal Aviation Administration (FAA)
manages a Federal grant program for airports called the Airport
Improvement Program (AIP). AIP grant recipients must follow 49 U.S.C.
50101, Buy American Preferences.
    Under 49 U.S.C. 50101(b)(3), the Secretary of Transportation may
waive the Buy American Preference requirement if the goods are not
produced in a sufficient and reasonably available amount or are not of
a satisfactory quality.
    The purpose of this notice is to request manufacturers of both
passive and active in-pavement runway surface condition sensor systems,
both domestic and foreign, to advise FAA of the system that they
manufacture and whether it can meet the FAA Advisory Circular technical
requirements. The detailed instructions for submitting the
qualifications statement, including forms, may be found on the FAA Web
site at: http://www.faa.gov/airports/aip/procurement/federal_contract_provisions/ at the tab entitled, In-Pavement Runway Surface
Condition Sensor Systems Request For Qualifications.
    The FAA wants to determine if there is sufficient quantity of
domestic manufacturers capable of meeting the FAA technical
requirements. If the FAA cannot find that there are USA manufacturers,
it will issue a nationwide waiver to the foreign manufacturers
identified as being capable of meeting the technical requirements.
    Technical Requirements: FAA Advisory Circular (AC) 150/5220-30,
Airport Winter Safety and Operations recommends that in-pavement runway
sensor systems comply with the performance and installation
requirements of SAE Aerospace Recommended Practice 5533, Stationary
Runway Weather Information System (In-pavement). The SAE specification
is available for purchase at http://www.sae.org. Because the
recommendations in an Advisory Circular become mandatory for airports
using AIP grant funds, an in-pavement runway surface condition sensor
system project that includes any AIP grant funding must meet the
requirements of SAE ARP5533.
    After review, the FAA may issue a nationwide waiver to Buy American
Preferences for foreign manufacturers or United States manufacturers
that do not meet the Buy American Preference requirements. Waivers will
not be issued for manufacturers that do not fully meet the technical
requirements. This ``nationwide waiver'' allows equipment to be used on
airport projects without having to receive separate project waivers.
Having a nationwide waiver allows projects to start quickly without
have to wait for the Buy American analysis to be completed for every
project, while still assuring the funds used for airport projects under
the Act are being directed to U.S. manufacturers.
    Items that have been granted a ``nationwide waiver'' can be found
on the FAA Web site at: http://www.faa.gov/airports/aip/procurement/federal_contract_provisions/ at the tab entitled, Equipment Meeting
Buy American Requirements.

Issued in Washington, DC, October 11, 2011.
Frank J. San Martin,
Manager, Airports Financial Assistance Division.
[FR Doc. 2011-26791 Filed 10-27-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: July 13, 2010 (Volume 75, Number 133)]
[Notices]
[Page 40020-40021]
[DOCID:fr13jy10-134]

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

DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration, DOT

[Docket No. FRA-2010-0005-N-16]

Agency Information Collection Activities; Proposals, Submissions,
and Approvals

ACTION: Notice and request for comments.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.), this notice announces that the Information
Collection Requirements (ICRs) abstracted below have been forwarded to
the Office of Management and Budget (OMB) for review and comment. The
ICRs describes the nature of the information collections and their
expected burdens. The Federal Register notice with a 60-day comment
period soliciting comments on the following collections of information
was published on May 4, 2010 (75 FR 23839).

DATES: Comments must be submitted on or before August 12, 2010.

FOR FURTHER INFORMATION CONTACT: Mr. Robert Brogan, Office of Safety,
Planning and Evaluation Division, RRS-21, Federal Railroad
Administration, 1200 New Jersey Ave., SE., Mail Stop 17, Washington, DC
20590 (telephone:<PHONE_NUMBER>), or Ms. Kimberly Toone, Office of
Information Technology, RAD-20, Federal Railroad Administration, 1200
New Jersey Ave., SE., Mail Stop 35, Washington, DC 20590 (telephone:
(202) 493-6132). (These telephone numbers are not toll-free.)

SUPPLEMENTARY INFORMATION: The Paperwork Reduction Act of 1995 (PRA),
Public Law 104-13, Sec.  2, 109 Stat. 163 (1995) (codified as revised
at 44 U.S.C. 3501-3520), and its implementing regulations, 5 CFR part
1320, require Federal agencies to issue two notices seeking public
comment on information collection activities before OMB may approve
paperwork packages. 44 U.S.C. 3506, 3507; 5 CFR 1320.5, 1320.8(d)(1),
1320.12. On May 4, 2010, FRA published a 60-day notice in the Federal
Register soliciting comment on ICRs that the agency was seeking OMB
approval. 75 FR 23839. FRA received no comments after issuing this
notice. Accordingly, DOT announces that these information collection
activities have been re-evaluated and certified under 5 CFR 1320.5(a)
and forwarded to OMB for review and approval pursuant to 5 CFR
1320.12(c).
    Before OMB decides whether to approve these proposed collections of
information, it must provide 30 days for public comment. 44 U.S.C.
3507(b); 5 CFR 1320.12(d). Federal law requires OMB to approve or
disapprove paperwork packages between 30 and 60 days after the 30-day
notice is published. 44 U.S.C. 3507 (b)-(c); 5 CFR 1320.12(d); see also
60 FR 44978, 44983, Aug. 29, 1995. OMB believes that the 30-day notice
informs the regulated community to file relevant comments and affords
the agency adequate time to digest public comments before it renders a
decision. 60 FR 44983, Aug. 29, 1995. Therefore, respondents should
submit their respective comments to OMB within 30 days of publication
to best ensure having their full effect. 5 CFR 1320.12(c); see also 60
FR 44983, Aug. 29, 1995.
    The summaries below describe the nature of the information
collection requirements (ICRs) and the expected burden. The revised
requirements are being submitted for clearance by OMB as required by
the PRA.
    Title: Foreign Railroads' Foreign-Based (FRFB) Employees Who
Perform Train or Dispatching Service in the United States.
    OMB Control Number: 2130-0555.
    Type of Request: Extension without change of a currently approved
collection.
    Affected Public: Railroads.
    Form(s): None.
    Abstract: The collection of information is used by FRA to determine
compliance of FRFB train and dispatching service employees and their
employers with the prohibition against the abuse of alcohol and
controlled substances. Because of the increase in cross-border train
operations and the increased risk posed to the safety of train
operations in the United States, FRA seeks to apply all of the
requirements of 49 CFR 219 to FRFB train and dispatching service
employees. The basic information--evidence of unauthorized use of drugs
and alcohol--is used by FRA to help prevent accidents/incidents by
screening FRFB who perform safety-sensitive functions for unauthorized
drug or alcohol use. FRFB train and dispatching service employees
testing positive for unauthorized use of alcohol and drugs are removed
from service, thereby enhancing safety and serving as a deterrent to
other FRFB train and dispatching service employees who might be tempted
to engage in the unauthorized use of drugs or alcohol.
    Annual Estimated Burden: 28 hours.
    Title: Special Notice for Repairs.
    OMB Control Number: 2130-0504.
    Type of Request: Extension without change of a currently approved
collection.
    Affected Public: Railroads.
    Form(s): FRA F 6180.8; FRA F 6180.8a.
    Abstract: The Special Notice For Repairs is issued to notify the
carrier in writing of an unsafe condition involving a locomotive, car,
or track. The carrier must return the form after repairs have been
made. The collection of information is used by State and Federal
inspectors to remove freight cars or locomotives until they can be
restored to a serviceable condition. It is also used by State and
Federal inspectors to reduce the maximum authorized speed on a section
of track until repairs can be made.
    Annual Estimated Burden: 10 hours.

ADDRESSES: Send comments regarding these information collections to the
Office of Information and Regulatory Affairs, Office of Management and
Budget, 725 Seventeenth Street, NW., Washington, DC 20503, Attention:
FRA Desk Officer.
    Comments are invited on the following: Whether the proposed
collections of information are necessary for the proper performance of
the functions of the Department, including whether the information will
have practical utility; the accuracy of the Department's estimates of
the burden of the proposed information collections; ways to enhance the
quality, utility, and clarity of the information to be collected; and
ways to minimize the burden of the collections of information on
respondents, including the use of

automated collection techniques or other forms of information
technology.
    A comment to OMB is best assured of having its full effect if OMB
receives it within 30 days of publication of this notice in the Federal
Register.

    Authority:  44 U.S.C. 3501-3520.

    Issued in Washington, DC on July 7, 2010.
Kimberly Coronel,
Director, Office of Financial Management, Federal Railroad
Administration.
[FR Doc. 2010-17008 Filed 7-12-10; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 77, Number 129 (Thursday, July 5, 2012)]
[Rules and Regulations]
[Pages 39633-39638]
[FR Doc No: 2012-16296]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Parts 100 and 165

[Docket Number USCG-2012-0111]
RIN 1625-AA00; 1625-AA08

Special Local Regulation and Safety Zones; Marine Events in
Captain of the Port Sector Long Island Sound Zone

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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

SUMMARY: The Coast Guard is establishing temporary special local
regulations and safety zones for marine events on the navigable waters
within the Captain of the Port (COTP) Sector Long Island Sound zone for
regattas, fireworks displays and swim events. This action is necessary
to provide for the safety of life on navigable waters during the
events. Entering into, transiting through, remaining, anchoring or
mooring within these regulated areas would be prohibited unless
authorized by the COTP Sector Long Island Sound.

DATES: This rule is effective from August 6, 2012 until November 11,
2012.
    This rule will be enforced during the specific dates and time
listed in TABLE 1 and 2 to Sec.  165.T01-0111.

ADDRESSES: Documents mentioned in this preamble are part of docket
[USCG-2012-0111]. To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type the
docket number in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rulemaking. You may also
visit the Docket Management Facility in Room W12-140 on the ground
floor of the Department of Transportation West Building, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Petty Officer Joseph Graun, Prevention Department, Coast
Guard Sector Long Island Sound,<PHONE_NUMBER>,
<EMAIL_ADDRESS>If you have questions on viewing or submitting

material to the docket, call Renee V. Wright, Program Manager, Docket
Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking
LIS Long Island Sound

A. Regulatory History and Information

    On April 4, 2012 the Coast Guard published a notice of proposed
rulemaking (NPRM) entitled Special Local Regulations and Safety Zones;
Marine Events in Captain of the Port Sector Long Island Sound Zone, in
the Federal Register (77 FR 20324).
    We received no comments on the NPRM. No requests for a public
meeting were received and no public meetings were held.

B. Basis and Purpose

    The legal basis for this temporary rule is 33 U.S.C. 1226, 1231,
1233; 46 U.S.C. Chapters 454, 701, 3306, 3703; 50 U.S.C. 191, 195; 33
CFR 1.05-1, 6.04-1, 6.04-6 and 160.5; Public Law 107-295, 116 Stat.
2064; Department of Homeland Security Delegation No. 0170.1 which
collectively authorize the Coast Guard to define regulatory special
local regulations and safety zones.
    This temporary rule establishes special local regulations and
safety zones in order to provide for the safety of life on navigable
waterways during regattas, fireworks displays and swim events.

C. Discussion of Comments, Changes and the Final Rule

    In the NPRM the Coast Guard stated the following events: Davis Park
Fireworks, Charles W. Morgan Anniversary Fireworks and Waves of Hope
Swim, had not chose a date and time for their events and we would
announce them in the final rule. The dates for each of the events are
as follows: The Davis Park Fireworks have been removed from the table
because the sponsor has decided not to hold the event. Charles W.
Morgan Anniversary Fireworks will be held on November 3, 2012 and Waves
of Hope Swim will be held on August 13, 2012. The dates can also be
found in TABLE 1 & 2 to Sec.  165.T01-0111.
    The following events have been removed from this rulemaking and
placed in a separate rulemaking under docket number (USCG-2012-0477)
titled Safety Zones; Fireworks Displays in Captain of the Port Long
Island Sound Zone. Salute to Veterans Devon Yacht Club Fireworks, Dolan
Family Fourth Fireworks, Islip Fireworks, Madison Fireworks, Stratford
Fireworks, Rowayton Fireworks, Quarentello Wedding Fireworks and
Niantic Bay Fireworks. These events have been moved because there was
less than 30 days between publication of this rule and the start of
each events. Moving these events to a separate rulemaking allows the
Coast Guard to accommodate a 30 day window between this rule
publication and first day of being effective.

D. 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 or executive orders.

1. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders.
    The Coast Guard determined that this rulemaking is not a
significant regulatory action for the following reasons: The regulated
areas are of limited duration and cover only a small portion of the
navigable waterways. Furthermore, vessels may transit the navigable
waterways outside of the regulated areas. Persons or vessels requiring
entry into the regulated areas may be authorized to do so by the COTP
Sector Long Island Sound or designated representative.
    Advanced public notifications will also be made to the local
maritime community through the Local Notice to Mariners as well as
Broadcast Notice to Mariners.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The Coast Guard
received no comments from the Small Business Administration on this
rule. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities. This rule will affect the following entities, some of
which may be small entities: the owners or operators of vessels
intending to enter, transit, anchor or moor within the regulated areas
during the enforcement periods stated for each event listed below in
the List of Subjects.
    These temporary special local regulations and safety zones will not
have a significant economic impact on a substantial number of small
entities for the following reasons: the regulated areas are of limited
size and of short duration, vessels that can safely do so may navigate
in all other portions of the waterways except for the areas designated
as regulated areas, and vessels requiring entry into the regulated
areas may be authorized to do so by the COTP Sector Long Island Sound
or designated representative. Additionally, before the effective
period, notifications will be made to the local maritime community
through the Local Notice to Mariners and Broadcast Notice to Mariners
well in advance of the events.

3. Assistance for Small Entities

    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
contact the person listed in the FOR FURTHER INFORMATION CONTACT,
above.
    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.

4. 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).

5. Federalism

    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 determined that this rule does
not have implications for federalism.

6. 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.

7. 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.

8. Taking of Private Property

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

9. Civil Justice Reform

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

10. Protection of Children

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

11. Indian Tribal Governments

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

12. Energy Effects

    This action is not a ``significant energy action'' under Executive
Order 13211, Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use.

13. Technical Standards

    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have 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 establishment of special local
regulations and safety zones. This rule is categorically excluded from
further review under paragraph 34(g)&(h), of Figure 2-1 of the
Commandant Instruction. An environmental analysis checklist supporting
this determination and a 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 rule.

List of Subjects

33 CFR Part 100

    Marine safety, Navigation (water), Reporting and recording
requirements, Waterways.

33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, and Waterways.
    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR parts 100 and 165 as follows:

PART 100--SAFETY OF LIFE ON NAVIGABLE WATERS

0
1. The authority citation for part 100 continues to read as follows:

    Authority:  33 U.S.C. 1233.

0
2. Add Sec.  100.35T01-0111 to read as follows:

Sec.  100.35T01-0111  Special Local Regulations; Regattas in the Coast
Guard Sector Long Island Sound Captain of the Port Zone.

    (a) Regulations. The following regulations apply to the marine
events listed in TABLE 1 to Sec.  100.35T01-0111. These regulations
will be enforced for the duration of each event, on the dates
indicated. Notifications will be made to the local maritime community
through all appropriate means such as Local Notice to Mariners or
Broadcast Notice to Mariners well in advance of the events. First Coast
Guard District Local Notice to Mariners can be found at: http://www.navcen.uscg.gov/.
    (b) Definitions. The following definitions apply to this section:
    (1) Designated Representative. A ``designated representative'' is
any Coast Guard commissioned, warrant or petty officer of the U.S.
Coast Guard who has been designated by the Captain of the Port (COTP),
Sector Long Island Sound, to act on his or her behalf. The designated
representative may be on an official patrol vessel or may be on shore
and will communicate with vessels via VHF-FM radio or loudhailer. In
addition, members of the Coast Guard Auxiliary may be present to inform
vessel operators of this regulation.
    (2) Official Patrol Vessels. Official patrol vessels may consist of
any Coast Guard, Coast Guard Auxiliary, state, or local law enforcement
vessels assigned or approved by the COTP Sector Long Island Sound.
    (3) Spectators. All persons and vessels not registered with the
event sponsor as participants or official patrol vessels.
    (c) Vessel operators desiring to enter or operate within the
regulated areas shall contact the COTP Sector Long Island Sound at 203-
468-4401 (Sector LIS command center) or the designated representative
via VHF channel 16.
    (d) Vessels may not transit the regulated areas without the COTP
Sector Long Island Sound or designated representative approval. Vessels
permitted to transit must operate at a no wake speed, in a manner which
will not endanger participants or other crafts in the event.
    (e) Spectators or other vessels shall not anchor, block, loiter, or
impede the transit of event participants or official patrol vessels in
the regulated areas during the effective dates and times, or dates and
times as modified through the Local Notice to Mariners, unless
authorized by COTP Sector Long Island Sound or designated
representative.
    (f) The COTP Sector Long Island Sound or designated representative
may

control the movement of all vessels in the regulated area. When hailed
or signaled by an official patrol vessel, a vessel shall come to an
immediate stop and comply with the lawful directions issued. Failure to
comply with a lawful direction may result in expulsion from the area,
citation for failure to comply, or both. The COTP Sector Long Island
Sound or designated representative may delay or terminate any marine
event in this subpart at any time it is deemed necessary to ensure the
safety of life or property.
    (g) For all regattas listed, vessels not participating in the
event, swimmers, and personal watercraft of any nature are prohibited
from entering or moving within the regulated area unless authorized by
the COTP Sector Long Island Sound or designated representative. Vessels
within the regulated area must be at anchor within a designated
spectator area or moored to a waterfront facility in a way that will
not interfere with the progress of the event.

                                 TABLE 1
                       [to Sec.   100.35T01-0111]
------------------------------------------------------------------------

------------------------------------------------------------------------
1 Hartford Dragon Boat Regatta.........   Dates: August 18 and
                                          19, 2012.
                                          Time 8 a.m. until 4:30
                                          p.m. each day.
                                          Regulated area: All
                                          waters of the Connecticut
                                          River in Hartford, CT between
                                          the Bulkeley Bridge
                                          41[deg]46'10.10'' N,
                                          072[deg]39'56.13'' W and the
                                          Wilbur Cross Bridge
                                          41[deg]45'11.67'' N,
                                          072[deg]39'13.64'' W North
                                          American Datum 1983 (NAD 83).
2 Kayak for a Cause Regatta............   Date: July 21, 2012.
                                          Time: 8 a.m. until 3
                                          p.m.
                                          Regulated area: All
                                          water of Long Island Sound
                                          within a nine mile long and
                                          half mile wide rectangle
                                          shaped regatta course
                                          connecting Norwich, CT and
                                          Crab Meadow, NY. The regulated
                                          area beginning in Norwich CT
                                          east of Shady Beach at
                                          41[deg]5'32.24'' N,
                                          073[deg]23'11.18'' W then
                                          heads south crossing Long
                                          Island Sound to a point east
                                          of Crab Meadow Beach, Crab
                                          Meadow, NY at
                                          40[deg]55'37.21'' N,
                                          073[deg]19'2.14'' W then turns
                                          west connecting to a point
                                          west of Crab Meadow Beach at
                                          40[deg]55'48.3'' N,
                                          073[deg]19'51.88'' W, then
                                          turns north crossing Long
                                          Island Sound to the western
                                          boundary of Calf Pasture Beach
                                          Norwich, CT at
                                          41[deg]4'57.54'' N,
                                          073[deg]23'53.21'' W then
                                          turns east back to its
                                          starting point at
                                          41[deg]5'32.24'' N,
                                          073[deg]23'11.18'' W North
                                          American Datum 1983 (NAD 83).
                                          Additional
                                          stipulations: (1) Spectators
                                          must maintain a minimum
                                          distance of 100 yards from
                                          each event participant and
                                          support vessel. (2) Vessels
                                          that maintain the minimum
                                          required distance from event
                                          participants and support
                                          vessels may transit through
                                          the regatta course.
------------------------------------------------------------------------

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. Chapters 454, 701,
3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6 and
160.5; Public Law 107-295, 116 Stat. 2064; Department of Homeland
Security Delegation No. 0170.1.

0
4. Add Sec.  165.T01-0111 to read as follows:

Sec.  165.T01-0111  Safety Zones; Fireworks Displays and Swim Events in
Captain of the Port Long Island Sound Zone

    (a) Regulations. The general regulations contained in 33 CFR 165.23
as well as the following regulations apply to the fireworks displays,
air shows, and swim events listed in TABLE 1 and TABLE 2 of Sec.
165.T01-0111. These regulations will be enforced for the duration of
each event. Notifications will be made to the local maritime community
through all appropriate means such as Local Notice to Mariners or
Broadcast Notice to Mariners well in advance of the events. Mariners
should consult their Local Notice to Mariners to remain apprised of
schedule or event changes. First Coast Guard District Local Notice to
Mariners can be found at http://www.navcen.uscg.gov/.
    (b) Definitions. The following definitions apply to this section:
    (1) Designated Representative. A ``designated representative'' is
any Coast Guard commissioned, warrant or petty officer of the U.S.
Coast Guard who has been designated by the Captain of the Port (COTP),
Sector Long Island Sound, to act on his or her behalf. The designated
representative may be on an official patrol vessel or may be on shore
and will communicate with vessels via VHF-FM radio or loudhailer. In
addition, members of the Coast Guard Auxiliary may be present to inform
vessel operators of this regulation.
    (2) Official Patrol Vessels. Official patrol vessels may consist of
any Coast Guard, Coast Guard Auxiliary, state, or local law enforcement
vessels assigned or approved by the COTP Sector Long Island Sound.
    (3) Spectators. All persons and vessels not registered with the
event sponsor as participants or official patrol vessels.
    (c) Vessel operators desiring to enter or operate within the
regulated areas should contact the COTP Sector Long Island Sound at
203-468-4401 (Sector LIS command center) or the designated
representative via VHF channel 16 to obtain permission to do so.
    (d) Spectators or other vessels shall not anchor, block, loiter, or
impede the transit of event participants or official patrol vessels in
the regulated areas during the effective dates and times, or dates and
times as modified through the Local Notice to Mariners, unless
authorized by COTP Sector Long Island Sound or designated
representative.
    (e) Upon being hailed by a U.S. Coast Guard vessel or the
designated representative, by siren, radio, flashing light or other
means, the operator of the vessel shall proceed as directed. Failure to
comply with a lawful direction may result in expulsion from the area,
citation for failure to comply, or both.
    (f) The COTP Sector Long Island Sound or designated representative
may delay or terminate any marine event in this subpart at any time it
is deemed necessary to ensure the safety of life or property.

    (g) The regulated area for all fireworks displays listed in TABLE 1
to Sec.  165.T01-0111 is that area of navigable waters within a 1000
foot radius of the launch platform or launch site for each fireworks
display, unless otherwise noted in TABLE 1 to Sec.  165.T01-0111 or
modified in USCG First District Local Notice to Mariners at: http://www.navcen.uscg.gov/.
    (h) Fireworks barges used in these locations will also have a sign
on their port and starboard side labeled ``FIREWORKS--STAY AWAY''. This
sign will consist of 10 inch high by 1.5 inch wide red lettering on a
white background. Shore sites used in these locations will display a
sign labeled ``FIREWORKS--STAY AWAY'' with the same dimensions. These
zones will be enforced from 8:30 p.m. to 10:30 p.m. each day a barge
with a ``FIREWORKS--STAY AWAY'' sign on the port and starboard side is
on-scene or a ``FIREWORKS--STAY AWAY'' sign is posted in a location
listed in TABLE 1 to Sec.  165.T01-0111.
    (i) Enforcement period.
    (1) Each fireworks display will be enforced from 8:30 p.m. until 10
p.m. on the respective dates listed in Table 1 of Sec.  165.T01-0111.
    (2) Each swim event will be enforced during the date and time
listed in Table 2 of Sec.  165.T01-0111.

                                 Table 1
                        [To Sec.   165.T01-0111]
------------------------------------------------------------------------

------------------------------------------------------------------------
8                                                     August
------------------------------------------------------------------------
8.1 Shelter Island Yacht Club Fireworks   Date: August 11, 2012.
                                          Rain date: August 12,
                                          2012.
                                          Location: Waters of
                                          Dering Harbor north of Shelter
                                          Island Yacht Club in Shelter
                                          Island, NY in approximate
                                          position 41[deg]05'23.47'' N,
                                          072[deg]21'11.18'' W (NAD 83).
8.2 Stamford Fireworks.................   Date: August 30, 2012.
                                          Rain date: August 31,
                                          2012.
                                          Location: Waters of
                                          Stamford Harbor, off
                                          Kosciuszco Park in Stamford,
                                          CT in approximate position
                                          41[deg]1'48.46'' N,
                                          073[deg]32'15.32'' W (NAD 83).
------------------------------------------------------------------------
11                                                   November
------------------------------------------------------------------------
1 Charles W. Morgan Anniversary           Date: November 3,
 Fireworks.                               2012.
                                          Rain date: November
                                          10, 2012.
                                          Location: Waters of
                                          the Mystic River, north of the
                                          Mystic Seaport Light, Mystic,
                                          CT in approximate position
                                          41[deg]21'56.455'' N,
                                          071[deg]57'58.32'' W (NAD 83).
------------------------------------------------------------------------

                                 Table 2
                 [To Sec.   165.T01-0111 July & August]
------------------------------------------------------------------------

------------------------------------------------------------------------
1 Waves of Hope Swim...................   Date: August 13, 2012.
                                          Time: 8 a.m. until 10
                                          a.m.
                                         Location: All waters of the
                                          Great South Bay off
                                          Amityville, NY shoreward of a
                                          line created by connecting the
                                          following points. Beginning at
                                          40[deg]39'22.38'' N,
                                          073[deg]25'31.63'' W then to
                                          40[deg]39'2.18'' N,
                                          073[deg]25'31.63'' W then to
                                          40[deg]39'2.18'' N,
                                          073[deg]24'03.81'' W, ending
                                          at 40[deg]39'18.27'' N,
                                          073[deg]24'03.81'' W North
                                          American Datum 1983 (NAD 83).
2 Stonewall Swim.......................   Date: August 4, 2012.
                                          Time: 8:30 a.m. until
                                          12:30 p.m.
                                         Location: All navigable waters
                                          of the Great South Bay within
                                          a three miles long and half
                                          mile wide box connecting
                                          Snedecor Avenue in Bayport, NY
                                          to Porgie Walk in Fire Island,
                                          NY. Formed by connecting the
                                          following points. Beginning at
                                          40[deg]43'40.24'' N,
                                          073[deg]03'41.5'' W then to
                                          40[deg]43'40'' N,
                                          073[deg]03'13.4'' W, then to
                                          40[deg]40'4.13'' N,
                                          073[deg]03'43.81'' W then to
                                          40[deg]40'8.3'' N,
                                          073[deg]03'17.7'' W and ending
                                          at the beginning point
                                          40[deg]43'40.24'' N,
                                          073[deg]03'41.5'' W (NAD 83).
------------------------------------------------------------------------

    Dated: June 7, 2012.
J.M. Vojvodich,
Captain, U.S. Coast Guard, Captain of the Port Sector Long Island
Sound.
[FR Doc. 2012-16296 Filed 7-3-12; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 77, Number 193 (Thursday, October 4, 2012)]
[Notices]
[Pages 60704-60705]
[FR Doc No: 2012-24479]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2012-M-0371, FDA-2012-M-0372, FDA-2012-M-0373, FDA-
2012-M-0390, FDA-2012-M-0407, FDA-2012-M-0562, and FDA-2012-M-0638]

Medical Devices; Availability of Safety and Effectiveness
Summaries for Premarket Approval Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
premarket approval applications (PMAs) that have been approved. This
list is intended to inform the public of the availability of safety and
effectiveness summaries of approved PMAs through the Internet and the
Agency's Division of Dockets Management.

ADDRESSES: Submit written requests for copies of summaries of safety
and effectiveness data to the Division of Dockets Management (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Please cite the appropriate docket number as listed in table
1 of this document when submitting a written request. See the
SUPPLEMENTARY INFORMATION section for electronic access to the
summaries of safety and effectiveness.

FOR FURTHER INFORMATION CONTACT: Nicole Wolanski, Center for Devices
and Radiological Health, Food and Drug

Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1650, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with sections 515(d)(4) and (e)(2) of the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360e(d)(4) and
(e)(2)), notification of an order approving, denying, or withdrawing
approval of a PMA will continue to include a notice of opportunity to
request review of the order under section 515(g) of the FD&C Act. The
30-day period for requesting reconsideration of an FDA action under
Sec.  10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a
PMA begins on the day the notice is placed on the Internet. Section
10.33(b) provides that FDA may, for good cause, extend this 30-day
period. Reconsideration of a denial or withdrawal of approval of a PMA
may be sought only by the applicant; in these cases, the 30-day period
will begin when the applicant is notified by FDA in writing of its
decision.
    The regulations provide that FDA publish a quarterly list of
available safety and effectiveness summaries of PMA approvals and
denials that were announced during that quarter. The following is a
list of approved PMAs for which summaries of safety and effectiveness
were placed on the Internet from April 1, 2012, through June 30, 2012.
There were no denial actions during this period. The list provides the
manufacturer's name, the product's generic name or the trade name, and
the approval date.

Table 1--List of Safety and Effectiveness Summaries for Approved PMAs Made Available From April 1, 2012, Through
                                                  June 30, 2012
----------------------------------------------------------------------------------------------------------------
        PMA No., Docket No.               Applicant                Trade name                Approval date
----------------------------------------------------------------------------------------------------------------
P020018/S040, FDA-2012-M-0371.....  Cook, Inc............  Zenith[supreg] Fenestrated  April 4, 2012.
                                                            AAA Endovascular Graft
                                                            (with the adjunctive
                                                            Zenith Alignment Stent).
P110029, FDA-2012-M-0372..........  Abbot Laboratories...  ARCHITECT HBsAg             April 12, 2012.
                                                            Qualitative, ARCHITECT
                                                            HBsAg Qualitative
                                                            Confirmatory, ARCHITECT
                                                            HBsAg Qualitative
                                                            Confirmatory Manual
                                                            Diluent, ARCHITECT HBsAg
                                                            Qualitative Calibrators,
                                                            and ARCHITECT HBsAg
                                                            Qualitative Controls.
P110004, FDA-2012-M-0407..........  Medinol Ltd..........  Presillion\TM\ plus CoCr    April 12, 2012.
                                                            Coronary Stent on RX
                                                            System.
P110035, FDA-2012-M-0373..........  Boston Scientific      Epic\TM\ Vascular Self-     April 13, 2012.
                                     Corp.                  Expanding Stent System.
P090015, FDA-2012-M-0390..........  Leica Biosystems.....  BOND\TM\ ORACLE\TM\ HER2    April 18, 2012.
                                                            IHC System.
P110010/S001, FDA-2012-M-0562.....  Boston Scientific      PROMUS[supreg] Element\TM\  June 1, 2012.
                                     Corp.                  Plus Everolimus-Eluting
                                                            Platinum Chromium
                                                            Coronary Stent System
                                                            (Monorail\TM\ and Over-
                                                            the-Wire).
P090026, FDA-2012-M-0638..........  Beckman Coulter, Inc.  Access[supreg]              June 14, 2012.
                                                            Hybritech[supreg] p2PSA
                                                            on the Access Immunoassay
                                                            Systems.
----------------------------------------------------------------------------------------------------------------

II. Electronic Access

    Persons with access to the Internet may obtain the documents at
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/default.htm.

    Dated: September 28, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-24479 Filed 10-3-12; 8:45 am]
BILLING CODE 4160-01-P