[Federal Register Volume 76, Number 115 (Wednesday, June 15, 2011)]
[Notices]
[Pages 34999-35000]
[FR Doc No: 2011-14789]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0378]

Draft Guidance for Industry and Food and Drug Administration
Staff; Establishing the Performance Characteristics of In Vitro
Diagnostic Devices for the Detection of Methicillin-Resistant
Staphylococcus Aureus for Culture-Based Devices; 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availability of the draft guidance entitled ``Establishing the
Performance Characteristics of In Vitro Diagnostic Devices for the
Detection of Methicillin-Resistant Staphylococcus Aureus for Culture-
Based Devices.'' This draft guidance document provides industry and
Agency staff with recommendations for studies for establishing the
performance characteristics of in vitro diagnostic devices for the
detection of methicillin-resistant S. aureus (MRSA), including those
for the detection or detection and differentiation of MRSA versus S.
aureus (SA) in either human specimens or bacterial growth detected by
continuous monitoring blood culture systems. This draft guidance is not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 on 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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by September 13, 2011.

ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Establishing the Performance
Characteristics of In Vitro Diagnostic Devices for the Detection of
Methicillin-Resistant Staphylococcus Aureus (MRSA) for Culture-Based
Devices'' 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. Send one self-addressed adhesive label to
assist that office in processing your request, or fax your request to
301-847-8149. 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: Alexandra Wong, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 5502, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is issuing this draft guidance to provide industry and Agency
staff with recommendations for studies for establishing the performance

characteristics of in vitro diagnostic devices for the detection of
MRSA, including those for the detection or detection and
differentiation of MRSA versus SA in either human specimens or
bacterial growth detected by continuous monitoring blood culture
systems. These devices are used to aid in the prevention and control of
MRSA/SA infections in health care settings. This document is limited to
studies intended to establish the performance characteristics of
devices that detect MRSA by growth in culture media or those devices
that test for the protein, penicillin-binding protein 2a (PBP2a or
PBP2'), expressed by the mecA gene. This includes culture-based devices
that use selective or chromogenic media. It does not address the
detection of serological response from the host to the MRSA antigens or
establish the performance of non-MRSA components of multianalyte or
multiplex nucleic acid based devices.

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 establishing
the performance characteristics of in vitro diagnostic devices for the
detection of MRSA for culture-based devices. 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. A search capability for all CDRH guidance
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at  http://www.regulations.gov. To receive
``Establishing the Performance Characteristics of In Vitro Diagnostic
Devices for the Detection of Methicillin-Resistant Staphylococcus
Aureus (MRSA) for Culture-Based Devices,'' you may either send an e-
mail 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 1729 to identify the guidance you are
requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations and guidance documents. These
collections of information are subject to review by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3520). The collections of information in 21 CFR part
807, subpart E have been approved under OMB control number 0910-0120;
the collections of information in 21 CFR part 812 have been approved
under OMB control number 0910-0078; the collections of information in
21 CFR part 801 and 21 CFR 809.10 have been approved under OMB control
number 0910-0485; and the collections of information in 42 CFR 493.15
have been approved under OMB control number 0910-0598.

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. It is no
longer necessary to send two copies of mailed 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.

    Dated: June 9, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-14789 Filed 6-14-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 80, Number 16 (Monday, January 26, 2015)]
[Notices]
[Pages 4021-4023]
[FR Doc No: 2015-01252]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-74099; File No. SR-Phlx-2015-07]

Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change Relating to
SPY Pilot Program

January 20, 2015.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on January 13, 2015, NASDAQ OMX PHLX LLC (``Phlx'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II 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 extend the pilot program that eliminates
position limits for options on the SPDR[supreg] S&P 500[supreg]
exchange-traded fund (``SPY ETF'' or ``SPY''),\3\ which list and trade
under the symbol SPY (``SPY Pilot Program'').
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    \3\ ``SPDR[supreg],'' ``Standard & Poor's[supreg],''
``S&P[supreg],'' ``S&P 500[supreg],'' and ``Standard & Poor's 500''
are registered trademarks of Standard & Poor's Financial Services
LLC. The SPY ETF represents ownership in the SPDR S&P 500 Trust, a
unit investment trust that generally corresponds to the price and
yield performance of the SPDR S&P 500 Index.
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    The text of the proposed rule change is available on the Exchange's
Web site at http://nasdaqomxphlx.cchwallstreet.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 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 these 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 aspects of such
statements.

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

1. Purpose
    The purpose of the proposed rule change is to amend Rule 1001,
entitled ``Position Limits,'' to extend the current pilot, which
expires on February 4, 2015, to July 12, 2015 (``Extended Pilot'').
This filing does not propose any substantive changes to the SPY Pilot
Program. In proposing to extend the SPY Pilot Program, the Exchange
reaffirms its consideration of several factors that supported the
original proposal of the SPY Pilot Program, including (1) the
availability of economically equivalent products and their respective
position limits; (2) the liquidity of the option and the underlying
security; (3) the market capitalization of the underlying security and
the related index; (4) the reporting of large positions and
requirements surrounding margin; and (5) the potential for market on
close volatility.
    The Exchange submitted a report to the Commission on January 2,
2015, which report reflected, during the time period from December 1,
2013 through November 30, 2014, the trading of standardized SPY options
with no position limits consistent with option exchange provisions.\4\
The report was prepared in the manner specified in Phlx's filing
extending the SPY Pilot Program.\5\ The Exchange notes that it is
unaware of any problems created by the SPY Pilot Program and does not
foresee any as a result of the proposed extension.
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    \4\ The report is attached as Exhibit 3.
    \5\ See Securities Exchange Act Release No. 70879 (November 14,
2013), 78 FR 69731 (November 20, 2013) (SR-Phlx-2013-108).
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    As with the original proposal, related to the SPY Pilot Program,
the Exchange represents that a Pilot Report will be submitted at least
thirty (30) days before

the end of the Extended Pilot and would analyze that period. The Pilot
Report will detail the size and different types of strategies employed
with respect to positions established as a result of the elimination of
position limits in SPY. In addition, the report will note whether any
problems resulted due to the no limit approach and any other
information that may be useful in evaluating the effectiveness of the
Extended Pilot. The Pilot Report will compare the impact of the SPY
Pilot Program, if any, on the volumes of SPY options and the volatility
in the price of the underlying SPY shares, particularly at expiration
during the Extended Pilot. In preparing the report the Exchange will
utilize various data elements such as volume and open interest. In
addition the Exchange will make available to Commission staff data
elements relating to the effectiveness of the SPY Pilot Program.
    Conditional on the findings in the Pilot Report, the Exchange will
file with the Commission a proposal to extend the pilot program, adopt
the pilot program on a permanent basis or terminate the pilot. If the
SPY Pilot Program is not extended or adopted on a permanent basis by
the expiration of the Extended Pilot, the position limits for SPY would
revert to limits in effect at the commencement of the SPY Pilot
Program.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \6\ in general, and furthers the objectives of Section
6(b)(5) of the Act \7\ 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, to
remove impediments to and perfect the mechanism of a free and open
market and a national market system and, in general, to protect
investors and the public interest.
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    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(5).
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    The Exchange believes that the proposed rule change would be
beneficial to market participants, including market makers,
institutional investors and retail investors, by permitting them to
establish greater positions when pursuing their investment goals and
needs. The Exchange also believes that economically equivalent products
should be treated in an equivalent manner so as to avoid regulatory
arbitrage, especially with respect to position limits. Treating SPY and
SPX options differently by virtue of imposing different position limits
is inconsistent with the notion of promoting just and equitable
principles of trade and removing impediments to perfect the mechanisms
of a free and open market. At the same time, the Exchange believes that
the elimination of position limits for SPY options would not increase
market volatility or facilitate the ability to manipulate the market.

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

    The proposed rule change does not impose any burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Act. In this regard and as indicated below, the Exchange notes that
the rule change is being proposed as a competitive response to similar
filings by other options exchanges. The Exchange believes this proposed
rule change is necessary to permit fair competition among the options
exchanges and to establish uniform position limits for a multiply
listed options class.

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

    No written comments were either solicited or received.

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) of the Act \8\ and Rule 19b-4(f)(6) thereunder.\9\ Because
the foregoing 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 for 30
days from the date on which it was filed, or such shorter time as the
Commission may designate, it has become effective pursuant to Section
19(b)(3)(A) of the Act and Rule 19b-4(f)(6) thereunder.\10\
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    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 17 CFR 240.19b-4(f)(6).
    \10\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change, along
with a brief description and the text of the proposed rule change,
at least five business days prior to the date of filing of the
proposed rule change, or such shorter time as designated by the
Commission. The Exchange has satisfied this requirement.
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    A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the
Act \11\ normally does not become operative for 30 days after the date
of its filing. However, Rule 19b-4(f)(6)(iii) \12\ permits the
Commission to designate a shorter time if such action is consistent
with the protection of investors and the public interest. The Exchange
has asked the Commission to waive the 30-day operative delay so that
the proposal may become operative immediately upon filing. The Exchange
believes that waiver of the operative delay is consistent with the
protection of investors and the public interest because it will permit
the SPY Pilot Program to continue without interruption. The Commission
believes that waiving the 30-day operative delay is consistent with the
protection of investors and the public interest. Therefore, the
Commission hereby waives the operative delay and designates the
proposed rule change operative upon filing.\13\
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    \11\ 17 CFR 240.19b-4(f)(6).
    \12\ 17 CFR 240.19b-4(f)(6)(iii).
    \13\ 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 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-2015-07 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-Phlx-2015-07. This file
number should be included on the

subject line if email is used. To help the Commission process and
review your comments more efficiently, please use only one method. The
Commission will post all comments on the Commission's Internet Web site
(http://www.sec.gov/rules/sro.shtml). Copies of the submission, all
subsequent amendments, all written statements with respect to the
proposed rule change that are filed with the Commission, and all
written communications relating to the proposed rule change between the
Commission and any person, other than those that may be withheld from
the public in accordance with the provisions of 5 U.S.C. 552, will be
available for Web site viewing and printing in the Commission's Public
Reference Room, 100 F Street NE., Washington, DC 20549 on official
business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of
such 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-Phlx-2015-07, and should be submitted on or before
February 17, 2015.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
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    \14\ 17 CFR 200.30-3(a)(12).
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Brent J. Fields,
Secretary.
[FR Doc. 2015-01252 Filed 1-23-15; 8:45 am]
BILLING CODE 8011-01-P