[Federal Register Volume 82, Number 140 (Monday, July 24, 2017)]
[Notices]
[Page 34346]
[FR Doc No: 2017-15406]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-81164; File No. SR-CBOE-2017-043]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Designation of a Longer Period for Commission
Action on a Proposed Rule Change To Adopt Rule 6.97, Consolidated Audit
Trail (CAT) Compliance Rule--Fee Dispute Resolution

July 18, 2017.
    On May 23, 2017, Chicago Board Options Exchange, Incorporated
(``CBOE'' or the ``Exchange'') filed with the Securities and Exchange
Commission (``Commission''), pursuant to Section 19(b)(1) of the
Securities Exchange Act of 1934 (``Act'' or ``Exchange Act'') \1\ and
Rule 19b-4 thereunder,\2\ a proposed rule change to adopt Rule 6.97
(Consolidated Audit Trail--Fee Dispute Resolution). The proposed rule
change was published for comment in the Federal Register on June 7,
2017.\3\ The Commission received no comment letters on the proposed
rule change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Securities Exchange Act Release No. 80832 (June 1, 2017), 82
FR 26523 (``Notice'').
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    Section 19(b)(2) of the Act \4\ provides that, within 45 days of
the publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding or as to which the self-regulatory organization
consents, the Commission shall either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the proposed rule change should be disapproved. The
Commission is extending this 45-day time period.
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    \4\ 15 U.S.C. 78s(b)(2).
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    The Commission finds that it is appropriate to designate a longer
period within which to take action on the proposed rule change so that
it has sufficient time to consider the proposed rule change. The
proposed rule change would establish the procedures for resolving
potential disputes related to CAT Fees charged to Industry Members.
    Accordingly, the Commission, pursuant to Section 19(b)(2) of the
Act,\5\ designates September 5, 2017, as the date by which the
Commission should either approve or disapprove or institute proceedings
to determine whether to disapprove the proposed rule change (File
Number SR-CBOE-2017-043).
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    \5\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
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    \6\ 17 CFR 200.30-3(a)(31).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-15406 Filed 7-21-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: January 19, 2007 (Volume 72, Number 12)]
[Notices]
[Page 2578-2581]
[DOCID:fr19ja07-101]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-55109; File No. SR-NYSEArca-2007-05]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
of Proposed Rule Change Regarding a Proposed Combination Between NYSE
Group, Inc. and Euronext N.V.

January 16, 2007.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of
1934, as amended, (``Exchange Act'') \1\ and Rule 19b-4 thereunder,\2\
notice is hereby given that on January 12, 2007, NYSE Arca, Inc.
(``NYSE Arca'' or ``Exchange'') 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 substantially
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)(l).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    NYSE Arca is submitting the proposed rule change to the Commission
in connection with the proposed business combination (the
``Combination'') of NYSE Group, Inc., a Delaware corporation (``NYSE
Group''), with Euronext N.V., a company organized under the laws of The
Netherlands (``Euronext''). As a result of the Combination, the
businesses of NYSE Group (including that of NYSE Arca) and Euronext
will be held under a single, publicly traded holding company named NYSE
Euronext, a Delaware corporation (``NYSE Euronext''). The Combination
involves certain modifications to the organizational documents of NYSE
Group,\3\ the current indirect parent

company of NYSE Arca, and of NYSE Euronext, which upon completion of
the Combination will be the new indirect parent company of NYSE Arca.
The organizational documents and independence policies of NYSE Group
and NYSE Euronext and the trust documents constitute rules of the
Exchange. The resolutions of the board of directors of NYSE Group and
the changes to the Certificate of Incorporation of Archipelago
Holdings, Inc., current direct parent of NYSE Arca are also rules of
the Exchange requiring Commission approval. Accordingly, NYSE Arca
submits this proposed rule change to reflect the rule changes to be
implemented in connection with the Combination.
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    \3\ Upon the consummation of the Combination, NYSE Group will be
merged with and into Jefferson Merger Sub, Inc. and the name of
Jefferson Merger Sub, Inc. will be changed to NYSE Group, Inc. The
changes to the NYSE Group organizational documents refer to changes
from the current NYSE Group organizational documents. Technically,
however, the Amended and Restated Certificate of Incorporation and
Amended and Restated Bylaws of NYSE Group that will be operative
upon the consummation of the Combination will be amended and
restated forms of the Certificate of Incorporation and Bylaws of
Jefferson Merger Sub, Inc.
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    The text of the proposed rule change and Exhibits 5A through 5H \4\
are available at the Exchange, the Commission's Public Reference Room,
and http://www.nysearca.com.

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    \4\ The proposed Amended and Restated Certificate of
Incorporation of NYSE Euronext is Exhibit 5A; the proposed Amended
and Restated Bylaws of NYSE Euronext are Exhibit 5B; the proposed
NYSE Euronext Director Independence Policy, which policy will
replace the current NYSE Group Director Independence Policy, is
Exhibit 5C; the proposed Amended and Restated Certificate of
Incorporation of NYSE Group is Exhibit 5D; the proposed Amended and
Restated Bylaws of NYSE Group are Exhibit 5E; the resolutions of the
board of directors of NYSE Group are Exhibit 5F; the proposed
Amended and Restated Certificate of Incorporation of Archipelago
Holdings, Inc. (``Arca Holdings'') is Exhibit 5G and the proposed
Trust Agreement for the Delaware Trust is Exhibit 5H. Each of these
Exhibits will be operative as of the consummation of the
Combination.
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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. 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
    NYSE Arca is submitting the proposed rule change to the Commission
in connection with the Combination of NYSE Group with Euronext. As a
result of the Combination, the businesses of NYSE Group (including that
of NYSE Arca) and Euronext will be held under a single, publicly traded
holding company named NYSE Euronext. The Combination involves certain
modifications to the organizational documents of NYSE Group, the
current indirect parent company of NYSE Arca, and of NYSE Euronext,
which upon completion of the Combination will be the new indirect
parent company of NYSE Arca. The organizational documents and
independence policies of NYSE Group and NYSE Euronext and the trust
documents constitute rules of the Exchange. The resolutions of the
board of directors of NYSE Group and the changes to the Certificate of
Incorporation of Archipelago Holdings, Inc., current direct parent of
NYSE Arca are also rules of the Exchange requiring Commission approval.
Accordingly, NYSE Arca submits this proposed rule change to reflect the
rule changes to be implemented in connection with the Combination.
    For a description of the Combination and related rule changes
regarding NYSE Euronext, NYSE Group, and the Delaware Trust, see the
rule filing submitted by the New York Stock Exchange LLC (``NYSE'')
relating to the Combination (File Number SR-NYSE-2006-120) (the ``NYSE
Rule Filing'').\5\
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    \5\ See Securities Exchange Act Release No. 55026 (December 29,
2006), 72 FR 814 (January 8, 2007).
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    As a self-regulatory organization also owned by NYSE Group, the
Exchange is making reference in this proposed rule change to the
applicable matters described in the NYSE Rule Filing. In particular,
the NYSE Rule Filing describes the following matters:
     Corporate structure of NYSE Euronext following the
Combination. In particular, Arca Holdings will remain a wholly owned
subsidiary of NYSE Group. NYSE Arca Holdings, Inc., a Delaware
corporation (``NYSE Arca Holdings''), and NYSE Arca L.L.C., a Delaware
limited liability company (``NYSE Arca LLC''), will remain wholly owned
subsidiaries of Arca Holdings. NYSE Arca will remain a wholly owned
subsidiary of NYSE Arca Holdings and NYSE Arca Equities, Inc., a
Delaware corporation formerly known as PCX Equities, Inc. (``NYSE Arca
Equities''), will remain a wholly owned subsidiary of NYSE Arca. NYSE
Arca will continue to maintain its status as a registered national
securities exchange and self-regulatory organization. Arca Holdings'
businesses and assets will continue to be held by it and its
subsidiaries. Pursuant to a services agreement, NYSE Regulation will
perform many of the regulatory functions of NYSE Arca.
    There will be no change to the current manner of election or
appointment of the directors and officers of Arca Holdings, NYSE Arca
Holdings, NYSE Arca LLC, NYSE Arca or NYSE Arca Equities (or of the
Euronext exchanges) as a result of the Combination. The Combination
will have no effect on the ability of any party to trade securities on
NYSE Arca or NYSE Arca Equities.
     Board of directors and board committees of NYSE Euronext.
Specifically, in contrast to the current independence policy of NYSE
Group, the independence policy of NYSE Euronext will not provide as a
categorical matter that a person fails to be independent if he or she
is an executive officer of a foreign private issuer of securities
listed on the NYSE or NYSE Arca. The Exchange believes that this change
is important because NYSE Euronext will be a multinational company,
with European Persons comprising half of its initial directors, most of
whom will initially be former directors of Euronext. Euronext does not
prohibit executive officers of companies listed on Euronext exchanges
from serving as directors of Euronext because Euronext does not (and
NYSE Euronext will not) regulate these companies in the way that the
Exchange regulates its listed companies. The Exchange therefore
believes that a categorical requirement prohibiting all executive
officers of foreign private issuers listed on the NYSE on NYSE Arca
could preclude a large pool of otherwise highly qualified director
candidates from serving on the NYSE Euronext board of directors and is
not necessary.
    In addition, the director independence policy will contain a
transition period so that the independence requirements will not apply
to the European Persons on the NYSE Euronext board of directors until
the annual meeting of NYSE Euronext stockholders in 2008.
    Finally, in contrast to the current independence policy of NYSE
Group, the independence policy of NYSE Euronext will not provide as a
categorical matter that a person fails to be independent if he or she
is a director of an affiliate of a member organization

(which includes member organizations of NYSE (as defined in paragraph
(b) of Rule 2 of NYSE), OTP Firms of NYSE Arca (as defined in Rules
1.1(r) of NYSE Arca) and ETP Holders of NYSE Arca Equities, Inc. (as
defined in Rule 1.1(n) of NYSE Arca Equities, Inc.)).
    The independence policy of NYSE Euronext will require, however,
that (1) Executive officers of foreign private issuers (including, for
the avoidance of doubt, companies whose securities are listed on a
Euronext exchange), (2) executive officers of NYSE Euronext, (3) any
European Person on the NYSE Euronext board of directors who would not
satisfy the independence requirements in the independence policy but
for the transition period, and (4) any director of an affiliate of a
member organization, taken together, shall constitute no more than a
minority of the total number of directors of NYSE Euronext. In
addition, none of (1) An executive officer of an issuer whose
securities are listed on the NYSE or NYSE Arca (regardless of whether
such issuer is a foreign private issuer), (2) a European Person on the
NYSE Euronext board of directors who would not satisfy the independence
requirements in the independence policy but for the transition period,
or (3) any director of an affiliate of a member organization can
qualify as an independent director of the NYSE, NYSE Market or NYSE
Regulation. Consequently, the Exchange believes that the proposed
changes, when taken together, do not present significant concerns
regarding the independence of the board of NYSE Euronext.
     Management of NYSE Euronext.
     Voting and ownership limitations on the shares of NYSE
Euronext.
     Protection of the self-regulatory functions and
oversight.\6\
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    \6\ In particular, to facilitate compliance with the
requirements of Rule 17a-1(b) under the Exchange Act, NYSE Euronext
shall maintain in the United States originals or copies of
Overlapping Records (as defined in the NYSE Rule Filing) covered by
Rule 17a-1(b) promptly after creation of such Overlapping Records.
---------------------------------------------------------------------------

    The Exchange understands that the Commission is also concerned
about potential unfair competition and conflicts of interest between a
U.S. exchange's self-regulatory obligations and its commercial
interests that could exist if such exchange were to become affiliated
with one of its members, as well as the potential for unfair
competitive advantage that the affiliated member could have by virtue
of informational or operational advantages, or the ability to receive
preferential treatment.\7\ The Exchange acknowledges that ownership of,
or a control relationship with, a member organization by NYSE Euronext
or any of its subsidiaries would necessitate that the foregoing
concerns be first addressed with, and to the satisfaction of, the
Commission \8\ and/or, as appropriate, the European Regulators.
---------------------------------------------------------------------------

    \7\ See Securities Exchange Act Release No. 52497 (September 22,
2005), 70 FR 56949 (September 29, 2005) (File Number SR-PCX-2005-
90); and Securities Exchange Act Release No. 53382 (February 27,
2006), 71 FR 11251 (March 6, 2006) (File Number SR-NYSE-2005-77).
    \8\ We note that the Commission has specifically approved the
ownership and operation of the outbound router function of
Archipelago Securities by Archipelago, subject to the conditions
specified in Securities Exchange Act Release No. 52497.
---------------------------------------------------------------------------

     Provisions relating to the Delaware Trust and Dutch
Foundation, including:
     Administration of the Delaware Trust and Dutch Foundation,
     Material adverse changes in law,
     Remedies of the Dutch Foundation and Delaware Trust,
     Unwinding of remedies,
     Consequences of the exercise of remedies,
     Automatic suspension and repeal of certain provisions in
the NYSE Euronext organizational documents,
     Transfer of Foundation and Trust property,
     Submission to jurisdiction,
     Other duties,
     Initiatives by the Board of Trustees of the Delaware Trust
and the Board of Directors of the Foundation,
     Duration of the Dutch Foundation, and
     Term of the Delaware Trust.
     NYSE Group waiver of its ownership and voting limitations.
    In this regard, an extract with the relevant resolutions is
attached to this rule filing as Exhibit 5F.
    The Exchange hereby requests that the Commission allow NYSE
Euronext to wholly own and vote all of the outstanding common stock of
NYSE Group, either alone or with its related persons, except for any
related person of NYSE Euronext which is an ETP Holder of NYSE Arca
Equities, OTP Holder or OTP Firm of NYSE Arca, or member or member
organization of the NYSE, upon the consummation of the Combination.
     Regulation following the Combination.
     Changes to the organizational documents of NYSE Group.
    In addition, Article Fourth of the Certificate of Incorporation of
Arca Holdings is being amended to provide for voting or ownership of
the shares of stock of Arca Holdings by the Delaware Trust pursuant to
the terms and conditions of the Trust Agreement by and among NYSE
Euronext, Inc., NYSE Group, Inc. and the trustees and Delaware trustee
thereto.\9\
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    \9\ See proposed Amended and Restated Certificate of
Incorporation of Arca Holdings., Article Fourth (C)(1) and (D)(1).
---------------------------------------------------------------------------

    The proposed rule change, if approved by the Commission, will not
be operative until the consummation of the Combination.
2. Statutory Basis
    The Exchange believes that this filing is consistent with Section
6(b)(1) of the Exchange Act,\10\ in general, and furthers the
objectives of Section 6(b)(1) in particular, in that it enables the
Exchange to be so organized as to have the capacity to be able to carry
out the purposes of the Exchange Act and to comply, and to enforce
compliance by its exchange members and persons associated with its
exchange members, with the provisions of the Exchange Act, the rules
and regulations thereunder, and the rules of the Exchange. The Exchange
also believes that this filing furthers the objectives of Section
6(b)(5) of the Exchange Act \11\ because the rules summarized herein
would create a governance and regulatory structure that is designed to
prevent fraudulent and manipulative acts and practices, to promote just
and equitable principles of trade, to remove impediments to, and
perfect the mechanism of a free and open market and a national market
system and, in general, to protect investors and the public interest.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78f(b)(1).
    \11\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change would
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Exchange Act.

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

    The Exchange has neither solicited nor received written comments on
the proposed rule change.

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

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) As the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory

organization consents, the Commission will:
    (A) By order approve such proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be 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 e-mail to<EMAIL_ADDRESS>Please include

File Number SR-NYSEArca-2007-05 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEArca-2007-05. 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 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-NYSE-2007-05 and should be submitted on or before
February 5, 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. E7-754 Filed 1-18-07; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 115 (Thursday, June 14, 2018)]
[Notices]
[Page 27807]
[FR Doc No: 2018-12753]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-83398; File No. SR-FINRA-2018-013]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Designation of Longer Period for Commission
Action on a Proposed Rule Change To Establish a Second Trade Reporting
Facility in Conjunction With Nasdaq, Inc.

June 8, 2018.
    On April 19, 2018, the Financial Industry Regulatory Authority,
Inc. (``FINRA'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to establish a second Trade Reporting Facility to
be operated in conjunction with Nasdaq, Inc. The proposed rule change
was published for comment in the Federal Register on April 26, 2018.\3\
The Commission received no comment letters on the proposal.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 83082 (April 20,
2018), 83 FR 18379 (``Notice'').
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \4\ provides that, within 45 days of
the publication of the notice of the filing of a proposed rule change,
or within such longer period up to 90 days as the Commission may
designate if it finds such longer period to be appropriate and
publishes its reasons for so finding or as to which the self-regulatory
organization consents, the Commission shall either approve the proposed
rule change, disapprove the proposed rule change, or institute
proceedings to determine whether the proposed rule change should be
disapproved. The 45th day for this filing is June 10, 2018. The
Commission is extending this 45-day time period.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    The Commission has determined that it is appropriate to designate a
longer period within which to take action on the proposed rule change
so that it has sufficient time to consider the issues raised by the
proposed rule change. Accordingly, pursuant to Section 19(b)(2) of the
Act,\5\ the Commission designates July 25, 2018, as the date by which
the Commission shall either approve, disapprove, or institute
proceedings to determine whether to disapprove the proposed rule change
(File No. SR FINRA-2018-013).
---------------------------------------------------------------------------

    \5\ Id.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
---------------------------------------------------------------------------

    \6\ 17 CFR 200.30-3(a)(31).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-12753 Filed 6-13-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 158 (Tuesday, August 16, 2011)]
[Notices]
[Pages 50740-50741]
[FR Doc No: 2011-20727]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0514]

Draft Guidance for Industry and Food and Drug Administration
Staff; Procedures for Handling Section 522 Postmarket Surveillance
Studies; 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 ``Procedures for Handling
Section 522 Postmarket Surveillance Studies.'' This guidance document
is intended to assist device manufacturers subject to a section 522
postmarket surveillance order imposed by FDA by providing an overview
of section 522 of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act), procedural information on how to fulfill section 522 obligations,
and recommendations on the format, content, and review of postmarket
surveillance study submissions. 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 November 14, 2011.

ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Procedures for Handling Section 522
Postmarket Surveillance Studies'' 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 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: Mary Beth Ritchey, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 4115, Silver Spring, MD 20993-0002, 301-
96-6638.

SUPPLEMENTARY INFORMATION:

I. Background

    Postmarket surveillance under section 522 of the FD&C Act (21
U.S.C. 306l) is one means by which FDA can obtain additional
information when it is necessary to protect the public health or
provide safety and/or effectiveness data for a device after it has been
cleared or approved. The Food and Drug Administration Amendments Act of
2007 amended section 522 of the FD&C

Act to expand the situations in which FDA may order postmarket
surveillance and allow longer surveillance periods in certain
circumstances. This guidance document is intended to assist device
manufacturers subject to a section 522 postmarket surveillance order by
providing an overview of section 522 of the FD&C Act, procedural
information on how to fulfill section 522 obligations, and
recommendations on the format, content, and review of postmarket
surveillance study submissions.

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 ``Procedures
for Handling Section 522 Postmarket Surveillance Studies.'' 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
``Procedures for Handling Section 522 Postmarket Surveillance Studies''
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 301-847-
8149 to receive a hard copy. Please use the document number 1754 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. 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 822 have been approved under
OMB control number 0910-0449.

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: August 10, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-20727 Filed 8-15-11; 8:45 am]
BILLING CODE 4160-01-P