[Federal Register Volume 79, Number 84 (Thursday, May 1, 2014)]
[Notices]
[Pages 24805-24807]
[FR Doc No: 2014-09918]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-72018; File No. SR-NYSEArca-2014-40]

Self-Regulatory Organizations; NYSE Arca Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change Amending Exchange
Rules Governing Letters of Guarantee and Letters of Authorization

April 25, 2014.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that on April 21, 2014, NYSE Arca, Inc. (the ``Exchange'' or
``NYSE Arca'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The Exchange proposes to amend Exchange rules governing Letters of
Guarantee and Letters of Authorization. The text of the proposed rule
change is available on the Exchange's Web site at www.nyse.com, at the
principal office of the Exchange, and at the Commission's Public
Reference Room.

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

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

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

1. Purpose
    As further described below, each OTP Holder acting as either a
Market Maker or Floor Broker on NYSE Arca currently is required to
submit to the Exchange a Letter of Guarantee or Letter of Authorization
for its trading activities from a Clearing Member.\4\ Typically, by a
Letter of Guarantee, the Clearing Member accepts financial
responsibility for all Exchange transactions of a Market Maker \5\ and,
by a Letter of Authorization, a Clearing Member is responsible for the
clearance of the Exchange transactions of a Floor Broker.\6\
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    \4\ A Clearing Member is an Exchange OTP Firm or OTP Holder
which has been admitted to membership in the Options Clearing
Corporation pursuant to the provisions of the Rules of the Options
Clearing Corporation. See Rule 6.1(b)(3).
    \5\ See Rule 6.36(a).
    \6\ See Rule 6.45(a).
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    The purpose of the proposal is to amend various Exchange rules
governing Letters of Guarantee and Authorization to:
     Provide that any written notice of revocation of a Letter
of Guarantee or Letter of Authorization will become effective upon
processing by the Exchange.
     give the Exchange the ability to prevent access and
connectivity if a Market Maker or Floor Broker is subject to written
notice of revocation.
Changes to Rule 6.36--Letters of Guarantee
    Rule 6.36(c) states that a Letter of Guarantee filed with the
Exchange shall remain in effect until a final written notice of
revocation has been filed with the Exchange. The current rule sets
forth a time period for the effectiveness of a revocation to take
place. However the Exchange does not believe that a

specified timeframe is necessary. Because the Exchange can process such
revocations at any time after receipt, the Exchange proposes to amend
Rule 6.36(c) to provide that notices of revocation shall become
effective as soon as the Exchange is able to process the revocation.
The Exchange notes that the proposed rule change is consistent with the
rules governing the processing of the revocation of a Letter of
Guarantee on the Chicago Board Options Exchange (``CBOE'').\7\
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    \7\ See CBOE Rule 8.5(c).
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    Once a notice of revocation has been processed, a Market Maker no
longer has in effect a Letter of Guarantee, as required by Rule
6.36(a). If a Market Maker no longer has a valid Letter of Guarantee,
that Market Maker presents risk to the marketplace and the Exchange
believes it is appropriate to terminate access and connectivity to the
Exchange in these situations. Accordingly, the Exchange proposes to
further amend Rule 6.36(c) by stating that upon the effectiveness of a
notice of revocation, the Exchange will be permitted to prevent access
and connectivity to the Exchange by that Market Maker. Preventing
access and connectivity by a Market Maker who does not have a valid
Letter of Guarantee is consistent with similar procedures of the
CBOE.\8\
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    \8\ See CBOE Rule 3.28(b).
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Changes to Rule 6.45--Letters of Authorization
    Rule 6.45(c) states that a Letter of Authorization filed with the
Exchange shall remain in effect until a written notice of revocation
has been filed with the Exchange. The current rule sets forth a time
period for the effectiveness of a revocation to take place. However the
Exchange does not believe that a specified timeframe is necessary.
Because the Exchange can process such revocations at any time after
receipt, the Exchange proposes to amend Rule 6.45(c) to provide that a
notice of revocation shall become effective as soon as the Exchange is
able to process the revocation. The Exchange notes that the proposed
rules change is consistent with the rules governing the processing of
the revocation of a Letter of Authorization on the CBOE.\9\
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    \9\ See CBOE Rule 6.72(c).
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    Once a notice of revocation has been processed, a Floor Broker no
longer has in effect a Letter of Authorization, as required by Rule
6.45(a). If a Floor Broker no longer has a valid Letter of
Authorization, that Floor Broker presents risk to the marketplace and
the Exchange believes it is appropriate to terminate access and
connectivity to the Exchange in these situations. Accordingly, the
Exchange proposes to further amend Rule 6.45(c) by stating that upon
the effectiveness of a notice of revocation, the Exchange will be
permitted to prevent access and connectivity to the Exchange by that
Floor Broker. Preventing access and connectivity to a Floor Broker who
does not have on file an effective Letter of Authorization is
consistent with similar procedures of the CBOE.\10\
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    \10\ Supra note 8.
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    The Exchange also proposes to adopt an additional provision to Rule
6.45(c) stating that final revocation shall in no way relieve a
Clearing OTP Holder or OTP Firm of responsibility for clearing
transactions effected by a Floor Broker prior to the effectiveness of
such final revocation. The Exchange believes that this provision, which
currently applies when a Market Maker is subject to a notice of
revocation, is equally appropriate in instances when a Floor Broker is
subject to a notice of revocation. The Exchange notes that the proposed
rule change is consistent with the rules governing the processing of
the revocation of a Letter of Authorization on the CBOE.\11\
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    \11\ Supra note 9.
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    The Exchange notes that nothing in existing or proposed rules would
prohibit a Market Maker or Floor Broker from seeking to gain access and
connectivity to the Exchange once that individual is able to again
acquire the required Letter of Guarantee or Letter of Authorization.
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) of the
Act,\12\ in general, and furthers the objectives of Section
6(b)(5),\13\ in particular, in that it is designed to prevent
fraudulent and manipulative acts and practices, to promote just and
equitable principles of trade, to foster cooperation and coordination
with persons engaged in facilitating transactions in securities, and to
remove impediments to and perfect the mechanism of a free and open
market and a national market system.
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    \12\ 15 U.S.C. 78f(b).
    \13\ 15 U.S.C. 78f(b)(5).
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    Preventing access and connectivity to the Exchange by a Market
Maker or Floor Broker subject to a notice of revocation will promote
just and equitable principles of trade and serves to protect investors
and the public because it prevents trading by a Market Maker or Floor
Broker without financial or clearing guarantees for its trading. A
Market Maker or Floor Broker who no longer has a valid Letter of
Guarantee or Authorization presents risk to the marketplace and the
Exchange believes it is appropriate to prevent access and connectivity
to the Exchange in these situations. In addition, making a notice of
revocation effective upon processing by the Exchange, instead of being
encumbered by a specified time frame, will permit the Exchange to act
swiftly to take measures aimed at market integrity and investor
protection.
    The Exchange believes the proposed rule change is also consistent
with the requirements that the rules of an exchange provide a fair
procedure for the denial or limitation by an exchange of any person
with respect to access to services offered by the Exchange because the
Exchange would not prohibit or limit a Floor Broker or Market Maker
from seeking to gain access and connectivity to the Exchange once that
individual is able to again acquire the required Letter of Guarantee or
Letter of Authorization.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The proposed rule changes
will apply equally to all Floor Brokers and Market Makers and is
designed to protect all OTP Holders, OTP Firms and public investors
effecting transactions on the Exchange. In addition, the proposed
changes will not impose any unnecessary burden on the operation of the
Exchange because the changes will allow the Exchange to adopt more
efficient procedures for the processing notices of revocation.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \14\ and Rule 19b-4(f)(6) thereunder.\15\
Because the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii)

impose any significant burden on competition; and (iii) become
operative prior to 30 days from the date on which it was filed, or such
shorter time as the Commission may designate, if consistent with the
protection of investors and the public interest, the proposed rule
change has become effective pursuant to Section 19(b)(3)(A) of the Act
and Rule 19b-4(f)(6)(iii) thereunder.
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    \14\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \15\ 17 CFR 240.19b-4(f)(6).
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    The Exchange has asked the Commission to waive the 30-day operative
delay so that the proposal may become operative immediately upon
filing, noting that a waiver of the operative delay will allow the
Exchange to promptly adopt and implement new procedures aimed at market
integrity and investor protection. For this reason, the Commission
believes that waiving the 30-day operative delay is consistent with the
protection of investors and the public interest. As such, the
Commission waives the operative delay and designates the proposed rule
change to be operative upon filing.\16\
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    \16\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \17\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
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    \17\ 15 U.S.C. 78s(b)(2)(B).
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IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEArca-2014-40 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-2014-40. 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 at 100 F Street NE.,
Washington, DC 20549-1090 on official business days between the hours
of 10:00 a.m. and 3:00 p.m. Copies of such filing also will be
available for inspection and copying at the principal 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-2014-40, and should be submitted on or before May 22, 2014.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\18\
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    \18\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-09918 Filed 4-30-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 135 (Friday, July 13, 2012)]
[Notices]
[Pages 41413-41415]
[FR Doc No: 2012-17078]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0530]

Draft Guidance for Industry and Food and Drug Administration
Staff; Medical Devices: The Pre-Submission Program and Meetings With
FDA Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Medical Devices: The Pre-
Submission Program and Meetings with FDA Staff.'' The purpose of this
guidance is to describe the Pre-Submission program (formerly the pre-
Investigational Device Exemption (IDE) program) for medical devices
reviewed in the Center for Devices and Radiological Health (CDRH) and
the Center for Biologics Evaluation and Research (CBER). In addition,
the guidance provides recommendations regarding information that should
be included in a Pre-Submission Package. This guidance also describes
the procedures that CDRH and CBER intend to follow when industry
representatives or application sponsors request a meeting with review
staff. This draft guidance is not final nor is it in effect at this
time.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment of this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by October 11, 2012. Submit either written or electronic
comments on this collection of information by September 11, 2012.

ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Medical Devices: The Pre-Submission
Program and Meetings with FDA Staff'' to the Division of Small
Manufacturers, International and Consumer Assistance, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993-0002;
or Office of Communication, Outreach and Development (HFM-40), Center
for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-
1448. Send one self-addressed adhesive label to assist that office in
processing your request, or fax your request to<PHONE_NUMBER>. See the
SUPPLEMENTARY INFORMATION section for information on electronic access
to the guidance.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Angela Krueger, Center for Devices and Radiological Health, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1666,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or
Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17),
Food and Drug Administration, 1401 Rockville Pike, Suite 200N,
Rockville, MD 20852-1448,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Since its establishment in 1995, the pre-IDE program has been a
successful resource for both medical device applicants and the FDA.
Originally, this program was designed to provide applicants a mechanism
to obtain FDA feedback on future IDE applications prior to their
submission. Over time, the pre-IDE program evolved to include feedback
on other device submission program areas, such as Premarket Approval
(PMA) applications, Humanitarian Device Exemption (HDE) applications,
and Premarket Notification (510(k)) Submissions, as well as to address
questions related to whether a clinical study requires submission of an
IDE. The purpose of this guidance is to update the pre-IDE program to
reflect this broader scope and make important modifications to reflect
changes in the premarket program areas as a result of the Food and Drug
Administration Amendments Act of 2007 (FDAAA) (Pub. L. 110-85). This
guidance also broadens the scope of the program to include those
devices regulated by CBER. Accordingly, FDA is changing the name for
this program from the pre-IDE program to the Pre-Submission (Pre-Sub)
program.
    The main purpose of the Pre-Sub program remains the same as the
pre-IDE program: to facilitate providing advice to applicants when they
have specific questions during product development and early protocol

planning, about device studies that present significant risk(s) (SR) as
well as non-significant risk(s) (NSR) or when developing protocols for
clinical studies conducted outside of the United States to support
future U.S. marketing applications (Ref. 1). Consequently, the Pre-Sub
program can provide an efficient path from device concept to market
while facilitating the Agency's goal of meeting FDAAA and Medical
Device User Fee Act of 2008 (MDUFA II) review milestones.
    The Pre-Sub program has also faced several challenges, and the
guidance is intended to address these challenges and improve the Pre-
Sub program by: (1) Describing the types of information that FDA would
recommend submitting in order to get the best possible feedback from
FDA; (2) outlining the process by which FDA meetings should be
scheduled; and (3) explaining the Agency's expectations regarding
advice given during the Pre-Sub process.
    This guidance outlines clear recommendations for sponsors and for
FDA staff and managers as well as expected timeframes for scheduling
meetings. FDA intends to provide the best possible advice in accordance
with the information provided, ensure it is captured accurately in the
meeting minutes drafted by the sponsor, and commit to that advice
unless the circumstances sufficiently change such that our advice is no
longer applicable, such as when a sponsor changes the intended use of
their device after we provide feedback. It is also our intention to
hold timely meetings with appropriate staff and managers present, if
resources permit. However, both our ability to provide advice and to
hold timely meetings are dependent on our receiving the necessary
information in advance of the meeting.
    In addition, this guidance also describes the procedures that CDRH
and CBER intend to follow when industry representatives or application
sponsors request a meeting with review staff, either as the preferred
method of feedback in response to a Pre-Sub, or to discuss an existing
regulatory submission. This guidance also recommends how to prepare for
meetings with FDA staff. FDA plans to revise the document as necessary
to reflect any MDUFA III agreements.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on Medical
Device Pre-Submissions and Meetings with CDRH and CBER Staff. It does
not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternative approach may be used
if such approach satisfies the requirements of the applicable statute
and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by using the Internet. To receive ``Medical Devices: Pre-Submissions
and Meetings with FDA Staff,'' you may either send an email request to
<EMAIL_ADDRESS>to receive an electronic copy of the document or
send a fax request to<PHONE_NUMBER> to receive a hard copy. Please use
the document number 1677 to identify the guidance you are requesting. A
search capability for all CDRH guidance documents is available at
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm; a search capability for all CBER
guidance documents is available at  http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. Guidance documents are also available at  http://www.regulations.gov.

IV. Paperwork Reduction Act of 1995

    Under the PRA (44 U.S.C. 3501-3502), Federal Agencies must obtain
approval from the Office of Management and Budget (OMB) for each
collection of information they conduct or sponsor. ``Collection of
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and
includes Agency requests or requirements that members of the public
submit reports, keep records, or provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires
Federal Agencies to provide a 60-day notice in the Federal Register
concerning each proposed collection of information before submitting
the collection to OMB for approval. To comply with this requirement,
FDA is publishing notice of the proposed collection of information set
forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Draft Guidance for Industry and Food and Drug Administration Staff;
Medical Devices: The Pre-Submission Program and Meetings With FDA Staff

    This draft guidance describes the Pre-Submission program for
medical devices reviewed in CDRH and CBER. The guidance provides
recommendations regarding the information that should be submitted in a
Pre-Submission Package and procedures that should be followed for
meetings between CDRH and CBER staff and industry representatives or
application sponsors. When final, this document will supersede ``Pre-
IDE Program: Issues and Answers--Blue Book Memo D99-1'' dated March 25,
1999.
    A Pre-Submission is defined as a formal written request from an
applicant for feedback from FDA to be provided in the form of a formal
written response or, if the manufacturer chooses, a meeting or
teleconference in which the feedback is documented in meeting minutes.
A Pre-Submission is appropriate when FDA's feedback on specific
questions is necessary to guide product development and/or application
preparation. The proposed collections of information are necessary to
allow the Agency to receive Pre-Submission Packages in order to
implement this voluntary submission program.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                                                Average
  Submission of information for      Number of       Numer of      Total annual     burden per
     Pre-Submission Program         respondents    responses per     responses      respondent      Total hours
                                                    respondent                      (in hours)
----------------------------------------------------------------------------------------------------------------
CDRH............................            2465               1            2465             137         337,705
CBER............................              79               1              79             137          10,823
                                 -------------------------------------------------------------------------------
    Total.......................            2544               1            2544             137         348,528
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Respondents are medical device manufacturers subject to FDA's laws
and regulations. FDA estimates that it will receive approximately 2544
pre-submission packages annually. The Agency reached this estimate by
reviewing the number of submissions received by the Agency under the
Pre-IDE program over the past 10 years. Based on FDA's experience with
the Pre-IDE program, FDA expects the Pre-Submission program to continue
to be utilized as a viable program in the future and expects that the
number of pre-submission packages will increase over its current rate
and reach a steady state of approximately 2544 submissions per year.
    FDA estimates from past experience with the Pre-IDE program that
the complete process involved with the program takes approximately 137
hours. This average is based upon estimates by FDA administrative and
technical staff that is familiar with the requirements for submission
of a Pre-Submission and related materials, have consulted and advised
manufacturers on these requirements, and have reviewed the
documentation submitted.
    Therefore, the total reporting burden hours is estimated to be
348,528 hours.

                                 Table 2--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                                 Total burden
                    Number of respondents                           hours         Hourly wage       Total cost
                                                                  annualized          rate          annualized
----------------------------------------------------------------------------------------------------------------
2544.........................................................             137             $150      $52,279,200
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The average to industry per hour for this type of work is $150,
resulting in a cost of $20,550 per respondent. The estimated submission
cost of $20,550 multiplied by 2544 submissions per year equals
$52,279,200, which is the aggregated industry reporting cost
annualized.
    This draft guidance also refers to previously approved information
collections found in FDA regulations. The collections of information in
21 CFR part 803 are approved under OMB control number 0910-0437; the
collections of information in 21 CFR part 807, subpart E is approved
under OMB control number 0910-0120; and the collections of information
in 21 CFR part 812 are approved under OMB control number 0910-0078.

V. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), either electronic or written comments regarding this
document. It is only necessary to send one set of comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

VI. References

    The following references have been placed on display in the
Division of Dockets Management (see Comments) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
(FDA has verified the Web site addresses, but FDA is not responsible
for any subsequent changes to the Web sites after this document
publishes in the Federal Register.)
    1. Please see 21 CFR 812.3(m) and FDA's Web page on Clinical
Trials, available at www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm.

    Dated: July 9, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-17078 Filed 7-12-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: March 25, 2008 (Volume 73, Number 58)]
[Notices]
[Page 15798-15799]
[DOCID:fr25mr08-101]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-406; OMB Control No. 3235-0463]

Extension; Comment Request; ``Tell Us How We're Doing!''

    Upon written request, copies available from: Securities and
Exchange Commission, Office of Investor Education and Advocacy,
Washington, DC 20549-0213.
    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collection of
information summarized below. The Commission plans to submit this
previously-approved questionnaire to the Office of Management and
Budget for approval.
    The Commission currently sends the questionnaire to persons who
have used the services of the Commission's Office of Investor Education
and Advocacy. The questionnaire consists mainly of eight (8) questions
concerning the quality of services provided by OIEA. Most of the
questions can be answered by checking a box on the questionnaire.
    The Commission needs the information to evaluate the quality of
services provided by OIEA. Supervisory personnel of OIEA use the
information collected in assessing staff performance and for
determining what improvements or changes should be made in OIEA
operations for services provided to investors.
    The respondents to the questionnaire are those investors who
request assistance or information from OIEA.
    The total reporting burden of the questionnaire in 2004 was
approximately 5 hours and 45 minutes. This was calculated by
multiplying the total number of investors who responded to the
questionnaire times how long it is estimated to take to complete the
questionnaire (23 respondents x 15 minutes = 5 hours and 45 minutes).
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the agency's estimate of
the burden of the collection of information; (c) ways to enhance the
quality, utility, and clarity of the information collected; and (d)
ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information

technology. Consideration will be given to comments and suggestions
submitted in writing within 60 days of this publication.
    Please direct your written comments to R. Corey Booth, Director/
Chief Information Officer, Securities and Exchange Commission, C/O
Shirley Martinson, 6432 General Green Way, Alexandria, Virginia 22312;
or send an e-mail to<EMAIL_ADDRESS>
    Dated: March 17, 2008.
Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E8-5920 Filed 3-24-08; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register: June 7, 2006 (Volume 71, Number 109)]
[Notices]
[Page 32943-32944]
[DOCID:fr07jn06-66]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

May 31, 2006.
    Take notice that the Commission received the following electric
rate filings.

    Docket Numbers: ER02-2310-004.
    Applicants: Crescent Ridge LLC.
    Description: Crescent Ridge LLC submits its triennial market power
analysis in compliance with Commission's order issued 8/21/02.
    Filed Date: 4/11/2006.
    Accession Number: 20060411-5032.
    Comment Date: 5 p.m. Eastern Time on Wednesday, June 7, 2006.

    Docket Numbers: ER04-1232-003.
    Applicants: Southwest Power Pool, Inc.
    Description: Southwest Power Pool, Inc submits revised pages to its
OATT intended to implement a rate change for Southwestern Public
Service Co.
    Filed Date: 5/16/2006.
    Accession Number: 20060522-0075.
    Comment Date: 5 p.m. Eastern Time on Tuesday, June 6, 2006.

    Docket Numbers: ER06-451-002; ER06-1047-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Southwest Power Pool Inc submits revisions to its
OATT, revising real-time energy imbalance market proposal in compliance
with the Commission's 3/1/06 order.
    Filed Date: 5/19/2006.
    Accession Number: 20060524-0208.
    Comment Date: 5 p.m. Eastern Time on Friday, June 9, 2006.

    Docket Numbers: ER06-1019-000.
    Applicants: American Transmission Company LLC.
    Description: American Transmission Company LLC submits an executed
Distribution--Transmission Interconnection Agreement w/Cuba City Light
& Water.
    Filed Date: 5/19/2006.
    Accession Number: 20060530-0160.
    Comment Date: 5 p.m. Eastern Time on Friday, June 9, 2006.

    Docket Numbers: ER06-1027-000.
    Applicants: Wisconsin Public Service Corporation.
    Description: Wisconsin Public Service Corp submits an amendment to
its 6/7/05 Wind-Up Plan filing.
    Filed Date: 5/19/2006.
    Accession Number: 20060530-0274.
    Comment Date: 5 p.m. Eastern Time on Friday, June 9, 2006.

    Docket Numbers: ER06-1032-000.
    Applicants: Westar Energy, Inc.
    Description: Westar Energy, Inc on behalf of Kansas Gas & Electric
Co submits a notice of cancellation of its wholesale electric service
agreement, Rate Schedule No. 152, with Missouri Public Service Co.
    Filed Date: 5/25/2006.
    Accession Number: 20060530-0037.
    Comment Date: 5 p.m. Eastern Time on Thursday, June 15, 2006.

    Docket Numbers: ER06-1034-000.
    Applicants: ISO New England Inc.; ISO New England Power Pool
Participants Committee.
    Description: ISO New England Inc & New England Power Pool
Participants Committee submits a limited package of clarifying &
technical revisions to the market rules associated with Phase II of the
Ancillary Services Market Project filed 2/6/06.
    Filed Date: 5/25/2006.
    Accession Number: 20060530-0036.
    Comment Date: 5 p.m. Eastern Time on Thursday, June 15, 2006.

    Docket Numbers: ER06-1035-000.
    Applicants: American Electric Power Service Corporation.
    Description: American Electric Power Service Corp submits a power
purchase and sale agreement, Rate Schedule No. 229, between AEP Texas
North Co and CSW Power Marketing, Inc.
    Filed Date: 5/25/2006.
    Accession Number: 20060530-0035.
    Comment Date: 5 p.m. Eastern Time on Thursday, June 15, 2006.

    Docket Numbers: ER06-1043-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest Independent Transmission System Operator, Inc
submits an Amended and Restated Standard Large Generator
Interconnection Agreement with High Prairie Wind Farm I, LLC.
    Filed Date: 5/24/2006.
    Accession Number: 20060530-0088.
    Comment Date: 5 p.m. Eastern Time on Wednesday, June 14, 2006.

    Docket Numbers: ER06-1044-000.
    Applicants: Florida Power Corporation.
    Description: Florida Power Corp dba Progress Energy Florida Inc
submits a Notice of Cancellation of Rate Schedule 110, Contract for
Purchase of Economy Energy with Duke Power Co.
    Filed Date: 5/24/2006.
    Accession Number: 20060530-0087.
    Comment Date: 5 p.m. Eastern Time on Wednesday, June 14, 2006.

    Docket Numbers: ER06-1045-000.
    Applicants: California Independent System Operator Corporation.
    Description: California Independent System Operator Corp submits
Amendment 1 to its Participating Load Agreement with the California
Department of Water Resources.
    Filed Date: 5/24/2006.
    Accession Number: 20060530-0086.
    Comment Date: 5 p.m. Eastern Time on Wednesday, June 14, 2006.

    Docket Numbers: ER06-1046-000.
    Applicants: Western Kentucky Energy Corporation; LG&E Energy
Marketing, Inc.; Louisville Gas and Electric Company; Kentucky
Utilities Company.
    Description: LG&E Energy Marketing Inc, Louisville Gas and Electric
Co, Kentucky Utilities Company and Western Kentucky Energy Corp submits
amendments to their market-based rate tariffs.
    Filed Date: 5/24/2006.
    Accession Number: 20060530-0085.
    Comment Date: 5 p.m. Eastern Time on Wednesday, June 14, 2006.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously

intervened in the same docket. Protests will be considered by the
Commission in determining the appropriate action to be taken, but will
not serve to make protestants parties to the proceeding. Anyone filing
a motion to intervene or protest must serve a copy of that document on
the Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov.
 To facilitate electronic service, persons with Internet

access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>
or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
[FR Doc. E6-8829 Filed 6-6-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 190 (Tuesday, October 1, 2013)]
[Notices]
[Pages 60302-60303]
[FR Doc No: 2013-23840]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2007-0008]

National Advisory Council

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Committee Management; Notice of Federal Advisory Committee
Meeting.

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

SUMMARY: The Federal Emergency Management Agency (FEMA) National
Advisory Council (NAC) will meet in person on October 16, 2013 in
Philadelphia, PA. The meeting will be open to the public.

DATES: The NAC will meet on Wednesday, October 16, 2013, from 8:30 a.m.
to 5:00 p.m. Eastern Daylight Time (EDT). Please note that the meeting
may close early if the committee has completed its business.

ADDRESSES: The meeting will be held at the FEMA Region III Office
located at 615 Chestnut Street, Philadelphia, PA 19106. All visitors to
the FEMA Region III Office will have to register with FEMA to be
admitted to the building. Photo identification is required to access
the building. Please provide your name, telephone number, email
address, title, and organization by close of business on October 11,
2013, to the contact person listed in FOR FURTHER INFORMATION CONTACT
below.
    For information on facilities or services for individuals with
disabilities or to request special assistance at the meeting, contact
the person listed in FOR FURTHER INFORMATION CONTACT below as soon as
possible.
    To facilitate public participation, members of the public are
invited to provide written comments on the issues to be considered by
the NAC (see ``Agenda''). Written comments must be submitted and
received by October 10, 2013, identified by Docket ID FEMA-2007-0008,
and submitted by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
     Email<EMAIL_ADDRESS>Include the docket number in
the subject line of the message.

     Fax:<PHONE_NUMBER>.
     Mail: Regulatory Affairs Division, Office of Chief
Counsel, FEMA, 500 C Street SW., Washington, DC 20472-3100.
    Instructions: All submissions received must include the words
``Federal Emergency Management Agency'' and the docket number for this
action. Comments received will be posted without alteration at http://www.regulations.gov, including any personal information provided.
    Docket: For access to the docket to read comments received by the
NAC, go to http://www.regulations.gov, and search for the Docket ID
listed above.
    A public comment period will be held during the meeting from 3:00
p.m. to 3:30 p.m. EDT, and speakers are requested to limit their
comments to 3 minutes. Contact the individual listed below to register
as a speaker by October 11, 2013. Please note that the public comment
period may end before the time indicated, following the last call for
comments.

FOR FURTHER INFORMATION CONTACT: Alexandra Woodruff, Alternate
Designated Federal Officer, Office of the National Advisory Council,
Federal Emergency Management Agency, 500 C Street SW., Washington, DC
20472-3100, telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>, and email
<EMAIL_ADDRESS>The NAC Web site is: http://www.fema.gov/national-advisory-council.

SUPPLEMENTARY INFORMATION: Notice of this meeting is given under the
Federal Advisory Committee Act, 5 U.S.C. App. (Pub. L. 92-463).
    The NAC advises the FEMA Administrator on all aspects of emergency
management. The NAC incorporates State, local, and tribal governments,
nonprofit, and private sector input in the development and revision of
FEMA plans and strategies.
    Agenda: In addition to swearing in new members, the NAC will engage
in open discussion with the FEMA Administrator and Deputy
Administrator. The NAC will receive report outs from its subcommittees
on the following topics: Review and update of the National Incident
Management System (NIMS); Public Assistance Pilot Programs of Debris
Removal and Permanent Work; National Mass Care Strategy; and the
Biggert-Waters Flood Insurance Reform Act of 2012. The NAC will review
the information presented on each topic, deliberate on any
recommendations presented in the subcommittees' reports, and formulate
recommendations for FEMA's consideration.
    The NAC will also receive briefings from FEMA Executive Staff on
the following topics: Implementation of the National Preparedness
System; the Preparedness Campaign; the National Preparedness Grant
Program; the FEMA Strategic Plan; and the Integrated Public Alert and
Warning System. The full agenda and any related committee documents
will be posted on the NAC Web site at http://www.fema.gov/national-advisory-council.

    Dated: September 23, 2013.
W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2013-23840 Filed 9-30-13; 8:45 am]
BILLING CODE 9111-48-P


[Federal Register Volume 82, Number 103 (Wednesday, May 31, 2017)]
[Notices]
[Page 25018]
[FR Doc No: 2017-11178]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

[Release Nos. 33-10366; 34-80767; File No. 265-28]

Investor Advisory Committee Meeting

AGENCY: Securities and Exchange Commission.

ACTION: Notice of meeting of Securities and Exchange Commission Dodd-
Frank Investor Advisory Committee.

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

SUMMARY: The Securities and Exchange Commission Investor Advisory
Committee, established pursuant to Section 911 of the Dodd-Frank Wall
Street Reform and Consumer Protection Act of 2010, is providing notice
that it will hold a public meeting. The public is invited to submit
written statements to the Committee.

DATES: The meeting will be held on Thursday, June 22, 2017 from 9:30
a.m. until 2:35 p.m. (ET). Written statements should be received on or
before June 22, 2017.

ADDRESSES: The meeting will be held in Multi-Purpose Room LL-006 at the
Commission's headquarters, 100 F Street NE., Washington, DC 20549. The
meeting will be webcast on the Commission's Web site at www.sec.gov.
Written statements may be submitted by any of the following methods:

Electronic Statements

    [ssquf] Use the Commission's Internet submission form (http://www.sec.gov/rules/other.shtml); or
    [ssquf] Send an email message to<EMAIL_ADDRESS>Please
include File No. 265-28 on the subject line; or

Paper Statements

    [ssquf] Send paper statements to Brent J. Fields, Secretary,
Securities and Exchange Commission, 100 F Street NE., Washington, DC
20549-1090.

All submissions should refer to File No. 265-28. This file number
should be included on the subject line if email is used. To help us
process and review your statement more efficiently, please use only one
method.
    Statements also will be available for Web site viewing and printing
in the Commission's Public Reference Room, 100 F Street NE., Room 1503,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. All statements received will be posted without
change; we do not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly.

FOR FURTHER INFORMATION CONTACT: Marc Oorloff Sharma, Chief Counsel,
Office of the Investor Advocate, at<PHONE_NUMBER>, Securities and
Exchange Commission, 100 F Street NE., Washington, DC 20549.

SUPPLEMENTARY INFORMATION: The meeting will be open to the public,
except during that portion of the meeting reserved for an
administrative work session during lunch. Persons needing special
accommodations to take part because of a disability should notify the
contact person listed in the section above entitled FOR FURTHER
INFORMATION CONTACT.
    The agenda for the meeting includes: Remarks from Commissioners;
nominations for open officer positions; a discussion regarding capital
formation, smaller companies, and the declining number of initial
public offerings; the announcement of election results for open officer
positions on the Investor Advisory Committee; an overview of certain
provisions of the Financial CHOICE Act of 2017 relating to the SEC; and
a nonpublic administrative work session during lunch.

    Dated: May 25, 2017.
Brent J. Fields,
Secretary.
[FR Doc. 2017-11178 Filed 5-30-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: October 3, 2008 (Volume 73, Number 193)]
[Notices]
[Page 57618]
[DOCID:fr03oc08-46]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EF06-2011-002]

Bonneville Power Administration; Notice of Filing

September 29, 2008.
    Take notice that on September 29, 2008, Bonneville Power
Administration filed a proposed 2009 supplemental wholesale power
rates, WP-07 Supplemental Rates, for interim and final approval by the
Federal Energy Regulatory Commission, and to become effective October
1, 2008.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant and all the parties in this proceeding.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on October 13, 2008.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-23367 Filed 10-2-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 159 (Thursday, August 16, 2012)]
[Notices]
[Page 49450]
[FR Doc No: 2012-20106]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Issues in the Design of Clinical Trials of Antibacterial Drugs
for the Treatment of Non-Cystic Fibrosis Bronchiectasis; Public
Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing a public
workshop focusing on the design of clinical trials of antibacterial
drugs for the treatment of non-cystic fibrosis (non-CF) bronchiectasis.
This public workshop is intended to provide information for, and gain
perspective from, health care providers, patients and patient advocacy
organizations, academia, and industry on various aspects of the design
of clinical trials. The input from this public workshop will useful in
developing topics for further discussion.
    Date and Time: The public workshop will be held on September 7,
2012, from 8 a.m. to 3:30 p.m.
    Location: The public workshop will be held at the Sheraton Silver
Spring Hotel, 8777 Georgia Ave., Silver Spring, MD 20910. The hotel's
phone number is<PHONE_NUMBER>. Seating is limited and available on a
first-come, first-served basis.

CONTACT PERSON FOR MORE INFORMATION: Christine Moser or Lori Benner,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 22, rm. 6204, Silver Spring, MD 20993-
0002,<PHONE_NUMBER>.
    Registration: Registration is free for the public workshop.
Interested parties are encouraged to register early. Seating will be
available on a first-come, first-served basis. To register
electronically, email your registration information (including name,
title, firm name, address, telephone, and fax number) to
<EMAIL_ADDRESS>Those without access to the
Internet may call<PHONE_NUMBER> to register. Persons needing a sign
language interpreter or other special accommodations should notify
Christine Moser or Lori Benner (see CONTACT PERSON FOR MORE
INFORMATION) at least 7 days in advance.
    Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at http://www.regulations.gov. It may
be viewed at the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD. A
transcript will also be available in either hardcopy or on CD-ROM after
submission of a Freedom of Information request. Written requests should
be sent to Division of Freedom of Information (ELEM-1029), Food and
Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD
20857. Transcripts will also be available on the Internet (http://www.fda.gov/Drugs/NewsEvents/ucm305463.htm) approximately 45 days after
the workshop.

SUPPLEMENTARY INFORMATION: FDA is announcing a public workshop focusing
on scientific considerations in the design of clinical trials of
antibacterial agents for the treatment of non-CF bronchiectasis.
Discussions will focus on natural history; patient populations for
enrollment in clinical trials; current standard of care and unmet need;
clinical trial endpoints, including exacerbation and patient-reported
outcomes; and clinical trial design elements, including duration of
treatment and patient followup.
    FDA encourages individuals, patient advocates, industry, consumer
groups, health care professionals, researchers, and other interested
persons to attend this public workshop.

    Dated: August 10, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-20106 Filed 8-15-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: June 1, 2010 (Volume 75, Number 104)]
[Rules and Regulations]
[Page 30292-30294]
[DOCID:fr01jn10-12]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2010-0272; Directorate Identifier 2010-CE-009-AD;
Amendment 39-16310; AD 2010-11-05]
RIN 2120-AA64

Airworthiness Directives; AVOX Systems and B/E Aerospace Oxygen
Cylinders as Installed on Various 14 CFR Part 23 and CAR 3 Airplanes

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

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for certain
AVOX Systems and B/E Aerospace oxygen cylinders, as installed on
various 14 CFR part 23 or CAR 3 airplanes. This AD requires you to
inspect for and remove substandard oxygen cylinders from the airplane.
This AD was prompted by the reported rupture of a high-pressure gaseous
oxygen cylinder, which had insufficient strength characteristics due to
improper heat treatment. We are issuing this AD to prevent an oxygen
cylinder from rupturing, which, depending on the location, could result
in structural damage and rapid decompression of the airplane, damage to
adjacent essential flight equipment, deprivation of the necessary
oxygen supply for the flightcrew, and injury to cabin occupants or
other support personnel.

DATES: This AD becomes effective on July 6, 2010.
    On July 6, 2010, the Director of the Federal Register approved the
incorporation by reference of certain publications listed in this AD.

ADDRESSES: For service information identified in this AD, contact B/E
Aerospace, Inc., Commercial Aircraft Products Group, RGA Department,
10800 Pflumm Road, Lenexa, Kansas 66215; telephone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>; Internet: http://www.beaerospace.com; and AVOX
Systems, 225 Erie Street, Lancaster, New York 14086-9502; telephone:
(716) 683-5100; fax:<PHONE_NUMBER>; Internet: http://www.avoxsys.com,
as applicable.
    To view the AD docket, go to U.S. Department of Transportation,
Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200
New Jersey Avenue, SE., Washington, DC 20590, or on the Internet at
http://www.regulations.gov. The docket number is FAA-2010-0272;
Directorate Identifier 2010-CE-009-AD.

FOR FURTHER INFORMATION CONTACT: David Hirt, Aerospace Engineer, FAA,
Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri
64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    On March 11, 2010, we issued a proposal to amend part 39 of the
Federal Aviation Regulations (14 CFR part 39) to include an AD that
would apply to certain AVOX Systems and B/E Aerospace oxygen cylinders,
as installed on various 14 CFR part 23 or CAR 3 airplanes. This
proposal was published in the Federal Register as a notice of proposed
rulemaking (NPRM) on March 17, 2010 (75 FR 12713). The NPRM proposed to
require removing the affected oxygen cylinder from various 14 CFR part
23 or CAR 3 airplanes and replacing it with a serviceable oxygen
cylinder.

Comments

    We provided the public the opportunity to participate in developing
this AD. We received no comments on the proposal or on the
determination of the cost to the public.

Conclusion

    We have carefully reviewed the available data and determined that
air safety and the public interest require adopting the AD as proposed
except for minor editorial corrections. We have determined that these
minor corrections:
     Are consistent with the intent that was proposed in the
NPRM for correcting the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.

Costs of Compliance

    We estimate that this AD will affect 10,000 airplanes in the U.S.
registry.
    We estimate the following costs to do the inspection:

----------------------------------------------------------------------------------------------------------------
                                                                                Total cost on U.S.
                                                                                operators based on
                                                                          Total cost  per       all airplanes
                Labor cost                          Parts cost                airplane       having the affected
                                                                                oxygen cylinder
                                                                                installed
----------------------------------------------------------------------------------------------------------------
0.5 work-hour x $85 per hour = $42.50....  Not applicable.............              $42.50             $425,000
----------------------------------------------------------------------------------------------------------------

     We estimate the following costs to do any necessary removal and
replacement that will be required based on the results of the
inspection. We have no way of determining the number of airplanes that
may need this replacement:

------------------------------------------------------------------------
                                                       Total cost  per
          Labor cost                 Parts cost            airplane
------------------------------------------------------------------------
2 work-hours x $85 per hour =               $1,675               $1,845
 $170.........................
------------------------------------------------------------------------

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 AD.

Regulatory Findings

    We have determined that this AD will not have federalism
implications under Executive Order 13132. This AD will not have a
substantial direct effect on the States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government.
    For the reasons discussed above, I certify that this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a summary of the costs to comply with this AD (and
other information as included in the Regulatory Evaluation) and placed
it in the AD Docket. You may get a copy of this summary by sending a
request to us at the address listed under ADDRESSES. Include ``Docket
No. FAA-2010-0272; Directorate Identifier 2010-CE-009-AD'' in your
request.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the Federal Aviation Administration amends part 39 of the Federal
Aviation Regulations (14 CFR part 39) as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

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

Sec.  39.13  [Amended]

0
2. FAA amends Sec.  39.13 by adding the following new AD:

2010-11-05 AVOX Systems and B/E Aerospace: Amendment 39-16310;
Docket No. FAA-2010-0272; Directorate Identifier 2010-CE-009-AD.

Effective Date

    (a) This AD becomes effective on July 6, 2010.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to oxygen cylinders with a capacity of 114/
115 cubic feet, approved under United States Department of
Transportation Regulations for Type 3HT cylinders, identified in
Table 1 of this AD. These oxygen cylinders may be installed on
various 14 CFR part 23 and CAR 3 airplanes, certificated in any
category. The affected oxygen cylinders may be installed as a
component of, but not limited to, the AVOX Systems Inc. and B/E
Aerospace cylinder assemblies listed in Table 2 of this AD.

         Table 1--Affected Oxygen Cylinder Serial Numbers (S/N)
------------------------------------------------------------------------
         Cylinder manufacturer                    Affected S/N
------------------------------------------------------------------------
AVOX Systems..........................  ST82307 through ST82309.
                                        ST82335 through ST82378.
                                        ST82385 through ST82506, except
                                         ST82498 (out of service).
                                        ST82550 through ST82606.
                                        ST82617 through ST82626.
                                        ST83896 through ST83905.
                                        ST84209 through ST84218.
                                        ST84224 through ST84236.
                                        ST86138, ST86143, ST86145,
                                         ST86150, ST86169, ST86172, and
                                         ST86177.
                                        ST86299 through ST86307.
B/E Aerospace.........................  K495120 through K495121.
                                        K629573 through K629577.
                                        K674451 through K674455.
------------------------------------------------------------------------

      Table 2--Affected Oxygen Cylinder Assembly Part Numbers (P/N)
------------------------------------------------------------------------
             Manufacturer                             P/Ns
------------------------------------------------------------------------
AVOX Systems..........................  \*\6350A34 series, 800112-03,
                                         800112-10, 800112-13, 801293-
                                         03, 801307-00, 801307-01,
                                         801307-02, 801307-03, 801307-
                                         07, 801307-09, 801307-23,
                                         801307-24, 801365-04, 801365-
                                         14, 801375-00, 801977-05, and
                                         \*\8915 series.
                                        (\*\For example, 6350A34-X-X or
                                         8915XX-XX, where ``X'' denotes
                                         a P/N digit.)
B/E Aerospace.........................  176018-115, 176112-115, 176177-
                                         115, 176181-115, and 176529-97.
------------------------------------------------------------------------

Subject

    (d) Air Transport Association of America (ATA) Code 35: Oxygen.

Unsafe Condition

    (e) This AD was prompted by the reported rupture of a high-
pressure gaseous oxygen cylinder, which had insufficient strength
characteristics due to improper heat treatment. We are issuing this
AD to prevent an oxygen cylinder from rupturing, which, depending on
the location, could result in structural damage and rapid
decompression of the airplane, damage to adjacent essential flight
equipment, deprivation of the necessary oxygen supply for the
flightcrew, and injury to cabin occupants or other support
personnel.

Compliance

    (f) To address this problem, you must do the following, unless
already done:
    (1) Within 60 days after July 6, 2010 (the effective date of
this AD), inspect the oxygen cylinder installed in the airplane to
determine the serial number. The serial number is stamped into the
steel cylinder near the neck. A review of airplane records is
acceptable in lieu of this inspection if the serial number of the
oxygen cylinder can be positively determined from that review. For
any oxygen cylinder that has a serial number identified in Table 1
of this AD, before further flight, remove it from the airplane and
replace it with a serviceable oxygen cylinder. Do the inspection and
removal following B/E Aerospace Service Bulletin 176000-35-01, dated
November 2, 2009; and Zodiac Aerospace AVOX Systems, Inc. Service
Bulletin 6084-34-35-01, Revision 1, dated December 9, 2009, as
applicable.
    (2) As of July 6, 2010 (the effective date of this AD), do not
install on any airplane a United States Department of Transportation
Type 3HT oxygen cylinder that has a serial number identified in
Table 1 of this AD.

    Note:  United States Department of Transportation hazardous
materials regulations apply to the shipping of oxygen cylinders.

Alternative Methods of Compliance (AMOCs)

    (g) The Manager, Standards Office, FAA, has the authority to
approve AMOCs for this AD, if requested using the procedures found
in 14 CFR 39.19. Send information to ATTN: David Hirt, Aerospace
Engineer, FAA, Small Airplane Directorate, 901 Locust, Room 301,
Kansas City, Missouri 64106; telephone:<PHONE_NUMBER>; fax: (816)
329-4090; e-mail<EMAIL_ADDRESS>Before using any approved AMOC
on any airplane to which the AMOC applies, notify your appropriate
principal inspector (PI) in the FAA Flight Standards District Office
(FSDO), or lacking a PI, your local FSDO.

Material Incorporated by Reference

    (h) You must use B/E Aerospace Service Bulletin 176000-35-01,
dated November 2, 2009; and Zodiac Aerospace AVOX Systems, Inc.
Service Bulletin 6084-34-35-01, Revision 1, dated December 9, 2009,
to do the actions required by this AD, unless the AD specifies
otherwise.
    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact B/E
Aerospace, Inc., Commercial Aircraft Products Group, RGA Department,
10800 Pflumm Road, Lenexa, Kansas 66215; telephone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>; Internet: http://www.beaerospace.com; and AVOX
Systems, 225 Erie Street, Lancaster, New York 14086-9502; telephone:
(716) 683-5100; fax:<PHONE_NUMBER>; Internet: http://
www.avoxsys.com, as applicable.
    (3) You may review copies of the service information
incorporated by reference for this AD at the FAA, Central Region,
Office of the Regional Counsel, 901 Locust, Kansas City, Missouri
64106. For information on the availability of this material at the
Central Region, call<PHONE_NUMBER>.
    (4) You may also review copies of the service information
incorporated by reference for this AD at the National Archives and
Records Administration (NARA). For information on the availability
of this material at NARA, call<PHONE_NUMBER>, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.

    Issued in Kansas City, Missouri, on May 13, 2010.
Kim Smith,
Manager, Small Airplane Directorate, Aircraft Certification Service.
[FR Doc. 2010-12173 Filed 5-28-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: October 6, 2010 (Volume 75, Number 193)]
[Notices]
[Page 61745]
[DOCID:fr06oc10-76]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER10-2720-000]

Minco Wind, LLC; Supplemental Notice That Initial Market-Based
Rate Filing Includes Request for Blanket Section 204 Authorization

September 21, 2010.
    This is a supplemental notice in the above-referenced proceeding of
Minco Wind, LLC's application for market-based rate authority, with an
accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426, in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214). Anyone filing a motion to intervene or protest must serve a
copy of that document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is October 12, 2010.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please e-mail<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2010-25086 Filed 10-5-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: July 3, 2008 (Volume 73, Number 129)]
[Notices]
[Page 38194-38195]
[DOCID:fr03jy08-40]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

June 26, 2008.
    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

    Docket Numbers: RP96-359-037.
    Applicants: Transcontinental Gas Pipe Line Corp.
    Description: Transcontinental Gas Pipeline Corporation submits an
executed service agreement containing a negotiated rate which pertains
to Rate Schedule FT firm transportation service under Transco's
Momentum Expansion Project.
    Filed Date: 06/13/2008.
    Accession Number: 20080616-0082.
    Comment Date: 5 p.m. Eastern Time on Tuesday, July 1, 2008.

    Docket Numbers: RP05-422-027.
    Applicants: El Paso Natural Gas Company.
    Description: Supplemental Refund Report to its January 17, 2008
Original Refund Report of El Paso Natural Gas Company.
    Filed Date: 06/25/2008.
    Accession Number: 20080625-5062.
    Comment Date: 5 p.m. Eastern Time on Monday, July 7, 2008.

    Docket Numbers: RP08-123-002.
    Applicants: Central Kentucky Transmission Corporation.
    Description: NiSource Gas Transmission & Storage submits Second
Revised Sheet 35 et al. to FERC Gas Tariff, Second Revised Volume 1, to
become effective 8/1/08.
    Filed Date: 06/25/2008.
    Accession Number: 20080626-0060.
    Comment Date: 5 p.m. Eastern Time on Monday, July 7, 2008.

    Docket Numbers: RP08-125-002.
    Applicants: Crossroads Pipeline Company.
    Description: Crossroads Pipeline Company submits Third Revised
Sheet 50 et al. for inclusion in FERC Gas Tariff, First Revised Volume
1, to become effective 8/1/08.
    Filed Date: 06/25/2008.
    Accession Number: 20080626-0059.
    Comment Date: 5 p.m. Eastern Time on Monday, July 7, 2008.

    Docket Numbers: RP08-420-000.
    Applicants: Millennium Pipeline Company, L.L.C.
    Description: Millennium Pipeline Company, L.L.C. submits non-
conforming firm transportation service and negotiated rate agreements
with Consolidated Edison Company of New York, Inc. et al.
    Filed Date: 06/23/2008.
    Accession Number: 20080624-0167.
    Comment Date: 5 p.m. Eastern Time on Monday, July 7, 2008.

    Docket Numbers: RP08-421-000.
    Applicants: Petal Gas Storage, L.L.C.
    Description: Petal Gas Storage, L.L.C. submits its FERC Gas Tariff
Original Volume 1, to become effective 7/23/08.
    Filed Date: 06/24/2008.
    Accession Number: 20080625-0090.
    Comment Date: 5 p.m. Eastern Time on Monday, July 7, 2008.

    Docket Numbers: RP08-422-000.
    Applicants: Eastern Shore Natural Gas Company.
    Description: Eastern Shore Natural Gas Company submits Twenty-First
Revised Sheet 4 et al. to FERC Gas Tariff, Second Revised Volume 1, to
become effective 7/1/08.
    Filed Date: 06/25/2008.
    Accession Number: 20080625-0185.
    Comment Date: 5 p.m. Eastern Time on Monday, July 7, 2008.

    Docket Numbers: CP98-150-011.
    Applicants: Millennium Pipeline Company, L.L.C.
    Description: Millennium Pipeline Company, L.L.C., submits Original
Sheet 0, et al., to FERC Gas Tariff, Original Volume No. 1, to become
effective 11/1/08.
    Filed Date: 06/23/2008.
    Accession Number: 20080624-0172.
    Comment Date: 5 p.m. Eastern Time on Friday, July 11, 2008.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>
or call

(866) 208-3676 (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. E8-15098 Filed 7-2-08; 8:45 am]

BILLING CODE 6717-01-P