[Federal Register Volume 80, Number 85 (Monday, May 4, 2015)]
[Notices]
[Pages 25298-25299]
[FR Doc No: 2015-10338]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-E-0785]

Determination of Regulatory Review Period for Purposes of Patent
Extension; RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for the RELAY THORACIC STENT-GRAFT WITH PLUS
DELIVERY SYSTEM and is publishing this notice of that determination as
required by law. FDA has made the determination because of the
submission of an application to the Director of the U.S. Patent and
Trademark Office (USPTO), Department of Commerce, for the extension of
a patent which claims that medical device.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written petitions (two copies are required) and written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Submit petitions electronically to http://www.regulations.gov at Docket
No. FDA-2013-S-0610.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of
Management, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Campus, Rm. 3180, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Pub. L. 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For medical devices, the testing
phase begins with a clinical investigation of the device and runs until
the approval phase begins. The approval phase starts with the initial
submission of an application to market the device and continues until
permission to market the device is

granted. Although only a portion of a regulatory review period may
count toward the actual amount of extension that the Director of USPTO
may award (half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a medical
device will include all of the testing phase and approval phase as
specified in 35 U.S.C. 156(g)(3)(B).
    FDA has approved for marketing the medical device RELAY THORACIC
STENT-GRAFT WITH PLUS DELIVERY SYSTEM. RELAY THORACIC STENT-GRAFT WITH
PLUS DELIVERY SYSTEM is indicated for the endovascular repair of
fusiform aneurysms and saccular aneurysms/penetrating atherosclerotic
ulcers in the descending thoracic aorta in patients having appropriate
anatomy. Subsequent to this approval, the USPTO received a patent term
restoration application for the RELAY THORACIC STENT-GRAFT WITH PLUS
DELIVERY SYSTEM (U.S. Patent No. 8,062,345 B2) from Bolton Medical
Inc., and the USPTO requested FDA's assistance in determining this
patent's eligibility for patent term restoration. In a letter dated
March 18, 2014, FDA advised the USPTO that this medical device had
undergone a regulatory review period and that the approval of the RELAY
THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM represented the first
permitted commercial marketing or use of the product. Thereafter, the
USPTO requested that FDA determine the product's regulatory review
period.
    FDA has determined that the applicable regulatory review period for
RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM is 2,852 days. Of
this time, 2,529 days occurred during the testing phase of the
regulatory review period, while 323 days occurred during the approval
phase. These periods of time were derived from the following dates:
    1. The date an exemption under section 520(g) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(g)) involving
this device became effective: December 2, 2004. The applicant claims
that the investigational device exemption (IDE) required under section
520(g) of the FD&C Act for human tests to begin became effective on
December 3, 2004. However, FDA records indicate that the IDE was
determined substantially complete for clinical studies to have begun on
December 2, 2004, which represents the IDE effective date.
    2. The date an application was initially submitted with respect to
the device under section 515 of the FD&C Act (21 U.S.C. 360e): November
4, 2011. FDA has verified the applicant's claim that the premarket
approval application (PMA) for the RELAY THORACIC STENT-GRAFT WITH PLUS
DELIVERY SYSTEM (PMA P110038) was initially submitted November 4, 2011.
    3. The date the application was approved: September 21, 2012. FDA
has verified the applicant's claim that PMA P110038 was approved on
September 21, 2012.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 225 days of patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) either electronic or written comments and ask for a
redetermination by July 6, 2015. Furthermore, any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period
by November 2, 2015. To meet its burden, the petition must contain
sufficient facts to merit an FDA investigation. (See H. Rept. 857, part
1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the
format specified in 21 CFR 10.30.
    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments and written or
electronic petitions. It is only necessary to send one set of comments.
Identify comments with the docket number found in brackets in the
heading of this document. If you submit a written petition, two copies
are required. A petition submitted electronically must be submitted to
http://www.regulations.gov, Docket No. FDA-2013-S-0610. Comments and
petitions that have not been made publicly available on http://www.regulations.gov may be viewed in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: April 28, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-10338 Filed 5-1-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 183 (Friday, September 20, 2013)]
[Notices]
[Pages 57850-57852]
[FR Doc No: 2013-22847]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2009-1017; FRL-9396-3]

Product Cancellation Order for Certain Pesticide Registrations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces EPA's order for the cancellations,
voluntarily requested by the registrants and accepted by the Agency, of
the products listed in Table 1 of Unit II., pursuant to the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA). This cancellation
order follows a June 12, 2013 Federal Register Notice of Receipt of
Requests from the registrants listed in Table 2 of Unit II. to
voluntarily cancel these product registrations. In the June 12, 2013
Federal Register notice, EPA indicated that it would issue an order
implementing the cancellations, unless the Agency received substantive
comments within the 30-day comment period that would merit its further
review of these requests, or unless the registrants withdrew their
requests. The Agency received two comments on the June 12, 2013 Federal
Register notice but only one merited its further review of the
requests. Further, the registrants did not withdraw their requests.
Accordingly, EPA hereby issues in this notice a cancellation order
granting the requested cancellations. Any distribution, sale, or use of
the products subject to this cancellation order is permitted only in
accordance with the terms of this order, including any existing stocks
provisions.

DATES: The cancellations are effective September 20, 2013.

FOR FURTHER INFORMATION CONTACT: John W. Pates, Jr., Pesticide Re-
Evaluation Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, and agricultural advocates; the chemical industry; pesticide
users; and members of the public interested in the sale, distribution,
or use of pesticides. Since others also may be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action.

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

    The docket for this action, identified by docket identification
(ID) number EPA-HQ-OPP-2009-1017 is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

II. What action is the Agency taking?

    This notice announces the cancellation, as requested by
registrants, of products registered under FIFRA section 3. These
registrations are listed in sequence by registration number in Table 1
of this unit.

                     Table 1--Product Cancellations
------------------------------------------------------------------------
   EPA Registration No.          Product name          Chemical name
------------------------------------------------------------------------
000100-01104..............  Tralkoxydim Technical  Tralkoxydim.
000100-01130..............  Achieve SC Herbicide.  Tralkoxydim.
000192-00163..............  Dexol Rose & Floral    Piperonyl butoxide,
                             Insect Killer.         Pyrethrins (no inert
                                                    use).
000192-00198..............  Dexol Multipurpose     Permethrin.
                             Insect Spray.
000192-00222..............  Allpro Permeththrin    Permethrin.
                             ICG .5%.
000239-02709..............  Ortho MAT28S RTU.....  Aminocyclopyrachlor.
000239-02710..............  Ortho MAT28N RTU.....  Aminocyclopyrachlor.
000239-02711..............  Ortho MAT28NS Conc...  Aminocyclopyrachlor.
000239-02712..............  Ortho MAT28N Combo...  Aminocyclopyrachlor,
                                                    Dicamba, Quinclorac.
000239-02713..............  Ortho MAT28N Combo     Aminocyclopyrachlor,
                             Concentrate.           Dicamba, Quinclorac.
000264-01028..............  Mepiquat Chloride      Mepiquat chloride.
                             Technical Plant
                             Regulator.
000499-00465..............  Pro-Control Fogger II  MGK 264, Piperonyl
                                                    butoxide, Pyrethins
                                                    (no inert use).
000538-00319..............  Ortho MAT28N Combo     Aminocyclopyrachlor.
                             Concentrate.
000538-00320..............  Scotts 65 MAT Weed &   Aminocyclopyrachlor.
                             Feed.
000538-00321..............  Scotts 55 MAT Weed &   Aminocyclopyrachlor.
                             Feed.
000538-00322..............  Scotts 60 MAT Weed &   Aminocyclopyrachlor.
                             Feed.
000577-00541..............  Cuprinol Wood          Copper naphthenate.
                             Preservative Green
                             No. 10.
001021-01060..............  D-trans Allethrin 90%  d-trans-Chrysanthemum
                             Concentrate.           monocarboxylic ester
                                                    of dl-2-allyl-4-
                                                    hydoroxy-3-methyl-2-
                                                    cylopenten-1-one.
001021-01128..............  D-trans Intermediate   d-trans-Chrysanthemum
                             1868.                  monocarboxylic ester
                                                    of dl-2-allyl-4-
                                                    hydoroxy-3-methyl-2-
                                                    cylopenten-1-one,
                                                    MGK 264, Piperonyl
                                                    butoxide.
001021-01550..............  Evercide Intermediate  d-trans-Chrysanthemum
                             2416.                  monocarboxylic ester
                                                    of dl-2-allyl-4-
                                                    hydoroxy-3-methyl-2-
                                                    cylopenten-1-one,
                                                    MGK 264, Permethrin.
001021-01575..............  Evercide Intermediate  d-trans-Chrysanthemum
                             2491.                  monocarboxylic ester
                                                    of dl-2-allyl-4-
                                                    hydoroxy-3-methyl-2-
                                                    cylopenten-1-one,
                                                    MGK 264 Piperonyl
                                                    butoxide,
                                                    Esfenvalerate.
001021-01594..............  Evercide Residual      d-trans-Chrysanthemum
                             Pressurized Spray      monocarboxylic ester
                             2523.                  of dl-2-allyl-4-
                                                    hydoroxy-3-methyl-2-
                                                    cylopenten-1-one,
                                                    MGK 264, Piperonyl
                                                    butoxide,
                                                    Esfenvalerate.
001021-01607..............  Evercide Residual      d-trans-Chrysanthemum
                             Pressurized Spray      monocarboxylic ester
                             2581.                  of dl-2-allyl-4-
                                                    hydoroxy-3-methyl-2-
                                                    cylopenten-1-one,
                                                    MGK 264, Permethrin.
005481-00130..............  Fruit Fix Concentrate  Ammonium 1-
                             800.                   naphthaleneacetate.

005481-00459..............  Prune Smart Sprout     Ethyl 1-
                             Inhibitor.             naphthaleneacetate.
005481-00496..............  Snaap-2..............  Potassium 1-
                                                    naphthaleneacetate.
005481-00497..............  Snaap-8..............  Potassium 1-
                                                    naphthaleneacetate.
009779-00298..............  Riverside Copper       Copper hydroxide.
                             Hydroxide 77DF.
010163-00293..............  GWN-3771 Technical     Thifensulfuron.
                             Herbicide.
010163-00294..............  GWN-3124 WDG           Thifensulfuron.
                             Herbicide.
010163-00299..............  GWN-3125 WDG           Tribenuron-methyl.
                             Herbicide.
010163-00300..............  GWN-3123 WDG           Tribenuron-methyl,
                             Herbicide.             Thifensulfuron.
010807-00436..............  Konk Insect Killer...  d-trans-Chrysanthemum
                                                    monocarboxylic ester
                                                    of dl-2-allyl-4-
                                                    hydroxy-3-methyl-2-
                                                    cyclopenten-1-one,
                                                    MGK 264, Permethrin.
045385-00093..............  CTX/Cyber Blast......  MGK 264, Prallethrin,
                                                    Esfenvalerate.
053883-00128..............  Propiconazole HG.....  Propiconazole.
053883-00220..............  Oryzalin 2G..........  Oryzalin,
                                                    Benfluralin.
055260-00007..............  BDL 1633 Industrial    Dodecylguanidine
                             Microbiocide.          hydrochloride.
062190-00032..............  Arch CMIT/MIT........  5-Chloro-2-methyl-
                                                    3(2H)-isothiazolone,
                                                    2-Methyl-3(2H)-
                                                    isothiazolone.
062190-00035..............  Arch CMIT/MIT 14 MUP.  2-Methyl-3(2H)-
                                                    isothiazolone, 5-
                                                    Chloro-2-methyl-
                                                    3(2H)-isothiazolone.
082397-00002..............  Chem-Fish Synergized.  Piperonyl butoxide,
                                                    Rotenone, Cube
                                                    Resins other than
                                                    rotenone.
082397-00003..............  Powdered Cube Root...  Rotenone, Cube Resins
                                                    other than rotenone.
086363-00014..............  KT Propicon 3.6EC....  Propiconazole.
MN070006..................  Chem Sect Brand Chem   Piperonyl butoxide,
                             Fish Synergized.       Rotenone, Cube
                                                    Resins other than
                                                    rotenone.
OR910030..................  K-Salt Fruit Fix 200.  Potassium 1-
                                                    naphthaleneacetate.
OR910031..................  K-Salt Fruit Fix 800.  Potassium 1-
                                                    naphthaleneacetate.
WA050004..................  Fruitone-N...........  Sodium 1-
                                                    naphthaleneacetate.
WA910050..................  K-Salt Fruit Fix 200.  Potassium 1-
                                                    naphthaleneacetate.
------------------------------------------------------------------------

    Table 2 of this unit includes the names and addresses of record for
all registrants of the products in Table 1 of this unit, in sequence by
EPA company number. This number corresponds to the first part of the
EPA registration numbers of the products listed in Table 1 of this
unit.

               Table 2--Registrants of Cancelled Products
------------------------------------------------------------------------
       EPA Company No.                  Company name and address
------------------------------------------------------------------------
100..........................  Syngenta Crop Protection, LLC, 410 Swing
                                Rd., P.O. Box 18300, Greensboro, NC
                                27419-8300.
192..........................  Value Garden Supply, LLC, D/B/A Value
                                Garden Supply, P.O. Box 585, Saint
                                Joseph, MO 64502.
239..........................  The Scotts Company, D/B/A The Ortho
                                Group, P.O. Box 190, Marysville, OH
                                43040.
264..........................  Bayer Cropscience, LP, 2 T.W. Alexander
                                Drive, P.O. Box 12014, Research Triangle
                                Park, NC 27709.
499..........................  Whitmore Micro-Gen Research Laboratories,
                                Inc., Agent: BASF Corporation, 3568 Tree
                                Court Industrial Blvd., St. Louis, MO
                                63122-6682.
538..........................  The Scotts Company, 14111 Scottslawn Rd.,
                                Marysville, OH 43041.
577..........................  Sherwin-Williams Co., 101 Prospect Ave.,
                                Cleveland, OH 44115-1075.
1021.........................  McLaughlin Gormley King Co., D/B/A MGK,
                                8810 Tenth Ave. North, Minneapolis, MN
                                55427-4319.
5481, OR910030, OR910031,      Amvac Chemical Corporation, 4695
 WA050004, WA910050.            MacArthur Court, Suite 1200, Newport
                                Beach, CA 92660-1706.
9779.........................  Winfield Solutions, LLC, P.O. Box 64589,
                                St. Paul, MN 55164-0589.
10163........................  Gowan Company, P.O. Box 5569, Yuma, AZ
                                85366-8844.
10807........................  Amrep, Inc., 990 Industrial Park Dr.,
                                Marietta, GA 30062.
45385........................  CTX-Cenol, Inc., 1393 East Highland Rd.,
                                Twinsburg, OH 44087.
53883........................  Control Solutions, Inc., 5903 Genoa-Red
                                Bluff Rd., Pasadena, TX 77507-1041.
55260........................  Agriphar S.A., Agent: Ceres
                                International, LLC, 1087 Heartsease Dr.,
                                West Chester, PA 19382.
62190........................  Arch Wood Protection, Inc., 5660 New
                                Northside Dr., NW., Suite 1100, Atlanta,
                                GA 30328.
82397, MN070006..............  Tifa International, LLC 109 Stryker Lane,
                                Hillsborough, NJ 08844.
86363........................  Kaizen Technologies, LLC, Agent:
                                Lighthouse Product Services, 1966 W 15th
                                St., Suite 6, Loveland, CO 80538.
------------------------------------------------------------------------

III. Summary of Public Comments Received and Agency Response to
Comments

    The Agency received two comments on the voluntary cancellation
notice but only one merited its further review of the requests. The one
comment the Agency received that merited further review of the requests
was a comment regarding the request for voluntary cancellation of
tralkoxydim registrations. The comment was submitted by Dow
AgroSciences Canada Inc. (DASCI), and requested that, as a result of
DASCI's interests in Canada, the EPA retain the U.S. tolerances that
currently exist for tralkoxydim for import purposes. The comment
submitted by DASCI does not impact the Agency's decision to grant the
request for voluntary cancellation of the tralkoxydim registrations.
EPA is not proposing any tolerance actions for tralkoxydim at this
time. If any tolerance actions are necessary in the future, there will
be an announcement in the Federal Register and there will be a public
comment period on the proposed action. For these reasons, the Agency
does not believe that the comments submitted during the comment period
merit further review or

a denial of the requests for voluntary cancellation.

IV. Cancellation Order

    Pursuant to FIFRA section 6(f), EPA hereby approves the requested
cancellations of the registrations identified in Table 1 of Unit II.
Accordingly, the Agency hereby orders that the product registrations
identified in Table 1 of Unit II. are canceled. The effective date of
the cancellations that are the subject of this notice is September 20,
2013. Any distribution, sale, or use of existing stocks of the products
identified in Table 1 of Unit II., in a manner inconsistent with any of
the provisions for disposition of existing stocks set forth in Unit VI.
will be a violation of FIFRA.

V. What is the agency's authority for taking this action?

    Section 6(f)(1) of FIFRA provides that a registrant of a pesticide
product may at any time request that any of its pesticide registrations
be canceled or amended to terminate one or more uses. FIFRA further
provides that, before acting on the request, EPA must publish a notice
of receipt of any such request in the Federal Register. Thereafter,
following the public comment period, the EPA Administrator may approve
such a request. The notice of receipt for this action was published for
comment in the Federal Register issue of June 12, 2013 (78 FR 35268)
(FRL-9388-5). The comment period closed on July 12, 2013.

VI. Provisions for Disposition of Existing Stocks

    Existing stocks are those stocks of registered pesticide products
which are currently in the United States and which were packaged,
labeled, and released for shipment prior to the effective date of the
cancellation action. The existing stocks provisions for the products
subject to this order are as follows.
    1. For Products<PHONE_NUMBER>4 and<PHONE_NUMBER>0 identified in Table 1
of Unit II.:
    Thereafter, registrants will be prohibited from selling or
distributing the products<PHONE_NUMBER> and<PHONE_NUMBER>0 identified in
Table 1 of Unit II., except for export in accordance with FIFRA section
17, or proper disposal.
    The registrant may continue to sell and distribute the existing
stocks of these products until November 1, 2014. Persons other than the
registrant may sell, distribute, or use existing stocks of these
products until existing stocks are exhausted, provided that such sale,
distribution, or use is consistent with the terms of the previously
approved labeling on, or that accompanied, the cancelled products.
    2. For all other products identified in Table 1 of Unit II.:
    The registrants may continue to sell and distribute existing stocks
of products listed in Table 1 of Unit II., until September 22, 2014,
which is 1 year after the publication of the cancellation order in the
Federal Register. Thereafter, the registrants are prohibited from
selling or distributing products listed in Table 1 of Unit II., except
for export in accordance with FIFRA section 17, or proper disposal.
Persons other than the registrants may sell, distribute, or use
existing stocks of products listed in Table 1 of Unit II., until
existing stocks are exhausted, provided that such sale, distribution,
or use is consistent with the terms of the previously approved labeling
on, or that accompanied, the canceled products.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: September 13, 2013.
 Richard P. Keigwin, Jr.,
Director, Pesticide Re-Evaluation Division, Office of Pesticide
Programs.
[FR Doc. 2013-22847 Filed 9-19-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: June 7, 2006 (Volume 71, Number 109)]
[Notices]
[Page 33021-33022]
[DOCID:fr07jn06-143]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-53910; File No. SR-ISE-2006-22]

Self-Regulatory Organizations; International Securities Exchange,
Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change and Amendment No. 1 Thereto Relating to Fee Changes

May 31, 2006.
    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on April 26, 2006, the International Securities Exchange, Inc.
(``ISE'' or ``Exchange'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I, II, and III below, which Items have been prepared by the ISE.
On May 18, 2006, ISE filed Amendment No. 1 to the proposed rule
change.\3\ The ISE has designated this proposal as one establishing or
changing a due, fee, or other charge imposed by the ISE under section
19(b)(3)(A)(ii) of the Act,\4\ and Rule 19b-4(f)(2) thereunder,\5\
which renders the proposal effective upon filing with the Commission.
The Commission is publishing this notice to solicit comments on the
proposed rule change, as amended, from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Amendment No. 1 made certain clarifying changes to the
purpose section regarding fees charged to non-ISE market makers for
transactions in options on the Premium Products that are the subject
of this filing. These changes did not affect the fees covered by
this filing.
    \4\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \5\ 17 CFR 240.19b-4(f)(2).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The ISE is proposing to amend its Schedule of Fees to establish
fees for transactions in options on two Premium Products.\6\ The text
of the proposed rule change, as amended, is available on the ISE's Web
site (http://www.iseoptions.com/legal/proposed --rule--changes.asp), at

the principal office of the ISE, and at the Commission's Public
Reference Room.
---------------------------------------------------------------------------

    \6\ ``Premium Products'' is defined in the ISE's Schedule of
Fees as the products enumerated therein. The Exchange represents
that the Premium Products that are the subject of this proposed rule
change, iShares S&P 500 Index Fund and iShares MSCI Hong Kong Index
Fund, constitute ``Fund Shares,'' as defined by ISE Rule 502(h).
---------------------------------------------------------------------------

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 ISE 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 ISE has prepared summaries, set forth in Sections A,
B, and C below, of the most significant aspects of such statements.

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

1. Purpose
    The Exchange is proposing to amend its Schedule of Fees to
establish fees for transactions in options on the following two Premium
Products: iShares S&P 500 Index Fund (``IVV'') \7\ and iShares MSCI
Hong Kong Index Fund (``EWH'').\8\ Specifically, the Exchange is
proposing to adopt an execution fee and a comparison fee for all
transactions in options on IVV and EWH.\9\ The amount of the execution
fee and comparison fee for products covered by this filing shall be
$0.15 and $0.03 per contract, respectively, for all Public Customer
Orders \10\ and Firm Proprietary orders. The amount of the execution
fee and comparison fee for all ISE Market Maker transactions and all
non-ISE Market Maker transactions shall be equal to the execution fee
and comparison fee currently charged by the Exchange for ISE Market
Maker transactions and non-ISE Market Maker transactions in equity
options.\11\ All of the applicable fees covered by this filing are
identical to fees charged by the Exchange for all other Premium
Products. The Exchange believes the proposed rule change will further
the Exchange's goal of

introducing new products to the marketplace that are competitively
priced.
---------------------------------------------------------------------------

    \7\ iShares[supreg] is a registered trademark of Barclays Global
Investors, N.A. (``BGI''), a wholly owned subsidiary of Barclays
Bank PLC. ``Standard & Poor's[supreg],'' ``S&P[supreg],'' ``S&P
500[supreg],'' are trademarks of The McGraw-Hill Companies, Inc.
(``McGraw-Hill''), and have been licensed for use for certain
purposes by BGI. IVV is not sponsored, sold or endorsed by Standard
& Poor's, (``S&P''), a division of McGraw-Hill, and S&P makes no
representation regarding the advisability of investing in IVV. BGI,
McGraw-Hill and S&P have not licensed or authorized ISE to (i)
engage in the creation, listing, provision of a market for trading,
marketing, and promotion of options on IVV or (ii) to use and refer
to any of their trademarks or service marks in connection with the
listing, provision of a market for trading, marketing, and promotion
of options on IVV or with making disclosures concerning options on
IVV under any applicable federal or state laws, rules or
regulations. BGI, McGraw-Hill and S&P do not sponsor, endorse, or
promote such activity by ISE and are not affiliated in any manner
with ISE.
    \8\ iShares[supreg] is a registered trademark of BGI, a wholly
owned subsidiary of Barclays Bank PLC. ``MSCI Hong Kong Index'' is a
service mark of Morgan Stanley Capital International (``MSCI'') and
has been licensed for use for certain purposes by BGI. All other
trademarks and service marks are the property of their respective
owners. EWH is not sponsored, endorsed, issued, sold or promoted by
MSCI. BGI and MSCI have not licensed or authorized ISE to (i) engage
in the creation, listing, provision of a market for trading,
marketing, and promotion of options on EWH or (ii) to use and refer
to any of their trademarks or service marks in connection with the
listing, provision of a market for trading, marketing, and promotion
of options on EWH or with making disclosures concerning options on
EWH under any applicable federal or state laws, rules or
regulations. BGI and MSCI do not sponsor, endorse, or promote such
activity by ISE, and are not affiliated in any manner with ISE.
    \9\ The Exchange represents that these fees will be charged only
to Exchange members. Under a pilot program that is set to expire on
July 31, 2006, these fees will also be charged to Linkage Orders (as
defined in ISE Rule 1900).
    \10\ Public Customer Order is defined in ISE Rule 100(a)(33) as
an order for the account of a Public Customer. Public Customer is
defined in ISE Rule 100(a)(32) as a person that is not a broker or
dealer in securities.
    \11\ Telephone conversation between Samir Patel, Assistant
General Counsel, ISE, and Richard Holley III, Special Counsel,
Division of Market Regulation, Commission, on May 31, 2006.
---------------------------------------------------------------------------

    Additionally, the Exchange proposes to remove SWH (Software HOLDRS)
from the list of Premium Products on the Schedule of Fees. SWH has been
delisted from ISE and no longer trades on the Exchange.
2. Statutory Basis
    The Exchange believes that the basis under the Act for this
proposed rule change is the requirement under section 6(b)(4) of the
Act \12\ that an exchange have an equitable allocation of reasonable
dues, fees and other charges among its members and other persons using
its facilities.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

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

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

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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

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

    Because the foregoing rule change, as amended, establishes or
changes a due, fee, or other charge imposed by the Exchange, it has
become effective pursuant to section 19(b)(3) of the Act \13\ and Rule
19b-4(f)(2) \14\ thereunder. At any time within 60 days of the filing
of such amended proposed rule change, the Commission may summarily
abrogate such rule change if it appears to the Commission that such
action is necessary or appropriate in the public interest, for the
protection of investors, or otherwise in furtherance of the purposes of
the Act. \15\
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78s(b)(3)(A).
    \14\ 17 CFR 19b-4(f)(2).
    \15\ The effective date of the original proposed rule is April
26, 2006. The effective date of Amendment No. 1 is May 18, 2006. For
purposes of calculating the 60-day period within which the
Commission may summarily abrogate the proposed rule change under
section 19(b)(3)(C) of the Act, the Commission considers the period
to commence on May 18, 2006, the date on which the ISE submitted
Amendment No. 1. See 15 U.S.C. 78s(b)(3)(C).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change, as amended, 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 No. SR-ISE-2006-22 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-ISE-2006-22. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all

written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room. Copies of such
filing also will be available for inspection and copying at the
principal office of the ISE. 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-ISE-2006-22 and should be submitted on or before June
28, 2006.
---------------------------------------------------------------------------

    \16\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\16\
J. Lynn Taylor,
Assistant Secretary.
[FR Doc. E6-8806 Filed 6-6-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 78, Number 219 (Wednesday, November 13, 2013)]
[Notices]
[Pages 68077-68079]
[FR Doc No: 2013-27014]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2013-0194]

Navigation Safety Advisory Council

AGENCY: United States Coast Guard, DHS.

ACTION: Notice of Federal Advisory Committee Meeting.

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SUMMARY: The Navigation Safety Advisory Council (NAVSAC) will meet
December 3-4, 2013, in Portsmouth, Virginia to discuss matters relating
to maritime collisions, rammings, groundings; Inland and International
Rules of the Road; navigation regulations and equipment; routing
measures; marine information; diving safety; and aids to navigation
systems. The meeting will be open to the public.

DATES: NAVSAC will meet Tuesday, December 3, 2013, from 8 a.m. to 5
p.m., and Wednesday, December 4, 2013, from 8 a.m. to 1 p.m. Please
note that the meeting may close early if the Council has completed its
business. Written comments are due by November 26, 2013.

ADDRESSES: The meeting will be held at the Renaissance Portsmouth Hotel
and Convention Center, 425 Waters Street, Portsmouth, Virginia 23704.
For information on facilities or services for individuals with
disabilities or to request special assistance at the meeting, contact
Mr. Burt Lahn listed in the FOR FURTHER INFORMATION CONTACT section
below as soon as possible.
    To facilitate public participation, we are inviting public comment
on the issues to be considered by the council prior to the formulation
of recommendations as listed in the ``Agenda'' section below.
    You may submit written comments no later than November 26, 2013,
and must

be identified by USCG-2013-0194 using one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments (preferred method to
avoid delays in processing). Simply enter ``USCG-2013-0194'' in the
``SEARCH'' field, click on , then click on  next
to the Meeting Announcement.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Management Facility (M-30), U.S. Department
of Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE. Washington, DC 20590-0001.
     Hand Delivery: Same as mail address above, between 9 a.m.
and 5 p.m., Monday through Friday, except Federal holidays. The
telephone number is<PHONE_NUMBER>.
    Instructions: All submissions received must include the words
``Department of Homeland Security'' and the docket number for this
action. Comments received will be posted without alteration at http://www.regulations.gov, including any personal information provided. You
may review a Privacy Act notice regarding our public dockets in the
January 17, 2008, issue of the Federal Register (73 FR 3316).
    Docket: For access to the docket to read documents or comments
related to this notice, go to http://www.regulations.gov. Simply enter
``USCG-2013-0194'' in the ``SEARCH'' field, click on , click on
 next to the Meeting Announcement, then click on
the title of any comment you wish to review.

A public comment period will be held during the meeting on December 3,
2013, from 3:00 p.m. to 4:00 p.m. and December 4, 2013, from 11:00 a.m.
until the close of the meeting. Public presentations may also be given.
Speakers are requested to limit their presentation and comments to 10
minutes. Please note that the public comment period may end before the
time indicated, following the last call for comments. To register as a
speaker, contact Mr. Burt Lahn listed in the FOR FURTHER INFORMATION
CONTACT section below.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
meeting, please contact Mr. Mike Sollosi, the NAVSAC Alternate
Designated Federal Officer (ADFO), by telephone at<PHONE_NUMBER> or via
email at<EMAIL_ADDRESS>or Mr. Burt Lahn, NAVSAC meeting
coordinator, at telephone<PHONE_NUMBER> or email<EMAIL_ADDRESS>
If you have questions on viewing or submitting material to the docket,
call Barbara Hairston, Program Manager, Docket Operations, telephone
202-366-9826.

SUPPLEMENTARY INFORMATION: Notice of this meeting is given under the
Federal Advisory Committee Act (FACA), 5 U.S.C. Appendix (Pub. L. 92-
463).
    The NAVSAC is an advisory council authorized by 33 U.S.C. 2073 and
chartered under the provisions of the FACA. NAVSAC provides advice and
recommendations to the Secretary of Homeland Security, through the
Commandant of the U.S. Coast Guard, on matters relating to prevention
of maritime collisions, rammings, and groundings; Inland and
International Rules of the Road; navigation regulations and equipment;
routing measures; marine information; diving safety; and aids to
navigation systems.
    The meeting will be held at the Renaissance Portsmouth Hotel and
Convention Center, 425 Waters Street, Portsmouth, Virginia 23704.
https://maps.google.com/maps?f=q&source=s_q&hl=en&geocode=&q=425+water+st+portsmouth+va&aq=&vps=1&jsv=466g&sll=37.857507,95.625&sspn=36.699081,78.837891&vpsrc=3&t=h&ie=UTF8&ct=clnk&cd=1&spell=1.
    Agenda: The NAVSAC will meet to review, discuss and formulate
recommendations on the following topics:

Tuesday, December 3, 2013

    (1) Risk assessment updates. At the April 2013 Council meeting the
Coast Guard provided an overview of ongoing risk assessments for
several U.S. ports/waterways. The Council will receive an updated brief
on the status of the risk assessments and the progress made since the
April 2013 meeting.
    (2) E-Navigation Strategy. The Council will receive an updated
brief on activities of the Committee on the Marine Transportation
System, and progress made on the development of the National E-
Navigation Strategy.
    (3) Atlantic Coast Ports Access Route Study (ACPARS).
    The Council will receive an update on the ACPARS undertaken to
accommodate offshore wind energy development. The update will include a
presentation on what activities are currently in progress, and those
expected to commence in calendar year 2014.
    (4) Navigation Rules Regulatory Project. The Council will receive
an update on the Coast Guard's progress toward implementing NAVSAC
proposed changes to the Inland Navigation Rules.
    (5) Electronic Charts and Publications. The Council will receive an
update on recent changes announced by the National Oceanic and
Atmospheric Administration, Office of Coast Survey, to the printing and
distribution of paper nautical charts and publications.
    Following the above presentations, the Council will form working
groups to discuss and provide recommendations on the following tasks as
appropriate:
    (1) NAVSAC Task 12-03--Unmanned vehicles/vessels (UV). The Council
was asked to review current UV standards of operation, consider whether
the latest generation of these vessels should employ AIS, and propose
additional rules/standards of operation for both unmanned underwater
vehicles, and unmanned surface vessels. NAVSAC previously discussed
this task at both the November 2012 meeting and the April 2013 meeting.
At the conclusion of the April 2013 meeting NAVSAC agreed to continue
discussions and deliberations at the fall 2013 meeting. The Council
will be asked to continue discussions on this task and provide a
Resolution that includes recommendations for rules/standards of
operation for unmanned surface vessels.
    (2) NAVSAC Task 13-02--Discussion of vessel crossing situations
outlined in the Inland Navigation Rules, 33 CFR 83.15(b). The Council
will be asked to begin discussions and provide recommendations on
amending Rule 15(b), including what impacts any proposed amendments may
have on vessels crossing situations on the western rivers system.
    (3) NAVSAC Task 13-03--Continued use of Dayshapes to indicate
status. The Council will be asked to begin discussions and provide
recommendations on the continued display of Dayshapes for vessels as
required by 33 CFR subpart C of the Inland Navigation Rules.
    Public comments or questions will be taken during the meeting after
the Council discusses each issue and prior to the Council formulating
recommendations on each issue. There will also be a public comment
period at the end of the meeting.

Wednesday, December 4, 2013

    (1) Working Group Discussions continued from December 3, 2013.
    (2) Working Group Reports presented to the Council.
    (3) New Business:
    a. Summary of NAVSAC Action Items.
    b. Schedule Next Meeting Date--Spring 2014.

    c. Council discussions and summary of new tasks and pending action
items.
    A public comment period will be held after the discussion of new
tasks. Speakers' comments are limited to 10 minutes each. Public
comments or questions may also be taken during the discussion and
recommendations, and new business portions of the meeting.

    Dated: November 5, 2013.
G.C. Rasicot,
Director, Marine Transportation Systems, U.S. Coast Guard.
[FR Doc. 2013-27014 Filed 11-12-13; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: May 30, 2008 (Volume 73, Number 105)]
[Notices]
[Page 31123-31127]
[DOCID:fr30my08-57]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2000-P-0924] (Formerly Docket No. 2000P-1533)

Cardiovascular Devices; Reclassification of Certain Percutaneous
Transluminal Coronary Angioplasty Catheters

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of panel recommendation.

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

SUMMARY: The Food and Drug Administration (FDA) is issuing for public
comment the recommendation of the Circulatory System Devices Panel (the
Panel) to reclassify Percutaneous Transluminal Coronary Angioplasty
(PTCA) catheters, other than cutting/scoring PTCA catheters, from class
III (premarket approval) to class II (special controls). The Panel made
this recommendation after reviewing the reclassification petition
submitted by Cook Group Inc. (COOK) and other publicly available
information. FDA is also announcing for public comment its tentative
findings based on the Panel's recommendation and other publicly
available information. After considering any public comments on the
Panel's recommendation and FDA's tentative findings, FDA will approve
or deny the reclassification petition by order in the form of a letter
to the petitioner. FDA's decision on the reclassification petition will
be announced in the Federal Register. Elsewhere in this issue of the
Federal Register, FDA is announcing the availability of the draft
guidance document that FDA intends will serve as the special control
for this device type, if it is reclassified.

DATES: Submit written or electronic comments by August 28, 2008.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2000-
P-0924, 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 document. 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 ``Request for 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: Kathryn O'Callaghan or Suzanne Kaiser,
Center for Devices and Radiological Health (HFZ-450), Food and Drug
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-
4222.

SUPPLEMENTARY INFORMATION:

I. Background (Regulatory Authorities)

    The Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301
et seq.), as amended by the Medical Device Amendments of 1976 (the 1976
amendments) (Public Law 94-295), the Safe Medical Devices Act of 1990
(the SMDA) (Public Law 101-629), and the Food and Drug Administration
Modernization Act of 1997 (FDAMA) (Public Law 105-115), 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).
    Devices that were not in commercial distribution prior to May 28,
1976, are generally referred to as postamendments devices, and are
classified automatically by statute (section 513(f) of the act) into
class III without any FDA rulemaking process. Those devices remain in
class III and require premarket approval, unless and until the device
is reclassified into class I or II or 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
predicate devices by means of premarket notification procedures in
section 510(k) of the act (21 U.S.C. 360(k)) and part 807 of the
regulations (21 CFR part 807).
    Section 513(f)(3) of the act, as amended by FDAMA, provides that
FDA may initiate the reclassification of a device classified into class
III under section 513(f)(1) of the act, or the manufacturer or importer
of a device may petition the Secretary for the issuance of an order
classifying the device in class I or class II. FDA's regulations in 21
CFR 860.134 set forth the procedures for a petition for
reclassification of such class III devices. In order to change the
classification of the device, it is necessary that the proposed new
class have sufficient regulatory controls to provide reasonable
assurance of the safety and effectiveness of the device for its
intended use.
    Under section 513(f)(3)(B)(i) of the act, the Secretary may, for
good cause shown, refer a petition to a device classification panel.
The Panel shall make a recommendation to the Secretary respecting
approval or denial of the petition. Any such recommendation shall
contain (1) a summary of the reasons for the recommendation, (2) a
summary of the data upon which the recommendation is based, and (3) an
identification of the risks to health (if any) presented by the device
with respect to which the petition was filed.

II. Regulatory History of the Device

    The PTCA catheter is a postamendments device classified into class
III under section 513(f)(1) of the act. Therefore, the device cannot be
placed in commercial distribution unless it is subject to an approved
premarket approval application (PMA) under section 515 of the act (21
U.S.C. 360e) or is reclassified.
    On September 21, 2000, FDA filed a petition submitted under section
513(f)(3) of the act from COOK requesting reclassification of PTCA
catheters from class III into class II (Ref. 1). This reclassification
petition did not include cutting or scoring PTCA catheters. In order to
reclassify the PTCA catheter into class II, it is necessary that the
proposed class have sufficient regulatory controls to provide
reasonable assurance of safety and effectiveness of the device for its
intended use.
    The COOK petition requests reclassification of PTCA catheters from
class III to class II when indicated for balloon dilatation of a
hemodynamically significant coronary artery or bypass graft stenosis in
patients evidencing coronary ischemia for the purpose of improving
myocardial perfusion. Consistent with the act and the regulation, FDA
referred the petition to the Panel for its recommendation on the
requested changes in classification. FDA also asked the Panel for its
recommendation on the reclassification of PTCA catheters when used for
treatment of acute myocardial infarction (MI), treatment of in-stent
restenosis (ISR) and/or post-deployment stent expansion.

III. Device Description

    The following device description for the PTCA catheter recommended
for reclassification from III to II is based on the Panel's
recommendations and the agency's review. The PTCA catheter is a device
that operates on the principle of hydraulic pressurization applied
through an inflatable balloon attached to the distal end. A PTCA
balloon catheter has a single or double lumen shaft. The catheter
features a balloon of appropriate compliance for the clinical
application, constructed from a polymer. The balloon is designed to
uniformly expand to a specified diameter and length at a specific
pressure as labeled, with well characterized rates of inflation and
deflation and a defined burst pressure. The device generally features a
type of radiographic marker to facilitate fluoroscopic visualization of
the balloon during use. A PTCA catheter is intended for balloon
dilatation of a hemodynamically significant coronary artery or bypass
graft stenosis in patients evidencing coronary ischemia for the purpose
of improving myocardial perfusion. A PTCA catheter may also be intended
for the treatment of acute myocardial infarction; treatment of in-stent
restenosis (ISR) and/or post-deployment stent expansion.
    This notice of panel recommendation does not include cutting/
scoring PTCA catheters. A cutting/scoring PTCA catheter is a balloon-
tipped catheter with cutting/scoring elements attached, which is used
in those circumstances where a high pressure balloon resistant lesion
is encountered. A cutting/scoring PTCA catheter is intended for the
treatment of hemodynamically significant coronary artery stenosis for
the purpose of improving myocardial perfusion. A cutting/scoring PTCA
catheter may also be indicated for use in complex type C lesions or for
the treatment of in-stent restenosis.

IV. Recommendation of the Panel

    At a public meeting on December 4, 2000, the Panel recommended
(seven to one) that PTCA catheters be reclassified from class III to
class II, when indicated for balloon dilatation of a hemodynamically
significant coronary artery or bypass graft stenosis in patients
evidencing coronary ischemia for the purpose of improving myocardial
perfusion; or for treatment of acute myocardial infarction. The Panel
recommended a guidance document, labeling, and postmarket surveillance
as special controls. The Panel stated that the special controls will
diminish some of the risks to health associated with certain PTCA
catheters. The guidance document and labeling controls are intended to
ensure the appropriate performance and use of the device by physicians.
The Panel recommended postmarket surveillance as a special control to
confirm that the other special controls being applied to these devices
would be sufficient to ensure that there would not be an increase in
adverse consequences to patients. In summary, the Panel believed that
class II with special controls would provide reasonable assurance of
the safety and effectiveness of the device.

V. Risks to Health

    After considering the information discussed by the Panel during the
December 4, 2000, meeting and other publicly available information
(Refs. 2 and 3), FDA believes that certain PTCA catheters should be
reclassified into class II because special controls, in addition to
general controls, can provide reasonable assurance of the safety and
effectiveness of the device, and there is sufficient information to
establish special controls to provide such assurance. Based on the
information in the petition, the Panel's deliberations, the published
literature, and medical device reports, FDA has identified the
following risks to health are associated with the use of PTCA
catheters: Adverse tissue reaction, device failure, adverse interaction
with other devices, user error, vessel damage, and infection. The draft
guidance document entitled ``Class II Special Controls Guidance
Document for Certain Percutaneous Transluminal Coronary Angioplasty
(PTCA) Catheters'' aids in mitigating the risks through recommendations
on biocompatibility, performance and animal testing, clinical
information, sterilization, shelf life, and labeling.

A. Adverse Tissue Reaction

    Materials used to manufacture PTCA catheters may cause adverse
tissue reactions in the patient, such as localized cell death,
irritation, hemolysis, complement activation, thrombus formation, and
febrile reactions.

B. Device Failure

    Balloon burst or rupture can be caused by over-inflation of the
balloon during the procedure, use of a defective balloon, improper
balloon sizing, the use of improper balloon inflation medium, or tissue
calcification. PTCA catheter shaft breakage can be caused by failure of
the manufacturing bonds or by use of excessive force during the
procedure. Device failure may lead to reaction to contrast agent,
vessel damage, air embolism, stroke, aneurysm formation, need for
emergency bypass surgery or death.

C. Adverse Interaction with Other Devices

    PTCA catheters are used with accessory devices such as introducers,
guiding catheters, and guidewires. Use with incompatible devices may
result in a failed PTCA procedure and adverse clinical consequences.
Guidewire entrapment or fragmentation by a PTCA catheter may lead to
vessel damage, acute MI, unstable angina, coronary artery spasm, or
arrhythmias, and is usually caused by excessive tortuosity of the
coronary vessels or a complex coronary vascular anatomy.

D. User Error

    Operator inexperience and improper use of the device are common
contributors to failed PTCA procedures. Examples of improper use
include over-inflation of the balloon, improper balloon sizing,
excessively slow deflation of the balloon, use of excessive force
during the procedure, and improper balloon delivery or retraction.
    During a PTCA procedure it is possible that air embolization may
occur as a result of incomplete aspiration of the guiding catheter,
balloon rupture, or insinuation of air with the PTCA catheter during
insertion or withdrawal. Air embolization may cause a stroke.
    The risk of vascular access site complications, including
hematomas, arteriovenous (A-V) fistulas, infections, and
pseudoaneurysms may be the result of the use of excessive force during
the procedure, difficulty placing the device, inadequate treatment of
the access site following the procedure, puncture of an adjacent artery
and vein, or inadequate aseptic techniques.

E. Vessel Damage

    Injury to the coronary vessel wall, resulting in dissection,
perforation, or rupture, is a risk that can occur with any PTCA
procedure. Vessel damage may be caused by balloon rupture or burst,
perforation or rupture of the vessel with an accessory device (e.g.,
guidewire or catheter), inappropriate balloon sizing, and expansion of
an intramural hematoma. Vessel damage may lead to acute vessel closure,
acute MI, unstable angina, coronary artery spasm, embolization or
fragmentation of thrombotic or atherosclerotic material, or aneurysm
formation.

F. Infection

    Infection may be caused by contamination of the device prior to use
or inadequate aseptic techniques.

VI. Summary of the Reasons for the Recommendation

    After considering the data and information contained in the
petition and provided by FDA, the open discussion during the Panel
meeting, and their knowledge of and clinical experience with the
device, the Panel gave the following reasons in support of its
recommendation to reclassify PTCA catheters from class III to class II,
except when indicated for the treatment of in-stent restenosis and/or
post-deployment stent expansion. The Panel believed that the devices
should be reclassified 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.
    The Panel recommended that PTCA catheters for the treatment of in-
stent restenosis and/or post-deployment stent expansion not be included
because of a lack of sufficient information about this use. Since the
Panel meeting, however, additional data regarding this use have become
available and have been reviewed by the agency (see section IX of this
document, FDA's Findings).

VII. Summary of Data Upon Which the Panel Recommendation is Based

    Based on the information discussed during the on December 4, 2000,
Panel meeting, information presented in the reclassification petition,
published literature, and medical device reports, the Panel believes
there is reasonable knowledge of the benefits of the device. PTCA
catheters provide a minimally invasive means of treating coronary
artery disease and may be a less traumatic alternative to coronary
artery bypass surgery in some patients.

VIII. Special Controls

    In addition to general controls, FDA believes that the draft
guidance entitled ``Class II Special Controls Guidance Document for
Certain Percutaneous Transluminal Coronary Angioplasty (PTCA)
Catheters,'' along with general controls, would address the risks to
health associated with the use of the device described in section V of
this document. The draft class II special controls guidance document
references voluntary consensus standards and describes testing and
labeling recommendations intended to address the Panel's concerns.
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 intends to use as the special control for this
device type.
    The draft class II special controls guidance document contains
specific recommendations with regard to device performance testing and
other information that FDA believes should be included in premarket
(510(k)) notification submissions for PTCA catheters. Particular
sections of the draft guidance document address the following topics:
Biocompatibility testing, performance testing, animal testing, clinical
information, labeling, sterilization, and sterilization and shelf life.

    In Table 1 of this document, FDA has identified the risks to health
associated with the use of the device in the first column and the
recommended mitigation measures identified in the class II special
controls guidance document in the second column. These recommendations
will also help ensure that the device has appropriate performance
characteristics and labeling for its use.
    Following the effective date of any final reclassification rule
based on this proposal, any firm submitting a 510(k) submission for a
PTCA catheter will need to address the issues covered in the class II
special controls guidance document. However, the firm need only show
that its device meets the recommendations of the class II special
controls guidance document or in some other way provides equivalent
assurances of safety and effectiveness.

                                Table 1.
------------------------------------------------------------------------
       Identified Risk              Recommended Mitigation Measures
------------------------------------------------------------------------
Adverse Tissue Reaction        Biocompatibility Testing
------------------------------------------------------------------------
Device Failure                 Performance Testing
                               Sterilization and Shelf Life
------------------------------------------------------------------------
Adverse Interaction With       Performance Testing
 Other Devices                 Animal Testing
------------------------------------------------------------------------
User Error                     Animal Testing
                               Clinical Information
                               Labeling
------------------------------------------------------------------------
Vessel Damage                  Animal Testing
                               Clinical Information
------------------------------------------------------------------------
Infection                      Sterilization and Shelf Life
------------------------------------------------------------------------

IX. FDA's Findings

    The Panel and FDA believe that PTCA catheters, other than cutting/
scoring PTCA catheters, should be reclassified from class III 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.
    The Panel recommended a guidance document, labeling, and postmarket
surveillance as special controls. Although the Panel included the
possibility of requiring postmarket surveillance in their
recommendation, FDA does not believe that specific postmarket
surveillance such as device tracking or postapproval studies are needed
for PTCA catheters. FDA believes that periodic assessment of adverse
event reports through medical device reporting submitted to the agency
is sufficient to address adverse effects caused by these devices and is
the least burdensome way to gather this data for PTCA catheters. This
practice is consistent with the manner in which these devices have been
regulated as class III devices since the Panel meeting.
    Further, after a review of adverse event reports submitted to FDA's
Manufacturer and User Facility Device Experience (MAUDE) Database (Ref.
3), the agency believes that the types of risks associated with the use
of PTCA catheters for the treatment of in-stent restenosis and/or post-
deployment stent expansion are similar enough to the risks associated
with treatment of de novo lesions, such that the special controls
discussed at the Panel meeting, with the addition of recommendations
for specific nonclinical performance testing and the recommendation
that in-stent restenosis patients be included in the clinical
evaluation, when necessary, are adequate to control the risks to health
for these devices.

X. References

    The following references have been placed on display in the Dockets
Management Branch (see ADDRESSES) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday:
    1. Petition for Reclassification of Percutaneous Transluminal
Coronary Angioplasty (PTCA) Catheters submitted by COOK, Inc.,
Lafeyette, IN, received September 12, 2000.
    2. Transcript of the Circulatory System Devices Panel Meeting,
December 4, 2000, vol. I, pp. 1-282.
    3. FDA's Manufacturer and User Facility Device Experience
(MAUDE) Database is publicly accessible at http://
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Search.cfm. Enter
product code LOX to search for reports regarding PTCA catheters.

XI. Environmental Impact

    The agency has determined under 21 CFR 25.34(b) that this
reclassification 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.

XII. Analysis of Impacts

    FDA has examined the impacts of the reclassification action 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 reclassification action 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. Because reclassification of the device from class
III to class II will relieve all manufacturers of the device of the
cost of complying with the premarket approval requirements in section
515 of the act, the agency certifies that this reclassification action
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 $127 million, using the most current (2006) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
reclassification action to result in any 1-year expenditure that would
meet or exceed this amount.

XIII. Federalism

    FDA has analyzed this reclassification action in accordance with
the principles set forth in Executive Order 13132. FDA has determined
that the reclassification action does not contain policies that have
substantial direct effects 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.
Accordingly, the agency has concluded that the reclassification action
does not contain policies that have federalism implications as defined
in the Executive order and, consequently, a federalism summary impact
statement is not required.

XIV. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this reclassification action
contains no

collections of information. Therefore, clearance by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(the PRA) (44 U.S.C. 3501-3520) is not required.
    FDA also tentatively concludes that the draft special control
guidance document does not contain new information collection
provisions that are subject to review and clearance by OMB under the
PRA. Elsewhere in this issue of the Federal Register, FDA is publishing
a notice announcing the availability of the draft guidance document
entitled ``Class II Special Controls Guidance Document for Certain
Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters;'' the
notice contains an analysis of the paperwork burden for the draft
guidance.

XV. Request for 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 name of the device and 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
through FDMS only at http://www.regulations.gov.

    Dated: May 21, 2008.
Daniel G. Schultz,
Director, Center for Devices and Radiological Health.
[FR Doc. E8-12079 Filed 5-29-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register: October 2, 2008 (Volume 73, Number 192)]
[Notices]
[Page 57399-57401]
[DOCID:fr02oc08-125]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-58647; File No. SR-NYSEArca-2008-99]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change Relating to the
ProShares Trust II

September 25, 2008.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Exchange Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby
given that on September 18, 2008, NYSE Arca, Inc. (``NYSE Arca'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change described in Items I and II
below, which Items have been prepared by the Exchange. The Commission
is publishing this notice to solicit comments on the proposed rule
change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

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

    Pursuant to the provisions of Section 19(b)(1) of the Exchange
Act,\3\ NYSE Arca, through its wholly-owned subsidiary NYSE Arca
Equities, Inc. (``NYSE Arca Equities''), is submitting this proposed
rule change in connection with the listing and trading on the Exchange
of shares (``Shares'') of fourteen (14) funds (``Funds'') of ProShares
Trust II (formerly known as Commodities & Currency Trust) (``Trust'')
based on several currencies, commodities and commodities indexes,
relating to the names of the Trust and the Funds, the Funds' Web site
disclosure relating to the availability of information regarding the
Shares, and the expected price of the Shares at commencement of
trading. The text of the proposed rule change is available on the
Exchange's Web site at www.nyse.com, at the Exchange's principal office
and at the Commission's Public Reference Room.
---------------------------------------------------------------------------

    \3\ 15 U.S.C. 78s(b)(1).
---------------------------------------------------------------------------

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 self-regulatory organization
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 parts of such statements.

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

1. Purpose
    The Commission has approved the listing of the Shares on the
Exchange pursuant to Section 19(b)(2) \4\ of the Exchange Act. The
Exchange intends to list and trade the Shares pursuant to NYSE Arca
Equities Rule 8.200, Commentary .02, which permits the trading of Trust
Issued Receipts (``TIRs'') either by listing or pursuant to unlisted
trading privileges (``UTP'').\5\ The Commission previously approved the
Shares for listing on the American Stock Exchange LLC (``Amex'') \6\
and for trading on the Exchange pursuant to UTP.\7\ The Exchange is
filing this proposal to reflect changes to the names of the Trust and
the Funds, to clarify the Funds' Web site disclosure relating to the
availability of information regarding the Shares, and to correct a
representation in the NYSE Arca Order regarding the expected price of
the Shares at commencement of trading. Additional information regarding
the Funds and the Trust is included in the NYSE Arca Order and the Amex
Order.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78(s)(b)(2).
    \5\ See Securities Exchange Act Release No. 58457 (September 3,
2008), 73 FR 52711 (September 10, 2008) (SR-NYSEArca-2008-91)
(``NYSE Arca Order'').
    \6\ See Securities Exchange Act Release No. 58161 (July 15,
2008), 73 42380 (July 21, 2008) (SR-Amex-2008-39). Notice of the
Amex proposed rule change was published in Securities Exchange Act
Release No. 57932 (June 5, 2008), 73 FR 33467 (June 12, 2008)
(``Amex Order'')
    \7\ See Securities Exchange Act Release No. 58162 (July 15,
2008), 73 FR 42391 (July 21, 2008) (SR-NYSEArca-2008-73).
---------------------------------------------------------------------------

    In the NYSE Arca Order, the Commission approved listing on the
Exchange of the following Funds of the Trust (formerly known as
Commodities & Currency Trust): (1) Ultra DJ-AIG Commodity ProShares,
(2) UltraShort DJ-AIG Commodity ProShares, (3) Ultra DJ-AIG Agriculture
ProShares, (4) UltraShort DJ-AIG Agriculture ProShares, (5) Ultra DJ-
AIG Crude Oil ProShares, (6) UltraShort DJAIG Crude Oil ProShares, (7)
Ultra Gold ProShares, (8) UltraShort Gold ProShares, (9) Ultra Silver
ProShares, (10) UltraShort Silver ProShares, (11) Ultra Euro ProShares,
(12) UltraShort Euro ProShares, (13) Ultra Yen ProShares and (14)
UltraShort Yen ProShares. The Trust has advised

the Exchange that the Trust intends to rebrand the Funds as follows:
(1) ProShares Ultra DJ-AIG Commodity, (2) ProShares UltraShort DJ-AIG
Commodity, (3) ProShares Ultra DJ-AIG Agriculture, (4) ProShares
UltraShort DJ-AIG Agriculture, (5) ProShares Ultra DJ-AIG Crude Oil,
(6) ProShares UltraShort DJAIG Crude Oil, (7) ProShares Ultra Gold, (8)
ProShares UltraShort Gold, (9) ProShares Ultra Silver, (10) ProShares
UltraShort Silver, (11) ProShares Ultra Euro, (12) ProShares UltraShort
Euro, (13) ProShares Ultra Yen and (14) ProShares UltraShort Yen.
Availability of Information Regarding the Shares
    To clarify the representations made in the NYSE Arca Order
regarding availability of information, the Web sites for the Funds and/
or the Exchange, which are publicly accessible at no charge, will
contain the following information: (a) The most current NAV per Share;
(b) the reported closing 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 reported closing price against the NAV per Share, within
appropriate ranges for each of the four (4) previous calendar quarters;
(e) the prospectus; and (f) other applicable quantitative information.
    All other information relating to availability of information
regarding the Shares remains as stated in the NYSE Arca Order.
Criteria for Initial and Continued Listing.
    To correct a representation made in the NYSE Arca Order regarding
the criteria for initial and continued listing, the price of the Shares
is expected to be in a range from $20 to $70 per Share at the
commencement of trading on the Exchange. The Shares will not be subject
to an initial offering period as described in the Amex Order and the
NYSE Arca Order and the expected price range does not relate to any
such offering period.
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) \8\ of the
Exchange Act in general and furthers the objectives of Section 6(b)(5)
\9\ in particular in that it is designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, to foster cooperation and coordination with
persons engaged in regulating, clearing, settling, processing
information with respect to, and facilitating transaction in
securities, and, in general to protect investors and the public
interest. The proposal provides clarifying information regarding the
operation of the Funds. The Exchange believes that the proposal will
facilitate the listing and trading of additional types of commodity and
currency-based investments that will enhance competition among market
participants, to the benefit of investors and the marketplace.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

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

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    The Exchange has designated the proposed rule change as one 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 from the date on which it was filed, or such shorter time as the
Commission may designate if consistent with the protection of investors
and the public interest. Therefore, the foregoing proposed rule change
has become effective pursuant to Section 19(b)(3)(A) of the Exchange
Act \10\ and Rule 19b-4(f)(6) thereunder.\11\
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) normally does
not become operative until 30 days after the date of filing.\12\
However, Rule 19b-4(f)(6)(iii) \13\ permits the Commission to designate
a shorter time if such action is consistent with the protection of
investors and the public interest. In view of the immediate nature of
the relief requested, the Exchange seeks to have the proposed
amendments become operative immediately. The Exchange requests that the
Commission waive the 30-day delayed operative date, so that the
proposed rule change may become immediately operative pursuant to
Section 19(b)(3)(A) and Rule 19b-4(f)(6) thereunder. The Exchange
believes that waiver of the 30-day operative delay is consistent with
the protection of investors and the public interest because the
proposed rule change should benefit investors by clarifying information
regarding the names and operation of the Funds. The Commission believes
that waiving the 30-day operative delay is consistent with the
protection of investors and the public interest. The Commission
therefore grants the Exchange's request and designates the proposal to
be operative upon filing.\14\
---------------------------------------------------------------------------

    \12\ Id. In addition, Rule 19b-4(f)(6)(iii) requires a s 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.
    \13\ 17 CFR 240.19b-4(f)(6).
    \14\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Exchange 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 Exchange Act. Comments may be submitted
by any of the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NYSEArca-2008-99 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-NYSEArca-2008-99. 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 the filing also will be available for inspection and
copying at the principal office of the self-regulatory organization.
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-NYSEArca-2008-
99 and should be submitted on or before October 23, 2008.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
---------------------------------------------------------------------------

    \15\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Acting Secretary.
 [FR Doc. E8-23192 Filed 10-1-08; 8:45 am]

BILLING CODE 8011-01-P