[Federal Register Volume 80, Number 49 (Friday, March 13, 2015)]
[Notices]
[Pages 13395-13396]
[FR Doc No: 2015-05710]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0722]

Gastroenterology and Urology Devices Panel of the Medical Devices
Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    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: Gastroenterology and Urology 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 May 14 and 15, 2015,
from 8 a.m. to 6 p.m.
    Addresses: FDA is opening a docket for interested persons to submit
electronic or written comments regarding this meeting. The Docket No.
is FDA-2015-N-0722. Please see the Procedure section of the notice for
further information.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions including information
regarding special accommodations due to a disability, visitor parking,
and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    Contact Person: Natasha Facey, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 1552, 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). 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 at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
    Agenda: On May 14 and 15, 2015, the committee will discuss recent
reports and epidemiologic investigations of transmission of infections
associated with the use of duodenoscopes in endoscopic retrograde
cholangiopancreatography (ERCP) procedures in hospitals in the United
States.
    FDA is convening this committee to seek expert scientific and
clinical opinion related to reprocessing of duodenoscopes and other
endoscopes, as well as automated endoscope reprocessors, based on
available scientific information. The committee will make
recommendations on: (1) The effectiveness of cleaning, high level
disinfection, and sterilization methods; (2) the amount and type of
premarket validation data and information needed to support labeling
claims and technical instructions; (3) the appropriate use of other
risk mitigations, such as surveillance cultures; (4) best practices and
guidelines for reprocessing duodenoscopes and endoscopes at user
facilities to minimize the transmission of infections; and (5)
recommended approaches for ensuring patient safety during ERCP
procedures, including a discussion of appropriate patient selection.
    Recommendations on these issues will assist FDA in minimizing
patient exposure to infectious agents that may result from reprocessed
duodenoscopes and endoscopes.
    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 meeting
link.
    CDRH plans to provide a live Webcast of the May 14 and 15, 2015,
meeting of the Gastroenterology and Urology Devices Panel. While CDRH
is working to make Webcasts available to the public for all advisory
committee meetings held at the White Oak campus, there are instances
where the Webcast transmission is not successful; staff will work to
re-establish the transmission as soon as possible. The link for the
Webcast is available at: https://collaboration.fda.gov/gudpm052015/.

Further information regarding the Webcast, including the Web address
for the Webcast, will be made available at least 2 days in advance of
the meeting at the following Web site: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/Gastroenterology-UrologyDevicesPanel/default.htm. Select the link for 2015 Meeting Materials.
    Procedure: 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
April 30, 2015. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. on May 14 and between
approximately 9 a.m. and 10 a.m. on May 15. 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 April 15, 2015. 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 April 20, 2015.
    FDA is opening a docket for public comment on this document. The
Docket No. is FDA-2015-N-0722. The docket will close on May 28, 2015.
Interested persons are encouraged to use the docket to submit
electronic or written comments regarding this meeting. Comments
received on or before April 30, 2015, will be provided to the
committee. Comments received after that date will be taken into
consideration by the Agency. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. Submit a single copy of electronic comments or two
paper copies of any mailed comments. Comments are to be identified with
the docket number found in brackets in the heading of this document.
Received comments may be seen in the Divisions of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to
the docket at http://www.regulations.gov.
    For press inquiries, please contact the Office of Media Affairs at
<EMAIL_ADDRESS>or<PHONE_NUMBER>.
    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 AnnMarie Williams,
at<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: March 9, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-05710 Filed 3-12-15; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 193 (Tuesday, October 6, 2015)]
[Notices]
[Pages 60391-60393]
[FR Doc No: 2015-25349]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-3402]

Electronic Submission of Final Approved Risk Evaluation and
Mitigation Strategies and Summary Information in a Standard Structured
Product Labeling Format; Pilot Project

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of pilot project, request for comments.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
a pilot project for the submission of final approved Risk Evaluation
and Mitigation Strategies (REMS) and certain REMS summary information
electronically in a standard Structured Product Labeling (SPL) format.
Participation in the pilot is voluntary and is open to application
holders of drugs with REMS. The pilot is intended to help application
holders, FDA, and other interested stakeholders evaluate a potential
approach to converting REMS into SPL format and evaluate the usefulness
of the REMS information to be provided in SPL format. This project also
will help provide FDA with feedback on these topics from pilot
participants and other interested stakeholders.

DATES: Submit requests to participate in the REMS SPL pilot from
October 6, 2015 to December 7, 2015. See the ``Participation'' section
for instructions on how to submit a request to participate. The pilot
will proceed for 4 months, from October 6, 2015 to February 3, 2016.
This pilot may be extended as resources and needs allow.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2015-N-3402 for ``Electronic Submission of Final Approved Risk
Evaluation and Mitigation Strategies and Summary Information in a
Standard Structured Product Labeling Format; Pilot Project.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be

made publicly available, submit your comments only as a written/paper
submission. You should submit two copies total. One copy will include
the information you claim to be confidential with a heading or cover
note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.''
The Agency will review this copy, including the claimed confidential
information, in its consideration of comments. The second copy, which
will have the claimed confidential information redacted/blacked out,
will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets
Management. If you do not wish your name and contact information to be
made publicly available, you can provide this information on the cover
sheet and not in the body of your comments and you must identify this
information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Adam Kroetsch at
<EMAIL_ADDRESS>or at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing a pilot project for the submission of final
approved REMS and certain REMS summary information electronically in an
SPL format. This pilot is being conducted as a part of the ``Pharmacy
Systems Under REMS Project: Standardizing REMS Information for
Inclusion Into Pharmacy Systems Using Structured Product Labeling
(SPL).'' More information on this project--one of four predefined
priority projects that are a part of the larger REMS Integration
Initiative--can be found in the report ``Standardizing and Evaluating
Risk Evaluation and Mitigation Strategies (REMS)'' (the REMS report)
(http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM415751.pdf). FDA intends to eventually make
REMS in SPL format accessible to the public via a free, publicly
available Web site.
    As described in the REMS report, stakeholders have expressed
concern that information about REMS materials, tools, and requirements
are not communicated to stakeholders in a clear and consistent manner.
They also have told FDA that REMS materials and requirements may be
difficult to locate, and specific activities and requirements of
various stakeholders (e.g., prescriber, pharmacist) are not clearly
outlined. Furthermore, some stakeholders have difficulty integrating
REMS materials and procedures into their existing health information
systems and healthcare delivery processes. Because of these factors,
stakeholders reported spending excessive time trying to locate,
understand, and comply with different REMS requirements. (For more
general background information on REMS, as well as a more comprehensive
discussion of the issues mentioned in this paragraph, please refer to
the Background Materials (http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM362078.pdf) for the July 2013 REMS
Standardization and Evaluation Public Meeting.)
    To help address the problems described in the previous paragraph of
this document, FDA committed to develop a standardized REMS format that
can be included in SPL. FDA believes that this project, when completed,
will address many of the concerns described previously regarding REMS
because SPL information can be easily shared and made available online,
and is readily incorporable into health information technology.
Furthermore, FDA and application holders are both familiar with SPL and
possess much of the institutional knowledge needed to create and
disseminate files in this format. Ultimately, SPL can serve as a
conduit of structured REMS information to healthcare providers and
patients, while also providing accessible information about what
requirements exist and who is responsible for their completion. SPL may
also promote efficiency in the development and review of REMS
documents.

II. About the REMS SPL Pilot

    For all REMS programs (both REMS with and without elements to
assure safe use (ETASU)) included in the pilot, the REMS document will
be captured using standardized section headings. More information about
the REMS document is available in FDA's draft guidance for industry
``Format and Content of Proposed Risk Evaluation and Mitigation
Strategies (REMS), REMS Assessments, and Proposed REMS Modifications''
(http://www.fda.gov/downloads/Drugs/.../Guidances/UCM184128.pdf). For
REMS with ETASU, the SPL will include additional information about the
requirements these ETASU impose. This information is captured in two
places: A human-readable ``REMS Summary'' (described in detail in ``The
REMS Summary'' section of this document) and associated machine-
readable data elements. Both the REMS Summary and the data elements
will capture four basic pieces of information about each requirement:
     Who is required to carry out the requirement: For example,
a requirement may be carried out by the healthcare provider who
prescribes the drug or dispenses it.
     What that individual is required to do: This could include
a clinical activity, such as counseling a patient, or an administrative
one, such as completing an enrollment form.
     When the activity must be carried out: For example, a REMS
activity may need to be completed before a drug is prescribed or
dispensed, or before a patient is able to receive the drug.
     References to REMS materials that may contain additional
information about the requirement, such as forms and educational
materials.
    For REMS approved as a shared system, the REMS information
submitted in SPL format should be identical for each product in the
shared system.

A. The REMS Summary

    For REMS with ETASU, the REMS Summary will be presented in a
tabular format that facilitates coding of REMS data elements and allows
stakeholders to quickly obtain a reader-friendly overview of what the
REMS requires. It uses language that is similar to that found in
existing REMS documents and the summaries found on FDA's REMS Web site
(http://www.fda.gov/REMS). Detailed instructions for creating the REMS
Summary are available in the Draft REMS SPL Implementation Guide
Excerpt on FDA's SPL Web site (http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm). The REMS Summary
does not replace the approved REMS document, which will continue to be
the enforceable document establishing the REMS requirements.

B. REMS Data Elements

    For REMS with ETASU, the REMS data elements describe REMS
requirements using a standardized, machine-readable format that permits
integration of REMS information into electronic health information
technology, including clinical decision support, e-Prescribing systems,
and electronic pharmacy systems. FDA has developed terminology to
assist in the coding of REMS data elements. This terminology is
available as part of the Draft REMS SPL Implementation Guide Excerpt on
FDA's SPL Web site (http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm). The REMS Data Elements do not
replace the approved REMS document, which will continue to be the
enforceable document establishing the REMS requirements.

III. How To Participate in the REMS SPL Pilot

A. Participation

    Volunteers interested in participating in the pilot should contact
pilot staff by email at<EMAIL_ADDRESS>The following
information should be included in the request: Contact name, contact
phone number, and contact email address. FDA will contact interested
applicants to discuss the pilot. FDA is seeking a limited number of
participants (no more than nine) to participate in this pilot. FDA is
also seeking comment from any stakeholder on its proposed approach for
capturing REMS information in SPL format in this pilot, as described in
section II.

B. Procedures

    To create an SPL file and submit it to FDA, a participant will need
the following tools: Appropriate software, knowledge of terminology and
standards, and access to FDA's Electronic Submissions Gateway (ESG)
(http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm). The ESG is an Agency-wide means of accepting electronic
regulatory submissions. The FDA ESG enables the secure submission of
regulatory submissions. Instructions and information regarding the
creation of an SPL file and the converting of REMS information into SPL
can be found at http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. There should be no additional
cost associated with obtaining the software. In 2010, FDA collaborated
with Pragmatic Data, LLC (http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm189651.htm), to make available free SPL
authoring software that SPL authors may use to create new SPL documents
or edit previous versions.
    After the SPL is created, the participant would upload the file
through the ESG. The Internet portal can be found at http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm. Prior
to uploading an SPL file, one must obtain a digital certificate.
Instructions regarding obtaining a digital certificate used with FDA's
ESG and uploading the SPL file for submission can be found at http://www.fda.gov/esg/default.htm. The digital certificate binds together the
owner's name and a pair of electronic keys (a public and a private key)
that can be used to encrypt and sign documents. A fee of up to
approximately $20 is charged for the digital certificate. Application
holders should have already secured a digital certificate because they
are required to do so when they register and list.
    During the pilot, FDA staff will be available to answer any
questions or concerns that may arise. Pilot participants will be asked
to comment on and discuss their experiences converting their REMS into
SPL format. Their comments are expected to assist FDA in its completion
of the REMS SPL project.

IV. Duration of the REMS SPL Pilot

    FDA will accept requests for participation in the REMS SPL pilot
from October 6, 2015 to December 7, 2015. The pilot will proceed for 4
months, from October 6, 2015 to February 3, 2016. This pilot may be
extended as resources and needs allow.

V. Paperwork Reduction Act of 1995

    This notice refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 314 have been approved under
OMB control number 0910-0001.

    Dated: September 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-25349 Filed 10-5-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 15 (Friday, January 23, 2015)]
[Notices]
[Pages 3687-3689]
[FR Doc No: 2015-01108]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-74088; File No. SR-NYSEArca-2014-117]

Self-Regulatory Organizations; NYSE Arca, Inc.; Order Instituting
Proceedings To Determine Whether To Approve or Disapprove a Proposed
Rule Change To Remove the Exchange's Quote Mitigation Plan as Provided
by Commentary .03 to Exchange Rule 6.86

January 16, 2015.

I. Introduction

    On October 2, 2014, NYSE Arca, Inc., (``NYSE Arca'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to remove the Exchange's quote mitigation plan as
provided by Commentary .03 to NYSE Arca Rule 6.86. The proposed rule
change was published for comment in the Federal Register on October 21,
2014.\3\ On December 2, 2014, pursuant to Section 19(b)(2) of the
Act,\4\ the Commission designated a longer period within which to
approve the proposed rule change, disapprove the proposed rule change,
or institute proceedings to determine whether to disapprove the
proposed rule change.\5\ On January 8, 2015, the Exchange submitted a
letter in further support of the proposal.\6\ The Commission received
no comments on the proposal. This order institutes proceedings under
Section 19(b)(2)(B) of the Act \7\ to determine whether to approve or
disapprove the proposal.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 73362 (October 15,
2014), 79 FR 62983 (``Notice'').
    \4\ 15 U.S.C. 78s(b)(2).
    \5\ See Securities Exchange Act Release No. 73720, 79 FR 72747
(December 8, 2014). The Commission designated January 19, 2014, as
the date by which it should approve, disapprove, or institute
proceedings to determine whether to disapprove the proposed rule
change.
    \6\ See Letter from Elizabeth King, Secretary & General Counsel,
Exchange, to Kevin O'Neill, Deputy Secretary, Commission, dated
January 8, 2015 (``NYSE Arca Letter'') available at http://www.sec.gov/comments/sr-nysearca-2014-117/nysearca2014117.shtml.
    \7\ 15 U.S.C. 78s(b)(2)(B).
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II. Description of the Proposal

    In 2007, the Exchange adopted a quote mitigation plan in connection
with the Penny Pilot Program.\8\ According to the Exchange, the quote
mitigation plan was designed to reduce the number of quotation messages
sent by the Exchange to the Options Price Reporting Authority
(``OPRA'') by only submitting quote messages for ``active'' series.\9\
The Exchange defines active series under the quote mitigation plan in
Commentary .03 to Exchange Rule 6.86 as: (i) Series that have traded on
any options exchange in the previous 14 calendar days; or (ii) series
that are solely listed on the Exchange; or (iii) series that have been
trading ten days or less, or; (iv) series for which the Exchange has
received an order.\10\ In addition, under the Exchange's quote
mitigation plan, the Exchange may define a series as active on an
intraday basis if: (i) The series trades at any options exchange; (ii)
the Exchange receives an order in the series; or (iii) the Exchange
receives a request for quote from a customer in that series.\11\
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    \8\ See Securities and Exchange Release No. 55156 (January 23,
2007), 72 FR 4759 (February 1, 2007) (Order Granting Approval of SR-
NYSEArca-2006-73) (``Quote Mitigation Approval Order''). The Penny
Pilot Program permitted certain options classes to be quoted in
pennies. See id.
    \9\ See Notice, supra note 3, at 62983.
    \10\ See Exchange Rule 6.86, Commentary .03, and Notice, supra
note 3, at 62983.
    \11\ See id.
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    The Exchange proposes to remove its quote mitigation plan from its
rules by deleting Commentary .03 to Exchange Rule 6.86.\12\ The
Exchange believes that its quote mitigation plan is no longer necessary
primarily for three reasons. First, the Exchange states that its

incorporation of select provisions of the Options Listing Procedures
Plan (``OLPP'') \13\ in Exchange Rule 6.4A serves to reduce the
potential for excess quoting because the OLPP limits the number of
options series eligible to be listed, which, according to the Exchange,
reduces the number of options series a market maker would be obligated
to quote.\14\ Second, the Exchange states its view that Exchange Rule
6.37B Commentary .01, which removes certain options series from market
makers' continuous quoting obligations, reduces the number of quote
message traffic that the Exchange sends to OPRA.\15\ The Exchange
states that reliance on the OLPP, via Exchange Rule 6.4A, and the
refined market maker quoting obligations, pursuant to Commentary .01 to
Exchange Rule 6.37B, is sufficient as a quote mitigation plan.\16\
Third, the Exchange states that both its systems capacity and OPRA's
systems capacity are more than sufficient to accommodate any additional
increase in quote traffic that might be sent to OPRA as a result of the
deletion of the quote mitigation strategy.\17\ The Exchange represents
that it continually assesses its capacity needs and ensures that the
capacity that it requests from OPRA is sufficient and compliant with
the requirements established in the OPRA Capacity Guidelines.\18\
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    \12\ In addition, the Exchange proposes to amend paragraphs
(b)(1) and (b)(2) of Exchange Rule 6.86 to delete references to the
``Quote Mitigation Plan,'' which refer to the quote mitigation plan
set forth in Commentary .03 to Exchange Rule 6.86. See Notice, supra
note 3, at 62984.
    \13\ See Amendment to Plan for the Purpose of Developing and
Implementing Procedures Designed to Facilitate the Listing and
Trading of Standardized Options Submitted Pursuant to Section
11A(a)(3)(B) of the Securities Exchange Act available at http://www.theocc.com/clearing/industry-services/olpp.jsp (providing for
the most current OLPP). See also Securities and Exchange Release No.
44521 (July 6, 2001), 66 FR 36809 (July 13, 2001) (order approving
the OLPP).
    \14\ See Notice, supra note 3, at 62984. See also Securities and
Exchange Release No. 61977 (April 23, 2010), 75 FR 22884 (April 30,
2010) (in which the Exchange adopted select provisions of the OLPP
into Exchange Rule 6.4A).
    \15\ Commentary .01 to Exchange Rule 6.37B provides that
Exchange market makers continuous quoting obligations do not apply
``to adjusted option series, and series with a time to expiration of
nine months or greater, for options on equities and Exchange Traded
Fund Shares, and series with a time to expiration of twelve months
or greater for Index options.'' See also Notice, supra note 3, at
62984.
    \16\ See id. The Exchange states its view that limiting the
number of options series listed on the Exchange is preferable to
suppressing the quotes of inactive options series, as required under
current Exchange Rule 6.86, because all quotes sent by Exchange
market makers are actionable even if not displayed. See id.
    \17\ See Notice, supra note 3, at 62984.
    \18\ See id.
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    The Exchange represents that it has in place certain measures that
the Exchange believes serve as additional safeguards against excessive
quoting.\19\ According to the Exchange, these safeguards include
monitoring and alerting market makers disseminating an unusual number
of quotes, a business plan designed to ensure that new listings are
actively traded,\20\ and a ratio threshold fee designed to encourage
the efficient use of orders.\21\
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    \19\ See id.
    \20\ See id. at n.13 (citing to NYSE Arca Options Listing Policy
Statement, available at, http://www.nyse.com/pdfs/TraderNoticeArcaLOPSChanges092713.pdf).
    \21\ See id. at n.14 (citing to NYSE Arca Options Fee Schedule,
available at, https://www.theice.com/publicdocs/nyse/markets/arca-options/NYSE_Arca_Options_Fee_Schedule.pdf).
---------------------------------------------------------------------------

    The Exchange proposes to announce the implementation date of the
proposed rule change by Trader Update and publish such announcement no
later than 60 days following the effective date of this proposal.\22\
---------------------------------------------------------------------------

    \22\ See id. at 62984.
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III. Proceedings to Determine Whether To Approve or Disapprove SR-
NYSEArca-2014-117 and Grounds for Disapproval Under Consideration

    The Commission is instituting proceedings pursuant to Section
19(b)(2)(B) of the Act \23\ to determine whether the proposed rule
change should be approved or disapproved. Institution of such
proceedings is appropriate at this time in view of the legal and policy
issues raised by the proposed rule change, as discussed below.
Institution of proceedings does not indicate that the Commission has
reached any conclusions with respect to any of the issues involved.
Rather, as described in greater detail below, the Commission seeks and
encourages interested persons to provide additional comment on the
proposed rule change.
---------------------------------------------------------------------------

    \23\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

    Pursuant to Section 19(b)(2)(B) of the Act,\24\ the Commission is
providing notice of the grounds for disapproval under consideration.
The Commission is instituting proceedings to allow for additional
analysis of, and input from commenters with respect to the consistency
of the proposed rule change, as supplemented by the NYSE Arca
Letter,\25\ with Section 6(b)(5) of the Act, which require that the
rules of a national securities exchange be designed, among other
things, to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to remove impediments
to and perfect the mechanism of a free and open market and a national
market system, and, in general, to protect investors and the public
interest; and not be designed to permit unfair discrimination between
customers, issuers, brokers, or dealers.\26\
---------------------------------------------------------------------------

    \24\ Id. Section 19(b)(2)(B) of the Exchange Act also provides
that proceedings to determine whether to disapprove a proposed rule
change must be concluded within 180 days of the date of publication
of notice of the filing of the proposed rule change. See id. The
time for conclusion of the proceedings may be extended for up to 60
days if the Commission finds good cause for such extension and
publishes its reasons for so finding. See id.
    \25\ See NYSE Arca Letter, supra note 6.
    \26\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

IV. Procedure: Request for Written Comments

    The Commission requests that interested persons provide written
submissions of their views, data, and arguments with respect to the
concerns identified above, as well as any other concerns they may have
with the proposed rule change. Although there do not appear to be any
issues relevant to approval or disapproval which would be facilitated
by an oral presentation of views, data, and arguments, the Commission
will consider, pursuant to Rule 19b-4, any request for an opportunity
to make an oral presentation.\27\ Interested persons are invited to
submit written data, views, and arguments regarding whether the
proposal should be approved or disapproved by February 13, 2015. Any
person who wishes to file a rebuttal to any other person's submission
must file that rebuttal by February 27, 2015.
---------------------------------------------------------------------------

    \27\ Section 19(b)(2) of the Act, as amended by the Securities
Act Amendments of 1975, Public Law 94-29 (June 4, 1975), grants the
Commission flexibility to determine what type of proceeding--either
oral or notice and opportunity for written comments--is appropriate
for consideration of a particular proposal by a self-regulatory
organization. See Securities Act Amendments of 1975, Senate Comm. on
Banking, Housing & Urban Affairs, S. Rep. No. 75, 94th Cong., 1st
Sess. 30 (1975).
---------------------------------------------------------------------------

    The Commission invites the written views of interested persons
concerning whether the proposal is consistent with Section 6(b)(5) \28\
or any other provision of the Act, or the rules and regulations
thereunder. The Commission asks that commenters address the sufficiency
and merit of the Exchange's statements in support of the proposed rule
change, in addition to any other comments they may wish to submit about
the proposed rule change. In particular, the Commission seeks comment
on the following:
---------------------------------------------------------------------------

    \28\ Id.
---------------------------------------------------------------------------

    1. As described above, the Exchange adopted its quote mitigation
plan as provided in Commentary .03 to Exchange Rule 6.86 in connection
with its adoption of the Penny Pilot Program, which permits quoting of
certain options series in certain increments.\29\ The Commission has
previously noted

that the Penny Pilot Program has contributed to an increase in
quotation message traffic from the options markets.\30\ In approving
the extension and expansion of the Penny Pilot Program in 2009, the
Commission relied, in part, on the Exchange's representation that it
would continue to use quote mitigation strategies that would continue
to mitigate quotation traffic sent to OPRA.\31\
---------------------------------------------------------------------------

    \29\ See supra note 8 and accompanying text.
    \30\ See Securities and Exchange Release No. 60711 (September
23, 2009), 74 FR 49419, 49422 (September 28, 2009) (Order Granting
Partial Accelerated Approval of a Proposed Rule Change, as Modified
by Amendment Nos. 1 and 3 thereto, Amending NYSE Arca Rule 6.72 and
Expanding the Penny Pilot Program).
    \31\ See id. The Commission stated: ``While the Commission
anticipates that NYSE Arca's proposed expansion of the Pilot Program
will contribute to further increases in quotation message traffic,
the Commission believes that NYSE Arca's proposal is sufficiently
limited such that it is unlikely to increase quotation message
traffic beyond the capacity of market participants' systems and
disrupt the timely receipt of quote information. NYSE Arca has
proposed to roll out the additional 300 classes over time, in groups
of 75 classes each quarter beginning on October 26, 2009. The
Commission further notes that a June 2, 2009 sustained message
traffic peak of 852,350 messages per second reported by OPRA is
still well below OPRA's current messages per second capacity limit
of 2,050,000. Moreover, NYSE Arca has adopted and will continue to
utilize quote mitigation strategies that should continue to mitigate
the expected increase in quotation traffic.'' Id.
---------------------------------------------------------------------------

    As noted above, the Exchange believes that its quote mitigation
strategy is no longer necessary because: (1) The Exchange has
incorporated select provisions of the OLPP in Exchange Rule 6.4A, which
the Exchange believes limits the number of series eligible to be
listed; (2) current Exchange Rule 6.37B Commentary .01 removes certain
options series from market makers' continuous quoting obligations,
which the Exchange believes reduces the number of quote messages that
the Exchange sends to OPRA; and (3) both the Exchange's systems
capacity and OPRA's systems capacity are more than sufficient to
accommodate any additional increase in quote traffic that might be sent
to OPRA as a result of the deletion of the quote mitigation
strategy.\32\ Do commenters believe that reliance on the Exchange's
current rules and the existing systems capacity of the Exchange and
OPRA are sufficient or insufficient means to mitigate quote message
traffic from the Exchange to OPRA? Please explain.
---------------------------------------------------------------------------

    \32\ See supra notes 13-18 and accompanying text.
---------------------------------------------------------------------------

    2. What are commenters' views on the impact, if any, that might
result from the Exchange's proposal to remove its current quote
mitigation plan as provided in Commentary .03 to Exchange Rule 6.86?
For example, what are commenters' views on the impact the Exchange's
proposal would have, if any, on OPRA's system capacity? Please explain.
Or, what are commenters' views on the impact the Exchange's proposal
would have on market participants using OPRA and/or the Exchange's
quotation message feeds? Please explain.
    Comments may be submitted by any of the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEArca-2014-117 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEArca-2014-117. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filings also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSEArca-2014-117 and should
be submitted on or before February 13, 2015. Rebuttal comments should
be submitted by February 27, 2015.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\33\
---------------------------------------------------------------------------

    \33\ 17 CFR 200.30-3(a)(57).
---------------------------------------------------------------------------

Brent J. Fields,
Secretary.
[FR Doc. 2015-01108 Filed 1-22-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 98 (Tuesday, May 21, 2013)]
[Notices]
[Pages 29752-29753]
[FR Doc No: 2013-12101]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9815-8]

Notification of a Public Teleconference of the Clean Air Act
Advisory Committee (CAAAC)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of meeting.

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SUMMARY: The Environmental Protection Agency (EPA) announces a public
teleconference of the Clean Air Act Advisory Committee (CAAAC). The EPA
established the CAAAC on November 19, 1990, to provide

independent advice and counsel to EPA on policy issues associated with
implementation of the Clean Air Act of 1990. The Committee advises on
economic, environmental, technical, scientific and enforcement policy
issues.

 Dates & Addresses:  Pursuant to 5 U.S.C. App. 2 Section 10(a) (2),
notice is hereby given that the CAAAC will hold its next meeting via
teleconference on June 25, 2013, from 3:00 p.m. to 5:00 p.m. (Eastern
Time).
    Inspection of Committee Documents: The Committee agenda and any
documents prepared for the meeting will be publicly available on the
CAAAC Web site at http://www.epa.gov/oar/caaac/ prior to the meeting.
Thereafter, these documents, together with CAAAC meeting minutes, will
be available by contacting the Office of Air and Radiation Docket and
requesting information under docket EPA-HQ-OAR-2004-0075. The Docket
office can be reached by email at<EMAIL_ADDRESS>or FAX: 202-
566-9744.

FOR FURTHER INFORMATION CONTACT: Any member of the public who wants
further information concerning the CAAAC's public teleconference may
contact Jeneva Craig, Designated Federal Officer (DFO), Office of Air
and Radiation, U.S. EPA by telephone at<PHONE_NUMBER> or by email at
<EMAIL_ADDRESS>Additional information on these meetings can be
found on the CAAAC Web site: http://www.epa.gov/oar/caaac/.
    For information on access or services for individuals with
disabilities, please contact Ms. Jeneva Craig at<PHONE_NUMBER> or
<EMAIL_ADDRESS>preferably at least 10 days prior to the meeting
to give EPA as much time as possible to process your request.

    Dated: May 14, 2013.
Jeneva Craig,
Designated Federal Officer, Clean Air Act Advisory Committee, Office of
Air and Radiation.
[FR Doc. 2013-12101 Filed 5-20-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 98 (Wednesday, May 21, 2014)]
[Rules and Regulations]
[Pages 29098-29099]
[FR Doc No: 2014-11795]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2014-0227]

Safety Zone; Fourth of July Fireworks, Redwood City, Redwood City
Harbor, Redwood City, CA

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce the safety zone for the Redwood
City Fourth of July Fireworks display in the Captain of the Port, San
Francisco area of responsibility on July 4, 2014, from 9:30 p.m. to 10
p.m. This action is necessary to protect life and property of the
maritime public from the hazards associated with the fireworks display.
During the enforcement period, unauthorized persons or vessels are
prohibited from entering into, transiting through, or anchoring in the
safety zone, unless authorized by the Patrol Commander (PATCOM).

DATES: The regulations in 33 CFR 165.1191, Table 1, Item number 6 will
be enforced from 9:30 p.m. to 10 p.m. on July 4, 2014.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice,
call or email Lieutenant Junior Grade William Hawn, U.S. Coast Guard
Sector San Francisco; telephone<PHONE_NUMBER> or email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the safety zone
established in 33 CFR 165.1191, Table 1, Item number 6 on July 4, 2014.
Upon commencement of the 30 minute fireworks display, scheduled to
begin at 9:30 p.m. on July 4, 2014, the safety zone will encompass the
navigable waters surrounding the land based launch site on the pier
located in

Redwood City Harbor within a radius of 600 feet in approximate position
37[deg]30'34'' N, 122[deg]12'42'' W (NAD 83) for the Fourth of July
Fireworks, Redwood City in 33 CFR 165.1191, Table 1, Item number 6.
Upon the conclusion of the fireworks display the safety zone shall
terminate. This safety zone will be in effect from 9:30 p.m. to 10 p.m.
on July 4, 2014.
    Under the provisions of 33 CFR 165.1191, unauthorized persons or
vessels are prohibited from entering into, transiting through, or
anchoring in the safety zone during all applicable effective dates and
times, unless authorized to do so by the PATCOM. Additionally, each
person who receives notice of a lawful order or direction issued by an
official patrol vessel shall obey the order or direction. The PATCOM is
empowered to forbid entry into and control the regulated area. The
PATCOM shall be designated by the Commander, Coast Guard Sector San
Francisco. The PATCOM may, upon request, allow the transit of
commercial vessels through regulated areas when it is safe to do so.
    This notice is issued under authority of 33 CFR 165.1191 and 5
U.S.C. 552(a). In addition to this notice in the Federal Register, the
Coast Guard will provide the maritime community with extensive advance
notification of the safety zone and its enforcement period via the
Local Notice to Mariners.
    If the Captain of the Port determines that the regulated area need
not be enforced for the full duration stated in this notice, a
Broadcast Notice to Mariners may be used to grant general permission to
enter the regulated area.

    Dated: April 24, 2014.
Gregory G. Stump,
Captain, U.S. Coast Guard, Captain of the Port San Francisco.
[FR Doc. 2014-11795 Filed 5-20-14; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 79, Number 134 (Monday, July 14, 2014)]
[Notices]
[Pages 40786-40787]
[FR Doc No: 2014-16430]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2007-0041]

FM Global Approvals LLC: Grant of Renewal of Recognition

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Notice.

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

SUMMARY: This notice announces the Occupational Safety and Health
Administration's final decision granting renewal of recognition of FM
Global Approvals LLC, as a Nationally Recognized Testing Laboratory
(NRTL) under 29 CFR 1910.7.

DATES: The renewal of recognition becomes effective on July 14, 2014.

FOR FURTHER INFORMATION CONTACT: Information regarding this notice is
available from the following sources:
    Press inquiries: Contact Mr. Frank Meilinger, Director, OSHA Office
of Communications, U.S. Department of Labor, 200 Constitution Avenue
NW., Room N-3647, Washington, DC 20210; telephone:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>    General and technical information: Contact Mr. David Johnson,
Director, Office of Technical Programs and Coordination Activities,
Directorate of Technical Support and Emergency Management, Occupational
Safety and Health Administration, U.S. Department of Labor, 200
Constitution Avenue NW., Room N-3655, Washington, DC 20210; telephone:
(202) 693-2110; email<EMAIL_ADDRESS>OSHA's Web page
includes information about the NRTL Program (see http://www.osha.gov/dts/otpca/nrtl/index.html).

SUPPLEMENTARY INFORMATION:

I. Background

    OSHA recognition of an NRTL signifies that the organization meets
the requirements specified by 29 CFR 1910.7. Recognition is an
acknowledgment that the organization can perform independent safety
testing and certification of the specific products covered within its
scope of recognition, and is not a delegation or grant of government
authority. As a result of recognition, employers may use products
properly approved by the NRTL to meet OSHA standards that require
testing and certification. OSHA maintains an informational Web site for
each NRTL at http://www.osha.gov/dts/otpca/nrtl/index.html that details
its scope of recognition.
    OSHA processes applications submitted by an NRTL for renewal of
recognition following requirements in Appendix A to 29 CFR 1910.7. OSHA
conducts renewals in accordance with the procedures in 29 CFR 1910.7,
App. A II.C. In accordance with these procedures, NRTLs submit a
renewal request to OSHA between nine months and one year before the
expiration date of its current recognition. A renewal request includes
a request for renewal and any additional information demonstrating its
continued compliance with the terms of its recognition and 29 CFR
1910.7. If OSHA has not conducted an on-site assessment of the NRTL
headquarters and any key sites within the past 18 to 24 months, it will
schedule the necessary on-site assessment prior to the expiration date
of the NRTL's recognition. Upon review of the submitted material and,
as necessary, the successful completion of the on-site assessment, OSHA
announces its preliminary decision to grant or deny renewal in the
Federal Register and solicits comments from the public. OSHA then
publishes a final Federal Register notice responding to any comments
and renewing the NRTL's recognition for a period of five years, or
denying the renewal of recognition.
    FM Global Approvals LLC (FM) initially received OSHA recognition as
an NRTL on June 13, 1988 (see 60 FR 16167, March 29, 1995). The most
recent renewal for FM was on September 12, 2001, for a five-year period
expiring on September 12, 2006. FM submitted a timely request for
renewal, dated November 29, 2005 (see Ex. OSHA-2007-0041-0006), and
retained its recognition pending OSHA's final decision in this renewal
process. The current addresses of FM facilities recognized by OSHA and
included as part of the renewal request are:
    1. FM Norwood, 1151 Boston-Providence Turnpike, Norwood,
Massachusetts 02062; and
    2. FM West Gloucester, 743 Reynolds Road, West Gloucester, Rhode
Island 02814.
    OSHA evaluated FM's application for renewal and made a preliminary
determination that FM can continue to meet the requirements prescribed
by 29 CFR 1910.7 for recognition. OSHA conducted audits of FM's
facilities on October 24-26, 2012, August 17-19, 2009, and August 5-6,
2008. OSHA found non-conformances with the requirements of 29 CFR
1910.7. FM addressed these issues sufficiently to meet the applicable
NRTL requirements. Accordingly, OSHA determined that it did not need to
conduct an on-site review of FM's facilities for this request for
renewal, based on its evaluation of FM's application and all other
available information.
    OSHA published the preliminary notice announcing FM's renewal
request in the Federal Register on February 24, 2014 (79 FR 10192). The
Agency requested comments by March 11, 2014, but received no comments
in response to this notice. OSHA now is proceeding with this final
notice to grant FM's request for renewal of recognition.
    To obtain or review copies of all public documents pertaining to
the FM's application, go to www.regulations.gov or contact the Docket
Office, Occupational Safety and Health Administration, U.S. Department
of Labor, 200 Constitution Avenue NW., Room N-2625, Washington, DC
20210. Docket No. OSHA-2007-0041 contains all materials in the record
concerning FM's recognition.

II. Final Decision and Order

    Pursuant to the authority granted under 29 CFR 1910.7, OSHA hereby
gives notice of the renewal of recognition of FM as an NRTL. OSHA NRTL
Program staff reviewed the renewal request for FM and other pertinent
information. Based on this review of the renewal request for FM and
other pertinent information, OSHA finds that FM meets the requirements
of 29 CFR 1910.7 for renewal of its

recognition, subject to the specified limitation and conditions. OSHA
limits the renewal of FM's recognition to include the terms and
conditions of FM's scope of recognition. The scope of recognition for
FM is available in the Federal Register notice dated March 29 1995 (60
FR 16167), or on OSHA's Web site at http://www.osha.gov/dts/otpca/nrtl/fm.html.

Conditions

    In addition to those conditions already required by 29 CFR 1910.7,
FM also must abide by the following conditions of recognition:
    1. FM must inform OSHA as soon as possible, in writing, of any
change of ownership, facilities, or key personnel, and of any major
change in its operations as an NRTL, and provide details of the
change(s);
    2. FM must meet all the terms of its recognition and comply with
all OSHA policies pertaining to this recognition; and
    3. FM must continue to meet the requirements for recognition,
including all previously published conditions on FM's scope of
recognition, in all areas for which it has recognition.

III. Authority and Signature

    David Michaels, Ph.D., MPH, Assistant Secretary of Labor for
Occupational Safety and Health, 200 Constitution Avenue NW.,
Washington, DC 20210, authorized the preparation of this notice.
Accordingly, the Agency is issuing this notice pursuant to 29 U.S.C.
657(g)(2), Secretary of Labor's Order No. 1-2012 (77 FR 3912, Jan. 25,
2012), and 29 CFR 1910.7.

David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2014-16430 Filed 7-11-14; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register Volume 83, Number 99 (Tuesday, May 22, 2018)]
[Notices]
[Page 23704]
[FR Doc No: 2018-10824]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4346-DR; Docket ID FEMA-2018-0001]

South Carolina; Amendment No. 2 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of South Carolina (FEMA-4346-DR), dated October 16, 2017,
and related determinations.

DATES: The amendment was issued on May 3, 2018.

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

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, Robert D.
Samaan, of FEMA is appointed to act as the Federal Coordinating Officer
for this disaster.
    This action terminates the appointment of Warren J. Riley as
Federal Coordinating Officer for this disaster.

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

Brock Long,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2018-10824 Filed 5-21-18; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 77, Number 177 (Wednesday, September 12, 2012)]
[Proposed Rules]
[Pages 56172-56174]
[FR Doc No: 2012-22425]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-0934; Directorate Identifier 2011-NM-260-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for all
Airbus Model A330-200 and -300 series airplanes. This proposed AD was
prompted by a report of a prematurely fractured main landing gear (MLG)
bogie beam. This proposed AD would require replacing certain MLG bogie
beams before reaching new reduced life limits. We are proposing this AD
to prevent fracture of the MLG bogie beam, which, under high speed,
could ultimately result in the airplane departing the runway, the bogie
beam detaching from the airplane, or collapse of the MLG; and
consequent structural damage to the airplane and injury to the
occupants.

DATES: We must receive comments on this proposed AD by October 29,
2012.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, 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.
    For service information identified in this proposed AD, contact
Messier-Dowty: Messier Services Americas, Customer Support Center,
45360 Severn Way, Sterling, VA 20166-8910; telephone<PHONE_NUMBER>; fax
703-404-1621; Internet https://techpubs.services/messier-dowty.com. You
may review copies of the referenced service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call 425-
227-1221.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Operations office (telephone<PHONE_NUMBER>) is
in the ADDRESSES section. Comments will be available in the AD docket
shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Vladimir Ulyanov, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2012-0934;
Directorate Identifier 2011-NM-260-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
Airworthiness Directive 2011-0212, dated October 31, 2011 (referred to
after this as ``the MCAI''), to correct an unsafe condition for the
specified products. The MCAI states:

    During ground load test cycles on an A340-600 aeroplane, the MLG
bogie beam has prematurely fractured.
    The results of the investigation identified that this premature
fracture was due to high tensile standing stress, resulting from dry
fit axle assembly method. Improvement has been introduced
subsequently with a grease fit axle assembly method.
    Fatigue and damage tolerance analyses were performed, whose
results demonstrated that the current life limit of certain MLG
bogie beams with dry fit axles installed on A330 aeroplanes only
must be reduced compared to the life limit stated in the A330
Airworthiness Limitations Section (ALS) Part 1--Safe Life
Airworthiness Limitation Items revision 05 approved by EASA on 29
July 2010.
    Failure to comply with the reduced life limit of the MLG bogie
beam with dry fit axle might jeopardize the MLG structural
integrity.
    For the reasons described above, this [EASA] AD requires the
replacement of the affected MLG bogie beams before reaching the new
reduced life limit.

The unsafe condition is a possible fracture of the MLG bogie beam,
which, under high speed, could ultimately result in the airplane
departing the runway, the bogie beam detaching from the airplane, or
collapse of the MLG; and consequent structural damage to the airplane
and injury to the occupants. You may obtain further information by
examining the MCAI in the AD docket.

Relevant Service Information

    Messier-Dowty has issued Service Letter A33-34 A20, Revision 5,

including Appendices A through F, dated July 31, 2009. The actions
described in this service information are intended to correct the
unsafe condition identified in the MCAI.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 53 products of U.S. registry. We also estimate that
it would take about 16 work-hours per MLG bogie beam (2 MLG bogie beams
per airplane) to comply with the basic requirements of this proposed
AD. The average labor rate is $85 per work-hour. Required parts would
cost about $255,000 per MLG bogie beam. Where the service information
lists required parts costs that are covered under warranty, we have
assumed that there will be no charge for these parts. As we do not
control warranty coverage for affected parties, some parties may incur
costs higher than estimated here. Based on these figures, we estimate
the cost of the proposed AD on U.S. operators to be up to $27,174,160,
or $256,360 per MLG bogie beam.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

    1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

Airbus: Docket No. FAA-2012-0934; Directorate Identifier 2011-NM-
260-AD.

(a) Comments Due Date

    We must receive comments by October 29, 2012.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Airbus Model A330-201, -202, -203, -223,
-243, -301, -302, -303, -321, -322, -323, -341, -342, and -343
airplanes; certificated in any category; all manufacturer serial
numbers (S/Ns).

(d) Subject

    Air Transport Association (ATA) of America Code 32, Landing
gear.

(e) Reason

    This AD was prompted by a report of a prematurely fractured main
landing gear (MLG) bogie beam. We are issuing this AD to prevent
fracture of the MLG bogie beam, which, under high speed, could
ultimately result in the airplane departing the runway, the bogie
beam detaching from the airplane, or collapse of the MLG; and
consequent structural damage to the airplane and injury to the
occupants.

(f) Compliance

    You are responsible for having the actions required by this AD
performed within the compliance times specified, unless the actions
have already been done.

(g) Bogie Beam Replacement

    At the later of the times specified in paragraph (g)(1) or
(g)(2) of this AD, replace all MLG bogie beams having part number
(P/N) 201485300, 201485301, 201272302, 201272304, 201272306, or
201272307, except those that have S/Ns S2A, S2B, or S2C, as
identified in Messier-Dowty Service Letter A33-34 A20, Revision 5,
including Appendices A through F, dated July 31, 2009, with a new or
serviceable part, in accordance with a method approved by the
Manager, International Branch, ANM-116, Transport Airplane
Directorate, FAA, or European Aviation Safety Agency (EASA) (or its
delegated agent).
    (1) Before the accumulation of the flight hours or landings,
whichever occurs first, specified in table 1 of this AD, as
applicable to airplane type, model, and weight variant (WV).

    Table 1 to Paragraph (g)(1) of This AD--MLG Bogie Beam Life Limit
------------------------------------------------------------------------
                                                Life limit from first
            Affected airplanes--              installation of MLG bogie
                                                beam on an airplane--
------------------------------------------------------------------------
Model A330-201, -202, -203, -223, -243,      50,000 landings or 72,300
 weight variant (WV)02x, WV05x (except        total flight hours'
 WV058), and WV06x series.
Model A330-201, -202, -203, -223, -243       50,000 landings or 57,900
 WV058.                                       total flight hours.

Model A330-301, -302, -303, -321, -322, -    46,000 landings or 75,000
 323, -341, -342, -343 WV00x, WV01x, WV02x,   total flight hours.
 WV05x series.
------------------------------------------------------------------------

     (2) Within 6 months after the effective date of this AD.

(h) Parts Installation Limitations

    As of the effective date of this AD, a MLG bogie beam having any
part number identified in paragraph (g) of this AD, may be installed
on an airplane, provided its life has not exceeded the life limit
defined in table 1 to paragraph (g)(1) of this AD, and is replaced
with a new or serviceable part before reaching the life limit
defined in table 1 to paragraph (g)(1) of this AD.

(i) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. In accordance with 14 CFR 39.19, send your request to your
principal inspector or local Flight Standards District Office, as
appropriate. If sending information directly to the International
Branch, send it to ATTN: Vladimir Ulyanov, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone (425) 227-
1138; fax<PHONE_NUMBER>. Information may be emailed to<EMAIL_ADDRESS>Before using any approved AMOC, notify your
appropriate principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office/
certificate holding district office. The AMOC approval letter must
specifically reference this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.

(j) Related Information

    (1) Refer to MCAI EASA Airworthiness Directive 2011-0212, dated
October 31, 2011; and Messier-Dowty Service Letter A33-34 A20,
Revision 5, including Appendices A through F, dated July 31, 2009;
for related information.
    (2) For service information identified in this AD, contact
Messier-Dowty: Messier Services Americas, Customer Support Center,
45360 Severn Way, Sterling, VA 20166-8910; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>; Internet https://techpubs.services/messier-dowty.com. You may review copies of the referenced service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on August 24, 2012.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2012-22425 Filed 9-11-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 198 (Wednesday, October 14, 2015)]
[Notices]
[Page 61803]
[FR Doc No: 2015-26070]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14694-000; Project No. 14711-000]

Lock+\TM\ Hydro Friends Fund XI, LLC; Energy Resources USA Inc.;
Notice of Competing Preliminary Permit Applications Accepted for Filing
and Soliciting Comments, Motions To Intervene, and Competing
Applications

    On July 20, 2015, and September 2, 2015 Lock+TM Hydro
Friends Fund XI, LLC (Hydro Friends Fund) and Energy Resources USA Inc.
(Energy Resources) respectively, filed preliminary permit applications
pursuant to section 4(f) of the Federal Power Act proposing to study
the feasibility of a hydropower project, to be located at the existing
Mississippi River Lock and Dam No. 25 on the Mississippi River, near
the city of Winfield in Lincoln County, Missouri and Calhoun County,
Illinois. Mississippi River Lock and Dam No. 25 is owned by the United
States government and operated by the United States Army Corps of
Engineers. The sole purpose of a preliminary permit, if issued, is to
grant the permit holder priority to file a license application during
the permit term. A preliminary permit does not authorize the permit
holder to perform any land-disturbing activities or otherwise enter
upon lands or waters owned by others without the owner's express
permission.
    Hydro Friends Fund's proposed project would consist of: (1) Three
new 450-foot-wide by 25-foot-deep modular hydropower systems, each
containing ten new 1-megawatt (MW) turbine-generator units, having a
total combined generating capacity of 30 megawatts; (2) a new 200-foot-
long by 450-foot-wide tailrace; (3) a new 7-mile-long, 69-kilovolt
transmission line; (4) a new 25-foot by 50-foot switchyard; and (5)
appurtenant facilities. The project would have an estimated annual
generation of 170,000 megawatt-hours.
    Applicant Contact: Mr. Wayne Krouse, P.O. Box 43796, Birmingham, AL
35243;<PHONE_NUMBER>, extension 709.
    Energy Resources' proposed project would consist of: (1) A new 770-
foot-long by 300-foot-wide intake area; (2) a new 90-foot by 220-foot
reinforced concrete powerhouse; (3) four 3-MW turbine-generators,
having a total combined generating capacity of 12-MW; (4) a new 1,000-
foot-long by 220-foot-wide tailrace area; (5) a new 40-foot by 35-foot
substation; (6) a new 50-foot-wide by 60-foot-long substation; (7) a
new 7.69-mile-long, 115-kilovolt transmission line; and (8) appurtenant
facilities. The project would have an estimated annual generation of
101.9 gigawatt-hours.
    Applicant Contact: Mr. Ander Gonzalez, 2655 Le June Road, Suite
804, Coral Gables, FL 33134; +34 93 252 3840.
    FERC Contact: Tyrone A. Williams,<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Competing applications and notices of intent must meet the requirements
of 18 CFR 4.36. The Commission strongly encourages electronic filing.
Please file comments, motions to intervene, notices of intent, and
competing applications using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief
comments up to 6,000 characters, without prior registration, using the
eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You
must include your name and contact information at the end of your
comments. For assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). In lieu of electronic filing, please send a paper copy to:
Secretary, Federal Energy Regulatory Commission, 888 First Street NE.,
Washington, DC 20426. The first page of any filing should include
docket number P-14694-000 or P-14711-000.
    More information about this project, including a copy of either
application can be viewed or printed on the ``eLibrary'' link of
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-14694 or P-14711) in the docket number field
to access the document. For assistance, contact FERC Online Support.

    Dated: October 7, 2015.
Kimberly D. Bose,
 Secretary.
[FR Doc. 2015-26070 Filed 10-13-15; 8:45 am]
BILLING CODE 6717-01-P


Summary of Personal Communications with Brandon Saunders, Polar
Refrigerant Technologies (New Hampshire), Randy Blackburn, Commercial
Fuel Recycling, LLC. (Idaho), and several other people who didn’t want
to give their names.  They all provided the following similar
information:

•	The steps to use the used oil are: test for on-spec vs. off-spec
(although it was noted that nearly all is on-spec these days); using
solvents, remove as much water (and sometimes antifreeze) from the oil
as possible; filter out metal scraps and other larger particles using
screens.

•	The filtering can be done when the oil is collected, or in the
burner when the oil is added.

•	The oil is also allowed to set and can be extracted at a depth with
a higher rate of purity.

•	As far as what percent, the filtering and extracting of water is
standard practice in the industry.