[Federal Register: March 30, 2006 (Volume 71, Number 61)]
[Notices]
[Page 16140]
[DOCID:fr30mr06-57]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

March 24, 2006.
    Take notice that the Commission received the following electric
rate filings.

    Docket Numbers: ER06-255-002.
    Applicants: Midwest Independent Transmission System.
    Description: Midwest Independent Transmission System Operator Inc
submits a Large Generator Interconnection Agreement among FirstEnergy
Generation Corp and American Transmission System, Inc.
    Filed Date: 03/15/2006.
    Accession Number: 20060324-0039.
    Comment Date: 5 p.m. Eastern Time on Wednesday, April 05, 2006.

    Docket Numbers: ER06-757-000.
    Applicants: Eastman Cogeneration L.P.
    Description: Application for blanket authorization, certain waivers
and order approving rate schedule on behalf of Eastman Cogeneration,
LP.
    Filed Date: 03/16/2006.
    Accession Number: 20060324-0017.
    Comment Date: 5 p.m. Eastern Time on Thursday, April 06, 2006.

    Docket Numbers: ER06-758-000.
    Applicants: Chambers Cogeneration, Limited Partnership.
    Description: Petition of Chambers Cogeneration, LP for order
accepting market-based rate schedule for filing and granting waivers of
blanket approvals.
    Filed Date: 03/16/2006.
    Accession Number: 20060324-0018.
    Comment Date: 5 p.m. Eastern Time on Thursday, April 06, 2006.

    Docket Numbers: ER06-759-000.
    Applicants: Selkirk Cogen Partners, L.P.
    Description: Petition of Selkirk Cogen Partners, LP for order
accepting market-based rate schedule for filing and granting waivers
and blanket approvals.
    Filed Date: 03/16/2006.
    Accession Number: 20060324-0019.
    Comment Date: 5 p.m. Eastern Time on Thursday, April 06, 2006.

    Docket Numbers: ER06-760-000.
    Applicants: North American Energy Credit and Clearing--Risk
Management LLC.
    Description: North American Energy Credit & Clearing--Risk
Management LLC submits its petition for acceptance of initial rate
schedule, waivers and blanket authority.
    Filed Date: 03/15/2006.
    Accession Number: 20060324-0020.
    Comment Date: 5 p.m. Eastern Time on Wednesday, April 05, 2006.

    Docket Numbers: ER06-761-000.
    Applicants: Rumford Paper Company.
    Description: Rumford Paper Company submits its Petition for Market-
Based Rate Authority and Acceptance of Initial Rate Schedule.
    Filed Date: 03/16/2006.
    Accession Number: 20060324-0022.
    Comment Date: 5 p.m. Eastern Time on Thursday, April 06, 2006.

    Docket Numbers: ER06-764-000.
    Applicants: The Premcor Refining Group Inc.
    Description: The Premcor Refining Group, Inc., submitted an
application for market-based authorization and request for waivers and
blanket authorizations.
    Filed Date: 03/16/2006.
    Accession Number: 20060324-0024.
    Comment Date: 5 p.m. Eastern Time on Thursday, April 06, 2006.

    Docket Numbers: ER06-769-000.
    Applicants: New York Independent System Operator, Inc.
    Description: New York Independent System Operator Inc submits
revisions to its OATT and its Market Administration and Control Area
Services Tariff.
    Filed Date: 03/17/2006.
    Accession Number: 20060324-0050.
    Comment Date: 5 p.m. Eastern Time on Friday, April 07, 2006.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern Time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov.
 To facilitate electronic service, persons with Internet

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

Magalie R. Salas,
Secretary.
[FR Doc. E6-4656 Filed 3-29-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: January 8, 2008 (Volume 73, Number 5)]
[Notices]
[Page 1342-1343]
[DOCID:fr08ja08-59]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. ER08-200-000; ER08-200-001]

Waterbury Generation, LLC; Notice of Issuance of Order

December 27, 2007.
    Waterbury Generation, LLC (Waterbury) filed an application for
market-based rate authority, with an accompanying market-based rate
tariff. The proposed market-based rate tariff provides for the sale of
energy, capacity and ancillary services at market-based rates.
Waterbury also requested waivers of various Commission regulations. In
particular, Waterbury requested that the Commission grant blanket
approval under 18 CFR part 34 of all future issuances of securities and
assumptions of liability by Waterbury.
    On December 26, 2007, pursuant to delegated authority, the
Director, Division of Tariffs and Market Development--West, granted the
requests for blanket approval under part 34 (Director's Order). The
Director's Order also stated that the Commission would publish a
separate notice in the Federal Register establishing a period of time
for the filing of protests. Accordingly, any person desiring to be
heard concerning the blanket approvals of issuances of securities or
assumptions of liability by Waterbury, should file a protest with the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426, in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure. 18 CFR 385.211, 385.214
(2007).
    Notice is hereby given that the deadline for filing protests is
January 28, 2008.
    Absent a request to be heard in opposition to such blanket
approvals by the deadline above, Waterbury is authorized to issue
securities and assume obligations or liabilities as a guarantor,
indorser, surety, or otherwise in respect of any security of another
person; provided that such issuance or assumption is for some lawful
object within the corporate purposes of Waterbury, compatible with the
public interest, and is reasonably necessary or appropriate for such
purposes.
    The Commission reserves the right to require a further showing that
neither public nor private interests will be adversely affected by
continued approvals of Waterbury's issuance of securities or
assumptions of liability.

    Copies of the full text of the Director's Order are available from
the Commission's Public Reference Room, 888 First Street, NE.,
Washington, DC 20426. The Order may also be viewed on the Commission's
Web site at http://www.ferc.gov, using the eLibrary link. Enter the

docket number excluding the last three digits in the docket number
filed to access the document. Comments, protests, and interventions may
be filed electronically via the internet in lieu of paper. See, 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. The Commission strongly encourages
electronic filings.

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-60 Filed 1-7-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: December 20, 2007 (Volume 72, Number 244)]
[Notices]
[Page 72424-72426]
[DOCID:fr20de07-103]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-56969; File No. SR-Amex-2007-53]

Self-Regulatory Organizations; American Stock Exchange LLC; Order
Granting Accelerated Approval of a Proposed Rule Change, as Modified by
Amendment Nos. 1, 2, and 3 Thereto, and Notice of Amendment No. 3 to
the Proposed Rule Change Relating to the Listing and Trading of the
GreenHaven Continuous Commodity Index Fund

 December 14, 2007.
    On May 29, 2007, the American Stock Exchange LLC (``Amex'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') a proposed rule change pursuant to Section 19(b)(1) of
the Securities Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4
thereunder \2\ list and trade shares (``Shares'') of the GreenHaven
Continuous Commodity Index Fund (``Fund'') pursuant to Commentary .07
to Amex Rule 1202. On July 31, 2007, Amex filed Amendment No. 1 to the
proposed rule change, and on November 16, 2007, Amex filed Amendment
No. 2 to the proposed rule change. The proposed rule change, as
amended, was published for comment in the Federal Register on November
26, 2007 for a 15-day comment period.\3\ The Commission did not receive
any comments regarding the proposal. On December 13, 2007, Amex filed
Amendment No. 3 to the proposed rule change.\4\ This order approves the
proposed rule change, as modified by Amendment Nos. 1, 2, and 3
thereto, on an accelerated basis. Simultaneously, the Commission is
providing notice of and soliciting comments from interested persons
regarding Amendment No. 3.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 56802 (November 16,
2007), 72 FR 65994 (``Notice'').
    \4\ Amendment No. 3 would amend the proposed rule change by: (a)
Clarifying that only Reuters determines the composition of the Index
(defined infra), and stating that Reuters: (i) considers information
about changes to the Index and related matters to be potentially
market-moving, material, and confidential; and (ii) has policies and
procedures in place to ensure to prevent the use and dissemination
of such information; (b) stating that the Web sites for the Fund
and/or the Exchange will disseminate information the information
discussed infra (including the composition of the portfolio of the
Fund) to everyone at the same time; (c) adding information
concerning halting of trading in the Shares; (d) adding information
about applicable existing rules that would govern specialists'
potential conflicts of interest; and (e) stating that the
Information Circular (described infra) would discuss the regulatory
jurisdiction over the physical trading of commodities or the futures
contracts on which the value of the Shares is based, and that there
is no regulated source of last sale information regarding physical
commodities.
    The text of Amendment No. 3 to the proposed rule change is
available at the Commission's Public Reference Room, at the
Exchange, and at http://www.amex.com.

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I. Description

    As described in the Exchange's proposal,\5\ the Fund's primary
investment objective is to reflect the performance of the Continuous
Commodity Total Return Index (the ``Index'' or ``CCI-TR''), over time,
less the expenses of the operations of the Fund and the Master Fund.
The Master Fund will invest in a portfolio of exchange-traded futures
(``Commodity Futures Contracts'') on the commodities comprising the
Index.\6\
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    \5\ Substantially all of the assets of the Fund will be invested
in the Master Fund. For a more detailed description of the Fund and
Master Fund, including their structure, holdings, applicable
exchange listing and trading rules, disclosure of pricing
information, surveillance, and other regulation, see Notice at
65997-66001. Terms not otherwise defined herein have the same
meaning as the meaning given in the Notice.
    \6\ For information regarding the Commodity Futures Contracts,
see Notice at 65996-65997.
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    GreenHaven Commodity Services LLC, a Delaware limited liability
company, will serve as Managing Owner of the Fund and the Master Fund.
The Managing Owner will serve as the commodity pool operator and
commodity trading advisor of the Fund and the Master Fund. The Managing
Owner is registered as a commodity pool operator and commodity trading
advisor with the Commodity Futures Trading Commission (``CFTC'') and
with the National Futures Association (``NFA'').\7\
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    \7\ As a registered commodity pool operator and commodity
trading advisor with respect to both the Fund and the Master Fund,
the Managing Owner is required to comply with various regulatory
requirements under the Commodity Exchange Act and the rules and
regulations of the CFTC and the NFA, including investor protection
requirements, antifraud prohibitions, disclosure requirements, and
reporting and recordkeeping requirements.
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II. Commission Findings and Accelerated Approval

    After careful review, the Commission finds that the proposed rule
change is consistent with the requirements of the Act and the rules and
regulations thereunder applicable to a national securities exchange.\8\
In particular, the Commission finds that the proposed rule change is
consistent with Section 6(b)(5) of the Act,\9\ which requires that the
rules of an exchange be designed, among other things, 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.
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    \8\ In approving this proposed rule change, the Commission notes
that it has considered the proposed rule's impact on efficiency,
competition, and capital formation. See 15 U.S.C. 78c(f).
    \9\ 15 U.S.C. 78f(b)(5).
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    The Commission also finds that the proposal is consistent with
Section 11A(a)(1)(C)(iii) of the Act,\10\ which sets forth Congress'
finding that it is in the public interest and appropriate for the
protection of investors and the maintenance of fair and orderly markets
to assure the availability to brokers, dealers, and investors of
information with respect to quotations for and transactions in
securities. The Exchange represents that futures contract quotes and
last sale information for the Commodity Futures Contracts are widely
disseminated through a variety of market data vendors worldwide,
including Bloomberg and Reuters. In addition, the Exchange further
represents that complete real-time data for the Commodity Futures
Contracts is available by subscription from Reuters and Bloomberg. The
relevant futures exchanges also provide delayed futures information on
current and past trading sessions and market news free of charge on
their respective Web sites. The specific contract specifications for
each Commodity Futures Contract are also available from the various
futures exchanges on their Web sites as well as other financial
informational sources. Further, the Web sites for the Fund and/or the
Exchange, which are publicly accessible at no charge, will disseminate
the following information to everyone at the same time: (a) The current
NAV per Share daily and the prior business day's NAV per Share and the
reported closing price; (b) the mid-point of the bid-ask price in
relation to the NAV per Share as of the time it is calculated (the
``Bid-Ask Price''); (c) calculation of the premium or discount of such
price against the NAV per Share; (d) data in chart form displaying the
frequency distribution of discounts and premiums of the Bid-Ask Price
against the NAV per Share, within appropriate ranges for each of the
four previous calendar quarters; (e) the Prospectus; (f) the
composition of the portfolio of the Fund; and (g) other applicable
quantitative information.
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    \10\ 15 U.S.C. 78k-1(a)(1)(C)(iii).
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    The Commission believes that the proposal to list and trade Shares
is reasonably designed to promote fair disclosure of information that
may be necessary to price the Shares appropriately. The Commission
notes that the Exchange will obtain from the Fund, prior to listing the
Shares, a representation that the NAV per Share will be calculated
daily and made available to all market participants at the same time.
In addition, as mentioned above, the Exchange represents that the Web
site disclosure of the portfolio composition of the Fund will be made
to all market participants at the same time. Moreover, the Exchange
states that: (1) Only Reuters determines the composition of the Index;
and (2) Reuters (a) considers information about changes to the Index
and related matters to be potentially market-moving, material, and
confidential, and (b) has policies and procedures in place to ensure to
prevent the use and dissemination of such information. Further, the
trading of the Shares would subject to certain conflict of interest
provisions set forth in Commentary .07(e) to Amex Rule 1202.\11\
Additionally, Commentary .07(g)(3) to Amex Rule 1202 prohibits the
specialist in the Shares from using any material nonpublic information
received from any person associated with a member, member organization
or employee of such person regarding trading by such person or employee
in the Index commodities, related futures or options on futures, or any
other related derivatives.
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    \11\ Specifically, Commentary .07(e) provides that the
prohibitions in Rule 175(c) apply to a specialist in the Shares so
that the specialist or affiliated person may not act or function as
a market maker in an underlying asset, related futures contract or
option or any other related derivative. An affiliated person of the
specialist consistent with Rule 193 may be afforded an exemption to
act in a market making capacity, other than as a specialist in the
Shares on another market center, in the underlying asset, related
futures or options or any other related derivative. Commentary
.07(e) further provides that an approved person of an equity
specialist that has established and obtained Exchange approval for
procedures restricting the flow of material, non-public market
information between itself and the specialist member organization,
and any member, officer, or employee associated therewith, may act
in a market making capacity, other than as a specialist in the
Shares on another market center, in the underlying asset or
commodity, related futures or options on futures, or any other
related derivatives.
    Commentary .07(e) to Rule 1202 also ensures that specialists
handling the Shares provide the Exchange with all the necessary
information relating to their trading in physical assets or
commodities, related futures contracts and options thereon or any
other derivative.
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    The Commission also believes that the Exchange's trading halt rules
are reasonably designed to prevent trading in the Shares when
transparency is impaired. The Exchange states that trading in the
Shares will be halted in the event the market volatility halt
parameters set forth in Amex Rule 117 have been reached. The Exchange
also states that it will halt trading in the Shares if trading in the
Commodity Futures Contracts is halted or suspended. Additionally, if
the value of the Index or the Indicative Fund Value is not being
disseminated on at least a 15-second basis during the hours the Shares
trade on the Exchange, the Exchange may halt trading during the day in
which the interruption to the dissemination of the value of the Index
or the Indicative Fund Value occurs. If the interruption to the
dissemination the value of the Index or the Indicative Fund Value
persists past the trading day in which it occurred, the Exchange will
halt trading no later than the beginning of the trading day following
the interruption. Further, with respect to a halt in trading that is
not specified above, the Exchange may consider other relevant factors
and the existence of unusual conditions or circumstances that may be
detrimental to the maintenance of a fair and orderly market.
    The Commission further believes that the trading rules and
procedures to which the Shares will be subject pursuant to this
proposal are consistent with the Act. The Exchange has represented that
the Shares are equity securities subject to Amex's rules governing the
trading of equity securities.
    In support of this proposal, the Exchange has made the following
representations:
    (1) The Exchange's surveillance procedures are adequate to properly
monitor the trading of the Shares. Specifically, Amex will rely on its
existing surveillance procedures governing Trust Issued Receipts,
Portfolio Depository Receipts and Index Fund Shares. The Exchange
states that it currently has in place comprehensive surveillance
sharing agreements with the InterContinental Exchange, the London
Metals Exchange, and the New York Mercantile Exchange for the purpose
of providing information in connection with trading in or related to
futures contracts traded on their respective exchanges comprising the
Indexes. The Exchange also notes that the Chicago Board Options
Exchange, Chicago Mercantile Exchange, and New York Board Of Trade are
members of the Intermarket Surveillance Group. As a result, the
Exchange asserts that market surveillance information is available from
relevant futures exchanges, if necessary, due to regulatory concerns
that may arise in connection with the Commodity Futures Contracts.
    (2) Prior to the commencement of trading, the Exchange will inform
its members and member organizations in an Information Circular
regarding the prospectus delivery requirements

applicable to the Shares. The Information Circular also will highlight
the special risks and characteristics of the Fund and Shares, as well
as applicable Exchange rules. In addition, the Information Circular
will also reference the fact that there is no regulated source of last
sale information regarding physical commodities and discuss the
relevant regulatory jurisdiction over the trading of physical
commodities or the futures contracts on which the value of the Shares
is based.

This approval order is based on the Exchange's representations.
    The Commission finds good cause, pursuant to Section 19(b)(2) of
the Act,\12\ for approving the proposed rule change, as modified by
Amendment Nos. 1, 2, and 3, prior to the 30th day after the date of
publication of notice in the Federal Register. Amendment No. 3 made
only minor changes to the overall proposal, which was subject to a 15-
day comment period.\13\ The Commission notes that the present proposal,
as amended, is similar to prior proposals that the Commission has
approved,\14\ and is consistent with current Amex listing requirements.
The Commission does not believe that the proposed rule change, as
modified by Amendment Nos. 1, 2, and 3, raises any novel regulatory
issues. Consequently, the Commission believes that it is appropriate to
permit investors to benefit from these additional investment choices
without delay. Accordingly, the Commission finds that there is good
cause, consistent with Section 6(b)(5) of the Act,\15\ to approve the
proposal, as modified by Amendment Nos. 1, 2, and 3, on an accelerated
basis.
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    \12\ 15 U.S.C. 78s(b)(2).
    \13\ As mentioned above, the Commission did not receive any
comments regarding the proposed rule change and Amendment Nos. 1 and
2 following publication in the Federal Register.
    \14\ See, e.g., Securities Exchange Act Release No. 55632 (April
13, 2007), 72 FR 19987 (April 20, 2007) (SR-Amex-2006-112)
(approving the listing and trading of the United States Natural Gas
Fund, LP); Securities Exchange Act Release No. 53582 (March 31,
2006), 71 FR 17510 (April 6, 2006) (SR-Amex 2005-127) (approving the
listing and trading of the United States Oil Fund, LP); and
Securities Exchange Act Release No. 53105 (January 11, 2006), 71 FR
3129 (January 19, 2006) (SR-Amex 2005-059) (approving the listing
and trading of the DB Commodity Index Tracking Fund).
    \15\ 15 U.S.C. 78f(b)(5).
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III. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning Amendment No. 3, including whether it 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-Amex-2007-53 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-Amex-2007-53. 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, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 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-Amex-2007-53 and should be
submitted on or before January 4, 2008.

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\16\ that the proposed rule change (SR-Amex-2007-53), as modified
by Amendment Nos. 1, 2, and 3 thereto, be, and it hereby is, approved
on an accelerated basis.
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    \16\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
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    \17\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. E7-24729 Filed 12-19-07; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register: December 16, 2005 (Volume 70, Number 241)]
[Notices]
[Page 74798-74800]
[DOCID:fr16de05-56]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. EG06-13-000 et al.]

ANP ERCOT Acquisiton, LLC, et al.; Electric Rate and Corporate
Filings

December 9, 2005-12-13
    The following filings have been made with the Commission. The
filings are listed in ascending order within each docket
classification.

ANP ERCOT Acquisition, LLC, Docket Nos. EG06-13-000
ANP ERCOT Development, LLC, EG06-14-000
ANP NE Acquisition, LLC, EG06-15-000
ANP NE Development, LLC, EG06-16-000
ANP PJM Acquisition, LLC, EG06-17-000
ANP PJM Development, LLC, EG06-18-000
ANP Acquisition, LLC, EG06-19-000
ANP Development, LLC, EG06-20-000
ANP Operations II, LLC, EG06-21-000

    Take notice that on December 2, 2005, the above listed ANP Entities
(Applicants) pursuant to section 32(a)(1) of the Public Utility Holding
Company Act of 1935 hereby submit for filing their Applications for
Determination of Exempt Wholesale Generator Status.

    Applicants state that they are a Delaware limited liability company
with its principal place of business in Marlborough, Massachusetts and
its sole purpose of each facilities will be used for the generation of
electric energy exclusively for sale at wholesale.
    Comment Date: 5 p.m. Eastern Time on December 23, 2005.

 2. California Independent System Operator

[Docket Nos. ER04-115-005, EL04-47-005, ER04-242-004, ER05-367-002,
EL04-50-003]

    Take notice that on November 30, 2005, the California Independent
System Operator (CA ISO) in compliance to ``Order Approving Uncontested
Settlement'' issued on September 22, 2005, CA ISO provides details of
refunds in Attachment A.
    Comment Date: 5 p.m. Eastern Time on December 21, 2005.

3. Knedergy LLC

[Docket No. ER06-250-000]

    Take notice that on November 28, 2005, Knedergy LLC tendered for
filing a Petition for Acceptance of initial Rate Schedule, Waivers, and
Blanket Authority for Rate Schedule FERC No. 1.
    Comment Date: 5 p.m. Eastern Time on December 19, 2005.

4. Southern California Edison Company

[Docket No. ER06-259-000]

    Take notice that on November 30, 2005, Southern California Edison
Company (SCE) tenders for filing revisions to it Transmission Owner
tariff, FERC Electric Tariff, Second Revised Volume No. 6, and to
certain Existing Transmission Contracts to reflect a change to SCE's
Reliability Services Rates.
    Comment Date: 5 p.m. Eastern Time on December 21, 2005.

5. California Independence System Operator Corporation

[Docket No. ER06-54-001]

    Take notice that on November 29, 2005, the California Independent
System Operator Corporation (ISO) tendered for filing Attachment A,
signature page, to the filing submitted on October 19, 2005.
    Comment Date: 5 p.m. Eastern Time on December 19, 2005.

6. DTE Energy Trading, Inc.

[Docket No. EC06-30-000]

    Take notice that on November 23, 2005, DTE Energy Trading, Inc.
(DTE-ET) tendered for filing an Application for Authorization under
section 203 of the Federal Power Act and as amended on November 28,
2005. DTE-ET requests Commission authorization to dispose of
jurisdictional facilities by way of an assignment of the rights,
obligations and interest in certain of its wholesale electric power
sales agreement and associated books and records to Morgan Stanley
Capital Group Inc.
    Comment Date: 5 p.m. Eastern Time on December 20, 2005.

7. Ameren Services Company

[Docket Nos. EC06-35-000 and ES06-17-000]

    Take notice that on December 7, 2005, Ameren Services Company
(Ameren Services) tendered for filing an application on behalf of
itself and its associate companies, Union Electric Company (d/b/a
AmerenUE), Central Illinois Public Service Company (d/b/a AmerenCIPS),
Central Illinois Light Company (d/b/a AmerenCILCO), Illinois Power
Company (d/b/a Ameren IP), CILCORP Inc., Ameren Energy Resources
Company, AmerenEnergy Resources Generating Company (f/k/a Central
Illinois Generation, Inc.), Ameren Energy Generating Company (AEG),
Ameren Energy Development Company, Ameren Energy Marketing Company,
AmerenEnergy Medina Valley Cogen (No. 2), L.L.C., Ameren Energy Medina
Valley Cogen, (No. 4) L.L.C., AmerenEnergy Median Valley Cogen, L.L.C.,
Electric Energy, Inc., and Ameren Corporation (collectively the
Applicants) for an order pursuant to section 204 of the Federal Power
Act authorizing AmerenUE, AmerenCIPS, AmerenCILCO and AEG (the section
204 Applicants) to issue short-term debt securities, for AEG to issue
long-term debt securities, and for the section 204 Applicants to
receive cash capital contributions and non-interest bearing open
account advances from their respective parents. The Applicants also
request pursuant to section 203 of the Federal Power Act, an order
granting blanket authorization for the Applicants to acquire
securities.
    Comment Date: 5 p.m. Eastern Time on December 28, 2005.

8. San Diego Gas & Electric Company and Pacific Gas and Electric
Company

[Docket Nos. EL00-95-170 and EL00-98-156]

    Take notice that on December 1, 2005, Pacific Gas and Electric
Company (PG&E) submitted compliance filing pursuant to a Commission
Order issued August 8, 2005. PG&E states that this filing addresses
outstanding disputes that are specific to PG&E and is being submitted
to the Commission in conjunction with a contemporaneous pleading filed
by certain California parties to address further disputes relating to
offsets and market re-runs.
    Comment Date: 5 p.m. Eastern Time on January 3, 2006.

9. City of Azusa, California

[Docket No. EL06-23-000]

    Take notice that on December 2, 2005, City of Azusa, California
(Azusa) submitted for filing its third annual revision to it
Transmission Revenue Balancing Account Adjustment Azusa request an
effective date of January 1, 2006.
    Comment Date: 5 p.m. Eastern Time on January 3, 2006.

10. Midwest Independent Transmission System Operator, Inc.

[Docket No. ER02-2458-006]

    Take notice that on December 1, 2005, Midwest Independent
Transmission System Operator, Inc. submitted for filing an amended
contested settlement agreement.
    Comment Date: 5 p.m. Eastern Time on December 19, 2005.

11. National Grid plc and National Grid USA

[Docket Nos. ES06-9-000, EC06-34-000, EL06-22-000]

    Take notice that on December 2, 2005, National Grid plc and
National Grid USA (collectively, Applicants) submited for filing an
application and petition on behalf of themselves and certain of their
subsidiaries and affiliates, to issue securities under section 204 of
the Federal Power Act and part 34 of the Commission's regulations and
authorization to acquire securities and for limited intra-family
mergers and reorganization under section 203 of the Federal Power Act
and part 33 of the Commission's regulations.
    Comment Date: 5 p.m. Eastern Time on December 23, 2005.

Standard Paragraph

    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy

of that document on the Applicant and all the parties in this
proceeding.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
[FR Doc. E5-7422 Filed 12-15-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 242 (Tuesday, December 19, 2023)]
[Notices]
[Pages 87830-87832]
[FR Doc No: 2023-27786]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-99162; File No. SR-CboeBZX-2023-105]

Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To Amend
BZX Rule 14.11(e)(4)(C)(i) (Commodity-Based Trust Shares)

December 13, 2023.
    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 December

12, 2023, Cboe BZX Exchange, Inc. (``Exchange'' or ``BZX'') 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 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.
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Cboe BZX Exchange, Inc. (``BZX'' or the ``Exchange'') is filing
with the Securities and Exchange Commission (``Commission'' or ``SEC'')
a proposed rule change to (1) to amend Exchange Rule 14.11(e)(4)(C)(i)
(``Commodity-Based Trust Shares''); and (2) amend 14.11(e)(4)(C)(ii) to
state that the term ``commodity'' is defined in section 1a(9) of the
Commodity Exchange Act.
    The text of the proposed rule change is also available on the
Exchange's website (http://markets.cboe.com/us/equities/regulation/rule_filings/bzx/), 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 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 the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes (1) to amend Exchange Rule 14.11(e)(4)(C)(i)
(``Commodity-Based Trust Shares''); and (2) to amend 14.11(e)(4)(C)(ii)
to state that the term ``commodity'' is defined in section 1a(9) of the
Commodity Exchange Act. The proposed rules are identical to NYSE Arca,
Inc. (``Arca'') Rules 8.201-E(c)(1) and (2), respectively.\5\
---------------------------------------------------------------------------

    \5\ See Securities and Exchange Act Nos. 89310 (July 14, 2020)
85 FR 43932 (July 20, 2020) (SR-NYSEArca-2020-59) (Notice of Filing
of Proposed Rule Change To Amend NYSE Arca Rule 8.201-E (Commodity-
Based Trust Shares) and To Permit the Listing and Trading of Shares
of the United States Gold and Treasury Investment Trust Under NYSE
Arca Rule 8.201-E); 90216 (October 16, 2020) 85 FR 67401 (October
22, 2020) (Order Granting Accelerated Approval of a Proposed Rule
Change, as Modified by Amendment No. 3, To Amend NYSE Arca Rule
8.201-E (Commodity-Based Trust Shares) and To Permit the Listing and
Trading of Shares of the Wilshire [w]Shares Enhanced Gold Trust
Under Amended NYSE Arca Rule 8.201-E).
---------------------------------------------------------------------------

    Under Exchange Rule 14.11(e)(4), the Exchange may propose to list
and/or trade pursuant to UTP ``Commodity-Based Trust Shares.'' \6\ Rule
14.11(e)(4)(C)(1) currently states that such securities are issued by a
trust in a specified aggregate minimum number in return for a deposit
of a quantity of the underlying commodity, and that, when aggregated in
the same specified minimum number, may be redeemed at a holder's
request by such trust which will deliver to the redeeming holder the
quantity of the underlying commodity.
---------------------------------------------------------------------------

    \6\ Commodity-Based Trust Shares are securities issued by a
trust that represents investors' discrete identifiable and undivided
beneficial ownership interest in the commodities deposited into the
Trust. Rule 14.11(e)(4)(C)(i) defines the term ``Commodity-Based
Trust Shares'' as follows: the term ``Commodity-Based Trust Shares''
means a security (a) that is issued by a trust (``Trust'') that
holds a specified commodity deposited with the Trust; (b) that is
issued by such Trust in a specified aggregate minimum number in
return for a deposit of a quantity of the underlying commodity; and
(c) that, when aggregated in the same specified minimum number, may
be redeemed at a holder's request by such Trust which will deliver
to the redeeming holder the quantity of the underlying commodity.
---------------------------------------------------------------------------

    The Exchange proposes to amend Rule 14.11(e)(4)(C)(1) to provide:
the term ``Commodity-Based Trust Shares'' means a security (a) that is
issued by a trust (``Trust'') that holds (1) a specified commodity
deposited with the Trust, or (2) a specified commodity and, in addition
to such specified commodity, cash; (b) that is issued by such Trust in
a specified aggregate minimum number in return for a deposit of a
quantity of the underlying commodity and/or cash; and (c) that, when
aggregated in the same specified minimum number, may be redeemed at a
holder's request by such Trust which will deliver to the redeeming
holder the quantity of the underlying commodity and/or cash. Given the
competitive marketplace for exchange listings, the Exchange is
conforming its listing rules to that of another exchange.\7\
---------------------------------------------------------------------------

    \7\ See Arca Rule 8.201-E(c)(1).
---------------------------------------------------------------------------

    The Exchange further proposes to amend Rule 14.11(e)(4)(C)(ii) to
state that the term ``commodity'' is defined in section 1a(9) of the
Commodity Exchange Act (rather than section 1(a)(4) as currently
referenced in Rule 14.11(e)(4)(C)(ii)) to reflect an amendment to the
Commodity Exchange Act included in the Dodd-Frank Wall Street Reform
and Consumer Protection Act of 2010.\8\
---------------------------------------------------------------------------

    \8\ Public Law 111-203, 124 Stat. 1900 (2010).
---------------------------------------------------------------------------

    Last, the Exchange proposes to correct ministerial errors in Rule
14.11(e)(4)(C)(ii) to remove several errant parentheses.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Act and the rules and regulations thereunder applicable to the
Exchange and, in particular, the requirements of section 6(b) of the
Act.\9\ Specifically, the Exchange believes the proposed rule change is
consistent with the section 6(b)(5) \10\ requirements that the rules of
an exchange be 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 regulating,
clearing, settling, processing information with respect to, and
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.
Additionally, the Exchange believes the proposed rule change is
consistent with the section 6(b)(5) \11\ requirement that the rules of
an exchange not be designed to permit unfair discrimination between
customers, issuers, brokers, or dealers.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78f(b).
    \10\ 15 U.S.C. 78f(b)(5).
    \11\ Id.
---------------------------------------------------------------------------

    As noted above, the marketplace for exchange listings is highly
competitive, and the Exchange's proposal is merely conforming its
listing rules to that of another exchange. The Exchange believes the
proposed change will facilitate the listing and trading of additional
types of exchange-traded derivative securities products that will
enhance competition among market participants, to the benefit of
investors and the marketplace.
    The Exchange's proposal to amend Rule 14.11(e)(4)(C)(ii) to state
that the term ``commodity'' is defined in section 1a(9) of the
Commodity Exchange Act (rather than section 1(a)(4) as currently
referenced in 14.11(e)(4)(C)(ii)) reflects an amendment to the
Commodity Exchange Act included in the Dodd-Frank Wall Street Reform
and Consumer

Protection Act of 2010.\12\ Furthermore, the proposed amendment is
identical to Arca Rule 8.201-E(c)(2). The Exchange also believes its
proposal to correct ministerial errors in Rule 14.11(e)(4)(C)(ii) will
provide clarity in the Exchange's rulebook to the benefit of all
investors.
---------------------------------------------------------------------------

    \12\ Supra note 6.
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The proposed rule change to
Rule 14.11(e)(4)(C)(ii) does not address competitive issues, but
rather, as discussed above, is merely intended to correct a reference
to a modified Commodity Exchange Act rule. The Exchange believes the
proposed rule change to Rule 14.11(e)(4)(C)(i) will enhance competition
by accommodating Exchange trading of additional exchange-traded
products.

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
proposed rule change.

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

    Pursuant to section 19(b)(3)(A) of the Act \13\ and Rule 19b-
4(f)(6) \14\ thereunder, the Exchange has designated this proposal as
one that effects a change that: (i) does not significantly affect the
protection of investors or the public interest; (ii) does not impose
any significant burden on competition; and (iii) by its terms, does not
become operative for 30 days after the date of the filing, or such
shorter time as the Commission may designate if consistent with the
protection of investors and the public interest.\15\
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78s(b)(3)(A).
    \14\ 17 CFR 240.19b-4(f)(6).
    \15\ In addition, Rule 19b-4(f)(6) requires a self-regulatory
organization to give 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 Exchange has satisfied this
requirement.
---------------------------------------------------------------------------

    A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the
Act normally does not become operative for 30 days after the date of
its filing. However, Rule 19b-4(f)(6)(iii) \16\ permits the Commission
to designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange requested
that the Commission waive the 30-day operative delay so that the
proposal may become operative immediately upon filing. The proposed
rule change, which modifies the Exchange's rules by conforming the
definition of Commodity-Based Trust Shares with the same definition
used by another national securities exchange \17\ and corrects the
citation for the term ``commodity,'' as defined in the Commodity
Exchange Act, raises no unique or novel legal or regulatory issues and
will lessen any potential confusion among market participants.
Therefore, the Commission believes that waiver of the 30-day operative
delay is consistent with the protection of investors and the public
interest. Accordingly, the Commission hereby waives the 30-day
operative delay and designates the proposed rule change operative upon
filing.\18\
---------------------------------------------------------------------------

    \16\ 17 CFR 240.19b-4(f)(6)(iii).
    \17\ See supra note 7.
    \18\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    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.

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 (https://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
file number SR-CboeBZX-2023-105 on the subject line.

Paper Comments

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

All submissions should refer to file number SR-CboeBZX-2023-105. 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 website (https://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 website 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
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the Exchange. Do not
include personal identifiable information in submissions; you should
submit only information that you wish to make available publicly. We
may redact in part or withhold entirely from publication submitted
material that is obscene or subject to copyright protection. All
submissions should refer to file number SR-CboeBZX-2023-105 and should
be submitted on or before January 9, 2024.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\19\
---------------------------------------------------------------------------

    \19\ 17 CFR 200.30-3(a)(12), (59).
---------------------------------------------------------------------------

Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-27786 Filed 12-18-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: June 21, 2010 (Volume 75, Number 118)]
[Proposed Rules]
[Page 34953-34956]
[DOCID:fr21jn10-21]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2010-0463; Directorate Identifier 2010-CE-021-AD]
RIN 2120-AA64

Airworthiness Directives; GA 8 Airvan (Pty) Ltd Models GA8 and
GA8-TC320 Airplanes

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

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for the
products listed above that would revise an existing AD. This proposed
AD results from mandatory continuing airworthiness information (MCAI)
originated by an aviation authority of another country to identify and
correct an unsafe condition on an aviation product. The MCAI describes
the unsafe condition as: Inspection of a high time

aircraft has revealed cracks in the Horizontal Stabilizer rear spar
splice plate and inboard main ribs around the area of the Horizontal
Stabilizer rear pivot attachment. Additionally, failure of some attach
bolts in service may be due to improper assembly. This amendment is
issued to include an applicability matrix (Table 1, page 2) in the
compliance section of the service bulletin for improved clarity. The
proposed AD would require actions that are intended to address the
unsafe condition described in the MCAI.

DATES: We must receive comments on this proposed AD by August 5, 2010.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

FOR FURTHER INFORMATION CONTACT: Doug Rudolph, Aerospace Engineer, FAA,
Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri
64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2010-0463;
Directorate Identifier 2010-CE-021-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://
regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    On April 20, 2010, we issued AD 2010-10-01, Amendment 39-16280 (75
FR 23577, May 4, 2010). That AD required actions intended to address an
unsafe condition on the products listed above.
    Since we issued AD 2010-10-01, the foreign authority has issued an
amendment to include an applicability matrix in the compliance section
of the manufacturer's service bulletin for improved clarity. The FAA is
proposing to revise this AD to allow the use of issue 6 or issue 5 of
the service bulletin. An operator would be in compliance if the
operator chose to only accomplish issue 5 of the SB. This proposed
revision of the FAA's AD will make the FAA AD more in line with the
latest version of the received MCAI.
    The Civil Aviation Safety Authority (CASA), which is the aviation
authority for Australia, has issued AD/GA8/5, Amdt 4, dated May 11,
2010 (referred to after this as ``the MCAI''), to correct an unsafe
condition for the specified products. The MCAI states:

    Inspection of a high time aircraft has revealed cracks in the
Horizontal Stabilizer rear spar splice plate and inboard main ribs
around the area of the Horizontal Stabilizer rear pivot attachment.
Additionally, failure of some attach bolts in service may be due to
improper assembly.
    This amendment is issued to include an applicability matrix
(Table 1, page 2) in the compliance section of the service bulletin
for improved clarity.
    The previous amendment included reference to the GA8-TC 320
variant in the applicability section.
    Amendment 2 was issued because the requirement document now
contains an inspection for cracking in horizontal stabilizers which
have load transferring fittings installed.
    Previous amendments of this AD listed the AD requirements in
full. Due to the extensive use of diagrams and photographs, it is no
longer appropriate or practical to write the requirements of the
service bulletin out in full in this AD. All requirements,
accomplishment instructions and illustrations are contained in the
service bulletin.

You may obtain further information by examining the MCAI in the AD
docket.

Relevant Service Information

    Gippsland Aeronautics has issued Mandatory Service Bulletin SB-GA8-
2002-02, Issue 6, dated April 21, 2010. The actions described in this
service information are intended to correct the unsafe condition
identified in the MCAI.

FAA's Determination and Requirements of the Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with this State of Design Authority, they
have notified us of the unsafe condition described in the MCAI and
service information referenced above. We are proposing this AD because
we evaluated all information and determined the unsafe condition exists
and is likely to exist or develop on other products of the same type
design.

Differences Between This Proposed AD and the MCAI or Service
Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have proposed different actions in this AD from those
in the MCAI in order to follow FAA policies. Any such differences are
highlighted in a Note within the proposed AD.

Costs of Compliance

    We estimate that this proposed AD will affect 25 products of U.S.
registry. We also estimate that it would take about 1 work-hour per
product to comply with the basic requirements of this proposed AD. The
average labor rate is $85 per work-hour. Required parts would cost
about $0 per product.
    Based on these figures, we estimate the cost of the proposed AD on
U.S. operators to be $2,125, or $85 per product.
    In addition, we estimate that any necessary follow-on actions would
take about 5 work-hours and require parts costing $200, for a cost of
$625 per product. We have no way of determining the number of products
that may need these actions.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

    2. The FAA amends Sec.  39.13 by removing Amendment 39-16280 (75 FR
23577, May 4, 2010), and adding the following new AD:

GA 8 Airvan (Pty) Ltd.: Docket No. FAA-2010-0463; Directorate
Identifier 2010-CE-021-AD.

Comments Due Date

    (a) We must receive comments by August 5, 2010.

Affected ADs

    (b) This AD revises AD 2010-10-01, Amendment 39-16280.

Applicability

    (c) This AD applies to the following model and serial number
airplanes, certificated in any category:
    (1) Group 1 Airplanes (retains the actions and applicability
from AD 2009-05-01): Model GA8 airplanes, serial numbers GA8-00-004
and up; and
    (2) Group 2 Airplanes: Model GA8-TC320 airplanes, all serial
numbers.

Subject

    (d) Air Transport Association of America (ATA) Code 55:
Stabilizers.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:
    Inspection of a high time aircraft has revealed cracks in the
Horizontal Stabiliser rear spar splice plate and inboard main ribs
around the area of the Horizontal Stabiliser rear pivot attachment.
Additionally, failure of some attach bolts in service may be due to
improper assembly.
    This amendment is issued to include an applicability matrix
(Table 1, page 2) in the compliance section of the service bulletin
for improved clarity.
    The previous amendment included reference to the GA8-TC 320
variant in the applicability section.
    Amendment 2 was issued because the requirement document now
contains an inspection for cracking in horizontal stabilisers which
have load transferring fittings installed.
    Previous amendments of this AD listed the AD requirements in
full. Due to the extensive use of diagrams and photographs, it is no
longer appropriate or practical to write the requirements of the
service bulletin out in full in this AD. All requirements,
accomplishment instructions and illustrations are contained in the
service bulletin.
    The FAA is revising AD 2010-10-01 to allow the use of issue 6 or
issue 5 of the service bulletin. An operator is in compliance if the
operator chooses to only accomplish issue 5 of the SB. This proposed
revision of the FAA's AD will make the FAA AD more consistent with
the latest version of the MCAI.

Actions and Compliance

    (f) For Group 1 Airplanes: Unless already done, do the following
actions:
    (1) Within the next 10 hours time-in-service (TIS) after March
2, 2009 (the effective date retained from AD 2009-05-01):
    (i) For all aircraft not incorporating computer numeric control
(CNC) machined elevator hinges, inspect and repair the left and
right horizontal stabilizer rear pivot attachment installation
following instruction ``3. Rear Pivot Attachment Inspection,'' of
Gippsland Aeronautics Mandatory Service Bulletin SB-GA8-2002-02,
Issue 5, dated November 13, 2008; or Gippsland Aeronautics Mandatory
Service Bulletin SB-GA8-2002-02, Issue 6, dated April 21, 2010; and,
    (ii) For all aircraft, inspect the left and right rear attach
bolt mating surfaces for damage or an out of square condition and
replace the left and right rear attach bolts following instruction
``5. Rear Attach Bolt Replacement,'' of Gippsland Aeronautics
Mandatory Service Bulletin SB-GA8-2002-02, Issue 5, dated November
13, 2008; or Gippsland Aeronautics Mandatory Service Bulletin SB-
GA8-2002-02, Issue 6, dated April 21, 2010. Reworking the mating
surfaces by spotfacing is no longer acceptable. If the mating
surfaces are damaged, not square, or were previously reworked by
spotfacing the surface, replace the parts as specified in Gippsland
Aeronautics Mandatory Service Bulletin SB-GA8-2002-02, Issue 5,
dated November 13, 2008; or Gippsland Aeronautics Mandatory Service
Bulletin SB-GA8-2002-02, Issue 6, dated April 21, 2010.
    (2) Within the next 10 hours TIS after March 2, 2009 (the
effective date retained from AD 2009-05-01) and repetitively
thereafter at intervals not to exceed 100 hours TIS or 12 months,
whichever occurs first, for all aircraft:
    (i) Inspect the horizontal stabilizer externally following
instruction ``2. External Inspection (Lower flange, Stabilizer rear
spar),'' of Gippsland Aeronautics Mandatory Service Bulletin SB-GA8-
2002-02, Issue 5, dated November 13, 2008; or Gippsland Aeronautics
Mandatory Service Bulletin SB-GA8-2002-02, Issue 6, dated April 21,
2010; and
    (ii) Inspect the horizontal stabilizer internally following
instruction ``4. Internal Inspection,'' of Gippsland Aeronautics
Mandatory Service Bulletin SB-GA8-2002-02, Issue 5, dated November
13, 2008; or Gippsland Aeronautics Mandatory Service Bulletin SB-
GA8-2002-02, Issue 6, dated April 21, 2010.
    (3) If during the inspection required by paragraph (f)(2) of
this AD any excessive local deflection or movement of the lower skin
surrounding the lower pivot attachment, cracking, or working (loose)
rivet is found, before further flight, obtain an FAA-approved repair
scheme from the manufacturer and incorporate this repair scheme. Due
to FAA policy, the repair scheme/modification for crack damage must
include an immediate repair of the crack. The repair scheme cannot
be by repetitive inspection only. The repair scheme/modification may
incorporate repetitive inspections in addition to the repetitive
inspections required in paragraph (f)(2) of this AD. Continued
operational flight with un-repaired crack damage is not permitted.

    (g) For Group 2 Airplanes: Unless already done, do the following
actions:
    (1) Within the next 10 hours TIS after May 10, 2010 (the
effective date retained from AD 2010-10-01):
    (i) For all aircraft not incorporating computer numeric control
(CNC) machined elevator hinges, inspect and repair the left and
right horizontal stabilizer rear pivot attachment installation
following instruction ``3. Rear Pivot Attachment Inspection,'' of
Gippsland Aeronautics Mandatory Service Bulletin SB-GA8-2002-02,
Issue 5, dated November 13, 2008; or Gippsland Aeronautics Mandatory
Service Bulletin SB-GA8-2002-02, Issue 6, dated April 21, 2010; and,
    (ii) For all aircraft, inspect the left and right rear attach
bolt mating surfaces for damage or an out of square condition and
replace the left and right rear attach bolts following instruction
``5. Rear Attach Bolt Replacement,'' of Gippsland Aeronautics
Mandatory Service Bulletin SB-GA8-2002-02, Issue 5, dated November
13, 2008; or Gippsland Aeronautics Mandatory Service Bulletin SB-
GA8-2002-02, Issue 6, dated April 21, 2010. Reworking the mating
surfaces by spotfacing is no longer acceptable. If the mating
surfaces are damaged, not square, or were previously reworked by
spotfacing the surface, before further flight, replace the parts as
specified in Gippsland Aeronautics Mandatory Service Bulletin SB-
GA8-2002-02, Issue 5, dated November 13, 2008; or Gippsland
Aeronautics Mandatory Service Bulletin SB-GA8-2002-02, Issue 6,
dated April 21, 2010.
    (2) Within the next 10 hours TIS after May 10, 2010 (the
effective date retained from AD 2010-10-01) and repetitively
thereafter at intervals not to exceed 100 hours TIS or 12 months,
whichever occurs first, for all aircraft:
    (i) Inspect the horizontal stabilizer externally following
instruction ``2. External Inspection (Lower flange, Stabilizer rear
spar),'' of Gippsland Aeronautics Mandatory Service Bulletin SB-GA8-
2002-02, Issue 5, dated November 13, 2008; or Gippsland Aeronautics
Mandatory Service Bulletin SB-GA8-2002-02, Issue 6, dated April 21,
2010; and
    (ii) Inspect the horizontal stabilizer internally following
instruction ``4. Internal Inspection,'' of Gippsland Aeronautics
Mandatory Service Bulletin SB-GA8-2002-02, Issue 5, dated November
13, 2008; or Gippsland Aeronautics Mandatory Service Bulletin SB-
GA8-2002-02, Issue 6, dated April 21, 2010.
    (3) If during the inspection required by paragraph (g)(2) of
this AD any excessive local deflection or movement of the lower skin
surrounding the lower pivot attachment, cracking, or working (loose)
rivet is found, before further flight, obtain an FAA-approved repair
scheme from the manufacturer and incorporate this repair scheme. Due
to FAA policy, the repair scheme/modification for crack damage must
include an immediate repair of the crack. The repair scheme cannot
be by repetitive inspection only. The repair scheme/modification may
incorporate repetitive inspections in addition to the repetitive
inspections required in paragraph (g)(2) of this AD. Continued
operational flight with un-repaired crack damage is not permitted.

FAA AD Differences

    Note:  This AD differs from the MCAI and/or service information
as follows:
    (1) ``Requirement: 1. Daily Inspection (Stabilizer attach
bolt)'' of the service information requires a daily inspection of
the stabilizer attach bolt. The daily inspection is not a
requirement of this AD. Instead of the daily inspection, we require
you to perform, within 10 hours TIS, ``Requirement 3. Rear Pivot
Attachment Inspection'' and ``Requirement 5. Rear Attachment Bolt
Replacement'' of the service information. Compliance with
requirement 3. and 5. is a terminating action for the daily
inspection, and we are requiring these within 10 hours TIS after the
effective date of AD 2009-05-01 for Group 1 airplanes and AD 2010-
10-01 for Group 2 airplanes.
    (2) ``Requirement: 2. External Inspection (Lower flange,
Stabilizer rear spar)'' of the service information does not specify
any action if excessive local deflection or movement of lower skin,
cracking, or working (loose) rivet is found. We require obtaining
and incorporating an FAA-approved repair scheme from the
manufacturer before further flight.
    (3) The MCAI does not state if further flight with known cracks
is allowed. FAA policy is to not allow further flight with known
cracks in critical structure. We require that if any cracks are
found when accomplishing the inspection required in paragraphs
(f)(2) and (g)(2) of this AD, you must repair the cracks before
further flight.
    (4) The service information does not state that parts with
spotfaced nut and bolt mating surfaces require replacement. However,
the service information no longer allows reworking of the mating
surfaces by spotfacing. We require that if any nut and bolt surfaces
were previously reworked by spotfacing, you must replace the parts.

Other FAA AD Provisions

    (h) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Standards Office, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. Send
information to Attn: Doug Rudolph, Aerospace Engineer, FAA, Small
Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri
64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>. Before using
any approved AMOC on any airplane to which the AMOC applies, notify
your appropriate principal inspector (PI) in the FAA Flight
Standards District Office (FSDO), or lacking a PI, your local FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act (44
U.S.C. 3501 et seq.), the Office of Management and Budget (OMB) has
approved the information collection requirements and has assigned
OMB Control Number 2120-0056.

Related Information

    (i) Refer to MCAI Civil Aviation Safety Authority AD No. AD/GA8/
5, Amdt 4, dated May 11, 2010; Gippsland Aeronautics Mandatory
Service Bulletin SB-GA8-2002-02, Issue 5, dated November 13, 2008;
and Gippsland Aeronautics Mandatory Service Bulletin SB-GA8-2002-02,
Issue 6, dated April 21, 2010, for related information.

    Issued in Kansas City, Missouri, on June 14, 2010.
Sandra J. Campbell,
Acting Manager, Small Airplane Directorate, Aircraft Certification
Service.

[FR Doc. 2010-14986 Filed 6-18-10; 8:45 am]
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[Federal Register: December 22, 2008 (Volume 73, Number 246)]
[Proposed Rules]
[Page 78239-78242]
[DOCID:fr22de08-24]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. FDA-2008-N-0604]

General and Plastic Surgery Devices: Proposed Classification for
the Tissue Expander

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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

SUMMARY: The Food and Drug Administration (FDA) is proposing to
classify into class II (special controls) the tissue expander, as a
device intended for temporary (less than 6 months) subdermal
implantation to stretch the skin for surgical applications,
specifically to develop surgical flaps and additional tissue coverage.
Elsewhere in this issue of the Federal Register, FDA is announcing the
availability of the draft guidance that FDA intends will serve as the
special control if FDA classifies this device type into class II.

DATES:  Submit written or electronic comments by March 23, 2009. See
section IV of this document for the proposed effective date of a final
rule based on this proposed rule.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2008-
N-0604, by any of the following methods:
Electronic Submissions
    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
    Submit written submissions in the following ways:
     FAX:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions]: Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of comments, FDA is no longer
accepting comments submitted to the agency by e-mail. FDA encourages
you to continue to submit electronic comments by using the Federal
eRulemaking Portal, as described previously, in the ADDRESSES portion
of this document under Electronic Submissions.
    Instructions: All submissions received must include the agency name
and docket number for this rulemaking. All comments received may be
posted without change to http://www.regulations.gov, including any
personal information provided. For additional information on submitting
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION
section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Nada Hanafi, Center for Devices and
Radiological Health (HFZ-4), Food and Drug Administration, 7520
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Federal Food, Drug, and Cosmetic Act (the act), as amended by
the Medical Device Amendments of 1976 (the 1976 amendments) (Public Law
94-295), the Safe Medical Devices Act of 1990 (Public Law 101-629), and
the Food and Drug Modernization Act of 1997 (FDAMA) (Public Law 105-
115), the Food and Drug Administration Amendments Act of 2007 (Public
Law 110-85), among other amendments, established a comprehensive system
for the regulation of medical devices intended for human use. Section
513 of the act (21 U.S.C. 360c) established three categories (classes)
of devices, depending on the regulatory controls needed to provide
reasonable assurance of their safety and effectiveness. The three
categories of devices are class I (general controls), class II (special
controls), and class III (premarket approval).
    Under section 513 of the act, FDA refers to devices that were in
commercial distribution before May 28, 1976 (the date of enactment of
the 1976 amendments), as ``preamendments devices.'' FDA classifies
these devices after the agency has taken the following steps:

    (1) Receives a recommendation from a device classification panel
(an FDA advisory committee);
    (2) Publishes the panel's recommendation for comment, along with a
proposed regulation classifying the device type; and
    (3) Publishes a final regulation classifying the device type.
    FDA has classified most preamendments devices under these
procedures.
    FDA refers to devices that were not in commercial distribution
before May 28, 1976, as ``postamendments devices.'' These device types
are classified automatically by statute (section 513(f) of the act)
into class III without any FDA rulemaking process. Those device types
remain in class III and require premarket approval, unless and until:
    (1) FDA reclassifies the device type into class I or II;
    (2) FDA issues an order classifying the device type into class I or
II in accordance with new section 513(f)(2) of the act, as amended by
FDAMA; or
    (3) FDA issues an order finding the device to be substantially
equivalent, under section 513(i) of the act, to a predicate device that
does not require premarket approval.
    The agency determines whether new devices are substantially
equivalent to previously offered devices by means of premarket
notification procedures in section 510(k) of the act (21 U.S.C. 360(k))
and 21 CFR part 807 of the regulations.
    A person may market a preamendments device that has been classified
into class III through premarket notification procedures, without
submission of a premarket approval application (PMA), until FDA issues
a final regulation under section 515(b) of the act (21 U.S.C. 360e(b))
requiring premarket approval.
    The tissue expander is a preamendment device type that was not
classified in the final rule published in the Federal Register of June
24, 1988, classifying other General and Plastic Surgery Devices (53 FR
23856). Consistent with the act and the regulations, FDA consulted with
the Panel, an FDA advisory committee, regarding the classification of
this device type.

II. Recommendation of the Panel

    At a public meeting held on August 25 and 26, 2005, the Panel
unanimously recommended that the tissue expander be classified into
class II (Ref. 1). The Panel believed that class II, special controls,
in addition to general controls, would reasonably assure the safety and
effectiveness of this device type. The Panel also recommended that the
special control for the device type be a guidance document.

A. Identification

    FDA is proposing the following identification based on the Panel's
recommendation and the available information: A tissue expander is a
device intended for temporary (less than 6 months) subdermal
implantation to stretch the skin for surgical applications,
specifically to develop surgical flaps and additional tissue coverage.
It is made of an inflatable silicone elastomer shell filled with Normal
Physiological Saline (injection grade).

B. Recommended Classification of the Panel

    The Panel unanimously recommended that the tissue expander be
classified into class II. The Panel believed that class II with the
special controls (a guidance document and labeling) would provide
reasonable assurance of the safety and effectiveness of the device.
Elsewhere in this issue of the Federal Register, FDA is announcing the
availability of the draft guidance that will serve as the special
control for this device type.

C. Summary of Reasons for Recommendation

    After reviewing the information provided by FDA, and after
consideration of the open discussions during the Panel meeting and the
Panel members' personal knowledge of and clinical experience with the
device system, the Panel provided the following reasons in support of
its recommendation to classify the generic device type, tissue expander
intended for temporary (less than 6 months) subdermal implantation to
develop surgical flaps and additional coverage for surgical
applications, into class II. The Panel believed the tissue expander
should be classified into class II because special controls, in
addition to general controls, would provide reasonable assurance of the
safety and effectiveness of the device and there is sufficient
information to establish special controls to provide such assurance.

D. Summary of the Data Upon Which the Recommendation is Based

     In addition to the potential risks to health associated with
implantation of the tissue expander described in section II.E of this
document, ``Risks to Health,'' there is reasonable knowledge of the
benefits of the device type. Specifically, the tissue expander develops
tissue flaps and coverage needed for surgical applications, such as
breast reconstruction following mastectomy, treatment of underdeveloped
breasts, scar revision, and treatment of soft tissue deformities or
injuries.

E. Risks to Health

    After considering the Panel's comments and recommendation, the
published literature, and medical device reports, FDA has evaluated the
risks to health associated with use of the tissue expander. FDA
believes the following are risks to health associated with use of the
device type:
    Skin trauma, including necrosis, thinning and slough;
    Device failure, including rupture and injection site/port failure;
    Infection--Infection is a risk to health associated with all
surgical procedures and implanted devices. Incompatible or impure
material composition may irritate the surrounding tissue which could
increase the risk of infection. Use of a device that is not pyrogen
free may elicit a fever.
    Adverse tissue reaction--Adverse tissue reaction is a risk to
health common to all implanted devices. The implantation of the tissue
expander will elicit a mild inflammatory reaction typical of a normal
foreign body response. Incompatible material or impurities in the
materials may increase the severity of a local tissue reaction or cause
a systemic tissue reaction.
    Pain--Pain is a risk to health associated with all surgical
procedures and implanted devices.

F. Special Controls

    In addition to general controls, FDA believes that the draft
guidance document entitled ``Class II Special Controls Guidance: Tissue
Expander'' (the draft class II special controls guidance document) is a
special control adequate to address the risks to health associated with
the use of the device type described in section II.E of this document.
FDA believes that the draft class II special controls guidance document
addresses the Panel's concerns and provides reasonable assurance of the
safety and effectiveness of the device type. Elsewhere in this issue of
the Federal Register, FDA is publishing a notice of availability of the
draft class II special controls guidance document that the agency would
use as the special control for this device type.
    The draft class II special controls guidance document sets forth
the information FDA recommends submitters include in premarket
notification submissions (510(k)s) for a tissue expander. FDA has
identified the risks to health associated with the use

of the device type in the first column of table 1 of this document. The
recommended mitigation measures identified in the draft class II
special controls guidance document is in the second column of table 1
of this document. FDA believes that addressing these risks to health in
a 510(k) in the manner identified in the draft class II special
controls guidance document, or in an acceptable alternative manner, is
necessary to provide reasonable assurance of the safety and
effectiveness of the device type.

            Table 1.--Risks to Health and Mitigation Measures
------------------------------------------------------------------------
           Identified Risk              Recommended Mitigation  Measures
------------------------------------------------------------------------
Skin trauma (e.g., necrosis,           Labeling
 thinning, sloughing).
------------------------------------------------------------------------
Device failure (e.g., rupture,         Preclinical testing
 injection site/port failure).         Labeling
------------------------------------------------------------------------
Infection............................  Sterility
------------------------------------------------------------------------
Adverse tissue reaction..............  Biocompatibility
------------------------------------------------------------------------
Pain.................................  Labeling
------------------------------------------------------------------------

III. Proposed Classification

    FDA concurs with the Panel's recommendation that a tissue expander
should be classified into class II because special controls, in
addition to general controls, would provide reasonable assurance of the
safety and effectiveness of the device, and there is sufficient
information to establish special controls to provide such assurance.

IV. Proposed Effective Date

    FDA proposes that any final regulation based on this proposal
become effective 30 days after its date of publication in the Federal
Register.

V. Environmental Impact

    The agency has determined under 21 CFR 25.34(b) that this proposed
classification action is of a type that does not individually or
cumulatively have a significant effect on the human environment.
Therefore, neither an environmental assessment nor an environmental
impact statement is required.

VI. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this proposed rule is not a significant regulatory action as defined by
the Executive order.
    The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Classification of this device type into class II
will have a negligible impact on manufacturers because manufacturers of
the device type currently must provide premarket notification before
marketing the device and because FDA believes that manufacturers are
already substantially in compliance with the recommendations in the
draft guidance document. Because classification into class II will not
increase regulatory costs with respect to this device type, the agency
proposes to certify that the final rule will not have a significant
economic impact on a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $130 million, using the most current (2007) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
proposed rule to result in any 1-year expenditure that would meet or
exceed this amount.

VII. Federalism

    FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. Section 4(a) of the
Executive order requires agencies to ``construe * * * a Federal statute
to preempt State law only where the statute contains an express
preemption provision or there is some other clear evidence that the
Congress intended preemption of State law, or where the exercise of
State authority conflicts with the exercise of Federal authority under
the Federal statute.'' Federal law includes an express preemption
provision that preempts certain State requirements ``different or in
addition to'' certain federal requirements applicable to devices (21
U.S.C. 360k; Medtronic v. Lohr, 518 U.S. 470 (1996); Riegel v.
Medtronic, 128 S.Ct. 999 (2008)). In this proposed rulemaking, FDA has
tentatively determined that general controls by themselves are
insufficient to provide reasonable assurance of the safety and
effectiveness of the device, and that there is sufficient information
to establish special controls to provide such assurance. FDA therefore
proposes to establish special controls to address the issues of safety
or effectiveness identified in the special controls draft guidance
document. If this proposed rule is made final, these special controls
would create ``requirements'' for specific medical devices under 21
U.S.C. 360k, even though product sponsors would have some flexibility
in how they meet those requirements (Papike v. Tambrands, Inc., 107
F.3d 737, 740-42 (9th Cir. 1997)).
    In addition, if this rule becomes final, as with any Federal
requirement, if a State law requirement makes compliance with both
Federal law and State law impossible, or would frustrate Federal
objectives, the State requirement would be preempted. (See Geier v.
American Honda Co., 529 U.S. 861 (2000); English v. General Electric
Co., 496 U.S. 72, 79 (1990); Florida Lime & Avocado Growers, Inc., 373
U.S. 132, 142-43 (1963); Hines v. Davidowitz, 312 U.S. 52, 67 (1941).)

VIII. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no new
collections of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 (44
U.S.C. 3501-3520) is not required. This proposed rule designates a
guidance document as a special control.
    Elsewhere in this issue of the Federal Register, FDA is publishing
a notice of availability of the draft guidance document entitled
``Class II Special Controls Guidance Document: Tissue Expander,'' which
contains an analysis of the paperwork burden for the draft guidance.

IX. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this 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.
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.

X. References

    The following reference has been placed on display in the Division
of Dockets Management (see ADDRESSES) and may be seen by interested
persons between 9 a.m. and 4 p.m., Monday through Friday.
    1. General and Plastic Surgery Devices Panel, Transcript, August
25 and 26, 2005, pp. 11 through 58 of the August 26, 2005,
transcripts.

List of Subjects in 21 CFR Part 878

    Medical devices.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, FDA proposes
to amend 21 CFR part 878 as follows:

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

    1. The authority citation for 21 CFR part 878 continues to read as
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 3601, 371.
    2. Add Sec.  878.3600 to subpart D to read as follows:

Sec.  878.3600  Tissue expander.

    (a)  Identification. A tissue expander is a device intended for
temporary (less than 6 months) subdermal implantation to stretch the
skin for surgical applications, specifically to develop surgical flaps
and additional tissue coverage. It is made of an inflatable silicone
elastomer shell filled with Normal Physiological Saline (injection
grade).
    (b) Classification. Class II (special controls). The special
control for this device is FDA's guidance document entitled ``Class II
Special Controls Guidance Document: Tissue Expander.'' See Sec.
878.1(e) for availability information of guidance documents.

    Dated: December 16, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-30439 Filed 12-19-08; 8:45 am]

BILLING CODE 4160-01-S