[Federal Register Volume 78, Number 13 (Friday, January 18, 2013)]
[Notices]
[Pages 4184-4186]
[FR Doc No: 2013-01026]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-68648; File No. SR-Phlx-2013-02]

Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Reduce
the Fees Assessed for Certain Co-location Services

January 14, 2013.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on January 2, 2013, NASDAQ OMX PHLX LLC (``PHLX'' or ``Exchange'')
filed with the Securities and Exchange Commission (``Commission'') a
proposed rule change as described in Items I, II and III below, which
Items have been prepared by the Exchange. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The Exchange proposes to reduce the fees assessed under Section
X(a) of the PHLX Fee Schedule for certain co-location services. PHLX is
proposing that the implementation date of the proposed rule change will
be January 2, 2013. The text of the proposed rule change is available
at http://nasdaqomxphlx.cchwallstreet.com, at PHLX's principal office,
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 Exchange 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 III [sic] 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
    The Exchange proposes to amend Section X(a) of the PHLX Fee
Schedule to reduce the monthly recurring cabinet (``MRC'') fees
assessed for the installation of certain new co-location cabinets. The
reduced MRC fees will apply to new cabinets ordered by customers using
the CoLo Console \3\ during the months of January and February of 2013,
provided that such cabinets are fully operational by May 31, 2013. The
reduced fee shall apply to any cabinet that increases the number of
dedicated cabinets beyond the total number dedicated to that customer
as of December 31, 2012 (``Baseline Number''), for so long as the total
number of dedicated cabinets exceeds that customer's Baseline Number.
The reduced MRC fees will apply for a period of 24 months from the date
the new cabinet becomes fully operational under Phlx rules, provided
that the customer's total number of cabinets continues to exceed the
Baseline Number.
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    \3\ The ``CoLo Console'' is Phlx's web-based ordering tool, and
it is the exclusive means for ordering colocation services.
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    The Exchange proposes to reduce the applicable fees as follows:

------------------------------------------------------------------------
                                              Current         Reduced
              Cabinet type                    ongoing         ongoing
                                            monthly fee     monthly fee
------------------------------------------------------------------------
Low Density.............................          $4,000          $2,000
Medium Density..........................           5,000           2,500
Medium-High Density.....................           6,000           3,500

High Density............................           7,000           4,500
Super High Density......................          13,000           8,000
------------------------------------------------------------------------

    New cabinets shall be assessed standard installation fees.
    Phlx proposes to reduce colocation cabinet fees by different
amounts to maintain a sliding scale of lower fees for higher density
cabinets on a per kilowatt basis. The chart below reflects this scale:

----------------------------------------------------------------------------------------------------------------
                                                                    Reduced MRC
                  Cabinet type                        Max kW            fee         Discount %      Fee per KW
----------------------------------------------------------------------------------------------------------------
Low Density.....................................            2.88          $2,000           50.00         $694.44
Medium Density..................................            5              2,500           50.00          500.00
Medium-High Density.............................            7              3,500           41.67          500.00
High Density....................................           10              4,500           35.71          450.00
Super High Density..............................           17              8,000           38.46          470.59
----------------------------------------------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the provisions of Section 6 of the Act,\4\ in general, and with
Section 6(b)(4) of the Act,\5\ in particular, in that it provides for
the equitable allocation of reasonable dues, fees and other charges
among members and issuers and other persons using any facility or
system which the Exchange operates or controls. The proposed reduced
fee will be assessed equally on all customers that place an order for a
new cabinet during the designated period. The proposed amendments will
provide an incentive for customers to avail themselves of the
designated co-location services.
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    \4\ 15 U.S.C. 78f.
    \5\ 15 U.S.C. 78f(b)(4).
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    Phlx's proposal to reduce fees by differing amounts is fair and
equitable because it reflects the economic efficiency of higher density
colocation cabinets. First, the underlying costs for co-location
cabinets consists of certain fixed costs for the data center facility
(space, amortization, etc.) and certain variable costs (electrical
power utilized and cooling required). The variable costs are in total
higher for the higher power density cabinets, as reflected in their
higher current prices. Second, the higher density cabinets were
introduced later than the lower density cabinets (High Density cabinet
was introduced in 2009 and the Super High Density cabinet was
introduced in 2011). Due to the competitive pressures that existed in
2011 and 2012, the fees for Super High Density cabinets were further
reduced in 2012 to be more comparable with the lower fee per kilowatt
of the High Density cabinet. As a result of these already-reduced rates
on higher density cabinets, Phlx has greater flexibility to discount
fees for lower density cabinets, on a per kilowatt basis.
    Phlx operates in a highly competitive market in which market
participants can readily favor competing venues if they deem fee levels
at a particular venue to be excessive. In such an environment, Phlx
must continually adjust its fees to remain competitive with other
exchanges and with alternative trading systems that have been exempted
from compliance with the statutory standards applicable to exchanges.
Phlx believes that the proposed rule change reflects this competitive
environment because it is designed to ensure that the charges for use
of the Phlx colocation facility remain competitive.

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

    The Exchange does not believe that the proposed rule change will
result in any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act, as amended. To
the contrary, the Exchange's voluntary fee reduction is a response to
increased competition for colocation services by other exchanges and
trading venues. As more venues offer colocation services, competition
drives costs lower. The Exchange, in order to retain existing orders
and to attract new orders, is forced to offer a lower effective rate
for aggregate cabinet demand. This competition benefits users, members,
and investors by lowering the average aggregate cost of trading on the
Exchange.

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

    Written comments were neither solicited nor received.

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

    Pursuant to Section 19(b)(3)(A)(ii) of the Act,\6\ PHLX has
designated this proposal as establishing or changing a due, fee, or
other charge imposed by the self-regulatory organization on any person,
whether or not the person is a member of the self-regulatory
organization, which renders the proposed rule change effective upon
filing.
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    \6\ 15 U.S.C. 78s(b)(3)(A)(ii).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-Phlx-2013-02 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-Phlx-2013-02. 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 on official business
days between the hours of 10:00 a.m. and 3:00 p.m. Copies of such
filing also will be available for inspection and copying at the
principal offices of the Exchange. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-Phlx-2013-02, and should be submitted on or before
February 8, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
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    \7\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-01026 Filed 1-17-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 208 (Friday, October 26, 2012)]
[Proposed Rules]
[Page 65351]
[FR Doc No: 2012-26206]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 60

[EPA-HQ-OAR-2004-0490; FRL-9743-9]
RIN 2060-AQ29

Extension of the Comment Period for the Proposed Standards of
Performance for Stationary Gas Turbines; Standards of Performance for
Stationary Combustion Turbines

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice. Announcement of extension of public comment period.

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SUMMARY: The EPA is announcing that the period for providing public
comments on the August 29, 2012, proposed rule titled, ``Standards of
Performance for Stationary Gas Turbines; Standards of Performance for
Stationary Combustion Turbines'' is being extended for 60 days.

DATES: The public comment period for these actions is being extended
for 60 days to December 28, 2012, in order to provide the public
additional time to submit comments and supporting information.

ADDRESSES: Written comments on the proposed rule may be submitted to
the EPA electronically, by mail, by facsimile or through hand delivery/
courier. Please refer to the proposal for the addresses and detailed
instructions. Publicly available documents relevant to this action are
available for public inspection either electronically in http://www.regulations.gov or in hard copy at the EPA Docket Center, Room
3334, 1301 Constitution Avenue NW., Washington, DC. The Public Reading
Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding legal holidays. A reasonable fee may be charged for copying.

FOR FURTHER INFORMATION CONTACT: Mr. Christian Fellner, Energy
Strategies Group, Sector Policies and Programs Division (D243-01),
Office of Air Quality Planning and Standards, U.S. Environmental
Protection Agency, Research Triangle Park, North Carolina 27711;
Telephone number:<PHONE_NUMBER>; Fax number:<PHONE_NUMBER>; Email
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comment Period

    The proposed rule was published in the Federal Register on August
29, 2012, and a copy of the proposed rule is available in the docket
(77 FR 52554). Due to requests we have received from the public to
extend the public comment period for the August 29, 2012, proposed
Standards of Performance for Stationary Gas Turbines; Standards of
Performance for Stationary Combustion Turbines, the public comment
period is being extended for 60 days. Therefore, the public comment
period will end on December 28, 2012, rather than October 29, 2012.

How can I get copies of this document and other related information?

    The EPA has established the official public docket No. EPA-HQ-OAR-
2004-0490, available at www.regulations.gov.

List of Subjects in 40 CFR part 60

    Environmental protection, Administrative practice and procedure,
Air pollution control, Reporting and recordkeeping requirements.

    Dated: October 17, 2012.
Gina McCarthy,
Assistant Administrator.
[FR Doc. 2012-26206 Filed 10-25-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: May 8, 2009 (Volume 74, Number 88)]
[Notices]
[Page 21734-21735]
[DOCID:fr08my09-117]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Executive Committee of the Aviation Rulemaking Advisory
Committee; Meeting

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of meeting.

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SUMMARY: The FAA is issuing this notice to advise the public of a
meeting of the Executive Committee of the Aviation Rulemaking Advisory
Committee.

DATES: The meeting will be on June 10, 2009, at 10 a.m.

ADDRESS: The meeting will take place at the Federal Aviation
Administration, 800 Independence Avenue, SW., Washington, DC 20591,
10th floor, MacCracken Room.

FOR FURTHER INFORMATION CONTACT: Gerri Robinson, Federal Aviation
Administration, 800 Independence Avenue, SW., Washington, DC 20591,
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; e-mail
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under section 10(a)(2) of the Federal
Advisory Committee Act (5 U.S.C. App. 2), we are giving notice of a
meeting of the Executive Committee of the Aviation Rulemaking Advisory
Committee taking place on June 10, 2008, at the Federal Aviation
Administration, 800 Independence Avenue, SW., Washington, DC 20591. The
agenda includes:
    1. Leadership Transition, Executive Committee Officers
    2. Rescue and Firefighting Requirements Working Group Report
    3. New ARAC task--Maintenance Requirements for Commercial Air Tour
Operations
    4. Issue Area Status Reports from Assistant Chairs
    5. Continuous Improvement (Committee Process)
    6. Off-agenda remarks from other EXCOM members

    Attendance is open to the interested public but limited to the
space available. The FAA will arrange teleconference service for
individuals wishing to join in by teleconference if we receive notice
by June 1. Arrangements to participate by teleconference can be made by
contacting the person listed in the FOR FURTHER INFORMATION CONTACT
section. Callers outside the Washington metropolitan area are
responsible for paying long-distance charges.
    The public must arrange by June 1 to present oral statements at the
meeting. Members of the public may present written statements to the
executive committee by providing 25 copies to the Executive Director,
or by bringing the copies to the meeting.
    If you are in need of assistance or require a reasonable
accommodation for this meeting, please contact the person listed under
the heading FOR FURTHER INFORMATION CONTACT.

    Issued in Washington, DC on May 5, 2009.
Pamela A. Hamilton-Powell,
Executive Director, Aviation Rulemaking Advisory Committee.
[FR Doc. E9-10748 Filed 5-7-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 112 (Monday, June 11, 2018)]
[Notices]
[Pages 27010-27011]
[FR Doc No: 2018-12441]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-P-0327]

Determination That MUTAMYCIN (Mitomycin) Injectable, 5
Milligrams/Vial and 20 Milligrams/Vial, Was Not Withdrawn From Sale for
Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that MUTAMYCIN (mitomycin) injectable, 5 milligrams (mg)/
vial and 20 mg/vial, was not withdrawn from sale for reasons of safety
or effectiveness. This determination will allow FDA to approve
abbreviated new drug applications (ANDAs) for MUTAMYCIN (mitomycin)
injectable, 5 mg/vial and 20 mg/vial, if all other legal and regulatory
requirements are met.

FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation

and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
    MUTAMYCIN (mitomycin) injectable, 5 mg/vial and 20 mg/vial, is the
subject of NDA 050450, held by Bristol Laboratories Inc., and initially
approved on May 28, 1974. MUTAMYCIN has been shown to be useful in the
therapy of disseminated adenocarcinoma of the stomach or pancreas in
proven combinations with other approved chemotherapeutic agents and as
palliative treatment when other modalities have failed. MUTAMYCIN
(mitomycin) injectable, 5 mg/vial and 20 mg/vial, is currently listed
in the ``Discontinued Drug Product List'' section of the Orange Book.
    Fresenius Kabi USA, LLC submitted a citizen petition dated January
22, 2018 (Docket No. FDA-2018-P-0327), under 21 CFR 10.30, requesting
that the Agency determine whether MUTAMYCIN (mitomycin) injectable, 5
mg/vial and 20 mg/vial, was withdrawn from sale for reasons of safety
or effectiveness.
    After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec.  314.161 that MUTAMYCIN (mitomycin) injectable, 5 mg/vial
and 20 mg/vial, was not withdrawn for reasons of safety or
effectiveness. The petitioner has identified no data or other
information suggesting that this product was withdrawn for reasons of
safety or effectiveness. We have carefully reviewed our files for
records concerning the withdrawal of MUTAMYCIN (mitomycin) injectable,
5 mg/vial and 20 mg/vial, from sale. We have also independently
evaluated relevant literature and data for possible postmarketing
adverse events. We have found no information that would indicate that
this drug product was withdrawn from sale for reasons of safety or
effectiveness.
    Accordingly, the Agency will continue to list MUTAMYCIN (mitomycin)
injectable, 5 mg/vial and 20 mg/vial, in the ``Discontinued Drug
Product List'' section of the Orange Book. The ``Discontinued Drug
Product List'' identifies among other items, drug products that have
been discontinued from marketing for reasons other than safety or
effectiveness. FDA will not begin procedures to withdraw approval of
approved ANDAs that refer to this drug product. Additional ANDAs for
this drug product may also be approved by the Agency as long as they
meet all other legal and regulatory requirements for the approval of
ANDAs. If FDA determines that labeling for this drug product should be
revised to meet current standards, the Agency will advise ANDA
applicants to submit such labeling.

    Dated: June 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12441 Filed 6-8-18; 8:45 am]
 BILLING CODE 4164-01-P