[Federal Register: June 11, 2007 (Volume 72, Number 111)]
[Notices]
[Page 32151-32152]
[DOCID:fr11jn07-91]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-55853; File No. SR-CBOE-2007-56]

 Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing and Immediate Effectiveness of Proposed
Rule Change Relating to Market-Maker Obligations

June 4, 2007.
    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 May 30, 2007, the Chicago Board Options Exchange, Incorporated
(``Exchange'' or ``CBOE'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I, II, and III below, which Items have been prepared
substantially by the Exchange. The Exchange filed the proposal as a
``non-controversial'' proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \3\ and Rule 19b-4(f)(6) thereunder.\4\ 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.
    \3\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \4\ 17 CFR 240.19b-4(f)(6).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend CBOE's rules relating to Market-
Maker obligations. The text of the proposed rule change is available on
the Exchange's Web site (http://www.cboe.com), at the Exchange's Office

of the Secretary 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 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 the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    On January 23, 2007, the Commission approved CBOE's proposed rule
change to permit thirteen option classes to trade in penny increments
in connection with the Penny Pilot Program.\5\ In its proposed rule
change, CBOE discussed the various quote mitigation strategies that it
had already implemented and intended to implement. One of the quote
mitigation strategies was to amend Rule 8.7 to modify the continuous
electronic quoting obligation of Market-Makers and Remote Market-Makers
(``RMMs''). Specifically, CBOE amended these obligations to provide
that Market-Makers and RMMs shall provide continuous electronic quotes
in 60% of the series of his/her appointed class that have a time to
expiration of less than nine months. CBOE noted that this was
consistent with its Rule 5.8.
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    \5\ See Securities Exchange Act Release No. 55154, 72 FR 4743
(February 1, 2007).
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    Because CBOE's rule filing relating to the Penny Pilot Program was
only approved on a six-month pilot basis (which is scheduled to expire
on July 26, 2007), including apparently the proposed change to the
continuous electronic quoting obligation of Market-Makers and RMMs,
CBOE requests that the change to continuous electronic quoting
obligations be approved on a permanent basis.\6\ CBOE notes that this
quote mitigation strategy is similar to Phlx Rule 1014(b)(ii)(D)(4).\7\
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    \6\ It is unclear from the approval order whether the proposed
change to the continuous electronic quoting obligation of Market-
Makers and RMMs was intended to be approved only on a six-month
pilot basis, as opposed to the changes to the minimum increments for
the thirteen option classes participating in the Penny Pilot
Program.
    \7\ See Securities Exchange Act Release No. 55689 (May 1, 2007),
72 FR 26192 (May 8, 2007) (granting immediate effectiveness to SR-
Phlx-2007-36).
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2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Act and the rules and regulations under the Act applicable to a
national securities exchange and, in particular, the requirements of
Section 6(b) of the Act.\8\ Specifically, the Exchange believes the
proposed rule change is consistent with the Section 6(b)(5) Act \9\
requirements

that the rules of an exchange be designed to promote just and equitable
principles of trade, to prevent fraudulent and manipulative acts and,
in general, to protect investors and the public interest.
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    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    CBOE 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.

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

    The Exchange neither solicited nor received comments on the
proposal.

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

    Because the foregoing rule 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 if consistent with the protection of investors
and the public interest, provided that the self-regulatory organization
has given the Commission written notice of its intent to file 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 proposed rule change has become effective
pursuant to Section 19(b)(3)(A) of the Act \10\ and Rule 19b-4(f)(6)
thereunder.\11\ At any time within 60 days of the filing of such
proposed rule change, the Commission may summarily abrogate 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.
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    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f)(6). The Exchange provided the
Commission with written notice of its intention to file the proposed
rule change on May 16, 2007.
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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 e-mail to<EMAIL_ADDRESS>Please include

File Number SR-CBOE-2007-56 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-CBOE-2007-56. This file
number should be included on the subject line if e-mail 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 inspection and
copying in the Commission's Public Reference Room. Copies of such
filing also will be available for inspection and copying at the
principal office of the CBOE. 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-CBOE-2007-56 and should be submitted on or before July
2, 2007.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\12\
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    \12\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. E7-11158 Filed 6-8-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register: October 8, 2009 (Volume 74, Number 194)]
[Notices]
[Page 51864-51865]
[DOCID:fr08oc09-59]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0438]

Guidance for Industry and Food and Drug Administration Staff;
Implementation of Medical Device Establishment Registration and Device
Listing Requirements Established by the Food and Drug Administration
Amendments Act of 2007; 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 guidance entitled ``Implementation of Medical
Device Establishment Registration and Device Listing Requirements
Established by the Food and Drug Administration Amendments Act of
2007.'' The purpose of this guidance is to explain recent changes in
the device registration and listing program to owner/operators and
official correspondents of device establishments and to help them
fulfill these new requirements. The guidance also describes the
information that owner/operators of device establishments must submit
to register their establishments and list their devices electronically,
using FDA Form No. 3673. Those owner/operators seeking a waiver from
the electronic submission requirement must submit their requests in
writing to FDA with a complete explanation of why their registration
and listing information cannot reasonably be submitted electronically.
This guidance document is immediately in effect, but it remains subject
to comment in accordance with the agency's good guidance practices
(GGPs).

DATES: Submit written or electronic comments on this guidance at any
time. General comments on agency guidelines are welcome at any time.

ADDRESSES: Submit written requests for single copies of the guidance
document entitled ``Implementation of Medical Device Establishment
Registration and Device Listing Requirements Established by the Food
and Drug Administration Amendments Act of 2007'' 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<PHONE_NUMBER>. See the
SUPPLEMENTARY INFORMATION section for information on electronic access
to the guidance.
    Submit written comments concerning this guidance to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://www.regulations.gov. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: David Racine, Center for Devices and
Radiological Health (HFZ-410), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 2672, Silver Spring, MD 20993-0002, 301-
796-5777.

SUPPLEMENTARY INFORMATION:

I. Background

    In October 2002, section 510 of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 360) was amended by section 207 of
the Medical Device User Fee and Modernization Act of 2002 (Public Law
107-250) to add a requirement for electronic submission of registration
information. On September 27, 2007, the Food and Drug Administration
Amendments Act of 2007 (FDAAA) (Public Law-110-85) further amended the
device registration and listing provisions in section 510 of the act
and also added provisions to sections 737 and 738 of the act (21 U.S.C.
379i and 379j) to require certain types of device establishments to pay
user fees in connection with their initial or annual registration
beginning on October 1, 2007. As amended, section 510(p) of the act now
requires all device establishments to submit their device registration
and listing information by electronic means unless FDA grants their
request for a waiver.
    The guidance described in this document explains the new,
electronic process for registration and listing using the Internet and
the process for requesting a waiver from FDA. In addition, the guidance
specifies the user fee amounts for each fiscal year (FY) through FY
2012.
    FDAAA imposes new requirements on device establishments to submit
their registration and listing information to FDA through electronic
means and to pay user fees in connection with their registration
beginning on October 1, 2007. FDAAA was signed into law September 27,
2007. Because the law was immediately in effect, FDA determined that it
was not feasible to obtain public participation prior to implementing
the new FDAAA requirements described in this guidance. Therefore, in
accordance with FDA's GGP procedures at 21 CFR 10.115(g)(2), FDA is
issuing this as a level 1 guidance that is immediately in effect and
will accept comments on the guidance at any time.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's GGPs regulation
(21 CFR 10.115). The guidance represents the agency's current thinking
on this topic. 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 guidance may do so by
using the Internet. To receive ``Implementation of Medical Device
Establishment Registration and Device Listing Requirements Established
by the Food and Drug Administration Amendments Act of 2007,'' 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 (1657) to
identify the guidance you are requesting.
    CDRH maintains a web site on the Internet for easy access to
information including text, graphics, and files that may be downloaded
to a personal computer with Internet access. Updated on a regular
basis, the CDRH home page includes device safety alerts, Federal
Register reprints, information on premarket submissions (including
lists of approved applications and manufacturers' addresses), small
manufacturer's assistance, information on video conferencing and
electronic submissions, Mammography Matters, and other device-oriented
information. The CDRH web site may be accessed at http://www.fda.gov/
cdrh. A search capability for all CDRH guidance documents is available
at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also
available at http://www.regulations.gov.

IV. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that 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

this guidance were approved under OMB control number 0910-0625.

V. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments on this guidance
document. Submit a single copy of electronic comments or two paper
copies of any mailed comments, except that individuals may submit one
paper copy. Comments are to be identified with the docket number found
in brackets in the heading of this document. Received comments may be
seen in the Division of Dockets Management between 9 a.m. and 4 p.m.
Monday through Friday.

    Dated: September 30, 2009.
Jeffrey Shuren,
Acting Director, Center for Devices and Radiological Health.
[FR Doc. E9-24349 Filed 10-7-09; 8:45 am]

BILLING CODE 4160-01-S